Granisetron-AFT

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL; Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL

Tillgänglig från:

AFT Pharmaceuticals Ltd

INN (International namn):

Granisetron hydrochloride 1.12 mg/mL (equivalent to granisetron 1 mg/mL)

Dos:

1 mg/mL

Läkemedelsform:

Concentrate for injection

Sammansättning:

Active: Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection Active: Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL Excipient: Citric acid monohydrate Nitrogen Sodium chloride Sodium citrate Water for injection

Receptbelagda typ:

Prescription

Tillverkad av:

Qilu Pharmaceutical Co Ltd

Terapeutiska indikationer:

For the prevention & treatment of nausea & vomiting induced by cytotoxic chemotherapy (adults & children)

Produktsammanfattning:

Package - Contents - Shelf Life: Ampoule, glass, 1 mL per ampoule, 1 ampoule - 1 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, 3 mL per ampoule, 1 ampoule - 3 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, 1 mL per ampoule, 5 ampoules - 5 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, 3 mL per ampoule, 5 ampoules - 15 mL - 24 months from date of manufacture stored at or below 30°C protect from light

Tillstånd datum:

2013-05-02

Produktens egenskaper

NEW ZEALAND DATA SHEET
1.
GRANISETRON – AFT
Granisetron hydrochloride equivalent to Granisetron 1 mg/mL solution
for injection and 3 mg/3
mL, concentrated solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GRANISETRON-AFT injection is a sterile clear solution containing
granisetron hydrochloride.
Granisetron-AFT injection is available as an ampoule containing
granisetron hydrochloride,
equivalent to 3 mg of granisetron free base in 3 mL; and equivalent to
1 mg of granisetron free base
in 1 mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Granisetron-AFT, concentrated solution for injection, is indicated in:
Adults:
•
for the prevention and treatment of nausea and vomiting induced by
cytotoxic chemotherapy;
•
for the prevention of nausea and vomiting induced by radiotherapy.
•
prevention and treatment of post-operative nausea and vomiting
Children:
•
for the prevention of nausea and vomiting induced by cytotoxic
chemotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Chemotherapy induced nausea and vomiting
_Intravenous Administration _
_Adults:_
For prevention of nausea and vomiting in adults, a single dose of 3 mg
of GRANISETRON-
AFT should be administered as an intravenous infusion, diluted in 20
to 50 mL infusion fluid and
administered over 5 minutes prior to the start of chemotherapy. The
infusion should be commenced
within 30 minutes before the start of chemotherapy.
Prophylactic administration of GRANISETRON-AFT should be completed
prior to the start of
chemotherapy.
In clinical trials, the majority of patients have required only a
single dose of granisetron injection
to control nausea and vomiting over 24 hours.
For
treatment
of
established
nausea
and
vomiting
in
adults,
a
single
dose
of
1
mg
of
GRANISETRON-AFT should be administered as a 5 minute infusion. Further
treatment doses of
GRANISETRON-AFT may be administered if required at least 10 minutes
apart. The maximum
dose of GRAN