99-1-19
`
`lmferon®
`(iron dextran injection, USP)
`CAUTION: Federal law prohibits dispensing without prescription.
`WARNING:
`
`DESCRIPTION: IMFERON (Iron delctran lnjecUon, USP) Is a dar1< brown, slightly
`viscous sterile Uquld complex of ferrio oxyhydroxldo end low molecular weight
`dextran dorivallve In approximately 0.9% w/V eodlum chlorfdo for lntrawnous or
`Intramuscular use. fl conlalns the equivalent of 50 mg el11m1mtal Iron (as an Iron
`dextran complex) per ml. The pH of Ule solution IS between 5.2 and 6.5. Too
`mulUple dose vial also contains 0.511, wlv phenol (for Intramuscular use only).
`Electron microscopy has shown Illa molecule to have an Inner electron•donso
`Fe OOH core with a dlamolar af proxJmatlng 3 nm and an outer plastic (moldable)
`doxtran shofl willt a diameter o approxtmafely 13 nm. Almost all the Iron (98·99%)
`Is present as a stable fon1c-dell1ran ccmpfox. Toe remaining Iron ropresents a
`very weak lerrous complex.
`Therapeutic Class: Heriiatinlc
`CLINICAL PHARMACOLOGY: General, Alter fnlramuscular lnjecUon Iron dmran
`la absorbed lrom the fn/i!ctlon site into tho caplllarles and tho lymphauc system.
`Clrculallng Iron doxtr.m s removed from tho ~fasma by cells of the rottouloondothe(cid:173)
`flal syslom, whlclt spill tile complox Into Its components of Iron and dextren, The
`Iron rs lmmodlalely bound to tho avallablo protein moieties 10 form ltomoslderln
`or forriUn, the physiological forms ot Iron or lo a lesser extent 10 translerrln,
`This Iron which Is subject 10 physloloolca/ control replenishes hemoglobin and
`depleted Iron stores.
`Oextran , a polygfucoseil Is eflher me_tabollzed or excniled. NegHglble amounts ot
`Iron ani lost vla the u nary or allmenlaiy pathways aller administration of Iron
`do,clren. When Iron de>11ran Is admlnislered during hemodlalysls only negligible
`amounts may cross Iha dialysis membranes,
`The major porllon of Intramuscular ln/ectfons of Iron dextran Is absorbed wllhln
`72 hours; most of tho remaining Iron s absotbod over fhe ensuing 3 to 4 weeks.
`Staining from lnadvorlenl deposition ol Iron dextran In subGUlaneous and/or
`cutaneous flssues usually resolves or lades within several weel<s or monllls; In
`some rare Instances. however, such stains ltavo been reporlOd to por1ifst for
`several years.
`Various sltJdles Involving Intravenously administered [59Fo] Iron doxlran to Iron
`deficient subjects, some of whom had coexJst~ dlse11Se~ nave yielded helf.lffe
`
`~~~'i::11~01:f 1~¥ r~i~ 1rohno~~~~n r~: ::,~dy lh~~u~ed lagotr~~r ~:l~~d::
`soparafa the clrculatlngJ9Fe] ·Jron de~ran from the transferrln-bound [59Fok
`:~~1i~~u;n~al~iu~JI.~ It s~e~l~-~~e u~~:~t~1 ~~11~!:t~~ri-l~~~if~::jdob::O~
`represent clearance of iron lrom lhe body. Iron Is no1 easily eliminated from the
`body and accumulation of Iron can be toxic,
`INDICATIONS: Intravenous or Intramuscular Injections of Iron dextran are lndloated
`for treatment of patients with documcnllld Iron deficiency In whom oral adminis•
`!ration Is un&atlslactory or Impossible.
`CONTRAINDICATIONS: Hypersensltlvlly to the product. All anemias not associated
`with iron deliciency.
`WARNINGS: See Boxed WARNING.
`A risk of carcinogenesis may atttnd the Intramuscular Injection ol lron-cart>oltyd•
`rate complexes. Such complexes have been found under exporlmanlal conditions
`~~:~o~i~~w~~~c~~!n ~~0~t~'.g~1f:.S:~a°\~t~1~. da~3~1:1~1~dl~~:~::'~~~t lhe
`The 10110 latent portoil betwe~n the ln/eoUon of a potential carcinogen and Ille
`appearance of a tumor makes It lmposs blo to measuro occuralely the risk in man.
