Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rifampicin
Viatris UK Healthcare Ltd
J04AB02
Rifampicin
300mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900; GTIN: 5016695180076
V1 Mar 2022 Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code Viatris SAP No. Vendor Job No. Artwork Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type TrackWise/GLAMS Job No . MA No . Packing Site/Printer Superseded Supplier Code Sign-offs 3D Render ID New Supplier Code Rifampicin, 300 mg, 100 21 JUN 2022 12:47 Label Leaflet (All types) TBC N.A. N.A. N.A. N.A. 0 I of II 8 pt 4 pt SUB-28364-01 1 N.A. United Kingdom McDermott Laboratories Ltd T/A Gerard Laboratories (Grange Rd : Dublin - IE) N.A. SUB-28364-01 N.A. 5016695180076 Myriad Pro N.A. 52 x 110 mm Keyline Varnish Free Area V1 Mar 2022 Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code Viatris SAP No. Vendor Job No. Artwork Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type TrackWise/GLAMS Job No . MA No . Packing Site/Printer Superseded Supplier Code Sign-offs 3D Render ID New Supplier Code Rifampicin, 300 mg, 100 21 JUN 2022 12:47 Label Leaflet (All types) TBC N.A. N.A. N.A. N.A. 0 II of II 8 pt 4 pt SUB-28364-01 1 N.A. United Kingdom McDermott Laboratories Ltd T/A Gerard Laboratories (Grange Rd : Dublin - IE) N.A. SUB-28364-01 N.A. 5016695180076 Myriad Pro N.A. 52 x 110 mm Keyline Braille Varnish Free Area Rifamp- icin #300 mg Capsule Rifamp- icin #300 mg Capsule V1 Mar 2022 Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code Viatris SAP No. Vendor Job No. Artwork Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type TrackWise/GLAMS Job No . MA No . Packing Site/Printer Superseded Supplier Code Sign-offs 3D Render ID New Supplier Code Rifampicin, 300 mg, 100 21 JUN 2022 12:47 Label Leaflet (All types) TBC N.A. N.A. N.A. N.A. 4 Black PMS 306 PMS Reflex Blue PMS 7508 1 of 48 8 Read the complete document
1. NAME OF THE MEDICINAL PRODUCT Rifampicin 300 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 300 mg rifampicin. Excipients with known effect: Each capsule contains 31 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Size no.1 hard gelatin capsules with a pink body and maroon cap, marked “RN 300” and “G”. (The capsule contents are brick red). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TUBERCULOSIS: Rifampicin, 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. Rifampicin is also effective against most atypical strains of mycobacteria. PROPHYLAXIS OF MENINGOCOCCAL MENINGITIS: Prophylaxis of meningococcal meningitis in close contact adult and paediatric patients. LEPROSY: Rifampicin is indicated in the combination treatment of multibacillary and paucibacillary leprosy in patients of all age groups. HAEMOPHILUS INFLUENZAE: Propylaxis of _Haemophilus influenzae_ _type b_ disease in close contacts. OTHER INFECTIONS: Rifampicin is indicated in the treatment of brucellosis, legionnaires disease, and serious staphylococcal infections. Rifampicin should be used in combination with another appropriate antibiotic to prevent emergence of resistant strains of the infecting organism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Tuberculosis Rifampicin should be given with other effective anti-tuberculosis drugs to prevent the possible emergence of rifampicin resistant strains of mycobacteria. _Adults_: The recommended single daily dose in tuberculosis is 8-12mg/kg. Usual daily dose: Patients weighing less than 50kg – 450mg Patients weighing 50kg or more – 600mg _Paediatric patients: _ _Children above 3 months_: Oral doses of 15 (10-20) mg/kg body weight daily are recommended, although a total daily dose should not usually exceed 600mg. Prophylaxis of Meningococcal Meningit Read the complete document