Rifadin Intravenous 600mg Powder and Solvent for Concentrate for Solution for Infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Rifampicin

זמין מ:

Sanofi-Aventis Ireland Limited T/A SANOFI

קוד ATC:

J04AB; J04AB02

INN (שם בינלאומי):

Rifampicin

כמות:

600 milligram(s)

טופס פרצבטיות:

Powder and solvent for concentrate for solution for infusion

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Antibiotics; rifampicin

מצב אישור:

Marketed

תאריך אישור:

1983-10-04

עלון מידע

Internal
RIFADIN
®
INTRAVENOUS 600MG POWDER
AND SOLVENT FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
_Rifampicin _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP.
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
- If any side effects gets serious, or if you notice any side effect
not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Rifadin is and what it is used for
2. Before you take Rifadin
3. How to take Rifadin
4. Possible side effects
5. How to store Rifadin
6. Further information
1. WHAT RIFADIN IS AND WHAT
1. WHAT RIFADIN IS AND WHAT IT IS USED FOR
IT IS USED FOR
Rifadin Intravenous 600mg Powder and Solvent for Concentrate for
Solution
for Infusion is one of a group of medicines called antibiotics. It is
used to
treat tuberculosis (also known as TB) and other similar types of
infection.
2. BEFORE YOU TAKE RIFADIN
2. BEFORE YOU USE RIFADIN
DO NOT TAKE RIFADIN IF:
- You are allergic (hypersensitive) to rifampicin or any of the other
ingredients.
- You have yellowing of the skin and eyes (jaundice).
- You are taking saquinavir or ritonavir for HIV infection (see
‘Taking other
medicines’ section below).
Do not use if any of the above apply to you. If you are not sure, talk
to
your doctor, nurse or pharmacist before having Rifadin.
Internal
WARNINGS AND PRECAUTIONS
INFORM YOUR DOCTOR IMMEDIATELY WHILE TAKING THIS MEDICINE
• If your symptoms of tuberculosis return or get worse (see 4.
Possible side effects)
• if you develop new or sudden worsening of shortness of breath,
possibly with a dry cough or fever
not responding to antibiotic treatment. These could be symptoms of
lung inflammation (interstitial lung
disease/pneumonitis) and can lead to serious breathing problems due

מאפייני מוצר

Health Products Regulatory Authority
14 March 2024
CRN00DR74
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rifadin Intravenous 600mg Powder and Solvent for Concentrate for
Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin 600mg
Excipients: Sodium 16mg per vial
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for concentrate for solution for infusion.
Red sterile lyophilized powder for reconstitution with the
accompanying ampoule of sterile solvent for dilution for use as an
intravenous infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rifadin for Infusion is indicated in patients with all forms of
tuberculosis who are unable to tolerate oral therapy, e.g. post
operative or comatose patients in whom gastro-intestinal absorption is
impaired.
Rifadin for Infusion is also indicated in patients with life
threatening or severe infections due to rifampicin sensitive
micro-organisms. In-vitro activity has been established against
streptococci, staphylococci, enterococci, pneumococci and in
addition, N. gonorrhoea, Proteus spp., H. influenza, E. coli and other
Gram-negative organisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Rifadin for Infusion should preferably include the
concomitant use of other appropriate antibiotics to prevent
the emergence of resistant strains of the causative organism. Rifadin
for infusion is for intravenous infusion only and must not
be administered by intramuscular or subcutaneous route (see 4.4
Special Warnings and Precautions for Use).
_Adults:_ a single daily administration of 600mg (8 to 12 mg/kg b.w.)
given in an intravenous infusion drip over 2 to 3 hours has
been found to be effective and well tolerated for adult patients.
Serum concentrations following the dosage regimen are similar to those
obtained after 600mg by mouth.
Lower doses are recommended for frail and elderly patients. A daily
dose of 8mg/kg bodyweight should not be exceeded in
patients with impaired