Amikacin Tillomed 250 mg/ml Injektions-/infusionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

amikacinsulfat

Tillgänglig från:

Tillomed Pharma GmbH

ATC-kod:

J01GB06

INN (International namn):

amikacin sulfate

Dos:

250 mg/ml

Läkemedelsform:

Injektions-/infusionsvätska, lösning

Sammansättning:

natriummetabisulfit Hjälpämne; amikacinsulfat 333,16 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Injektionsflaska, 5 x 2 ml; Injektionsflaska, 1 x 2 ml; Injektionsflaska, 1 x 4 ml; Injektionsflaska, 5 x 4 ml

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-05-03

Bipacksedel

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMIKACIN TILLOMED 250MG/ML SOLUTION FOR INJECTION/INFUSION
Amikacin
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 or pharmacist.
-
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 or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is an antibiotic used to treat serious infections in
adults and children
including, infants less than 4 weeks old.
Areas of application include infections of the respiratory tract and
the lungs, the urinary
and genital tract, the gastrointestinal tract, inflammation of the
inner lining of the heart
(endocarditis), infected burns as well as bacterial infections of the
blood associated with
one of the infections mentioned. Amikacin may also be used to treat
patients with low
white blood cell counts (neutropenia) who have fever due to bacterial
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE
•
if you are allergic to amikacin or any of the other ingredients of
this medicine (listed
in section 6);
•
if you are allergic to other aminoglycoside antibiotics.
•
if you have bronchial asthma with a known allergy to sulfites.
WARNINGS AND PRECAUTIONS
Please talk to your doctor or pharmacist before taking ,
especially
•
if you have kidney problems (impaired renal function)
•
if you

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amikacin Tillomed 250 mg/ml Solution for Injection/Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 250 mg of amikacin (as sulphate).
Each 2 ml vial contains 500 mg of amikacin (as sulphate).
Each 4 ml vial contains 1 g of amikacin (as sulphate).
Excipients with known effect:
Each 2 ml vial contains 6.6 mg of sodium metabisulphite (E223)
(equivalent to 4.44 mg SO
2
)
and 13.32 mg of sodium.
Each 4 ml vial contains 13.2 mg of sodium metabisulphite (E223)
(equivalent to 8.9 mg SO
2
)
and 26.65 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless to light straw-coloured solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Amikacin is indicated in the treatment of following infections in
adults and pediatric patients
including neonates (see section 5.1)
- Hospital-acquired pneumonia (HAP) including ventilator-associated
pneumonia (VAP)
- Complicated Urogenital tract infections including pyelonephritis
- Complicated Intraabdominal infections
-
Endocarditis (only in combination with other antibiotics),
-
Infected burns
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be
associated with, any of the infections listed above.
Amikacin may be used in the management of neutropenic patients with
fever that is suspected
to be due to a bacterial infection.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose must be adjusted individually, based on body weight and renal
function, and the
serum concentration must be monitored regularly.
Renal function status should be estimated by measuring the serum
creatinine concentration or
by calculating the endogenous creatinine clearance value. The BUN
(blood urea nitrogen) test
is much less reliable for this purpose. Evaluation