Source: Health Products Regulatory Authority (ZA) Revision Year: 2010 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
FORTIVA 1 mg (injection).
FORTIVA 2 mg (injection).
FORTIVA 5 mg (injection).
| Pharmaceutical Form |
|---|
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White to off-white cake that may be intact or fragmented. The reconstituted solution is a clear and colourless liquid, practically free from particulate matter. |
Each vial of FORTIVA 1 mg, contains 1 mg remifentanil base as remifentanil hydrochloride.
Each vial of FORTIVA 2 mg, contains 2 mg remifentanil base as remifentanil hydrochloride.
Each vial of FORTIVA 5 mg, contains 5 mg remifentanil base as remifentanil hydrochloride.
Excipient: Glycine.
Sugar free
| Active Ingredient | Description | |
|---|---|---|
| Remifentanil |
Remifentanil is a selective mu-opioid agonist with a rapid onset and very short duration of action. The mu-opioid activity, of remifentanil, is antagonised by narcotic antagonists, such as naloxone. |
| List of Excipients |
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FORTIVA 1 mg: 3 ml clear, Type 1 glass vials with grey bromobutyl rubber stoppers and secured with an aluminium overseal with a light blue plastic flip-off top. The vials are placed in a carboard carton together with a leaflet.
FORTIVA 2 mg: 5 ml clear, Type 1 glass vials with grey bromobutyl rubber stoppers and secured with an aluminium overseal with a royal blue plastic flip-off top. The vials are placed in a carboard carton together with a leaflet.
FORTIVA 5 mg: 10 ml clear, Type 1 glass vials with grey bromobutyl rubber stoppers and secured with an aluminium overseal with a dark blue plastic flip-off top. The vials are placed in a carboard carton together with a leaflet.
Not all strengths, packs and pack sizes are necessarily marketed.
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
FORTIVA 1 mg: 42/2.9/0751
FORTIVA 2 mg: 42/2.9/0752
FORTIVA 5 mg: 42/2.9/0753
Date of registration: 26 November 2010
| Drug | Countries | |
|---|---|---|
| FORTIVA | South Africa |
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