0
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`L· CYSTEIN E HYDROCHL X + v
`8 https:/ jweb.archive.org{web/20170403170533/http:/drugsdb.eu/drug.php?d = L ·cystein, lCllJ *
`lhttp:/ldrugscfb.eu/drug.php?d=l-cysteine%20H)'drochloride&m=Sandoz%20lnc&id=083366d6-0437-4ee0-90d4-440s5b5d03b5.x I~
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`ou are here: Home > Prescn t1on RX Dru s > l > l -c ste1ne H drochlonde Sandoz Inc
`
`l oadm
`
`Name: L-cysteine Hydrochloride
`
`Manufacturer: Sandoz Inc
`
`Category: Prescription Markeled Drugs
`
`Prescript ion Marketed Dr ugs A lphabetically
`Al Bl Ci DI El f l GI HI II JI Kl LI Ml NI 01 Pl 01 RI
`SI Tl UI VI WI XI YI ZI 0-9
`
`Cate11ories:
`Prescription(RX) Drugs
`
`Over-the-counter (OTC) Drugs
`
`Homeopathic Drugs
`
`Animal Drugs
`
`Feedback
`
`L-CYSTEINE HYDROCHLORIDE - cysteine
`hydrochloride injection, solution
`Sandoz Inc
`Disclaimer: This drug has not been found by FDA to be safe and
`ettectiVe, and tnis labeling has not been approved by FDA. For
`further information about unapproved drugs, click here.
`
`L-Cysteine
`Hydrochloride Injection, USP
`0.5 g/10 ml (50 mg/ml )
`
`PHARMACY BULK PACKAGE
`NOT FOR DIRECT INFUSION
`
`DESCRIPTION
`l -Cysteine Hydrochloride Injection, USP, 50 mg/ml, is a sterile, nonpyrogenic solution. Each ml
`ontains: 50 mg of l -Cysteine Hydrochloride Monohydrate USP; Water for Injection, USP q.s.; Air
`replaced With Nitrogen. pH 1.0-2.5
`l -Cysteine is a sulfur-containing amino acid. In premixed solutions of crystalline amino acids, cysteine
`is relatively unstable over time, eventually converting to insoluble cystine. To avoid such preciprtation,
`l -Cysteine Hydrochloride Injection USP is intended to be used as an addrtive with crystalline Amino
`cid Injections immediately prior to administration to the patient.
`he structural formula of Cysteine Hydrochloride Monohydrate USP is:
`H
`I
`HSCH2 - C - C00H•HCl•H20
`I
`NH2
`
`Molecular Weight Molecular Formula
`175.63
`C3H7N0;?S•HCl•H20
`
`
`
`Eton Ex. 1005
`1 of 11
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`

