Rifadin 600mg powder and solvent for solution for infusion vials

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Rifampicin

Verfügbar ab:

Sanofi

ATC-Code:

J04AB02

INN (Internationale Bezeichnung):

Rifampicin

Dosierung:

600mg

Darreichungsform:

Powder and solvent for solution for infusion

Verabreichungsweg:

Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 05010900; GTIN: 5015265300067

Gebrauchsinformation

_I_
RIFADIN® 600MG INFUSION
Rifampicin
TECHNICAL LEAFLET - RIFADIN® 600MG INFUSION
The following information is extracted from the SPC.
Technical
information
for
the
preparation
and
administration of Rifadin 600mg Infusion.
1.
NAME OF THE MEDICINAL PRODUCT
Rifadin for Infusion 600mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin 600mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate (for reconstitution prior to use) and
accompanying ampoule of solvent.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Rifadin for Infusion should include
concomitant use of other appropriate antibacterials
to prevent the emergence of resistant strains of
causative organism.
Tuberculosis:
Adults: A single daily administration of 600mg given
by intravenous infusion over 2 to 3 hours has been
found to be effective and well tolerated for adult
patients. Serum concentrations following this dosage
regimen are similar to those obtained after 600mg by
mouth.
Children: The usual paediatric regimen is a single
daily dose of up to 20mg/kg bodyweight; the total
daily dose should not normally exceed 600mg.
Leprosy: The recommended daily dose is 10 mg/kg.
Usual daily dose:
Patients weighing less than 50 kg - 450 mg.
Patients weighing 50 kg or more - 600 mg.
Alternatively, 600 mg doses of rifampicin may be
given once per month.
In the treatment of leprosy, rifampicin should always
be used in conjunction with at least one other
antileprosy drug.
Brucellosis,
Legionnaires
Disease
or
serious
staphylococcal infections:
Adults: The recommended daily dose is 600 - 1200mg
given in 2 to 4 divided doses, together with another
antibacterial agent with similar properties to prevent
the emergence of resistant strains.
Impaired liver function: A daily dose of 8mg/kg
should not be exceeded in patients with impaired
liver function.
Use in the elderly: In elderly patients, the renal
excretion of rifampicin is decreased proportionally
with physiological decrease of renal function; due to
compensatory increase o

Fachinformation

OBJECT 1
RIFADIN FOR INFUSION 600MG
Summary of Product Characteristics Updated 04-Apr-2018 | SANOFI
1. Name of the medicinal product
Rifadin for Infusion 600mg
2. Qualitative and quantitative composition
Rifampicin BP 600mg
3. Pharmaceutical form
Lyophilisate (for reconstitution prior to use) and accompanying
ampoule of solvent.
4. Clinical particulars
4.1 Therapeutic indications
Rifadin for Infusion is indicated for acutely ill patients who are
unable to tolerate oral therapy e.g. post
operative or comatose patients or patients in whom gastrointestinal
absorption is impaired.
Tuberculosis: Rifadin, used in combination with other active
anti-tuberculosis drugs, is indicated in the
treatment of all forms of tuberculosis, including fresh, advanced,
chronic and drug-resistant cases. Rifadin
is also effective against most atypical strains of Mycobacteria.
Leprosy: Rifadin, used in combination with at least one other active
anti-leprosy drug, is indicated in the
management of multibacillary and paucibacillary leprosy to effect
conversion of the infectious state to a
non-infectious state.
Other infections: Rifadin is indicated in the treatment of
Brucellosis, Legionnaires Disease, and serious
staphylococcal infections. To prevent emergence of resistant strains
of the infecting organisms, Rifadin
should be used in combination with another antibiotic appropriate for
the infection.
4.2 Posology and method of administration
Treatment with Rifadin for Infusion should include concomitant use of
other appropriate antibacterials to
prevent the emergence of resistant strains of the causative organism.
Tuberculosis:
Adults: A single daily administration of 600mg given by intravenous
infusion over 2 to 3 hours has been
found to be effective and well tolerated for adult patients. Serum
concentrations following this dosage
regimen are similar to those obtained after 600mg by mouth.
Children: The usual paediatric regimen is a single daily dose of up to
20mg/kg bodyweight; the total daily
dose should not normally exceed 600mg.
Lepros