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SPC: INVIRASE Film-coated tablet (2018)

Αναφορές

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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