Ondansetron 4mg/2ml Solution For Injection
Hospira
PACKAGE 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 further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Ondansetron Injection is and what it is used for
2. Before you take Ondansetron Injection
3. How to take Ondansetron Injection
4. Possible side effects
5. Storing Ondansetron Injection
Ondansetron 4 mg/2 ml and 8 mg/4 ml Solution for Injection
The active substance is ondansetron (as hydrochloride dihydrate).
Other ingredients are sodium chloride, citric acid monohydrate, sodium citrate and water for injections.
Marketing Authorisation Holder
Hospira Enterprises B.V.
Taurusavenue 19-21 2132LS Hoofddorp The Netherlands
Manufacturer
Hikma Farmaceutica (Portugal), Lda.
Estrada do Rio da M6 n.° 8, 8A e 8B - Fervenga
2705-906 Terrugem SNT
Portugal
1. What Ondansetron Injection is and what it is used for
Ondansetron Injection is a solution for injection, which is available as colourless glass ampoules containing 4 mg of ondansetron per 2 ml of solution and 8 mg of ondansetron per 4 ml of solution. Ondansetron Injection is packed in carton boxes of 5 ampoules.
The active substance of Ondansetron Injection belongs to a group of medicines known as antiemetics and antinau-seants being used to prevent vomiting and nausea induced by some medical treatments.
2. Before you take Ondansetron Injection
Do not take Ondansetron Injection
- if you are allergic to ondansetron or any of the other ingredients
Take special care with Ondansetron Injection
- if you are allergic to other antiemetic medicines
- if you have intestinal obstruction
- if you suffer from severe constipation
- if you have any liver disease
Also tell your doctor if you are taking any of the following medicines:
- Phenytoin
- Carbamazepine
- Rifampicin
- Tramadol
Pregnancy
Before starting treatment, you must tell your doctor if you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should receive Ondansetron Injection.
Breast-feeding
The ondansetron in Ondansetron Injection may pass into mother's milk. It is therefore better that mothers receiving Ondansetron Injection do not breast-feed.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, i.e. essentially 'sodium-free'.
3. How to take Ondansetron Injection
Daily dosage is fixed according to your individual need. Your doctor will tell you how long your treatment with Ondansetron Injection will last.
Ondansetron Injection will usually be given by a doctor or nurse.
Ondansetron Injection can be prescribed for two reasons:
- to prevent feelings of sickness (nausea) and sickness (vomiting) or
- to treat nausea and vomiting
For patients receiving chemotherapy and/or radiotherapy that causes nausea and vomiting:
The recommended dose is 8 mg given by intravenous injection (into a vein) or
intramuscular injection (into a muscle), immediately before chemotherapy
followed by an 8 mg tablet after 12 hours.
For patients receiving chemotherapy that causes severe nausea and vomiting any of the following dose schedules are recommended:
- 8 mg given by intravenous or intramuscular injection, immediately before chemotherapy
- 8 mg given by intravenous or intramuscular injection immediately before chemotherapy, followed by two further intravenous or intramuscular doses of 8 mg 2 to 4 hours apart, or by an intravenous infusion (drip) of 1 mg per hour for up to 24 hours.
- 32 mg given as an intravenous infusion (drip), over not less than 15 minutes, immediately before chemotherapy.
After the initial Ondansetron injection you may be given tablets or suppositories for up to 5 days to prevent any further nausea and vomiting.
If prescribed for a child, the dose depends on your child's weight and height, and is given by intravenous injection immediately before chemotherapy followed by a 4 mg tablet 12 hours later, which can be continued twice a day for up to 5 days following chemotherapy.
To prevent nausea and vomiting after an operation:
The usual adult dose is 4 mg given as an intravenous or intramuscular injection before the operation.
For children aged 2 years and over the dose is 0.1 mg per kilogram of body weight, up to a maximum of 4 mg, given as an intravenous injection before the operation.
To treat nausea and vomiting after an operation:
The usual adult dose is 4 mg given as an intravenous or intramuscular injection.
For children aged 2 years and over the dose is 0.1 mg per kilogram of body weight, up to a maximum of 4 mg, given as an intravenous injection.
Patients with moderate or severe liver disease:
The total daily dose should not be more than 8 mg.
