ALLOMARON TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

ALLOMARON TABLETS

COMPOSITION:
Each tablet contains:

PHARMACOLOGICAL CLASSIFICATION:
A.3.3. Anti-Gout Preparations.

PHARMACOLOGICAL ACTION:
ALLOMARON is a combination of two active principles, allopurinol and benzbromarone, a xanthine oxidase inhibitor and uricosuric agent, interfering simultaneously in two pathways of the body s handling of uric acid.

INDICATIONS:
ALLOMARONis indicated for the treatment of hyperuricaemia.

CONTRA-INDICATIONS:
ALLOMARON should not be used for the treatment of an acute attack of gout.
Additionally, ALLOMARON therapy should not be initiated for any purpose during an acute attack.
Hypersensitivity to any of the ingredients of the product.
Safety in pregnancy and lactation has not been established.
Contra-indicated in porphyria.

WARNINGS:
Treatment should be stopped if any skin reactions or other signs of hypersensitivity develop. A cautious re-introduction at a lower dose may be attempted when mild skin reactions have cleared. ALLOMARON should not be re-introduced to those patients who have experienced other forms of hypersensitivity reactions.
The metabolism of azathioprine and mercaptopurine is inhibited by allopurinol and their doses should be reduced to one-quarter or one-third of the usual dose when either of them is given with allopurinol.

DOSAGE AND DIRECTIONS FOR USE:
Adults: One tablet daily after breakfast or lunch.
An adequate fluid intake is recommended during ALLOMARON treatment to prevent possible precipitation of urinary urate and oxypurines.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
The most common side-effect of allopurinol is skin rash. Rashes are generally maculopapular or pruritic, but more serious hypersensitivity reactions may occur and include exfoliative rashes, the Stevens-Johnson syndrome and toxic epidermal necrolysis. It is therefore recommended that allopurinol be withdrawn immediately if a rash occurs. Further symptoms of hypersensitivity include fever, chills, leucopenia or leucocytosis, eosinophilia and arthralgia and vasculitis leading to renal and hepatic damage. These hypersensitivity reactions may be severe, even fatal, and patients with hepatic or renal impairment are at special risk.
Hepatotoxicity and signs of altered liver function may be found in patients not exhibiting hypersensitivity.
Many other side-effects, usually of a less of serious nature, have been noted and include peripheral neuritis, alopecia, nausea, vomiting, abdominal pain, diarrhoea, headache, drowsiness and vertigo. In addition to these adverse effects patients may experience an increase in acute gouty attacks during the first few months of treatment. Benzbromarone may cause gastrointestinal side-effects, especially diarrhoea.
It may precipitate an acute attack of gout and renal symptoms of urate deposits.
Special Precautions:
ALLOMARON should be administered with care to patients with renal or hepatic impairment and doses may need to be reduced.
In all patients receiving allopurinol it is advisable to maintain a urinary output of not less than 2 litres per day and for the urine to be neutral or slightly alkaline.
An increase in hypersensitivity reactions, and possibly also other adverse effects, has been reported in patients receiving allopurinol with thiazide diuretics, particularly in patients with impaired renal function. There have also been reports of allopurinol enhancing the activity of, and possibly increasing the toxicity of, a number of other agents including some antibacterials, some anticoagulants, some antineoplastics, captopril, theophylline and vidarabine. A number of drugs increase uric acid concentrations and may require that the dose of allopurinol be adjusted.
Benzbromarone should be used with caution in patients with impaired renal function.
Salicylates antagonise the effect of benzbromarone.
Benzbromarone in doses in excess of those normally used therapeutically, may increase the anticoagulant activity of coumarin oral anticoagulants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions” above.
Treatment is symptomatic and supportive.

IDENTIFICATION:
White, biconvex film-coated tablets, scored on both sides.

PRESENTATION:
Blister packs containing 30 film-coated tablets.

STORAGE INSTRUCTIONS:
Keep dry.
Protect from light and store in a cool place between 15°C and 25°C.
Keep out of reach of children.

CLEARASIL MEDICATED FACIAL CLEANSER

SCHEDULING STATUS
Not scheduled

PROPRIETARY NAME
(and dosage form)

CLEARASIL MEDICATED FACIAL CLEANSER

COMPOSITION
Each 100 mL contains.

PHARMACOLOGICAL ACTION
A 13.1 Antiseptics, disinfectants, cleaning agents

PHARMACOLOGICAL ACTION
A skin cleanser with a mild keratolytic activity

INDICATIONS
Clearasil Medicated Facial Cleanser is indicated for the cleansing of skin of patients with oily skin and acne.

CONTRA-INDICATIONS
Known hypersensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE
Dampen sufficient cotton wool with the lotion and remove excess oil from the forehead, nose and chin. Avoid contact with eyes

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Salicylic Acid is a mild irritant and may cause dermatitis.
Application to large areas of skin and continuous application should not be employed.
For external use only. Keep away from eyes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of accidental ingestion the likely symptoms of intoxication could possibly include symptoms such as dizziness, tinnitus, sweating, nausea and vomiting, mental confusion, hyperventilation, respiratory alkalosis, metabolic acidosis, ketosis and depression of the central nervous system.
In children, serious signs of intoxication may develop rapidly. Consult a doctor or the nearest hospital immediately. Treatment is supportive and symptomatic.

