2 mg / ml solution for injection
ondansetron
What Ondansetron Fresenius Kabi is and what it is used for
Ondansetron Fresenius Kabi belongs to a group of medicines called antiemetics, which are medicines for nausea and vomiting. Some medical treatments with cancer treatment ( chemotherapy ) or radiation therapy may make you nauseous or cause vomiting. Even after surgery, you may feel sick or vomit. Ondansetron Fresenius Kabi can help counteract or stop these symptoms.
What you need to know before you use Ondansetron Fresenius Kabi
Do not use Ondansetron Fresenius Kabi
- if you are allergic to ondansetron, any other selective 5HT3 receptor antagonist (eg granisetron, dolastron) or any of the other ingredients of this medicine (listed in section 6).
- if you are being treated with apomorphine (a medicine used to treat Parkinson’s disease ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Ondansetron Fresenius Kabi
- if you have been shown to be hypersensitive to other medicines for nausea and vomiting, such as gransisetron or palonosetron.
- if you have a bowel movement or suffer from severe constipation. Ondansetron may reduce intestinal motility.
- if you have impaired liver function.
- if you have had surgery to remove the tonsils behind your neck (adenotonsillar surgery ).
- if you have ever had heart problems, incl. irregular heart rhythm ( arrhythmia ). Ondansetron prolongs the QT interval ( ECG sign of delayed repolarization of the heart after a heartbeat with risk of life-threatening arrhythmias ) in a dose-dependent manner.
- if you have problems with levels of salts in your blood, such as potassium , sodium and magnesium .
Other medicines and Ondansetron Fresenius Kabi
Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
If you take tramadol (for pain): ondansetron may reduce the analgesic effect of tramadol.
If you take phenytoin, carbamazepine ( antiepileptic drugs ), or rifampicin ( antibiotics for tuberculosis ): the concentration of ondansetron in your blood may decrease.
If you are taking heart toxic medicines (eg anthracyclines, cancer antibiotics such as doxorubicin, daunorubicin, or trastuzumab, a cancer medicine), antibiotics (such as erythromycin), antifungals (such as ketoconazole ), antiarrhythmics (eg amiodarone ), and beta-blockers ( beta-blockers) lower heart rhythm such as atenolol or timolol ): use of ondansetron with other QT-prolonging drugs may result in further QT -prolongation, ie increase the risk of cardiac arrhythmias.
If you are taking other serotonergic drugs such as selective serotonin reuptake inhibitors ( SSRIs ) or serotonin noradrenaline reuptake inhibitors ( SNRIs ) such as sertraline or duloxetine (both are antidepressants): There are case reports describing patients with the so-called serotonergic syndrome (eg increased alertness and increased alertness). heart rate and blood pressure, tremors and hypersensitivity reflexes) after concomitant use of ondansetron with other serotonergic drugs.
If you are taking apomorphine (medicines to treat Parkinson’s disease ): apomorphine should not be used with ondansetron, as there are case reports of severe hypotension (low blood pressure ) and unconsciousness when both medicines are given at the same time.
Pregnancy and breastfeeding
You should not use Ondansetron during the first three months of pregnancy (first trimester). The reason is that Ondansetron may increase the risk slightly that a child is born with cleft lip and/or cleft palate (opening or division in the upper lip or palate). If you are already pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Ondansetron. If you are a woman of childbearing potential, you may be advised to use contraception.
Ondansetron passes into breast milk. Therefore, mothers receiving ondansetron should NOT breast-feed.
Consult your doctor before taking any medication.
Driving and using machines
Ondansetron does not affect the ability to drive or use machines.
Ondansetron Fresenius Kabi contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.
How to use Ondansetron Fresenius Kabi
Method of administration
Ondansetron Fresenius Kabi is administered as an intravenous injection (into a vein) or, after dilution, as an intravenous infusion (for a long time). It is usually administered by a doctor or nurse.
Dosage
Adults (under 75 years of age)
Your doctor will determine the correct dose of ondansetron for you. Dosage one depends on what medical treatment you are receiving ( chemotherapy or surgery ), your liver function, and whether it is given as an injection or infusion.
For chemotherapy or radiation therapy, the usual dose is one for adults 8 – 32 mg ondansetron per day. A single dose of more than 16 mg should not be given. For the treatment of postoperative nausea and vomiting, a single dose of 4 mg ondansetron is usually administered. For the prevention of nausea and vomiting after surgery, a single dose of 4 mg ondansetron is usually administered.
