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GENTAMICIN PAEDIATRIC 20 MG/2 ML SOLUTION FOR INJECTION

Active substance(s): GENTAMICIN SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gentamicin Paediatric 20mg/2ml Solution for Injection
(gentamicin sulfate)
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 pharmacist or nurse.
! This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
! If you get any side effects, talk to your doctor,
or pharmacist or nurse. This includes any
possible side effects not listed in the leaflet.
See section 4.
What is in this leaflet:
1. What Gentamicin Paediatric Solution for
Injection is and what it is used for
2. What you need to know before you use
Gentamicin Paediatric Solution for Injection
3. How to use Gentamicin Paediatric Solution
for Injection
4. Possible side effects
5. How to store Gentamicin Paediatric
Solution for Injection
6. Contents of the pack and other information
1. WHAT GENTAMICIN PAEDIATRIC
SOLUTION FOR INJECTION IS AND WHAT
IT IS USED FOR
Gentamicin Paediatric Solution for Injection
contains a medicine called gentamicin sulfate. This
belongs to a group of antibiotics called
'aminoglycosides'.
Gentamicin Paediatric Solution for Injection is used
to treat a wide range of infections caused by
bacteria in children.
These may include the treatment of infections of
the blood (bacteraemia and septicaemia), chest
infections, urinary tract infections (including your
kidneys and bladder), infections in new born
babies and other infections due to susceptible
organisms.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE GENTAMICIN PAEDIATRIC SOLUTION
FOR INJECTION

Your doctor will want to monitor your child
during treatment with this medicine. They will
monitor their vision, hearing and kidney
function, as this medicine can have an effect
on them.
Other medicines and Gentamicin Paediatric
Solution for Injection
Please tell your doctor or pharmacist if your child is
taking or has recently taken any other medicines,
including medicines obtained without a
prescription. This includes herbal medicines.
Remember to take this medicine with you if your
child has to go to hospital.
In particular tell your doctor or pharmacist if
your child is taking any of the following:
! Cephalosporin antibiotics used to treat
infections e.g. cephaloridine
! Curare-type muscle relaxants given under
anaesthetic
! Diuretics used to treat high blood pressure
e.g.furosemide
! Neostigmine and pyridostigmine used to treat
myasthenia gravis
! Medicines to treat cancer e.g. cisplatin
! Amphoteracin B used to treat fungal infections
! Ciclosporin used in organ transplants or for
severe skin problems
! Indometacin used to treat pain and swelling
! Medicines used to stop blood clotting e.g.
warfarin
! Bisphosphonates used to treat osteoporosis
e.g. alendronic acid
! Botulinum toxin used to treat over active
muscles
Pregnancy and breastfeeding
If your child is pregnant, thinks she may be
pregnant or is breastfeeding, you should tell the
doctor before she is given this medicine.
Gentamicin Paediatric Solution for Injection
contains sodium metabisulpite
This medicine contains E223 - sodium
metabisulphite. This may rarely cause severe
hypersensitivity reactions and bronchospasm.
3. HOW TO USE GENTAMICIN PAEDIATRIC
SOLUTION FOR INJECTION

Your child should not be given Gentamicin
Paediatric Solution for Injection if:
! they are allergic (hypersensitive) to gentamicin
sulfate or any of the other ingredients in this
medicine
! they have a condition called myasthenia gravis
- weak muscles.

This product is for use in children only.

INFORMATION FOR HEALTHCARE
PROFESSIONALS
PLEASE DETACH BEFORE HANDING ABOVE
SECTION TO THE PATIENT
Gentamicin Paediatric Solution for Injection

With either method of administration the following
dosage applies:

Gentamicin Paediatric Solution for Injection is
given under the supervision of a doctor, who can
give you more information.

Gentamicin Paediatric Solution for Injection is
given into a vein from an intravenous drip or into a
muscle. Your doctor will decide on the most
Warnings and precautions
Consult your doctor or pharmacist before your child appropriate route to use.
is given Gentamicin Paediatric Solution for
The dose your child receives will be determined by
Injection if your child :
the doctor depending on your child's body weight.
! has hearing problems
Blood samples will be taken by your doctor or
! has kidney problems
nurse to make sure the dose is correct.
! has liver problems
! is extremely overweight
! has any muscle weakness problems.

Below is a summary of information to assist in the
administration of Gentamicin Paediatric Solution
for Injection.
Please refer to SPC for complete prescribing
information.
For paediatric use only.
Instructions for administration
Gentamicin Paediatric 20mg/2ml Solution for
Injection is normally administered intramuscularly
but may be given intravenously if required.
If intravenous administration is necessary the
normal intramuscular dose should be given as a
bolus injection into the tubing of the giving set or
directly into the venous system over a period of
two or three minutes. Gentamicin should not be
given as a slow infusion or mixed with other drugs
before use.

