Entecavir Tablets USP

Transcription

1 EMERGENCY OVERVIEW Each intended for oral administration contains Entecavir and excipients generally considered to be non- toxic and non-hazardous in small quantities and under conditions of normal occupational exposure. Section 1. Identification Identification of the product Product Name: Formula: Chemical Name: C 12 H 15 N 5 O 3 H 2 O 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4hydroxy-3- (hydroxymethyl)-2-methylenecyclopentyl]-6h-purin-6-one, monohydrate. Manufacturer / supplier identification Company: Cadila Healthcare Ltd., Matoda, India Address: Cadila Healthcare Limited, Plot No- 1A/1 & 2, Pharmez Special Economic Zone, Sarkhej- Bavla N.H. No. 8A, Near Village Matoda, Tal. Sanand, Dist. Ahmedabad , India Contact for information: Tel: Fax: Emergency Telephone No. Tel: Recommended use / Therapeutic Category Restriction on Use / Contraindications: Entecavir is a Hepatitis B virus nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

2 Section 2. Hazard(s) Identification Dose and Administration Adverse Effects Over Dose Effect Contraindications Pregnancy Comments Pregnancy Category Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). Recommended Dosage in Adults Compensated Liver Disease The recommended dose of entecavir tablets for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily. The recommended dose of entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtm204i/v with or without rtl180m, rtl80i/v, or rtv173l is 1 mg once daily. Decompensated Liver Disease The recommended dose of entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily. The following adverse reactions are discussed in other sections of the labeling: Exacerbations of hepatitis after discontinuation of treatment Lactic acidosis and severe hepatomegaly with steatosis There is limited experience of entecavir overdosage reported in patients. Healthy subjects who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had no increase in or unexpected adverse events. If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed approximately 13% of the entecavir dose None There are no adequate and well-controlled studies of entecavir in pregnant women. Because animal reproduction studies are not always predictive of human response, entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. C

3 Section 3. Composition / information on ingredients Component Exposure Limit CAS No. Principle Component: Entecavir Not Found Inactive Ingredients: Microcrystalline Cellulose 101(COMPRECEL M101D+) Not Found Lactose monohydrate Not Found Crospovidone (Type B) Not Found Isopropyl Alcohol Not Found Microcrystalline Cellulose 102 (COMPRECEL Ml02D+), Not Found Magnesium stearate Not Found Opadry White 03F Not Found Not Available Opadry Pink 03F Not Found Not Available Section 4. First -aid measures General After inhalation: Move to fresh air in case of accidental inhalation. assure fresh air breathing. After skin contact: Rinse skin with water/shower After eye contact: Rinse with water while holding the eyes wide open. Contact lenses should be removed. After swallowing: Rinse mouth out with water Information for doctor: Most important symptoms and effects, both acute and delayed- No further relevant information available. Indication of any immediate medical attention and special treatment needed- No further relevant information available. Overdose Treatment Limited data are available related to overdosage in humans. If symptomatic hypotension occurs, initiate supportive treatment.

4 Section 5. Fire -fighting measures Specific hazards arising from the chemical Extinguishing media Suitable extinguishing agents: Use extinguishing media appropriate for surrounding fire. Extinguishing blanket. Carbon dioxide. Dry powder Special hazards arising from the substance or mixture Stable under normal conditions. Advice for firefighters Small amounts: Use normal individual fire protective equipment. Large amounts: Not Protective equipment: Hand protection : Gloves Skin and body protection : Lab coat Respiratory protection : Quarter mask (DIN EN 140) No additional information available Special protective equipment and precautions for firefighters General fire hazards Use normal individual fire protective equipment No unusual fire or explosion hazards noted Section 6. Accidental Release Measures Personal precautions, protective Avoid raising dust. Wear suitable protective clothing, gloves equipment and emergency and eye or face protection. procedures Environmental precautions: No additional information available Methods and material for containment and cleaning up: Section 7. Handling and Storage Storage: Sweep spilled substance into containers; if appropriate, moisten first to prevent dusting. Ensure waste is collected and contained. Clean thoroughly. Poorly soluble in water. Clean with the help of detergents. Entecavir tablets should be stored in a tightly closed container at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Protect from light. Precautions for safe handling: Keep it dry & in a cool, well ventilated place away from heat. Store in original container Information about fire - and explosion protection: No special measures required.

5 Section 8. Exposure controls / personal protection Respiratory Protection Quarter mask (DIN EN 140) Skin protection Eye/face protection Protective Clothing Biological limit values Exposure guidelines Thermal hazards General hygiene considerations Engineering controls For prolonged or repeated skin contact use suitable protective gloves. If contact is likely, safety glasses with side shields are recommended. Protective clothing is not normally necessary, however it is good practice to use apron. No biological exposure limits noted for the ingredient(s). General ventilation normally adequate. Wear appropriate thermal protective clothing, when necessary. Keep away from foodstuffs, beverages and feed. Wash hands before breaks and at the end of work. Routinely wash work clothing and protective equipment to remove contaminants. For advice on suitable monitoring methods, seek guidance from a qualified environment, health and safety professional. Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section.

6 Section 9. Physical and chemical properties Appearance Description of 0.5 mg: White to off white, round Shaped, biconvex with beveled edge, Film coated tablets, debossed with 920 on one side and Plain on the other Side Description of 1.0 mg: Light Pink to Pink, round shaped, biconvex with beveled edge, film coated tablets, debossed with 921 on one side and plain on the other side. Solubility Odour. Boiling point. Melting Point. Evaporation rate. Vapour density. Reactivity in water. Vapour pressure. % Volatile by volume. Specific gravity. Section 10. Stability and Reactivity Conditions to avoid Stable Contact with incompatible materials. Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport. Chemical stability Hazardous reactions Decomposition products Incompatible materials Material is stable under normal conditions. No dangerous reaction known under conditions of normal use. When heated to decomposition, emits dangerous fumes. Strong Oxidizing agent

7 Section 11. Toxicological information General Ingestion Other Symptoms related to the physical, chemical and Toxicological characteristics Handling of formulated product is not expected to cause any toxicological affects. The data pertains to the ingredient in formulations, rather than this specie formulation. Health injuries are not known or expected under normal use. Expected to be a low ingestion hazard. However, ingestion is not likely to be a primary route of occupational exposure. Not Available Information on toxicological effects Acute toxicity Further information Section 12. Ecological information Poorly soluble in water. No data available on ecotoxicity. Section 13. Disposal Consideration Dispose the waste in accordance with all applicable Federal, State and local laws. Section 14. Transport Information The product is not hazardous when shipping via air (IATA), ground (DOT), or sea (IMDG). In accordance with ADR / RID / IMDG / IATA / ADN Section 15. Regulatory Information Generic Medicine. Under Approval by USFDA & the ANDA Number is Section 16. Other information None Date of issue: 28/06/17 Supersedes edition: New Edition The information contained herein is based on the state of our knowledge. It characterizes the product with regard to the appropriate safety precautions. It does not represent a guarantee of the properties of the product.