Gentamicin Intrathecal 5mg/1ml solution for injection ampoules

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Gentamicin sulfate

Доступна з:

Zentiva Pharma UK Ltd

Код атс:

J01GB03

ІПН (Міжнародна Ім'я):

Gentamicin sulfate

Дозування:

5mg/1ml

Фармацевтична форма:

Solution for injection

Адміністрація маршрут:

Intracerebroventricular; Intrathecal

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 05010400; GTIN: 5013011006485

інформаційний буклет

Approved 25/06/15
PATIENT INFORMATION LEAFLET
GENTAMICIN INTRATHECAL 5MG/ML 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 Intrathecal 5mg/ml 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 of the:

Brain - including meningitis

Spinal cord
2.
BEFORE YOU HAVE GENTAMICIN
DO NOT HAVE THIS MEDICINE IF:

You have Myasthenia Gravis or a related condition. This is a disease
that causes muscle weakness.

You are allergic (hypersensitive) to gentamicin sulphate, any other
aminoglycosides (such as
streptomycin) 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 before having gentamicin.
TAKE SPECIAL CARE WITH GENTAMICIN AND CHE

Характеристики продукта

OBJECT 1
GENTAMICIN INTRATHECAL 5MG/ML
Summary of Product Characteristics Updated 10-Jul-2015 | Zentiva
1. Name of the medicinal product
Gentamicin Intrathecal 5mg/ml Solution for Injection.
2. Qualitative and quantitative composition
Each ampoule (1ml) contains Gentamicin Sulphate Ph Eur equivalent to
5mg Gentamicin base.
3. Pharmaceutical form
Injection.
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 Intrathecal Injection is indicated as a supplement to
systemic therapy in bacterial meningitis,
ventriculitis and other bacterial infections of the central nervous
system.
4.2 Posology and method of administration
Bacterial meningitis and ventriculitis:
The starting dose of Gentamicin Intrathecal Injection for both
children and adults is 1mg daily,
intrathecally or intraventricularly, together with 1mg/kg every eight
hours intramuscularly.
The MIC of the infecting organism in the C.S.F. should be assessed
and, if necessary, the
intrathecal/intraventricular dose increased to 5mg daily, whilst
keeping the intramuscular dose at 1mg/kg
eight-hourly.
Treatment should be continued for at least 7 days but longer if
necessary.
Periodic serum and C.S.F. gentamicin assays should be carried out to
ensure that adequate antibiotic
levels are maintained and that serum and C.S.F. levels do not exceed
10mg/l.
ROUTE OF ADMINISTRATION
Intrathecal or intraventricular.
4.3 Contraindications
Gentamicin is contra-indicated in patients with a known allergy to it
and other aminoglycosides. Evidence
exists that gentamicin may cause neuromuscular blockade and is
therefore contra-indicated in myasthenia
gravis and related conditions.
4.4 Special warnings and precautions for use
Ototoxicity has