Dosage:
Children with normal renal function
! 3-6mg/kg body weight per day as 1 (preferred)
up to 2 single doses.
! The daily dose in infants after the first month of
life is 4.5-7.5mg/kg body weight per day as 1
(preferred) up to 2 single doses.
! The daily dose in newborns is 4-7mg/kg body
weight per day. Due to the longer half life,
newborns are given the required daily dose in 1
single dose.
In neonates, infants and children, subsequent
dosage will often need to be increased to achieve
therapeutic serum levels. Peak levels should be
measured about one hour after intramuscular or
intravenous injection and should reach
4 micrograms/ml, but not exceed
10 micrograms/ml.
Trough levels can be measured just prior to the
next injection.

The usual dose is as follows:

!
!
!
!
!

Children (aged 1 year and above):
The usual daily dose is 3-6 mg per kg of body
weight.
This can be given as 1 single dose (preferred) or
split into 2 doses.

!

fits or convulsions
feeling confused
feeling tired with no energy (lethargy)
feeling sad (depression)
seeing, hearing or feeling something that is not
real (hallucinations)
changes in the levels of certain chemicals in
the blood e.g. potassium or magnesium
have bloody diarrhoea, with or without stomach
cramps
headache
damage to the liver which will be picked up in a
blood test during monitoring

Babies (aged 4 weeks to 1 year of age):
The usual daily dose is 4.5-7.5 mg per kg of body
weight.
This can be given as 1 single dose (preferred) or
split into 2 doses.

!

New born babies (up to 4 weeks of age):
The usual daily dose is 4-7 mg per kg of body
weight.
This is given as a single dose.

Your child may also feel sick (nausea) or may be
sick (vomiting).

!
!

Reporting of side effects
If your child gets any side effects, talk to your
doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

Subsequent doses may need to be increased to
achieve the correct level of gentamicin required.
Children with kidney problems:
The dosage will be adjusted by your doctor.
If your child is given more Gentamicin
Paediatric Solution for Injection than he/she
should
The dose of Gentamicin Paediatric Solution for
Injection will be carefully calculated by the doctors
so overdose is unlikely. However, if too much is
given this is likely to make the usual side effects
worse (see Section 4, Possible side effects).

5. HOW TO STORE GENTAMICIN PAEDIATRIC
SOLUTION FOR INJECTION
Keep out of the sight and reach of children.
This medicine will be given by a doctor.
Store below 25°C. Store in the original package.
Protect from light.

If your child misses a dose of Gentamicin
Paediatric Solution for Injection
Gentamicin Paediatric Solution for Injection will be
given to your child by a doctor or nurse. It is most
unlikely that they will not be given the medicine as
it has been prescribed. If you think that a dose has
been missed talk to your nurse or doctor.

Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

If your child stops having Gentamicin
Paediatric Solution for Injection
It is important that the course of treatment that the
doctor has prescribed is finished. Your child may
start to feel better but it is important to continue
with the treatment until the doctor advises. If
treatment is stopped the infection may get worse.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Gentamicin Paediatric Solution for
Injection contains:
Gentamicin Paediatric Solution for Injection
contains the active ingredient, gentamicin sulfate.
Each 2ml of solution contains 20mg of gentamicin
sulfate.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gentamicin Paediatric Solution
for Injection, may cause your child to experience
some side effects, although not everybody gets
them.
If any of the following occur tell your child's
doctor or nurse immediately:
! allergic reactions may occur rarely, with
symptoms such as rash, itching, swelling of the
face, wheeziness, shortness of breath,
tightness in the chest, fever, low blood pressure
and feeling dizzy particularly when standing up.
! losing balance, feeling dizzy or their hearing
becomes poor. This is more likely to happen if
your child has kidney problems.
! your child is passing less water than usual or
there is blood in their urine. This may mean the
medicine is affecting their kidneys.
If your child experiences any of the following side
effects you should talk to the doctor:
! changes in the blood, which will be picked up in
a blood test during monitoring e.g. anaemia
! skin rashes
! itching
! mouth ulcers

The other ingredients are: sodium metabisulphite
(E223), sodium edetate, sodium citrate, citric acid
and water for injection.
What Gentamicin Paediatric Solution for
Injection looks like and contents of the pack
Gentamicin Paediatric Solution for Injection is
supplied in clear glass ampoules in packs of 5 with
2ml in each ampoule
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
Alfa Wassermann SPA
Via Enrico Fermi, 1
65020 ALANNO (PE)
Italy.
This leaflet was last revised in July 2015

Children with impaired renal function
The recommended daily dose should be decreased and adjusted to the renal function. The following
table for adults can serve as a guideline to these modified doses:
Blood Urea
(mg/100ml)

Creatinine Clearance
(GFR) (ml/minute)

Dose and frequency of
administration

<40

>70

80mg* 8 hourly

40-100

30-70

80mg* 12 hourly

100-200

10-30

80mg* daily

>200

5-10

80mg* every 48 hours

Twice-weekly intermittent haemodialysis

<5

80mg* after dialysis

*60mg if bodyweight <60kg

(80mg=80,000 I.U.)

Monitoring
Serum concentration monitoring of gentamicin is recommended, especially in elderly, in newborns and
in patients with impaired renal function. Samples are taken at the end of a dosing interval (trough
level). Trough levels should not exceed 2µg/ml administering gentamicin twice daily and 1µg/ml for a
once daily dose.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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