REYATAZ Hard capsules (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
REYATAZ 100 mg hard capsules. REYATAZ 150 mg hard capsules. REYATAZ 200 mg hard capsules. REYATAZ 300 mg hard capsules.
Qualitative and quantitative composition
REYATAZ 100 mg hard capsules: Each capsule contains 100 mg of atazanavir (as sulphate). Excipient with known effect: 54.79 mg of lactose per capsule. REYATAZ 150 mg hard capsules: Each capsule contains ...
Pharmaceutical form
Hard capsule. REYATAZ 100 mg hard capsules: Opaque blue and white capsule printed with white and blue inks, with BMS 100 mg on one half and with 3623 on the other half. REYATAZ 150 mg hard capsules: Opaque ...
Therapeutic indications
REYATAZ capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral ...
Posology and method of administration
Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Adults The recommended dose of REYATAZ capsules is 300 mg once daily taken with ritonavir 100 mg once ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. REYATAZ is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2). REYATAZ ...
Special warnings and precautions for use
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission ...
Interaction with other medicinal products and other forms of interaction
When REYATAZ and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir. The Summary of ...
Fertility, pregnancy and lactation
Pregnancy A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity of atazanavir. Animal studies do not indicate reproductive toxicity (see section ...
Effects on ability to drive and use machines
Patients should be informed that dizziness has been reported during treatment with regimens containing REYATAZ (see section 4.8).
Undesirable effects
Summary of the safety profile REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ ...
Overdose
Human experience of acute overdose with REYATAZ is limited. Single doses up to 1,200 mg have been taken by healthy volunteers without symptomatic untoward effects. At high doses that lead to high drug ...
Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors ATC code: J05AE08 Mechanism of action Atazanavir is an azapeptide HIV-1 protease inhibitor (PI). The compound selectively inhibits ...
Pharmacokinetic properties
The pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV-infected patients; significant differences were observed between the two groups. The pharmacokinetics of atazanavir ...
Preclinical safety data
In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin ...
List of excipients
REYATAZ 100 mg hard capsules Capsule contents: crospovidone, lactose monohydrate and magnesium stearate Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171) Blue ink containing: shellac, ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
REYATAZ 100 mg hard capsules: Each carton contains one high-density polyethylene (HDPE) bottle closed with child-resistant polypropylene closure. Each bottle contains 60 hard capsules. Each carton contains ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
BRISTOL-MYERS SQUIBB PHARMA EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
Marketing authorization number(s)
EU/1/03/267/001-006; 008-011
Date of first authorization / renewal of the authorization
Date of first authorisation: 02 March 2004 Date of latest renewal: 02 March 2009
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