`

`L-CYSTEINE HYDROCHL X + v
`8 https://web.archive.org/web/20170403170533/http:/drugsdb.eu/drug.php?d ;L -cystein, 1W1 *
`(cid:141)
`
`0
`
`lht1p:1/drugsdb.eu/drug.php?d=L•cysleine%20Hydrochloride&m: Ssndo-z'%201no&id: Q&3300dfl.0437-4ee0-90d4•440a5b5d03b5.xl ~ AUG
`
`2 captures
`24 "'41 2018 • 3 A{' 2017
`
`I L
`
`LINICAL PHARMACOLOGY
`L-Cysteine is synthesized from methionine via the trans-sulfuration pathway in the adult, but newborn
`infants lack the enzyme necessary to effect this conversion. Therefore. L-Cysteine is generally
`onsidered to be an essential amino acid in infants.
`
`L-Cysteine Hydrochloride Injection, USP is intended for use only after dilution as an additive to
`rystalline Amino Acid Injections to meet the intravenous amino acid nutritional requirements of infants
`receiving total parenteral nutrition.
`
`ONTRAINDICA TIO NS
`his preparation should not be used in patients with hepatic coma or metabolic disorders involving
`impaired nitrogen utilization.
`
`Peripheral intravenous infusion of amino acids may induce a rise in blood urea nitrogen {BUN)
`specially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be
`performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and
`ontinue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased
`protein intake.
`dministration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino
`cid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
`dminbtration of amino acid solutions in the presence of impaired renal function may augment an
`increasing BUN, as does any protein dietary component.
`IUtions containing sodium ion should be used with great care. if at all, in patients with congestive
`heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium
`retention.
`lutions which contain potassium ion should be used with great care, if at all, in patients with
`hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
`IUtions containing acetate ion should be used with great care in patients with metabolic or
`respiratory alkalosis. Acetate should be administered with great care in those conditions in which there
`is an increased level or an impaired utilization of this ion such as severe hepatic insufficiency.
`Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore
`it is essential that blood ammonia levels be measured frequently in infants.
`Instances of asymptomatic hyperammonemia have been reported in patients without overt liver
`ysfunction. The mechanisms of this reaction are not clearty defined but may involve genetic defects
`nd immature or subclinically impaired liver function.
`Frequent Clinical Evaluation and Laboratory Determinations are Necessary for Proper
`Monitoring During Administration. Blood studies should include glucose, urea nitrogen, serum
`lectrolytes, ammonia, cholesterol, acid-base balance, serum proteins, kidney and liver function tests,
`smolarity and hemogram. White blood count and blood cultures are to be determined if indicated.
`Urinary osmolarity and glucose should be determined frequently.
`le use during pregnancy has not been established, therefore, infusion of amino acids should be
`undertaken during pregnancy only when this is deemed essential to the patients' welfare, as judged by
`e physician.
`ARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with
`rolonged parenteral administration if kidney function is impaired. Premature neonates are particularly
`t risk because their kidneys are immature, and tney require large amounts of calcium and phosphate
`solutions, which contain aluminum.
`Research indicates that patients with impaired kidney tunction, including premature neonates, who
`receive parenteral levels of aluminum at greater than 4 to 5 mcglkg/day accumulate aluminum at levels
`ssociated witn central neNous system and bone toxicity. Tissue loading may occur at even lower
`ates of administration
`
`(cid:143)
`
`X
`
`MAY
`
`(cid:141) 2018
`
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`Eton Ex. 1005
`2 of 11
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`