IDENTIFICATION
Blue liquid with a characteristic odour.

PRESENTATION
Bottles of 75 mL and 100 mL

STORAGE INSTRUCTIONS
Store below 25°C. Keep out of reach of children.

GELACID TABLETS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

GELACID TABLETS

COMPOSITION:

PHARMACOLOGICAL CLASSIFICATION:
A 11.4 Antacids

PHARMACOLOGICAL ACTION:
GELACID has antacid and demulcent properties. It decreases acid reflux and increases esophageal clearance of acid. This compound has no demonstrable effect on lower oesophageal sphincter pressure and is not a potent antacid. The alginate component may protect the mucosa and mechanically impair reflux by forming a viscous layer on the surface of the gastric contents.

INDICATIONS:
GELACID tablets is indicated for the relief of gastroesophageal reflux, mild to moderate reflux, oesophagitis, heartburn and dyspepsia.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Obstructive disease of the gastro-intestinal tract, impaired renal function. Heart failure, hypertension, cirrhosis.
Safety in pregnancy and lactation has not been established.

WARNINGS:
Do not use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor. Hypermagnesaemia, aluminium encephalopathy and central nervous system depression with dementia may occur in patients with kidney function failure or gastro-intestinal atony or obstruction. Do not take this medicine if you are presently taking a prescription antibiotic containing any form of tetracycline.

DOSAGE AND DIRECTIONS FOR USE:
GELACID tablets should be chewed thoroughly or broken into pieces and swallowed with water or milk.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
The use of this medication may have the following side-effects:
Magnesium containing antacids may cause gastro-intestinal irritation and watery diarrhoea. Chronic diarrhoea due to long-term use of antacids, may result in electrolyte imbalance. Hypermagnesaemia may occur in patients suffering from impaired renal function. Symptoms of hypermagnesaemia may include loss of deep tendon reflexes and respiratory depression. Other symptoms may include nausea, vomiting, flushing of the skin, drowsiness, confusion, thirst, hypotension, muscle weakness, bradycardia, cardiac arrest and coma.
Aluminium containing antacids may cause constipation. Aluminium encephalopathy and osteomalacia have been associated with aluminium accumulation in patients suffering from renal failure. Excessive doses of aluminium hydroxide or even normal doses in patients on low phosphate diets may lead to phosphate depletion accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia.
Excessive administration of sodium bicarbonate may lead to hyperkalaemia and metabolic acidosis, especially in patients with impaired renal function. Symptoms may include muscle weakness, shortness of breath, tiredness, mood changes and irregular heartbeat. Stomach cramps, belching and flatulence have been reported. Congestive heart failure may occur due to excessive sodium absorption.
Special precautions
Patients suffering from renal impairment should avoid the prolonged and excessive use of antacids. Aluminium containing antacids should be given with caution to patients suffering from chronic renal failure, especially in children. Sodium containing antacids should be administered extremely cautiously to patients with heart failure, oedema, renal impairment, hypertension, eclampsia or aldosteronism.
Interaction
The absorption of tetracyclines, digoxin and oral iron preparations, may be decreased by the concurrent use of magnesium containing antacids. Administration should be separated by a number of hours.
Citrate containing preparations, including many effervescent or dispersible tablets, are best avoided by patients with renal failure, taking aluminium containing antacids.
Sodium containing antacids may increase the renal clearance of acidic drugs such as salicylates and barbiturates.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects and special precautions.
A feeling of abdominal distension may occur with very large doses of GELACID tablets.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Round chewable off-white tablet scored on one side.

PRESENTATION:
20 Tablets packed into a plastic tube.

STORAGE INSTRUCTIONS:
Store in an airtight container below 25°C.
Keep out of reach of children.
Keep well closed.

RAPIFEN® ۲ mL IV injection
RAPIFEN® ۱۰ mL IV injection

SCHEDULING STATUS
Schedule 7.

PROPRIETARY NAME
(and dosage form)

RAPIFEN^® ۲ mL IV injection
RAPIFEN^® ۱۰ mL IV injection

COMPOSITION
Each mL contains alfentanil hydrochloride 0,544 mg (equivalent to alfentanil base 0,50 mg) and sodium chloride 9,0 mg in water for injection.

PHARMACOLOGICAL CLASSIFICATION
A.2.7 Central nervous system depressants. Narcotic analgesics.

