DP SPECIAL STORAGE CONDITIONS
`Keep away from light.
`After opening: 15 days
`
`MA 338 618.7 (1961, approved in 1997)
`PRICE: 13.00 F (10ml bottle).
`65% Social Security reimbursement.
`License holder: Ciba Vision Ophthalmics
`Distributor:
`
`Laboratoires THÉA
`12, rue Louis-Blériot, ZI du Brézet, BP 72 Saint-Jean 63016 Clermont-Ferrand
`Cedex 1
`Pharmacovigilance:
`Tel. 04 73 98 14 36 Fax: 04 73 98 14 38
`Medical information:
`PHARMATHÉA
`12, rue Louis-Blériot, ZI du Brézet, BP 84, Saint-Jean 63016 Clermont-
`Ferrand Cedex 1
`Tel. 04 73 98 73 00 Fax: 04 73 98 73 09
`
`
`__________________________
`
`
`*VITAMINS B1-B6 ROCHE
`Thiamine, Pyridoxine
`
`
`FORMS and PRESENTATIONS
`(White) coated tablet: Tubs of 20 and 40.
`Hospital Pack: Box of 100
`
`COMPOSITION
`Thiamine (ICD) or vitamin
`B1...............................................
`Pyridoxine (ICD) Hydrochloride
`or vitamin B6...............................
`
`per tablet
`
`
`250mg
`
`35mg
`
` per tub
`of 20 of 40
`
`
`5g
`10g
`
`
`700mg
`1.4g
`
`
`Excipients: Core: mannitol, povidone K90, talc, magnesium stearate. Shell:
`hypromellose 2910/6 cP, aqueous dispersion of ethylcellulose 30%, macrogol
`6000, talc, titanium dioxide (E 171).
`
`DC INDICATIONS
`Adjunctive treatment of functional asthenia.
`
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`For adults only.
`1 to 4 tablets daily, spread throughout the day. The tablets should be
`swallowed, without chewing, with a glass of water.
`The duration of treatment will be limited to 4 weeks.
`
`DC CONTRAINDICATIONS
` Hypersensitivity to one of the constituents of the tablet.
`
`Lilly Ex. 2059 pg. 1
`Sandoz v. Lilly IPR2016-00318
`
`

`
` Levodopa (see Interactions).
`
`
`DC INTERACTIONS
`Contraindicated combination:
`- Levodopa: inhibition of the activity of Levodopa when it is used without a
`peripheral dopadecarboxylase inhibitor. Avoid any intake of pyridoxine in the
`absence of dopadecarboxylase inhibitor.
`
`DC PREGNANCY and BREASTFEEDING
`Pregnancy:
`The presence of vitamin B1 governs the prescription of this medication in the
`event of pregnancy. There are no reliable data on teratogenesis in animals.
`To date, in clinical practice, no particular malformative of fetotoxic effect has
`been observed. However, the monitoring of pregnancies exposed to this
`medication is insufficient to exclude all risk. Consequently, as a precaution,
`this medication should preferably not be used during pregnancy.
`Breastfeeding:
`In the absence of data, to be avoided during breastfeeding.
`
`DC UNDESIRABLE EFFECTS
`Linked to vitamin B6:
`Exceptional neurological manifestations, reversible once treatment has been
`stopped, have been reported after high doses and/or during prolonged
`treatment with vitamin B6.
`
`PP PHARMACODYNAMICS
`For antiasthenic use (A: digestive system and metabolism). Oral intake of
`thiamine hydrochloride (vitamin B1) and pyridoxine hydrochloride (vitamin B6).
`
`PP PHARMACOKINETICS
`B vitamins are absorbed through the intestine. Elimination is urinary in the form
`of metabolites.
`
`MA 311 398.6 (1960, approved in 1997) 20 tablets
` 329 569.7 (1987, approved in 1997) 40 tablets
` 553 308.9 (1992, approved in 1997) 100 tablets
`Indicative PRICE: 29.80 F (20 tablets)
` 56.20 F (40 tablets)
`No Social Security reimbursement. Collect. (100 tablets).
`Co-holders of MA: Produits Roche and Laboratoires Roche Nicholas SA.
`
`
`PRODUITS ROCHE
`52, bd du Parc, 92521 Neuilly-sur-Seine cedex
`Tel. 01 46 40 50 00
`__________________________
`
`
`*VITAMINE B6 RICHARD ®
`See:
`SUPPLEMENTARY SPECIFICATIONS
`__________________________
`
`Lilly Ex. 2059 pg. 2
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`
`

`
`
`To use VIDAL correctly, please refer to the Summary and Conventions
`__________________________
`*VITAMINE B12 AGUETTANT ®
`
`
`FORMS and PRESENTATIONS
`100 μg/ml Intramuscular injectable and oral solution: 1ml (glass) vials, box of
`100.
`1,000 μg/2ml Intramuscular injectable and oral solution: 2ml (glass) vials, box
`of 100.
`
`
`COMPOSITION
`Per vial:
`Cyanocobalamine (ICD) or vitamin
`B12.......
`
`
`1ml
`100μg
`
`
`2ml
`1,000μg
`
`
`Excipients: sodium chloride, concentrated hydrochloric acid qs, pH 4 to 5.5,
`WFI
`
`DC INDICATIONS
`Intramuscular injectable route:
`Proven vitamin B12 deficiencies due to an absorption defect: Biermer’s disease,
`total gastrectomy, resection of the terminal ileum and Imerslund’s disease.
`Oral route:
`Anaemia due to lack of vitamin B12 through food intake observed in those who
`have been strict vegans for more than 4 years.
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`Dosage:
`Vitamin B12 deficiencies due to an absorption defect (intramuscular injectable
`route).
`Initial treatment: 1mg (one 1,000μg vial) per day or three times per week
`
`by intramuscular injection, i.e. 10mg (10 x 1,000μg vials) in total.
` Maintenance treatment: one 100μg vial by intramuscular injection per
`month.
`Anaemia due to lack of vitamin B12 through food intake observed in strict
`vegans (oral route).
`Initial treatment: 1 x 1,000μg vial or 2 x 100μg vials per day for 15 days to
`
`1 month.
` Maintenance treatment: 1 x 1,000μg vial or 2 x 100μg vials every 10 days.
`
`
`Method of administration:
`Pour the contents of the vial into a glass of water.
`
`DC CONTRAINDICATIONS
` History of allergy to cobalamins (vitamin B12 and related substances)
` Malignant tumor: due to the action of vitamin B12 on the growth of tissues
`with a high rate of cellular multiplication, the risk of exacerbation must be
`taken into account.
`
`
`
`Lilly Ex. 2059 pg. 3
`Sandoz v. Lilly IPR2016-00318
`
`

`
`DC UNDESIRABLE EFFECTS
` Allergic reactions: pruritus, urticaria, eczema, erythema and oedema that
`may be severe: anaphylactic shock, cutaneous necrosis or Quincke’s
`oedema
` Risk of acne
` Possibility of pain at the injection site
` Red coloration of urine (corresponding to the urinary elimination of vitamin
`B12).
`
`
`DC OVERDOSE
`There is no B12 hypervitaminosis
`
`PP PHARMACODYNAMICS
`Antianemic, vitamin B12 (B: blood and hematopoietic organs).
`Cyanocobalamine: hematopoietic factor
`
`PP PHARMACOKINETICS
`Vitamin B12 is absorbed through the terminal ileum, after an enterohepatic
`cycle, by two mechanisms: a passive mechanism when the quantities are large
`and an active mechanism that allows the absorption of physiological doses and
`for which the presence of the intrinsic factor is essential.
`It is carried through the bloodstream by transcobalamins.
`The serum peak is reached one hour after intramuscular injection.
`Excretion is urinary at high doses and mainly biliary at low doses.
`
`DP INCOMPATIBILITIES
`The pH stability of vitamin B12 is 3.8 to 5.5.
`
`DP SPECIAL STORAGE CONDITIONS
`To be kept away from light.
`
`MA 553 755.5 (1963, approved in 1996, rev. 1997) 100 X 1ml vials
` 553 756.1 (1963, approved in 1996, rev. 1997) 100 X 2ml vials
`Only available from hospital pharmacies. Collect.
