Bramitob 300mg/4ml nebuliser solution 4ml ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tobramycin

Available from:

Chiesi Ltd

ATC code:

J01GB01

INN (International Name):

Tobramycin

Dosage:

75mg/1ml

Pharmaceutical form:

Nebuliser liquid

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010400; GTIN: 5028613002773

Patient Information leaflet

87P48.06/01
PAG. 1/2
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TECHNICAL WORKING
APPROVAL ARTWORK
FONTS: in tracciati
CORPO: /
(5)
SOST. COD. 87P48.05/01
REPARTO: /
CHIESI FARMACEUTICI
S.P.A. - PARMA - ITALIA
VIETATA LA MANOMISSIONE
D.Q.O.C. - UFFICIO GRAFICO
AUTORE: RB/ChB
mail:
[e-mail]
(1) DESCRIZIONE MATERIALE
DIMENSIONI FOGLIO STESO
150 x 500 mm
(4) CODICE
87P48.06/01
(8) DATA A.A.
09/06/2015
(2) F.TO A.A.
F049
(3)
N˚ PHARMACODE 172 (COD. A BARRE)
DIMENSIONI FOGLIO FINITO PIEGATO
150 x 62,5 mm
COLORI DI STAMPA N° 1
FUSTELLA
F.E. BRAMITOB 300MG 4ML SOL. DA NEB. CH. LTD
(7)
Rif. richiesta di codifica del 28/05/2015 -
(6)
Motivo:
- Regolatorio: - Chiesi UK address change
- Tecnico: modifica cod. Chiesi, cod. laetus, cod. UK
TOT. PAG. PDF: N.2
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NERO + retino 50%
TECHNICAL INFORMATION / INFORMAZIONI TECNICHE
DEFINITIVO: PDF per il fornitore e per Chiesi Farm.
DRAFT
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08/07/2015
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRAMITOB 300MG/4ML NEBULISER SOLUTION
Tobramycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. D

Summary of Product characteristics

OBJECT 1
BRAMITOB NEBULISER SOLUTION
Summary of Product Characteristics Updated 15-Sep-2015 | Chiesi
Limited
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 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