TOBI PODHALER 28 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TOBRAMYCIN

متاح من:

DEXCEL LTD, ISRAEL

ATC رمز:

J01GB01

الشكل الصيدلاني:

INHALATION POWDER HARD CAPSULES

تركيب:

TOBRAMYCIN 28 MG

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MYLAN PHARMACEUTICALS, INC USA

المجموعة العلاجية:

TOBRAMYCIN

المجال العلاجي:

TOBRAMYCIN

الخصائص العلاجية:

Suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.

تاريخ الترخيص:

2016-12-31

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TOBI Podhaler 28 mg inhalation powder, hard capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 28 mg tobramycin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Inhalation powder, hard capsule
Clear colourless capsules containing a white to almost white powder,
with "MYL TPH" printed in
blue on one part of the capsule and Mylan logo printed in blue on the
other part of the capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOBI Podhaler is indicated for the suppressive therapy of chronic
pulmonary infection due to
_Pseudomonas aeruginosa_ in adults and children aged 6 years and older
with cystic fibrosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of TOBI Podhaler is the same for all patients within the
approved age range, regardless
of age or weight. The recommended dose is 112 mg tobramycin (4 x 28 mg
capsules),
administered twice daily for 28 days. TOBI Podhaler is taken in
alternating cycles of 28 days on
treatment followed by 28 days off-treatment. The two doses (of 4
capsules each) should be
inhaled as close as possible to 12 hours apart and not less than 6
hours apart.
_Missed doses _
In case of missed dose with at least 6 hours until the next dose, the
patient should take the dose as
soon as possible. Otherwise, the patient should wait for the next dose
and not inhale more
capsules to make up for the missed dose.
_Duration of treatment _
Treatment with TOBI Podhaler should be continued on a cyclical basis
for as long as the
physician considers the patient is gaining clinical benefit from the
treatment with TOBI Podhaler
taking into account that long-term safety data are not available for
TOBI Podhaler. If clinical
deterioration of pulmonary status is evident, additional or
alternative anti-pseudomonal therapy
should be considered. See also information on clinical benefit and
tolerability in sections 4.4, 4.8
and 5.1.
Safety and efficacy have not been demonstra