CRIXIVAN Hard capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
CRIXIVAN 400 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains indinavir sulphate corresponding to 400 mg of indinavir. Excipient with known effect: Each 400 mg capsule contains 149.6 mg of lactose. For the full list of excipients, see section ...
Pharmaceutical form
Hard capsule. The capsules are semi-translucent white and coded CRIXIVAN 400 mg in green.
Therapeutic indications
CRIXIVAN is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.
Posology and method of administration
CRIXIVAN should be administered by physicians who are experienced in the treatment of HIV infection. On the basis of current pharmacodynamic data, indinavir must be used in combination with other antiretroviral ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Indinavir with or without ritonavir should not be administered concurrently with medicinal products with narrow ...
Special warnings and precautions for use
Nephrolithiasis and tubulointerstitial nephritis Nephrolithiasis has occurred with indinavir therapy in adult patients with a cumulative frequency of 12.4% (range across individual trials: 4.7% to 34.4%). ...
Interaction with other medicinal products and other forms of interaction
The metabolism of indinavir is mediated by the cytochrome P450 enzyme CYP3A4. Therefore, other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant patients. Indinavir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Given ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. There are no data to suggest that indinavir affects the ability to drive and use machines. However, patients should ...
Undesirable effects
Nephrolithiasis occurred in approximately 10% of patients treated with the recommended (unboosted) dose of CRIXIVAN in a pooled analysis of controlled clinical trials (see also below table and in section ...
Overdose
There have been reports of human overdose with CRIXIVAN. The most commonly reported symptoms were gastro-intestinal (e.g., nausea, vomiting, diarrhoea) and renal (e.g., nephrolithiasis, flank pain, haematuria). ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitor ATC code: JO5AE02 Mechanism of action Indinavir inhibits recombinant HIV-1 and HIV-2 protease with an approximate tenfold selectivity ...
Pharmacokinetic properties
Absorption Indinavir is rapidly absorbed in the fasted state with a time to peak plasma concentration of 0.8 hours ± 0.3 hours (mean ± S.D.). A greater than dose-proportional increase in indinavir plasma ...
Preclinical safety data
Crystals have been seen in the urine of rats, one monkey, and one dog. The crystals have not been associated with medicinal product-induced renal injury. An increase in thyroidal weight and thyroidal follicular ...
List of excipients
Capsule content: Anhydrous lactose Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Printing ink: titanium dioxide (E171), indigo carmine (E132) and iron oxide (E172)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years for HDPE bottles containing 90 and 180 hard capsules.
Special precautions for storage
Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
HDPE bottles with a polypropylene cap and a foil induction cap containing 90 or 180 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
The bottles contain desiccant canisters that should remain in the container. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/96/024/004 EU/1/96/024/005
Date of first authorization / renewal of the authorization
Date of first authorisation: 04 October 1996 Date of latest renewal: 18 July 2011
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