RIFADIN Capsule (2023)
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Περιεχόμενα
Name of the medicinal product
Rifadin 150 mg Capsules.
Qualitative and quantitative composition
Rifampicin Ph Eur 150 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsule, hard. The gelatin capsule is opaque, composed of a scarlet body and a light blue cap, marked R-150.
Therapeutic indications
Indications for use Tuberculosis: In combination with other active anti-tuberculosis drugs in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug-resistant cases. Rifadin ...
Posology and method of administration
Recommended Dosage For oral administration. The daily dose of Rifadin, calculated from the patients body weight, should preferably be taken at least 30 minutes before a meal or 2 hours after a meal to ...
Contraindications
Rifadin is contraindicated in: patients who are hypersensitive to any of the rifamycins or any of the excipients (see section 6.1) the presence of jaundice concurrent treatment with the combination of ...
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
No studies on the effects on the ability to drive and use machines have been performed.
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
Antimycobacterials, antibiotics <b>ATC Code:</b> J04AB02 Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and ...
Pharmacokinetic properties
Rifampicin is readily absorbed from the gastrointestinal tract. Peak serum concentrations of the order of 10 µg/ml occur about 2 to 4 hours after a dose of 10 mg/kg body weight on an empty stomach. Absorption ...
Preclinical safety data
Not applicable.
List of excipients
Corn starch Magnesium stearate <u>Capsule Shell:</u> Gelatin Erytrosine Indigotine Titanium dioxide
Incompatibilities
None stated.
Shelf life
3 years.
Special precautions for storage
Store below 25°C. Protect from light and moisture.
Nature and contents of container
Amber glass bottles of 100 capsules. Blister packs of 100 capsules in cardboard cartons. Blister material is aluminium foil/PVDC (Aluminium 0.025 mm; PVDC 20 gsm) and transparent PVC/PVDC foil (PVC 0.25 ...
Special precautions for disposal and other handling
No special requirements.
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 04425/5915R
Date of first authorization / renewal of the authorization
Date of First Authorisation: 15 June 1982 Date of latest renewal: 09 April 2005
Date of revision of the text
11 July 2023
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