`
`
`Laboratoire AGUETTANT
`1, rue Alexander-Fleming
`69007 Lyon Tel: 04 78 61 51 41
`__________________________
`
`
`*VITAMINE B12 ALLERGAN ®
`cyanocobalamine
`
`
`FORMS and PRESENTATIONS
`0.5% collyrium: 5ml (PE) bottle
`
`
`COMPOSITION
`
`Cyanocobalamine (ICD)......................
`
`
`per 100ml
`50mg
`
`
`per bottle
`2.5mg
`
`
`
`Lilly Ex. 2059 pg. 4
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Excipients: sodium chloride, benzododecinium bromide, sodium edetate,
`sodium hydroxide or hydrochloric acid, purified water.
`
`DC INDICATIONS
`Adjunctive treatment for corneal scarring disorders.
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`[illegible]
`
`DC CONTRAINDICATIONS
`Hypersensitivity to one of the ingredients of the product.
`
`DC WARNINGS and PRECAUTIONS FOR USE
`Due to the coloration of the Vitamine B12 Allergan collyrium and the presence
`of preservative, do not wear contact lenses throughout the duration of the
`treatment.
`In the event of concomitant treatment with another collyrium, wait 15 minutes
`between the two instillations.
`Do not touch the eye with the nozzle of the bottle.
`Replace the cap on the bottle after use.
`
`DC UNDESIRABLE EFFECTS
`Possibility of allergic reactions.
`
`PP PHARMACODYNAMICS
`Medication for ophthalmic use and curative therapy.
`(S: sense organs).
`
`DP SPECIAL STORAGE CONDITIONS
`After opening: use within 30 days
`
`MA 311 343.7 (1961, approved in 1997)
`PRICE: 14.00 F (5ml bottle).
`65% Social Security reimbursement.
`
`
`Laboratoires ALLERGAN FRANCE SA
`PO Box 442, Sophia Antipolis, 06251 Mougins Cedex
`Tel. 04 92 92 44 00
`
`
`__________________________
`
`
`VITAMINE B12 DELAGRANGE ®
`cyanocobalamine
`
`
`FORMS and PRESENTATIONS
`1000 μg [illegible] oral solution and by intramuscular injection [illegible]
`2ml vials, box of 6.
`
`
`COMPOSITION
`
`
`
`
`
`
`Lilly Ex. 2059 pg. 5
`Sandoz v. Lilly IPR2016-00318
`
`

`
`
`Cyanocobalamine (ICD) .........................
`
`per vial
`1mg
`
`[illegible]
`
`
`Excipients: concentrated hydrochloric acid, sodium chloride [illegible]
`
`DC INDICATIONS
`Injectable route:
`Proven vitamin B12 deficiencies due to an absorption defect: Biermer’s disease,
`total gastrectomy, resection of the terminal ileum and Imerslund’s disease.
`Oral route:
`Anaemia due to lack of vitamin B12 through food intake observed in those who
`have been strict vegans for more than 4 years.
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`Vitamin B12 deficiencies due to an absorption defect (intramuscular injectable
`route).
`Initial treatment: 1mg (one vial) per day [illegible] times per week by
`
`intramuscular injection, i.e. 1mg (one vial) [illegible] month.
`Anaemia due to lack of [illegible] observed in strict vegans (oral route).
`Initial treatment: 1 vial per day for [illegible] to 1 month.
`
` Maintenance treatment: 1 vial every 10 days.
`Pour the contents of the vial into a glass of water.
`
`DC CONTRAINDICATIONS
` History of allergy to cobalamins (vitamin [illegible] related substances)
` Malignant tumor: due to the action [illegible] on the growth of tissues with
`a high rate of cellular multiplication, the risk of exacerbation must be taken
`into account.
`
`
`DC UNDESIRABLE EFFECTS
` Allergic reactions: pruritus, urticaria, eczema, erythema and oedema that
`may be severe: anaphylactic shock, cutaneous necrosis or Quincke’s
`oedema
` Risk of acne
` Possibility of pain at the injection site
` Red coloration of urine (corresponding to the urinary elimination of vitamin
`B12).
