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GRANISETRON 1 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): GRANISETRON HYDROCHLORIDE

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Granisetron 1 mg/ml Concentrate
for Solution for Injection or Infusion
Granisetron hydrochloride

Other medicines and Granisetron
Tell your doctor, nurse or pharmacist if you are
taking, have recently taken or might take any other
medicines. This is because Granisetron can affect
the way some medicines work. Also some other
medicines can affect the way this injection works.

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, 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

In particular, tell your doctor, nurse or pharmacist if
you are taking the following medicines:
• medicines used to treat an irregular heartbeat
• other ‘5-HT3 receptor antagonist’ medicines such
as dolasetron or ondansetron (see “Warnings and
precautions” above)
• phenobarbital, a medicine used to treat epilepsy
• a medicine called ketoconazole used in the
treatment of fungal infections
• the antibiotic erythromycin used to treat bacterial
infections.

What is in this leaflet:
1. What Granisetron is and what it is used for
2. What you need to know before you use Granisetron
3. How to use Granisetron
4. Possible side effects
5. How to store Granisetron
6. Contents of the pack and other information

1.

Pregnancy and breast-feeding
You should not have this injection if you are
pregnant, trying to get pregnant or are
breast-feeding, unless your doctor has told you to.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor, nurse or pharmacist for advice before taking
any medicine.

What Granisetron is and what it is
used for

Driving and using machines
Granisetron has no or negligible effect on the ability
to drive or use machines.

Granisetron belongs to a group of medicines called
anti-emetics. It 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.

Granisetron contains sodium
This medicinal product contains 1.4 mmol (or
31.5 mg) sodium per maximum daily dosage (9 mg
granisetron). To be taken into consideration by
patients on a controlled sodium diet.

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

2.

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PACKAGE LEAFLET INFORMATION FOR THE USER

3.

What you need to know before you
use Granisetron

How to use Granisetron

The injection will be given to you by a doctor or
nurse. The dose of Granisetron varies from one
patient to another. It depends on your age, weight,
and whether you are being given the medicine to
prevent, or treat, nausea and vomiting. The doctor
will work out how much to give you.

Do not use Granisetron:
• if you are allergic to granisetron or any of the
other ingredients of this medicine (listed in section
6)
If you are not sure, talk to your doctor, nurse or
pharmacist before having the injection.

Granisetron can be given as an injection into the
veins (intravenous).

Warnings and precautions
Talk to your doctor, nurse or pharmacist before
having the injection:
• if you are having problems with your bowel
movements because of a blockage of your
gut (intestines)if you 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)
• if you are taking other ‘5-HT3 receptor
antagonist’ medicines. These include
dolasetron, ondansetron used like
Granisetron in the treatment and prevention
of nausea and vomiting.

Prevention of feeling or being sick following
radio- or chemotherapy
You will be given the injection before your radio- or
chemotherapy starts. The injection into your veins
will take between 30 seconds and 5 minutes and the
dose will usually be between 1 and 3 mg. The
medicine may be diluted before it is injected.

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Treatment of feeling or being sick following
radio- or chemotherapy
The injection will take between 30 seconds and 5
minutes and the dose will usually be between 1 and
3 mg. The medicine may be diluted before it is
injected into your veins. You may be given more
injections to stop your sickness after the first dose.
There will be at least 10 minutes between each injection. The most Granisetron you will be given is
9 mg a day.

Continued on the next page >>

Preparing the infusion

The following information is intended for healthcare
professionals only:

Adults: To prepare a dose of 1 mg or 3 mg, 1 ml or
3 ml is withdrawn from the vial and diluted in
infusion fluid to a total volume of 20 to 50 ml in any
of the following solutions: 0.9% w/v Sodium Chloride
Injection BP; 0.18% w/v Sodium Chloride and 4%
w/v Glucose Injection BP; 5% w/v Glucose Injection
BP; Hartmann's Solution for Injection BP; Sodium
Lactate Injection BP; or 10% Mannitol Injection BP.
No other diluents should be used.

Dilute before use. For single use only. Any unused
portion should be discarded.
Preparing the injection

Adults: To prepare a dose of 1 mg, 1 ml is
withdrawn from the vial and diluted to 5 ml with 0.9%
w/v Sodium Chloride Injection BP.
To prepare a dose of 3 mg, 3 ml is withdrawn from
the vial and diluted to 15 ml with 0.9% w/v Sodium
Chloride Injection BP (for bolus administration)

Continued on the next page >>

Artwork Proof Box
Ref: V008 - update SPC & PIL
Proof no.
005.0

SZ00000LT000

Date prepared:
10/01/2014

Colours:
Black
Dimensions: 136 x 296 mm

Font size:
7pt
Fonts:
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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 250 mg methyl-prednisolone,
which will be given both before and after your
radio- or chemotherapy.

side effects you can help provide more information
on the safety of this medicine.

