11MS5831 AMA Sale WEB-NP:Standard Default

40 Pages·2011·9.35 MB·English

by  John Argandona

11MS5831 AMA Sale WEB-NP:Standard Default 12/14/11 1:02 PM Page 1
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To Order: 1.800.P.SCHEIN (1.800.772.4346)8am–9pm, et • To Fax:[phone] Hrs
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Prevent Pneumonia.
S Pneumonia kills more people in the U.S. each year than all other
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Source: www.cdc.gov
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2.5-mL, 5-Dose Vial
(558-1814).............................................ea
0.5-mL SDV
(558-4195)......................................10/pkg
CPT®Code: 90732
Item stored under refrigeration. May be shippedseparately.
All vaccines include Federal Excise Tax (FET).
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V
A
HAVRIX®–Pediatric/Adolescent C
Hepatitis A (Inactivated) Vaccine, C
Thimerosal-Free, 720ELU/0.5mL I
N
Tip-Lok®, Latex-Free 0.5-mL Syringe
(254-0023).......................10/pkg $300.94 E
S
Td Vaccine
Adacel® Tetanus and Diphtheria Toxoids, Adsorbed
Tetanus Toxoid, Reduced Diphtheria Toxoid, 7+ Years, Latex-free and Preservative-Free
and Acellular Pertussis Vaccine Adsorbed Adults and adolescents should receive a Td
0.5-mL SDV vaccine booster shot every 10 years. Adults
(546-7789).......................10/pkg $407.62 over the age of 65 should receive the Td
vaccine instead ofTdap.
0.5-mL Prefilled Syringe without Needle Source: cdc.gov.
(546-4958).........................5/pkg $196.46
(558-0011)........................10/pkg $199.99
CPT®Code: 90715†
CPT®Code: 90714†
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Human Papillomavirus (HPV) Quadrivalent
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RecombinantVaccines
0.5-mL SDVs
(558-3890)..............................ea $129.99
(558-3149)........................10/pkg $1,293.09
0.5-mL Prefilled Luer-Lock Syringe without
Engerix-B®–Adult
SafetyNeedle
Hepatitis B (Recombinant) (558-7846).........................6/pkg $784.89 RECOMBIVAX HB®–Adult
Vaccine, Preservative-Free Hepatitis B (Recombinant) Vaccines,
CPT®Code: 90649†
Thimerosal-Free
20 μg/mL, 1-mL SDV Gardasil®is a registered trademark of Merck & Co., Inc.
(254-8254).......................10/pkg $568.05 10 μg/mL, 1-mLSDV
(558-3753)..............................ea $49.99
CPT®Code: 90744†
Item stored under refrigeration. May be shippedseparately. (558-0737).......................10/pkg $492.99
CPT®Code: 90746. When 2 doses are given to an
adolescent, CPT Code: 90743.
MENVEO®
[Meningococcal
(Groups A, C, Y and W-135)
Oligosaccharide Diphtheria CRM197
Conjugate Vaccine] Solution for
Intramuscular Injection
The CDC has updated its
recommendations to include vaccination for
Engerix-B®–
meningococcal disease for all children 11 VAQTA®–Pediatric/Adolescent
Pediatric/Adolescent
Hepatitis B Recombinant Vaccine through 18 years of age. Source: Hepatitis A (Inactivated) Vaccine,
10 µg, 0.5mL menveo.com. Thimerosal-Free, 25U
(258-0092).........................5/pkg $538.74 0.5-mLSDV
10 mcg, 0.5-mL SDV
(254-0632).......................10/pkg $231.19 CPT®Code: 90734† (558-4255).......................10/pkg $297.56
Do not freeze. Store refrigerated, away from the freezer CPT®Code: 90633†
10 mcg, 0.5-mL Syringe compartment, at 36°F to 46°F (2°C to 8°C). Protect All vaccines include Federal Excise Tax(FET).
(254-0026).......................10/pkg $231.19 from light. Do not use after the expirationdate. VAQTA®is a registered trademark of Merck & Co.,Inc.