`
`
`DC OVERDOSE
`There is no B12 hypervitaminosis
`
`PP PHARMACODYNAMICS
`Antianemic, vitamin B12 (B: blood and hematopoietic organs).
`Cyanocobalamine: haematopoietic factor
`
`PP PHARMACOKINETICS
`Vitamin B12 is absorbed through the terminal ileum [illegible] two mechanisms:
`a passive mechanism when the quantities are large and an active mechanism
`that allows the absorption of physiological doses and for which the presence of
`the intrinsic factor is essential.
`
`Lilly Ex. 2059 pg. 6
`Sandoz v. Lilly IPR2016-00318
`
`

`
`The serum peak is reached one hour after intramuscular injection.
`Excretion is mainly urinary.
`
`DP SPECIAL STORAGE CONDITIONS
`Keep away from light.
`
`MA 317 105.0 (1955, approved in 1996, rev. 1997)
`PRICE: 11.80 F (6 vials).
`65% Social Security reimbursement. Collect.
`
`
`Laboratoires SYNTHÉLABO
`Directorate and Medical Information
`[illegible]
`
`__________________________
`
`Lilly Ex. 2059 pg. 7
`Sandoz v. Lilly IPR2016-00318
`
`

`
`
`
`
`
`
`
`The Dictionary
`
`
`
`Lilly Ex. 2059 pg. 8
`Sandoz v. Lilly IPR2016-00318
`
`Lilly Ex. 2059 pg. 8
`Sandoz v. Lilly IPR2016-00318
`
`

`
`75th EDITION
`
`
`
`
`
`
`
`
`
`The Dictionary
`
`
`
`
`
`All rights to reproduction, addition and supplement are reserved for the Editor
`© Copyright by OVP 1998
`(This work is governed by the provisions of Articles 9 and 13 of the Law of 11 March 1957)
`
`Lilly Ex. 2059 pg. 9
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Momingside
`TI?1I]S121fj()l1S
`
`TRANSLATOR CERTIFICATION
`
`450 7th Ave
`6th Floor
`
`””IZ.°;i;2’,ZJ.§;§3
`Fax 2126430005
`wwwmorningtransrcom
`
`County of New York
`State of New York
`
`Date: September 13, 2016
`
`To whom it may concern:
`
`I, Jennifer Clay, a translator fluent in the French and English languages, on behalf of Morningside
`Translations, do solemnly and sincerely declare that the following is, to the best of my
`knowledge and belief, a true and correct translation of the document listed below in a form
`that best reflects the intention and meaning of the original text.
`
`The document is designated as:
`-
`77c - Vidal Dict - 1999 - French.pdf - 75th Edition:
`
`Pages Vita 2052, Book cover and Cover page
`
`i hereby declare that all of the statements made herein of my own knowledge are true and that
`all statements made on information and belief are believed to be true; and further that these
`
`statements were made with knowledge that willful false statements and the like so made are
`punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United
`States Code.
`
`ormé‘
`Signature of Jennifer Clay
`
`Accurate Translation Services 24/7
`
`Lilly Ex. 2059 pg. 10
`Sandoz v. Lilly IPR2016-00318
`
`

`
`1 000 pg/2 ml:
`,
`
`1m}
`
`2 ml
`
`2D52
`CONDITIONS PARTICULIERES de CONSERVATION
`A conserver ‘a l‘abri de la lurniere.
`Apres cuverture : 15 jours.
`AMM 338 618.7 (1961, validée 1997).
`PRIX: 13.00 F (tlacon de 10 ml).
`Flemb Sec soc a 65 %.
`Titulaire du visa: Ciba Vision Ophthalmics.
