Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride dihydrate, Quantity: 10 mg (Equivalent: ondansetron, Qty 8 mg)
Aspen Pharmacare Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; iron oxide yellow; hypromellose
Oral
15 tablets, 30 tablets, 4 tablets, 90 tablets, 10 tablets, 10 tablets foil blister pack
(S4) Prescription Only Medicine
Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy
Visual Identification: Yellow, oval, bi-convex tablets, engraved with "GXET5" on one face and plain on the other face.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-04-17
ZOFRAN ® TABLETS 1 ZOFRAN ® TABLETS _Ondansetron hydrochloride dihydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use Zofran Tablets. This leaflet answers some common questions about Zofran Tablets. 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 Zofran Tablets 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 IS ZOFRAN TABLETS USED FOR? Zofran Tablets contain a medicine called ondansetron. This belongs to a group of medicines called serotonin receptor-3 antagonists. Zofran Tablets are used to help stop the nausea (sick feeling) and vomiting which can occur after medical treatments and operations. Zofran Tablets should only be used to treat the nausea and vomiting for which they have been prescribed. Your doctor may have prescribed Zofran Tablets for another reason. If you want more information, ask your doctor. Zofran Tablets are not addictive. BEFORE YOU TAKE ZOFRAN TABLETS _DO NOT TAKE IF: _ You must not take Zofran Tablets 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 BREAST FEEDING, UNLESS YOUR DOCTOR SAYS IT IS SAFE. • THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED. • 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 MEDICINES YOU BUY WITHOUT Lestu allt skjalið
1 AUSTRALIAN PRODUCT INFORMATION ZOFRAN (ONDANSETRON HYDROCHLORIDE DIHYDRATE) INJECTIONS, TABLETS AND ORAL LIQUID, ZOFRAN (ONDANSETRON) SUPPOSITORIES AND ZOFRAN ZYDIS (ONDANSETRON) WAFERS 1 NAME OF THE MEDICINE Ondansetron hydrochloride dihydrate is the therapeutically active ingredient in Zofran injections, Zofran tablets and Zofran oral liquid. Ondansetron is the therapeutically active ingredient in Zofran suppositories and in Zofran Zydis wafers. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zofran 4 mg and 8 mg tablets contain 4 and 8 mg of ondansetron (as ondansetron hydrochloride dihydrate) and the following excipients: lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, magnesium stearate, hypromellose, titanium dioxide and iron oxide yellow. Excipients with known effect: sugars as lactose Zofran 24 mg tablets contain 24 mg of ondansetron (as ondansetron hydrochloride dihydrate) and the following excipients: lactose, microcrystalline cellulose, pregelatinised maize starch, magnesium stearate and Opadry Pink YS-1-14593-A (ARTG PI No: 3522). Excipients with known effect: sugars as lactose Zofran oral liquid contains 0.8 mg/mL of ondansetron (as ondansetron hydrochloride dihydrate) and the following excipients: citric acid, sodium citrate dihydrate, sodium benzoate, sorbitol solution (70 percent) (crystallising), purified water and Strawberry Flavouring Liquid SC887891 (ARTG PI No: 140281). Excipients with known effect: benzoates and sorbitol (12.6g per recommended maximum daily dose) which may have a laxative effect or cause diarrhoea Zofran Zydis wafers contain 4 and 8 mg of ondansetron and the following excipients: gelatin, mannitol, aspartame, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate and Strawberry Flavouring Liquid SC887891 (ARTG PI No: 140281). Excipients with known effect: aspartame, hydroxybenzoates and sulphites. Each 2 mL Zofran injection contains 4 mg of ondansetron (as ondansetron hydrochloride dihydrate) and the following excipients: citric acid monohydr Lestu allt skjalið