ZERIT Powder for oral solution (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zerit 200 mg powder for oral solution.
Qualitative and quantitative composition
Each bottle contains 200 mg of stavudine. The reconstituted solution contains 1 mg of stavudine per ml. Excipients with known effect: Each bottle contains 31.5 mg of propylhydroxybenzoate (E216). Each ...
Pharmaceutical form
Powder for oral solution. Off-white to pale-pink, gritty powder.
Therapeutic indications
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (from birth) only when other antiretrovirals can ...
Posology and method of administration
The therapy should be initiated by a doctor experienced in the management of HIV infection (see also section 4.4). For patients starting therapy with Zerit, the duration should be limited to the shortest ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with didanosine due to the potential for serious and/or life-threatening events notably lactic ...
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
The combination of stavudine with didanosine is contraindicated given that both drugs exhibits high risk of mitochondrial toxicity (see sections 4.3 and 4.4). Since stavudine is actively secreted by the ...
Fertility, pregnancy and lactation
Pregnancy Zerit should not be used during pregnancy unless clearly necessary. Clinical experience in pregnant women is limited, but congenital anomalies and abortions have been reported. In study AI455-094, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Stavudine may cause dizziness and/or somnolence. Patients should be instructed that if they experience these symptoms ...
Undesirable effects
Summary of the safety profile Stavudine therapy is associated with several severe adverse reactions, such as lactic acidosis, lipoatrophy and polyneuropathy, for which a potential underlying mechanism ...
Overdose
Experience in adults treated with up to 12 times the recommended daily dosage revealed no acute toxicity. Complications of chronic overdosage could include peripheral neuropathy and hepatic dysfunction. ...
Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors ATC code: J05AF04 Mechanism of action Stavudine, a thymidine analogue, is phosphorylated ...
Pharmacokinetic properties
Absorption The absolute bioavailability is 86±18%. After multiple oral administration of 0.5-0.67 mg/kg doses, a C<sub>max</sub> value of 810±175 ng/ml was obtained. C<sub>max</sub> and AUC increased proportionally ...
Preclinical safety data
Animal data showed embryo-foetal toxicity at very high exposure levels. An ex vivo study using a term human placenta model demonstrated that stavudine reaches the foetal circulation by simple diffusion. ...
List of excipients
Capsule contents: Lactose Magnesium stearate Microcrystalline cellulose Sodium starch glycolate Capsule shell: Gelatin Iron oxide colorant (E172) Silicon dioxide Sodium laurilsulphate Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store below 25°C (aclar/alu blisters). Do not store above 30°C (HDPE bottles). Store in the original package.
Nature and contents of container
HDPE bottles with child resistant screw cap (60 hard capsules per bottle). Aclar/aluminum blisters with 14 hard capsules per card and 4 cards (56 hard capsules) per carton. Not all pack sizes may be marketed. ...
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, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Marketing authorization number(s)
EU/1/96/009/001-008
Date of first authorization / renewal of the authorization
Date of first authorisation: 08 May 1996 Date of last renewal: 20 April 2011
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