Metronidazole solution for i/v infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

metronidazole

Available from:

Liqvor CJSC

ATC code:

J01XD01

INN (International Name):

metronidazole

Dosage:

5mg/ml

Pharmaceutical form:

solution for i/v infusion

Units in package:

plastic pack 100ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-30

Patient Information leaflet

1
INSTRUCTION
ON THE DRUG MEDICAL USE
METRONIDAZOLE
Solution for intravenous infusion
REGISTRATION NUMBER:
14148 (29.12.2014)
COMMERCIAL TITLE:
Metronidazole
INTERNATIONAL NONPROPRIETARY NAME:
Metronidazole
DOSAGE FORM:
Solution for intravenous infusion 0.5%
COMPOSITION:
Active ingredient: metronidazole – 5,0 g; inactive ingredients:
sodium chloride –
7,9 g,
sodium phosphate monobasic 2H
2
O - 0,355 g, sodium phosphate dibasic - 0,162 g, citric acid -
0,229 g, water for injection - up to 1L.
DESCRIPTION:
Clear, colorless or yellowish - greenish solution.
PHARMACOTHERAPEUTICAL GROUP –
Antiprotozoal agent with an antimicrobial activity,
nitroimidazole.
CODE ATC:
J01XD01
PHARMACOLOGICAL EFFECT
_PHARMACODYNAMICS _
Antiprotozoal
and
antimicrobial
drug,
5-nitroimidazole
derivative.
The
mechanism
of
action
is
biochemical reduction of 5-nitro group by intracellular transport
proteins of anaerobic microorganisms
and protozoa. Recovered 5-nitro group interacts with DNA of microbial
cells by inhibiting synthesis of
nucleic acids, which leads to the death of the bacteria.
The drug is
_active against_
:
Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis,
Giardia
intestinalis,
Lamblia
spp.;
_anaerobic _
_bacteria:_
Bacteroides
spp.
(Bacteroides
fragilis,
Bacteroides
distasonis,
Bacteroides
ovatus,
Bacteroides
thetaiotaomicron,
Bacteroides
vulgatus),
Fusobacterium spp., Veillonella spp., Prevotella spp. (Prevotella
bivia, Prevotella buccae, Prevotella
disiens), Eubacterium spp., Clostridium spp., Peptococcus spp.,
Peptostreptococcus spp.
MIC for these
strains is 0,125-6,25 µg/ml. In combination with amoxicillin is
active against Helicobacter pylori
(amoxicillin inhibits the development of resistance to metronidazole).
2
To the drug are resistant aerobic and facultative anaerobic
microorganisms, but in the presence of
mixed flora (aerobic and anaerobic) metronidazole acts synergistically
with antibiotics, effective
against aerobes.
The drug increases the sensitivity of tumors to radiation, has
disulfiram-