Pajjiż: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
FORMOTEROL FUMARATE
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
R03AC13
POWDER FOR INHALATION
FORMOTEROL FUMARATE 9 MCG/DOSE
INHALATION
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
FORMOTEROL
FORMOTEROL
For the relief of broncho-obstructive symptoms and prevention of exercise-induced symptoms in asthmatics when adequate treatment with corticosteroids is not sufficient. For the relief of bronco-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD).
2023-01-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ןכרצל ןכרצל ךיראת _____________________ FEBRUARY 28, 2013 __ םש רישכת __תילגנאב OXIS TURBUHALER 9 MCG/DOSE רפסמ _םושיר : 108 99 29180 00 ; 108 99 29180 01 םש לעב םושירה _ TEVA PHARMACEUTICAL INDUSTRIES LTD., POBOX 3190 PETACH TIKVA םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח ןיא יתמ שמתשהל רישכתב ןיא שמתשהל הפורתב ילבמ ץעוויהל אפורב ינפל תלחתה לופיט תורהזא ןיב תובוגת תויתפורת תופורת תורחא תוביחרמה יכרד המישנה יביחרמ( תונופמיס ןוגכ .)לומטובלס יאוול תועפות יאוול תועפות תושרודה תוסחייתה תדחוימ Aqra d-dokument sħiħ
OXIS TURBUHALER 31 5. 2012, RH " ע עבקנ הז ןולע טמרופ " רשואו קדבנ ונכותו תואירבה דרשמ י ." רשואמ ןולע : 31 יאמב 2012 “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved.” Date of approval: May 31, 2012. 1 NAME OF THE MEDICINAL PRODUCT O XIS T URBUHALER inhalation powder 4.5 micrograms/dose O XIS T URBUHALER inhalation powder 9 micrograms/dose. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose delivers: _Active Ingredient _ Formoterol fumarate dihydrate 4.5 micrograms or 9 micrograms. The delivered dose of formoterol fumarate dihydrate from Oxis Turbuhaler, (i.e., the dose to the patient) is 4.5 micrograms and 9 micrograms, respectively for the two strengths. To reach the targeted delivered dose, the metered dose consists of about 0.6 mg powder mixture containing 6 micrograms and 12 micrograms respectively, of formoterol fumarate dihydrate. _ _ _Other Ingredient _ Lactose monohydrate (which contains milk proteins). 3 PHARMACEUTICAL FORM Inhalation powder. White powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxis Turbuhaler is indicated for the relief of broncho-obstructive symptoms and prevention of exercise-induced symptoms in asthmatics when adequate treatment with corticosteroids is not sufficient. Oxis Turbuhaler is also indicated for the relief of broncho-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of OXIS TURBUHALER should be individualised. Oxis Turbuhaler is not recommended for use in children below 6 years due to insufficient data on safety and efficacy. 2 OXI S TURBUHALER 31 5. 2012, RH _RELIEF OF BRONCHO-OBSTRUCTIVE SYMPTOMS _ _Adults _ Normal dosage: 4.5 - 9 micrograms once or twice daily. The dose can be administered in the morning and/or at night. Some patients may need 18 micrograms once or twice daily. A daily dose above 36 micrograms is not recomme Aqra d-dokument sħiħ