Calvepen 250 mg/5 ml Powder for Oral Suspension

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

PHENOXYMETHYLPENICILLIN CALCIUM

Mevcut itibaren:

Clonmel Healthcare Ltd

ATC kodu:

J01CE; J01CE02

INN (International Adı):

PHENOXYMETHYLPENICILLIN CALCIUM

Doz:

250 mg/5ml

Farmasötik formu:

Powder for oral suspension

Reçete türü:

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

Terapötik alanı:

Beta-lactamase sensitive penicillins; phenoxymethylpenicillin

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

1986-01-20

Bilgilendirme broşürü

Page 1 of 4
Package leaflet: Information for the user
CALVEPEN
TM 250MG/5ML POWDER FOR ORAL SUSPENSION
Phenoxymethylpenicillin Calcium
This medicine will be referred to as CALVEPEN
TM 250 MG SUSPENSION throughout this leaflet.
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Calvepen
TM
250 mg Suspension is and what it is used for
2.
What you need to know before you take Calvepen
TM
250 mg Suspension
3.
How to take Calvepen
TM
250 mg Suspension
4.
Possible side effects
5.
How to store Calvepen
TM
250 mg Suspension
6.
Contents of the pack and other information
1.
WHAT CALVEPEN
TM 250 MG SUSPENSION IS AND WHAT IT IS USED FOR
Calvepen
TM
250 mg Suspension belongs to a group of medicines called antibiotics.
Calvepen
TM
is a
member of the penicillin family and is used to kill bacteria which
cause a number of different
infections.
Calvepen
TM
250 mg Suspension is used to treat certain kinds of infection. Your
doctor will decide if
this treatment is suitable for your infection. Calvepen
TM
is also used in patients with rheumatic fever
to prevent the infection returning.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALVEPEN
TM 250 MG SUSPENSION
DO NOT TAKE CALVEPEN
TM 250 MG SUSPENSION

if you are allergic to penicillin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Potentially life-threatening skin rashes (Stevens Johnson syndrome,
toxic epidermal necrolysis) have
been reported with the use of some penicillin’s appearing initially
as reddish target-like s

Ürün özellikleri

Health Products Regulatory Authority
27 March 2023
CRN00D3FW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calvepen 250 mg/5 ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5 ml contains 250 mg Phenoxymethylpenicillin
Calcium.
Excipients with known effect
Each 5 ml contains 5 mg methyl parahydroxybenzoate (E218), 2.5 g of
sucrose and 15 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white powder which on reconstitution with water forms a
homogenous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of infection due to micro-organisms sensitive to this
anti-infective.
In the prophylactic management of patients with rheumatic fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Oral penicillin should be given before meals, and in divided doses,
preferably four times per day.
ADULTS AND OVER 12 YEARS:
Typical dose is 250mg to 500mg given four times daily.
See local/national prescribing guidance for further detail including
weight based dosing, max daily doses and treatment
duration. Doses may be modified depending on the severity of the
condition.
PAEDIATRIC POPULATION
See local/national prescribing guidance for further detail including
weight based dosing, max daily doses and treatment
duration. Doses may be modified depending on the severity of the
condition.
_Children: 6-12 years: _
Typical dose is 250mg given four times daily
_Children: 1-6 years: _
Typical dose is 125mg given four times daily
_Infants under 1 year:_
Typical dose is 62.5mg given four times daily
RHEUMATIC FEVER PROPHYLAXIS
Typical dose is 250mg twice a day.
Health Products Regulatory Authority
27 March 2023
CRN00D3FW
Page 2 of 5
Dosage may be modified at the discretion of the physician according to
the severity of the condition.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, penicillins, including