CPT®Code: 90744†
Item stored under refrigeration. May be shipped separately.
M-M-R®II
HAVRIX®–Adult Measles, Mumps, and Rubella Vaccine ZOSTAVAX®
Hepatitis A (Inactivated) Zoster (Shingles) Vaccine, Live
0.5-mL SDV with Diluent
Vaccine, Thimerosal-Free (558-0110)........................10/pkg $551.12 0.7-mLSDV
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Prefilled Syringe CPT®Code: 90707† (558-2895).......................10/pkg $1,659.02
Items stored under refrigeration. May be shipped separately.
(124-0016)........................10/pkg $667.91 All vaccines include Federal Excise Tax(FET). Item stored frozen. May be shipped separately.
CPT®Code: 90633† M-M-R®II is a registered trademark of Merck & Co.,Inc. ZOSTAVAX®is a registered trademark of Merck & Co.,Inc.
To Order: 1.800.P.SCHEIN (1.800.772.4346)8am–9pm, et • To Fax:[phone] Hrs
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11MS5831 AMA Sale WEB-NP:Standard Default 12/14/11 1:05 PM Page 8
S
L
A
C
I
T
U Dexamethasone Sodium
E PhosphateInjectables
C Celestone®Soluspan® Compare to Decadron®
InjectableSuspension
A 4 mg/mL, 1-mL SDV Lidocaine HCl Injectable
M 6 mg/mL, 5-mLMDV (375-0168)........................25/pkg $36.25 Compare to Xylocaine®
(516-0266)..............................ea $41.95
4 mg/mL, 5 mL 50-mL MDVs
R
A (375-1975).......................25/pkg $69.75 1%
4 mg/mL, 30 mL (104-6817)........................25/box $36.74
H
(102-4486)..............................ea $17.99
P
10 mg/mL, 1 mL
(406-7616).......................25/pkg $107.25
10 mg/mL, 10-mL MDV
Betamethasone (112-3411)........................10/box $75.90
Sodium Phosphate
and Betamethasone Lidocaine with
Acetate Epinephrine
Compare to Celestone® Soluspan® 1:100Injectable
6 mg/mL, 5-mL MDV Compare to Xylocaine®
(114-8668)..............................ea $32.95 with Epinephrine
30-mL MDV
1%
Kenalog®-10 Injectable
(104-6822).......................25/box $70.08
Triamcinolone Acetonide
10 mg/mL, 5-mL MDV
(196-0545)..............................ea $9.99
Depo-Medrol®
Injectables
With Preservative
40 mg/mL, 1-mL SDV
(908-5362)..............................ea $7.99 Lidocaine HCl with
(231-1203)........................25/box $187.25 EpinephrineInjectable
Compare to Xylocaine®
80 mg/mL, 1-mL SDV
with Epinephrine
(908-7936)..............................ea $14.99 Kenalog®-40 Injectables
50-mL MDV
Triamcinolone Acetonide
1%
40 mg/mL, 1-mL SDV
(248-7453)..............................ea $4.05
(196-8300)..............................ea $7.99
40 mg/mL, 5-mL MDV
(196-1737)..............................ea $37.99
40 mg/mL, 10-mL MDV
(196-9429)..............................ea $59.99
Depo-Medrol®Injectables
Methylprednisolone Acetate
40 mg/mL, 5-mL MDV
(908-9783)..............................ea $28.99
40 mg/mL, 10-mL MDV
Lidocaine 1% with
(908-1188)..............................ea $49.99
Epinephrine Injectable
80 mg/mL, 5-mL MDV Compare to Xylocaine® with Epinephrine
(908-3787)..............................ea $49.99 Ketorolac Injectable
(104-7099).......................25/box $70.50
Compare to Toradol®
60 mg/2mL
30 mg/mL, 1-mL SDV, IM and IVUse
(115-8883)........................25/box $32.25
Depo®-Testosterone MedroxyPROGESTERone
Injectables–CIII Acetate InjectableSuspension
100 mg/mL, 10-mL MDV Compare to
(908-3439)..............................ea $74.99 Lidocaine HCl 1% Depo-Provera®Contraceptive
200 mg/mL, 10-mL MDV Injectable 150 mg/mL, 1-mL SDV
(908-0963)..............................ea $79.99 Nonreturnable (108-3517)..............................ea
200 mg/mL, 1-mL SDV 50-mL MDV (108-2357).......................25/box
(908-7332)..............................ea $22.49 (248-0644)..............................ea $2.09
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11MS5831
11MS5831 AMA Sale WEB-NP:Standard Default 12/14/11 1:05 PM Page 9
Treat B deficiency.