`

`MAY
`
`'t=
`(cid:141)
`
`2018
`
`0
`
`L-CYSTEIN E HYDROCHL X + v
`8 https:/ fweb.archive .orgjweb/20170403170533/htlp:/drugsdb.eu/drug.php?d ;L -cystein, 1W1 *
`lhttp:/.ldrugsdb.eu/drug.php?d:L•cysleine%20Hydrochloride&m=Ssndoz%201nc&id"'0833tltld~0437 •4ee0-90d4•440a5-b5d03b5.x I ~ AUG
`(cid:141)
`I [
`2 c.apt(cid:127) res
`24~2t18,3Afx2017
`
`PRECAUTIONS
`Special care must be taken when administering hypertonic glucose to prO\i de calories in diabetic or
`prediabetic patients.
`Because of its antianabolic activity, concurrent administration of tetracycline may reduce the nitrogen
`paring effects of infused amino acids.
`Do not withdraw vEnous blood for lllood chemistries through the peripheral infusion site, as
`interference with estimations of nitrogen containing substances may occur.
`Intravenous feeding regimens which include amino acids should Ile used With caution in patients with a
`l1i:slu1y ur 1e r1a l tJi:S~d:Se, µullllUl ldlY tH~a~. UI will l Ll:::lllliac i11:surrit:iern,.;y SJ d:S lu dVUill exce:s:sive nuitJ
`ccumulation.
`he effect of infusion of amino acids. without dextrose. upon carbohydrate metabolism of children is
`not known at this l ime.
`Nitrogen intake should Ile carefully monitored in patients with impaired renal function. For long-term
`otal nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous
`lories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of
`uch calories. Such strongly hypertonic nutrient solutions should be administered through an
`indwelling intravenous catheter with the lip located in the superior vena cava.
`
`DVERSE REACTIONS
`Local reactions consisting of a warm sensation, erythema, phlellttis and thromllosis al the infusion site
`have occurred with peripheral intravenous infusion of amino acids, particu0 rly if the other substances,
`uch as antilliotics. are also administered through the same site. In such cases the infusion site should
`Ile changed promptly to another vein. Use of large peripheral veins, inline niters, and slowing the rate
`f infusion may reduce the incidence of local venous irritation. Electrolyte additives snould Ile spread
`rough out the day. Irritating additive medications may need to be injected at another venous site.
`GeneraliZed fiushing, fever and nausea also nave Ileen reported during peripheral infusions of amino
`cid solutions.
`
`Drug Abuse and Depende nce
`None known.
`
`DOSAGE AND ADMINISTRATION
`L-Cysteine Hydrochloride lnJection USP is intended for use only after dilutbn in Crystalline Amino Acid
`Injection. Each 0 .5 gram of L-Cysteine Hydrochloride Monohydrate should Ile combined aseptically
`ith 12.5 grams of Crystalline Amino Acid Injection, such as that present in 250 ml of 5% Crystalline
`mino Acid lnjecticn. The admixture is then diluted with 250 ml of dextrose 50% or such lesser
`olume as indicated. Equal volumes of 5% Crystalline Amino Acid Injection and dextrose 50% produce
`final solution which contains Crystalline Amino Acid Injection 2.5% in dextrose 25%, which is suttable
`or administraliOn t y central venous infusion. Administration of the final admixture should begin within
`ne hour of mixing. Otherwise, the admixture should be refrigerated immediately and used within 24
`nours of the lime o' mixing. For the recommended rate of administration, see the Crystalline Amino
`cid Injection pack3ge insert.
`Parenteral drug products should be inspected visually for particulate maltH and discoloration prior to
`dministration, whenever solution and container permit.
`
`DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE
`he pharmacy llulk package is for use in a Pharmacy Admixture Service only.
`use or mis proauct 1s resmctea to a suKao1e won< area, sucn as a 1am1nar now nooa. Pnor to entenng
`e vial, remove the m~off seal and cleanse the rullber closure with a suttable antiseptic agent.
`he container closure may be penetrated only one time, utilizing a suitallle sterile transfer device or
`ispensing set which allows measured distribution of the contents. The da:e and time the vial was
`initially opened should be recorded in the space provided on the label. Transfer individual doses(s) to
`ppropriate intravenous infusion soluliOns. Use of a syringe with needle is not recommended. Multiple
`ntries increase the potential of microbial and particulate contamination.
`
`D
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`Eton Ex. 1005
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`(cid:157)
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`L· CYSTEINE HYDROCHL X + v
`cl https:j {Web.archive.o rg/web/20170403170533/http:/drugsdb.eu/drug.php?d =L ·cystein, W *
`(cid:141) , 2016
`
`lhtlpJ/drugsdb.eu/df\Jg.php?d=L-cys!e:ine%20Hydrochloride&m=Ssndoz%201nc&id=083366d6-0437-4ee0-90d4-440a5b5d03b5.x l ~ A UG
`
`2 captures
`2t~201fl•3Afx2017
`ntries i ncrease fne pofenlfal of microblal and particulate contam1nat1on.
`ne witndrawal of container contents snould be accomplisned witnout delay using aseptic tecnnique.
`However, snould tnis not be possible, a maximum time of 4 nours from initial closure entry is permitted
`o complete fluid transfer operations.
`
`RECOMMENDED STORAGE CONDITlONS AFTER OPENING
`Keep under laminar now nooo at room temperature. Any unused portion of tne vial must be discarded
`itnin 4 nours aner initial entry.
`
`HOW SUPPLIED
`l -Cysteine Hydrocnloride lnjectiOn, USP (50 mg/ml ) is supplied as follows:
`
`PHARMACY BULK
`PACKAGE
`
`olume
`10 ml
`10 X 10 m
`tore at controlled room temperature 15• -30°C (59° -86°F) Do not freeze.
`For Sandoz Inc. Customer Service, call Hl00-525-8747
`Rx only
`Manufactured for:
`SANDOZ
`Princeton, NJ 08540
`Revised: November 2009
`l -028-00
`
`NDC 66758-005-01
`
`Package Label - Principal Display Panel - 50 ml Vial
`SANDOZ
`Rx only
`L-Cysteine
`Hydrocnloride Injection, USP
`PHARMACY BULK PACKAGE
`NOT FOR DIRECT INFUSION
`O mg/ml
`For IV Use Only After Dilution
`o Not Dispense As A Unit
`50ml
`l -018-00
`PHARMACY BULK PACKAGE
`
`(cid:143)
`
`X
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`rL
`
`MAY
`
`(cid:141) 2018
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`
`
`Eton Ex. 1005
`4 of 11
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`

