Cidomycin 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: 5013011006508

Summary of Product characteristics

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