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古巴肺癌疫苗原版官方说明书 Monography Cimavax EGF
CIMAvax EGF
MONOGRAPHY OF THE PRODUCT
Recombinant vaccine rEGF +rP64K
Version: June 2009
CIMAB SA
206 street , No. 1926. Between 19 and 21. Atabey. Playa.
Havana City, Cuba.
POBox : 16040, Postal code: 11600.
Phone: ( 537) 2725162, 2725163, 271 5057 y 271 6275
Fax: (537) 273 3509
Web page: www.cim.sld.cu;
MONOGRAPHY CIMAvax EGF:
INDICE
1.1 RISK FACTORS 4
1.2 CELLULAR CLASSIFICATION OF LUNG CANCER 5
1.3 STAGING 6
1.4 TREATMENT OPTION OVERVIEW 6
SECTION 2. INTRODUCTION OF EGF/ EGFR SYSTEM AND CANCER. 7
SECTION 3. CIMAVAX EGF9
3.1 OUR THERAPEUTHICAL APPROACH: AN EGF BASED VACCINE. HOW IT ACTS? 9
3.2 PRODUCT DESCRIPTION. WHAT IS THE COMPOSITION OF CIMAVAX EGF?9
3.3 PHARMACEUTICAL COMPOSITION OF CIMAVAX EGF 10
SECTION 4. CLINICAL DATA 10
4.1 THERAPEUTHICAL INDICATIONS 10
4.2 POSOLOGY AND ADMINISTRATION FORM . 10
4.3 CONTRAINDICATIONS 12
4.4 SPECIAL ADVICES AND PRECAUTIONS FOR USE 12
4.5 INTERACTIONS WITH OTHER DRUGS 12
4.6 PREGNANCY AND BREASTFEEDING 12
4.7 EFFECTS ON DRIVING OR MACHINE CONDUCTION CAPACITY 12
4.8 SAFETY PROFILE 12
4.9 POST MARKETING EXPERIENCE 14
SECTION 5. PHARMACOLOGY PROPERTIES 14
5.1 PHARMACODINAMIC PROPERTY 14
5.2 MECANISM OF ACTION 15
5.3 INMUNOGENICITY 15
5.4 PHARMACOKINETIC PROPERTIES 15
5.5 NON CLINICAL SAFETY DATA 15
2
5.6 CLINICAL RESULTS: 16
SECTION 6. PHARMACEUTICAL DATA31
6.1 INCOMPATIBILITY 31
6.2 PERIOD OF GUARANTY 31
6.3 SPECIAL PRECAUTIONS FOR STORAGE 31
6.4 SPECIAL PRECAUTIONS 31
6.5 INSTRUCTION FOR USE 31
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