Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Clarithromycin

Tilgængelig fra:

Amdipharm Limited

ATC-kode:

J01FA; J01FA09

INN (International Name):

Clarithromycin

Dosering:

500 milligram(s)

Lægemiddelform:

Powder for concentrate for solution for infusion

Terapeutisk område:

Macrolides; clarithromycin

Autorisation status:

Marketed

Autorisation dato:

2010-08-13

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 500MG, POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Clarithromycin
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 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Clarithromycin 500mg, powder for
concentrate for solution for infusion,
which will be referred to as Clarithromycin throughout this leaflet.
WHAT IS IN THIS LEAFLET
1
What Clarithromycin is and what it is used for
2
What you need to know before receiving Clarithromycin
3
How Clarithromycin is given
4
Possible side effects
5
How to store Clarithromycin
6
Contents of the pack and other information
1. WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR
Clarithromycin is an antibiotic that belongs to a group of medicines
called macrolides. Antibiotics
stop the growth of bacteria which cause infections. Clarithromycin is
used whenever an intravenous
(injection into the vein) antibiotic is required to treat severe
infections or, alternatively, if a patient
cannot swallow Clarithromycin tablets.
It is used to treat infections caused by bacteria such as:
•
Chest infections like acute bronchitis and pneumonia
•
Throat and sinus infections
•
Skin and tissue infections.
2. WHAT YOU NEED TO KNOW BEFORE RECEIVING CLARITHROMYCIN
DO NOT RECEIVE CLARITHROMYCIN:
•
If you (or your child) are allergic to clarithromycin, other
macrolides (similar antibiotics such as
erythromycin, azithromycin), or any of the other ingredients of this
medicine (listed in Section 6). An
allergic reaction may include rash, itching, diffi

Produktets egenskaber

Health Products Regulatory Authority
09 September 2021
CRN00C1K0
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg clarithromycin (as lactobionate).
Each millilitre of final reconstituted/diluted solution for infusion
contains 2 mg clarithromycin (as lactobionate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Concentrate for Solution for Infusion.
White crystalline powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin 500 mg, powder for concentrate for solution for
infusion is indicated when parenteral therapy is required for
treatment of infections, caused by clarithromycin-susceptible
organisms in the following conditions:
- Community acquired pneumonia
- Acute exacerbation of chronic bronchitis
- Acute bacterial sinusitis (adequately diagnosed)
- Bacterial pharyngitis and tonsillitis
- Skin and soft tissue infections
Clarithromycin 500 mg, powder for concentrate for solution for
infusion is indicated in adults and children 12 years and older.
“Consideration should be given to official guidance on the
appropriate use of antibacterial agents".
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents: The recommended dose is 1.0 gram daily of
Clarithromycin powder for concentrate for solution for
infusion (appropriately diluted as described below), administered as
two separate 500mg doses at 12 hourly intervals.
Renal Impairment:
Patients with severe renal impairment, with creatinine clearance less
than 30ml/min, the dosage of clarithromycin should be
reduced to one half of the normal recommended dose.
_Paediatric population_
Children aged 12 or less:
Use of Clarithromycin powder for concentrate for solution for infusion
is not recommended for children younger than 12 years.
Use clarithromycin Paediatric Suspension.
Children older than 12 years: As for adults.
Elderly: Sa