Klacid IV 500mg Powder for Concentrate for Solution for Infusion

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

CLARITHROMYCIN

Disponible des:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Codi ATC:

J01FA09

Designació comuna internacional (DCI):

CLARITHROMYCIN 500 mg

formulario farmacéutico:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

CLARITHROMYCIN 500 mg

tipo de receta:

POM

Área terapéutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estat d'Autorització:

Authorised

Data d'autorització:

2020-11-19

Informació per a l'usuari

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

Fitxa tècnica

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 infections for 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 (12-18 years) dosing is as for adults.
ELDERLY:
As for adults.
RENAL IMPAIRME