Benzylpenicillin 600mg powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benzylpenicillin sodium

Available from:

Genus Pharmaceuticals Ltd

ATC code:

J01CE01

INN (International Name):

Benzylpenicillin sodium

Dosage:

600mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010101; GTIN: 5011309237016 5011309236217

Patient Information leaflet

PRODUCT SUMMARY
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzylpenicillin sodium available as 600 mg and 1200 mg vials.
PHARMACEUTICAL FORM
White crystalline, water-soluble sterile powder for injection.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS:
Benzylpenicillin 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.
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.
600 mg vial
_Intramuscular injection:_
600 mg (1 mega unit) is usually
dissolved in 1.6 to 2.0 ml of Water for Injections BP.
600 mg and 1200 mg vials
_Intravenous Injection:_
A suitable concentration is 600 mg
(1 mega unit) dissolved in 4 to 10 ml of Water for Injections BP
or Sodium Chloride Injection BP and 1200 mg (2 mega units)
disso

Summary of Product characteristics

OBJECT 1
BENZYLPENICILLIN SODIUM 600MG POWDER FOR
INJECTION
Summary of Product Characteristics Updated 16-Sep-2016 | Genus
Pharmaceuticals
1. Name of the medicinal product
Benzylpenicillin sodium 600mg Powder for Injection
2. Qualitative and quantitative composition
Each vial contains Benzylpenicillin sodium 600 mg
3. Pharmaceutical form
Powder for injection
White crystalline, water-soluble sterile powder.
4. Clinical particulars
4.1 Therapeutic indications
Benzylpenicillin 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.
600 mg vial
_Intramuscular injection_: 600 mg (1 mega unit) is usually dissolved
in 1.6 to 2.0 ml of Water for Injections
BP