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GAMIDARIN 2 MG/ML SOLUTION FOR INJECTION/INFUSION

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To prevent nausea and vomiting after an operation
-- The usual dose for adults is 4 mg given by an injection into your vein. This will be given just before your operation.
-- For children aged over 6 months and adolescents, the usual dose for children is a dose of 0.15 mg/kg (body weight).
The maximum dose is 4 mg given as an injection into the vein. This will be given just before the operation.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gamidarin 2 mg/ml Solution for Injection/infusion
ondansetron
The name of your medicine is Gamidarin 2 mg/ml Solution for Injection/infusion, which will be called Gamidarin injection
or Gamidarin throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
-- Keep this leaflet. You may need to read it again.
-- If you have any further questions, ask your doctor 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Gamidarin injection is and what it is used for
2. Before you are given Gamidarin injection
3. How you are given Gamidarin injection
4. Possible side effects
5. How to store Gamidarin injection
6. Further information
1. What Gamidarin injection is and what it is used for
Gamidarin injection is a clear solution containing the active ingredient ondansetron (as ondansetron hydrochloride
dihydrate), which is an anti-emetic (prevents nausea [feeling sick] and vomiting).
Gamidarin injection is used to prevent and treat nausea and vomiting caused by chemotherapy or radiotherapy and for
the prevention and treatment of nausea and vomiting after surgery.
2. Before you are given Gamidarin injection
You should not be given Gamidarin injection if:
You are hypersensitive to ondansetron or to other selective 5HT3 receptor antagonists (e.g. granisetron, dolasetron) or to
any of the excipients (see list of ingredients in section 6).
Take special care with Gamidarin injection if:
-- you have a blockage in your gut or suffer from severe constipation. Gamidarin can enhance the blockage or constipation
-- you have ever had heart problems
-- you have an uneven heart beat (arrhythmias)
-- you are having your tonsils out
-- you have liver problems
-- you have undergone surgery to remove tonsils situated at the back of the nose (adenotonsillar surgery).
Taking other medicines:
You should tell your doctor if you are taking or have taken any of the following medicines as they may
interact with your Gamidarin injection:
-- phenytoin, carbamazepine (treatments for epilepsy)
-- rifampicin (an antibiotic)
-- tramadol (a painkiller)
-- beta-blockers (drugs that slow heart rate)
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines
obtained without a prescription.
It may still be alright for you to be given Gamidarin injection and your doctor will be able to decide what is suitable for you.
Pregnancy and lactation
Please tell your doctor if you are pregnant or planning to be pregnant. Ondansetron passes into breast milk, therefore
nursing mothers should not breast-feed.
Driving and using machines
Gamidarin injection has no effect on your ability to drive or use machines.
Important information about some of the ingredients in Gamidarin injection
This medicinal product contains 2.52 mmol (57.6 mg) sodium per maximum daily dose of 32 mg. To be taken into
consideration by patients on a controlled sodium diet.
3. How you are given Gamidarin injection
Method of administration
Gamidarin injection is given as intravenous injection (into a vein) or, after dilution, as intravenous infusion (for a longer
time). It will usually be given by a doctor or a nurse.
To prevent nausea and vomiting from chemotherapy or radiotherapy
On the day of chemotherapy or radiotherapy
-- the usual adult dose is 8 mg given by an injection into your vein, just before your treatment, and another 8 mg twelve
hours later. The usual dose in adults is 8 to 32 mg ondansetron a day. After chemotherapy, your medicine will usually
be given by mouth as an 8 mg Ondansetron tablet or 10 ml (8 mg) Ondansetron syrup.
On the following days
-- the usual adult dose is one 8 mg tablet or 10 ml (8 mg) syrup taken twice a day
-- this may be given for up to 5 days.
If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given more than the usual
dose of Gamidarin injection. Your doctor will decide this.
Children aged over 6 months and adolescents
The usual dose for children is a single intravenous dose of 5 mg/m2 (body area) immediately before chemotherapy; two
further intravenous doses may be given in 4-hourly intervals. 4 mg orally twice daily should be continued for up to 5 days
after a course of treatment.
On the day of chemotherapy or radiotherapy
-- the first dose is given by an injection into the vein, just before your child’s treatment. After chemotherapy, your child’s
medicine will usually be given by mouth; the usual dose is a 4 mg Ondansetron tablet or 5 ml (4 mg) Ondansetron
syrup twelve hours later.
On the following days
-- one 4 mg tablet or 5 ml (4 mg) syrup twice a day
-- this can be given for up to five days.

