FTPF/AFP(EN)/01/UV/E/06/09
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`LAVOISIER SODIUM CHLORIDE 0,9 %, injectable solution
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`line. Regulate the perfusion flow rate.
`Place the adequate intravenous line after initial puncture of the trocar, purge the intravenous
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`To reconstitute powders, a double-needle transfer set must be used.
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`For drug addition, inject into the syringe through the site of injection.
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`Puncture the trocar access.
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`Remove the pouch from the overwrap, inspect for limpidity and physical integrity of container.
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`Instructions for use, Drug handling instruction
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`- Polypropylene ampoules: 5ml, 10 ml, 20 ml
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`- Polyéthylene bottles of 100ml, 250ml, 500 ml, 1000 ml
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`or 50 units pack.
`available in 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml or 2000 ml overwrap; 1, 4, 5, 6, 10, 20, 30
`- Vinyl polychloride plasticized bags closed with a makrolon stopper (polycarbonate of bisphenol A),
`- 2 ml, 5 ml, 10 ml or 20 ml ampoule, colorless glass (type I); 10, 50 or 100 units pack.
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`- 125 ml, 250 ml, 500 ml or 1000 ml bottles (type II glass), closed with a chlorobutyl stopper;
`Nature and contents of container
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`1, 6, 12 or 24 units pack.
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`- Ampoules (glass and polypropylene) and (glass and polyethylene) bottles: no special storage
`Special precautions for storage
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`- Bag (PVC): to be stored at controlled temperature not exceeding 25°C (77° F)
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`precautions required
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`- Bag (PVC): 27 months
`- Bottles (Polyethylene) and ampoules (polypropylene): 3 years
`- Ampoules and bottles (glass): 5 years
`Shelf life
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`- Prior to any drug admixture, check whether its pH space efficacy matches that of sodium
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`Inspect for possible discoloration and/or formation of precipitate, insoluble complex or crystals.
`Incompatibilities
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`- When a drug is added to this solution, admixture should be dispensed instantly.
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`chloride 0.9% solution.
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`Parenteral solution to rebalance ions blood flow. The properties are those of sodium and chloride ions.
`(B: hematopoietic stem cells blood and lymphoid organs).
`ISOTONIC SODIUM SUPPLEMENTATION
`CLINICAL PHARMACOLOGY
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`PHARMACEUTICAL DATA
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`LAVOISIER SODIUM CHLORIDE 0.9 %, injectable solution
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`QUALITATIVE AND QUANTITATIVE COMPOSITION
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`-
`- Verify physical integrity of container
`For ampoules:
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`Inspect for limpidity of the solution
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`
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`- Cleanse stopper.
`-
`- Verify physical integrity of container and its closures
`For bottles:
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`Inspect for limpidity of the solution
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`WARNINGS
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`
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`- oedemato-ascitic syndrome in cirrhotics.
`- Cardiac insufficiency
`All the states of sodium retention and particularly:
`CONTRA-INDICATIONS
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`1 g of sodium chloride corresponds to 17 mmol of sodium ion.
`24 hours.
`As suggested indication for adults, depending on patient’s weight and state: from 500 ml to 3000 ml by
`Injectable route.
`POSOLOGY AND ADMINISTRATION
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`
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`- Hypovolemia.
`- Vehicle for therapeutic supplementation.
`- Extracellular dehydration.
`- Rebalance of ions with sodium and chloride supplements.
`THERAPEUTIC INDICATIONS
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`Injectable solution
`PHARMACEUTICAL FORM
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`pH ranging from 4.5 to 7
`Osmolarity: ................................308 mOsm/l
`Chlorides:......................... 15.4 mmol/100 ml
`Sodium: ............................15.4 mmol/100 ml
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`Water for injectable preparations …...................................................…s.q.......100 ml
`SODIUM CHLORIDE........................................................................................... 0.9 g
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`in each 100 ml of injectable solution
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`
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`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1001 – Page 1
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`

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` FTPF/AFP(EN)/01/UV/E/06/09
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`LAVOISIER SODIUM CHLORIDE 0,9 %, injectable solution
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`Tel : +33 1 55 37 83 83 E-mail : contact@lavoisier.com Fax : +33 1 55 37 83 84
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`Laboratoires Chaix et Du Marais - 7, rue Labie - 75017 PARIS - FRANCE
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`CDM LAVOISIER
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`June 2009
`DATE OF REVISION
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`
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`Not applicable.
