Zofran Injection 2mg/Ml
Dummy Code
Zofran® Flexi-amp® injection 2 mg/ml
ondansetron (as hydrochloride dihydrate)
lb NOVARTIS Package Leaflet: Information for the Physician
Please refer to the Summary of Product Characteristics (SPC) for further details on tiis product.
Trade Name of the Medicinal Product
Zofran Flexi-amp Injection
Qualitative and Quantitative Composition
Zofran injection 2 mg/ml:
• 2 ml ampoules each containing 4 mg ondansetron (as hydrochloride dihydrate)
• 4 ml ampoules each containing 8 mg ondansetron (as hydrochloride dihydrate)
n aqueous solution for intramuscular or intravenous administration. n aqueous solution for intravenous or intramuscular administration.
Posology and Method of Administration
Chemotherapy and Radiotherapy induced nausea and vomiting Adults
The emetogenic potential of cancer treatment varies according to the doses and coi administration and dose of Zofran should be flexible in the range of 8-32 mg a day Emetogenic chemotherapy and radiotherapy: Zofran can be given either by rectal, oral receiving emetogenic chemotherapy or radiotherapy, Zofran 8 mg should be admin injection immediately before treatment, followed by 8 mg orally twelve hourly. To p treatment with Zofran should be continued for up to 5 days after a course of treatmei Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemot intramuscular administration. Zofran has been shown to be equally effective in the
• A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds)
• A dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or in intravenous injections (in not less than 30 seconds) or intramuscular doses of 8
• A maximum initial dose of 16 mg diluted in 50-100 ml of saline or other compa i minutes immediately before chemotherapy. The initial dose of Zofran may be fo l intramuscular doses four hours apart.
mbinations of chemotherapy and radiotherapy regimens used. The route of and selected as shown below.
(tablets or syrup), intravenous or intramuscular administration. For most patients stered as a slow intravenous injection (in not less than 30 seconds) or intramuscular otect against delayed or prolonged emesis after the first 24 hours, oral or rectal nt.
herapy, e.g. high-dose cisplatin, Zofran can be given either by rectal, intravenous or ollowing dose schedules over the first 24 hours of chemotherapy:
' or intramuscular injection immediately before chemotherapy.
ramuscular injection immediately before chemotherapy, followed by two further
Efour hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
infusion fluid (See Instructions for Use/Handling) and infused over not less than 15 lowed by two additional 8 mg intravenous doses (in not less than 30 seconds) or
• A single dose greater than 16 mg must not be given due to dose dependent inc ■ The selection of dose regimen should be determined by the severity of the emetogeni The efficacy of Zofran in highly emetogenic chemotherapy may be enhanced by the administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral or recta 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 -Zofran injection should be diluted in 5% dextrose or 0.9% sodium chloride or other over not less than 15 minutes.
There are no data from controlled clinical trials on the use of Zofran in the preventio use of Zofran for radiotherapy-induced nausea and vomiting in children Dosing by BSA:
Zofran should be administered immediately before chemotherapy as a single intravei
ease of QT-prolongation risk (see sections 4.4, 4.8 and 5.1 of the SPC). ic challenge.
addition of a single intravenous dose of dexamethasone sodium phosphate, 20 mg treatment with Zofran should be continued for up to 5 days after a course of
see below.
compatible infusion fluid (see Instructions for Use/Handling) and infused intravenously n of delayed or prolonged CINV. There are no data from controlled clinical trials on the
nous dose of 5 mg/m2. The single intravenous dose must not exceed 8 mg. Oral dosing 12 hours later and may be continued for up to 5 days (see SPC for dosing tables). The total dose over 24 hours (given as divided doses) must not exceed
can commence adult dose of 32 mg.
Dosing by bodvweiaht:
Weight-based dosing results in higher total daily doses compared to BSA-based do; intravenous dose of 0.15 mg/kg. The single intravenous dose must not exceed 8 mg.
. Zofran should be administered immediately before chemotherapy as a single Two further intravenous doses may be given in 4-hourly intervals.
sing.
