Zofran Flexi-amp 8mg/4ml solution for injection ampoules

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Ondansetron hydrochloride dihydrate

Fáanlegur frá:

Novartis Pharmaceuticals UK Ltd

ATC númer:

A04AA01

INN (Alþjóðlegt nafn):

Ondansetron hydrochloride dihydrate

Skammtar:

2mg/1ml

Lyfjaform:

Solution for injection

Stjórnsýsluleið:

Intravenous; Intramuscular

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04060000; GTIN: 5000123106295

Upplýsingar fylgiseðill

- 1 -
NOVARTIS (LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN
® FLEXI-AMP
® INJECTION 2 MG/ML
ONDANSETRON (AS HYDROCHLORIDE DIHYDRATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions about your illness or your medicine,
ask your doctor, nurse
or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist. This includes
any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Zofran injection is and what it is used for
2
What you need to know before you have Zofran injection
3
How to have Zofran injection
4
Possible side effects
5
How to store Zofran injection
6
Contents of the pack and other information
1
WHAT ZOFRAN INJECTION IS AND WHAT IT IS USED FOR
Zofran injection contains a medicine called ondansetron. This belongs
to a group of medicines
called anti-emetics.
Zofran injection is used for:

preventing nausea and vomiting caused by chemotherapy (in adults and
children) or
radiotherapy for cancer (adults only)

preventing nausea and vomiting after surgery.
Ask your doctor, nurse or pharmacist if you would like any further
explanation about
these uses.
2
WHAT YOU NEED TO KNOW BEFORE YOU HAVE ZOFRAN INJECTION
DO NOT HAVE ZOFRAN INJECTION IF:

you are taking apomorphine (used to treat Parkinson’s disease)

you are allergic (hypersensitive) to ondansetron or any of the other
ingredients in Zofran
injection (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
having Zofran injection.
WARNINGS AND PRECAUTIONS
Check with your doctor, nurse or pharmacist before having Zofran
injection if:

you have e

Vara einkenni

OBJECT 1
ZOFRAN FLEXI-AMP INJECTION
Summary of Product Characteristics Updated 13-Oct-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Zofran
®
Injection 2 mg/ml. Zofran Flexi-amp Injection 2 mg/ml.
2. Qualitative and quantitative composition
Zofran Injection 2 mg/ml: 2 ml glass ampoules each containing 4 mg
ondansetron (as hydrochloride
dihydrate) in aqueous solution for intramuscular or intravenous
administration. 4 ml glass ampoules each
containing 8 mg ondansetron (as hydrochloride dihydrate) in aqueous
solution for intravenous or
intramuscular administration.
Zofran Flexi-amp injection 2 mg/ml: 2 ml plastic ampoules each
containing 4 mg ondansetron (as
hydrochloride dihydrate) in aqueous solution for intramuscular or
intravenous administration. 4 ml plastic
ampoules each containing 8 mg ondansetron (as hydrochloride dihydrate)
in aqueous solution for
intravenous or intramuscular administration.
Excipients with a known effect: This product contains 7 mg of sodium
per 4 mg dose (see section 4.4).
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Injection (aqueous solution).
4. Clinical particulars
4.1 Therapeutic indications
_Adults:_
Zofran is indicated for the management of nausea and vomiting induced
by cytotoxic chemotherapy and
radiotherapy. Zofran is indicated for the prevention and treatment of
post-operative nausea and vomiting
(PONV).
_Paediatric Population:_
Zofran 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 induced nausea and vomiting.
_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 Zofran should be
flexible in the range of 8-32 mg a day and selected as shown below.
_Emetogenic chemotherapy and radiothera