`There have, however, beon soveralJeports In the lllllrature describing tumors at
`lite Injection slfe in humans who ha previously received Intramuscular Injections
`of lron-carboltydrale complc~es.
`large1nuavcnous doses, such as used wlih total dose Infusions (TOI), havo been
`associated ,with an Increased Incidence of adverse eftects. The adverse effects
`frequently are dolayod (f -2 days) reaotlons typltlod by one or more of Iha following
`symptoms: arlhralglo, baokache., ohllls, dizziness, moderafe 10 hlglt fever,
`headache, malaise, myalgla, nausea, and vomiting. The onset Is usually 24-48
`hours alter edmlnlstrallon and symptoms generally subside wllhln 3-4 d!s (such
`symptoms have been well rscognlz.ed since Iran dell1ran was llrst used • fhose
`symptoms have also been reporled following Intramuscular Injection an usually
`subsldo within 3·7 days. The ollology of these reoollons Is not known, The pofontlal
`for a delayed reaction must be considered whon estimating lhe rlsl(lbenent of
`treatrnont.
`The maximum intravenous dally dose should not exceed 2 ml undiluted Iron
`dextran.
`This preparation should be used with extreme care In patients wilh serious Impair(cid:173)
`ment cl liver function .
`ft sltould not be used during tile acute phase of infectious kidney disease.
`Patients wllh rhoumalold arthritis may have an acute oxacerballon of Joint pain
`arrd swelling following the Intravenous administration ol lMFERON.
`PRECAUTIONS: General: Unwarranted lllllrapy wllll parenteral Iron will cause
`excess storage of Iron with the consequent pesslbllily of exogonous homoslderosls.
`Such Iron overload Is partlGUlarlY apt to occur In patients wflh hon,oglobfnopathles
`and olhor refractory anemias tfiat mlgnl be erroneously diagnosed as Iron dofl•
`ciency anemias.
`IMFEAON should be used with caution in individuals with histories of significant
`allergies and/or aslhma.
`Epinephrine should be Immediately available in the event of acute hypersensitivil)'
`reactions. (Usual aduh dose: 0.5 ml of a 1 :1000 solution, by subcutaneous or
`Intramuscular In/action .) Noto: Patients using bota•blocklng agents may not re(cid:173)
`spond adequate y to eplnephrlno. lsoproterenol or similar beta-agonist agents
`may be required In those paUonts.
`
`Reports In the literature from ccunhws outside fho United States (In particular,
`Now Zealand) have s~~ested that the use of Intramuscular Iron dextran In neonalos
`~~! ~e;_ •~1_c1i~1i efferi/7r~~r~~!ei~~~1~~1~8~3~1/i'f i~e~R:~ef ~a~~
`been reporled.
`~:~~f~~~o:9:g~i:i:~e~rf~ l~:11i:s on~:Rgt_advlsed of the potential adverse
`Drug/l./Jbo111tory Tosi Interactions: Large doses of Iron d8X1,ran 15 ml or more)
`have been reported to give a brown color to serum from a blood sample drawn
`4 hours after admlriistrallon.
`The drug may cause falsely elevated values of serum blllrubln and falsely decreased
`values of serum calcium.
`Sorum Iron delllrmlnations by colorimetric asseys may not be meanlngtUI fer 3
`weeks following the administration of Iron dexlran, particularly after largo Intraven(cid:173)
`ous doses.
`Serum terrllin peaks approxlmalely 7 lo 9 days after an Intravenous dose of
`IMFERON and slowly returns lo normal after about 3 weeks.
`Examination of the bona marrow lor Iron stores may not be meanlnglul for
`prolonged periods followlno Iron dextran therapy because residual iron dextran
`may remain In the retlculoondothellal cells.
`Prolongation of lite partial fhromboplastin time has been reporled 10 occur after
`lnfrevenous admlnjslrallon of Iron dextran wlten the blood sample for the test Is
`mixed wllh anticoagulant citrate dextrose solutlon, USP. This lnterteronce appa(cid:173)
`rently does nol occur whon anllcoagulanl sodium citrate solution, USP Is used.
