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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIFAMPICIN

Available from:

Sanofi Malta Limited

ATC code:

J04AB02

INN (International Name):

RIFAMPICIN

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Composition:

RIFAMPICIN 600 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIMYCOBACTERIALS

Authorization status:

Authorised

Authorization date:

2006-12-29

Patient Information leaflet

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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 phar-
macist.
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
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 tuber-
culosis (also known as TB) and other sim-
ilar types of infection.
2. BEFORE YOU USE RIFADIN
DO NOT TAKE RIFADIN IF:
- You are allergic (hypersensitive) to ri-
fampicin 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 medi-
cines’ section below).
Do not use if any of the above apply to
you. If you are not sure, talk to your doc-
tor, nurse or pharmacist before having
Rifadin.
TAKE SPECIAL CARE WITH RIFADIN
TELL YOUR DOCTOR OR PHARMACIST IF:
- You have liver or kidney problems.
- You have a rare blood problem called
‘porphyria’.
- Rifadin may produce a discolouration
(yellow, orange, red, brown) of the
teeth, urine, sweat, sputum and tears. If
you wear contact lenses- please note
that Rifadin may permanently stain soft
contact lenses.
- If you have severe skin reaction such as
severe extensive skin damage (separa-
tion of the epidermis and superficial
mucous membranes) (toxic epidermal
necrolysis,
TEN,),
Skin
blistering,
red/purple

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 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
Rifadin