Rifadin Intravenous 600mg powder and solvent for concentrate for solution for Infusion

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

RIFAMPICIN

Tilgængelig fra:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC-kode:

J04AB02

INN (International Name):

RIFAMPICIN 600 mg

Lægemiddelform:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Sammensætning:

RIFAMPICIN 600 mg

Recept type:

POM

Terapeutisk område:

ANTIMYCOBACTERIALS

Autorisation status:

Withdrawn

Autorisation dato:

2006-12-29

Indlægsseddel

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.
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 to collection of

Produktets egenskaber

1.
NAME OF THE MEDICINAL PRODUCT
Rifadin Intravenous 600mg Powder and Solvent for Concentrate for
Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin 600 mg.
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 lyophilised powder for reconstitution with 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 liver function.
When patients are able to accept oral medication, they should be
transferred to Rifa