Clarithromycin 500 mg Powder for concentrate for solution for infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Clarithromycin lactobionate

זמין מ:

Noridem Enterprises Limited

קוד ATC:

J01FA09

INN (שם בינלאומי):

Clarithromycin lactobionate

כמות:

500 milligram(s)

טופס פרצבטיות:

Powder for concentrate for solution for infusion

איזור תרפויטי:

clarithromycin

מצב אישור:

Marketed

תאריך אישור:

2019-03-22

עלון מידע

PACKAGE LEAFLET
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,
nurse or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor, nurse 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
The name of your medicine is Clarithromycin 500 mg Powder for
concentrate for solution for
infusion. In the rest of this leaflet Clarithromycin 500 mg Powder for
concentrate for solution
for infusion is called Clarithromycin.
1.
WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR
Clarithromycin contains the active ingredient clarithromycin (as
clarithromycin lactobionate).
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 clarithromycin tablets.
It is used to treat infections such as:
1.
Chest infections such as bronchitis and pneumonia
2.
Throat and sinus infections
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_ _
YOU MUST NOT BE GIVEN CLARITHROMYCIN IF YOU:
•
are allergic to clarithromycin, ot

מאפייני מוצר

Health Products Regulatory Authority
04 July 2023
CRN00DJT9
Page 1 of 16
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 of clarithromycin (as clarithromycin
lactobionate).
After reconstitution in 10 mL of water for injection, reconstituted
solution contains 50 mg/mL of clarithromycin (as
clarithromycin lactobionate).
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White or almost white, crystalline lyophilized powder to be
reconstituted and further diluted before intravenous (IV)
administration.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin 500 mg Powder for concentrate for solution for infusion
is indicated for the treatment of the following
infections in adults and children 12 years and older.
Clarithromycin 500 mg Powder for concentrate for solution for infusion
is indicated whenever parenteral therapy is required for
treatment of infections caused by susceptible organisms (see section
5.1) in the following conditions:
- Bacterial pharyngitis
- Acute bacterial sinusitis
- Acute bacterial exacerbation of chronic bronchitis
- Mild to moderate community acquired pneumonia
- Skin and soft tissue infections (e.g. folliculitis, cellulitis,
erysipelas) (see section 4.4 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.
After reconstitution the solution should be clear.
ADULTS: The recommended dosage of Clarithromycin 500 mg Pow