Gentamicin 10mg/ml Solution for Injection or Infusion

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: myHealthbox

Thành phần hoạt chất:

Gentamicin Sulfate

Sẵn có từ:

Wockhardt UK Ltd

Mã ATC:

J01GB03

INN (Tên quốc tế):

Gentamicin Sulfate

Liều dùng:

10 mg/ml

Dạng dược phẩm:

Solution for injection or infusion

Tuyến hành chính:

Intravenous injection or infusion

Các đơn vị trong gói:

packs of 5 ampoules

Loại thuốc theo toa:

POM - Prescription Only Medicine

Sản xuất bởi:

CP Pharmaceuticals Ltd

Nhóm trị liệu:

Antibacterial for systemic use

Chỉ dẫn điều trị:

It is indicated in bacteraemia, urinary tract infections, chest infections, severe neonatal infections and other serious systemic infections due to susceptible organisms, in adults and children including neonates.

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2014-11-24

Tờ rơi thông tin

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
GENTAMICIN 10MG/ML SOLUTION FOR INJECTION OR INFUSION
AND
GENTAMICIN  40MG/ML SOLUTION FOR INJECTION OR INFUSION
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WHAT IS IN THIS LEAFLET:
1. What gentamicin is and what it is used for
2. What you need to know before you take gentamicin
3. How to take gentamicin 
4. Possible side effects
5. How to store gentamicin
6. Contents of the pack and other information
  1.  WHAT GENTAMICIN IS AND WHAT IT IS USED FOR
The name of this medicine is Gentamicin 10mg/ml Solution for 
Injection or Infusion and Gentamicin 40mg/ml Solution for Injection
or 
Infusion (called “gentamicin” in this leaflet).
It contains a medicine called gentamicin sulfate. This belongs to a 
group of antibiotics called aminoglycosides.
Gentamicin is used to treat infections caused by bacteria in adults
and 
children including new-borns. This includes infections in:
•  Your urinary tract (including your kidneys or bladder)
•  Your chest (including your lungs)
•  Your blood – this is sometimes called ‘bacteraemia’ 
•  Other serious infections
  2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE
       GENTAMICIN
DO NOT TAKE GENTAMICIN 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 (listed in section 6). Signs of an
allergic 
reaction include: a rash, swallowing or breathing problems, swelling 
of your lips, face, throat and tongue.
Do not take this medicine if any of the above applies to you. If you
are 
not sure, talk to your doctor or pharmacist before taking gentamicin.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gentamicin if:
•  You are pregnant, might become pregnant, or think you may be 
pregnant
•  You are breast-feeding (see ‘Pregnancy and breast-feeding’
section 
below)
•  You have any muscle weakness problems
•  You are extremely overweight
•  You hav

Đặc tính sản phẩm

Gentamicin 10mg/ml & 40mg/ml Solution for Injection or Infusion
Summary of Product Characteristics Updated 17­Jul­2015 | Wockhardt UK Ltd
1. Name of the medicinal product
Gentamicin 10mg/ml Solution for Injection or Infusion
Gentamicin 40mg/ml Solution for Injection or Infusion
2. Qualitative and quantitative composition
10mg/ml ­ 1 ml of solution for injection or infusion contains gentamicin sulphate equivalent to 10 mg gentamicin.
Each ampoule (2ml) contains Gentamicin Sulfate Ph Eur equivalent to 20mg Gentamicin.
40mg/ml ­ 1 ml of solution for injection or infusion contains gentamicin sulphate equivalent to 40 mg gentamicin.
Each ampoule (2ml) contains Gentamicin Sulfate Ph Eur equivalent to 80mg Gentamicin.
This medicine contains 0,78 mg of sodium per ampoule; it is essentially sodium free.
This medicine contains 3.2 mg of sodium metabisulfite
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection or Infusion.
Clear, colourless solution, having pH ranging from 3.0 to 5.5.
4. Clinical particulars
4.1 Therapeutic indications
Indications : gentamicin is indicated in bacteraemia, urinary tract infections, chest infections, severe neonatal infections
and other serious systemic infections due to susceptible organisms, in adults and children including neonates.
Please see section 5.1.
Consideration should be given to official local guidance on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
Adults:
Systemic infections: if renal function is not impaired, 3­5 mg/kg/day in divided doses according to severity of infection,
adjusting according to clinical response and body weight.
Serious infections: if renal function is not impaired, 5mg/kg daily in divided doses at six or eight hourly intervals. The
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