`0
`
`L-CYSTEIN E HYDROCH L X + v
`8 https://web.archive.org/web/20170403170533/hllp:/drugsdb.eu/drug.php?d = L -cystein, llllJ *
`jhttp:J/drugsdb.euldrug.php?d=l-cystein:e%20Hydrochloride&m=Sandoz%201no&id=OS3366dl3-0437-4ee0-90d4-440a5b5d03b5.x I 1~ AUG
`(cid:141)
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`... ,,
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`,& SANDOZ
`iikSiAii.w2illil
`
`f'tlU.~ IUlK ,ACKM'..E
`Wlt ffll 1\11.1-n INtt I~
`50 mg/ml
`r« IV UN Qlty Attn Dil\llion
`0.NotO"P-NAU.lf
`SOn1L
`t...,,e-u,
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`Wut'l-.g. tu IV "te ont,,· ~ t IN- d if11t,c,d ltd"•"' t,,,c.
`C011ffl3 lh,uld be ~tpem,ed p,ompl~ •ftt'f' lnltW donre
`Ste.• .. , t;Orll,.J.l.d ...om ,_,-n __
`p111d1,1rc. UliM'.,d YfflilMd c""tenU .d'kr -4 ltGun.
`
`15'..JO'C (s!"-16°1'). Do nol frMu
`Lf>ll.111":1 no mort! thUI :,,.JUO -,'ICS,l 0 1.alu t'IWntiM,
`MiwluL-v:hlf'Nt ,'Ir" S.nvf<u lnr-.
`l'Mcolon, 'II C85-40
`b~wr--i:-.- _________ _
`
`Package Label - Principal Display Panel - 50 ml Vial Carton
`SANDOZ
`NDC 66758-005-02
`5 " 50 ml Vials
`L-Cysteine Hydrochloride
`Injection, USP
`50 mg/ml
`Pharmacy Bulk Package
`Not For Direct Infusion
`For IV Use Only Alter Dilution
`Rx only
`
`& SANDOZ
`S Ir.SO ml V'woh
`l-Cysteine Hydrochloride
`lni(."Ction, USP
`50 mg/ml
`
`NOC647$a..ocg..o,i
`
`Item Code (Source)
`DEA Schedule
`
`N'OC:66758--005
`
`Basis of Strength
`CYSTEINE HYDROCHLORIDE
`
`Strength
`50mg in 1 ml
`
`L-CYSTEINE HYDROCHLORIDE
`1-cysteine hydrochloride injection, solution
`Product Information
`Product Type
`HUMAN PRESCRl?TION DRUG
`INTRAVENOUS
`Rout e of Administration
`Active Ingredient/Active Moiety
`Ingr edient Name
`CYSTEINE HYOROCHLORJOE (CYSTEINE}
`Inactive Ingredients
`Ingr edient Name
`WATER
`Product Characteristics
`Co lo r
`Shape
`Flavo r
`Contains
`Packaging
`Package Description
`#Item Code
`1 NDC:66758-005- 5 VIAL. PHARMACY SULK PACKAGE ( VIAL) ii 1
`02
`CARTON
`1 NDC:66758-005- 50 ml in 1 VI.AL, PHARJ.tACY BULK PACKAGE
`01
`
`Score
`Size
`Imp rint Code
`
`Strength
`
`Multilevel Packaging
`contains a VIAL, PHARMA.CY BUa..K PACKAGE (66758-005-
`01)
`This package is con!Ained within the CARTON (66758-005-02}
`
`Marketing Information
`M arketing Category
`Application Number or Monograph Citation
`U~
`roved dnigother
`
`Marketing Start D ate
`1Ml112008
`
`Marketing End Date
`
`Revised: 06/201 O
`
`San doz Inc
`
`Source: http://dailymed.nlm.nih.g ov
`Reproduced with permission of U.S. National Library or Medicine
`
`opyright © 2017 Drugsdb.eu by Dionisios Fentas II Terms of Use
`
`
`
`(cid:143)
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`MAY
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`(cid:141) 2018
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`
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`Eton Ex. 1005
`5 of 11
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`