`Bloo{Hyplno and cross-matching are 1101 affected by Iron dextran.
`Bono soans lnvolvfng 99mTc-dlpltosphonate have boon reporled to snow a dense,
`croscontlc area of activity In the buttocks. follbv.ng the contour of the Iliac crest,
`I to 6 days after lnlramusGUlar Injections ol lMFERON.
`Bone scans wllll 99mTc-fabeled bone seeking agents-, in the presence ol high
`serum ferrllln levels or following Iron dextran Infusions, have been reported to
`:~~~d1Yi~r a~~~J;~Jii~~·· marked renal actlvily, and excesslvo bloOd pool
`Caution should be used In interpreting resulls of serum Iron measurements when
`~l°l'JFi~"b~~s are obtained within 1 or 2 weeks of admlnislrallon of large doses
`
`Carcinogenesis, Mutagenes/s, Impairment al Ferl/1/fy: See WARNINGS,
`P199nancy: Pregnancy c.reoory C. IMFERON ltas been shown to be teralogonlc
`and ambrygcldal In mloe, rats, rabbits, dogs, and monkeys when given In doses
`ol aboul 3' limes the maximum human dose. No conrilstont adver.;e fetal elfecta
`were observed In mice, rafs, rebbjts, dogs and monkeys al doses of 50 mg
`lrolll1<g or lass. Felal and malomal tol!lclty has been reported In monkeys at a
`total lntrawnous doso of 90 mg Iron/kV over a 14 day period. Similar ofloots
`were obser,od In mice and rats on admlnistrallon of a single dose.01125 mo
`l~~l~~-!~1~1g~tW,"J1~~f~~i~.tn~ 1~g;o Y:i ~:r~~ ~~~~e1c~1n~5f h:~
`are no adequate and woll•controlled sludles In pregnanl women, IMFERON should
`~,:' 1~~re~~r1ng pregnancy only ~ the pdlllnllaf benefit jusflfies lhe polllnti.!I risk
`Placental Trans/an Vatlous animal studies and studies In pregnanl ltumans have
`der)lonstralod Inconclusive results wllh respecf lo the plaeonlaf transfer of Iron
`doxlran as Iron dextran. II appanr1< lhal some Iron does reach lho lotus, but the
`form In whlolt II crosses the placenta Is not clear.
`Nursing Mothers: Caution sllould be e<erelsed when IMFERON is administered
`10 A nursing woman. Only tracps of unmetabollzed iron dextran are excreted in
`human milk.
`Pod/atria USilge: Nol recommended for use In Infants undnr 4 months ol age (see
`OO§AGE ANO ADMINISTRATION) .
`..ADVERSE REACTIONS: Seve11J/fahll: Anaphylacllc reactions have been reported
`Wilh lite use of IMFERON; on rare ocoaslons ,these reactions nave boen fatal.
`Suclt raactlon,. which occur most often within the first several mlnufes of admin(cid:173)
`istration, have boon generally charactarlzed by sudden onsot of respiratory difficulty
`and/or cardiovascular collapse. The Incidence of tltese acute ltypersenslUvllY reac(cid:173)
`tions has been estlmalad between 0.2% lo 0.3% . (See boxed WARNING and
`PRECAUTIONS , Gonoral, l)<lrlalnlng to in,medials avallablllly of epinephrine.)
`Mlld/,noderete: Oelayed reacUons (see WAR~INGSJ. Toe Incidence of dolayod
`reactions reported In a longfludlnal study of pallnnla given multiple Intravenous
`lnjeetlons of IMFERON, usually 5 mL or greater, was appmxJmalefy 8% (4% ol
`the !Olaf number of lnjec1Ions gJven) ,
`Other sysfemle/loca/: Isolated or multiple signs/symptoms wltlt varying severity
`·
`have been reported.
`Cardiovascular. Chest pain, shock, hypotenslon, lachyc.irdla, /lushing.
`(Flushing and hypotenslon may occur from too rapid lnJocUons by lhe I, V. route.)
`·
`Ocrmalologlc: Urti<;aria, prurllus, purpura, rash.
`Gastrointestinal: Abdominal pain nausea, vomiting, diarrhea.