`Exploitant:
`Laboratoires THEA
`12, rue Louis-Blériot. ZJ du Brézet. BP 72 '_Salnt—.lean
`63016 CIarmont~Ferrand cedex 1
`1
`'
`Pharmaoovigiiance :
`1
`Tel :04 73 9814 36. Fax: 04 73 9814 38
`Information méclicale :
`-
`1
`,
`PHAHMATHEA
`12, rue Louis-Blériot. Zl du Brezel. BP 84 Sain1~Jean
`63016 Clermont—Ferrand cedex 1
`__
`04 T3 98 73.00. Fax : 04 73 98 73 09
`
`Tel
`
`1t'V|TAMINES B1-B6 ROCHE
`thiamine, pyridoxin'e'
`‘
`_
`Fonmras e1 PFIESENTATIONS
`Cornpr/mé pelliculé (blanc) : Etuis de'20 et de 40.
`Modéle-hospitalier: Boite de 100.
`fp étuj. .
`COMPOSITION
`p cp
`‘ cle 20
`1416.40
`'
`Thiamine (DCI) chlorhydrate ’1
`mg
`1250 mg
`_5 g
`ou vitamins ‘Bi
`.....
`'
`Pyridoxine (DCI) chlorhydrate
`_
`35 mg
`700 mg
`ou vitamine Be .....................
`1.4g
`Exclpients : Noyau : mannitol, povidone K90, talc, stéarate. tie magnet
`sium. Pelliculage : hypromellose 2910/6 cP, dispersiongoueuse
`d'e'thy|oellulose a 30 "Au, rnacrogol 6000, taic, dioxyde de iltal-r'eV(E 171)‘,
`morcnndns.
`1
`1
`,
`Traitement d'appoint de I’astnénie fonctionnelle.
`P=0"SOLO'GlEVet MODE EVADMINISTRATION
`7
`Reserve 3 l'adulte.
`’
`‘
`'
`‘
`_
`.
`1 a 4 compr_imes_p'a'r jour, _a_ _r'épar1ir dans la journée.
`Les comprimés sontaavaier, sans les croquer,=avsc un verre
`=
`1"
`1
`'
`.
`1
`La duree du -traitement sera limitée a 4 semaines.
`‘
`
`'
`
`.
`
`CONTFIE-INDICATIONS
`
`l-lypersensibilité la |‘un des composants du pm
`MISES i_aN_ GAFIDE et FRECAUTl0N3'D'1E
`En raison de la coloration du collyre vr:am'ries'1 I
`de la presence (19 conservateur,
`le pm des!‘
`contact est déconseillé pendant toute Ia durée du-
`En cas de traitsment concomitant par (in ad
`attendre 15'rninutes entre les deux instillalions.‘
`Ne pas toucher I‘<Bi| aver: -|‘ernD0u1 du flacq
`'
`Reboucher le tlacon apres utilisation.
`1
`_EI EFFETS INDESIRABLES
`Possibilite de ré-actions allergiques_
`,
`PHABMACODYNAMIE
`Médicament a usage ophtaimique, a vlsée oicatig
`organes sensoriels).
`.,
`"‘»--1
`cononrons PAFITlCULl'EFtES'de cm;
`Aprés otrverture: a utiliser dans les sq juu[5_ ’_
`AMM311343.7(1961,va|idé1997).
`'
`'
`PRIX: 14.00 F (tlacon de 5 ml).
`Fternb Séc soc a 65 %.
`Laboratoires ALLEl=tGAN FHAN(t'E1J
`as 442. Sophia Antipolis. 05251 Mougi
`1
`00 p.
`.
`
`'
`
`‘k VITA
`
`'1
`‘
`
`'
`
`\r
`FORMES11'et ‘PFtESENTATlO|,\lS_1.. .
`Solution but/able at
`lnfectable IM a
`Ampoules de 21ml, boite ds 6.
`'1
`1
`COMPOSITION
`Cyanocobaiamine (DCI) ......
`Excipients : acide cnlorhydrique conoentré, bhlom Ha
`INDICATIONS
`1
`-.1
`1-
`1
`Vole infectable :
`Deficits prouvés en vitamine B12 due a on-dél
`tion: maladie de Blermer, gastreotomiejplal
`l’i|éon terminal, maladie d'|me,rs_lund.
`_’ --
`_’
`Voieorale:
`'
`Anémie par carence d’appor1 a|imer'itaire' é‘n~ .
