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SPC: CELSENTRI Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CELSENTRI 25 mg film-coated tablets. CELSENTRI 75 mg film-coated tablets. CELSENTRI 150 mg film-coated tablets. CELSENTRI 300 mg film-coated tablets.

Qualitative and quantitative composition

CELSENTRI 25 mg film-coated tablets: Each film-coated tablet contains 25 mg of maraviroc. Excipient with known effect: each 25 mg film-coated tablet contains 0.14 mg of soya lecithin. CELSENTRI 75 mg film-coated ...

Pharmaceutical form

Film-coated tablet. CELSENTRI 25 mg film-coated tablets: Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with MVC 25. CELSENTRI 75 mg film-coated tablets: ...

Therapeutic indications

CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adults, adolescents and children of 2 years of age, and older and weighing at least 10 kg ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Before taking CELSENTRI it has to be confirmed that only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 ...

Contraindications

Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

General 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 ...

Interaction with other medicinal products and other forms of interaction

Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5. Co-administration of maraviroc with medicinal products that induce CYP3A4 may decrease maraviroc concentrations and reduce its therapeutic ...

Fertility, pregnancy and lactation

Pregnancy There are limited data from the use of maraviroc in pregnant women. The effect of maraviroc on human pregnancy is unknown. Studies in animals showed reproductive toxicity at high exposures. Primary ...

Effects on ability to drive and use machines

Maraviroc may have a minor influence on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with maraviroc. The clinical status of the patient ...

Undesirable effects

Summary of the safety profile Adults Assessment of treatment related adverse reactions is based on pooled data from two Phase 2b/3 studies in treatment-experienced adult patients (MOTIVATE 1 and MOTIVATE ...

Overdose

Symptoms The highest dose administered in clinical studies was 1,200 mg. The dose limiting adverse reaction was postural hypotension. Prolongation of the QT interval was seen in dogs and monkeys at plasma ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, other antivirals ATC code: J05AX09 Mechanism of action Maraviroc is a member of a therapeutic class called CCR5 antagonists. Maraviroc selectively ...

Pharmacokinetic properties

Absorption The absorption of maraviroc is variable with multiple peaks. Median peak maraviroc plasma concentrations are attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial ...

Preclinical safety data

Primary pharmacological activity (CCR5 receptor affinity) was present in the monkey (100% receptor occupancy) and limited in the mouse, rat, rabbit and dog. In mice and human beings that lack CCR5 receptors ...

List of excipients

Tablet core: Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous Sodium starch glycolate Magnesium stearate Film-coat: Poly (vinyl alcohol) Titanium dioxide (E171) Macrogol 3350 Talc Soya ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

This medicinal product does not require any special storage condition.

Nature and contents of container

CELSENTRI 25 mg film-coated tablets: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated ...

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands

Marketing authorization number(s)

CELSENTRI 25 mg film-coated tablets: EU/1/07/418/011 CELSENTRI 75 mg film-coated tablets: EU/1/07/418/012 CELSENTRI 150 mg film-coated tablets: EU/1/07/418/001 (180 tablets) EU/1/07/418/002 (30 tablets) ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 18th September 2007 Date of latest renewal: 20 July 2012

Πηγαίο έγγραφο

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