PHARMACOLOGICAL ACTION
Pharmacodynamics
RAPIFEN* injection is a narcotic analgesic with a pharmacologic profile similar to that of fentanyl. It differs from fentanyl, however, in that its analgesic potency is four times less than that of fentanyl.
Its depressant effects on the respiratory rate and alveolar ventilation are also shorter than those of fentanyl and in most cases the clinical analgesic effect lasts longer than significant respiratory depression. The onset of action of RAPIFEN* is four times more rapid than that of an equi-analgesic dose of fentanyl; the peak analgesic and respiratory depressant effects occur within 1 minute. The duration of action of RAPIFEN* is three times shorter than that of an equi-analgesic dose of fentanyl but is clearly dose-related.
The onset of the analgesic action of RAPIFEN* is rapid, the peak effect being reached within 1 minute. The duration of action is short, 11 minutes at twice and 17 minutes at four times the lowest ED₅₀.
At high doses (> ۱۲۰ µg/kg), RAPIFEN* induces sleep and can be used as an anaesthetic induction agent. The induction is smooth, pain-free and devoid of cardiovascular and hormonal stress responses to intubation.
Recovery after RAPIFEN* administration is rapid and smooth. All actions of RAPIFEN* are immediately and completely reversed by the specific narcotic antagonist naloxone hydrochloride.
RAPIFEN* maintains cardiovascular stability. RAPIFEN* has not been shown to cause histamine release (in doses used clinically).
Pharmacokinetics
RAPIFEN* has a low degree of ionisation (11% at pH = 7,4) which significantly contributes to a rapid distribution. Tissue distribution is limited : the total distribution volume varies from 0,4 to 1,0 L/kg. RAPIFEN*’s limited liposolubility and strong plasma protein binding (92%) contribute to its limited volume of distribution.
RAPIFEN* is metabolised mainly in the liver. Only 1% of the active substance is found unaltered in the urine. The plasma clearance averages 356 mL/minute. The metabolites are inactive and 70-80% of them are eliminated in the urine.
Elimination is very rapid; the sequential distribution half-lives are 1 and 14 minutes and the terminal half-life is 90-111 minutes (range 50-150 minutes). Accumulation of alfentanil may occur under the following circumstances: With prolonged continuous infusion or with repeated administration of single doses and in patients with reduced plasma clearance e.g. patients with compromised liver function and patients over the age of 65 years.
During average length to long-lasting surgery, analgesia can be maintained by repeating RAPIFEN* injections or by continuous infusion, subsequent to a bolus dose. Once steady-state has been reached after infusion, the elimination half-life remains unaltered.

INDICATIONS
RAPIFEN* is indicated for use as a narcotic analgesic in general anaesthesia for both short (bolus injections) and long (bolus, supplemented by increments or by infusion) surgical procedures. It may also be used as an anaesthetic induction agent.

CONTRA-INDICATIONS
RAPIFEN* is contra-indicated in patients with a known intolerance to the medicine or to morphinomimetics in general.
As is the case with any narcotic analgesic, it should not be used in patients who may be particularly susceptible to respiratory depression such as comatose patients who may have head injury or brain tumour.
Patients with a history of myasthenia gravis and myopathies.

WARNINGS
Alfentanil may cause bradycardia, an effect that may be marked and rapid in onset, but that can be antagonized by atropine. Bradycardia may be more pronounced when alfentanil is combined with other anaesthetic agents which depress the heart rate or increase vagal activity. Heart rate should therefore be monitored carefully.
As asystole has been reported on occasions in non-atropinised patients, it is advisable to be prepared to administer an anticholinergic drug if the heart rate is considered low.
The use of rapid bolus injections of opioids should be avoided in patients with compromised intracerebral compliance, in such patients the transient decrease in the mean arterial pressure has occasionally been accompanied by a short-lasting reduction of cerebral perfusion pressure.

Use in pregnancy and lactation:
The safe use of RAPIFEN* in pregnancy has not been established.
Administration (IM or IV) during childbirth (including caesarian section) is not recommended, because RAPIFEN* crosses the placenta and because the fetal respiratory centre is more sensitive to opiates. Nevertheless, if RAPIFEN* is administered, an antidote for the child should always be at hand.
RAPIFEN* may enter the maternal milk. Therefore nursing is not recommended during 24 hours following the administration of RAPIFEN*.

DOSAGE AND DIRECTIONS FOR USE

The dosage should be individualized. Some of the factors to be considered in determining the dose are age, body mass, physical status, underlying pathological condition, use of other medicines, type of anaesthesia to be used and type and duration of the surgical procedure.
The initial dose should be reduced in the elderly and debilitated patients. In children it should be increased. The effect of the initial dose should be taken into account in determining supplemental doses.
To avoid bradycardia, it is recommended to administer a small intravenous dose of an anticholinergic just before induction. Droperidol may be given to prevent nausea and vomiting.

When surgery is more prolonged or aggressive, analgesia should be maintained by:

or

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Adverse reactions:

Other adverse reactions reported to occur with RAPIFEN* are apnoea, (transient) hypotension, bradycardia, euphoria, miosis, dizziness, post-operative nausea and vomiting and less frequently laryngospasm, allergic reactions (such as anaphylaxis, bronchospasm and urticaria), asystole and arrhythmias.
Nausea and vomiting can be controlled with anti-emetics.

Precautions:
Patients who have received RAPIFEN* should remain under appropriate surveillance.