If you have the impression that the effect of Ondansetron Injection is too strong or too weak, talk to your doctor.
Ondansetron Injection should start to work soon after having the injection. If you continue to be sick or feel sick, tell your doctor.
If you think you may have missed a dose or had too much, let your doctor or nurse know.
4. Possible side effects
Like all medicines, Ondansetron Injection can have side effects.
Ondansetron Injection is generally well tolerated. However, the following side effects may occur in some patients during treatment.
If any of the following rare side effects come on soon after having your injection, tell your doctor immediately:
- sudden chest tightness or wheeziness
- swelling of eyelids, face lips or tongue
- skin rash - red spots or hives (skin lumps)
- collapse
- upward rolling of the eyes
- abnormal muscular stiffness, body movements or shaking
- fits
- blurring of vision
If you experience any of these symptoms, advise your
doctor as soon as
possible:
- irregular or slow heartbeat
- dizziness or lightheaded feeling
- headache
- flushes of the face
- feeling of warmth in the head or stomach
- Irritation and redness at the site of injection
- upset bowels, constipation
- hiccups
If you have any blood tests to check how your liver is working, this medicine may affect the results.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. Storing Ondansetron Injection
Keep out of the reach and sight of children.
Do not store above 30°C. Keep ampoules in the outer carton to protect from light.
Ondansetron Injection should not be used if the ampoule is damaged or contains particles or is cloudy.
Do not use after the expiry date stated on the carton box.
This leaflet was prepared in May 2006.
TECHNICAL PACKAGE LEAFLET
NAME OF THE MEDICINAL PRODUCT
Ondansetron 4 mg/2 ml and 8 mg/4 ml Solution for Injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule containing 2 ml solution contains 4 mg ondansetron and each ampoule containing 4 ml solution contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate). The strength of the solution is 2 mg/ml ondansetron.
PHARMACEUTICAL FORM
Solution for injection
The aqueous solution is clear and colourless.
POSOLOGY AND METHOD OF ADMINISTRATION
Chemotherapy and radiotherapy:
Adults and elderly:
Emetogenic chemotherapy and radiotherapy:
Ondansetron hydrochloride 8 mg should be administered as a slow intravenous or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly.
Highly emetogenic chemotherapy:
The following dose schedules over the first 24 hours of chemotherapy are effective:
- A single dose of 8 mg by slow intravenous or intramuscular injection immediately before chemotherapy
- A dose of 8 mg by slow intravenous or intramuscular injection immediately before chemotherapy, followed by two further intravenous or intramuscular doses of 8 mg two or four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours
- A single dose of 32 mg diluted in 50-100 ml of saline or other compatible infusion fluid (see Pharmaceutical Precautions) and infused over not less than 15 minutes immediately before chemotherapy
The selection of dose regimen should be determined by the severity of the emetogenic challenge.
Children:
Ondansetron hydrochloride may be administered as a single intravenous dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally twelve hours later. 4 mg orally twice daily should be continued for up to 5 days after a course of treatment.
Patients with renal impairment:
No alteration of daily dosage, frequency of dosing or route of administration is required.
Patients with hepatic impairment:
A total daily dose of 8 mg should not be exceeded.
Post-operative nausea and vomiting (PONV):
Adults and elderly:
Ondansetron hydrochloride may be administered as a single dose of 4 mg given by intramuscular or slow intravenous injection at induction of anaesthesia.
For treatment of established PONV a single dose of 4 mg given by intramuscular or slow intravenous injection is recommended.
Children (aged 2 years and over):
Ondansetron may be administered by slow intravenous injection at a dose of 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.
For treatment of established PONV in paediatric patients, ondansetron may be administered by slow intravenous injection at a dose of 0.1 mg/kg up to a maximum of 4 mg.
Patients with renal impairment:
No alteration of daily dosage, frequency of dosing or route of administration is required.
Patients with hepatic impairment:
A total daily dose of 8 mg should not be exceeded.
Patients with poor sparteine / debrisoquine metabolism:
No alteration of daily dosage or frequency of dosing is required.
PHARMACEUTICAL PARTICULARS
List of excipients
Sodium chloride Citric acid monohydrate Sodium citrate Water for injections
Incompatibilities
Ondansetron Solution for Injection should not be administered in the same syringe or infusion as any other medication.