Children aged> 6 months and adolescents
In chemotherapy, the usual dose is a single intravenous dose of 5 mg ondansetron per square meter of body surface area immediately before chemotherapy. The intravenous dose should not exceed 8 mg.
Children aged> 1 month and adolescents
For the treatment of nausea and vomiting after surgery, the usual dose is 0.1 mg/kg (body weight). The maximum dose is 4 mg as an injection into a vein.
For the prevention of nausea and vomiting after surgery, the usual dose is 0.1 mg/kg (body weight). The maximum dose is 4 mg as an injection into a vein. This will be given shortly before surgery.
Dose adjustment
Older:
During treatment with chemotherapy, the initial dose should not exceed 8 mg for patients aged 75 years and older.
Patients with hepatic impairment:
If you have liver problems, your doctor will adjust your dose to a maximum daily dose of 8 mg ondansetron.
Patients with renal impairment or slow metabolites of sparteine/debrisoquine:
No adjustment of the daily dose, dosing interval, or route of administration is necessary.
Treatment time
Your doctor will decide how long you should be treated with ondansetron.
Following intravenous administration of Ondansetron Fresenius Kabi, treatment with ondansetron tablets or suppositories may continue for up to 5 days.
If you use more Ondansetron Fresenius Kabi than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
There is currently limited information on the effects of an overdose of ondansetron. Overdose increases the likelihood of side effects described in section 4. In a few patients, the following symptoms have been observed after overdose: visual disturbances, severe constipation, low blood pressure, disturbed heart rhythm, and unconsciousness. In all cases, the symptoms disappeared completely.
Ondansetron will be given to you or your child by a doctor or nurse, so it is unlikely that you or your child will get too much. If you think you or your child has taken too much or missed a dose, tell your doctor or nurse.
As there is no specific antidote for ondansetron, only the symptoms will be treated in case of suspected overdose.
Tell your doctor if any of these symptoms occur.
Possible side effects
Like all medicines, Ondansetron Fresenius Kabi can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you experience any of the following:
Uncommon, may affect up to 1 in 100 people
- Chest pain, slow or irregular heartbeat
Rare may affect up to 1 in 1,000 people
- Hypersensitivity reaction , such as itchy skin rash, swelling of eyelids, face, lips, mouth and tongue
Other side effects may occur
Very common, may affect more than 1 user in 10
- Headache
Common, may affect up to 1 in 10 users
- Constipation
- Feeling of heat or redness
- Irritation and redness at the injection site
Uncommon, may affect up to 1 in 100 people
- Low blood pressure , which can make you feel weak or dizzy
- Unusual body movements or tremors
- Hiccup
- Disruption of liver value test
Rare may affect up to 1 in 1,000 people
- Dizziness or dizziness
- Dimsyn
- Cardiac arrhythmias (sometimes causing sudden unconsciousness)
Very rare: may affect up to 1 in 10,000 people
- Temporary blindness (usually disappeared within 20 minutes)
- Skin rash, e.g. red spots or lumps under the skin ( hives ) somewhere on the body that can turn into large blisters
Additional side effects are in children and adolescents
Side effects in children and adolescents are comparable to those in adults.
How to store Ondansetron Fresenius Kabi
Keep this medicine out of the sight and reach of children.
This medicine must not be administered after the expiry date which is stated on the ampoule and the carton. The expiration date is the last day of the specified month.
Protect the ampoules from light by storing them in the outer carton.
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.
Contents of the package and other information
Content declaration
The active substance is ondansetron.
Each ampoule of 2 ml contains 4 mg ondansetron.
Each 4 ml ampoule contains 8 mg ondansetron.
Each milliliter contains 2 mg of ondansetron as ondansetron hydrochloride dihydrate.
The other ingredients are sodium chloride, sodium citrate dihydrate, citric acid monohydrate, and water for injections.
What the medicine looks like and contents of the pack
Ondansetron Fresenius Kabi is a clear, colorless solution in clear glass ampoules containing 2 or 4 ml solution for injection.
Pack sizes: 1, 5, and 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi AB
SE-751 74 Uppsala
Manufacturer:
Labesfal Laboratorios Almiro SA,
Lagedo, 3465-157 Santiago de Besterios,
Portugal