AMIKACIN 1 g/4 ml FRESENIUS INJECTION

국가: 남아프리카

언어: 영어

출처: South African Health Products Regulatory Authority (SAHPRA)

제공처:

Fresenius Kabi Manufacturing SA (Pty) Ltd

복용량:

See ingredients

약제 형태:

INJECTION

구성:

EACH 4 ml SOLUTION CONTAINS AMIKACIN SULPHATE EQUIVALENT TO 1 g AMIKACIN

승인 상태:

Registered

승인 날짜:

1997-12-02

환자 정보 전단

Page 1 of 5
APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAMES AND DOSAGE FORM
AMIKACIN FRESENIUS 50 MG/2 ML Injection
AMIKACIN FRESENIUS 100 MG/2 ML Injection
AMIKACIN FRESENIUS 250 MG/2 ML Injection
AMIKACIN FRESENIUS 500 MG/2 ML Injection
AMIKACIN FRESENIUS 1 G/4 ML Injection
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN AMIKACIN
FRESENIUS.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

AMIKACIN FRESENIUS has been prescribed for you personally and you
should
not share your medicine with other people. It may harm them even if
their
symptoms are the same as yours.
WHAT AMIKACIN FRESENIUS CONTAINS
The active substance is amikacin.
EACH SINGLE DOSE 2 ML VIAL CONTAINS:
50 mg, 100 mg, 250 mg or 500 mg amikacin (as amikacin sulphate)
_THE OTHER INGREDIENTS ARE: _
Antioxidant: sodium metabisulphite - 0,1 % _m/v_, 0,13 % _m/v,_ 0,33 %
_m/v_ and 0,66
% _m/v_ respectively.
Water for injection.
Page 2 of 5
EACH SINGLE DOSE 4 ML SOLUTION (IN A 5 ML VIAL) CONTAINS:
1 g amikacin (as amikacin sulphate)
_THE OTHER INGREDIENTS ARE: _
Antioxidant: sodium metabisulphite - 0,66 % _m/v_
Water for injection.
WHAT AMIKACIN FRESENIUS IS USED FOR
AMIKACIN FRESENIUS is used for treatment of infections caused by
hospital
acquired organisms that are resistant to other antibiotics.
BEFORE YOU RECEIVE AMIKACIN FRESENIUS
YOU SHOULD NOT BE GIVEN AMIKACIN FRESENIUS:

if you are sensitive or allergic to amikacin or aminoglycosides or
other
ingredients of AMIKACIN FRESENIUS

if you are pregnant or breastfeeding

if you have myasthenia gravis (muscle weakness)

if you have kidney impairment

if you have a hearing problem
TAKE SPECIAL CARE WITH AMIKACIN FRESENIUS:

if you have a history of allergy

if you have partial hearing loss
PREGNANCY AND BREASTFEEDING:
Do not receive AMIKACIN FRESENIUS if you are pregnant or breast
feeding.
Page 3 of 5
If you are pregnant or breastfeeding you baby please consult yo

제품 특성 요약

Page 1 of 10
APPROVED PACKAGE INSERT FOR AMIKACIN FRESENIUS
SCHEDULING STATUS
S4
PROPRIETARY NAMES AND DOSAGE FORM
AMIKACIN FRESENIUS 50 MG/2 ML
AMIKACIN FRESENIUS 100 MG/2 ML
AMIKACIN FRESENIUS 250 MG/2 ML
AMIKACIN FRESENIUS 500 MG/2 ML
AMIKACIN FRESENIUS 1 G/4 ML
Injection
COMPOSITION
EACH SINGLE DOSE 2 ML VIAL CONTAINS:
50 mg, 100 mg, 250 mg or 500 mg amikacin (as amikacin sulphate)
_INACTIVE INGREDIENTS: _
Antioxidant: sodium metabisulphite - 0,1 % _m/v_, 0,13 % _m/v_, 0,33 %
_m/v_ and 0,66 % _m/v_ respectively.
Water for injections.
EACH SINGLE DOSE 4 ML SOLUTION (IN A 5 ML VIAL) CONTAINS:
1 g amikacin (as amikacin sulphate)
_INACTIVE INGREDIENTS: _
Antioxidant: sodium metabisulphite - 0,66 % _m/v _
Water for injections.
PHARMACOLOGICAL CLASSIFICATION
A.20.1.1 Broad and medium spectrum antibiotics.
Page 2 of 10
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Amikacin is a semisynthetic aminoglycoside, with a broad antimicrobial
activity and exhibits resistance
to aminoglycoside-inactivating enzymes.
PHARMACOKINETIC PROPERTIES
It is a bactericidal and is minimally protein bound. It is largely
excluded from most cells, from the
central nervous system and eye. Penetration into respiratory
secretions is poor. Diffusion into pleural
and synovial fluid is relatively slow, but concentrations that
approximate those in the plasma may be
achieved after repeated administration. High concentrations are found
in the renal cortex and in the
endolymph and perilymph of the inner ear. Inflammation increases its
penetration into peritoneal and
pericardial cavities.
Inadequate concentrations for the treatment of meningitis are achieved
in the cerebrospinal fluid in
adults.
Elimination of amikacin is almost entirely by glomerular filtration.
Amikacin has a half-life of 2 - 3 hours,
most of the dose being excreted within 24 hours.
Amikacin is effective _ in vitro_ against many species of
gram-negative bacteria including species of:
_Citrobacter, Escherichia, Enterobacter,_ _Klebsiella, Proteus,
Providencia, Pseudomonas_ and _S