Gentamicin 40mg/ml Solution for Injection or Infusion

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Gentamicin Sulfate

Available from:

Wockhardt UK Ltd

ATC code:

J01GB03

INN (International Name):

Gentamicin Sulfate

Dosage:

40mg/ml

Pharmaceutical form:

Solution for injection or infusion

Administration route:

Intravenous injection or infusion

Units in package:

packs of 5 ampoules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

CP Pharmaceuticals Ltd

Therapeutic group:

Antibacterial for systemic use

Therapeutic indications:

It is indicated in bacteraemia, urinary tract infections, chest infections, severe neonatal infections and other serious systemic infections due to susceptible organisms, in adults and children including neonates

Authorization status:

Authorised

Authorization date:

2014-11-24

Patient Information leaflet

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
GENTAMICIN 10MG/ML SOLUTION FOR INJECTION OR INFUSION
AND
GENTAMICIN  40MG/ML SOLUTION FOR INJECTION OR INFUSION
pg1/2
WHAT IS IN THIS LEAFLET:
1. What gentamicin is and what it is used for
2. What you need to know before you take gentamicin
3. How to take gentamicin 
4. Possible side effects
5. How to store gentamicin
6. Contents of the pack and other information
  1.  WHAT GENTAMICIN IS AND WHAT IT IS USED FOR
The name of this medicine is Gentamicin 10mg/ml Solution for 
Injection or Infusion and Gentamicin 40mg/ml Solution for Injection
or 
Infusion (called “gentamicin” in this leaflet).
It contains a medicine called gentamicin sulfate. This belongs to a 
group of antibiotics called aminoglycosides.
Gentamicin is used to treat infections caused by bacteria in adults
and 
children including new-borns. This includes infections in:
•  Your urinary tract (including your kidneys or bladder)
•  Your chest (including your lungs)
•  Your blood – this is sometimes called ‘bacteraemia’ 
•  Other serious infections
  2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE
       GENTAMICIN
DO NOT TAKE GENTAMICIN IF:
•  You have Myasthenia Gravis. This is a disease that causes
muscle 
weakness
•  You are allergic (hypersensitive) to gentamicin or to any of
the other 
ingredients of this medicine (listed in section 6). Signs of an
allergic 
reaction include: a rash, swallowing or breathing problems, swelling 
of your lips, face, throat and tongue.
Do not take this medicine if any of the above applies to you. If you
are 
not sure, talk to your doctor or pharmacist before taking gentamicin.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gentamicin if:
•  You are pregnant, might become pregnant, or think you may be 
pregnant
•  You are breast-feeding (see ‘Pregnancy and breast-feeding’
section 
below)
•  You have any muscle weakness problems
•  You are extremely overweight
•  You hav

Summary of Product characteristics

Gentamicin 10mg/ml & 40mg/ml Solution for Injection or Infusion
Summary of Product Characteristics Updated 17­Jul­2015 | Wockhardt UK Ltd
1. Name of the medicinal product
Gentamicin 10mg/ml Solution for Injection or Infusion
Gentamicin 40mg/ml Solution for Injection or Infusion
2. Qualitative and quantitative composition
10mg/ml ­ 1 ml of solution for injection or infusion contains gentamicin sulphate equivalent to 10 mg gentamicin.
Each ampoule (2ml) contains Gentamicin Sulfate Ph Eur equivalent to 20mg Gentamicin.
40mg/ml ­ 1 ml of solution for injection or infusion contains gentamicin sulphate equivalent to 40 mg gentamicin.
Each ampoule (2ml) contains Gentamicin Sulfate Ph Eur equivalent to 80mg Gentamicin.
This medicine contains 0,78 mg of sodium per ampoule; it is essentially sodium free.
This medicine contains 3.2 mg of sodium metabisulfite
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection or Infusion.
Clear, colourless solution, having pH ranging from 3.0 to 5.5.
4. Clinical particulars
4.1 Therapeutic indications
Indications : gentamicin is indicated in bacteraemia, urinary tract infections, chest infections, severe neonatal infections
and other serious systemic infections due to susceptible organisms, in adults and children including neonates.
Please see section 5.1.
Consideration should be given to official local guidance on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
Adults:
Systemic infections: if renal function is not impaired, 3­5 mg/kg/day in divided doses according to severity of infection,
adjusting according to clinical response and body weight.
Serious infections: if renal function is not impaired, 5mg/kg daily in divided doses at six or eight hourly intervals. The
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