Gentamicin 80mg/2ml solution for injection vials

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Gentamicin sulfate

Prieinama:

Pfizer Ltd

ATC kodas:

J01GB03

INN (Tarptautinis Pavadinimas):

Gentamicin sulfate

Dozė:

40mg/1ml

Vaisto forma:

Solution for injection

Vartojimo būdas:

Intramuscular; Intravenous

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 05010400; GTIN: 5015997273257

Pakuotės lapelis

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
GENTAMICIN 40 MG/ML INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1. What Gentamicin Injection is and what it is used for
2. Before you use Gentamicin Injection
3. How to use Gentamicin Injection
4. Possible side effects
5. How to store Gentamicin Injection
6. Further Information
1.
WHAT GENTAMICIN INJECTION IS AND WHAT IT IS USED FOR
Gentamicin Injection is an aminoglycoside antibiotic medicine, in the
form of a solution for injection
(a solution which can be given as an injection).
Gentamicin Injection is used to treat a wide variety of infections
such as chest, wound and blood
infections.
2.
BEFORE YOU USE GENTAMICIN INJECTION
DO NOT USE GENTAMICIN INJECTION

if you have shown signs of hypersensitivity (severe allergy) to
gentamicin or any other
ingredients listed in section 6 on previous occasions

if you suffer from a disorder called myasthenia gravis (severe
weakness of selected
muscles of the body)

if you are pregnant or breast-feeding
TAKE SPECIAL CARE WITH GENTAMICIN INJECTION

if treating premature babies

if you are an elderly patient

if your kidneys are not working properly

if you have diabetes

if you have an ear, hearing or balance disorder, a history of ear
infections or if you have
been treated with medicines that affect hearing in the past

if you experience muscle weakness

if you are very overweight
TAKING/USING OTHER MEDICINES
Special care is needed if you are taking/using other medicines such
as:

antibiotics that also
affect your
kidneys
or
hearing
such as other aminoglycosides,
cephalosporins, (notably cephalothin) and methicillin

medicines used to thin the blood, such as warfarin and phenindio

Prekės savybės

OBJECT 1
GENTAMICIN 40 MG/ML INJECTION
Summary of Product Characteristics Updated 08-May-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Gentamicin 40 mg/ml Injection
2. Qualitative and quantitative composition
1 ml of solution for injection contains 40 mg of gentamicin (as
sulphate)
1 vial of 2 ml solution for injection contains 80 mg of gentamicin (as
sulphate)
For excipients, see 6.1
3. Pharmaceutical form
Solution for injection.
Vials containing a clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Gentamicin is bactericidal and is active against many strains of
Gram-positive and Gram-negative
pathogens including species of _Escherichia, Enterobacter, Klebsiella,
Salmonella, Serratia, Shigella, _
_Staphylococcus aureus_, some _Proteus_ and against _Pseudomonas
aeruginosa_. Gentamicin is often
effective against strains of these organisms which are resistant to
other antibiotics such as streptomycin,
kanamycin and neomycin. Gentamicin is effective against
penicillin-resistant _Staphylococci_, but rarely
effective against _Streptococci_.
Gentamicin is indicated in the treatment of the following infections
when caused by susceptible
organisms.
Consideration should be given to official local guidance on the
appropriate use of antibacterial agents
SEVERE GRAM-NEGATIVE INFECTIONS:
Upper and lower urinary tract infections
Burn and wound infections
Septicaemia, Bacteraemia
Abscesses
Subacute Bacterial Endocarditis
Respiratory Tract infections (Bronchopneumonia)
Neonatal infections
Gynaecological infections
GRAM-POSITIVE INFECTIONS:
Bacteraemia
Abscesses
Accidental and operative trauma
Burns and serious skin lesions.
4.2 Posology and method of administration
Gentamicin is normally given by the intramuscular route, but can be
given intravenously when
intramuscular administration is not feasible.
Gentamicin is normally given by the intramuscular route, but can be
given intravenously when
intramuscular administration is not feasible, e.g. in shocked or
severely burned patients. When given