ZEPATIER Film-coated tablet (2022)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

ZEPATIER 50 mg/100 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir. Excipients with known effect: Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 69.85 mg of sodium. ...

3. Pharmaceutical form

Film-coated tablet. Beige, oval tablet of dimensions 21 mm x 10 mm debossed with 770 on one side and plain on the other.

4.1. Therapeutic indications

ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1). For hepatitis C ...

4.2. Posology and method of administration

ZEPATIER treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. Posology The recommended dose is one tablet once daily. Recommended regimens and ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 5.2). Co-administration ...

4.4. Special warnings and precautions for use

ALT elevations The rate of late ALT elevations during treatment is directly related to the plasma exposure to grazoprevir. During clinical studies with ZEPATIER with or without ribavirin, <1% of subjects ...

4.5. Interaction with other medicinal products and other forms of interaction

Potential for other medicinal products to affect ZEPATIER Grazoprevir is a substrate of OATP1B drug transporters. Co-administration of ZEPATIER with medicinal products that inhibit OATP1B transporters ...

4.6. Fertility, pregnancy and lactation

If ZEPATIER is co-administered with ribavirin, the information for ribavirin with regard to contraception, pregnancy testing, pregnancy, breast-feeding, and fertility also applies to this combination regimen ...

4.7. Effects on ability to drive and use machines

ZEPATIER (administered alone or in combination with ribavirin) is not likely to have an effect on the ability to drive and use machines. Patients should be informed that fatigue has been reported during ...

4.8. Undesirable effects

Summary of the safety profile The safety of ZEPATIER was assessed based on 3 placebo-controlled studies and 7 uncontrolled Phase 2 and 3 clinical studies in approximately 2,000 subjects with chronic hepatitis ...

4.9. Overdose

Human experience of overdose with ZEPATIER is limited. The highest dose of elbasvir was 200 mg once daily for 10 days, and a single dose of 800 mg. The highest dose of grazoprevir was 1,000 mg once daily ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, Direct acting antivirals, Antivirals for treatment of HCV infections ATC code: J05AP54 Mechanism of action ZEPATIER combines two direct-acting ...

5.2. Pharmacokinetic properties

Absorption Following administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir peak plasma concentrations occur at a median Tmax of 3 hours (range of 3 to 6 hours); grazoprevir peak plasma ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development with grazoprevir ...

6.1. List of excipients

Tablet core: Sodium laurilsulfate Vitamin E polyethylene glycol succinate Copovidone Hypromellose Microcrystalline cellulose Mannitol (E421) Lactose monohydrate Croscarmellose sodium Sodium chloride ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package until use to protect from moisture.

6.5. Nature and contents of container

The tablets are packaged into a carton containing two (2) cardboard cards, each cardboard card containing (2) 7-count aluminium blisters sealed in a cardboard card for a total of 28 tablets.

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

8. Marketing authorization number(s)

EU/1/16/1119/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 22 July 2016 Date of latest renewal: 06 May 2021

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf