Emend powder lyophilized for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fosaprepitant (fosaprepitant dimeglumine)

Available from:

Merck Sharp & Dohme B.V.

ATC code:

A04AD12

INN (International Name):

fosaprepitant (fosaprepitant dimeglumine)

Dosage:

150mg

Pharmaceutical form:

powder lyophilized for solution for infusion

Units in package:

(1) glass vial 10ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-03-17

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EMEND 150 mg powder for solution for infusion.
2.
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 (1 mg/ml) (see section 6.6).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white amorphous powder.
4.
CLINICAL PARTICULARS
4.1
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.
EMEND 150 mg is given as part of a combination therapy (see section
4.2).
4.2
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).
EMEND should be administered in
conjunction with a corticosteroid and a 5-HT3 antagonist as specified
in the tables below.
3
The following regimens are recommended for the prevention of nausea
and vomiting associated with
emetogenic cancer chemotherapy.
_Highly Emetogenic Chemotherapy Regimen_
Day 1
Day 2
Day 3
Day 4
EMEND
150 mg
intravenously
none
none
none
Dexamethasone
12 mg orally
8 mg orally
8 MG ORALLY TWICE
DAILY
8 MG ORALLY TWICE
DAILY
5-HT
3
antagonists
Standard dose of
5-HT
3
antagonists.
See the product
information for the
selected 5-HT
3
antagonist for
appropriate dosing
information
none
none
none
DEXAMETHASONE
should be administered 30 minutes prior to chemotherapy treatment on
Day 1 and in
the morning on Days 2 to 4. Dexamethasone should also be administered
in the evenings on
Days 3 and 4. The dose of dexamethasone accounts for active substance
interactions.
_Moderately Emetogenic Chemotherapy Regimen_
Day 1
EMEND
150 mg intravenously
Dexamethasone
12 mg ora