Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clopidogrel (clopidogrel bisulfate)
Apotex Inc.
B01AC04
clopidogrel (clopidogrel bisulfate)
75mg
tablets
(30/3x10/) in blister
Prescription
Registered
2018-05-07
210 mm 35 mm 280 mm 420 mm NOTE: Pharmacode is vendor-specific information and may vary. Page 1 of 2 New Material Code: SAP Ref #: N/A 419951 136437 Clopidogrel Film Coated Tablets Insert Canada N/A ECL Common Text#: Description: 2 C of A: 414960 Old Material Code: Minimum Font Size: Pantone Colours: Dimensions/Dieline#: Version No: Change Control #: 963164 PKGP-CA-INSERT Flat: 420 mm x 280 mm (16,54” x 11,02”) Folded: 210 mm x 35 mm (8,27” x 1,38”) BLACK DIELINE 9 PT SIDE EFFECTS AND WHAT TO DO ABOUT THEM Side effects may include: • joint pain and/or muscle pain • abdominal pain, diarrhea, indigestion (heartburn) • nausea, vomiting, constipation, loss of taste, taste disturbance • dizziness, headache • tingling sensation in the arms and/or legs • rash, itching • bruising • enlargement of breast tissue in men If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. For minor cuts and injuries, e.g. cutting yourself shaving, this is of no concern. However, if you are in any doubt at all, you should contact your doctor immediately. IF ANY OF THESE AFFECTS YOU SEVERELY, TELL YOUR DOCTOR OR PHARMACIST. SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom / effect Talk with your healthcare professional Stop taking drug and seek immediate medical help Only if severe In all cases Common Nose bleeds ü BLEEDING DISORDERS: blood in the stool, urine or eye, vomiting blood, coughing up blood, purple spotted rash ü ALLERGIC REACTION: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing ü Uncommon Fever, signs of infection, extreme tiredness ü LIVER DISORDER: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite ü BLEEDING IN THE BRAIN: sudden, severe headache, weakness, loss of speech or vision, confusion, nausea, vomiting, seizures, loss of consciousness ü Very rare EOSINOPHILIC PNEUMONIA: cough, fever, difficulty breathing, and sweating at night ü KOUNIS Прочитать полный документ
APPENDIX 1.9 THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC) _ _ Page 1 of 23 1. NAME OF THE MEDICINAL PRODUCT Apo-Clopidogrel (Clopidogrel Bisulfate Tablets USP 75 mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION *98.0mg of Clopidogrel Bisulfate USP is equivalent to 75.0 mg of Clopidogrel. ** Evaporates during manufacturing process and does not contribute to the final weight of the tablet 3. PHARMACEUTICAL FORM Tablets COMPONENT AND QUALITY STANDARD (AND GRADE, IF APPLICABLE) FUNCTION OF COMPONENT 75 MG % W/W QUANTITY (MG/TABLET) CORE Clopidogrel Bisulfate USP* Active 53.38 98.0 Anhydrous Lactose NF Filler 26.58 48.8 Methyl Cellulose USP 15 CPS Tablet Binder 9.26 17.0 Crospovidone NF Disintegrant 6.54 12.00 Colloidal Silicon Dioxide NF Glidant 0.22 0.400 Zinc Stearate USP Lubricant 2.07 3.80 TOTAL CORE 98.05 180.0 COATING Hydroxypropyl Cellulose NF (LF) Film-forming polymer 0.65 1.20 Hydroxypropyl Methyl Cellulose 2910 USP E5 Film-forming polymer 0.22 0.40 Polyethylene Glycol 8000 NF Plasticizer 0.44 0.80 Titanium Dioxide USP Pigment/Opaquant 0.64 1.17 Red Ferric Oxide NF- Orange Shade #34690 Tablet Pigment 0.02 0.03 Purified water USP** Solvent/suspension medium - - TOTAL COATING - 40.0 TOTAL COATING (EXCLUDING WATER) - 3.60 TOTAL (FILM COTED TABLET) 100.0 183.60 APPENDIX 1.9 THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC) _ _ Page 2 of 23 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MI, STROKE OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE APO-CLOPIDOGREL (Clopidogrel bisulfate) is indicated for the secondary prevention of atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with atherosclerosis documented by stroke, myocardial infarction, or established peripheral arterial disease. ACUTE CORONARY SYNDROME APO-CLOPIDOGREL (Clopidogrel bisulfate), in combination with acetylsalicylic acid (ASA), is indicated for the early and long-term secondary prevention of atherothrombotic events (myocardial infarction, ischemic stroke, cardiovascular death and/or refractory ischemia) i Прочитать полный документ