OMNOPON Solution for injection Ref.[51213] Active ingredients: Codeine Morphine Papaverine

Adults: 0,5–1,0 ml OMNOPON 20 FRESENIUS by subcutaneous or intramuscular injection, usually not given more often than four-hourly.

Children 1–12 years: Usual dose 0,01–0,015 ml/kg OMNOPON 20 FRESENIUS as maximum single dose.

OMNOPON 20 FRESENIUS may also be administered intravenously in doses of one-quarter to one-half the corresponding subcutaneous or intramuscular dose. A slow rate of intravenous or intramuscular injection is recommended.

The use of a small, graduated syringe is recommended for the accurate administration of dosages given to children. In the absence of graduated syringes, OMNOPON 20 FRESENIUS ampoule should be diluted with water for injections before measuring the dose. Maintenance of stability cannot be guaranteed when OMNOPON 20 FRESENIUS ampoule solution is diluted. OMNOPON 20 FRESENIUS ampoules are not recommended for use in babies under one year of age.

Elderly

Elderly patients are more sensitive to the actions of narcotic analgesics: the initial dose of OMNOPON 20 FRESENIUS should not exceed 0,5 ml.

Signs and symptoms of overdosage:

• Coma.
• Depressed respiration.
• Pinpoint pupils.
• Cold, clammy skin.
• Muscle flaccidity.
• Nausea and vomiting.
• Hypotension.
• Dilatation of the pupils occurs as hypoxia develops.
• Pulmonary oedema.
• Convulsions (especially in children).
• Rhabdomyolysis leading to renal failure.
• Circulatory failure may occur in severe cases.

Treatment:

• Maintain respiratory status by suitable means such as establishing a patent airway and ventilating the patient.
• Narcotic antagonists such as naloxone should be administered to reverse severe narcotic induced respiratory depression. If naloxone is not available, nalorphine or levallorphan should be used. It should be borne in mind that the half-life of OMNOPON 20 FRESENIUS is significantly longer than the duration of action of naloxone. Ventilatory depression may recur and further ventilatory support and/or repeat doses of naloxone may be necessary.

24 months.

Protect from light and store at or below 25°C.

1 ml clear glass OPC ampoule, with a blue ring above the neck, containing 1 ml of solution, packed into a blister tray and outer carton.

Pack size: 10 ampoules per outer carton.

Protect from light.