Because of its weak cholinergic activity, RAPIFEN* should be used with caution in patients with cardiac arrhythmias.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses.
Hyperventilation during anaesthesia may alter the patient’s response to CO₂, thus affecting respiration postoperatively.
Opioids may induce hypotension, especially in hypovolaemic patients. Appropriate measures to maintain a stable arterial pressure should be taken.
It is recommended to reduce the dosage in the elderly or debilitated patients. Opioids should be titrated with caution in patients with any of the following conditions: uncontrolled hypothyroidism; pulmonary disease; decreased respiratory reserve; alcoholism; impaired hepatic or renal function. Such patients also require prolonged postoperative monitoring.

Effects on driving ability and use of machinery:
Car driving and the operation of machinery can only be resumed when sufficient time has elapsed after administration of RAPIFEN*. Individual reactions vary greatly. On average, the patient should wait 3 to 6 hours after doses of 1 to 3 mL and 12 to 24 hours after higher doses and infusions.

Interactions:
Since MAO inhibitors have been reported to potentiate narcotic analgesics, the use of RAPIFEN* in patients who have received MAO inhibitors within 2 weeks should be avoided.
However, several reports describe the uneventful use of fentanyl (a related opioid) during surgical or anaesthetic procedures in patients on MAO-inhibitors.
When insufficient anticholinergic is administered or when RAPIFEN* is given in combination with non-vagolytic muscle relaxants, bradycardia may occur.
Medicines such as barbiturates, benzodiazepines, neuroleptics, halogenic gases and other non-selective central nervous depressants (e.g alcohol) may potentiate the respiratory depression of narcotics. When patients have received such medicines, the dose of RAPIFEN* required will be less than usual. Likewise, following the administration of RAPIFEN*, the dose of the other central nervous system depressant drugs should be reduced.
The concomitant use of erythromycin with RAPIFEN* may significantly inhibit RAPIFEN* clearance and may increase the risk of prolonged or delayed respiratory depression. Cimetidine reduces the distribution volume and impairs the clearance of RAPIFEN*. Therefore, smaller doses of RAPIFEN* will be required and the duration of action may be extended in patients receiving erythromycin or cimetidine. Theoretically, similar consideration may apply to other hepatic enzyme inhibitors.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms:
The manifestations of RAPIFEN* overdosage are an extension of its pharmacologic actions. Depending on the individual sensitivity, the clinical picture will be determined primarily by respiratory depression, varying from bradypnoea to apnoea.
Treatment:
In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted or controlled as indicated. Endotracheal intubation will be necessary for the administration of oxygen in apnoea. The specific narcotic antagonist (naloxone hydrochloride) should be available for use as indicated to manage respiratory depression. The adult dose of naloxone hydrochloride is 0,4 mg intravenously and in children the dosage is 0,01 mg/kg body mass, repeated at 2-3 minute intervals until sufficient reversal is obtained. This does not preclude the use of more immediate countermeasures.
If depressed respiration is associated with muscular rigidity, an intravenous neuromuscular blocking agent might be required to facilitate assisted or controlled respiration. The patient should be carefully observed; body warmth and adequate fluid intake should be maintained.
If hypotension occurs and is severe or persists, the possibility of hypovolaemia should be considered and managed with appropriate parenteral fluid therapy.

IDENTIFICATION
A clear colourless solution in 2 mL or 10 mL glass ampoules.

PRESENTATION
Cartons containing 5 x 2 mL and 5 x 10 mL ampoules.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

MABCAMPATH

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MABCAMPATH

Solution for intravenous infusion

COMPOSITION
Each ampoule contains 30 mg alemtuzumab (10 mg/mL concentrate solution).

PHARMACOLOGICAL CLASSIFICATION
A. 26 Cytostatic agents.

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21 to 28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes. Alemtuzumab was generated by the insertion of six complementarity-determining regions from an IgG2a rat monoclonal antibody into a human IgG1 immunoglobulin molecule.
Alemtuzumab causes the lysis of lymphocytes by binding to CD52, a highly expressed, non-modulating antigen which is present on the surface of essentially all B and T cell lymphocytes as well as monocytes, thymocytes and macrophages. The antigen has also been found on a small percentage (<5%) of granulocytes, but not on erythrocytes or platelets. The antibody mediates the lysis of lymphocytes via complement fixation and antibody-dependent cell mediated cytotoxicity. Alemtuzumab does not appear to damage haematopoietic stem cells or progenitor cells.
Pharmacokinetic properties
The pharmacokinetics of alemtuzumab were studied in patients who received MabCampath once weekly for a maximum of 12 weeks. Following single intravenous infusions of 7,5 mg, 24 mg or 75 mg, the maximum serum concentration (Cmax) and the area under the curve (AUC) showed relative dose proportionality. The median half-life ranged from ~ 23 to 30 hours.
The pharmacokinetics and pharmacodynamics profile of MabCampath administered as a 30 mg intravenous infusion 3 times per week was evaluated in non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia patients who were treated for a maximum of 12 weeks. In patients with chronic lymphocytic leukaemia, peak and trough levels of MabCampath rose during the first few weeks of treatment and then approached steady state by approximately week 6. The rise in serum concentration corresponded with a marked reduction in lymphocytosis. Patients with peripheral lymphocyte counts of >30 ۰۰۰/microL at baseline had significantly lower peak and trough levels of MabCampath during the first 4 to 5 weeks of treatment compared to those with lymphocyte counts <30 ۰۰۰ microL. This suggests that lymphocytosis represents a compartment in the blood in which MabCampath is concentrated.

