Amikacin 5 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amikacin

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J01GB; J01GB06

INN (International Name):

Amikacin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Other aminoglycosides; amikacin

Authorization status:

Marketed

Authorization date:

2020-12-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIKACIN 5 MG/ML SOLUTION FOR INFUSION
amikacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amikacin is and what it is used for
2.
What you need to know before you are given Amikacin
3.
How Amikacin is given
4.
Possible side effects
5.
How to store Amikacin
6.
Contents of the pack and other information
1.
WHAT AMIKACIN IS AND WHAT IT IS USED FOR
Amikacin contains the active substance amikacin. It belongs to a group
of medicines called antibiotics,
that is, they are used to treat severe infections with bacteria that
can be killed by amikacin. This
medicine belongs to a group of substances called aminoglycosides.
You may receive Amikacin to treat the following conditions:
-
Infections of lungs and lower airways occurring during in-patient
treatment, including hospital-
acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP),
-
Complicated infections of kidneys, urinary ducts and bladder
-
Complicated infections within the belly, including inflammation of the
peritoneum Infections of
skin and soft tissues, including severe burns
-
Bacterial inflammation of the inner lining of the heart (only in
combination with other antibiotics).
Amikacin can also be used in the treatment of patients with an
inflammation of the entire body that
occurs in association with, or is suspected to be associated with, any
of the infections listed above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMIKACIN
_ _
YOU MUST NOT BE GIVEN AMIKACIN:
-
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 similar substances (othe

Summary of Product characteristics

HealthProductsRegulatoryAuthority
06June2023
CRN00DKK8
Page1of13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amikacin5mg/mlsolutionforinfusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachmlsolutionforinfusioncontains5mgamikacin(assulfate).
Eachbottlewith50 mlcontains250 mgamikacin.
Eachbottlewith100 mlcontains500 mgamikacin.
Eachbottlewith200 mlcontains1000 mgamikacin.
Excipient(s) with known effect
Eachmlalsocontains3.54
mgsodium(equivalentto0.154 mmolsodium).
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Solutionforinfusion
Aclearcolourlessaqueoussolution
pH:3.5 – 5.5
Osmolality:270 – 330 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amikacinisindicatedforthetreatmentofthefollowingsevereinfectionsinadultsandpaediatricpatients(includingneonates)
whenotherantimicrobialagentsarenotappropriate(seesection5.1).
-Nosocomiallowerrespiratorytractinfectionsincludinghospital-acquiredpneumonia(HAP)andventilator-associated
pneumonia(VAP),
-Complicatedandrecurrenturinarytractinfectionsincludingpyelonephritis,
-Complicateintra-abdominalinfectionsincludingperitonitis,
-Acutebacterialskinandskinstructureinfectionsincludingburn-woundinfections,
-Bacterialendocarditis(onlyincombinationwithotherantibiotics).
Treatmentofpatientswithbacteraemiathatoccursinassociationwith,orissuspectedtobeassociatedwith,anyofthe
infectionslistedabove.
Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.
4.2 POSOLOGY AND METHOD OF ADMINIS