Šalis: Malta
kalba: anglų
Šaltinis: Malta Medicines Authority
ONDANSETRON HYDROCHLORIDE, DIHYDRATE
Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland
A04AA01
ONDANSETRON HYDROCHLORIDE DIHYDRATE 2 mg/ml
SOLUTION FOR INJECTION/INFUSION
ONDANSETRON HYDROCHLORIDE DIHYDRATE 2 mg/ml
POM
ANTIEMETICS AND ANTINAUSEANTS
Withdrawn
2019-04-09
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ONDANSETRON 2 MG/ML SOLUTION FOR INJECTION OR INFUSION (ONDANSETRON) READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS ADMINISTERED TO YOU BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. • IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR PHARMACIST. • IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. WHAT IS IN THIS LEAFLET: 1. What Ondansetron Solution for Injection is and what it is used for 2. What you need to know before Ondansetron Solution for Injection is administered 3. How to administer Ondansetron Solution for Injection 4. Possible side effects 5. How to store Ondansetron Solution for Injection 6. Contents of the pack and other information The name of your medicine is Ondansetron 2mg/ml Solution for Injection or Infusion (also referred to as Ondansetron injection or Ondansetron throughout this leaflet). 1. WHAT ONDANSETRON SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR Ondansetron injection contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Ondansetron injection is used for: • preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only) • preventing nausea and vomiting after surgery. Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. 2. WHAT YOU NEED TO KNOW BEFORE ONDANSETRON SOLUTION FOR INJECTION IS ADMINISTERED DO NOT HAVE_ _ONDANSETRON SOLUTION FOR INJECTION • if you are taking apomorphine (used to treat Parkinson’s disease). • if you are allergic to ondansetron or any of the other ingredients in Ondansetron Injection (listed in Section 6). _ _ If you are not sure, talk to your doctor, nurse or pharmacist before having Ondansetron injection. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or p Perskaitykite visą dokumentą
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ondansetron 2mg/ml Solution for Injection or Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2mg of ondansetron (as hydrochloride dihydrate) Each 4ml ampoule contains 8mg of ondansetron (as hydrochloride dihydrate) For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection or Infusion Clear, colourless solution, free from particles 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Adults Ondansetron hydrochloride is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron hydrochloride is for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population Ondansetron hydrochloride is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months, and for the prevention and treatment of PONV in children aged ≥1 month. 4.2. 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 combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Ondansetron hydrochloride should be flexible in the range of 8-32mg a day and selected as shown below. _Emetogenic chemotherapy and radiotherapy_ : Ondansetron hydrochloride can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For most patients receiving emetogenic chemotherapy or radiotherapy, Ondansetron hydrochloride 8mg should be administered as a slow intravenous or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly. Page 2 of 17 To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron hydrochloride should be continued for up to five days after a course of treatment. _Highly emetogenic chem Perskaitykite visą dokumentą