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

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten 6020, Gqeberha, South Africa

Product name and form

OMNOPON 20 FRESENIUS solution for injection.

Pharmaceutical Form

Solution for injection.

A clear, colourless to yellowish-brown solution in colourless ampoules.

Qualitative and quantitative composition

Each 1 ml solution of OMNOPON 20 FRESENIUS per ampoule contains:

Morphine HCI 13,44 mg

Papaverine HCI 1,20 mg

Codeine HCl 1,04 mg

Sugar free.

Excipient with known effect: Each 1 ml solution of OMNOPON 20 FRESENIUS per ampoule contains ethyl alcohol 6,44% v/v which is equivalent to 50,88 mg ethyl alcohol per dosage unit.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Codeine

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain. The anti-tussive activity of codeine is probably due to its depressant effect on the medullary cough centre in the brain.

Morphine

Morphine is a narcotic analgesic obtained from opium. Morphine acts as an agonist at opiate receptors in the CNS particularly Mu and to a lesser extent Kappa receptors. Mu receptors are thought to mediate supraspinal analgesia, respiratory depression and euphoria, and Kappa receptors, spinal analgesia, miosis and sedation.

Papaverine
List of Excipients

Acetic acid glacial (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)
Ethyl alcohol
Water for injection

Pack sizes and marketing

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.

Marketing authorization holder

Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten 6020, Gqeberha, South Africa

Marketing authorization dates and numbers

B1006 (Act 101/1965)

Not applicable.

Drugs

Drug Countries
OMNOPON South Africa

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