NOVARTIS
®
ondansetron (as hydrochloride dihydrate)
Read all of this leaflet carefully before you start important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions about your illness or your
• This medicine has been prescribed for you only. Do not symptoms are the same as yours
• If any of the side effects get serious, or if you notice an; nurse or pharmacist. This includes any possible side effe
What is in this leaflet
1 What Zofran injection is and what it is used for
medicine, ask your doctor, nurse or pharmacist. pass it on to others. It may harm them, even if their
y side effects not listed in this leaflet, please tell your doctor, cts not listed in this leaflet. See section 4.
2 What you need to know before you have Zofran injection
3 How to have Zofran injection
4 Possible side effects
5 How to store Zofran injection
6 Contents of the pack and other information
• preventing nausea and v Ask your doctor, nurse or pharmacist if you would like any fi
Zofran injection contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetic Zofran injection is used for • preventing nausea and vo radiotherapy for cancer (ad
miting caused by chemotherapy (in adults and children) or ults only)
omiting after surgery. urther explanation about these uses.
Do not have Zofran injection if:
• you are taking apomorphine (used to treat Parkinson's
• you are allergic (hypersensitive) to ondansetron or any Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist
Warnings and precautions
Check with your doctor, nurse or pharmacist before having
disease)
of the other ingredients in Zofran injection (listed in before having Zofran injection.
Zofran injection if:
• you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles)
• you have an uneven heart beat (arrhythmias)
• you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
• you have liver problems
• you have a blockage in your gut
• you have problems with the levels of salts in your blood,
If you are not sure if any of the above apply to you, talk to
Other medicines and Zofran
Please tell your doctor, nurse or pharmacist if you are takirg,
This includes medicines that you buy without a prescription way some medicines work. Also some other medicines can
such as potassium, sodium and magnesium.
your doctor, nurse or pharmacist before having Zofran injection.
l, or have recently taken, or might take any other medicines. and herbal medicines. This is because Zofran can affect the
i affect the way Zofran works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
carbamazepine or phenytoin used to treat epilepsy rifampicin used to treat infections such as tuberculosis (TB) antibiotics such as erythromycin or ketoconazole anti-arrhythmic medicines used to treat an uneven heart beat
beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines tramadol, a pain killer
medicines that affect the heart (such as haloperidol or methadone) cancer medicines (especially anthracyclines and trastuzimab).
SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine,
duloxetme
If you are not sure if any of the above applies to you, talk to injection
Zofran injection should not be given in the same syringe o'
Pregnancy and breast-feeding
It is not known if Zofran is safe during pregnancy. If you an baby, ask your doctor or pharmacist for advice before havin' Do not breast-feed if you have Zofran. This is because sma midwife for advice.
your doctor, nurse or pharmacist before having Zofran
infusion (drip) as any other medication.
e pregnant, think you are pregnant or are planning to have a g Zofran injection.
l amounts pass into the mother's milk. Ask your doctor or
Important information about some of the ingre
This medicine contains sodium citrate and sodium chloride. 4 mg dose, which is less than 1 mmol sodium (23 mg) per
dients of Zofran injection
This means that Zofran injection contains 7 mg of sodium per cose i.e. essentially “sodium-free".
Zofran injection is normally given by a nurse or doctor. The you are having
To prevent nausea and vomiting from chemother
On the day of chemotherapy or radiotherapy • the usual adult dose is 8 mg given by a slow injection i another 8 mg twelve hours later. After chemotherapy, yoi Zofran tablet or 10 ml (8 mg) Zofran syrup.
On the following days
dose you have been prescribed will depend on the treatment apy or radiotherapy in adults
your vein or muscle, just before your treatment, and ur medicine will usually be given by mouth as an 8 mg
nto
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 Zofran. Your doctor will decide this.
To prevent nausea and vomiting from chemothera
The doctor will decide the dose depending on the child's si information
py in children aged over 6 months and adolescents
ze (body surface area) or weight. Look at the label for more
1492501 GB
Oral dosing can commence 12 hours later and may be continued for up to 5 days. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. (see sPc for further details).
Elderly
In patients 65 to 74 years of age, the dose schedule for adults can be followed. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see Instructions for Use/Handling) and infuse over 15 minutes.
In patients 75 years of age or older, the initial intravenous dose of Zofran should other compatible infusion fluid (see Instructions for Use/Handling) and infused over of 8 mg, infused over 15 minutes and given no less than four hours apart (see SPC)
Post-Operative Nausea and Vomiting (PONV)
Adults
For the prevention of PONV Zofran can be administered orally or by intravenous or intramuscular or slow intravenous injection at induction of anaesthesia. For treatmen intravenous injection is recommended.