`ohez les végétaliens stricts depuis plus file‘ 1
`El POSOLOGIE et MODE D'.ADMlNl§T,
`Deficits en vitamins B12 dus a un défaut ,
`injectable intramusculaire] :
`,
`,
`_
`—Traitementd‘attaque :1 mg (unea poulelpdi
`lois par semaine en JM, soit 1_D:h1g'rT(1[J:_,ani
`- Traitement d'entretien :
`1 mg (unergrn
`mors.
`1
`'_
`Anémie par carence d’ap,o_ort alfrnenrarre.
`cl'rez.les végétaliens strlcts (vole orale
`A
`_
`-Traitementdattaque :1 ampoule par
`1
`1
`1“;~'1
`at mois.
`1
`—1Traitement d’entre1ien : 1 ampoule 1095165 .
`Verser le contenu cle Fampoule _dans un_ W
`CONTRE-INDICATIONS
`,-?l'l. '
`- Antécédents d’a||ergie aux_cObal__aI'I1I_fl65
`substances apparentées).
`,
`.
`_
`1
`—_Tumeu”r rnaligne :,en raison de_l?_a
`"sur la cioissance des tissue a iau:_t-
`cellulaire élevé, Ie risque demusséeé ,
`en compte.
`'
`1
`
`EFFETS INDESIRABLES
`— Reactions allergiques : prurill UlT|0§"9
`oedema 1-pouvant étre ‘severe: :-:1¢_=|16°
`nécrose cutanée ou cedeme de‘0U|l1°k9'.
`_—_Fiisque d’acné.
`1
`.
`_.
`.
`.— Possibilité de douleur au pornt_d1If|l9°
`— Coloration rouge des urines (00395
`J 11
`urinalre dejla vitamine B12).
`_
`1
`
`1
`91
`SUFIDOSAGE
`ll n’existe pas d’hyperv1aminose Bga
`
`,
`
`..-.1
`‘ 1'
`Pl-IARMACODYNAM|_E
`Antianémique, vitamins E12 (3"~'1§3'}9‘,.h3
`poiétiques).
`1
`'1
`" "
`‘
`1
`
`_
`
`PHARMAc9crNETlq}lI§_
`La vltamine B122 est absorbee au nl
`deux mécanismes :
`.
`quantités sont _imp0flfiflI€5:'
`permet l‘absorptIon des __d0§95 Pi‘
`la presence du facteur rntrrnséqlée he“
`Le pic sérlque est attelnt U”.
`intramusculaire.
`_
`‘
`'1
`L'excrétion se fait prlnclpalement Pia! '
`.
`do
`OONDlT!ONS PAnTrcuL!E,'?,E5
`
`1312 AGUE1TANT®
`.
`FOFIMES et PRESENTATIONS
`Solution injectable W! at buvable a‘ 100 pg/ml: Arnpoules
`(verre) de 1 ml, boite do 100. _
`Solution injectable ml at buvable a
`Arnpoules (_verr_e) da 2 ml, boite de 100.
`COMPOS1TlON
`Par ampoule :
`Cyanocobalamine (DQI)
`1 000 pg
`100 pg
`ou vitamins E112 ............................ ..
`Excipients :'chloru're cle sodium, acids ohlorhydrique ooncentre qsp pH
`4 a 5,5, eau ppi.
`INDICATIONS
`‘
`'
`1
`Vole inlectaole lM :
`Deficits prouvés an vitamins B12 dus a un defaut d'absorp-
`tlon : maladie de Biermer, gastrectomie tota|e,‘re"section de,
`l’lleon -terminal, maladie d’lmerslund.
`Vole-orale :,
`—
`Anémie par
`rence d'apport'allmentalree'n vitamine B12
`1 chez les végétaliens stricts depuis plus de 4 ans.
`POSOLOGIE et MODE D’ADMlNlSTRATI_ON
`Posologie:
`‘
`.
`Deficits en vitamins B12 dus a un cléfaut d’absorpffan ‘(vole
`infectaole lM) :
`'
`- Traitement d"attaque : 1 mg.(u'ne ampoule a 1 000 pg) par
`jour ou trois fols par semaine an IM,
`soil 10 mg
`(10 ampoules a 1 000 pg) au total.
