Klacid IV 500mg Powder for Concentrate for Solution for Infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Clarithromycin

Disponível em:

Viatris Healthcare Limited

Código ATC:

J01FA; J01FA09

DCI (Denominação Comum Internacional):

Clarithromycin

Forma farmacêutica:

Powder for concentrate for solution for infusion

Área terapêutica:

Macrolides; clarithromycin

Status de autorização:

Marketed

Data de autorização:

1994-11-10

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KLACID
® IV 500MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
(CLARITHROMYCIN)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Klacid IV is and what it is used for
2. What you need to know before you receive Klacid IV
3. How is Klacid IV given?
4. Possible side effects
5. How to store Klacid IV
6. Contents of the pack and other information
1. WHAT KLACID IV IS AND WHAT IT IS USED FOR
Klacid IV contains the active ingredient clarithromycin. Klacid IV
belongs to a group of medicines called macrolide
antibiotics. Antibiotics stop the growth of bacteria (bugs) which
cause infections.
Klacid IV is used whenever an intravenous (injection into the vein)
antibiotic is required to treat severe infections or,
alternatively, if a patient cannot swallow Klacid in the tablet
formulation.
It is used to treat infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and soft tissue infections such as cellulitis, folliculitis or
erysipelas
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE KLACID IV
DO NOT RECEIVE KLACID IV IF;
• you know that you are ALLERGIC to clarithromycin, other macrolide
antibiotics such as erythromycin or azithromycin, or
any of the other ingredients in Klacid IV.
• you are taking medicines called ergot alkaloids, for example
ergotamine or dihydroergotamine tablets or use ergotamine
inhalers for migraine. Consult your doctor for advice on alternative
medicines.
• you are taking medicines called simvastatin or lovastatin (used to
lower increased blood fats such as cholesterol and
triglycerides).
• you are takin

Características técnicas

Health Products Regulatory Authority
17 November 2023
CRN00DWHR
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid IV 500mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg clarithromycin (as lactobionate).
When reconstituted and diluted as directed, the final diluted solution
contains approximately 1.9mg/ml of Clarithromycin.
Excipient with known effect:
The quantity of sodium per vial is 0.273 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Concentrate for Solution for Infusion
A white to off-white caked, lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid IV is indicated in adults and children aged 12 years and older
whenever parenteral therapy is required for treatment of
infections caused by susceptible organisms in the following
conditions;
- Lower respiratory tract infections for example, acute and chronic
bronchitis, and pneumonia (see section 4.1 and 5.1
regarding Sensitivity Testing).
- Upper respiratory tract infections for example, sinusitis and
pharyngitis.
- Skin and soft tissue infectionsfor example, folliculitis,
cellulitis, erysipelas (see section 4.1 and 5.1 regarding Sensitivity
Testing).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous administration only.
Intravenous therapy may be given for 2 to 5 days in the very ill
patient and should be changed to oral clarithromycin therapy
whenever possible as determined by the physician.
ADULTS: The recommended dosage of Klacid IV in adults 18 years of age
or older is 1.0 gram daily, divided into two 500mg
doses, appropriately diluted as described below.
CHILDREN YOUNGER THAN 12 YEARS: There are insufficient data to
recommend a dosage regimen for use of the clarithromycin IV
formulation in patients less than 12 years of age (see Klacid
Paediatric Suspension).
In adolescents (12-1