Ondansetron-Teva

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

ondansetron (ondansetron hydrochloride dihydrate)

Dostupné z:

Teva Pharmaceutical Works Private Limited Company

INN (Medzinárodný Name):

ondansetron (ondansetron hydrochloride dihydrate)

Dávkovanie:

2mg/ml

Forma lieku:

solution for injection

Typ predpisu:

Prescription

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
Ondansetron-Teva 2mg/ml Solution for Injection
2. QUALITATIVE UND QUANTITATIVE COMPOSITION
Each 2 ml glass ampoule contains 2 ml of aqueous solution containing 4
mg ondansetron (as
hydrochloride dihidrate).
Each 2 ml glass ampoule contains 4 ml of aqueous solution containing 8
mg ondansetron (as
hydrochloride dihidrate).
For a complete list of other ingredients see Section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection
Ondansetron-Teva 2mg/ml Solution for Injection in a colorless, clear
solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults: _
Ondansetron is indicated for the management of nausea and vomiting
induced by cytotoxic
chemotherapy and radiotherapy, and for the prevention and treatment of
post-operative nausea and
vomitinh (PONV).
_Paediatric: _
Ondansetron is indicated for the management of chemotherapy- induced
nausea and vomiting
(CINV) in children aged ≥6 months, and for the prevention and
treatment of PONV in children aged
≥1 month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Chemotherapy and radiotherapy:_ _
_Adults: _
The
emetogenic
potential
of
cancer
treatment
varies
according
to
the
doses
and
combinations of chemotherapy and radiotherapy regimens used. the route
of administration and
dose of ondansetron should be flexible in the range of 8-32 mg a day
and selected as shown below.
Adults and young people are given 1 ampoule of Metoclopramide 1 – 3
times daily (corresponding
to 10 mg Metoclopramide 1 – 3 times daily).
_Emetogenic chemotherapy and radiotherapy: _ Ondansetron can be given
either by oral (tablets),
intravenous or intramuscular administration. For most patients
receiving emetogenic chemotherapy
or
radiotherapy, ondansetron 8 mg should be administered as a slow
intravenous or intramuscular
injection immediately before treatment, followed by 8 mg orally twelve
hourly.
To protect against delayed or prolonged emesis after the first 24
hours, oral treatment with
ondansetron should be c