Gentamicin Pharmexon 40 mg/ml solution for injection/infusion

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Gentamicin sulfate

Pieejams no:

Pharmexon Consulting s.r.o

ATĶ kods:

J01GB; J01GB03

SNN (starptautisko nepatentēto nosaukumu):

Gentamicin sulfate

Deva:

40 milligram(s)/millilitre

Zāļu forma:

Solution for injection/infusion

Ārstniecības joma:

Other aminoglycosides; gentamicin

Autorizācija datums:

2020-03-20

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GENTAMICIN PHARMEXON 40 MG/ML,
SOLUTION FOR INJECTION/INFUSION
Gentamicin sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on
to others.
It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor. This includes
any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Gentamicin Pharmexon is and what it is used for
2. What you need to know before you use Gentamicin Pharmexon
3. How to use Gentamicin Pharmexon
4. Possible side effects
5. How to store Gentamicin Pharmexon
6. Contents of the pack and other information.
1. WHAT GENTAMICIN PHARMEXON IS AND WHAT IT IS USED FOR
Gentamicin Pharmexon belongs to a group of medicines called
antibiotics, that
is, they are used to treat severe infections with bacteria that can be
killed by the
active substance gentamicin.
Gentamicin Pharmexon should only be used in combination with other
antibiotics
except for complicated infections of the kidneys, urinary tract and
bladder.
You may receive Gentamicin Pharmexon to treat the following diseases:
• Complicated infections of the urinary tract
• Infections and inflammation within the belly
• Infections of lungs and airways occurring during hospital
treatment
• Infections of lungs from cystic fibrosis
• Inflammation of the inner lining of the heart (to treat
infections)
• Infections of the skin related to severe burns
• Serious infections with bacteria in the blood
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTAMICIN PHARMEXON
DO NOT USE GENTAMICIN PHARMEXON:
• if you are allergic to gentamicin or any of the other ingredients
of this medicine
(listed in section 6);
WARNINGS AND PRECAUTIONS
Talk to your doctor bef

Produkta apraksts

Health Products Regulatory Authority
20 March 2020
CRN008K6L
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gentamicin Pharmexon 40 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 40 mg of gentamicin (corresponding to 67.8 mg
gentamicin sulfate).
Each ampoule of 2 mL contains 80 mg of gentamicin (corresponding to
135.6 mg gentamicin sulfate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gentamicin Pharmexon is indicated for the treatment of the following
infections in adults and children from birth when less
toxic antimicrobial agents are not effective (see sections 4.4 and
5.1)
Under these conditions, Gentamicin Pharmexon is indicated in the
treatment of the following infections:
- Complicated urinary tract infection (cUTI), including acute
pyelonephritis
- Complicated intra-abdominal infection (cIAI)
- Hospital-acquired pneumonia (HAP) including ventilator-associated
pneumonia (VAP)
- Broncho-pulmonary infections in patients with cystic fibrosis
- Infective endocarditis
- Burn wound infections
- Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
Gentamicin Pharmexon should for all indications, except complicated
urinary tract infections, only be used in combination with
other relevant antibiotics (predominantly together with a beta-lactam
antibiotic or with an antibiotic effective against
anaerobic bacteria).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CAUTION:
In
the
absence
of
data,
administration
of
Gentamicin
solution
for
injection/infusion
via
inhalation
is
not
recommended (see section 4.4)
Posology
The dose depends on the severity of the clinical picture, the setting,
the patient's renal function