`Hematologlc/lympltalfc: Leucocylosls, lymphadenopaihy (gonorally Inguinal and
`assoclalad wllh I.M. Injections).
`Musculoskeletallsolt tissue: Artltralgla . arthritis (may repres,,nt reactivation In
`seo PRECAUTIONS, General),
`patients v.lh quiescent rheumatoid arthr1tls -
`rnyalgfa, Including backauhe; absC9ss formation (storllo); neorosls; atrophy/fib(cid:173)
`rosis (1.M. injection silo): cellulllls, swelling; btown skin and/or underlying
`tissue dlscolerallon (staining) (See vONICAl PHARMACOLOGY), soreness or
`pain al or near Intramuscular lnlec1Ion sites,_ which In some Isolated lnsrences
`was reported to persist for over a year; variable dngree ot inflammation; local
`pltlobllls al or near I. V, Injection site.
`Nourologtc: Convulsions (may accompany anaphylaxls) , syncol)<I, headache,
`weakness, pareslhesla, fob1llo oplsodes, chills.
`~:rc11~f ~~:,~~~~~~spasm, (fyspnea.
`Mls~laneous: Fobrllc oplsodes, swea\lng, chills.
`
`• The human duso presonted hore Is lho loin! Iron required for treating ao Iron
`deflclonf state In a represontallve patient, ihe calculatron reprasenls a 50 kg
`patient wllh a hemoglobin value of 8 g/dl requiring 30 rnL ol lMFERON or 150
`mg Iron - equlvalanl lo 30 mg/kg,
`
`• 1
`
`

`

`lmferon®
`(iron dextran injection, USP)
`OVERDOSAOE: Ovemosage wllh IMFERON Is unlikely to be associated with any
`acute manllestatlom Exa,1sslve doses of iMFERON beyond the requirements for
`to
`load
`restoration of homoglobln and fl!Plonlshment of iron S1ores, m&l
`hemoS1derosls. forloalc monltorlng of sorum femtin levels may be helpful In
`recognizing a doleterlous progressive accumulation of Iron resulting from Impaired
`u~like of Iron from the retlculoendolhellal system In concurrent me~lcal oondtllons
`such as chronic' renal failure. Hodgkins disease, and rl1eumalold arthritis, The
`LD50 ol lMFERON is not less than 500 mg/kg In th8 mouse .
`Dlalysls · (!. sludy·of (59Fel Iron dexl11':11 utilizing Isotonic 6illlne in a 4•hour In
`vitro dialysis nm, lnd1C11tcd that Im than Q.5% of the Injected radlolabeled Iron
`dextran traversed the dialysis rnombraoo.
`DOSAGE AND ADMINISTRATION: Oral iron sllauld be discontinued prior to admln•
`lstrallon of IMFERON,
`OOSAOE
`I. Iron Oeliclenty Anemia
`Periodic hematologlo delermlnatlon (hemo.globln and homalocrH) Is a simple and
`accurate technique for monitoring hemato)Oglcal response, and should be used
`,. a guide In theropy. It shoutd be recognized that Iron storage may lag behind
`lhe appearane'o of nonmal blood morphology. Serum Iron, lolal Iron binding
`capaqty (TIBC) and percenI saturallon of transfemn aro other Important tests for
`detoctlng and monitoring the Iron dollcient state .
`After admlnlstrallon ol Tron dextran complex, ovldenoo of a lheropeullo response
`can be seen In a few days as an Increase In tho rellculocyte count. If lhore has
`nol'been a 1 gram per 100 mL rise In hemoglobin within 2 woeks of starting Iron
`deKtran lherapy, Iha diagnosis' of Iron deffclency anemia should be reviewed.
`Allhough ·serum ferrilln ls usually e good guide 10 body Iron stores, the correlallon
`of b.ody Iron stores and serum lerritln may not be valid In patients on t:1uonIc
`rooal dla1Y1]Is who aro also reoelvlng lrun deldran comptox,
`Although f11ere ore slgnlllcant varlallons In body build and weight dlstrtbution
`amona mates and fomalos, tho accompanying tobla and formulae reproseni a
`oonvenltinl ml)3J1s for eetlmallng the total Iron required . This total Iron requireJTicnl
`reflects the amount of hon needsd to restore hemoglobin concenlratlon lo normal
`or near normal levels plus an additional allowance to provide adequate replenish•
`ment of Iron stores In mosi Individuals wtth modorately or severely roduced levels
`of hsmogloblo. It sllauld be reinembfred that Iron deflclenoy anemia will nol
`ar,pear unlll esaentlally all Iron stores ~ave been depletsd. Thorapy, lhus, should
`am al not only replenishment ol homO{llobin iron but Iron stores as well.
