Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten 6020, Gqeberha, South Africa
OMNOPON 20 FRESENIUS solution for injection.
Pharmaceutical Form |
---|
Solution for injection. A clear, colourless to yellowish-brown solution in colourless ampoules. |
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) |
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.
Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten 6020, Gqeberha, South Africa
B1006 (Act 101/1965)
Not applicable.
Drug | Countries | |
---|---|---|
OMNOPON | South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.