Amikacin Caragen 250 mg/ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amikacin

Available from:

Caragen Limited

ATC code:

J01GB06

INN (International Name):

Amikacin

Dosage:

250 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

amikacin

Authorization status:

Marketed

Authorization date:

2021-06-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIKACIN CARAGEN 250 MG/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, pharmacist or
nurse.
−
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, 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 Caragen is and what it is used for
2.
What you need to know before you use Amikacin Caragen
3.
How to use Amikacin Caragen
4.
Possible side effects
5.
How to store Amikacin Caragen
6.
Contents of the pack and other information
1.
WHAT AMIKACIN CARAGEN IS AND WHAT IT IS USED FOR
Amikacin Caragen contains amikacin which belongs to a group of
antibiotics called ‘aminoglycosides’.
Amikacin Caragen is used in the treatment of serious infections caused
by bacteria sensitive to amikacin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AMIKACIN CARAGEN
DO NOT USE THIS MEDICINE
−
if you are allergic (hypersensitivity) to amikacin or any of the other
ingredients of this medicine
(listed in section 6)
−
If you have a history of allergy (hypersensitivity) or serious toxic
reactions to other
aminoglycoside antibiotics
−
If you suffer from a disorder called myasthenia gravis (severe
weakness of certain muscles of the
body)
WARNINGS AND PRECAUTIONS
Tell your doctor, pharmacist or nurse if
−
you have kidney problems
−
you have shown kidney or hearing problems after taking any other
antibiotics
−
you have hearing difficulties or tinnitus (ringing or buzzing in the
ears)
−
you are elderly
−
you have any muscular disorders such a Parkinson’s disease
−
you or your family members have a mitochondrial mutation diseas

Summary of Product characteristics

Health Products Regulatory Authority
30 May 2023
CRN00DL3F
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amikacin Caragen 250 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution for injection/infusion contains 250 mg of
amikacin (as sulfate).
Each vial of 2 ml of solution for injection/infusion contains 500 mg
of amikacin (as sulfate).
Excipients with known effect
Sodium 7.5 mg/ml
Sodium metabisulfite 6.60 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless to pale yellow solution
pH 3.5-5.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amikacin is indicated in the short-term treatment of serious
infections due to susceptible strains of Gram-negative bacteria,
including _Pseudomonas_ species, _Escherichia coli_, indole-positive
and indole-negative _Proteus_ species, _Providencia_ sp, _Klebsiella_
sp, _Enterobacter_ sp, _Serratia_ sp and _Acinetobacter_ sp. Many
strains of these Gram-negative organisms resistant to gentamicin
and tobramycin show sensitivity to amikacin _in vitro_.
Amikacin may also be indicated for the treatment of known or suspected
staphylococcal disease. The principal Gram-positive
organism sensitive to amikacin is _Staphylococcus aureus_, including
some methicillin-resistant strains. Amikacin has some activity
against other Gram-positive organisms including certain strains of
_Streptococcus pyogenes_, _Enterococci_ and _Diplococcus _
_pneumoniae_.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Amikacin sulfate injection may be given intramuscularly or
intravenously.
For most infections, the intramuscular route is preferred. However, in
life-threatening infections or in patients for whom
intramuscular administration is not possible, the medicine can be
administered intravenously, either as is (2-3 minutes) or by
slow infusion within 30 to