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`L-CYSTEINE HYDROCHL X l._+ __ v ____________ _ _
`8 https:f fweb.archive.orgfweb/20160824090050/hltp:/drugsdb.eu/d rug.php?d =L -cysteine%20Hydrochloride&m = 1
`
`(cid:143)
`
`X
`
`lhttp:/ldrugsdb.eu/drug.php?d=L-cysteine%20Hydroctlloride&m=Sandoz%201nc&id=083366d6-0437-4ee0-90d4--440a5b5d03b5.xl [§i] JUL
`
`(cid:141)
`
`''"''·dru~,l)lt~·u
`
`\Vith (ll'rmission of
`L.S. '.\ational Lihrar~
`of ~k11il·im·
`
`You are here: Home > Prescription(RX) Drugs > l > l-cysteine Hydrochloride (Sandoz Inc)
`
`l oading
`
`Name: L-cysteine Hydrochloride
`
`Manufacturer: Sandoz Inc
`
`Category: Prescription Marketed Drugs
`
`Prescription Marketed Drugs A lphabetica lly
`~ ~ a~ 6 ~ ~~ , A~u ~~ a ~a~
`SI Ti UI VI WI XI YI ZI 0-9
`
`Categories:
`Prescription(RX) Drugs
`
`Over-the-counter (OTC) Drugs
`
`Homeopathic Drugs
`
`Animal Drugs
`
`Feedback
`
`L-CYSTEINE HYDROCHLORIDE· cysteine
`hydrochloride injection, solution
`Sandoz Inc
`Disclaimer: This drug has not been found by FDA to be safe and
`effective, and this labeling has not been approved by FDA. For
`further information about unapproved drugs, click here.
`
`L-Cysteine
`Hydrochloride Injection, USP
`0.5 g/10 mL (50 mg/mL)
`
`PHARMACY BULK PACKAGE
`NOT FOR DIRECT INFU SION
`
`DESCRIPTION
`l-Cysteine Hydrochloride Injection, USP, 50 mg/ml , is a sterile, nonpyrogenic solution. Each ml
`contains: 50 mg of l -Cysteine Hydrochloride Monohydrate USP; Water for Injection, USP q.s.; A ir
`replaced with Nitrogen. pH 1.0-2.5
`l -Cysteine is a sulfur-containing amino acid. In premixed solutions of crystalline amino acids, cysteine
`is relatively unstable over time, eventually converting to insoluble cystine. To avoid such precipitation,
`l -Cysteine Hydrochloride Injection USP is intended to be used as an additive with crystalline Amino
`cid Injections immediately prior to administration to the patient.
`The structural formula of Cysteine Hydrochloride Monohydrate USP is:
`H
`I
`HSCH2 - C - C00H•HCl•H20
`
`
`
`
`
`Eton Ex. 1005
`6 of 11
`
`

`

`L·CYSTEINE HYDROCHL X ~I _+ __ v ____________ _
`0
`
`8 https;/ ;web.archive.org;web/20160824090050/http;tdrugsdb.eu/drug.php?d =L -cysteine%20Hydrochloride&m=!
`
`lhttp:/ldrugsdb.eu/drug.php?d=L-cysteine%20Hydrochloride&m=Sandoz%201nc&id=083366d6-0437-4ee0-90d4-440aSbSd03bS.xl [QQJ JUL
`
`(cid:141) 2015
`
`2 captures
`24.A.ug 2016 - 3Apr2017
`HSCH2 - C - C00H•HCl•H20
`I
`NH2
`
`Molecular Weight
`175.63
`
`Molecular Formula
`C3H7N02S•HCl•H20
`
`II
`
`CLINICAL PHARMACOLOGY
`L-Cysteine is synthesized from methionine via the trans-sulfurat ion pathway in the adult, but newborn
`infants lack the enzyme necessary to effect this conversion. The refore, L-Cysteine is generally
`considered to be an essential amino acid in infants
`
`INDICATIONS AND USAGE
`L-Cysteine Hydrochloride Injection, USP is intended for use only after dilution as an additive to
`Crystalline Amino Acid Injections to meet the intravenous amino acid nutritional requirements of infants
`receiving total parenteral nutrition.
`
`CONTRAINDICATIONS
`This preparation should not be used in patients with hepatic coma or metabolic disorders involving
`impaired nitrogen utilization.
`
`ARNINGS
`Peripheral intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN)
`especially in patients with impaired hepatic or renal function. App ropriate laboratory tests should be
`performed periodically and infusion discontinued if BUN levels exceed normal postprand ial limits and
`continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased
`protein intake.
`dministration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino
`acid imbalances, metabolic alkalosis, prerenal azotemia, hypera mmonemia, stupor and coma.
`dministration of amino acid solutions in the presence of impaired renal function may augment an
`increasing BUN, as does any protein d ietary component.
`Solutions containing sodium ion should be used with great care, if at all, in patients with congestive
`heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium
`retention
`Solutions which contain potassium ion should be used with great care, if at all, in patients with
`hyperkalem1a, severe renal failure and in conditions m which pot assium retention 1s present.
`Solutions containing acetate ion should be used with great care in patients with metabolic or
`respiratory alkalosis. Acetate should be administered with great care in those conditions in which the re
`is an increased level or an impaired utilization of this ion such as severe hepatic insufficiency.
`Hyperammonemia is of special significance in infants, as it can result in mental reta rdation. Therefore
`it is essential that blood ammonia levels be measured frequently in infants.
`Instances of asymptomatic hyperammonemia have been reported in patients without overt liver
`dysfunction. The mechanisms of this reaction are not clearly defined but may involve genetic defects
`and immature or subclinically impaired liver function.
`Frequent Clinical Evaluation and Laboratory Determinations are Necessary for Proper
`Monitoring During Administration. Blood studies should include glucose, urea nitrogen, serum
`.
`.
`.
`-
`' .
`.
`
`X
`
`(cid:143)
`Le
`
`(i) (i) 0
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`
`* fL
`(cid:141)
`
`APR
`
`2017
`
`
`
`Eton Ex. 1005
`7 of 11
`
`