INDICATIONS
MabCampath is indicated for the treatment of patients with chronic lymphocytic leukaemia who have been treated with alkylating agents and who have failed to achieve a complete or partial response or who achieved only a short remission (less than 6 months) following fludarabine phosphate therapy.

CONTRA-INDICATIONS

WARNINGS
Acute adverse reactions may occur during initial dose escalation due to the release of cytokines and include hypotension, rigors, fever, shortness of breath, chills and rashes. If these events are moderate to severe, then dosing should continue at the same level with appropriate premedication, until each dose is well tolerated (eg infusion-related toxicities are <grade ۲). See “Dosage and directions for use” for dose adjustments and/or discontinuation of treatment. If therapy is withheld for more than 7 days, MabCampath should be reinstituted with gradual dose escalation.
Transient hypotension has occurred in patients receiving MabCampath. Caution should be used in treating patients with ischaemic heart disease, angina and/or in patients receiving antihypertensive medication.
It is recommended that patients be premedicated with an oral antihistamine and an analgesic 30 minutes prior to first MabCampath treatment at 3 mg, at each subsequent dose escalation, and thereafter, if clinically indicated. The recommended premedication is per oral 50 mg diphenhydramine and 500 mg paracetamol. In cases where severe infusion-related events prevent escalation of the dose, pre-treatment with intravenous (iv) 200 mg hydrocortisone may be useful in decreasing infusion-related reactions.
Profound lymphocyte depletion inevitably occurs and may be prolonged. CD4 and CD8 lymphocyte counts begin to rise following the discontinuation of treatment, but may not return to baseline levels for periods of longer than a year. This may predispose patients to opportunistic infections such as tuberculosis, acute bacterial pneumonia and septicaemia. It is highly recommended that anti-infective prophylaxis against Pneumocystis carinii pneumonia and an oral anti-herpes agent should be initiated while on therapy, and administered up to a minimum of 2 months following cessation of MabCampath treatment. If severe or serious infection does occur, MabCampath treatment should be discontinued until the event has resolved. MabCampath treatment may be reinstituted following resolution of the event.

Complete blood counts and platelet counts should be obtained at regular intervals during MabCampath therapy, and more frequently in patients who develop cytopenias.
It is not proposed that regular and systematic monitoring of CD52 expression should be carried out as routine clinical practice. However, if retreatment is considered, it may be prudent to confirm the presence of CD52 expression.
Patients may have allergic or hypersensitivity reactions to MabCampath and to murine or chimeric monoclonal antibodies.
Males and females of childbearing potential should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy.
No studies have been conducted which specifically address the effect of age on MabCampath disposition and toxicity. In general, older patients (over 65 years of age) tolerate cytotoxic therapy less well than younger individuals. Since chronic lymphocytic leukaemia occurs commonly in this older age group, these patients should be monitored carefully (see “Dosage and directions for use”).

INTERACTIONS
No formal drug interaction studies have been performed with MabCampath. There are no known clinically significant interactions of MabCampath with other medicinal products. However, it is recommended that MabCampath should not be given within 3 weeks of other chemotherapeutic agents.
Although it has not been studied, it is recommended that patients should not receive live viral vaccines in, at least, the 12 months following MabCampath therapy. The ability to generate a primary or anamnestic humoral response to any vaccine has not been studied.

PREGNANCY AND LACTATION
See “Contra-indications”.

DOSAGE AND DIRECTIONS FOR USE
MabCampath should be administered under the supervision of a physician experienced in the use of cancer therapy.
Patients should be premedicated with an appropriate antihistamine and analgesic prior to the first dose, at each escalation, and prior to subsequent infusions, as clinically indicated (see “Warnings”).
Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment (see “Warnings”).
During the first week of treatment, MabCampath should be administered in escalating doses: 3 mg on day ۱, ۱۰ mg on day ۲ and 30 mg on day ۳, assuming that each dose is well tolerated (eg infusion-related toxicities are < grade ۲). Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days, up to a maximum of 12 weeks.
In most patients, dose escalation to 30 mg can be accomplished in 3 to 7 days. However, if acute severe adverse reactions (especially hypotension, rigors, fever and bronchospasm) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated prior to further escalation (see “Warnings”).
The majority of major responses to MabCampath have been achieved with treatment durations of 4 to 12 weeks. Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored. If a patient improves (ie achieves a partial response or stable disease) and then reaches a plateau without further improvement for 4 weeks or more, then MabCampath should be discontinued and the patient monitored. Therapy should be discontinued if there is evidence of disease progression.
In the event of serious infection or severe haematological toxicity, MabCampath should be discontinued until the event resolves. It is recommended that MabCampath should be discontinued in patients whose platelet count fills to <25 ۰۰۰/microL or whose absolute neutrophil count (ANC) drops to <250/microL. MabCampath may be reinstituted after the infection or toxicity has resolved. The following table outlines the recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy:

