Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride dihydrate, Quantity: 4.986 mg
Arrotex Pharmaceuticals Pty Ltd
Ondansetron hydrochloride dihydrate
Tablet, film coated
Excipient Ingredients: magnesium stearate; pregelatinised maize starch; lactose; titanium dioxide; hypromellose; microcrystalline cellulose; triacetin
Oral
10, 30, 4, 90
(S4) Prescription Only Medicine
Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.
Visual Identification: White to off-white, oval shaped, film-coated tablets debossed with 'E' on one side and '01' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2011-09-29
APX-ONDANSETRON CONSUMER MEDICINE INFORMATION Ondansetron (as hydrochloride dihydrate) 4 mg and 8 mg film-coated tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use APX-ONDANSETRON. This leaflet answers some common questions about APX-ONDANSETRON. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking APX-ONDANSETRON against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT APX-ONDANSETRON IS USED FOR APX-ONDANSETRON contains a medicine called ondansetron. This belongs to a group of medicines called serotonin receptor-3 antagonists. APX-ONDANSETRON is used to help stop the nausea (sick feeling) and vomiting which can occur after medical treatments and operations. APX-ONDANSETRON should only be used to treat the nausea and vomiting for which they have been prescribed. Your doctor may have prescribed APX-ONDANSETRON for another reason. If you want more information, ask your doctor. APX-ONDANSETRON is not addictive. BEFORE YOU TAKE APX-ONDANSETRON _ _ _DO NOT TAKE IF: _ You must not take APX-ONDANSETRON if: • YOU ARE TAKING APOMORPHINE (USED TO TREAT PARKINSON’S DISEASE); • YOU HAVE EVER HAD AN ALLERGIC REACTION TO ONDANSETRON OR ANY OF THE INGREDIENTS LISTED TOWARD THE END OF THIS LEAFLET (SEE "INGREDIENTS"); • YOU ARE PREGNANT, TRYING TO BECOME PREGNANT OR BREASTFEEDING, UNLESS YOUR DOCTOR SAYS IT IS SAFE; • THE EXPIRY DATE PRINTED ON THE PACK HAS PASSED; OR • THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. _TELL YOUR DOCTOR IF: _ You must tell your doctor if: • YOU ARE ALLERGIC TO FOODS, DYES, PRESERVATIVES OR ANY OTHER MEDICINES; • YOU HAVE HAD TO STOP TAKING ANOTHER MEDICINE FOR YOUR NAUSEA OR VOMITING; • YOU ARE TAKING ANY OTHER MEDICINES, INCLUDING read_full_document
1 AUSTRALIAN PRODUCT INFORMATION APX-ONDANSETRON (ondansetron hydrochloride dihydrate) tablets 1 NAME OF THE MEDICINE Ondansetron hydrochloride dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APX-ONDANSETRON is available as tablets containing 4 mg or 8 mg of ondansetron as hydrochloride dihydrate. Excipient of known effect: Contains sugars as lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM APX-ONDANSETRON (4MG): White to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side. APX-ONDANSETRON (8MG): Yellow coloured, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. 4.2 D OSE AND METHOD OF ADMINISTRATION 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 should be flexible in the range of 8-32 mg a day and selected as shown below. The lowest effective dose should be used. 2 ADULTS _ _ _EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY _ For the control of chemotherapy or radiotherapy induced emesis or nausea in adults, two oral doses of 8 mg each at 12 hourly intervals may be given, the first dose being administered 2 hours prior to chemotherapy or radiotherapy. To protect against delayed emesis after the first 24 hours, ondansetron should be continued orally at a dosage of 8 mg twice daily. CHILDREN _ _ _EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY _ Experience is currently limited but ondansetron was effective and well tolerated in children over 4 years of age following chemotherapy, oral therapy at doses of 4 mg twice daily for up to five days can be given. _PONV IN CHILDREN AND ADOLESCENTS (AGED 1 MONTH TO 17 YEARS) _ _ _ _Oral Formulations _ No studies read_full_document