`

`(cid:143)
`
`X
`
`® ® O
`IJ Cl
`
`L·CYSTEIN E HYDROCHL X
`
`0
`
`.. I _+ __ v _____________ _
`8 https:/ fweb.archive.orgfweb/20160824090050/htlp:/drugsdb.eu/drug.php?d = L ·cysteine%20Hydrochloride&m = ~
`
`lhttp:/ldrugsdb.eu/drug.php?d: L-cysteine%20Hydrochloride&m:Sandoz%201nc&icl=083366d6-0437-4 ee0-90d4--440a5b5d03b5.xl [QQ] JUL
`
`(cid:141) 2015
`
`2 captures
`24Alg2016-3-6¥2017
`
`e lectrolytes, ammonia, cholesterol, acid-base balance, serum proteins, kidney and liver function tests,
`osmolarity and hemogram. White blood count and blood cultures are to be determined if indicated.
`Urinary osmolarity and glucose should be determined frequently.
`Safe use during pregnancy has not been established, therefore, infusion of amino acids should be
`u ndertaken during pregnancy only when th is is deemed essential to the patients' welfare, as Judged by
`he physician.
`ARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with
`rolonged parenteral administration if kidney function is impaired. Premature neonates are particularly
`at risk because their kidneys are immature, and they require large amounts of calcium and phosphate
`solutions, which contain aluminum.
`Research indicates that patients with impaired kidney function, including premature neonates, who
`receive parenteral levels of aluminum at greater than 4 to 5 mcglkglday accumulate aluminum at levels
`associated with central nervous system and bone toxicity. Tissue loading may occur at even lower
`rates of administration
`
`PRECAUTIONS
`Special care must be taken when administering hypertonic glucose to provide calories in diabetic or
`p rediabetic patients.
`Because of its antianabolic activity, concurrent administration of tetracycline may reduce the nitrogen
`sparing effects of infused amino acids.
`Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as
`interference with estimations of nitrogen containing substances may occur.
`Intravenous feed ing regimens which include amino acids should be used with caution in patients with a
`h istory of renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid
`accumulation.
`The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is
`not known at this time.
`Nitrogen intake should be carefully monitored in patients with impaired renal function. For long-term
`otal nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous
`calories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of
`such calories. Such strongly hypertonic nutrient solutions should be administered through an
`indwelling intravenous catheter with the tip located in the superior vena cava.
`
`DVERSE REACTIONS
`Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis al the infusion site
`have occurred with peripheral intravenous infusion of amino acids, particularly if the other substances,
`such as antibiotics, are also administered through the same site. In such cases the infusion site should
`be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate
`of infusion may reduce the incidence of local venous irritation. Electrolyte additives should be spread
`hroughout the day. Irritating additive medications may need to be injected at another venous site.
`G eneralized flushing, fever and nausea also have been reported during peripheral infusions of amino
`acid solutions.
`
`Drug Abuse and Dependence
`None known.
`
`DOSAGE AND ADMINISTRATION
`L-Cysteine Hydrochloride Injection USP is intended for use only after dilution in Crystalline Amino Acid
`
`
`
`Eton Ex. 1005
`8 of 11
`
`

