Gentamicin Paediatric 20mg/2ml solution for injection vials

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Gentamicin sulfate

थमां उपलब्ध:

Zentiva Pharma UK Ltd

ए.टी.सी कोड:

J01GB03

INN (इंटरनेशनल नाम):

Gentamicin sulfate

डोज़:

10mg/1ml

फार्मास्यूटिकल फॉर्म:

Solution for injection

प्रशासन का मार्ग:

Intravenous; Intramuscular

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 05010400; GTIN: 5013011006478

सूचना पत्रक

Approved 25/06/15
PATIENT INFORMATION LEAFLET
GENTAMICIN PAEDIATRIC 20MG/2ML SOLUTION FOR INJECTION
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 further questions, please 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.

Your doctor may have given you this medicine before from another
company. It may have looked slightly
different. However, either brand will have the same effect.
IN THIS LEAFLET:
1.
What gentamicin is and what it is used for
2.
Before you have gentamicin
3.
How to have gentamicin
4.
Possible side effects
5.
How to store gentamicin
6.
Further information
1.
WHAT GENTAMICIN IS AND WHAT IT IS USED FOR
The name of this medicine is Gentamicin Paediatric 20mg/2ml Solution
for Injection (called gentamicin 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’

Newborn babies
2.
BEFORE YOU HAVE GENTAMICIN
DO NOT HAVE THIS MEDICINE IF:

You have Myasthenia Gravis. This is a disease that causes muscle
weakness.

You are allergic (hypersensitive) to gentamicin or to any of the other
ingredients of this medicine (see
Section 6: Further Information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face,
throat and tongue.
Do not have this medicine if any of the above applies to you. If you
are not sure, talk to your doctor or
pharmacist b

उत्पाद विशेषताएं

OBJECT 1
GENTAMICIN PAEDIATRIC 20MG/2ML
Summary of Product Characteristics Updated 10-Jul-2015 | Zentiva
1. Name of the medicinal product
Gentamicin Paediatric 20mg/2ml Solution for Injection.
2. Qualitative and quantitative composition
Each vial (2ml) contains Gentamicin Sulphate Ph Eur equivalent to 20mg
Gentamicin base.
For 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,
enterobacer spp., Citrobacter spp.
and providencia spp.
Indications : gentamicin injection and gentamicin paediatric injection
are indicated in bacteraemia,
septicaemia, urinary tract infections, chest infections, severe
neonatal infections and other serious
systemic infections due to susceptible 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, 3-5 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, 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 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