RIFADIN Solvent (2023)
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Περιεχόμενα
Name of the medicinal product
Rifadin for Infusion 600 mg.
Qualitative and quantitative composition
Rifampicin BP 600 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Lyophilisate (for reconstitution prior to use) and accompanying ampoule of solvent.
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. ...
Posology and method of administration
Treatment with Rifadin for Infusion should include concomitant use of other appropriate anti-bacterials to prevent the emergence of resistant strains of the causative organism. Tuberculosis Adults: A single ...
Contraindications
Rifadin for Infusion is contraindicated in: patients who are hypersensitive to rifamycins or any of the excipients concurrent treatment with the combination of saquinavir/ritonavir (see section 4.5). ...
Special warnings and precautions for use
Rifampicin should be given under the supervision of a respiratory or other suitably qualified physician. Cautions should be taken in case of renal impairment if dose > 600 mg/day. All tuberculosis patients ...
Interaction with other medicinal products and other forms of interaction
Interference with laboratory and diagnostic tests Therapeutic levels of rifampicin have been shown to inhibit standard microbiological assays for serum folate and Vitamin B12. Thus, alternative assay methods ...
Pregnancy and lactation
Pregnancy At very high doses in animals rifampicin has been shown to have teratogenic effects. There are no well controlled studies with rifampicin in pregnant women. Although rifampicin has been reported ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%, Unknown (cannot be estimated from available ...
Overdose
Human Experience Signs and Symptoms Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur ...
Pharmacodynamic properties
Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin ...
Pharmacokinetic properties
After intravenous administration of a 300 or 600 mg dose of Rifadin infusion infused over 30 minutes to healthy male volunteers (n = 12), mean peak plasma concentrations were 9.0 and 17.5 µg/ml, respectively. ...
Preclinical safety data
Not applicable.
List of excipients
Sodium sulfoxylate formaldehyde Sodium hydroxide Solvent: Water for injections
Incompatibilities
Compatibilities: Rifadin for Infusion is compatible with the following infusion solutions: up to 6 hours with Saline Solution and up to 8 hours with Glucose 5%. Incompatibilities: Rifadin for Infusion ...
Shelf life
Unopened vial of lyophilisate: 36 months. Unopened ampoule of solvent: 60 months. Shelf life after dilution or reconstitution: Water for Injections (10 ml WFI): Up to 30 hours. Water for injections (10 ...
Special precautions for storage
Store below 25°C.
Nature and contents of container
20ml clear neutral glass vial sealed with butyl rubber stopper and aluminium/plastic flip-off cap (colour coded blue) containing 600mg Rifampicin and 10ml clear glass ampoule containing solvent. Pack size: ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0051
Date of first authorization / renewal of the authorization
Date of First Authorisation: 15 December 1982 Date of latest renewal: 09 April 2005
Date of revision of the text
11 July 2023
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