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EMEND Hard capsule (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

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 nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12. EMEND 125 mg/80 mg is given as part of combination therapy ...

Posology and method of administration

Posology Adults EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT<sub>3</sub> antagonist. The recommended dose is 125 mg orally once daily one hour before start of ...

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 non-hormonal back-up methods of contraception ...

Effects on ability to drive and use machines

EMEND may have minor influence on the ability to drive, cycle 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 adults in more than 50 studies and 184 children and adolescents in 2 pivotal paediatric clinical trials. ...

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: A04AD12 Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK<sub>1</sub>) receptors. 3-day regimen ...

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, toxicity to reproduction and development. ...

List of excipients

<u>Capsule content:</u> Sucrose Microcrystalline cellulose (E460) Hydroxypropylcellulose (E463) Sodium laurilsulfate <u>Capsule shell (125 mg):</u> Gelatin Titanium dioxide (E171) Red iron oxide (E172) ...

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. Aluminium blister containing one 80 mg capsule. Aluminium blister containing two 80 mg capsules. 5 Aluminium blisters each containing one ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/03/262/001 EU/1/03/262/002 EU/1/03/262/003 EU/1/03/262/004 EU/1/03/262/005 EU/1/03/262/006

Date of first authorization / renewal of the authorization

Date of first authorisation: 11 November 2003 Date of latest renewal: 22 September 2008

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