Source: Web Search Revision Year: 2021 Publisher: sanofi-aventis south africa (pty) ltd, 2 Bond Street, 1685, Midrand, SA
Acute, severe colicky pains of the biliary, urinary and gastro-intestinal tract.
Not to be given to children under 12 months of age.
1 ampoule of 5 ml by slow intravenous injection; if possible the patient should be in a lying position. The injection should be given over at least 5 minutes.
If necessary the same dose may be repeated 2 to 3 times daily at intervals of several hours.
Should intravenous injection be impossible, the preparation may be given by intramuscular injection.
Not to be administered subcutaneously.
The administration of BUSCOPAN COMPOSITUM 20 mg/2,5 g injection should be under medical supervision and be monitored.
BUSCOPAN COMPOSITUM 20 mg/2,5 g injection should only be injected intravenously or intramusculary. Inadvertent intra-arterial use may cause necrosis in the distal vascular area.
With intramuscular injection the following technique should be carefully observed: Site of injection: Only in the upper, outer quadrant of the buttock.
Direction: Sagittally and directed towards the iliac crest.
Depth: A sufficiently long needle to ensure the injection reaches the muscle.
In the case of overdose, anticholinergic effects may be observed. Toxic doses cause tachycardia, rapid respiration, hyperpyrexia and central nervous system stimulation marked by restlessness, confusion and, excitement, paranoid and psychotic reactions, hallucinations and delirium, and occasionally seizures or convulsions. A rash may appear on the face and upper trunk.
After very high doses, elimination of the metabolic rubazonic acid can cause reddish discolouration of the urine.
Acute overdosage or chronic use in excessive dosage lead to dizziness, nausea, emesis, gastrointestinal pains, state of agitation, convulsion, clonic cramp, shock, coma, respiratory paralysis, liver and renal damage, sodium and fluid retention with pulmonary oedema in cardiac patients, risk of allergy and anaphylactic reactions, leucopoenia, thrombocytopenia, agranulocytosis and aplastic anaemia.]
Treat spastic conditions first – diazepam 10-20 mg i.v./i.m. Symptoms of BUSCOPAN COMPOSITUM overdosage respond to parasympathomimetics. In patients with glaucoma, pilocarpine should be used locally.
Further treatment: Symptomatic and supportive.
If required, parasympathomimetic medicines should be administered.
Opthalmological advice should be sought urgently in cases of glaucoma.
Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: intubation or artificial respiration should be considered. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be used as required.
There is no known specific antidote for metamizole. If metamizole was administered only recently, absorption-reducing measures (e.g. activated charcoal) can be administered in an effort to limit absorption by the body. The major metabolite (4-N-methyl-amino-antipyrine) can be eliminated by means of haemodialysis, haemofiltration, haemoperfusion or plasma filtration. Treatment of intoxication and prevention of severe complications may require general and specific intensive medical monitoring and treatment.
At the first signs (e.g. skin reactions such as urticaria and flushing, restlessness, headache, profuse sweating, nausea) stop the administration immediately.
Leave the cannula in the vein or set up a venous access. In addition to the usual emergency measures such as tilting the head and upper body back, maintaining the airways, administering oxygen, it may be necessary to administer sympathomimetics, volume expanders or glucocorticoids.
36 months.
Store at or below 25°C. [Keep out of reach of children.]
Ampoules of 5 ml in boxes of three ampoules.
No special requirements.
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