Genticin 80mg/2ml Solution for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Gentamicin sulfate

Tersedia dari:

Amdipharm Limited

Kode ATC:

J01GB; J01GB03

INN (Nama Internasional):

Gentamicin sulfate

Dosis:

80 mg/2ml

Bentuk farmasi:

Solution for injection

Jenis Resep:

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

Area terapi:

Other aminoglycosides; gentamicin

Status otorisasi:

Marketed

Tanggal Otorisasi:

1995-04-20

Selebaran informasi

Package leaflet: Information for the patient
GENTICIN
® 80MG/2ML SOLUTION FOR INJECTION
Gentamicin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Genticin 80mg/2ml Solution for Injection
it will be called
Genticin Injection for ease here after.
WHAT IS IN THIS LEAFLET
1.
WHAT GENTICIN INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTICIN INJECTION
3.
HOW YOU WILL BE GIVEN GENTICIN INJECTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE GENTICIN INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT GENTICIN INJECTION IS AND WHAT IS IT USED FOR
The name of your medicine is Genticin Injection. This medicine
contains the active ingredient
gentamicin which belongs to a group of medicines called antibiotics.
Genticin Injection is used in adults and children to treat bacterial
infections such as severe chest
infections, urinary tract infections and septicaemia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTICIN INJECTION
YOU SHOULD NOT BE GIVEN GENTICIN INJECTION:

if you are allergic to gentamicin or to a similar medicine containing
an aminoglycoside
antibiotic or any of the other ingredients of this medicine (listed in
section 6)

if you suffer from
MYASTHENIA GRAVIS
(a disease causing muscle weakness).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given Genticin
Injection:

if you have any problems with your kidney or liver

if you have any problems with your hearing

if you have any infections or a fever

if you have low blood pressure or low blood volume

if you are considered to be significantly overweight

if you have Parki

Karakteristik produk

Health Products Regulatory Authority
31 August 2021
CRN00CGQZ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Genticin 80mg/2ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml ampoule contains gentamicin sulfate equivalent to 80 mg
gentamicin base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Each ampoule contains a sterile, clear colourless to pale yellow
solution. The solution is preservative free.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Genticin Solution for Injection is indicated in adolescents, children
and adults for the following:
The treatment of systemic infections due to susceptible bacteria such
as, bacteraemia, septicaemia, urinary-tract infections and
severe chest infections.
Consideration should be given to official local guidance on the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose recommended in children, adolescents and adults with
normal renal function, is 3-6 mg/kg body weight per day
as 1 (preferred) up to 2 single doses.
_Paediatric population (newborns and infants)_
The daily dose in newborns is 4.0- 7.0 mg/kg body weight per day. Due
to the longer half-life, newborns are given the required
daily dose in 1 single dose.
The daily dose in infants after the first month of life is 4.5-7.5
mg/kg body weight per day as 1 (preferred) up to 2 single doses.
In children and in neonates, it can be expected that serum levels will
be lower than those found in adults at equivalent dosage
per kg body weight.
_Elderly population_
Adjust dosage according to weight and renal function. Older people may
require lower maintenance doses than younger
adults because of impaired renal function.
_Serious infections_
In life-threatening infections the frequency of dosage may need to be
increased to 6-hourly and the quantity of each dose may
also be increased at the discretion of the clinician up to a total
dosage of 6 mg/kg in 24 hours. In