BRAMITOB

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TOBRAMYCIN

متاح من:

KAMADA LTD, ISRAEL

ATC رمز:

S01AA12

الشكل الصيدلاني:

SOLUTION FOR INHALATION

تركيب:

TOBRAMYCIN 300 MG / 4 ML

طريقة التعاطي:

NEBULISATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CHIESI FARMACEUTICI S.P.A., ITALY

المجموعة العلاجية:

TOBRAMYCIN

المجال العلاجي:

TOBRAMYCIN

الخصائص العلاجية:

Management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older.

تاريخ الترخيص:

2015-07-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only.
BRAMITOB
Solution for Inhalation
.
Intended for inhalation with a nebuliser. See “
Instructions for Use
” section.
COMPOSITION
Each 4 ml ampoule contains the active ingredient:
∙ Tobramycin 300 mg
Inactive ingredients: see section 6 in the leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about
the medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It may harm them,
even if it seems to you that their ailment is similar.
THE MEDICINE IS NOT INTENDED FOR CHILDREN BELOW THE AGE OF 6.
Bramitob contains an aminoglycoside antibiotic called tobramycin, that
acts against infections caused by the
Pseudomonas aeruginosa
bacterium.
1. WHAT IS THE MEDICINE INTENDED FOR?
Bramitob is used to treat chronic lung infection caused by the
Pseudomonas aeruginosa
bacterium, in patients with
cystic fibrosis above the age of 6. The medicine kills the bacteria
and helps to improve breathing. Pseudomonas is
a very common bacterium and infects the lungs of nearly all patients
with cystic fibrosis at some time during their
lives. Some people get the bacterium at a later stage in life, while
others get it at a very young age. If the infection
is not properly treated, it will continue to cause damage to the lungs
as well as additional problems. As Bramitob is
administered by inhalation, the tobramycin antibiotic directly reaches
the lungs to act against the infecting bacteria.
To achieve the best treatment results, please use the medicine in
accordance with the recommended instructions.
THERAPEUTIC GROUP: Aminoglycoside class antibiotic.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ you are sensitive )allergic( to the active ingredient tobramycin,
to any of the other ingredi

خصائص المنتج

_1/11 _
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Bramitob 300 mg/4ml Nebuliser Solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 ml single-dose container contains tobramycin 300 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser solution.
Clear, yellowish solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of chronic pulmonary infection due to
_Pseudomonas aeruginosa_
in patients with
cystic fibrosis aged 6 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Bramitob is intended for inhalation only and not for parenteral use.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Therapy should be initiated by a physician experienced in the
management of cystic fibrosis.
The recommended dose for adults and children above 6 years is one
single-dose container
(300mg) twice daily (morning and evening) for 28 days. The dose
interval should be as close as
possible to 12 hours. After 28 days of therapy with Bramitob, patients
should stop treatment for
the next 28 days. Alternate cycles of 28-days of active therapy
followed by 28 days without
treatment should be maintained (a cycle of 28 days with therapy and 28
days without treatment).
Children under 6 years old
The efficacy and safety of Bramitob have not been demonstrated in
patients less than 6 years of
age.
Elderly patients
Tobramycin should be used with caution in elderly patients who may
have reduced renal function
(see section 4.4).
Patients with renal impairment
Tobramycin should be used with caution in patients with known or
suspected renal dysfunction.
Bramitob should be discontinued in the case of nephrotoxicity until
serum concentration of
tobramycin falls below 2 µg/mL (see section 4.4).
Patients with hepatic insufficiency
No changes in Bramitob dose are required in hepatic insufficiency.
_2/11 _
Dosage is not adjusted for body weight. All patients should be
administered one single-dose
container of Bramitob (