INVIRASE Film-coated tablet (2018)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Roche Registration GmbH |
|---|---|
| Διεύθυνση | Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany |
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Περιεχόμενα
Name of the medicinal product
INVIRASE 500 mg film-coated tablets.
Qualitative and quantitative composition
One film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate. Excipient with known effect: Lactose monohydrate: 38.5 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Light orange to greyish or brownish orange film-coated tablet of oval cylindrical biconvex shape with the marking SQV 500 on the one side and ROCHE on the other side.
Therapeutic indications
Invirase is indicated for the treatment of HIV-1 infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).
Posology and method of administration
Posology Therapy with Invirase should be initiated by a physician experienced in the management of HIV infection. In combination with ritonavir The recommended dose of Invirase is 1000 mg (2 500 mg film-coated ...
Contraindications
Invirase is contraindicated in patients with: hypersensitivity to the active substance or to any of the excipients listed in section 6.1 decompensated liver disease (see section 4.4) congenital or documented ...
Special warnings and precautions for use
Considerations when initiating Invirase therapy Invirase should not be given as the sole protease inhibitor. Invirase should only be given in combination with ritonavir (see section 4.2). Invirase is not ...
Interaction with other medicinal products and other forms of interaction
Most drug interaction studies with saquinavir have been completed with unboosted Invirase or unboosted saquinavir soft capsules. A limited number of studies have been completed with ritonavir boosted Invirase ...
Fertility, pregnancy and lactation
Pregnancy Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri- and post-natal ...
Effects on ability to drive and use machines
Invirase may have a minor influence on the ability to drive and use machines. Dizziness, fatigue and visual impairment have been reported during treatment with Invirase. No studies on the effects on the ...
Undesirable effects
a. Summary of the safety profile Limited data is available from two clinical studies where the safety of saquinavir soft capsule (1000 mg twice daily) used in combination with low dose ritonavir (100 mg ...
Overdose
There is limited experience of overdose with saquinavir. Whereas acute or chronic overdose of saquinavir alone did not result in major complications, in combination with other protease inhibitors, overdose ...
Pharmacodynamic properties
Pharmaco-therapeutic group: Antiviral agent ATC code: J05AE01 Mechanism of action The HIV protease is an essential viral enzyme required for the specific cleavage of viral gag and gag-pol polyproteins. ...
Pharmacokinetic properties
Saquinavir is essentially completely metabolised by CYP3A4. Ritonavir inhibits the metabolism of saquinavir, thereby increasing (boosting) the plasma levels of saquinavir. Absorption In HIV-infected adult ...
Preclinical safety data
Acute and chronic toxicity Saquinavir was well tolerated in oral acute and chronic toxicity studies in mice, rats, dogs and marmosets. Mutagenesis Mutagenicity and genotoxicity studies, with and without ...
List of excipients
Tablet core: Microcrystalline cellulose Croscarmellose sodium Povidone Lactose (monohydrate) Magnesium stearate Tablet coat: Hypromellose Titanium dioxide (E171) Talc Glycerol triacetate Iron oxide yellow ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Plastic bottles (HDPE) containing 120 tablets.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/96/026/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 04 October 1996 Date of latest renewal: 04 October 2006
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