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SPC, UK: EMEND 80mg, 125mg hard Capsules (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Sharp & Dohme Limited
Διεύθυνση :
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Name of the medicinal product

EMEND 125 mg hard capsules. EMEND 80 mg hard capsules.

Qualitative and quantitative composition

Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant. Excipient with known effect: Each capsule contains 125 mg of sucrose (in the 125 mg capsule). Excipient ...

Pharmaceutical form

Hard capsule. The 125 mg capsule is opaque with a white body and pink cap with 462 and 125 mg printed radially in black ink on the body. The 80 mg capsules are opaque with a white body and cap with 461 ...

Therapeutic indications

Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy in adults. Prevention of nausea and vomiting associated with moderately emetogenic ...

Posology and method of administration

Posology EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended posology of EMEND is 125 mg orally once daily one hour before start of chemotherapy ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with pimozide, terfenadine, astemizole or cisapride. (see section 4.5).

Special warnings and precautions for use

Patients with moderate to severe hepatic impairment There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. EMEND should be used with ...

Interaction with other medicinal products and other forms of interaction

Aprepitant (125 mg/80 mg) is a substrate, a moderate inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9. During treatment with EMEND, CYP3A4 is inhibited. After the end of treatment, ...

Fertility, pregnancy and lactation

Contraception in males and females The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of EMEND. Alternative or back-up methods of contraception should be ...

Effects on ability to drive and use machines

EMEND may have minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration of EMEND (see section 4.8).

Undesirable effects

Summary of the safety profile The safety profile of aprepitant was evaluated in approximately 6,500 individuals. The most common adverse reactions reported at a greater incidence in patients treated with ...

Overdose

In the event of overdose, EMEND should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, emesis induced by a medicinal ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiemetics and antinauseants ATC code: A04A D12 Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors. 3-day regimen of aprepitant ...

Pharmacokinetic properties

Aprepitant displays non-linear pharmacokinetics. Both clearance and absolute bioavailability decrease with increasing dose. Absorption The mean absolute oral bioavailability of aprepitant is 67 % for the ...

Preclinical safety data

Pre-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. However, it ...

List of excipients

Capsule content Sucrose Microcrystalline cellulose (E 460) Hydroxypropyl cellulose (E 463) Sodium laurilsulfate Capsule shell (125 mg) Gelatin Titanium dioxide (E 171) Red iron oxide (E 172) Yellow iron ...

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

Different pack sizes including different strengths are available. 80 mg capsules Aluminium blister containing one 80 mg capsule. Aluminium blister containing two 80 mg capsules. 5 Aluminium blisters each ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN 11 9BU United Kingdom

Marketing authorization number(s)

80 mg x 1: EU/1/03/262/001 80 mg x 2: EU/1/03/262/002 80 mg x 5: EU/1/03/262/003 125 mg x 1: EU/1/03/262/004 125 mg x 5: EU/1/03/262/005 80 mg x 2 and 125 mg x 1: EU/1/03/262/006

Date of first authorization / renewal of the authorization

Date of first authorisation: 11 November 2003 Date of latest renewal: 11 November 2008

Date of revision of the text

December 2011