12
Sustain serum B levels.
12
Nascobal®.
The nasal spray that
sustains serum B levels.*1,2
12
INDICATION
Nascobal®(Cyanocobalamin, USP) Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission
following intramuscular vitamin B12therapy and who have no nervous system involvement. Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12
defi ciencies including: dietary deficiency of vitamin B12occurring in strict vegetarian diets; malabsorption of vitamin B12resulting from conditions including HIV infection,
AIDS, and Crohn’s disease; inadequate secretion of intrinsic factor resulting from lesions that destroy the gastric mucosa and other conditions associated with gastric
atrophy including multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron defi ciency, and subtotal gastrectomy; total gastrectomy; competition for vitamin
B12by intestinal parasites or bacteria; and inadequate utilization of vitamin B12that may occur if antimetabolites for the vitamin are employed in the treatment
of neoplasia.
IMPORTANT SAFETY INFORMATION
Nascobal®(Cyanocobalamin, USP) Nasal Spray is contraindicated in patients with sensitivity to cobalt and/or vitamin B12or any component of the medication.
If a patient is not properly maintained with Nascobal Nasal Spray, intramuscular vitamin B12is necessary. Vitamin B12concentrations must be monitored.
Patients with pernicious anemia should be instructed that they will require weekly administration of Nascobal Nasal Spray for the remainder of their lives. Failure to do so
will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Patients with early Leber’s disease
(hereditary optic nerve atrophy) who were treated with vitamin B12suffered severe and swift optic atrophy. Vitamin B12defi ciency may suppress the signs of polycythemia
vera. Treatment with vitamin B12may unmask this condition. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely with
vitamin B12.
Side effects thought to be related to Nascobal use are usually mild and include headache, nausea, and rhinitis.
Please see adjacent brief summary of prescribing information.
*In a separate study Nascobal nasal spray and Nascobal nasal gel were bioequivalent3
References: 1. Nascobal®(Cyanocobalamin, USP) Nasal Spray Prescribing Information; 2011. 2. Data on file. PAR-NAS-001. Par Pharmaceutical, Inc.
3. Data on File. PAR-NAS-002. Par Pharmaceutical, Inc.
©2011 Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.
Nascobal is a registered trademark of Par Pharmaceutical, Inc.
NAS00 0249 Printed in USA 09/11
To Order: 1.800.P.SCHEIN (1.800.772.4346)8am–9pm, et • To Fax:[phone] Hrs
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11MS5831 AMA Sale WEB-NP:Standard Default 12/14/11 1:05 PM Page 10
Nascobal® Nasal Spray
ADVERSE REACTIONS
(Cyanocobalamin, USP) The incidence of adverse experiences described in the Table below are based on data from a short-term clinical
500 mcg/spray trial in vitamin B12 deficient patients in hematologic remission receiving Nascobal Gel for Intranasal Administration
BRIEF SUMMARY: FOR COMPLETE DETAILS, PLEASE SEE FULL PRESCRIBING INFORMATION. (aNn=d 2N4a)s acnodb ainl tNraamsaul sGceull,a trh veit ainmciidne Bnc1e2 (oNf= a2d5v)e.r sIne tehvee pnhtsa wrmaas csoimkinilaetr.ic study comparing Nascobal Nasal Spray
INDICATIONS AND USAGE
Table: Adverse Experiences by Body System, Number of Patients and Number of Occurrences by Treatment
Nascobal® Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients Following Intramuscular and Intranasal Administration of Cyanocobalamin.
