LUPIN LIMITED SAFETY DATA SHEET Sectin 1: Identificatin Sectin 1, Identificatin Material Manufacturer Distributr Nrgestimate and Ethinyl Estradil Tablets USP 0.25 mg and 0.035 mg Lupin Limited Pithampur (M.P.) - 454 775 India Lupin Pharmaceuticals, Inc. 111 Suth Calvert Street, Harbrplace Twer, 21st Flr, Baltimre, Maryland 21202 United States Tel. 001-410-576-2000 Fax. 001-410-576-2221 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
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 35189-28-7 Ethinyl Estradil USP 57-63-6 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
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
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 68180-840-11) cntaining 28 tablets packed in a puch (NDC 68180-840-11). Such three puches are packaged in a cartn (NDC 68180-840-13). 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 0.035 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
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