ZOFRAN 16 Milligram Suppositories

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

ONDANSETRON

Dostupno od:

Novartis Pharmaceuticals UK Ltd

ATC koda:

A04AA01

INN (International ime):

ONDANSETRON

Doziranje:

16 Milligram

Farmaceutski oblik:

Suppositories

Tip recepta:

Product subject to prescription which may not be renewed (A)

Područje terapije:

Serotonin (5HT3) antagonists

Status autorizacije:

Authorised

Datum autorizacije:

2016-01-22

Uputa o lijeku

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
ZOFRAN® 16 MG SUPPOSITORIES 
ONDANSETRON  

READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START  USING  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 signs of illness are the same as yours. 

  If  you  get  any  side  effects,  talk  to  your  doctor,  nurse  or  pharmacist.  This  includes  any 
possible side effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET: 
1 
What Zofran suppositories are and what they are used for 
2 
What you need to know before you use Zofran suppositories  
3 
How to use Zofran suppositories 

4 
Possible side effects 
5 
How to store Zofran suppositories 
6 
Contents of the pack and other information 

1  
WHAT ZOFRAN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR  

Zofran  suppositories  contain  a  medicine  called  ondansetron.  This  belongs  to  a  group  of 
medicines  called  anti-emetics.  ZOFRAN  SUPPOSITORIES  ARE  FOR  USE  IN  YOUR  BACK  PASSAGE 
ONLY (RECTAL USE). THEY SHOULD NOT BE SWALLOWED. 

Zofran suppositories are used for: 

  preventing nausea and vomiting caused by chemotherapy 
[http://www.netdoctor.co.uk/medicines/effect/cancer.shtml]or
radiotherapy for cancer 
[http://www.netdoctor.co.uk/cancer/index.shtml] 
Ask  your  doctor,  nurse  or  pharmacist  if  you  would  like  any  further  explanation  about 
these uses. 

Zofran suppositories should start to work�

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 16 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 16.00 mg of ondansetron.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppositories.
White, smooth, homogeneous suppository with a torpedo shape.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zofran Suppositories are indicated for the management of nausea and
vomiting induced by cytotoxic chemotherapy and
radiotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zofran is also available for parenteral and oral 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.
_CINV AND RINV IN ADULTS:_
The recommended dose of Zofran Suppositories is one 16mg suppository
given 1-2 hours before treatment.
To protect against delayed or prolonged emesis after the first 24
hours, rectal treatment with Zofran should be
continued for up to 3 days, or oral treatment for up to 5 days after a
course of treatment. The recommended daily dose
of Zofran Suppositories is one 16mg suppository.
_PAEDIATRIC POPULATION:_
CINV IN CHILDREN AND ADOLESCENTS (AGED 6 MONTHS TO 17 YEARS)
The use of Zofran Suppositories in children is not recommended.
The usual method of administration is a single intravenous dose
immediately before chemotherapy, followed by an oral
dose twelve hours later. Oral therapy should be continued for up to 5
days after a course of treatment.
In paediatric clinical studies, ondansetron was given by IV infusion
diluted in 25 to 50 ml of saline or other compatible
infusion fluid (see section 6.6 Instructions for Use and Handling) and
infused over not less than 15 minutes.
_CINV AND RINV IN ELDERLY:_
Zofran is well tolerated