Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride dihydrate, Quantity: 10 mg (Equivalent: ondansetron, Qty 8 mg)
Dr Reddys Laboratories Australia Pty Ltd
Ondansetron hydrochloride dihydrate
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; lactose monohydrate; pregelatinised maize starch; sodium starch glycollate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400
Oral
10 tablet, 6 tablet, 4 tablet
(S4) Prescription Only Medicine
Prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.
Visual Identification: Dark yellow, oval, biconvex, film coated tablets embossed 'OND' on one side and '8' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2010-10-28
ONDANSETRON SZ 1 ONDANSETRON SZ _Ondansetron hydrochloride dihydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use ONDANSETRON SZ tablets. This leaflet answers some common questions about ONDANSETRON SZ 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 ONDANSETRON SZ 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 ARE ONDANSETRON SZ TABLETS USED FOR? ONDANSETRON SZ tablets contain a medicine called ondansetron. This belongs to a group of medicines called serotonin receptor-3 antagonists. ONDANSETRON SZ tablets are used to help stop the nausea (sick feeling) and vomiting which can occur after medical treatments. ONDANSETRON SZ tablets should only be used to treat the nausea and vomiting for which they have been prescribed. Your doctor may have prescribed ONDANSETRON SZ tablets for another reason. If you want more information, ask your doctor. ONDANSETRON SZ tablets are not addictive. BEFORE YOU TAKE ONDANSETRON SZ TABLETS _DO NOT TAKE IF: _ You must not take ONDANSETRON SZ 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. Y Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION – ONDANSETRON SZ (ONDANSETRON HYDROCHLORIDE DIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Ondansetron hydrochloride dihydrate 2 & 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM ONDANSETRON SZ tablet contains 4 mg or 8 mg of ondansetron (as ondansetron hydrochloride dihydrate). Ondansetron hydrochloride dihydrate is a white to off white powder with a melting point of 177°C. It is sparingly soluble in water and in alcohol, soluble in methanol and slightly soluble in methylene chloride. It is soluble in saline (0.9% w/v) to about 8 mg/mL. The pKa of ondansetron hydrochloride dihydrate as determined by a solubility procedure is 7.4. The distribution coefficient between n-octanol and water is pH dependent with log D = 2.2 at a pH of 10.6 and log D = 0.6 at a pH of 5.95. EXCIPIENTS WITH KNOWN EFFECT: Contains sugars (as lactose) Ondansetron SZ 4 mg and 8 mg tablets contain the following excipients: Lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, magnesium stearate, sodium starch glycollate, colloidal anhydrous silica, Opadry Yellow 03B52375 and Opadry Yellow 03B52246. Ondansetron SZ 4 mg tablets: Light yellow, oval, biconvex, film coated tablets embossed ‘OND’ on one side and ‘4’ on other side. Ondansetron SZ 8 mg tablets: Dark yellow, oval, biconvex, film coated tablets embossed ‘OND’ on one side and ‘8’ on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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 to 32 mg a day and selected as shown below. The lowest effective dose should be used. ADULTS. EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY For the control of chemotherapy or radiotherapy induced emesis or Przeczytaj cały dokument