Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE
NOVARTIS ISRAEL LTD
A04AA01
TABLETS
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE 8 MG
PER OS
Required
ASPEN BAD OLDESLOE GMBH, GERMANY
ONDANSETRON
ONDANSETRON
Adults:Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population:Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy.
2020-07-31
:لافطلأا _يواميكلا _ _جلاعلا_ _ ءارج تاؤيقتلاو نايثغلا جلاعل_ ةحاسم( لفطلا سيياقم رابتعلإا نيعب ً اذخآ ةيئاودلا ةعرجلا بيبطلا ددحي .)مسجلا _)طقف رابكلا( ةيحارج ةيلمع دعب تاؤيقتلاو نايثغلا جلاعو عنمل_ ةصاخلا ةيحارجلا ةيلمعلا لبق غلم 16 يه رابكلل ةيدايتعلإا ةيئاودلا ةعرجلا .كب _)طقف رابكلا( دبكلا يف ةديدش وأ ةلدتعم لكاشم مهيدل نوجلاعم_ .غلم 8 زواجتت لاأ بجي ةيلامجلإا ةيمويلا ةيئاودلا ةعرجلا .ةيئاودلا ةعرجلا لوانت نم نيتعاس وأ ةعاس للاخ نارفوز صارقأ لوعفم أدبي _اهب ىصوملا ةيئاودلا ةعرجلا_ _ زواجت زوجي لا_ _ةيئاودلا ةعرجلا لوانت نم ةعاس للاخ تأيقت اذإ_ ةيناث ةرم ةيئاودلا ةعرجلا سفن لوانت • .بيبطلا هب كاصوأ امم رثكأ نارفوز صارقأ لوانتت لاف ،لاإو • .كبيبطل كحإ ،كيدل نايثغلاب روعشلا رمتسإ اذإ .اهغضم وأ اهرطش ،اهقحس زوجي لاو ةيلطم صارقلأا نإ _ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ_ بيبطلل ً لااح هجوت ،ءاودلا نم أطخلاب لفط علب اذإ وأ ةطرفم ةيئاود ةعرج تلوانت اذإ .كعم ءاودلا ةبلع رضحأو ىفشتسملا يف ئراوطلا ةفرغل وأ _ءاودلا لوانت تيسن اذإ_ :أيقتت وأ نايثغب رعشت _تنكو_ ةيئاود ةعرج تيسن اذإ مث نمو ،نكمي ام عرسأ يف نارفوز صارقأ لوانت • .يدايتعلإا دعوملا يف كب صاخلا يلاتلا صرقلا لوانت • ةيئاودلا ةعرجلا نع ضيوعتلل ة Izlasiet visu dokumentu
ZOF TAB API APR23 V3 _Page 1 of 13 _ _ _ 1. TRADE NAME OF THE MEDICINAL PRODUCT Zofran ® Tablets 4 mg Zofran ® Tablets 8 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Zofran Tablet 4mg contains ondansetron 4 mg (as hydrochloride dihydrate). Each Zofran Tablet 8mg contains ondansetron 8 mg (as hydrochloride dihydrate). Excipients with known effect: Zofran Tablets 4 mg: contains lactose (anhydrous) 81.875 mg (see section 4.4). Zofran Tablets 8 mg: contains lactose (anhydrous) 163.75 mg (see section 4.4). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. Zofran Tablet 4mg is a yellow, oval, biconvex tablet engraved with "GXET3" on one face and plain on the other. Zofran Tablet 8mg is a yellow, oval, biconvex tablet engraved with "GXET5" on one face and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults: _ Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). _Paediatric Population: _ Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Chemotherapy and radiotherapy induced nausea and vomiting (CINV and RINV) . _Adults _ ZOF TAB API APR23 V3 _Page 2 of 13 _ _ _ The emetogenic potential of cancer 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. _Emetogenic Chemotherapy and Radiotherapy_ : Zofran can be given either by oral (tablets), intravenous or intramuscular administration. The recomended oral dose is: 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis. _For highly emetogenic chemotherapy_ To protect against delayed or pro Izlasiet visu dokumentu