Crystapen 600mg Powder for Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzylpenicillin Sodium

Available from:

Clonmel Healthcare Ltd

ATC code:

J01CE; J01CE01

INN (International Name):

Benzylpenicillin Sodium

Dosage:

600 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Beta-lactamase sensitive penicillins; benzylpenicillin

Authorization status:

Marketed

Authorization date:

2001-04-20

Patient Information leaflet

Page 1 of 3
CRYSTAPEN 600MG POWDER
FOR SOLUTION FOR INJECTION OR INFUSION
Benzylpenicillin Sodium PACKAGE LEAFLET
This leaflet tells you about the medicine you are receiving. It does
not contain all the information about your
medicine. If you have any questions or are unsure about anything, ask
your doctor or pharmacist.
WHAT DOES YOUR MEDICINE CONTAIN?
Crystapen Injection is available in 600mg vials, which contain 600mg
of benzylpenicillin sodium, as the active
ingredient in each vial. Benzylpenicillin sodium is also known as
penicillin G.
The 600mg vial is available in packs of 2 and 25 vials. Not all pack
sizes may be marketed.
Benzylpenicillin sodium is one of a group of medicines known as
penicillins, which are antibiotics. Antibiotics
are used to kill the bacteria ('germs'), which cause infection.
Benzylpenicillin sodium is used to treat infections
of the ear, nose, throat, chest, heart, bones and skin. It may also be
used to treat some sexually transmitted
infections (e.g. gonorrhoea and syphilis), meningitis, brain
abscesses, gangrene, blood infections, anthrax,
tetanus, diphtheria, listeria (a type of food poisoning),
leptospirosis (an infection from animals), pasteurellosis
(an infection following animal bites), severe Lyme disease (an
infection from tick bites), actinomycosis (an
infection caused by trauma/surgery) and some infections caused by rat
bites. Benzylpenicillin sodium is also
used for the prevention of infection in newborn babies (specifically
group B streptococcal infection).
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
_MARKETING AUTHORISATION HOLDER: _
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, E91
D768, Ireland.
_MANUFACTURERS: _
Sandoz GmbH, A-6250 Kundl, Tirol, Austria
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD? 5QH, UK.
BEFORE YOUR MEDICINE IS USED
IF THE ANSWER IS
YES
TO ANY OF THE FOLLOWING QUESTIONS, PLEASE TELL YOUR
DOCTOR BEFORE YOUR MEDICINE IS USED:
•
Are you pregnant, think you might be pregnant, or intending to become
pregnant?
•
Are you

Summary of Product characteristics

Health Products Regulatory Authority
21 June 2021
CRN00CD36
Page 1 of 8
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 600 mg benzylpenicillin sodium.
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
Posology
The following dosages apply to both intramuscular and intravenous
injection.
Alternate sites should be used for repeated injections.
Adults
600 to 3,600 mg (1 to 6 mega units) daily, divided into 4 to 6 doses,
depending on the indication. Higher doses (up to 14.4
g/day (24 mega units) in divided doses) may be given in serious
infections such as adult meningitis by