LUPIN LIMITED SAFETY DATA SHEET

Transcription

1 LUPIN LIMITED SAFETY DATA SHEET Sectin 1: Identificatin Sectin 1, Identificatin Material Manufacturer Distributr Nrgestimate and Ethinyl Estradil Tablets USP 0.25 mg and mg Lupin Limited Pithampur (M.P.) India Lupin Pharmaceuticals, Inc. 111 Suth Calvert Street, Harbrplace Twer, 21st Flr, Baltimre, Maryland United States Tel Fax Sectin 2, Hazard(s) identificatin Sectin 2: Hazard(s) Identificatin Health D nt prescribe nrgestimate and ethinyl estradil tablets t wmen wh are knwn t have the fllwing cnditins: A high risk f arterial r venus thrmbtic diseases. Examples include wmen wh are knwn t: Smke, if ver age 35 Have deep vein thrmbsis r pulmnary emblism, nw r in the past Have inherited r acquired hypercagulpathies Have cerebrvascular disease Have crnary artery disease Have thrmbgenic valvular r thrmbgenic rhythm diseases f the heart (fr example, subacute bacterial endcarditis with valvular disease, r atrial fibrillatin) Have uncntrlled hypertensin Have diabetes mellitus with vascular disease Have headaches with fcal neurlgical symptms r migraine headaches with aura Wmen ver age 35 with any migraine headaches Liver tumrs, benign r malignant, r liver disease Undiagnsed abnrmal uterine bleeding Pregnancy, because there is n reasn t use COCs during pregnancy Breast cancer r ther estrgen- r prgestin-sensitive cancer, nw r in the past MSDS : 146/00 Page 1 f 5

2 Envirnment N infrmatin is available abut the ptential f this prduct t prduce adverse envirnmental effects. Sectin 3: Cmpsitin/Infrmatin n Ingredients Sectin 3, Cmpsitin/infrmatin n ingredients Ingredients CAS Nrgestimate USP Ethinyl Estradil USP Sectin 4, First-aid measures Sectin 4: First-Aid Measures Ingestin Inhalatin Skin Cntact Eye Cntact If cnscius, give water t drink and induce vmiting. D nt attempt t give any slid r liquid by muth if the expsed subject is uncnscius r semicnscius. Wash ut the muth with water. Obtain medical attentin. Mve individual t fresh air. Obtain medical attentin if breathing difficulty ccurs. If nt breathing, prvide artificial respiratin assistance. Remve cntaminated clthing and flush expsed area with large amunts f water. Wash all expsed areas f skin with plenty f sap and water. Obtain medical attentin if skin reactin ccurs. Flush eyes with plenty f water. Get medical attentin. NOTES TO HEALTH PROFESSIONALS Medical Treatment OVERDOSAGE Treat accrding t lcally accepted prtcls. Fr additinal guidance, refer t the current prescribing infrmatin r t the lcal pisn cntrl infrmatin center. Prtect the patient s airway and supprt ventilatin and perfusin. Meticulusly mnitr and maintain, within acceptable limits, the patient s vital signs, bld gases, serum electrlytes, etc. There have been n reprts f serius ill effects frm verdsage f ral cntraceptives, including ingestin by children. Overdsage may cause withdrawal bleeding in females and nausea. Sectin 5, Fire-fighting measures Sectin 5: Fire-Fighting Measures Fire and Explsin Hazards Extinguishing Media Special Firefighting Prcedures Assume that this prduct is capable f sustaining cmbustin. Water spray, carbn dixide, dry chemical pwder r apprpriate fam. Fr single units (packages): N special requirements needed. MSDS : 146/00 Page 2 f 5