`1
`- Traitement d'entretien ; une ampoule a 100 pg en lM par
`rnois.
`.
`1
`.
`1
`Anemia par carence dfapport alrmentafre en vitamine B12
`cnez les végétaliens stricts (voie orale) :
`,
`g ou
`—.Traitement d‘attaque '.
`1 ampoule a 1 000
`2 ampoules a 10[_)pg parlour pendant 15 jours a mois.
`-—Traitement d'entretien’-:
`'1 ampoule a 1' 000 pg ou
`2 ampoules a 100 pg tous les 10jours,,
`Mode d’administration:
`1
`9
`'1
`'
`Verser le contenu de Pampoule dans‘un'verre ’d'eau.
`GONTRE-INDICATIONS
`-. Antecedents d’a||ergie aux cobalamlnes (vitamine Bu2"et
`substances apparentées).
`.
`.
`1
`.
`— Tumeur m_al_igne : en raison.de Faction de larvltamine B12
`sur la croissance des .tissus .a taux dezmuitiplication
`_ cellulaire elevé, le risque de poussée evolutive doit étre pris
`an compte.
`1
`1
`.
`
`_
`‘
`CONTRE-INDICATIONS
`— Hypersensibilité a |’un des constituents du corriprimé.
`-Lévodopa (of interactions).
`'
`1.
`1
`’1
`INTERACTIONS
`Interactions médicamenteuses: '
`‘
`1
`1
`'
`_
`Association contre-indfquée :
`_
`— Lévodopa: inhibition de l'actlvité de la lévodopa'lorsqu’elle
`est utilisée sans inhlbiteur de la dopadécarboxylase
`péripherique. Evlter tout apport de pyridoxlne en |'absence
`d’inhibiteur de la dopadécarboxylase.
`GFl0SSESSE1et ALLAITEMENT
`Grossesse:
`_
`‘
`I
`_
`"
`La presence de vitamins E: conditionne la concluite a tenir
`avec ce medicament en castle grossesse. ll n’y a pas de
`données fiables de téra1ogene'se"cl1ez.Fanlmal.
`11
`1
`'
`En clinlque, aucun effet malfqrmatlf ou foetotoxique particu-
`Iier grest apparu a ce jour. Toutefois, le suivi d_e,.grossesses
`fexposées a oe medicament est insuffisant poL1r,exE:,lure tout
`risque. En consequence, par mesure de préc_a'ution,'il est
`preferable de ne pas utiliser ce medicament pendant la_
`:
`'
`'
`Allaitement:
`.
`,
`,
`En |'a_bsence de données, a .éviter pendant l’allaltemenl.
`EFFETS lNDE5lFlABLES
`1
`1
`1 1..
`1
`1
`Lies 3 la vitamins Ba.‘
`'_ 1,='.,1
`1
`Des manifestations neurologiques exceptionnelles et raver;
`sibles a l‘arrét du lraitement ont été signalees ,ap'ré-,5 de lortes
`doses et/ou en cures prolongées de vitamine Ba.
`,
`1
`1
`V
`1
`1
`PHARMACQDYNAMIE 1
`V
`11
`,,1
`A visée antiasthénique (A : appareil digestif et métabollsrne).
`Apport de ch1orhydrate1cle,thiamine (v1tamine,Et1) at da
`chlorhydrate do pyridoxine (vitamins Ba) par _voie orale.
`1
`- PHAFtMACOClNETlQUE-
`;
`-1
`11
`1
`Les vitaminss B sont absorbées au niveau de ’|'intestin.
`L’élimina_tion est urinaire sous forme de metabolites.
`'
`AMM 311 398.6 (1960, validée 1997) 20 comprirnes.
`329 569.7 (1987, v.alidée,1997 40 comprimés.
`553 308.9 (1992, valldée 199? 100 compriitnés.
`PRIX indicatif : 29.80 F (20 colttpilmés).
`'
`‘
`"
`56,20 F (40 oomprimés).
`.
