Cidomycin 80mg/2ml solution for injection ampoules

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Gentamicin sulfate

Verfügbar ab:

Advanz Pharma

ATC-Code:

J01GB03

INN (Internationale Bezeichnung):

Gentamicin sulfate

Dosierung:

40mg/1ml

Darreichungsform:

Solution for injection

Verabreichungsweg:

Intravenous; Intramuscular

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 05010400; GTIN: 5013011006508

Fachinformation

CIDOMYCIN ADULT 80MG/2ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 14-May-2015 | SANOFI
1. Name of the medicinal product
Cidomycin Adult 80mg/2ml Solution for Injection
2. Qualitative and quantitative composition
Each ampoule or vial (2ml) contains Gentamicin Sulphate Ph Eur
equivalent to 80mg Gentamicin base.
Also contains 3.6 mg of methyl parahydroxybenzoate (E218) and 0.4 mg
of propyl parahydroxybenzoate
(E216).
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 an aminoglycoside antibiotic with broad-spectrum
bactericidal activity. It is usually active
against most strains of the following organisms : Escherichia coli,
Klebsiella spp., Proteus spp. (indole
positive and indole negative), Pseudomonas aeruginosa, Staphylococci,
Enterobacter spp., Citrobacter spp
and Providencia spp.
Gentamicin injection and gentamicin paediatric injection are indicated
in urinary-tract infections, chest
infections, bacteraemia, septicaemia, severe neonatal infections and
other systemic infections due to
sensitive organisms.
_Consideration should be given to official local guidance on the
appropriate use of antibacterial agents._
4.2 Posology and method of administration
ADULTS:
Serious infections: If renal function is not impaired, 5mg/kg/daily in
divided doses at six or eight hourly
intervals. The total daily dose may be subsequently increased or
decreased as clinically indicated.
Systemic infections: If renal function is not impaired, 3-5mg/kg/day
in divided doses according to
severity of infection, adjusting according to clinical response and
body weight.
Urinary tract infections: As “Systemic infections“. Or, if renal
function is not impaired, 160mg once
daily may be used.
PAEDIATRIC PATIENTS:
The daily dose recommended in children aged 1 year and above and
adolescents with normal renal
function, is 3-6 mg/kg body weight per day as 1 (preferred) up to 2
single dose