who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement
Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including: Number of Patients (Occurrences)
I. Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare). Body System Adverse Vitamin B12 Intramuscular
II. Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where Experience Nasal Gel, Vitamin B12,
intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. 500 mcg 100 mcg
These conditions include HIV infection, AIDS, Crohn’s disease, tropical sprue, and nontropical sprue N=24 N=25
(idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually Body as a Whole Asthenia 1 (1) 4 (4)
more severe than vitamin B12 deficiency. Back Pain 0 (0) 1 (1)
III. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa Generalized Pain 0 (0) 2 (3)
(ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable Headache 1 (2)* 5 (11)
degree of gastric atrophy (such as multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, Infectiona 3 (4) 3 (3)
iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Cardiovascular System Peripheral Vascular Disorder 0 (0) 1 (1)
Smtarulicgtnuaranlc lieessi,o entsc .leading to vitamin B12 deficiency include regional ileitis, ileal resections, Digestive System Dyspepsia 0 (0) 1 (2)
Glossitis 1 (1) 0 (0)
I V . laCatotruommpph)e yat.i btTisohoner bbfoslir nh vduit galoemo qpinu s aByn1nt2id tbrieoys mi noetfe mvsittaianyma pli rnpo adBrua1c2s eiat endsde fi oicnr ifbeeanscctetyed or ipfa av. tiTiteahnmet sifin so hBft 1et2an po her awfovoelar mates .(s Docipiahtyelldo bgoatshtrriicu m NNVoaauumssieetiaan g& Vomiting 100 (((100)))* 111 (((111)))
V . Iinna tdheeq tureaatetm uetinlitz aotfi onne oopf lavistaiam.in B12. This may occur if antimetabolites for the vitamin are employed Musculoskeletal System Arthritis 0 (0) 2 (2)
Myalgia 0 (0) 1 (1)
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel Nervous System Abnormal Gait 0 (0) 1 (1)
b“Dacrutegr/iLaal boovreartgorroyw Ttehs,t eInxpteurlasciotino nosf” fi)s, hu staep oefw ao grmlu,t ednis fcroenet dinieuta tinio nno onft rdorpuigcsa ll esapdruineg, toor vaidtammininis mtraatliaobns oofr patniotinb i(osteices in Anxiety 0 (0) 1 (1)*
tropical sprue. Such measures remove the need for long-term administration of vitamin B12. DHyizpzoineestshesia 00 ((00)) 31 ((31))
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, Incoordination 0 (0) 1 (2)*
malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation. Nervousness 0 (0) 1 (3)*
Nascobal Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test). Paresthesia 1 (1) 1 (1)
CONTRAINDICATION Respiratory System Dyspnea 0 (0) 1 (1)
Sensitivity to cobalt and/or vitamin B12 or any component of the medication is a contraindication. Rhinitis 1 (1)* 2 (2)
WARNINGS aS ore throat, common cold *There may be a possible relationship between these adverse experiences and the
aPnadti esnwtsif tw oitpht ice aartlryo Lpehbye.r’s disease (hereditary optic nerve atrophy) who were treated with vitamin B12 suffered severe sctoundcyo dmruitgasn.t Tthheersaep ay.dverse experiences could have also been produced by the patient’s clinical state or other
Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely with The intensity of the reported adverse experiences following the administration of Nascobal Gel for Intranasal
vaainntademm iriirnae .vB eE1rx2s.c ilbFuolselii vcne ea uucrsiodel oiosgf nifcoo ldti caa m ascuaibgdse it.nit utrtee aftoinr gvi tvaitmamini nB 1B21 a2-ldtheofiucgiehn itt mmeagya ilmobplraosvteic v aitnaemminia B c1o2-udledfi rceiesunltt mine pgraologbrelasssitvice fiAnodtllrmoawimniiunssgtrc aiuntlitaorarn md aounssdicn iugnl ta(rtraw mdoou shsiecnaugdl.a aSrc ivmhietialsam arlinyn,d Ba r 1hf2ei nwwiet iarsed; vogenerense ed reyasxlplpyee mpriseiilnadc,. eaOsrn tohefr ipmtiasot,i deaennrtda r tedepi zionzrtitneenedss ssite)y,v wearneedr e hd eroeaspdionargcte hwdei tfho llowing
Ahanvaep hbyeleanct irce psohroteckd ainn dc ldineiacathl thraiavles bweitehn N raespcoortbeadl aNfatesra pl Sarpernatye orar lN vaitsacmoibna Bl (12C yaadnmoicnoisbtaralatimonin. ,N UoS sPu)c Nha rseaalc Gtioeln.s NThaes cmoabjaolr Gitye lo ffo trh Ien trreapnoarsteadl Aaddmveinrsiset reaxtpioenri e(onncee sh feoalldoawcihneg, dinofseicntgio wn,it ha nNda psacorebsathl Geseila f)o.r Intranasal Administration
hBaluvnintegd b oorn iem mpeadrreodw t hseurpappreeusstiacn rte psrpoopnesreti etos vsiutachm ains Bc1h2l omraamy pbhe ednuiceo tlo, asnudch c oconncudritrieonnts i raosn i nofre fcotliiocn a, cuirde dmeifiac, idernucgys. atohnf ed“ p rieonlstarstaiibomlneus”sh criupe llataort i osvtintuasdhmyi pidn rt uoBg 1t2 hw ewa essrt uejud jdyug ddegrdue gda, s ta o“n bpxeoie sitsnyit,be ilrnecc”uo roorrer dn“irtn eeamvteioontnet”,s ..a OFnodf r t nhtheeer va oodtuvhseenrrse erse sep xwopreteerredie ranedcpevoesr rtjesuedd egfoxelpdloe twroiie nbngec es,
PRECAUTIONS intramuscular vitamin B12 and headache, nausea, and rhinitis were reported following dosing with Nascobal Gel
GENERAL for Intranasal Administration.
Aton p inattireandtesr msuaslp teecstte ddo osfe coyfa pnaorceonbtearlaaml viinta smenins iBti1v2i tiys. rVeictaommimn eBn12d edde fibceiefonrcey Nthaastc oisb aalll oNwaesadl tSop praroyg irse assd mfoirn istered GTheen eforallloizweidn:g adverse reaActnioanphs yhlaacveti cb seheonc rke apnodrt edde awtihth ( Speaere Wntaerrnailn vgitsa amnidn PB1r2e:cautions).
longer than three months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid Cardiovascular: Pulmonary edema and congestive heart failure early in treatment; peripheral
greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic vascular thrombosis.
manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage Hematological: Polycythemia vera.
will result. Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with Gastrointestinal: Mild transient diarrhea.
folate deficiency. Indiscriminate administration may mask the true diagnosis. The validity of diagnostic vitamin B12 Dermatological: Itching; transitory exanthema.
or folic acid blood assays could be compromised by medications, and this should be considered before relying Miscellaneous: Feeling of swelling of the entire body.
