IVEMEND Powder for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
IVEMEND 150 mg powder for solution for infusion.
Qualitative and quantitative composition
Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant ...
Pharmaceutical form
Powder for solution for infusion. White to off-white amorphous powder.
Therapeutic indications
Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older. IVEMEND 150 mg is given as part of a combination ...
Posology and method of administration
Posology Adults The recommended dose is 150 mg administered as an infusion over 20-30 minutes on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6). IVEMEND should be administered ...
Contraindications
Hypersensitivity to the active substance or to polysorbate 80 or any of the other 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. IVEMEND should be used with ...
Interaction with other medicinal products and other forms of interaction
When administered intravenously fosaprepitant is rapidly converted to aprepitant. Fosaprepitant 150 mg, given as a single dose, is a weak inhibitor of CYP3A4. Fosaprepitant does not seem to interact with ...
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 fosaprepitant. Alternative non-hormonal back-up methods of contraception ...
Effects on ability to drive and use machines
IVEMEND may have minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration of IVEMEND (see section 4.8).
Undesirable effects
Summary of the safety profile In clinical studies, various formulations of fosaprepitant have been administered to a total of 2,687 adults including 371 healthy subjects and 2,084 patients, and 199 children ...
Overdose
In the event of overdose, fosaprepitant should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, emesis induced by a ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiemetics and antinauseants ATC code: A04AD12 Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant (see section ...
Pharmacokinetic properties
Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant. Plasma concentrations of fosaprepitant are below quantifiable levels within 30 minutes of the ...
Preclinical safety data
Pre-clinical data obtained with intravenous administration of fosaprepitant and oral administration of aprepitant reveal no special hazard for humans based on conventional studies of single and repeated ...
List of excipients
Disodium edetate (E386) Polysorbate 80 (E433) Lactose anhydrous Sodium hydroxide (E524) (for pH adjustment) and/or Hydrochloric acid diluted (E507) (for pH adjustment)
Incompatibilities
IVEMEND is incompatible with any solutions containing divalent cations (e.g. Ca2+, Mg2+), including Hartmans and lactated Ringers solutions. This medicinal product must not be mixed with other medicinal ...
Shelf life
2 years. After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the medicinal product should be used ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Nature and contents of container
10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap. Pack sizes: 1 or 10 vials. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
IVEMEND must be reconstituted and then diluted prior to administration. Preparation of IVEMEND 150 mg for intravenous administration: Inject 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection into ...
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/07/437/003 EU/1/07/437/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 January 2008 Date of latest renewal: 11 January 2013
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