`

`L-CYSTEINE HYDROCHL X + v
`----------------~
`
`0 ~ : //Web.archive.org/Web/20160824090050/http:/drugsdb.eu/drug.php?d =L-cysteine%20Hydrochloride&m=~
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`I http://d rugsd b. eu/drug. php ?d =L-cyste ine%20 H ydrochlorid e&m= Sand oz%201nc&id=083366d6-043 7 -4ee0-90d 4-440aSbSd0 3b5 .x I [Qi] JUL
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`(cid:141) 2015
`
`2 captures
`2(cid:141) Aug2016 - 3/lp'"2017
`
`Injection. Each 0.5 gram of l -Cysteine Hydrochloride Monohydrate should be combined aseptically
`ith 12.5 grams of Crystalline Amino Acid Injection, such as that present in 250 ml of 5% Crystalline
`mino Acid Injection. The admixture is then diluted with 250 ml of dextrose 50% or such lesser
`volume as indicated. Eq ual volumes of 5% Crystalline Amino Acid Injection and dextrose 50% produce
`a final solution which contains Crystalline Amino Acid Injection 2.5% in dextrose 25%, which is suitable
`or administration by central venous infusion. Administ ration of the final admixture should begin within
`one hour of mixing. Otherwise, the admixture should be refrigerated immediately and used within 24
`hours of the time of mixing. For the recommended rate of administration, see the Crystalline Amino
`cid Injection package insert.
`Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
`administration, whenever solution and container permit
`
`DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE
`The pharmacy bulk package is for use in a Pharmacy Admixture Service only.
`Use of this product is restricted to a suitable work area, such as a laminar flow hood. Prior to entering
`he vial, remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent.
`The container closure may be penetrated only one time, utilizing a suitable sterile transfer device or
`dispensing set which allows measured distribution of the contents. The date and time the vial was
`initially opened should be recorded in the space provided on the label. Transfer individual doses(s) to
`appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended. Multiple
`entries increase the potential of microbial and particulate contamination.
`The withdrn.wal of container contc nt3 ::;hould be accompli::;hcd without delay using a Gcptic technique .
`However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted
`o complete fluid transfe r operations.
`
`RECOMMENDED STORAGE CONDITIONS AFTER OPENING
`Keep under laminar flow hood at room temperature. Any unused portion of the vial must be d iscarded
`ithin 4 hours after initial entry.
`
`HOW SUPPLIED
`l -Cysteine Hydrochloride Injection, USP (50 mg/ml ) is supplied as follows:
`
`PHARMACY BULK
`PACKAGE
`
`x 50 ml
`
`10 x 10ml
`Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.
`For Sandoz Inc. Customer Service, call 1-800-525-8747
`Rx only
`Manufactured for:
`SANDOZ
`Princeton, NJ 08540
`
`
`
`Eton Ex. 1005
`9 of 11
`
`

