Bramitob 300mg/4ml Nebuliser Solution

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Tobramycin

제공처:

Chiesi Limited

ATC 코드:

J01GB; J01GB01

INN (International Name):

Tobramycin

복용량:

300/4 milligram(s)/millilitre

약제 형태:

Nebuliser solution

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Other aminoglycosides; tobramycin

승인 상태:

Marketed

승인 날짜:

2007-06-01

환자 정보 전단

CHIESI ITEM
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRAMITOB 300MG/4ML NEBULISER SOLUTION
Tobramycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CON-
TAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT BRAMITOB IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRAMITOB
3. HOW TO USE BRAMITOB
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BRAMITOB
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT BRAMITOB IS AND WHAT IT IS USED FOR
Bramitob contains tobramycin which is an antibiotic belonging to a
family called the
aminoglycosides. It fights infections caused by Pseudomonas
aeruginosa.
Bramitob is used for treating chronic chest infections in patients
with cystic fibrosis caused by
Pseudomonas bacteria. It kills the bacteria and helps to improve your
breathing. Pseudomonas
is a very common bacterium that infects nearly all patients with
cystic fibrosis at some time
during their lives. Some people do not get this infection until later
on in their lives while others
get it very young. If infection is not properly controlled it will
continue to damage the lungs
causing further problems. As Bramitob is breathed-in the antibiotic,
tobramycin, can get straight
into your lungs to work against the bacteria causing the infection.
Bramitob is indicated only for patients aged 6 years and older.
To achieve the best results please make every effort to use your
medicine as instructed.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRAMITOB
DO NOT USE BRAMITOB:
• If you are allergic (hypersensitive) to tobramycin, any of the
other ingredients of
thi

제품 특성 요약

Health Products Regulatory Authority
09 April 2019
CRN008JR8
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bramitob 300mg/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 fall below 2 µg/mL (see section 4.4).
PATIENTS WITH HEPATIC INSUFFICIENCY
No changes in Bramitob dose are required in hepatic insufficiency.
Dosage is not adjusted for body weight. All patients should be
admin