totmhhnere orsgamuapclboyho.b ctTleayhstseottsrisce if sfoao rcnr eoteh,um esldrieaa ro,pu cyimnc. du Vpiris otucatparmiosmisnnii n ucBamo1tn2e lvi esuev srneseoli soto naaf n vosdiftu asbtmhesevtiie ntpur lBetae 1tm2 ef ocleeorgt u facolldoloi ucbm nlaaatc sssitkdhic ot ahtunoeldd nt rbsouiernem c mdaeiol a inetg irmntyootirhgserihdsot. p ciHomaiyreppesrofoiuskvl alewyl e ifdtomhul iirvcaiin taaagcnm itddhi n ed reBafip1c2y i.e nt ONAdoVm EoRivnDeirsOdtrSoaAstaiGogEne ohra psa breenetne rraelp voirttaemd iwn iBth12 N.ascobal Nasal Spray, Nascobal (Cyanocobalamin, USP) Gel for Intranasal
Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this DOSAGE AND ADMINISTRATION
condition. If a patient is not properly maintained with Nascobal Nasal Spray, intramuscular vitamin B12 is necessary The recommended initial dose of Nascobal Nasal Spray is one spray (500 mcg) administered in ONE nostril once
for adequate treatment of the patient. No single regimen fits all cases, and the status of the patient observed in weekly. Nascobal Nasal Spray should be administered at least one hour before or one hour after ingestion of hot
fnoallsoawl -cuopn gise tshtieo nfi,n aalll ecrrgitiecr irohnin fiotirs a adnedq uuapcpye ro rf etshpeirraaptoy.r yT hinef eecffteiocntisv ehnaess nso ot fb Neaesnc doebtaelr mNainseadl .S Tphraeyre ifno rpea,t iterenatstm weitnh t foods or liquids. Periodic monitoring of serum B12 levels should be obtained to establish adequacy of therapy.
with Nascobal Nasal Spray should be deferred until symptoms have subsided. Priming (Activation) of Pump
Before the first dose and administration, the pump must be primed. Remove the
LABORATORY TESTS clear plastic cover and the plastic safety clip from the pump. To prime the pump,
Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. If folate place nozzle between the first and second finger with the thumb on the bottom of
levels are low, folic acid should also be administered. All hematologic parameters should be normal when the bottle. Pump the unit firmly and quickly until the first appearance of spray.
beginning treatment with Nascobal Nasal Spray. Then prime the pump an additional 2 times. Now the nasal spray is ready
tVrietaamtmine nBt1 w2 bitlho oNda slecvoeblasl aNnads aple Sripprhaeyr,a al nbdlo tohde nc oaut nintst emrvuaslst boef 3m toon 6ito mreodn tinhist.ially at one month after the start of fimorm uesed.i aTtheely ubneifto mreu esta bche raed-mpriinmisetdra btieofno roef edaocshe sd 2os teh.r oPurigmhe 4 t.he pump once
A decline in the serum levels of B12 after one month of treatment with B12 nasal spray may indicate that the dose INFORMATION FOR PATIENTS
may need to be adjusted upward. Patients should be seen one month after each dose adjustment; continued low Patients with pernicious anemia should be instructed that they will require weekly intranasal administration of
levels of serum B12 may indicate that the patient is not a candidate for this mode of administration. Nascobal Nasal Spray for the remainder of their lives. Failure to do so will result in return of the anemia and in
Patients with pernicious anemia have about 3 times the incidence of carcinoma of the stomach as in the general development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be
population, so appropriate tests for this condition should be carried out when indicated. warned about the danger of taking folic acid in place of vitamin B12, because the former may prevent anemia but
allow progression of subacute combined degeneration of the spinal cord.
DPbleRorUosodGn /aLssA tsaBakOyisnR.g AC TmoOlocRshYti caTinEntSeib,T i poIaNtirTcaEs-,Ra mmACeintThoIoOsatNrleiScx yaltiec oarc ipdy arinmde htheaamvyi naelc ionhvaolli dinattaek efo floicr alocnidg earn tdh avinta 2m wine eBk12s dmiaagyn porsotdicu ce (aHdomt ifnoiostdesr mNaasyc coabuasl eN naassaal lS spercarye atito lnesa astn odn ae rheosuurlt ibnegf olores so ro fo mnee dhiocuart iaofnte; rt hinegreefsotrioen, poaf thieontt sfo sohdosu oldr lbiqeu tiodlsd) .to
CLmoAanRlgaC-btIesNormOrpG tsiEtouNndE ioSefIs Sv ii,nt aM amnUiinTmA BaG1l2Es. NtoE SeIvSa,l uIaMteP AcIaRrMcinEoNgTe OniFc FpEoRteTnILtiIaTYl h ave not been done. There is no evidence from vAvTeih tvgaeeem ngtaeeinrte aidBar ni1fa2o .mnr T odvhitieteharteme wrfsiohn rwi ecBh,h1 op2 c aiwostie neirntnaecti rsnbe srfaeo nsalelosod twa fbneinyidmg ,p aesreulv gepcnhnroa atdnh ucdocyiuet gsat hn(s dihtnh ocleaulu clmddta iobntitegoh neam.rd siDvl khies afipedcrdo i endtonou c ctsyaty skmh eoa prNs t eoabgmsegcesosn )ob rfade ldoc Neeofisag csnniaeiozlnt e Scsdpyu ripanapt y il tnywh faeae nnetyitkms l yoe. f.
