Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
ISENTRESS 100 mg granules for oral suspension.
| Pharmaceutical Form |
|---|
|
Granules for oral suspension. White to off-white, granular powder that may contain yellow or beige to tan particles, in a single-use sachet. |
Each sachet contains 100 mg of raltegravir (as potassium). Following reconstitution the oral suspension has a concentration of 10 mg per mL.
Excipients with known effect: Each sachet contains approximately: 0.5 mg fructose, 1.5 mg sorbitol and 4.7 mg sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Raltegravir |
Raltegravir is an integrase strand transfer inhibitor active against the Human Immunodeficiency Virus (HIV-1). Raltegravir inhibits the catalytic activity of integrase, an HIV-encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of the HIV genome into the host cell genome. |
| List of Excipients |
|---|
|
Hydroxypropyl cellulose |
PET/aluminium/LLDPE sachets.
One carton contains 60 sachets, two 1 mL, two 3 mL and two 10 mL oral dosing syringes and 2 mixing cups.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/07/436/005
Date of first authorisation: 20 December 2007
Date of latest renewal: 14 May 2014
| Drug | Countries | |
|---|---|---|
| ISENTRESS | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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