Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
ISENTRESS 25 mg chewable tablets.
ISENTRESS 100 mg chewable tablets.
| Pharmaceutical Form |
|---|
|
Chewable tablet. Chewable tablet 25 mg: Pale yellow, round, chewable tablet with MSD corporate logo on one side and “473” on the other side. Chewable tablet 100 mg: Pale orange coloured, oval shaped, chewable tablet scored on both sides with the MSD corporate logo and “477” on one side and without inscription on the other side. The tablet can be divided into equal 50 mg doses. |
Each chewable tablet contains 25 mg of raltegravir (as potassium).
Each chewable tablet contains 100 mg of raltegravir (as potassium).
Excipients with known effect 25 mg: Each chewable tablet contains approximately 0.46 mg fructose, approximately 0.05 mg phenylalanine (as a component of aspartame) and approximately 1.4 mg sorbitol.
Excipients with known effect 100 mg: Each chewable tablet contains approximately 0.93 mg fructose, approximately 0.10 mg phenylalanine (as a component of aspartame) and approximately 2.8 mg sorbitol.
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 |
|---|
|
Chewable tablet 25 mg: Hydroxypropyl cellulose Chewable tablet 100 mg: Hydroxypropyl cellulose |
High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure, induction seal and silica gel desiccant: 60 tablets.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/07/436/003 – 25 mg
EU/1/07/436/004 – 100 mg
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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