Cidomycin Paediatric 20mg/2ml Solution for Injection

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Gentamicin sulfate

Disponible depuis:

Sanofi-Aventis Ireland Limited T/A SANOFI

Code ATC:

J01GB; J01GB03

DCI (Dénomination commune internationale):

Gentamicin sulfate

Dosage:

20 mg/2ml

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

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

Domaine thérapeutique:

Other aminoglycosides; gentamicin

Statut de autorisation:

Marketed

Date de l'autorisation:

1977-03-09

Notice patient

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
CIDOMYCIN PAEDIATRIC
20MG/2ML
SOLUTION FOR INJECTION
Gentamicin
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it
again
•
If you have any further questions, ask
your doctor or pharmacist
•
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours
•
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
IN THIS LEAFLET:
1.
What Cidomycin Paediatric is and what it
is used for
2.
Before you use Cidomycin Paediatric
3.
How to have Cidomycin Paediatric
4.
Possible side effects
5.
How to store Cidomycin Paediatric
6.
Further information
1. WHAT CIDOMYCIN PAEDIATRIC IS AND
WHAT IT IS USED FOR
The name of this medicine is Cidomycin
Paediatric 20mg/2ml Solution for Injection
(called Cidomycin in this leaflet). It contains
a medicine called gentamicin sulphate. This
belongs to a group of antibiotics called
‘aminoglycosides’.
Gentamicin is used to treat infections caused
by bacteria. This includes infections in:
•
Your urinary tract (including your kidneys
or bladder)
• Your chest (including your lungs)
• Your blood – this is sometimes called
‘bacteraemia’ or ‘septicaemia’
2. BEFORE YOU USE CIDOMYCIN PAEDIATRIC
DO NOT HAVE THIS MEDICINE IF:
•
You have Myasthenia Gravis. This is a
disease that causes muscle weakness.
•
You are allergic (hypersensitive) to
Cidomycin or to any of the other
ingredients of this medicine (see Section 6:
Further Information). Signs of an allergic
reaction include: a rash (hives), itching,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
Cidomycin must not be given by injection to
the brain (Intraventricular administration) to
infants (un

Résumé des caractéristiques du produit

Health Products Regulatory Authority
10 June 2021
CRN00CCNW
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cidomycin Paediatric 20mg/2ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml vial contains Gentamicin Sulphate equivalent to 20mg
Gentamicin base (10mg/ml).
Each 2ml vial also contains less than 1mmol sodium (<23mg).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gentamicin is indicated for the treatment of serious systemic
infections including those of the central nervous system due to
organisms sensitive to this anti-infective. Such infections include
urinary tract infections, chest infections, bacteraemia,
septicaemia, severe neonatal infections and other systemic infections
due to sensitive organisms.
Gentamicin is usually active against most strains of the following
organisms; _Eschericha coli_, _Klebsiella_ spp., _Proteus_ spp.
(indole
positive and indole negative) _Pseudomonas aeruginosa_,
_Staphylococci_, _Enterobacter_ spp., _Citrobacter_ spp. and
_Providencia_ spp.
Consideration should be given to official local guidance on the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
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.
The daily dose in newborns is 4-7 mg/kg body weight per day. Due to
the longer half-life, newborns are given the required
daily dose in 1 single dose.
In impaired renal function, the recommended daily dose has to be
decreased and adjusted to the renal function.
Renal impairment:
Gentamicin is excreted by simple glomerular filtration and, therefore,
reduced dosage is necessary where renal function is
impaired. Nomograms are