* If therapy has been withheld for more than 7 days, MabCampath must be reinstituted by gradual dose escalation.
Children and adolescents (below 17 years of age):
No studies have been conducted (see “Contra-indications”).
Elderly (over 65 years of age):
Recommendations are as stated above for adults. Patients should be monitored carefully (see “Warnings”).
Patients with renal or hepatic impairment:
Treatment with MabCampath is not recommended (see “Warnings”).
All doses should be administered by intravenous infusion over approximately 2 hours.
The ampoule contents should be inspected for particulate matter and discolouration prior to administration. If particulate matter is present or the concentrate is coloured, then the ampoule should not be used.
MabCampath contains no antimicrobial preservatives, therefore it is recommended that it should be prepared using aseptic techniques and that the diluted solution for infusion should be administered immediately or within 8 hours after preparation. The required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 micron filter, to 100 mL of 0,9% sodium chloride solution or 5% glucose solution. The bag should be inverted gently to mix the solution.
This medicinal product should not be reconstituted with solvents other than sodium chloride and glucose solution.
There are no known incompatibilities with other medicinal products.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line.
Women who are pregnant or planning pregnancy should not handle MabCampath.
Procedures for proper handling and disposal should be observed. Any spillage or waste material should be disposed of by incineration.
Caution should be exercised in the handling and preparation of the MabCampath solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the ampoule or other accidental spillage.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
More than 80% of patients may be expected to experience adverse reactions; the most commonly reported reactions usually occurring during the first week of therapy.
Infusion-related reactions
Reactions reported have been acute infusion-related reactions including fever, rigors, nausea, vomiting, hypotension, fatigue, rash, urticaria, dyspnoea, headache, pruritus and diarrhoea. The majority of these reactions are mild to moderate in severity. Acute infusion-related reactions usually occur during the first week of therapy and decline substantially thereafter. Grade ۳ or 4 infusion-related reactions are uncommon after the first week of therapy. These symptoms can be ameliorated or avoided if premedication and dose escalation are utilised (see “Warnings”).
Infections
Grade ۳ or 4 infections have been reported, including herpes simplex and pneumonia of grade ۳ or 4 severity. Opportunistic infections including Pneumocystis carinii pneumonia, cytomegalovirus, Aspergillus pneumonia and herpes zoster occur. Rhinocerebral mucormycosis has been reported. None of the patients with Pneumocystis carinii pneumonia or herpes zoster had received the anti-infective prophylaxis. Such therapy appears to be effective in reducing the risk of infections due to these opportunistic pathogens (see “Warnings”).
Haematological reactions
Severe bleeding reactions have been reported. One patient developed fatal idiopathic thrombocytopenic purpura following MabCampath therapy. Pancytopenia has been reported and may be grade ۳ or 4 in severity or serious in nature. A positive Coombs test is observed; clinically apparent haemolysis has not been reported in patients treated to date.
The table below reports adverse reactions by body system and in descending order of severity:

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Patients have received repeated unit doses of up to 240 mg of MabCampath. The frequency of grade ۳ or 4 adverse events such as fever, hypotension and anaemia may be higher in these patients. There is no known specific antidote for MabCampath overdosage. Treatment consists of discontinuation of MabCampath and supportive therapy.

IDENTIFICATION
Clear, colourless to slightly yellow solution, essentially free from visible particles.

PRESENTATION
Each cardboard carton contains 3 x 5 mL clear glass ampoules each with 3 mL concentrate.

STORAGE INSTRUCTIONS
Store at 2 to 8°C in a refrigerator. Do not freeze. Protect from light. Do not remove from the outer container until immediately before use. Keep out of reach of children. Discard any unused portion of the solution.
Reconstituted solution
MabCampath contains no antimicrobial preservative. MabCampath should be used immediately after dilution or within 8 hours if stored at 15 to 30°C. This can only be accepted if preparation of the solution takes place under strict aseptic conditions and the solution is protected from light.

CLEARASIL MEDICATED FACIAL CLEANSER

SCHEDULING STATUS
Not scheduled

PROPRIETARY NAME
(and dosage form)

CLEARASIL MEDICATED FACIAL CLEANSER

COMPOSITION
Each 100 mL contains.

PHARMACOLOGICAL ACTION
A 13.1 Antiseptics, disinfectants, cleaning agents

PHARMACOLOGICAL ACTION
A skin cleanser with a mild keratolytic activity

INDICATIONS
Clearasil Medicated Facial Cleanser is indicated for the cleansing of skin of patients with oily skin and acne.

CONTRA-INDICATIONS
Known hypersensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE
Dampen sufficient cotton wool with the lotion and remove excess oil from the forehead, nose and chin. Avoid contact with eyes

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Salicylic Acid is a mild irritant and may cause dermatitis.
Application to large areas of skin and continuous application should not be employed.
For external use only. Keep away from eyes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of accidental ingestion the likely symptoms of intoxication could possibly include symptoms such as dizziness, tinnitus, sweating, nausea and vomiting, mental confusion, hyperventilation, respiratory alkalosis, metabolic acidosis, ketosis and depression of the central nervous system.
In children, serious signs of intoxication may develop rapidly. Consult a doctor or the nearest hospital immediately. Treatment is supportive and symptomatic.

