0617-ROF-01 -A ( α-2a) Roferon -A 1. 1.1 / 1.2 Roferon-A 1.3 1.4 α-2a α-2a DNA 0.5 ml 3MIU α- 2a Sodium chloride, Ammonium acetate, Benzyl alcohol, polysorbate 80, Glacial acetic acid, sodium hydroxide, water for injection. 2. 2.1 Roferon-A : Kaposi's sarcoma (hairy cell leukemia B (chronic myeloid leukemia) T (cutaneous T cell lymphoma) C chronic hepatitis C(renal
cell carcinoma) (non-hodgkin s lymphoma) (condylomata acuminata) Roferon-A (hairy cell leukemia) T (cutaneous T cell lymphoma (chronic myelogenous leukemia(low grade non-hodgkin s lymphoma (AIDS-related Kaposi's sarcoma(renal cell carcinoma) B HBV-DNA DNA HBeAg C A B HCV HCV-RNA (Child's class A ALT 2.2 Roferon-A Roferon-A ribavirin ribavirin 2.2.1 Hairy cell leukemia : 3 MIU 16 24 1.5 MIU 3 3 3 MIU 3 1.5 MIU 6 20 T Cutaneous T cell lymphoma, CTCL 18 3-18 MIU 12 1 3 3 MIU 4 6 9 MIU 7 84 18 MIU
Roferon-A 18 MIU 3 8 12 12 40 3 6 12 Chronic myelogenous leukemia, CML 18 Roferon-A 3-9 MIU 8 12 1 3 3 MIU 4 6 6 MIU 7 84 9 MIU 8 12 18 9 MIU ( ) 9 MIU 3 () 2 (Low-grade non-hodgkin s lymphoma) Roferon-A ( ) 3 MIU 3 12 Roferon-A 4 6 Roferon-A ( cyclophosphamide prednisone vincristine doxorubicin ) 28 22 26 6 MIU/m 2 Roferon-A AIDS-related Kaposi's sarcoma 18 3 MIU Roferon-A 18 MIU 36 MIU 10 12 1 3 3 MIU 4 6 9 MIU 7 9 18 MIU
10 84 36 MIU Roferon-A 36 MIU 10 12 3 20 (Advanced renal cell carcinoma) Roferon-A ( 36 MIU) Roferon-A (18 MIU 3 ) vinblastine 3 Roferon-A Roferon-A ( 2 MIU/m 2 ) Roferon-A vinblastine Roferon-A Roferon-A vinblastine a) Roferon-A 3 MIU Roferon-A 18 MIU 36 MIU 8 12 1 3 3 MIU 4 6 9 MIU 7 9 18 MIU 10 84 36 MIU Roferon-A 36 MIU 3 8 12 16 b) Roferon-A vinblastine 3 MIU 3 9 MIU 18 MIU 3 8 12 vinblastine 0.1 mg/kg 3 1 Roferon-A 18 MIU 3 9 MIU 3 vinblastine 3 12 3 B Chronic active hepatitis B
Roferon-A B HBV- DNA DNA HBeAg 4.5-9 MIU 3 4-6 3 4 2 7.5 MIU/m 2 B C Chronic hepatitis C ribavirin Roferon-A C ribavirin Roferon-A Roferon-A ribavirin (Treatment naïve patients) Roferon-A 3 MIU 3 6 (Relapsed patients) Roferon-A 4.5 MIU 3 6 α-2a ribavirin 6 C 6-12 ribavirin ribavirin Roferon-A 3-6 MIU 3 6-12 ALT 3 Roferon-A ribavirin Roferon-A Roferon-A (Condylomata acuminata 1-3 MIU 3 1-2 2.3 Roferon-A : α-2a
Roferon-A HLA CML 3 Roferon-A (benzyl alcohol) ribavirin Roferon-A ribavirin 2.4 2.4.1 Roferon-A α Roferon-A α Roferon-A α Roferon-A α ( Roferon-A)( )
( Roferon-A) Roferon-A Roferon-A ( ) α-2a Roferon-A Roferon-A/ribavirin Roferon-A Roferon- A/ribavirin α ( α-2a) () Roferon-A Roferon-A/ribavirin Roferon-A α α α Roferon-A 2.4.2 Roferon-A 2.4.3 α P450
α theophylline ribavirin α-2a ribavirin C ribavirin 2.5 2.5.1 Roferon-A Roferon-A Roferon-A Roferon-A Roferon-A ribavirin ribavirin C α-2a ribavirin ribavirin 2.5.2 Roferon-A 2.6 B C ribavirin 2.6.1 paracetamol 2/3
: ( [2.6.1.1]) B / (comedications) BUN ( 2.6.1.1) /
ribavirin α-2a ribavirin C ribavirin α ( Roferon-A) ribavirin 2.6.1.1 B Roferon-A 7 10 ITP 2.6.2 Roferon-A α Roferon-A / 2.7 3. 3.1.1 Roferon-A 3.1.2 / Roferon-A HT 29 DNA RNA Roferon-A
Roferon-A Roferon-A AIDS Roferon-A T Roferon-A Roferon-A (Philadelphia chromosome-positive) (CML) Roferon-A 60% CML 18 α-2a 40 Roferon-A Roferon-A CML CML Roferon-A ( ) Roferon-A Roferon-A ( 36 MIU) Roferon-A (18 MIU 3 ) vinblastine 3 Roferon-A Roferon-A ( 2 MIU/m 2 )Roferon-A vinblastine Roferon-A Roferon-A vinblastine Roferon-A vinblastine Roferon-A B C Roferon-A
3.2 3.2.1 80% 36 MIU 1500 2580 pg/ml 2020 pg/ml 3.8 36 MIU 1250 2320 pg/ml (1730 pg/ml) 7.3 3.2.2 Roferon-A 3 198 MIU 36 MIU 0.22 0.75 l/kg 0.40 l/kg α-2a 3.2.3 Roferon-A 36 MIU α-2a 3.7 8.5 5.1 2.14 3.62 ml/min/kg 2.79 ml/min/kg 3.2.4 3.2.3 3.2.5 B α-2a 198 MIU 2 0.5 36 MIU 1 54 MIU 3 1 136 MIU 28 α-2a Roferon-A 28 2 4 ribavirin ribavirin
3.3 3.3.1 ([2.5.1] ) 3.3.2 ([2.5.1] ) 4. 4.1 Exp. 2-8 C 4.2 / / ( ) / 4.3 Roferon-A solution, 3 MIU/0.5 ml prefilled syringes: 1
2014 06 CDS 7.0 07.14-ROF-3B01 000700 F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124, CH-4070 Basel, Switzerland. F. Hoffmann-La Roche Ltd. Wurmisweg, CH-4303 Kaiseraugst, Switzerland ( ): 1 91 : 3 134 9 :(02)2715-3111 Roferon