DBL™ Amikacin
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
05-01-2024
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Active ingredient:
Amikacin sulfate 325 mg/mL equivalent to 250 mg/mL Amikacin
Available from:
Pfizer New Zealand Limited
INN (International Name):
Amikacin sulfate 325 mg/mL (Equiv to 250 mg/mL Amikacin)
Dosage:
500 mg/2mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Amikacin sulfate 325 mg/mL equivalent to 250 mg/mL Amikacin Excipient: Sodium citrate dihydrate Sodium hydroxide Sodium metabisulfite Sulfuric acid Water for injection
Units in package:
Vial, 5 x 2mL, 10 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Qilu Tianhe Pharmaceutical Co Ltd
Product summary:
Package - Contents - Shelf Life: Vial, 2mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C
Authorization date:
1992-02-11
Summary of Product characteristics
Version: pfdamiki10923
Supersedes pfdamiki10522
Page 1 of 17
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL™ Amikacin 500 mg/2 mL solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amikacin is a semisynthetic aminoglycoside antibiotic derived from
kanamycin. The injection
consists of the sulfate salt.
Each
2
mL
vial
contains
amikacin
sulfate
equivalent
to
amikacin
activity
500
mg
(500,000 I.U.).
EXCIPIENT(S) WITH KNOWN EFFECT
•
Sodium metabisulfite
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL Amikacin Injection is a sterile clear, colourless to pale yellow
solution, free from specks,
lint, or other visible evidence of contamination.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
Amikacin Injection is indicated in the short-term treatment of serious
infections caused
by susceptible strains of Gram-negative bacteria (see section 5.1).
_ _
_Staphylococcus aureus,_
including methicillin-resistant strains is the principal Gram-positive
organism sensitive to amikacin.
The use of amikacin in the treatment of staphylococcal infections
should be restricted to
second-line therapy, and should be confined to patients suffering from
severe infections caused
by susceptible strains of stapylococcus who have failed to respond or
are allergic to other
available antibiotics.
DBL Amikacin Injection is indicated in the treatment of neonatal
sepsis when sensitivity testing
indicates that other aminoglycosides cannot be used.
In certain severe infections such as neonatal sepsis, concomitant
therapy with a penicillin type
drug may be indicated because of the possibility of infections due to
Gram-positive organisms
such as streptococci or pneumococci. If concomitant treatment with a
penicillin type drug is
indicated, then the drugs should be administered separately and at
different sites because
_in-_
_vitro _
mixing of the two drugs causes inactivation of amikacin.
Version: pfdamiki10923
Supersedes pfdamiki10522
Page 2 of 17
Clinical studies have shown amikacin to be effective in
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