Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
lopinavir, ritonavir
AbbVie Deutschland GmbH Co. KG
J05AR10
lopinavir, ritonavir
Antivirals for systemic use, Protease inhibitors
HIV Infections
Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Revision: 61
Authorised
2001-03-19
124 9. SPECIAL STORAGE CONDITIONS STORE IN A REFRIGERATOR In use storage: If kept outside of the refrigerator, do not store above 25 C and discard any unused contents after 42 days (6 weeks). It is advised to write the date of removal from the refrigerator on the package. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AbbVie (logo) 12. MARKETING AUTHORISATION NUMBER(S) 13. BATCH NUMBER Lot 14. GENERAL CLASSIFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE 17. UNIQUE IDENTIFIER – 2D BARCODE 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 MG/50 MG TABLETS – CARTON OF 1 BOTTLE 1. NAME OF THE MEDICINAL PRODUCT Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer. 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS 120 film-coated tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. Oral use 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP 9. SPECIAL STORAGE CONDITIONS 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 126 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany 12. MARKETING AUTHORISATION NUMBER(S) EU/1/01/172/004 13. BATCH NUMBER Lot 14. GENERAL CLASSIFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE Kaletra 200 mg/50 mg tablets 17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included. 18. UNIQUE IDENTIFIER – Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kaletra (80 mg + 20 mg) / ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer. Excipients with known effect: Each 1 ml contains 356.3 mg of alcohol (42.4% v/v), 168.6 mg of high fructose corn syrup, 152.7 mg of propylene glycol (15.3% w/v) (see section 4.3), 10.2 mg of polyoxyl 40 hydrogenated castor oil and 4.1 mg of acesulfame potassium (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution The solution is light yellow to orange. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older. The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kaletra should be prescribed by physicians who are experienced in the treatment of HIV infection. Posology _Adults and adolescents_ The recommended dosage of Kaletra is 5 ml of oral solution (400/100 mg) twice daily taken with food. _Paediatric population aged from 14 days and older_ The oral solution formulation is the recommended option for the most accurate dosing in children based on body surface area or body weight. However, if it is judged necessary to resort to solid oral dosage form for children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m 2 and able to swallow tablets, Kaletra 100 mg/25 mg tablets may be used. The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m 2 . Kaletra tablets are administered Lue koko asiakirja