Metronidazole Sandoz IV (Metronidazole 500 mg/ 100 mL Injection Solution Bag.

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

환자 정보 전단 환자 정보 전단 (PIL)
01-12-2017
제품 특성 요약 제품 특성 요약 (SPC)
01-12-2017
공공 평가 보고서 공공 평가 보고서 (PAR)
01-12-2017

유효 성분:

metronidazole

제공처:

Sandoz Pty Ltd

INN (International Name):

Metronidazole

수업:

Medicine Registered

승인 상태:

Registered

환자 정보 전단

                                METRONIDAZOLE SANDOZ
IV
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Metronidazole
Sandoz IV.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Metronidazole
Sandoz IV against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT METRONIDAZOLE
SANDOZ IV IS USED FOR
The name of your medicine is
Metronidazole Sandoz IV. It contains
the active ingredient metronidazole.
Metronidazole Sandoz IV is an
antimicrobial agent used to treat
infections in different parts of the
body caused by certain micro-
organisms.
Metronidazole Sandoz IV is also
used to prevent infections before,
during and after surgery.
Metronidazole Sandoz IV belongs to
a group of antimicrobials called
nitroimidazoles. These antimicrobials
work by killing the micro-organisms
that are causing your infection.
Your doctor may have prescribed
Metronidazole Sandoz IV for another
reason. Ask your doctor if you have
any questions about why
Metronidazole Sandoz IV has been
prescribed for you.
Metronidazole Sandoz IV is available
only with a doctor's prescription.
Metronidazole Sandoz IV is not
addictive.
BEFORE YOU ARE GIVEN
METRONIDAZOLE SANDOZ
IV
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE METRONIDAZOLE SANDOZ
IV IF:
1.
YOU HAVE AN ALLERGY TO
METRONIDAZOLE, ANY OTHER
NITROIMIDAZOLES OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Some of the symptoms of an
allergic reaction may include
wheezing, shortness of breath,
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing, skin rash, itching or
hives.
2.
YOU HAVE OR HAVE EVER HAD A
BLOOD DISORDER
3.
YOU HAVE A DISEASE OF THE BRAIN,
SPINAL CORD OR NERVES
DO NOT USE METRONIDAZOLE SANDOZ
IV IF THE PACKAGING IS
                                
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제품 특성 요약

                                _Product Information _
_ _
_Page 1 _
_Metronidazole Sandoz IV 500mg/100mL Injection Solution _
_05/2015 _
_Sandoz Pty Ltd _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Version 02 _
PRODUCT INFORMATION
METRONIDAZOLE SANDOZ
® IV 500MG/100ML INJECTION SOLUTION
BAG AND VIALS
NAME OF THE MEDICINE
Metronidazole
Chemical structure of metronidazole:
Chemical name: 2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethanol
Molecular Formula: C
6
H
9
N
3
O
3
Molecular weight: 171.2
CAS: 443-48-1
DESCRIPTION
Active: metronidazole, concentration: 500 mg/100 mL
Inactive: citric acid monohydrate, sodium phosphate – dibasic
anhydrous, sodium chloride
and water for injections.
Metronidazole is a white or yellowish crystalline powder with melting
point 159-162°C.
Solubility in water at 20°C is 1 g/100 mL; in ethyl alcohol, 0.5
g/100 mL; in chloroform,
0.4 g/100 mL; slightly soluble in ether and soluble in dilute acids.
When reconstituted as
Metronidazole Sandoz IV, it has a pH of between 4.5 and 6.0. Each mL
contains 0.139
mmol sodium.
PHARMACOLOGY
Metronidazole is a nitro-imidazole anti-infective agent which has
specific activity against
a number of obligate anaerobic organisms and protozoa.
_MODE OF ACTION_
: Metronidazole is bactericidal, amoebicidal and trichomonicidal. The
exact mode of action has not been fully elucidated. Metronidazole is
reduced by low-redox-
potential electron transfer proteins (eg. nitro-reductases such as
ferredoxin) to unidentified
polar product(s) which lack the nitro group. The reduction product(s)
appears to be
responsible for the cytotoxic and antimicrobial effects of the drug
which include disruption
of DNA and inhibition of nucleic acid synthesis.
_MICROBIOLOGY_
: Metronidazole is bactericidal
_in vitro_
against many anaerobic Gram-
negative bacilli including
_Bacteroides fragilis_
, and other
_Bacteroides_
species, also other
species including
_Fusobacterium_
. The drug is effective against many anaerobic Gram-
positive bacilli including
_Clostridium_
species,
_Eubacterium_
, and anaerobic
_Streptococcus_
.
The MI
                                
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