3 Fr larger amunts (multiple packages/pallets) f prduct: Since txic, crrsive r flammable vaprs might be evlved frm fires invlving this prduct and assciated packaging, self-cntained breathing apparatus and full prtective equipment are recmmended fr firefighters. Hazardus Cmbustin Prducts Hazardus cmbustin r decmpsitin prducts are expected when the prduct is expsed t fire. Sectin 6, Accidental release measures Sectin 6: Accidental Release Measures Persnal Precautins Envirnmental Precautins Clean-up Methds Keep unnecessary persnnel away. Keep peple away frm and upwind f spill/leak. Wear apprpriate prtective equipment and clthing during clean-up. Avid release t the envirnment. Prevent further leakage r spillage if safe t d s. Avid discharge int drains, water curses r nt the grund. Infrm apprpriate managerial r supervisry persnnel f all envirnmental releases. Cllect and place it in a suitable, prperly labeled cntainer fr recvery r dispsal. Sectin 7, Handling and strage Sectin 7: Handling and Strage Handling N special cntrl measures required fr the nrmal handling f this prduct. Nrmal rm ventilatin is expected t be adequate fr rutine handling f this prduct. Strage Stre at 25 C (77 F); excursins permitted t 15 t 30 C (59 t 86 F) [see USP Cntrlled Rm Temperature]. Prtect frm light. Sectin 8: Expsure Cntrls/Persnal Prtectin Sectin 8, Expsure cntrls/persnal prtectin Wear apprpriate clthing t avid skin cntact. Wash hands and arms thrughly after handling. MSDS : 146/00 Page 3 f 5

4 Sectin 9, Physical and chemical prperties Sectin 9: Physical and Chemical Prperties Physical Frm Nrgestimate and ethinyl estradil tablets USP are available in a wallet pack (NDC ) cntaining 28 tablets packed in a puch (NDC ). Such three puches are packaged in a cartn (NDC ). Each wallet (28 tablets) cntains in the fllwing rder: 21 blue, rund, film cated tablets, debssed with E27 n ne side and LU n the ther side f the tablet cntains 0.25 mg nrgestimate and mg ethinyl estradil 7 green, rund, bicnvex, film cated tablets (nn-hrmnal placeb) debssed with LU n ne side and E24 n the ther side cntains inert ingredients Keep ut f reach f children. Sectin 10, Stability and reactivity Stable under recmmended strage cnditins. Sectin 10: Stability and Reactivity Sectin 11, Txiclgical infrmatin Sectin 11: Txiclgical Infrmatin Carcinma f Breast and Cervix Nrgestimate and ethinyl estradil tablets are cntraindicated in wmen wh currently have r have had breast cancer because breast cancer may be hrmnally sensitive. There is substantial evidence that COCs d nt increase the incidence f breast cancer. Althugh sme past studies have suggested that COCs might increase the incidence f breast cancer, mre recent studies have nt cnfirmed such findings. Sme studies suggest that COC use has been assciated with an increase in the risk f cervical cancer r intraepithelial neplasia. Hwever, there cntinues t be cntrversy abut the extent t which such findings may be due t differences in sexual behavir and ther factrs. Sectin 12: Eclgical Infrmatin N relevant studies identified. Sectin 12: Eclgical Infrmatin MSDS : 146/00 Page 4 f 5

5 Sectin 13: Dispsal Cnsideratins Sectin 13: Dispsal Cnsideratins Incinerate in an apprved facility. Fllw all federal state and lcal envirnmental regulatins. Sectin 14: Transprt Infrmatin IATA/ICAO - Nt Regulated IATA Prper shipping Name : N/A IATA UN/ID N : N/A IATA Hazard Class : N/A IATA Packaging Grup : N/A IATA Label : N/A IMDG - Nt Regulated IMDG Prper shipping Name : N/A IMDG UN/ID N : N/A IMDG Hazard Class : N/A IMDG Flash Pint : N/A IMDG Label : N/A DOT - Nt Regulated DOT Prper shipping Name : N/A DOT UN/ID N : N/A DOT Hazard Class : N/A DOT Flash Pint : N/A DOT Packing Grup : N/A DOT Label : N/A Sectin 14: Transprt Infrmatin Sectin 15: Regulatry Infrmatin Sectin 15: Regulatry Infrmatin This Sectin Cntains Infrmatin relevant t cmpliance with ther Federal and/r state laws. Sectin 16: Other infrmatin Sectin 16: Other Infrmatin The abve infrmatin is believed t be crrect but des nt purprt t be all-inclusive and shall be used nly as a guide. Nthing herein shall be deemed t create any warranty, express r implied. It is the respnsibility f the user t determine the applicability f this infrmatin and the suitability f the material r prduct fr any particular purpse. Lupin shall nt be held liable fr any damage resulting frm handling r frm cntact with the abve prduct. Lupin reserves the right t revise this SDS. MSDS : 146/00 Page 5 f 5