To treat nausea and vomiting after an operation
-- The usual adult dose is 4 mg given by an injection into your vein.
-- For children aged over 6 months and adolescents, the usual dose for children is a dose of 0.1 mg/kg (body weight).
The maximum dose is 4 mg given as an injection into the vein.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg.
If you keep feeling or being sick
Gamidarin injection should start to work soon after having the injection. If you continue to be sick or feel sick, tell your
doctor or nurse.
If you have been given more Gamidarin injection than you should
Your doctor or nurse will give you Gamidarin injection so it is unlikely that you will receive too much. If you think you have
been given too much or have missed a dose, tell your doctor or nurse.
If you forget to take Gamidarin injection
If you think you have missed a dose, please tell your doctor or nurse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Gamidarin injection can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, tell your doctor or a member of the medical staff straight away. The signs may include:
-- sudden wheezing and chest pain or chest tightness
-- swelling of your eyelids, face, lips, mouth or tongue
-- skin rash - red spots or lumps under your skin (hives) anywhere on your body
-- collapse.
Side effects can be listed according to how often they occur:
Very common:
affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,0000
Not known:
frequency cannot be estimated from the available data
The following side effects have been reported:
Very common
-- headache
Common
-- constipation
-- sensation of warmth or flushing
-- interference with liver function tests
-- irritation and redness at the site of injection
-- local burning sensation following insertion of suppositories
Uncommon
-- low blood pressure, which can make you feel faint or dizzy
-- uneven heart beat
-- chest pain- fits
-- unusual body movements or shaking
-- hiccups
Rare
-- feeling dizzy or light headed
-- blurred vision
-- disturbance in heart rhythm (sometimes causing a sudden loss of consciousness)
Very rare
-- temporary blindness (most resolved within 20 minutes)
If any of the side effects gets serious, or if you notice any side effect not listed in the leaflet, please tell your
doctor or pharmacist.
5. How to store Gamidarin injection
Keep out of the reach and sight of children.
Your doctor or pharmacist knows how to store Gamidarin injection.
Do not use Gamidarin injection after the expiry date, which is stated on the packaging after “Exp”. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage temperature. Keep ampoules in the outer carton, in order to
protect from light.
Shelf life after opening
After first opening the medicinal product should be used immediately.
Shelf life after dilution of the solution
Chemical and physical in-use stability has been demonstrated for 36 hours at 2-8ºC with the solutions given in section
6.6.
The diluted solutions should be stored protected from light.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2
to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Only clear solutions practically free from particles should be used. Do not use if container is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.
6. Further information
What Gamidarin injection contains:
The active ingredient is ondansetron (as ondansetron hydrochloride dihydrate).
Each ml of solution for injection contains 2 mg ondansetron (as ondansetron hydrochloride dihydrate).
Each 2 ml ampoule contains 4 mg ondansetron (as ondansetron hydrochloride dihydrate)
Each 4 ml ampoule contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate)
The other ingredients are:
citric acid monohydrate, sodium citrate, sodium chloride, water for injections

What Gamidarin injection looks like and contents of the pack
Gamidarin injection is a clear colourless solution for injection/infusion filled in clear glass ampoule.
2 ml type I clear glass ampoules containing 2 ml of solution: pack size of 5 or 25 ampoules.
5 ml type I clear glass ampoules containing 4 ml of solution: pack size of 5 or 25 ampoules.
Not all pack sizes may be marketed
Marketing Authorization Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

Post-Operative Nausea and Vomiting (PONV):
Adults:
For treatment of established PONV a single dose of 4mg given by slow intravenous injection is recommended.
Paediatric population
PONV in children aged >1 month and adolescents
For prevention and treatment of PONV in paediatric patients having surgery performed under general anaesthesia, a
single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of
0.1mg/kg up to a maximum of 4mg either prior to, at or after induction of anaesthesia.
There are no data on the use of ondansetron in the treatment of PONV in children below 2 years of age.
Elderly:
There is limited experience in the use of ondansetron in the prevention and treatment of PONV in the elderly, however
Ondansetron is well tolerated in patients over 65 years receiving chemotherapy.

Manufacturer:
Pfizer Service Company BVBA
Hoge Wei 10 – B-1930
Zaventem
Belgium

Patients with Renal Impairment:
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with Hepatic Impairment:
Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or
severe impairment of hepatic function. In such patients a total daily dose of 8mg should not be exceeded.

Pfizer PGM
Zone Industrielle 29, route des Industries
37530 POCE-SUR-CISSE
France

Patients with poor Sparteine/Debrisoquine Metabolism:
No alteration of daily dosage or frequency of dosing is required.

This leaflet was last revised in 03/2014

2. Handling Instructions
Information for Healthcare professionals,
The following information is intended for medical or healthcare professionals only:

Compatibility with intravenous fluids:
0.08mg/ml concentration of Ondansetron with each diluents at the storage of 2-8 ºC for 36 hours. The solution must not
be sterilised in an autoclave.

1. Administration
Chemotherapy and Radiotherapy:

The solution is to be visually inspected prior to use (also after dilution). Only clear solutions practically free from particles
should be used. Do not use if container is damaged.

Adults:
The route of administration and dose of ondansetron should be flexible in the range of 8- 32mg a day and selected as
shown below.

Any unused product or waste material should be disposed of in accordance with local requirements.

