EMEND IV Fosaprepitant for injection (2018)
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
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
EMEND IV Fosaprepitant for injection. 150 mg fosaprepitant /vial (as fosaprepitant dimeglumine).
Summary product information
Route of Administration Dosage Form/Strength Non-Medicinal Ingredients Intravenous Lyophilized powder/150 mg/vial Edetate disodium, polysorbate 80, lactose anhydrous, sodium hydroxide and/or hydrochloric ...
Indications and clinical use
EMEND IV (fosaprepitant dimeglumine), in combination with a 5-HT<sub>3</sub> antagonist class of antiemetics and dexamethasone, is indicated for the: prevention of acute and delayed nausea and vomiting ...
Contraindications
Patients who are hypersensitive to EMEND IV, aprepitant, polysorbate 80, or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the ...
Warnings and precautions
Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock, during or soon after infusion of fosaprepitant have occurred. Symptoms including flushing, erythema, ...
Adverse reactions
Clinical Trial Adverse Experiences The overall safety of fosaprepitant was evaluated in approximately 1600 individuals. Moderately Emetogenic Chemotherapy (MEC) In an active-controlled clinical trial in ...
Drug interactions
Following the infusion of fosaprepitant 150 mg, a higher aprepitant C<sub>max</sub> (~2.6-fold) was observed compared to oral aprepitant (125 mg). A theoretical risk for increased adverse experiences due ...
Dosage and administration
Dosing Consideration EMEND IV is available as a 150 mg for IV infusion. EMEND IV has not been demonstrated to be effective as a single anti-emetic agent and must be administered with other anti-emetic ...
Overdosage
For management of a suspected drug overdose, contact your regional Poison Control Centre. No specific information is available on the treatment of overdosage. Single doses up to 200 mg of fosaprepitant ...
Action and clinical pharmacology
Mechanism of Action Fosaprepitant is a prodrug of aprepitant and accordingly, its antiemetic effects are attributable to aprepitant. Aprepitant has a unique mode of action; it is a selective high affinity ...
Storage and stability
Vials: store at 2-8°C.
Dosage forms, composition and packaging
EMEND IV is available as a 150 mg single dose per 10 mL glass vial as a white to off-white lyophilized solid to be administered intravenously as an infusion, upon reconstitution and dilution. One vial ...
Pharmaceutical information
Drug Substance Common name: Fosaprepitant dimeglumine Chemical name: Fosaprepitant dimeglumine is a prodrug of aprepitant and is chemically described as 1-Deoxy-1-(methylamino)-Dglucitol[3 -[[(2R,3S)-2 ...
Detailed pharmacology
Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant, a substance P/neurokinin 1 (NK1) receptor antagonist. Plasma concentrations of fosaprepitant ...
Clinical trials
Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant. Oral administration of EMEND (aprepitant) in combination with ondansetron and dexamethasone has ...
Toxicology
Animal Toxicology Acute Toxicity The approximate oral LD<sub>50</sub> of aprepitant was >2000 mg/kg in female mice and rats. The approximate intraperitoneal LD<sub>50</sub> of aprepitant was >800 mg/kg, ...
Marketing authorization holder
Merck Canada Inc., 16750 route Transcanadienne, Kirkland, QC Canada H9H 4M7, www.merck.ca
Submission control number
218162
Date of revision
October 17, 2018
References
de Wit R, Herrstedt J, Rapoport B, Carides AD, Guoguang-Ma J, Elmer M et al. The oral NK(1) antagonist, aprepitant, given with standard antiemetics provides protection against nausea and vomiting over ...
Serious warnings and precautions box
Drug interactions may occur with: Medicinal products, including chemotherapeutic agents that are metabolized through CYP3A4. Increased plasma concentrations of concomitant products may occur (see DRUG ...
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
