Clarithromycin 500 mg powder for concentrate for solution for infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Clarithromycin

Prieinama:

hameln pharma gmbh

ATC kodas:

J01FA09

INN (Tarptautinis Pavadinimas):

Clarithromycin

Dozė:

500 milligram(s)

Vaisto forma:

Powder for concentrate for solution for infusion

Gydymo sritis:

clarithromycin

Autorizacija statusas:

Not marketed

Leidimo data:

2021-03-19

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLARITHROMYCIN 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
clarithromycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
-
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 Clarithromycin is and what it is used for
2. What you need to know before you are given 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 contains the active ingredient clarithromycin.
Clarithromycin belongs to a
group of medicines called macrolide antibiotics. Antibiotics stop the
growth of bacteria (bugs)
that 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 tablets.
It is used to treat infections caused by bacteria such as:
1. A flare-up of chronic bronchitis and infection of the lungs
(pneumonia)
2. Severe infection of the sinuses (sinusitis), throat (pharyngitis)
and tonsils (tonsillitis)
3. Skin and tissue infections
Clarithromycin is used in adults and children 12 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLARITHROMYCIN
CLARITHROMYCIN MUST NOT BE GIVEN
:
−
if you are allergic to clarithromycin, other macrolide antibiotics
such as erythromycin or
azithromycin, or any of the other ingredients of this medicine (listed
in section 6).
−
if you are taking medicines called ergot alkaloid tablets (e.g.
ergotamine or
dihydroergotamine) or use ergotamine inhalers for migraine.
−
if you are taking medicines called terfenadine or astemizole (widely
take

Prekės savybės

Health，Products，Regulatory，Authority
25，November，2022
CRN00D37Q
Page，1，of，15
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，clarithromycin，lactobionate.，
When， reconstituted， and， diluted， as， directed,， the，
final， diluted， solution， contains， 2， mg/ml， of，
clarithromycin， as， clarithromycin，
lactobionate.，
For，the，full，list，of，excipients,，see，section，6.1.
3 PHARMACEUTICAL FORM
Powder，for，concentrate，for，solution，for，infusion.
White，to，off，white，cake，or，powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin，is，indicated，in，adults，and，children，12，years，and，older.
Clarithromycin，is，indicated，when，parenteral，therapy，is，required，for，treatment，of，infections，caused，by，susceptible，organisms，in，
the，following，conditions，(see，sections，4.4，and，5.1);

Acute，exacerbation，of，chronic，bronchitis

Community，acquired，pneumonia

Acute，bacterial，sinusitis，(adequately，diagnosed)

Streptococcal，pharyngitis，and，tonsillitis

Skin，and，soft，tissue，infections
Consideration，should，be，given，to，official，guidance，on，the，appropriate，use，of，antibacterial，agents.，
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.，The，total，duration，of，treatment，with，clarithromycin，should，not，extend，14，
days.
_Adults_
The，recommended，dosage，of，Clarithromycin，500，mg，powder，for，concentrate，for，solution，for，infusion，is，