Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: 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: lactose monohydrate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; 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
2017-08-09
Ondansetron Mylan CMI v1 Page 1 of 4 CONSUMER MEDICINE INFORMATION ONDANSETRON MYLAN TABLETS _Ondansetron hydrochloride dihydrate _ WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use Ondansetron Mylan tablets. This leaflet answers some common questions about Ondansetron Mylan 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 Mylan 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 MYLAN TABLETS USED FOR? Ondansetron Mylan tablets contain a medicine called ondansetron. This belongs to a group of medicines called serotonin receptor‐3 antagonists. Ondansetron Mylan tablets are used to help stop the nausea (sick feeling) and vomiting which can occur after medical treatments. Ondansetron Mylan tablets should only be used to treat the nausea and vomiting for which they have been prescribed. Your doctor may have prescribed Ondansetron Mylan tablets for another reason. If you want more information, ask your doctor. Ondansetron Mylan tablets are not addictive. BEFORE YOU TAKE ONDANSETRON MYLAN TABLETS _DO NOT TAKE IF:_ You must not take Ondansetron Mylan 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 Izlasiet visu dokumentu
AUSTRALIAN PRODUCT INFORMATION – ONDANSETRON MYLAN (ONDANSETRON HYDROCHLORIDE DIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Ondansetron hydrochloride dihydrate 2 & 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM 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 Mylan 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 Mylan 4 mg tablets: Light yellow, oval, biconvex, film coated tablets embossed ‘OND’ on one side and ‘4’ on other side. Ondansetron Mylan 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 nausea in adults, two oral doses of 8 mg each at 12 hourly intervals may be given (tablet Izlasiet visu dokumentu