Kytril 3 mg/3 ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Granisetron hydrochloride

Available from:

Atnahs Pharma Netherlands B.V.

ATC code:

A04AA; A04AA02

INN (International Name):

Granisetron hydrochloride

Dosage:

3 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Serotonin (5HT3) antagonists; granisetron

Authorization status:

Marketed

Authorization date:

1991-12-16

Patient Information leaflet

1
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 or radiotherapy for cancer, 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 pharmacist before
having the injection.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using Kytril,
especially if you:

are having problems with your bowel movements because of a blockage of
your gut (intestines)

have heart problems, are being treated for cancer with a medicine that
is known to damage your
heart or have problems with levels of salts, such as potassium, sodium
or calci

Summary of Product characteristics

Health Products Regulatory Authority
23 March 2021
CRN009X9N
Page 1 of 8
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 minutes apart. The maximum dose to be
administered over 24 hours should not exceed 9 mg.
_Combination with adrenocortical steroid _
The efficacy of parenteral granisetron