Children (aged over 1 month and adolescents)
not exceed 8 mg. All intravenous doses should be diluted in 50-100 ml of saline or 15 minutes. The initial dose of 8 mg may be followed by two further intravenous doses
ntramuscular injection. Zofran may be administered as a single dose of 4 mg given by it of established PONV a single dose of 4 mg given by intramuscular or slow
Injection:
For prevention of PONV in paediatric patients having surgery performed under genera (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg either 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 0.1 mg/kg up to a maximum of 4 mg. There are no data on the use of Zofran in the treatment of PONV in children below 2 years of age.
Elderly
There is limited experience in the use of Zofran in the prevention and treatment of PONV in the elderly, however Zofran is well tolerated in patients over 65 years receiving chemotherapy.
For all indications:
Renal impairment
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Hepatic impairment
pr oi
anaesthesia, a single dose of Zofran may be administered by slow intravenous injection r to, at or after induction of anaesthesia. For the treatment of PONV after surgery in
Clearance of Zofran is significantly reduced and serum half-life significantly prolong a total daily dose of 8 mg should not be exceeded.
Poor sparteine/debrisoquine metabolism
The elimination half-life of ondansetron is not altered in subjects classified as poor dosing will give drug exposure levels no different from those of the general populat
d in subjects with moderate or severe impairment of hepatic function. In such patients
metabolisers of sparteine and debrisoquine. Consequently in such patients repeat on. No alteration of daily dosage or frequency of dosing are required.
Special precautions for disposal and other handling
Zofran Flexi-amp injection should not be autoclaved.
Compatibility with intravenous fluids
Zofran injection should only be admixed with those infusion solutions which are recommended:
• Sodium Chloride Intravenous Infusion BP 0.9% w/v
• Glucose Intravenous Infusion BP 5% w/v
• Mannitol Intravenous Infusion BP 10% w/v
• Ringers Intravenous Infusion
• Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Intravenous Infusion BP
• Potassium Chloride 0.3% w/v and Glucose 5% w/v Intravenous Infusion BP
In keeping with good pharmaceutical practice dilutions of Zofran 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 pol be conferred by the use of polyethylene infusion bags or Type 1 glass bottles. Dilutior to be stable in polypropylene syringes. It is considered that Zofran injection diluted wi Compatibility with other drugs
Zofran may be administered by intravenous infusion at 1 mg/hour, e.g. from an infu Zofran giving set for ondansetron concentrations of 16 to 160 micrograms/ml (e.g. i Cisplatin: Concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml) administered ov
lyvinyl chloride administration sets. It is considered that adequate stability would also s of Zofran in sodium chloride 0.9% w/v or in glucose 5% w/v have been demonstrated ith other compatible infusion fluids would be stable in polypropylene syringes.
5-Fluorouracil: Concentrations up to 0.8 mg/ml (e.g. 2.4 g in 3 litres or 400 mg in 50 concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluoro
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 51 Etoposide: Concentrations in the range 0.14 mg/ml to 0.25 mg/ml (e.g. 72 mg in 500 Ceftazidime: Doses in the range 250 mg to 2000 mg reconstituted with Water for Ii
ion bag e pump. The following drugs may be administered via the Y-site of the i mg/500 ml and 8 mg/50 ml respectively); er one to eight hours.
0 ml) administered at a rate of at least 20 ml per hour (500 ml per 24 hours). Higher uracil infusion may contain up to 0.045% w/v magnesium chloride in addition to
2 g ceftazidime) and given as an intravenous bolus injection over approximately five Cyclophosphamide: Doses in the range 100 mg to 1 g, reconstituted with Water for manufacturer and given as an intravenous bolus injection over approximately five m Doxorubicin: Doses in the range 10-100 mg reconstituted with Water for Injections intravenous bolus injection over approximately 5 minutes.
Dexamethasone: Dexamethasone sodium phosphate 20 mg may be administered as delivering 8 or 16 mg of ondansetron diluted in 50-100 ml of a compatible infusion fli phosphate and ondansetron has been demonstrated supporting administration of th 32 microgram - 2.5 mg/ml for dexamethasone sodium phosphate and 8 microgram
1 ml to 990 mg in 100 ml), administered over ten minutes to one hour. ml to 250 mg in 1 litre), administered over thirty minutes to one hour. n ections BP as recommended by the manufacturer (e.g. 2.5 ml for 250 mg and 10 ml for
minutes.
njections BP, 5 ml per 100 mg cyclophosphamide, as recommended by the inutes.