`

`L-CYSTEIN E HYDROCHL X
`
`.,1 _+ __ v _______________ _
`
`0
`
`8 https://web.archive.org{web/20160824090050/http:/drugsdb.eu/drug.php?d = L -cysteine%20Hydrochloride&m = !
`I http:/ldrugsdb. eu/drug .ph p ?d=L .cyste in e%20 Hydrochloride&m=S and oz% 20 In c&id: 083366d6.0 437 .4ee0.90d4--440 a5b5d0 3b5 .x I [§iJ JUL
`(cid:141)
`2 captures
`241ulg2016 - 3f'¥2017
`
`2015
`
`1 1
`
`Revised: November 2009
`L-028-00
`
`NDC 66758-005-01
`
`Package Label • Pri nci pal Display Panel • 50 mL Vial
`SANDOZ
`Rx only
`L-Cysteine
`Hydrochloride lnJection, USP
`PHARMACY BULK PACKAGE
`NOT FOR DIRECT INFUSION
`50 mg/mL
`For IV Use On ly After Di lution
`Do Not Dispense As A Unit
`50 mL
`L-018-00
`PHARMACY BULK PACKAGE
`
`&, SANDOZ
`
`l -Cysleine
`Hydmt:Hri,I* lrieclnn USP
`l'tl'1.M,\CY •ulk PAO.AGE
`.... n, rf'M: n,.,n 1N1PQ!"li"'-I
`SO mg/ml
`for IV I.M O,ly AftN Oilt,Cion
`D'1 f'h,J 01,pc!tr,e ,VJt UJ,/f
`,..,..,,
`!O ml
`,...,., .. ri • ..,...,.. . . 11,
`
`EMh ml COl'lllun5: S(I mg L.C)steine. H~O<'hlottde
`
`;~:t:~• i~:v.::~ '°i.~rb, USf, 4~; l\t
`Dtiocuoo,; for u~ * pick"'Jo lnJffl.
`W1.,,,&,,g: r iar IV U M -ay Mwt be dll~cd Dr{~ Ulllt.
`Coirtmll lhoukf W mpeMff p,omptl¥ •fttt ln:Ual dOMe
`pil.td:Uf~. Disa1d Uf'luted <otilffl.U •fttt (cid:141) houn.
`Stor• at c.ntroll-4 Hom ,_,,,...~""111
`15'..JO-C (Sf'-86"f). Oo nol fnuc
`LOltltr.5. no~ INfl 3,,JUU l'l:Kg,l. 0 1 ~ Ul'llf'IUJl\.
`Manulvtun..-tfn,, ~,nrtntlrw-
`Prince-.oo, ""I 08540
`o..a.itr ... &.i.,..dl __ __ _____ _
`
`Package Label - Pri nci pal Display Panel - 50 mL Vial Carton
`SANDOZ
`NDC 66758-005-02
`5 x 50 mL Vials
`L-Cysteine Hydrochloride
`Injection, USP
`50 mg/mL
`Pharmacy Bulk Package
`Not For Direct Infusion
`For IV Use Only After Dilution
`Rx only
`
`(cid:143)
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`(cid:141)
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`2017
`
`
`
`Eton Ex. 1005
`10 of 11
`
`

`

`L-CYSTEIN E HYDROCHL X ~I _+ __ v __ __ _________ _
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`0
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`
`(cid:141) 2015
`
`APR
`
`(cid:141)
`
`2017
`
`2 captures
`24Aug 2016- 3Apr2017
`
`For IV Use Only After Dilution
`Rx only
`
`II
`
`.&_ SANDOZ
`5.xS0 mlVi.ais
`L-Cysteine t-lydrochloride
`Injection, USP
`50 mg/ml
`
`.
`
`fo, ,V Ow, OnlyAf!«Ollut.on ________ _ _
`
`Item Code (Source)
`DEA Schedule
`
`NOC:66758-005
`
`Basis of Strength
`CYSTEINE HYDROCHLORIDE
`
`Strength
`50mg in1ml
`
`L-CYSTEINE HYDROCHLORIDE
`1-c steine drochloride in·ecuon. solutio
`Product Information
`HUMAN PRESCRIPTION DRUG
`Product Type
`INTRAVENOUS
`Route of Administration
`Active Ingredient/Active Moiety
`Ingredient Name
`CYSTEINE HYDROCHLORIDE (CYSTEINE)
`Inactive Ingredients
`Ingredient Name
`WATER
`Product Characteristics
`Colo r
`Shape
`f lavor
`Contains
`Packaging
`#Item Code
`1 NDC:66758-005-
`02
`1 NDC:66758-005-
`01
`
`Score
`Size
`Imprint Code
`
`Package Description
`5 VIAL, PHARMACY BULK PACKAGE ( VIAL) in 1
`CARTON
`50 ml in 1 VIAL, PHARMACY BULK PACKAGE
`
`Strength
`
`Multilevel Packaging
`conlains a VIAL, PHARMACY BULK PACKAGE (66758-005-
`01)
`This package is contained within the CARTON (66758-005-02)
`
`Marketing Information
`Application Number or Monograph Citation
`
`Marketing Start Date
`12/0112008
`
`Labeler - Sandoz Inc (005387188)
`
`Revised: 06/20 10
`
`Sandoz Inc
`
`Source: http://dailymed.nlm.nih.gov
`Reproduced with permission of U.S. National Liorary o f Medicine
`
`Copyright© 2016 Drugsdb.eu by Dionisios Fentas II Terms of Use
`
`(cid:143)
`
`X
`
`I!'?
`
`fL
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`
`
`Eton Ex. 1005
`11 of 11
`
`