Genticin Injectable 80mg/2ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gentamicin sulfate

Available from:

Advanz Pharma

ATC code:

J01GB03

INN (International Name):

Gentamicin sulfate

Dosage:

40mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010400; GTIN: 5060064171691

Patient Information leaflet

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 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 Gentamicin 40mg/ml Solution
for Injection is and what it is used
for
2.
What you need to know before you
are given Gentamicin 40mg/ml
Solution for Injection
3.
How you will be given Gentamicin
40mg/ml Solution for Injection
4.
Possible side effects
5.
How to store Gentamicin
40mg/ml Solution for Injection
6.
Contents of the pack and other
information
1.
WHAT GENTAMICIN 40MG/ML
SOLUTION FOR INJECTION IS AND
WHAT IT IS USED FOR
The name of your medicine is
Gentamicin 40mg/ml Solution for
Injection.
Gentamicin 40mg/ml Solution for
Injection contains the active ingredient
gentamicin which belongs to a group
of medicines called antibiotics.
Gentamicin 40mg/ml Solution for
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 GENTAMICIN
40MG/ML SOLUTION FOR INJECTION
YOU SHOULD NOT BE GIVEN Gentamicin
40mg/ml Solution for Injection:
•
if you are ALLERGIC to gentamicin or
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 or nurse before
being given Gentamicin 40mg/ml
Solution for Injection:
•
if you have any problems with your
kidneys, liver or 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 Parkinson’s disease or
any other disease causing muscle

Summary of Product characteristics

OBJECT 1
GENTICIN (GENTAMICIN) 40MG/ML INJECTABLE
Summary of Product Characteristics Updated 24-Apr-2018 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Genticin Injectable
Gentamicin 40 mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each ampoule (2 ml) contains Gentamicin Sulphate 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 solution. The
solution is preservative free.
4. Clinical particulars
4.1 Therapeutic indications
Gentamicin 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
Adults
The daily recommended dose in adults with normal renal function is
3-6mg/kg body weight per day as
one (preferred) up to two single doses.
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
5mg/kg in 24 hours. In such cases it is advisable to monitor
gentamicin serum levels.
If renal function is not impaired, 160mg once daily may be used in
some cases.
Renal impairment
In cases of impaired renal function a reduction in dosage frequency is
recommended. The following table
is a guide to recommended dosage schedules:
Blood urea
(mg/100ml)
Creatinine clearance (GFR)
(ml/min)
Dose and frequency of administration
<40
40 - 100
100 - 200
>200
Twice-weekly intermittent
haemodialysis
>70
30 - 70
10 - 30
5 - 10
<5
80mg† 8-hourly
80mg† 12-hourly
80mg† daily
80mg† every 48 hours
80mg† after dialysis
† 60mg if body weight <60kg
Paediatric population:
Th