OXIS TURBUHALER 9 MCGDOSE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FORMOTEROL FUMARATE

Available from:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC code:

R03AC13

Pharmaceutical form:

POWDER FOR INHALATION

Composition:

FORMOTEROL FUMARATE 9 MCG/DOSE

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

FORMOTEROL

Therapeutic area:

FORMOTEROL

Therapeutic indications:

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).

Authorization date:

2013-01-31

Patient Information leaflet

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

Summary of Product characteristics

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