IDENTIFICATION
Blue liquid with a characteristic odour.

PRESENTATION
Bottles of 75 mL and 100 mL

STORAGE INSTRUCTIONS
Store below 25°C. Keep out of reach of children.

ZENTEL^® TABLETS 200 mg (tablets)
ZENTEL^® SUSPENSION 20 mg/mL (suspension)

COMPOSITION:
The chemical name of albendazole is methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate.
Each ZENTEL 200 mg tablet contains 200 mg albendazole.
The suspension contains 100 mg albendazole in each 5 mL, preserved with potassium sorbate 0,39% m/v, benzoic acid 0,2% m/v and sorbic acid 0,08% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A12 Anthelmintics.

PHARMACOLOGICAL ACTION:
Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Animal studies have shown that albendazole exhibits vermicidal, ovacidal and larvacidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerization. This causes the disruption of the helminth metabolism, including energy depletion, which immobilises and then kills the susceptible helminth. In man, after oral administration, albendazole is absorbed and completely metabolized. At a dose of 6,6 mg/kg of albendazole the plasma concentration of its main metabolite, the sulfoxide, attains a maximum of 0,25 to 0,30 micrograms/mL after approximately 2½ hours. The half-life of the sulfoxide in the plasma is 8% hours. The metabolite is essentially eliminated via the urine,

WARNINGS:
It has been noted that leucopaenia has occurred when used for periods longer than recommended.

INDICATIONS:
ZENTEL is indicated in the treatment of single or mixed intestinal parasites. Clinical studies have shown albeneffective in the treatment of Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm/threadworm), Ancylostoma duodenale and Necator americanus (hookworm), Taenia spp. (tapeworm) and Strongyloides stercoralis.
ZENTEL has been shown to be effective in the treatment of Giardia (duodenalis or intestinalis or lamblia) infections in children.

CONTRA-INDICATIONS:
Albendazole is known to be teratogenic and embryotoxic in animals. The safety of albendazole during pregnancy has not been established, and ZENTEL should not be taken by pregnant women at any stage of their pregnancy or by women who are likely to become pregnant, during or shortly after the course of therapy. ZENTEL is contra-indicated in patients with a known history of hypersensitivity to albendazole or constituents.

DOSAGE AND DIRECTIONS FOR USE:
Usual Dose:
400 mg (two ZENTEL 200 mg tablets) or 20 mL (400 mg) of ZENTEL suspension as a single dose in both adults and children over two years of age. The tablets may be chewed, swallowed or crushed and mixed with food. The usual dose in children between one and two years of age is 10 mL (200 mg) of ZENTEL suspension as a single dose. In heavy mixed infestation involving Strongyloides or Taeniasis, a single daily dose may be inadequate and the dose may be given for three consecutive days.
Note:
If the patient is not cured after three weeks, a second course of treatment may be given. No special procedures, such as fasting or purging, are required.
Albendazole has not been adequately studied in children under one year of age.
Giardiasis (dose in children over 2 years of age):
A single 400 mg daily dose (two 200 mg tablets or 20 mL suspension) for five days.
The tablets may be chewed, swallowed or crushed and they should be taken with food.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal discomfort, diarrhoea, headache and dizziness have been reported.
Hypersensitivity reactions including rash. pruritus and urticaria have been reported less frequently.
Interactions:
Praziquantel has been reported to increase the plasma levels of the albendazole active metabolite.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated.

IDENTIFICATION:
ZENTEL 200 mg tablets are off-white, circular, bevel-edged, film-coated tablets incorporating a slightly raised, pentagonal projection on both sides, odourless or almost odourless.
ZENTEL suspension is a white, pleasant tasting, orange-vanilla flavoured suspension.

PRESENTATION:
ZENTEL 200 mg tablets are available in blister pack strips of two tablets and packs of 100 x 2 tablets. ZENTEL suspension is available in 20 mL bottles.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). Protect suspension from light.
KEEP OUT OF REACH OF CHILDREN.

EMULSION OF LIQUID PARAFFIN WITH AGAR B.P.C. 1949.

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

EMULSION OF LIQUID PARAFFIN WITH AGAR B.P.C. 1949.

COMPOSITION:
Each 10 mL contains:

Preservative -

PHARMACOLOGICAL CLASSIFICATION:
11.5 Laxatives:

PHARMACOLOGICAL ACTION:
Emulsion of Liquid Paraffin with Agar is a laxative with lubricant properties.

INDICATIONS:
To relieve temporary and chronic constipation.

CONTRA-INDICATIONS:
None. Constant use of a laxative is, however, undesirable.

