KYTRIL

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

GRANISETRON HYDROCHLORIDE

থেকে পাওয়া:

Atnahs Pharma UK Limited

এটিসি কোড:

A04AA02

INN (International Name):

GRANISETRON HYDROCHLORIDE

ডোজ:

3 Mg/Ml

ফার্মাসিউটিকাল ফর্ম:

Solution for Injection

প্রেসক্রিপশন টাইপ:

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

Therapeutic area:

granisetron

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1991-12-16

তথ্য লিফলেট

IE 735-1976 APIL 28051813
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this
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
See section 4.
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 calcium, in your body
(electrolyte abnormalities)
●
are taking other ‘5-HT
3
receptor antagonist’
medicines. These include dolasetron, ondansetron
used like Kytril in the treatment and preven

পণ্য বৈশিষ্ট্য

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 may be enhanced by an
additional intravenous dose of an adrenocortical stero