ZOFATRONE 4MG 3AMP; ondansteron, antiemetics .
ACTIVE-INGREDIENT OF ZOFATRONE 4MG 3AMP
each 2 ml ampoule contains : active ingredients : ondansetron hydrochloride dihydrate 5 mg . Equivalent to ondansetrone 4 mg .
INDICATION OF ZOFATRONE 4MG 3AMP
zofatrone is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy . Zofatrone is indicated for the prevention and treatment of post- operative nausea and vomiting ( PONV ) .
DOSAGE OF ZOFATRONE 4MG 3AMP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
chemotherapy and radiotherapy induced nausea and vomiting (CINV AND RINV ) : the emetogenic potential treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used . The selection of dose regimen should be determined by the severity of the emetogenic challenge . population : adults : emetrogenic chemotherapy and radiotherapy : the recommended iv or im dose of zofatrone is 8 mg administered as a slow injection immediately before treatment . oral or rectal treatment is recommended to protect against delayed or prolonged emesis after the first24 hours . highly emetogenic chemoptherapy ( e.g; high doses of ciplatin ) : ondasetron can be given either by rectal , oral ( tablets or syrup ) , intravenous or intramuscular injection immediately before chemotherapy . doses of greater than 8 mg up to 16 mg of ondasetron may be only given by intravenous infusion fluid and infused over not less than 15 minutes immediately before chemotheraby . a single dose greater than 15 minutes immediately before chemotherapy . a single dose greater than 16 mg must not be given . for management of highly emetogenic chemotherapy , a dose of 8 mg may be administered by slow intravenous in not less than 30 seconds , or intramuscular injection immediately before chemotherapy , followed by two further intravenous or intramuscular doses of 8 mg two to four hours apart , or by a constant infusion of 1 mg/hour for up to 24 hours . . the efficacy of zefatrone in highly . emetrogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate , 20 mg administered prior to chemotherapy . oral or rectal treatment is recommended to protect against delayed or prolonged emesis after the first 24 hours . cinv in children and adolescents 9 aged 6 months to 17 years ) : the dose for cinv can be calculated based on body surface area ( BSA ) or weight . ondasetron was given by iv infusion diluted in 25-50 ml of saline or other compatible infusion fluid and infused intravenously over not less than 15 minutes . dosing by BSA : zofatrone should be adminstered immediately before chemotherapy as a single intravenous dose of 5 mg/m2 . the intravenous dose must not exceeded 8 mg . oral dosing can commence twelve hours later and may be continued for up to 5 days , adult doses must be exceeded . BSA – based dosing for CINV in children and adolescents ( aged 6 months to 17 years ) : bsa OVER-DOSAGE OF ZOFATRONE 4MG 3AMP
symptoms and signs : there is limited experience of ondansetron overdose . In the majority of cases , symptoms were similar to those in patients receiving normal doses . Ondansetron prolongs the QT interval in a dose – dependent manner . ECG monitoring is recommended in cases of overdose . treatment : there is no specific antinode for ondasetron , therefore in all cases of suspected overdose , syptomatic and supportive therapy should be given as appropiate . the use of ipecacuanha to treat overdose with ondansetron is not recommended , as patients are unlikely to respond due to the anti-emetic action of ondasetron itself .
CONTRA-INDICATION OF ZOFATRONE 4MG 3AMP
based on reports of profound hypotension and loss of consciousness when consciousness when ondansetron was administrated with apomorphine hydrochloride , concomitant use with apomorphine is contraindicated . Patients with known hypersensitivity to any component of preparation .
STORAGE OF ZOFATRONE 4MG 3AMP
store at a temperature not exceeding 30 c . Keep out of the reach of children .
PACK OF ZOFATRONE 4MG 3AMP
carton box containing 3,5 or 10 transparent glass ampoules (type 1 ) each containing 2 ml solution . Ampoules are placed in plain white pvc cartidge with insert leaflet .
ZOFATRONE 4MG 3AMP MANUFACTURED BY
EVA PHARMA .