WARNINGS:
Keep all medicines out of reach of children.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
5 – 30 mL (1 – 6 medicine measures)
Children:
2,5 – 10 mL (½ – ۲ medicine measures)

Shake the bottle before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
May give rise to granulomatous reactions.
Prolonged use of liquid paraffin may interfere with the absorption of fat soluble vitamins.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excessive dosage may result in seepage and anal irritation. Treatment is symptomatic.

IDENTIFICATION:
A white smooth emulsion.

PRESENTATION:
Bottles of 200 mL, 500 mL, and 2,5 L.

STORAGE INSTRUCTIONS:
Store below 25°C. Do not refrigerate.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.

WONDERKROONESSENS

SCHEDULING STATUS:
Unscheduled.

PROPRIETARY NAME
(and dosage form)

WONDERKROONESSENS

COMPOSITION:
Each 5 mL contains:
The alcoholic extractives of

PHARMACOLOGICAL CLASSIFICATION:
A 11.10 Medicines acting on gastro-intestinal tract (Special combinations).

PHARMACOLOGICAL ACTION:
Laxative and digestive.

INDICATIONS:
Wonderkroonessens is an effective preparation for the treatment of constipation, winds and indigestion.

CONTRA-INDICATIONS:
Habitual use, undiagnosed abdominal pains, nausea and vomiting, and during pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Half to one medicine measureful (2,5 - ۵ mL) in water morning and night, when necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
As with all laxatives, continual use must be avoided. Large or overdoses may produce the following side-effects: griping, nausea, vomiting, excessive cathartic effects and gastro-intestinal irritation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”. Use of the preparation must be discontinued.

IDENTIFICATION:
Bright, dark brown liquid.

PRESENTATION:
20 mL Packs.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

WONDERKROONESSENS

SCHEDULING STATUS:
Unscheduled.

PROPRIETARY NAME
(and dosage form)

WONDERKROONESSENS

COMPOSITION:
Each 5 mL contains:
The alcoholic extractives of

PHARMACOLOGICAL CLASSIFICATION:
A 11.10 Medicines acting on gastro-intestinal tract (Special combinations).

PHARMACOLOGICAL ACTION:
Laxative and digestive.

INDICATIONS:
Wonderkroonessens is an effective preparation for the treatment of constipation, winds and indigestion.

CONTRA-INDICATIONS:
Habitual use, undiagnosed abdominal pains, nausea and vomiting, and during pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Half to one medicine measureful (2,5 - ۵ mL) in water morning and night, when necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
As with all laxatives, continual use must be avoided. Large or overdoses may produce the following side-effects: griping, nausea, vomiting, excessive cathartic effects and gastro-intestinal irritation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”. Use of the preparation must be discontinued.

IDENTIFICATION:
Bright, dark brown liquid.

PRESENTATION:
20 mL Packs.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

ACHILLEA COMP. DROPS

WELEDA Ref.No. U3254 Act 101/1965

ACHILLEA COMP. DROPS

Haemorrhoidal Remedy

COMPOSITION: Per 100 g

Aesculus, Cortex ethanolic Decoction D3 20g

Antimonit D8 20g

Gentiana lutea, Radix ethanolic Decoction D3 20g

Hamamelis, Cortex ethanolic Decoction D3 20g

Achillea millefolium Herba D1 20g

Alcohol 47% m/m

INDICATIONS:

1) Internal or protruding, painful haemorrhoids (piles)

2) Rectal eczema

3) Anal fistula

4) Proctitis (inflammation of the rectum)

5) Anal fissure (cracked or split anal skin)

MODE OF ACTION:

Aesculus: reduces vascular permeability.

Antimonit: reduces inflammation and stops bleeding.

Gentiana: promotes the digestive processes to regulate digestion and correct circulation deficiency.

Hamamelis: reduces vascular permeability.

Achillea: reduces the tendency to bleed and is a liver detoxicant.

DOSAGE: Unless otherwise directed,

5 – 15 drops to be taken in a little water three times daily about 10 minutes before meals.

COMMENT: Can be used together with Hamamelis comp. ointment (Weleda) applied externally and/or Weleda Haemorrhoidal suppositories.

It is beneficial to increase the amount of roughage in the diet in order to ensure that there is no constipation.

Be sure to advise the patient to consult a doctor if the condition continues for more than three or four weeks.

STIBIUM COMP SUPPOSITORIES

WELEDA Ref.No. U3693 Act 101/1965

STIBIUM COMP SUPPOSITORIES

Haemorrhoidal Suppositories

COMPOSITION: Per suppository

Extr. Hamamelis Fol. 10 mg

Aesculus cort. Decoct. 20 mg

Stibium Met. praep D8 8 mg

INDICATIONS:

1. Internal haemorrhoids (piles)

2. Anal fissures (anitis)

MODE OF ACTION:

Hamamelis: reduces vascular permeability,

Aesculus Cort: also reduces vascular permeability,

Stibium met. praep.(Antimonit) reduces inflammation and counteracts bleeding.

DOSAGE: NOT TO BE TAKEN

In the acute stage, insert one suppository twice daily – after stool, and before retiring. Thereafter insert one before retiring.

COMMENT: Can be used in conjunction with Hamamelis comp. ointment (Weleda) and Achillea comp. drops (Weleda)