EMEND Hard capsule (2018)
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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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