BP, 5 ml per 10 mg doxorubicin, as recommended by the manufacturer and given as an
a slow intravenous injection over 2-5 minutes via the Y-site of an infusion set uid over approximately 15 minutes. Compatibility between dexamethasone sodium ese drugs through the same giving set resulting in concentrations in line of 1 mg/ml for ondansetron.
Shelf Life
36 months (unopened)
24 hours (dilutions stored 2-8°C)
Special Precautions for Storage
• Protect from light
• Store below 30°C
Dilutions of Zofran 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.
Leaflet date: May 2016
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On the day of chemotherapy
• the first dose is given by an injection into the vein, just child's medicine will usually be given by mouth twelve On the following days
before your child's treatment. After chemotherapy, your hours later, as Zofran syrup or a Zofran tablet.
2.5 ml (2 mg) syrup twice a day for small children and those weighing 10 kg or less
• one 4 mg tablet or 5 ml (4 mg) syrup twice a day for larig
• two 4 mg tablets or 10 ml (8 mg) syrup twice a day for teen;
• these doses can be given for up to five days
To prevent and treat nausea and vomiting after Adult:
• The usual dose for adults is 4 mg given by a slow injectio prevention, this will be given just before your operation
Children:
• For children aged over 1 month and adolescents the doct a slow injection into the vein. For prevention, this will be
er children and those weighing more than 10 kg
agers (or those with a large body surface area)
an operation
n into your vein or an injection into your muscle. For
tor will decide the dose. The maximum dose is 4 mg given as given just before the operation.
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
Zofran 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 more Zofran injection than you shoul
Your doctor or nurse will give you or your child Zofran injei you or your child will receive too much. If you think you or too much or have missed a dose, tell your doctor or nurse.
iction so it is unlikely that your child have been given
Dummy Code
Like all medicines, Zofran 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.
Other side effects include:
Very common (may affect more than 1 in 10 people)
• headache.
Common (may affect up to 1 in 10 people)
• a feeling of warmth or flushing
• constipation
• changes to liver function test results (if you have Zofran effect is uncommon)
• irritation and redness at the site of injection.
Uncommon (may affect up to 1 in 100 people)
• hiccups
• low blood pressure, which can make you feel faint or di:
• uneven heart beat
• chest pain
injection with a medicine called cisplatin, otherwise this side
zzy
• fits
• unusual body movements or shaking.
Rare (may affect up to 1 in 1,000 people)
• feeling dizzy or light headed
• blurred vision
• disturbance in heart rhythm (sometimes causing a suddei
Very rare (may affect up to 1 in 10,000 people)
• poor vision or temporary loss of eyesight, which usually Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or this leaflet. You can also report side effects directly via the
n loss of consciousness) comes back within 20 minutes.
nurse. This includes any possible side effects not listed in Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Zofran injection after the expiry date which is stated on the pack after 'EXP'. The expiry date refers to the last day of that month.
Store Zofran injection below 30°C. Protect from light.
When Zofran injection is diluted in intravenous fluids:
• it must be stored at 2-8°C for not more than 24 hours
• it does not need to be protected from light during infusion.
Do not throw away any medicines via wastewater or hou medicines you no longer use. These measures will help |
sehold waste. Ask your pharmacist how to throw away protect the environment.
What Zofran injection contains
• The active ingredient is ondansetron. Each 2 ml Zofran injection ampoule contains ondansetron 4 mg. Each 4 ml Zofran injection ampoule contains ondansetron 8 mg.
• The other ingredients are citric acid (E330), sodium citrate
What Zofran injection looks like and contents of
Zofran injection is a clear, colourless liquid.
Zofran injection is available in:
• 2 ml (4 mg) Flexi-amps that are plastic ampoules
• 4 ml (8 mg) Flexi-amps that are plastic ampoules
:e (E331), sodium chloride and Water for Injections. f the pack
Packed in boxes of 5 ampoules.
Not all packs are marketed.
Marketing Authorisation Holder and Manufacturer
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom Leaflet date: May 2016
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