5.

Keep this medicine out of the sight and reach of
children.

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.

Do not use Granisetron after the expiry date which is
stated on the vial and carton after Exp. The expiry
date refers to the last day of that month.

Keep the vial in the outer carton in order to protect
from light.
Do not freeze.

Diluted solution
Chemical and physical in-use stability has been
demonstrated for 24 hours at 25°C. From a
microbiological point of view, the product should be
used immediately.

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.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

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.

6.

If you are given too much Granisetron
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.

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

If you notice the following problem you must see a
doctor straight away:
• allergic reactions (anaphylaxis). The signs may
include swelling of the throat, face, lips and
mouth, difficulty in breathing or swallowing.

What Granisetron looks like and contents of the
pack
Granisetron is a concentrate for solution for injection
or infusion. The solution is clear, colourless to
slightly yellow solution.

Other side effects that may be experienced while
taking this medicine are:

- 1 ml of concentrate for solution for injection or
infusion is contained in 2 ml clear type I glass vial
with a 13 mm rubber stopper and an aluminium
seal with a dark blue flip-off button.
- Pack sizes: 1 and 5 vials.

Very common (may affect more than 1 in 10 people):
• headache
• constipation. Your doctor will monitor your condition.
Common (may affect up to 1 in 10 people):
• problems sleeping (insomnia)
• changes in how your liver is working shown
by blood tests
• diarrhoea.

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Contents of the pack and other
information

What Granisetron contains
- The active substance is granisetron (as
hydrochloride).
- Each vial with 1 ml concentrate for solution for
injection or infusion contains granisetron
hydrochloride equivalent to 1 mg granisetron.
- Each vial with 3 ml concentrate for solution for
injection or infusion contains granisetron
hydrochloride equivalent to 3 mg granisetron.
- The other ingredients are citric acid,
monohydrate, sodium chloride, sodium hydroxide
(for pH adjustment), hydrochloric acid (for pH
adjustment) and water for injection.

If you have any further questions on the use of this
medicine, ask your doctor, nurse or pharmacist.

4.

How to store Granisetron

- 3 ml of concentrate for solution for injection or
infusion is contained in 5 ml clear type I glass vial
with a 13 mm rubber stopper and an aluminium
seal with a dark blue flip-off button or infusion or
6 ml clear type I glass vial with a 20 mm rubber
stopper and an aluminium seal with a dark blue
flip-off button.
- Pack sizes: 1, 5 and 10 vials.
Not all pack sizes may be marketed.

Uncommon (may affect up to 1 in 100 people):
• skin rashes or an allergic skin reaction or
“nettle-rash” or “hives” (urticaria). The signs
may include red, raised itchy bumps
• changes in the heartbeat (rhythm) and
changes seen on ECG readings (electrical
recordings of the heart)
• abnormal involuntary movements, such as
shaking, muscle rigidity and muscle contractions.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisaion Holder:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or Lek Pharmaceuticals
d.d., Verovškova 57, 1526 Ljubljana, Slovenia.

Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting

This leaflet was last revised in 01/2014.

Paediatric population: To prepare the dose of
40 µg/kg the appropriate volume (up to 3 ml) is
withdrawn from the vial and diluted with infusion fluid
(as for adults) to a total volume of 10 to 30 ml

Diluted solution
Chemical and physical in-use stability has been
demonstrated for 24 hours at 25°C. From a
microbiological point of view, the product should be
used immediately.

Intravenous injections and infusions of Granisetron
should be prepared at the time of administration and
used immediately from a microbiological point of
view. In-use storage times and conditions prior to
use are not supported by microbiological data and
are the responsibility of the user.

This medicinal product should not be mixed with
other medicinal products.
Prophylactic administration of Granisetron should be
completed prior to the start of cytostatic therapy.

The diluted injections and infusions are to be
inspected visually for particulate matter prior to
administration. They should only be used if the
solution is clear and free from particles.

D1007005

Artwork Proof Box
Ref: V008 - update SPC & PIL
Proof no.
005.0

D1007005
SZ00000LT000

Date prepared:
10/01/2014

Colours:
Black
Dimensions: 136 x 296 mm

Font size:
7pt
Fonts:
Helvetica

SZ00000LT000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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