Benzylpenicillin Potassium 625 mg powder for solution for injection or infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENZYLPENICILLIN POTASSIUM

Available from:

Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy

ATC code:

J01CE01

INN (International Name):

BENZYLPENICILLIN POTASSIUM 625 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

BENZYLPENICILLIN POTASSIUM 625 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2016-11-22

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
Benzylpenicillin Potassium 625 mg powder for solution for injection or
infusion
Benzylpenicillin Potassium 1250 mg powder for solution for injection
or infusion
Benzylpenicillin Potassium
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.

If you get any side-effects, talk to your doctor, pharmacist or nurse.
This includes any side-effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Benzylpenicillin Potassium is and what it is used for
2. What you need to know before you use Benzylpenicillin Potassium
3. How to use Benzylpenicillin Potassium
4. Possible side effects
5. How to store Benzylpenicillin Potassium
6. Contents of the pack and other information
1. WHAT BENZYLPENICILLIN POTASSIUM IS AND WHAT IT IS USED FOR
This medicine contains benzylpenicillin potassium, which is one of a
group of medicines known as
penicillins (‘antibiotics’). Antibiotics are used to kill the
bacteria (germs) which cause infections.
Benzylpenicillin Potassium is used to treat INFECTIONS OF THE EAR,
NOSE, THROAT, CHEST, HEART, BONES AND SKIN.
Benzylpenicillin Potassium is also used for the prevention of
infection in newborn babies.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENZYLPENICILLIN POTASSIUM
DO NOT USE BENZYLPENICILLIN POTASSIUM IF YOU:

are allergic to benzylpenicillin potassium, any other antibiotics (in
particular other penicillins,
cephalosporins or beta-lactams).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Benzylpenicillin
Potassium:

if you suffer from other allergies, especially an allergy to medicines

if you are pregnant, breast-feeding or think you could be pregnant

if you have kidney problems

if you have liver problems

if you have any heart problems

if you are diabetic
O

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benzylpenicillin Potassium 625 mg powder for solution for injection or
infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 625 mg of Benzylpenicillin Potassium, equivalent to
560 mg of
benzylpenicillin (1 mega unit)
Each vial of Benzylpenicillin Potassium 625 mg contains 1.67 mmol
(65.3 mg) of
potassium.
3
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White crystalline, water-soluble sterile powder for injection, very
soluble in water,
practically insoluble in fatty oils and in liquid paraffin.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Benzylpenicillin Potassium is indicated for the treatment of the
following infections (see
section 4.4 and 5.1):
•
Skin and soft tissue infections
•
Infections of the ear, nose and throat
•
Community acquired pneumonia
•
Acute exacerbation of chronic bronchitis
•
Acute and chronic osteomyelitis
•
Sub-acute bacterial endocarditis
•
Meningitis
•
Brain abscess
It is also used for the prevention of neonatal group B streptococcal
infections.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
Page 2 of 12
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 _
625 to 3,750 mg (1 to 6 mega units) daily, divided into 4 to 6 doses,
depending on the
indication. Higher doses (up to 15 g/day (24 mega units) in divided
doses) may be given
in serious infections such as adult meningitis by the intravenous
route.
In bacterial endocarditis, 7.5 to 12.5 g (12 to 20 mega units) or more
may be given daily
in divided doses by the intravenous route, often by infusion.
Doses up to 45 g (72 mega units) per day may be necessary for patients
with rapidly
spreading gas gangrene.
High doses should be administered by intravenous injection or
infusion, with intravenous
doses in exce