Zofran solution for i/v and i/m injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ondansetron (ondansetron hydrochloride dihydrate)

Available from:

GlaxoSmithKline Manufacturing S.p.A.

ATC code:

A04AA01

INN (International Name):

ondansetron (ondansetron hydrochloride dihydrate)

Dosage:

2mg/ml

Pharmaceutical form:

solution for i/v and i/m injection

Units in package:

(5) ampoules 4ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-02-15

Patient Information leaflet

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PATIENT INFORMATION LEAFLET (PIL)
PATIENT INFORMATION LEAFLET (PIL)
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PATIENT INFORMATION LEAFLET (PIL)
ZOFRAN™ INJECTION
ONDANSETRON HYDROCHLORIDE DIHYDRATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of aqueous solution contains 2 mg ondansetron as
hydrochloride dihydrate.
PHARMACEUTICAL FORM
A clear, colourless, sterile solution for injection or infusion.
CLINICAL PARTICULARS
INDICATIONS
_ADULTS_
_ZOFRAN _
injection is indicated for the management of nausea and vomiting
induced by
cytotoxic chemotherapy and radiotherapy.
_ZOFRAN _
is also indicated for the prevention and treatment of post-operative
nausea and
vomiting.
_PAEDIATRIC POPULATION_
_INJECTION AND ORAL FORMULATIONS:_
_ZOFRAN _
is indicated for the management of nausea and vomiting induced by
cytotoxic
chemotherapy.
No studies have been conducted on the use of orally administered
ondansetron in the
prevention or treatment of post-operative nausea and vomiting; IV
injection is
recommended for this purpose.
DOSAGE AND ADMINISTRATION
_ZOFRAN _
is available for oral, parenteral and rectal use to allow the route of
administration and dosing to be flexible.
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PATIENT INFORMATION LEAFLET (PIL)
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND
VOMITING (CINV AND RINV)
The emetogenic potential of cancer treatment varies according to the
doses and
combinations of chemotherapy and radiotherapy regimens used. The
selection of dose
regimen should be determined by the severity of the emetogenic
challenge.
POPULATIONS
•
CINV AND RINV IN ADULTS
The recommended intravenous (IV) or intramuscular (IM) dose of
_ZOFRAN _
is 8 mg
administered immediately before treatment.
For highly emetogenic chemotherapy, a maximum initial ondansetron dose
of 16 mg IV
infused over 15 minutes may be used. A single IV dose greater than 16
mg should not be
given.
The efficacy of
_ZOFRAN _
in highly emetogenic chemotherapy may be enhanced by the
addition of a single IV dose

Summary of Product characteristics

ANNEX I
SAMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICAL PRODUCT
ZOFRAN, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of aqueous solution contains 2 mg ondansetron as
hydrochloride dihydrate.
3.
PHARMACEUTICAL FORM
A clear, colourless, sterile solution for injection or infusion.
4.
CLINICAL PARTICULARS
4.1 INDICATIONS
_ADULTS_
_ZOFRAN _
injection is indicated for the management of nausea and vomiting
induced by
cytotoxic chemotherapy and radiotherapy.
_ZOFRAN _
is also indicated for the prevention and treatment of post-operative
nausea and
vomiting.
_PAEDIATRIC POPULATION_
_INJECTION AND ORAL FORMULATIONS:_
_ZOFRAN _
is indicated for the management of nausea and vomiting induced by
cytotoxic
chemotherapy.
No studies have been conducted on the use of orally administered
ondansetron in the
prevention or treatment of post-operative nausea and vomiting; IV
injection is
recommended for this purpose.
4.2 DOSAGE AND ADMINISTRATION
_ZOFRAN _
is available for oral, parenteral and rectal use to allow the route of
administration and dosing to be flexible.
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND
VOMITING (CINV AND RINV)
The emetogenic potential of cancer treatment varies according to the
doses and
combinations of chemotherapy and radiotherapy regimens used. The
selection of dose
regimen should be determined by the severity of the emetogenic
challenge.
POPULATIONS
CINV AND RINV IN ADULTS
The recommended intravenous (IV) or intramuscular (IM) dose of
_ZOFRAN _
is 8 mg
administered immediately before treatment.
For highly emetogenic chemotherapy, a maximum initial ondansetron dose
of 16 mg IV
infused over 15 minutes may be used. A single IV dose greater than 16
mg should not be
given.
The efficacy of
_ZOFRAN _
in highly emetogenic chemotherapy may be enhanced by the
addition of a single IV dose of dexamethasone sodium phosphate 20 mg,
administered
prior to chemotherapy.
IV doses greater than 8 mg and up to a maximum of 16 mg must be
diluted in 50 mL to
100
mL
of
0.9%
Sodium
Chloride