`HOW SUPPLIED
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`MA 553 510-2: 1000 ml - 6 units pack - Approved for Institutions
`MA 553 511-9: 500 ml - 12 units pack - Approved for Institutions
`MA 553 512-5: 250 ml - 12 units pack - Approved for Institutions
`MA 553 513-1: 125 ml - 24 units pack - Approved for Institutions
`MA 555 798-3: 100 ml in bottle of 125 ml – 24 units pack - Approved for Institutions
`MA 555 797-7: 50 ml in bottle of 125 ml – 24 units pack - Approved for Institutions
`Bottle (glass)
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`MA 565 346-8: 20 ml - 50 units pack - Approved for Institutions
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`MA 562 853-6: 1000 ml - 10 units pack
`MA 562 851-3: 500 ml - 20 units pack
`MA 572 089-7: 250 ml - 20 units pack
`MA 562 849-9: 100 ml - 50 units pack
`MA 562 848-2: 50 ml - 50 units pack
`Overwrap Bag (PVC)
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`
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`MA 390 778-1: 1000 ml – 10 units pack - Approved for Institutions
`MA 390 776-9: 500 ml – 10 units pack - Approved for Institutions
`MA 390 774-6: 250 ml – 10 units pack - Approved for Institutions
`MA 390 771-7: 100 ml – 10 units pack - Approved for Institutions
`Bottle (Polyethylene)
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`
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`MA 395 236 2 : 20 ml ampoule (polypropylene) – 50 units pack
`MA 575 420 6 : 10 ml ampoule (polypropylene) – 100 units pack
`MA 575 456 0 : 5 ml ampoule (polypropylene) – 100 units pack
`Ampoules (Polypropylène)
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`
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`MA 565 345-1: 10 ml - 100 units pack - Approved for Institutions
`MA 565 344-5: 5 ml - 100 units pack - Approved for Institutions
`MA 363 404-7: 2 ml - 10 units pack - Approved for Institutions
`Ampoule (glass)
`Hospital Packaging:
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`
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`MA 395 235 6 : 20 ml ampoule (polypropylene) – 10 units pack
`MA 395 233 3 : 10 ml ampoule (polypropylene) – 10 units pack
`MA 395 340 4 : 5 ml ampoule (polypropylene) – 10 units pack
`Ampoules (Polypropylène)
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`MA 390 777-5: 1000 ml – 1 unit pack
`MA 390 775-2: 500 ml – 1 unit pack
`MA 390 772-3: 250 ml – 1 unit pack
`MA 390 770-0: 100 ml – 1 unit pack
`Bottles (Polyethylene)
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`Public Price including VAT: 3.61 €
`1000 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
`Public Price including VAT: 2.86 € - Approved for Institutions
`
` - Approved for Institutions
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`MA 354 717-6:
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`MA 354 712-4: 500 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
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`Public Price including VAT: 2.49 € - Approved for Institutions
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`MA 354 708-7: 250 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
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`Public Price including VAT: 2.43 € - Approved for Institutions
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`
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`MA 354 705-8: 100 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
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`MA 354 702-9: 50 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
`Overwrap Bag (PVC)
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`Public Price including VAT: 2.19 € - Approved for Institutions
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`
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`Public Price including VAT: 3.61 €
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`MA 305 783-9: 1000 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
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`MA 305 784-5: 125 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
`Bottle (glass)
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`Public Price including VAT: 2.46 €
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`MA 363 408-2: 20 ml - 10 units pack - Approved for Institutions
`MA 363 407-6: 10 ml - 10 units pack - Approved for Institutions
`MA 363 405-3: 5 ml - 10 units pack - Approved for Institutions
`MA 363 404-7: 2 ml - 10 units pack - Approved for Institutions
`Ampoule (glass)
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`PACKAGING AND PRODUCT LICENSE NUMBER
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`Pharmacy Packaging:
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`MA 305 789-7: 250 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
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`Public Price including VAT: 2.51 €
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`
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`MA 305 794-0: 500 ml - 1 unit pack - Reimbursed by French Health Care Security 65 % -
`
`Public Price including VAT: 2.86 €
`
`
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1001 – Page 2
`
`