Cidomycin 80mg/2ml solution for injection vials

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:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010400; GTIN: 5013011006492

Patient Information leaflet

_I_
TURN
OVER
CIDOMYCIN®
80MG/2ML
SOLUTION FOR INJECTION
Gentamicin
TECHNICAL LEAFLET – CIDOMYCIN INJECTION
The following information is extracted from the SPC.
TECHNICAL INFORMATION FOR THE PREPARATION AND
ADMINISTRATION OF CIDOMYCIN.
1. NAME OF THE MEDICINAL PRODUCT
Cidomycin® 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.
Excipients with known effect:
Sodium chloride: 12.84mg/2ml ampoule or vial.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless solution.
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.
ELDERLY:
There is some evidence that elderly patients may be more
susceptible to aminoglycoside toxicity whether secondary to
previous auditory/vestibular impairment or borderline
renal dysfunction. Accordingly, therapy should be closely
monitored by frequent determination of gentamicin serum
levels, assessment of renal function and signs of ototoxicity.
RENAL IMPAIRMENT:
In impaired renal function, the recommended daily dose
has to be decreased and adjusted to the renal function.
Gentamicin is excreted by simple glomerular filtration
and therefore reduced dosage is necessary where renal
function is impaired. Nomograms are available for the
calculation of dose, which depends on the patient’s age,
weight and renal function. The following table may be
useful when treating adults.
_*60mg if body weight <60kg. Freq

Summary of Product characteristics

OBJECT 1
CIDOMYCIN 80MG/2ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 07-Jun-2018 | SANOFI
1. Name of the medicinal product
Cidomycin 80 mg/2 ml Solution for Injection
2. Qualitative and quantitative composition
Each ampoule or vial (2 ml) contains Gentamicin Sulphate Ph. Eur.
equivalent to 80 mg Gentamicin base.
Excipients with known effect:
Sodium chloride: 12.84 mg/2 ml ampoule or vial.
For the 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 indicated to
treat severe infections caused by bacteria susceptible to gentamicin
such as, but not limited to:
• Urinary tract infections
• Respiratory tract infections
• Intra-abdominal infections
• CNS infections
• Severe neonatal infections
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._
_Consideration should be given to official local guidance on the
appropriate use of antibacterial agents._
4.2 Posology and method of administration
Posology
Adults
_Serious infections:_ If renal function is not impaired, 5 mg/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 – 5
mg/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, 160 mg once
daily may be used.
Elderly
There is some evidence that elderly patients may be more susceptible
to aminoglycoside toxicity whether
secondary to previous auditory/vesti