Tobramycin 40 mg/ml Solution for Injection

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Tobramycin

Disponível em:

Pfizer Healthcare Ireland

Código ATC:

J01GB; J01GB01

DCI (Denominação Comum Internacional):

Tobramycin

Dosagem:

40 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

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

Área terapêutica:

Other aminoglycosides; tobramycin

Status de autorização:

Marketed

Data de autorização:

1993-07-14

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TOBRAMYCIN 40 MG/ML SOLUTION FOR INJECTION
TOBRAMYCIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Tobramycin is and what it is used for
2.
What you need to know before you use Tobramycin
3.
How to use Tobramycin
4.
Possible side effects
5.
How to store Tobramycin
6.
Contents of the pack and other information
1. WHAT TOBRAMYCIN IS AND WHAT IT IS USED FOR
Tobramycin is an antibiotic medicine (used to fight infections caused
by bacteria).
Tobramycin can be used to treat:
•
infections of the brain and spinal cord, e.g. meningitis
•
infections of the stomach or intestines
•
infections of the bladder or kidney (urinary tract infection)
•
infections of the lungs, e.g. pneumonia
•
infections of the bone, skin or soft tissue including burns
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOBRAMYCIN
TOBRAMYCIN MUST NEVER BE INJECTED INTRATHECALLY (INTO THE SPINE).
DO NOT USE TOBRAMYCIN:
•
if you are allergic to tobramycin or any of the other ingredients of
this medicine
(listed in section 6), or similar medicines (called aminoglycosides)
•
if you are pregnant or breast feeding
•
if you are taking potent diuretics (water tablets) such as frusemide
or ethacrynic acid
Tell your doctor if the above applies to you before this medicine is
used.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE USING TOBRAMYCIN:
•
if you or your family members have a mitochondrial mutation disease
(condition
caused by variants in the genome of mitochondria, the parts of your
cells which help
make energy) or loss of hearing due to antibiotic medicines; certain
mitochondrial
mutations may in

Características técnicas

Health Products Regulatory Authority
18 August 2022
CRN00C8ZV
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tobramycin 40 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 40 mg tobramycin.
Excipient with known effect
Each vial contains 2.4mg sodium metabisulphite (E223) per ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tobramycin Solution for injection is indicated in the treatment of the
following serious infections caused by susceptible
micro-organisms:

The treatment of central nervous system infections including
meningitis, septicaemia and neonatal sepsis;

The treatment of gastro-intestinal infections including peritonitis;

The treatment of complicated and recurrent urinary tract infections
such as pyelonephritis and cystitis;

The treatment of lower respiratory tract infections, including
pneumonia, bronchopneumonia and acute bronchitis;

The treatment of skin, bone and soft tissue infections including
burns.
Tobramycin may also be considered in serious staphylococcal infections
for which penicillin or other less potentially toxic drugs
are contraindicated and when bacterial susceptibility testing and
clinical judgement indicate its use.
Tobramycin Solution for injection (single dose regimen) is indicated
in the treatment of the following serious infections caused
by susceptible micro-organisms:

The treatment of lower respiratory tract infections, including
pneumonia, bronchopneumonia and acute bronchitis
in adults with normal renal function. (see section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Tobramycin Solution for Injection may be given intramuscularly or
intravenously and the dosage is the same for either route of
administration. To calculate the correct dosage, the patient's
pre-treatment bodyweight should be obtained.
To ensure the corre