KYTRIL 3 Mg/Ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GRANISETRON HYDROCHLORIDE

Available from:

Roche Products Limited

ATC code:

A04AA02

INN (International Name):

GRANISETRON HYDROCHLORIDE

Dosage:

3 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Serotonin (5HT3) antagonists

Authorization status:

Authorised

Authorization date:

1996-12-16

Patient Information leaflet

1 
Kytril-PIL-clean-1403-1mg-3mg-sol-for-inj-inf 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

KYTRIL 1 MG/1 ML SOLUTION FOR INJECTION 
KYTRIL 3 MG/3 ML SOLUTION FOR INJECTION 

Granisetron 

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, ask your doctor, nurse or
pharmacist. 
- 
This medicine has been prescribed for you. Do not pass it on to
others. It may harm 
them, even if their symptoms 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. See section 4. 

IN THIS LEAFLET:  
1. 
What Kytril is and what it is used for 
2. 
What you need to know before you are given Kytril 
3. 
How Kytril will be given 
4. 
Possible side effects 
5. 
How to store Kytril 
6. 
Contents of the pack and information 

1. 
WHAT KYTRIL IS AND WHAT IT IS USED FOR 

Kytril contains the active substance granisetron. This belongs to
a group of medicines called 
„5-HT
3
 receptor antagonists‟ or „anti-emetics‟. 

Kytril is used to prevent or treat nausea and
vomiting (feeling and being sick) caused by other 
medical treatments, such as chemotherapy 
[http://www.netdoctor.co.uk/medicines/effect/cancer.shtml]or radiotherapy for cancer, 
[http://www.netdoctor.co.uk/cancer/index.shtml]and by surgery. 

The solution for injection is for use in adults and children from
2 years old. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KYTRIL 

DO NOT USE KYTRIL  


  if you are allergic (hypersensitive) to
granisetron or any of the other ingredients of Kytril 
(listed in Section 6: Further information). 

If you are not sure, talk to your doctor, nurse or
pharmac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kytril 3 mg/3 ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is granisetron.
Each ml solution for injection contains 1 mg of granisetron (as the hydrochloride).
Excipient with known effect: sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The solution for injection is a clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kytril solution for injection is indicated in adults for the prevention and treatment of
- acute nausea and vomiting associated with chemotherapy and radiotherapy.
- post-operative nausea and vomiting.
Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with
chemotherapy and radiotherapy.
Kytril solution for injection is indicated in children aged 2 years and above for the prevention and treatment of acute
nausea and vomiting associated with chemotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV)_
_Prevention (acute and delayed nausea)_
A dose of 1-3 mg (10-40 µg/kg) of Kytril solution for injection should be administered either as a slow intravenous
injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy. The solution should be
diluted to 5ml per mg.
_Treatment (acute nausea)_
A dose of 1-3 mg (10-40 µg/kg) of Kytril solution for injection should be administered either as a slow intravenous
injection or as a diluted intravenous infusion and administered over 5 minutes. The solution should be diluted to 5ml
per mg. Further maintenance doses of Kytril solution for injection may be administered at least 10 minu