lwointhg -atenr min curseea sine dp ainticeidnetsn wceit ho fp cearrnciciniooumsa a onfe tmheia s tthoamt avcitha,m biunt Bth12i si si sc baercliienvoegde ntoic b. eP erernlaicteiodu tso a tnheem uinad iesr laysinsgo ciated Because the nasal dosage forms of Vitamin B12 have a lower absorption than intramuscular dosage, nasal dosage
pPaRtEhGoNloAgNy CaYn d not to treatment with vitamin B12. iftnohtrerm aemsn dau rsoecf u aalda mmr aoindnimsthtei,n rwiesedtre awktleiyoe nnk.al yTs,h arela atphdaemtri eitnhniats ntsr hathotieuo lnmd roaenlsstuohl ltuysn iindnte rsraisgmtanunifisdcc authnlaetlr y imd hopisgoahrgteaern .s cAeesr u osmfh ro eVwtiutnar mninini ntgh Befo1 F2r i lgfeouvlrleeol wsa -tbuhopav neb ,la oafotted r
Pregnancy Category C: Animal reproduction studies have not been conducted with vitamin B12. It is also not known tests every 3 to 6 months to confirm adequacy of the therapy.
ewbcasyhs petehatnhectie itFaryo .lv oAvitdidat aemamqniundina BN tae1u2n t adrcnia trdinoe nqwcu eaBilurole-sacmero defn,en ttNrtaosall ltaheioradenr msaintlu cwAdrcehieaaesdsn eeh amdad vdyme uo inrnfi oniSstgc tb eipeerreneedcng e ntd oa-o naNnc eapy tr.ii enoAg nmpnaraole nuRgtnen wtsaseno oatm frw cavhoint ma Comeor nuicn.na HcBnio1 la2 wf fotfeherva cpettr r ae,r ergvepint raaroemndctuio nwcm toBimom1n2ee innsd aend Casudapmrepiflnuieils ditn rwastititrohun ci ntoidof inNvsiad osuncao lt bhbaeol t atNlceatsus,aa ptlo rSorp caresadsyue srmehbso lufyol,d rr eubmsee og svivhaelo nou fltd os abthfeee td ype acmltiiopen,n spt.tr riAamltteihndog ut oog fhe t ahincesh ta rpucatcuttiiaeotnnotsr. afonrd p naatiseanlt s are
should be consumed during pregnancy. To report suspected adverse reactions, contact Par Pharmaceutical Companies, Inc. at 1-800-828-9393.
NURSING MOTHERS Distributed by:
Vbliotaomd ilne vBe1l2. aApmpoeuanrst si no ft hveit ammilikn oBf 1n2 uthrsaint ga rme orethceorms mine cnodnecde bnytr athtieo nFos owdh aicnhd aNpuptrroitxioimn aBtoea trhde, Nmaottihoenra’sl Avcitaadmeimn yB 1o2f Par PhSaprrminagc eVuatlliecay,l NCYo,m 1p0a9n7i7es , Inc.
Science-National Research Council for lactating women should be consumed during lactation. OS270-01-02 Rev. 08/2011
PEDIATRIC USE © 2011 Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.
Intake in pediatric patients should be in the amount recommended by the Food and Nutrition Board, National Nascobal is a registered trademark of Par Pharmaceutical, Inc.
Academy of Science-National Research Council. NAS00 0243 Printed in USA 09/11
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