Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Austell Pharmaceuticals (Pty) Ltd
500,0 mg
POWDER
EACH VIAL CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN
Registrered
Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for solution for infusion 15 August 2023 (v0.01) Page 1 of 12 APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE: MYCIBACT IV SCHEDULING STATUS: S4 MYCIBACT IV, 500MG POWDER FOR SOLUTION FOR INJECTION AZITHROMYCIN DIHYDRATE SUGAR FREE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MYCIBACT IV_ _ • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. WHAT IS IN THIS LEAFLET 1. What MYCIBACT IV is and what it is used for 2. What you need to know before you receive MYCIBACT IV 3. How to receive MYCIBACT IV 4. Possible side effects 5. How to store MYCIBACT IV 6. Contents of the pack and other information 1. WHAT MYCIBACT IV IS AND WHAT IT IS USED FOR MYCIBACT IV belongs to a group of antibiotics called macrolides. It is used to treat localised infections caused by bacteria. It is indicated for the treatment of serious infections or when oral treatment cannot be used. It is used for treatment of pneumonia (lung infection), caused by susceptible microorganisms. Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for solution for infusion 15 August 2023 (v0.01) Page 2 of 12 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE MYCIBACT IV MYCIBACT IV SHOULD NOT BE ADMINISTERED TO YOU • if you are hypersensitive (allergic) to azithromycin or any of the other ingredients of MYCIBACT IV (listed in section 6)_ _ • If you are taking any ergot derivative such as ergotamine used to treat migraine_ _ • if you have a liver problem. WARNINGS AND PRECAUTIONS Tell your doctor or health care provider before being given MYCIBACT IV: • if you have an allergic reaction such as red or white spots on the skin, itching and skin irritation, swelling of the skin, larynx (throat) or tongue, and difficulty in breathing, in which case you should stop treatment with MYCIBACT IV • if you have or have had kidney problems • if you have or have had li Read the complete document
Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for solution for infusion 15 August 2023 (v0.01) Page 1 of 23 APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE: MYCIBACT IV SCHEDULING STATUS S4 1. NAME OF THE MEDICINE MYCIBACT IV 500 MG POWDER FOR SOLUTION FOR INFUSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains azithromycin dihydrate equivalent to 500 mg of azithromycin, which after reconstitution results in a 100 mg/mL azithromycin solution. The concentrate should be further diluted to 1 mg/mL or 2 mg/mL. Sugar free. Contains 114 mg (4,96 mmol) sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. A white to off-white lyophilised powder. The reconstituted solution is clear and colourless, free of undissolved particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MYCIBACT IV is indicated for the treatment of community acquired pneumonia caused by susceptible organisms, including _ Legionella pneumophila, _ in patients who require initial intravenous therapy. The safety and efficacy of MYCIBACT IV for the treatment of infections in children has not been established. Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for solution for infusion 15 August 2023 (v0.01) Page 2 of 23 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For more severe infections, the recommended dose of MYCIBACT IV_ _for the treatment of adult patients with community acquired pneumonia requiring hospitalisation due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route as a single daily dose of 500 mg to complete a 7 to 10 day course of therapy. The timing of the conversion to oral therapy should be_ _done at the discretion of the medical practitioner and in accordance with clinical response. SPECIAL POPULATIONS ELDERLY POPULATION No dosage adjustment is necessary in elderly patients requi Read the complete document