Zofran

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Ondansetron hydrochloride dihydrate 2.5 mg/mL equivalent to to 2 mg/mL ondansetron base

Предлага се от:

Novartis New Zealand Ltd

INN (Международно Name):

Ondansetron hydrochloride dihydrate 2.5 mg/mL (equiv. to 2 mg/mL ondansetron base)

дозиране:

2 mg/mL

Лекарствена форма:

Solution for injection

Композиция:

Active: Ondansetron hydrochloride dihydrate 2.5 mg/mL equivalent to to 2 mg/mL ondansetron base Excipient: Citric acid monohydrate Sodium chloride Sodium citrate dihydrate Water for injection

Броя в опаковка:

Ampoule, plastic, 2 mL

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Glaxo Wellcome Manufacturing Pte Ltd

Терапевтични показания:

Zofran tablets, Zofran Solution for injection and Zofran Zydis wafers are indicated for: · management of nausea and vomiting induced by cytotoxic chemotherapy in children, adolescents and adults. · management of nausea and vomiting induced by radiotherapy in adults. Zofran Solution for Injection is also indicated for: · prevention of post-operative nausea and vomiting in children, adolescents and adults. Studies have not be conducted on the use of Zofran tablets or Zofran Zydis wafers in the prevention of post-operative nausea and vomiting in the paediatric population.

Каталог на резюме:

Package - Contents - Shelf Life: Ampoule, plastic, - 2 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, - 4 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 4mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 2mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 4mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 2mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Дата Оторизация:

1995-01-12

Листовка

 
1 
CONSUMER MEDICINE INFORMATION 
ZOFRAN
®
 INJECTION 
ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION 4MG/2ML AND
8MG/4ML  
WHAT IS IN THIS LEAFLET? 
Please read this leaflet carefully before you
start using Zofran. 
This leaflet answers some common
questions about Zofran Injection. It does not contain all of 
the available information. 
It does not take the place of talking
to your doctor or pharmacist. 
All medicines have risks and benefits. Sometimes new risks are
found even when a medicine 
has been used for many years. Your doctor has weighed the
risks of you using Zofran 
Injection against the
benefits they expect it will have for you. 
If you have any concerns about taking
this medicine, ask your doctor or pharmacist. 
KEEP THIS INFORMATION LEAFLET. You may need to read it again. 
WHAT ZOFRAN IS USED FOR 
Zofran is used to help stop the nausea (sick feeling) and
vomiting which can occur after 
certain treatments such as chemotherapy and
radiotherapy. It is also used for prevention of 
nausea and vomiting, which can occur after an operation. Zofran
should only be used to treat 
the nausea and vomiting for which it has been prescribed. 
Zofran is not addictive. 
BEFORE YOU USE ZOFRAN 
_WHEN YOU MUST NOT USE IT _
•  Do not use Zofran after the expiry or "use by" date
(EXP) printed on the pack. If you take it 
after the expiry date it may not work as well.  
•  Do not use Zofran if the
packaging is torn or shows signs of tampering or if the
solution in 
the injection looks cloudy, lumpy or discoloured.  
•  Do not give your Zofran Injection to anyone else.  
•  Do not use Zofran if you are taking apomorphine (used to
treat Parkinson’s disease) 
•  Do not take Zofran if you have ever had an
allergic reaction to ondansetron or any of the 
other ingredients in Zofran which are
li

Данни за продукта

 
1 
DATA SHEET

ZOFRAN
®
 INJECTION 
_ZOFRAN (ONDANSETRON HYDROCHLORIDE DIHYDRATE) INJECTION 4 MG _
_AND 8 MG _
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Zofran injection is a clear, colourless, sterile solution. 
Each 1 mL of aqueous 
solution contains 2 mg ondansetron as the hydrochloride
dihydrate.  Zofran 
injection is available in plastic ampoules containing ondansetron
4 mg in 2 mL 
or ondansetron 8 mg in 4 mL. 
PHARMACEUTICAL FORM 
Solution for IM or IV administration. 
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
Ondansetron injection is indicated for the management of nausea
and 
vomiting induced by cytotoxic chemotherapy and radiotherapy. 
Ondansetron 
injection is also indicated for the prevention and
treatment of post-operative 
nausea and vomiting. 
_POSOLOGY AND METHOD OF ADMINISTRATION _
Zofran is also available for oral use to allow the route
of administration and 
dosing to be flexible. 
•  CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND
VOMITING (CINV 
AND RINV) 
_ADULTS _
The
emetogenic potential of cancer treatment varies according to
the doses 
and combinations of chemotherapy and
radiotherapy regimens used. 
The dose range of Zofran injection is 8 to 32 mg a day and
selected as shown 
below:- 
The recommended intravenous or intramuscular dose of Zofran
is 8 mg 
administered immediately before treatment. 
For highly emetogenic chemotherapy, a maximum initial Zofran dose of 16
mg 
intravenous infused
over 15 minutes may be used. A single intravenous dose 
greater than 16 mg should not be given.  

2 
The efficacy of Zofran in
highly emetogenic chemotherapy may be enhanced 
by the addition of a single intravenous dose
of dexamethasone sodium 
phosphate 20 mg, administered prior to chemotherapy.  
Intravenous doses greater than 8 mg and up to
a maximum of 16 mg must be 
diluted in