Penicillin-G RS powder for solution for injection

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

benzylpenicillin (benzylpenicillin sodium)

Disponível em:

Reyoung Pharmaceutical Co. Ltd.

Código ATC:

J01CE01

DCI (Denominação Comum Internacional):

benzylpenicillin (benzylpenicillin sodium)

Dosagem:

1000000IU

Forma farmacêutica:

powder for solution for injection

Unidades em pacote:

(50) glass vial

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2016-03-16

Folheto informativo - Bula

_Instructions on the medicinal use of the drug for doctors and
consumers. _
PENICILLIN-G RS
BENZYLPENICILLIN SODIUM EQ. TO BENZYLPENICILLIN 1,000,000 IU
POWDER FOR INJECTION 1 MEGA
PHARMACEUTICAL FORM : POWDER FOR INJECTION .
The preparation is a white sterile crystalline powder, which is very
soluble in water. And has a property of moisture absorption it rapidly
lose its activity toward, acids, alkalies or oxidizer.
COMPOSITION:
Each vial contains:
Benzylpenicillin Sodium eq. to Benzylpenicillin 1,000,000 IU
PHARMACEUTICAL GROUP: Beta-lactamase sensitive penicillins.
ATC CODE: J01CE01
INDICATIONS AND USAGE FOR PENICILLIN-G RS
THERAPY
Benzylpenicillin
Injection
is
indicated
in
the
treatment
of
serious
infections
caused
by
susceptible
strains
of
the
designated
microorganisms in the conditions listed below. Appropriate culture and
susceptibility tests should be done before treatment in order to
isolate and identify organisms causing infection and to determine
their susceptibility to Benzylpenicillin.
Therapy with Benzylpenicillin Injection may be initiated before
results of such tests are known when there is reason to believe the
infection may involve any of the organisms listed below; however, once
these results become available, appropriate therapy should be
continued.
CLINICAL INDICATION
INFECTING ORGANISM
Septicemia,
empyema,
pneumonia,
pericarditis,
endocarditis, meningitis
Streptococcus pyogenes (group A β-hemolytic streptococcus),
other β-hemolytic streptococci including groups C, H, G, L and
M,
Streptococcus
pneumoniae
and
Staphylococcus
species
(non-penicillinase producing strains)
Anthrax
Bacillus anthracis
Actinomycosis
(cervico-facial
disease
and
thoracic
and
abdominal disease)
Actinomyces israelii
Botulism (adjunctive therapy to antitoxin), gas gangrene,
and tetanus (adjunctive therapy to human tetanus immune
globulin)
Clostridium species
Diphtheria (adjunctive therapy to antitoxin and prevention
of the carrier state)
Corynebacterium diphtheriae
Erysipelothrix endocarditis
Erysipelothrix rhusiopathia

Características técnicas

Appendix 1.9
PENICILLIN-G RS
BENZYLPENICILLIN SODIUM EQ. TO BENZYLPENICILLIN 1,000,000 IU
POWDER FOR INJECTION 1 MEGA
THE SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
PENICILLIN-G RS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION WITH INDICATION OF ACTIVE
SUBSTANCES
(INTERNATIONAL NONPROPRIETARY NAME OR CHEMICAL NAME), INDICATION OF
OTHER EXCIPIENTS
KNOWLEDGE OF WHICH IS ESSENTIAL FOR SAFE AND PROPER ADMINISTRATION OF
THE MEDICINAL PRODUCT.
Each vial contains:
Benzylpenicillin Sodium eq. to Benzylpenicillin 1,000,000 IU
3. PHARMACEUTICAL FORM: Powder for injection.
The preparation is a white sterile crystalline powder, which is very
soluble in water. And has a property of
moisture absorption it rapidly lose its activity toward, acids,
alkalies or oxidizer.
PHARMACEUTICAL GROUP:
Beta-lactamase sensitive penicillins.
ATC CODE:
J01CE01
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benzylpenicillin Injection is indicated in the treatment of serious
infections caused by susceptible strains of
the designated microorganisms in the conditions listed below.
Appropriate culture and susceptibility tests
should be done before treatment in order to isolate and identify
organisms causing infection and to
determine their susceptibility to Benzylpenicillin.
Therapy with Benzylpenicillin Injection may be initiated before
results of such tests are known when there is
reason to believe the infection may involve any of the organisms
listed below; however, once these results
become available, appropriate therapy should be continued.
CLINICAL INDICATION
INFECTING ORGANISM
Septicemia, empyema, pneumonia,
pericarditis, endocarditis, meningitis
Streptococcus pyogenes (group A β-
hemolytic streptococcus), other β-hemolytic
streptococci including groups C, H, G, L and
M, Streptococcus pneumoniae and
Staphylococcus species (non-penicillinase
producing strains)
Anthrax
Bacillus anthracis
Actinomycosis (cervico-facial disease and
thoracic and abdominal disease)
Actinomyces israelii
Botulism (adjunctive therapy