GRANISETRON TEVA 1 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GRANISETRON HYDROCHLORIDE

Available from:

Teva Pharma B.V.

ATC code:

A04AA02

INN (International Name):

GRANISETRON HYDROCHLORIDE

Dosage:

1 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

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

Therapeutic area:

Serotonin (5HT3) antagonists

Authorization status:

Authorised

Authorization date:

2008-05-30

Patient Information leaflet

each injection. The most Granisetron 
Teva you will be given is 9 mg in  
a day.
COMBINATION WITH STEROIDS
The effect of the injection may be 
improved by the use of medicines 
called adrenocortical steroids. 
The steroid will be given either 
as a dose between 8 and 20 mg 
dexamethasone before your radio- 
or chemotherapy or as a 250 mg 
methyl-prednisolone, which will be 
given both before and after your 
radio-or chemotherapy.
USE IN CHILDREN IN THE PREVENTION OR 
TREATMENT OF FEELING OR BEING SICK 
FOLLOWING RADIO- OR CHEMOTHERAPY 
Children will be given granisetron by 
injections into the vein as described 
above with the dose depending on 
the child’s weight. The injections 
will be diluted and be given before 
radio- or chemotherapy and will take 
5 minutes. Children will be given a 
maximum of 2 doses a day, at least 
10 minutes apart. 
TREATMENT OF FEELING OR BEING SICK 
FOLLOWING SURGERY 
The injection into your veins will take 
between 30 seconds and 5 minutes 
and the dose will usually be 1 mg. 
The most granisetron you will be 
given is 3 mg a day. 
USE IN CHILDREN IN THE PREVENTION OR 
TREATMENT OF FEELING OR BEING SICK 
FOLLOWING SURGERY 
Children should not be given this 
injection to treat sickness or the 
feeling of sickness after surgery. 
IF YOU ARE GIVEN TOO MUCH 
GRANISETRON TEVA
Because the injection will be given 
to you by a doctor or nurse, it 
is unlikely that you will be given 
too much. However, if you are 
worried talk to your doctor or nurse. 
Symptoms of overdose include 
mild headaches. You will be treated 
depending on your symptoms. 
If you have any further questions on 
the use of this medicine, ask your 
doctor, nurse or pharmacist. 
  POSSIBLE SIDE EFFECTS
Like all medicines, Granisetron Teva 
can cause side effects, although not 
everybody gets them. If you notice 
the following you must see a doctor 
straight away. 
•  allergic reactions (anaphylaxis).
The signs may include swelling 
of the throat, face, lips and

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Granisetron Teva 1 mg/1 ml Concentrate for Solution for Infusion or Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of concentrate contains 1 mg granisetron (as granisetron hydrochloride).
Each vial contains 1 ml of concentrate.
_Excipients_
Each 1 ml of concentrate contains 3.5 mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion or injection.
Sterile, clear colourless solution at pH 5.0-7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Granisetron concentrate for solution for infusion or 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.
Granisetron concentrate for solution for infusion or injection is indicated for the prevention of delayed nausea and
vomiting associated with chemotherapy and radiotherapy.
Granisetron concentrate for solution for infusion or 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 granisetron concentrate for solution for infusion or 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 5 ml per mg.
_Treatment (acute nausea)_
A dose of 1-3 mg (10-40 µg/kg) of granisetron concentrate for solution for infusion or injection should be administered
either