Emetogenic chemotherapy and radiotherapy: Ondansetron can be given either by rectal, oral (tablets or syrup), or
intravenous administration.
For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8mg should be administered as a
slow intravenous injection immediately before treatment, followed by 8mg orally twelve hourly.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron should
be continued for up to 5 days after a course of treatment.
Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin,
ondansetron can be given either by rectal or intravenous administration. Ondansetron has been shown to be equally
effective in the following dose schedules over the first 24 hours of chemotherapy:
A single dose of 8mg by slow intravenous injection immediately before chemotherapy.
A dose of 8mg by slow intravenous injection immediately before chemotherapy, followed by two further intravenous doses
of 8mg two to four hours apart, or by a constant infusion of 1mg/hour for up to 24 hours.
A single dose of 16 mg diluted in 50-100ml of saline or other compatible infusion fluid (see Pharmaceutical Precautions)
and infused over not less than 15 minutes immediately before chemotherapy.
A single dose greater than 16 mg must not be given due to dose dependant increase of QT prolongation risk (see sections
4.4, 4.8 and 5.1 of SPC).
The selection of dose regimen should be determined by the severity of the emetogenic challenge.
The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous
dose of dexamethasone sodium phosphate, 20mg administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron should
be continued for up to 5 days after a course of treatment.
Paediatric Population:
CINV in children aged > 6 months and adolescents
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below.
BSA-based dosing for Chemotherapy - Children aged > 6 months and adolescents
BSA

5 mg/m2 i.v. plus 2 mg syrup after
12 hrs

2 mg syrup every 12 hrs

≥ 0,6 m2
< 1,2 m2
b

Days 2-6(b)

< 0.6 m2

a

Day 1 (a,b)

5 mg/m2 i.v. plus 4 mg syrup or
tablet after 12 hrs

4 mg syrup or tablet every 12 hrs

The intravenous dose must not exceed 8mg.
The total daily dose must not exceed adult dose of 32 mg.

Weight-based dosing for Chemotherapy - Children aged > 6 months and adolescents
Weight

Day 1 (a,b)

Days 2-6(b)

≤ 10 kg

Up to 3 doses of 0.15 mg/kg every
4 hrs

2 mg syrup every 12 hrs

> 10 kg

b

Dilutions of Gamidarin in the above mentioned diluents have been demonstrated to be stable in polyvinyl chloride (PVC)
infusion bags, Non polyvinyl chloride (Non-PVC) infusion bags, Ph. Eur. Type I glass bottles and polyvinyl chloride (PVC)
administration sets.
Dilutions of Gamidarin in sodium chloride 0.9%w/v or in glucose 5%w/v have been demonstrated to be stable in
polypropylene syringes.
Compatibility with other drugs:
Gamidarin 2mg/ml Solution for Injection may be administered by intravenous infusion at 1mg/hour, e.g. from an infusion
bag or syringe pump. The following drugs may be administered via the Y-site of the Gamidarin 2mg/ml Solution for
Injection giving set for ondansetron concentrations of 16 to 160 micrograms/ml (e.g. 8 mg/500 ml and 8 mg/50 ml
respectively);
Cisplatin:
Concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml) administered over one to eight hours.
Carboplatin:
Concentrations in the range 0.18 mg/ml to 9.9 mg/ml (e.g. 90 mg in 500 ml to 990 mg in 100 ml), administered over
ten minutes to one hour.
Etoposide:
Concentrations in the range 0.14 mg/ml to 0.25 mg/ml (e.g. 72 mg in 500 ml to 250 mg in 1 litres), administered over
thirty minutes to one hour.
Ceftazidime:
Doses in the range 250 mg to 2000 mg reconstituted with Water for Injections BP as recommended by the manufacturer
(e.g. 2.5 ml for 250 mg and 10 ml for 2g ceftazidime) and given as an intravenous bolus injection over approximately
five minutes.
3. Storage information
Keep ampoules in the outer carton, in order to protect from light.
Shelf life after opening:
After first opening the medicinal product should be used immediately.
Shelf life after dilution of the solution:
Chemical and physical in-use stability has been demonstrated for 36 hours at 2-8ºC.
The diluted solutions should be stored protected from light.

For children with a body surface area of greater than 1.2 m2 an initial i.v. dose of 8 mg is administered immediately before
chemotherapy, followed by 8 mg orally 12 hours later. 8mg ondansetron, orally twice daily can be continued for up to five
days after a course of treatment.

a

Gamidarin 2mg/ml Solution for Injection should only be mixed with those infusion solutions, which are recommended:
Sodium Chloride Intravenous Infusion 0.9%w/v
Glucose Intravenous Infusion 5%w/v
Mannitol Intravenous Infusion 10%w/v
Ringers Intravenous Infusion
Potassium Chloride 0.3%w/v and Sodium Chloride 0.9%w/v Intravenous Infusion
Potassium Chloride 0.3%w/v and Glucose 5%w/v Intravenous Infusion

Up to 3 doses of 0.15 mg/kg every
4 hrs

4 mg syrup or tablet every 12 hrs

The intravenous dose must not exceed 8mg.
The total daily dose must not exceed adult dose of 32 mg.

Elderly:
Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of
administration are required.
Patients with Renal Impairment:
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with Hepatic Impairment:
Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or
severe impairment of hepatic function. In such patients a total daily dose of 8mg should not be exceeded.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at
2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.

Expand Transcript

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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