Benzylpenicillin sodium 3000 mg Powder for Solution for Injection/Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzylpenicillin

Available from:

Rowex Ltd

ATC code:

J01CE01

INN (International Name):

Benzylpenicillin

Dosage:

3000 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

benzylpenicillin

Authorization status:

Not marketed

Authorization date:

2021-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENZYLPENICILLIN SODIUM 600 MG POWDER FOR SOLUTION FOR
INJECTION/INFUSION
BENZYLPENICILLIN SODIUM 3000 MG POWDER FOR SOLUTION FOR
INJECTION/INFUSION
benzylpenicillin sodium
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Benzylpenicillin sodium is and what it is used for
2.
What you need to know before you use Benzylpenicillin sodium
3.
How to use Benzylpenicillin sodium
4.
Possible side effects
5.
How to store Benzylpenicillin sodium
6.
Contents of the pack and other information
1.
WHAT BENZYLPENICILLIN SODIUM IS AND WHAT IT IS USED FOR
Benzylpenicillin sodium is a medicine used to treat infections caused
by benzylpenicillin-sensitive
bacteria. It is used to treat adults, adolescents, children, newborn
infants and premature infants.
Benzylpenicillin sodium is used for the following bacterial
infections:
•
skin and wound infections
•
diphtheria
•
lung inflammation
•
pus accumulation in body cavities
•
infections of the superficial layer of the skin that shows up as a
particularly delimited extensive
reddening called St. Anthony’s fire
•
inflammation of the
-
inner lining of the heart
-
membrane which lines the abdomen cavity and covers the abdominal
organs
-
meninges
-
bone marrow
•
brain abscesses
•
certain infections of the genital tract
•
anthrax
•
tetanus
•
gas gangrene
•
an infection mainly spread by spoiled or perished food called
listeriosis
•
pasteurellosis, an infection that can be caught via

Summary of Product characteristics

Health Products Regulatory Authority
13 January 2023
CRN00D90Y
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benzylpenicillin sodium 3000 mg Powder for Solution for
Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3000 mg (equivalent to approximately 5 mega IU)
benzylpenicillin as sodium salt.
Each vial contains 193 mg of sodium.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off-white powder for solution for injection/infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benzylpenicillin sodium is indicated for the treatment of the
following infections in adults, adolescents, children, newborn
infants and pre-term infants, caused by penicillin-sensitive pathogens
(see section 5.1):
- skin and wound infections
- diphtheria (in addition to antitoxin)
- community acquired pneumonia
- empyema
- erysipelas
- bacterial endocarditis
- peritonitis
- meningitis
- brain abscesses
- osteomyelitis
- infections of the genital tract caused by fusobacteria.
Benzylpenicillin sodium is also used for the treatment of the
following specific infections:
- anthrax
- tetanus
- gas gangrene
- listeriosis
- pasteurellosis
- rat bite fever
- fusospirochaetosis
- actinomycosis.
Furthermore, Benzylpenicillin sodium is also used for complications in
gonorrhoea and syphilis (e.g. gonorrhoeal endocarditis
or arthritis, congenital syphilis), provided that the isolate of
_Neisseria gonorrhea _
is documented to have sensitivity to penicillin.
However, in uncomplicated cases, preference should be given to depot
penicillins. Benzylpenicillin sodium is not indicated for
the treatment of syphilis during pregnancy.
Benzylpenicillin sodium is also used in Lyme borreliosis from the
second stage of the disease onwards (meningopolyneuritis
Garin-Bujadoux-Bannwarth, acrodermatitis chronica atrophicans, Lyme
arthritis, Lyme carditis) if oral penicillin therapy is no
longer indicated. During pregnancy, high-dose parenteral
Benzylpenicillin sodium administra