12 months (unopened). 24 hours (dilutions stored at 2-8°C).
Special precautions for storage
Do not store above 30°C. Keep ampoules in the outer carton.
Dilutions of Ondansetron Solution for Injection in compatible intravenous infusion fluids are stable under normal room lighting conditions or daylight for at least 24 hours, thus no protection from light is necessary while infusion takes place.
Nature and contents of container
Ondansetron 4 mg/2 ml Solution for Injection, is contained in 2 ml Type I colourless ampoules with a green marking for the One-Point-Cut.
Ondansetron 8 mg/4 ml, Solution for Injection, is contained in 5 ml Type I colourless ampoules with a blue marking for the One-Point-Cut.
There are packs of 1, 2, 5, 6, 10, 25, 50 and 5x 50 ampoules.
Instructions for use and handling
Compatibility with intravenous fluids:
Ondansetron Solution for Injection should only be admixed with those infusion solutions, which are recommended:
- Sodium chloride intravenous infusion 0.9 %
- Glucose intravenous infusion 5 %
- Mannitol intravenous infusion 10 %
- Ringer's intravenous infusion
- Potassium chloride 0.3 % and sodium chloride 0.9 % intravenous infusion
- Potassium chloride 0.3 % and glucose 5 % intravenous infusion
Dilutions of Ondansetron Solution for Injection in intravenous fluids should be prepared at the time of infusion or stored at 2-8°C for no more than 24 hours before the start of administration.
Compatibility studies have been undertaken in polyvinyl chloride infusion bags and polyvinyl chloride administration sets. It is considered that adequate stability would also be conferred by the use of polyethylene infusion bags or type I glass bottles.
Dilutions of Ondansetron Solution for Injection in sodium chloride 0.9 % or in glucose 5 % have been demonstrated to be stable in polypropylene syringes. It is considered that Ondansetron Solution for Injection diluted with other compatible infusion fluids would be stable in polypropylene syringes.
Compatibility with other drugs:
Ondansetron Solution for Injection may be administered by intravenous infusion at 1 mg/hour, e.g. from an infusion bag or syringe pump. The following drugs may be administered via the Y-site of the Ondansetron 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.
5-Fluorouracil:
Concentrations up to 0.8 mg/ml (e.g. 2.4 g in 3 litres or 400 mg in 500 ml) administered at a rate of at least 20 ml per hour (500 ml per 24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-flourouracil infusions may contain up to 0.045% (w/v) magnesium chloride in addition to other excipients shown to be compatible.
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 litre) administered over thirty minutes to one hour.
Ceftazidime:
Doses in the range 250 mg to 2000 mg, reconstituted with water for injections as recommended by the manufacturer (e.g. 2.5 ml for 250 mg and 10 ml for 2 g ceftazidime), and given as an intravenous bolus injection over approximately five minutes.
Cyclophosphamide:
Doses in the range 100 mg to 1 g, reconstituted with water for injections, 5 ml per 100 mg cyclophosphamide, as recommended by the manufacturer and given as an intravenous bolus injection over approximately five minutes.
Doxorubicin:
Doses in the range 10-100 mg reconstituted with water for injections, 5 ml per 10 mg doxorubicin, as recommended by the manufacturer and given as an intravenous bolus injection over approximately 5 minutes.
Dexamethasone:
Dexamethasone sodium phosphate 20 mg may be administered as a slow intravenous injection over 2-5 minutes via the Y-site of an infusion set delivering 8 or 32 mg of ondansetron diluted in 50-100 ml of a compatible infusion fluid over approximately 15 minutes. Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated supporting administration of these drugs through the same giving set resulting in concentrations in line of 32 microgram - 2.5 mg/ml for dexamethasone sodium phosphate and 8 microgram -1 mg/ml for ondansetron.
MARKETING AUTHORISATION HOLDER
Hospira Enterprises B.V.
Taurusavenue 19-21 2132LS Hoofddorp The Netherlands
Manufacturer
HIKMA FARMAC&UTICA (PORTUGAL), LDA. Estrada do Rio da Mo n.° 8, 8A e 8B - Fervenga 2705-906 Terrugem SNT Portugal
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
May 4th, 2006
DATE OF REVISION OF THE TEXT
May 29th, 2006