Crystapen 600mg Powder for Solution for Injection or Infusion

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Benzylpenicillin sodium

MAH:

Genus Pharmaceuticals Limited

ATC_code:

J01CE; J01CE01

INN:

Benzylpenicillin sodium

dosage:

600 milligram(s)

pharmaceutical_form:

Powder for solution for injection/infusion

prescription_type:

Product subject to prescription which may not be renewed (A)

therapeutic_area:

Beta-lactamase sensitive penicillins; benzylpenicillin

authorization_status:

Marketed

authorization_date:

2001-04-20

PIL

_Please read the back of this leaflet._
* Trademark
CRYSTAPEN 600MG POWDER
FOR SOLUTION FOR INJECTION OR INFUSION
BENZYLPENICILLIN SODIUM
TECHNICAL LEAFLET
SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF MEDICINAL PRODUCT
Crystapen 600mg Powder for Solution for Injection or Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 600mg Benzylpenicillin sodium
For a full list of excipients, see Section 6.1
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White, crystalline, water-soluble powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
Crystapen is indicated for most wound infections, pyogenic
infections of the skin, soft tissue infections and infections of the
nose, throat, nasal sinuses, respiratory tract and middle ear, etc.
It is also indicated for the following infections caused by penicillin
-sensitive microorganisms: Generalised infections, septicaemia
and pyaemia from susceptible bacteria. Acute and chronic
osteomyelitis, sub-acute bacterial endocarditis and meningitis
caused by susceptible organisms.
Suspected meningococcal
disease. Gas gangrene, tetanus, actinomycosis, anthrax,
leptospirosis, rat-bite fever, listeriosis, severe Lyme disease,
and prevention of neonatal group B streptococcal infections.
Complications secondary to gonorrhoea and syphilis
(e.g. gonococcal arthritis or endocarditis, congenital syphilis and
neurosyphilis). Diphtheria, brain abscesses and pasteurellosis.
Consideration should be given to official local guidance
(e.g. national recommendations) on the appropriate use of
antibacterial agents.
Susceptibility of the causative organism to the treatment should
be tested (if possible), although therapy may be initiated before
the results are available.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION:
Intramuscular, intravenous.
PREPARATION OF SOLUTIONS:
Pharmaceutical preparation
Only freshly prepared solutions should be used. Reconstituted
solutions of benzylpenicillin sodium are intended for immediate
administration

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crystapen 600mg Powder for Solution for Injection or Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 600mg Benzylpenicillin Sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Solution for Injection or Infusion.
White, crystalline, water-soluble sterile powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Crystapen is indicated for most wound infections, pyogenic infections
of the skin, soft tissue infections and infections
of the nose, throat, nasal sinuses, respiratory tract and middle ear,
etc.
It is also indicated for the following infections caused by
penicillin-sensitive microorganisms: Generalised infections,
septicaemia and pyaemia from susceptible bacteria.
Acute and chronic osteomyelitis, sub-acute bacterial endocarditis
and meningitis caused by susceptible organisms. Suspected
meningococcal disease. Gas gangrene, tetanus,
actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis,
severe Lyme disease, and prevention of neonatal group
B streptococcal infections. Complications secondary to gonorrhoea and
syphilis (e.g. gonococcal arthritis or
endocarditis, congenital syphilis and neurosyphilis).
Diphtheria, brain abscesses and pasteurellosis.
Consideration should be given to official local guidance (e.g.
national recommendations) on the appropriate use of
antibacterial agents.
Susceptibility of the causative organism to the treatment should be
tested (if possible), although therapy may be
initiated before the results are available.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION:
Intramuscular, intravenous.
PREPARATION OF SOLUTIONS:
Pharmaceutical preparation
Only freshly prepared solutions should be used. Reconstituted
solutions of benzylpenicillin sodium are intended for
immediate administration.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_