`,,
`.1,
`,
`Non remb Sec soc. Collect (100 opJ.1
`1
`Cotitulaires de l’AMM : Produits Roche et ‘Laboratoires
`Roche Nicholas SA. '
`'
`‘
`PRODUITS ROCHE 1
`1
`.1
`52, bd du Parc. 92521 Neuilly-sur-Seine cede
`.
`'1014640500D
`‘
`1
`
`1 1111114111.“
`
`Be nrcr-iAno®
`
`‘
`
`1
`1
`EFFETS INDESIRABLES1
`— Reactions alierglques : prurit, urticaire, eczéma, érytheme,
`oedéme pouvant étre severe‘ 2' choc anaphylactique,
`nécrose cutanée _ou" oedema de"Quin'cks.
`— Fiisque d’acné.
`'
`‘
`V
`1
`_
`,
`m Possibilité de douleur au point d’injection.,
`— Coloration rouge des urines (correspondent a |‘élEmination'
`urlnalre de la vitamine B13).
`SURDOSAGE
`ll n’exlste pas d‘hy_penritaminose,B1z.
`PHAFt|_VlACQDYNAMlE
`Antianémlque, vitamlne_.B12 (B : sang ,et organés hemato-
`po'léti.queSl-
`1.
`;
`.
`_»
`.
`,
`.
`..
`,
`,
`Cyanocobalamlne : facteur hématopo'ietique.
`_
`1
`PHARMACOCINETIQUE 1
`-
`La vitamins B12 est ‘absbrbee au niveau de l’lleon1termina|,
`apres un cycle entérohépatidue; par deux mécanisrnes : Ul'_|
`mécanisme passif lorsque les duantités_ sont importantes, et
`un mecanisme actit qui perrnet
`|’absorption des‘ doses
`physiologlques et pour
`iequel
`la presence 1du tacteur
`intrinseque est indispensable.
`Le transport sanguin se talt par les _tralnscobalamines.,
`L_e pic serique est atteint“ une _h_eu,fé apres '_l’injection
`intramusculaire.
`'
`_‘j‘-'
`1
`1
`1
`1
`V
`ose.
`'
`‘
`'1
`'1
`‘1
`|a'e;‘<créti_on est urinaire Ea forte dose, et sLli1o'ut_biiiaire 2'3 tai_ble
`rt,‘
`JNCOMP,ATlBlLlTE$ _
`_
`_
`,
`,_
`Le pl-’| de stabilité de la vitamlne 'B12“est de 3,83‘-‘3 5,5.
`conornons Pnntrcufliiénes clé CDNSEEtyfATlON
`A conserve? a |’abri .de la lumiere.
`_
`3
`,
`.
`AMM 553 1755.5'(1963, val 1996, rév1'997)10D amp cle1 ml.
`553 756.1 (1El63,va|1995,rév1997)1OD amp de 2 ml.
`Disponihle‘ dans les seules pharmacies nospitalieres. Collect.
`Laboratoire AGUETTANT
`‘
`1, rue A|exander-Flemlfng -
`69007 Lyon. T-uél
`: 04 78 E11, 51 41
`
`,
`
`,
`
`.1 ,
`
`31' VITAMINE B12‘ ALLERGA
`_
`V
`cyanocobala'min’e
`"
`'
`FORMES et PFtESEN_TA1_‘l0NS
`C0'll‘yl'e a’ 0.5 %o.' Elacon (E) de 5 ml.
`. COMPOSITION
`p 100 ml
`Cyanocobalamine (DCI) ................ ..
`50_ mg
`
`p flacon
`, 2.5 mg
`
`Lilly Ex. 2059 pg. 11
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Lilly Ex. 2059 pg. 12
`Sandoz v. Lilly IPR2016-00318
`
`

`
`756 EDITION
`
`Vi D/-\L®
`-—-199 --
`
`LeDictionnaire
`
`Editions du Vidal“
`
`33, avenue de Wagram - 75854 PARIS Cedex 17
`Tél. : (33) 01 44 O9 50 50 - Fax : (33) 01 45 74 83 38
`Minitel grand public : 3617 VIDAL (5.57 F/min)
`Internet : http://www.vida|.fr
`
`Lilly Ex. 2059 pg. 13
`Sandoz v. Lilly IPR2016-00318