`•
`Factors contrlbullrig to the formula are ~hown below.
`x o hemoglobin
`mg Iron
`_ ml blood_
`JTig blood Iron
`lb bOdyweiaht ~ g nemoglobln
`lbbody\\!!lght
`a) Blood volume ...................................................... .. 7.0% body weight
`
`b) Nonmal ~!~~~ot~(~r:r.f~.~~'.~).: ............ ........ . 14.8 g/100 ml
`15 kg (33 lbs,) or less .. .. .. ................................ 12.0 g/100 ml
`c) Iron content of hemoglobin .. .. .................. .................. .. .... : .. .. 0.34%
`d) Weight
`Bassd on lhll above raotors, in<f'lvlduals with normal hemoglobin levels will have
`approxlmaloly 35 mg or blood lro,1 per ~logram ol body wolghl (16 mg/lb).
`Note: The tnblo.and accompanying lo1TT1u)ru, are applicable for dosage det,rmln;,tlons
`on[Y In patlentn wiU, Iron deflcloncy anemia; U1ey ara not 10 be used tor dosage
`dete1TT1lnatlonsi n paflcnls requiring iron replacement for blood loss.
`TOTAL DOSE OF IMFERON IN ML
`Observed Hemoglobin g/dl
`
`Body Weight
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`kg
`
`5
`to
`15
`20
`25
`30
`35
`40
`45
`50
`55
`60
`65
`70
`75
`80
`85
`90
`95
`100
`105
`110
`115
`120
`
`lb
`
`11
`22
`33
`44
`55
`66
`77
`88
`99
`110
`121
`132
`143
`154
`165
`176
`187
`198
`209
`220
`231
`242
`253
`264
`
`3
`6
`9
`15
`19
`23
`27
`30
`34
`38
`42
`46
`50
`53
`56
`59
`62
`65
`67
`70
`73
`76
`79
`81
`
`3
`6
`9
`14
`18
`21
`25
`29
`32
`36
`39
`43
`46
`50
`53
`55
`58
`60
`63
`65
`68
`71
`73
`76
`
`3
`5
`8
`13
`17
`20
`23
`27
`30
`33
`37
`40
`43
`47
`49
`51
`54
`56
`58
`61
`63
`65
`68
`70
`
`2
`5
`7
`12
`15
`19
`22
`25
`28
`31
`34
`37
`40
`43
`45
`48
`50
`52
`54
`56
`58
`60
`62
`64
`
`2
`4
`7
`11
`14
`17
`20
`23
`26
`29
`31
`34
`37
`40
`42
`44
`46
`47
`49
`51
`53
`55
`57
`59
`
`2
`4
`6
`to
`13
`16
`18
`21
`24
`26
`29
`31
`34
`37
`38
`40
`42
`43
`45
`46
`48
`50
`51
`53
`
`2
`3
`5
`10
`12
`14
`17
`19
`21
`24
`26
`29
`31
`33
`35
`36
`37
`39
`40
`42
`43
`44
`46
`47
`
`1
`3
`4
`9
`11
`13
`15
`17
`19
`21
`24
`26
`28
`30
`3t
`32 •
`33
`35
`36
`37
`38
`39
`40
`41
`
`OO&alJll was calculated using the fo1TT1uln: Dose = 0.0476 x W x (Normal H -Ob·
`servoa H) + 1 ml per 5 ko to a maximum ol 14 ml for Iron slllrBS.
`Adults and Chlld~n over 15 kg (33 pounds):
`, ~: Po1:8~s1a~~;,lmd may bo calculaltd. 11 lhc patitmt'S body wnlghl In kilngr.,ms
`Is W and the hemoglobin levol Is H g/dl:
`11) + lroo storus.
`Dose of IMFERON in ml required ~ 0.0476 x W x (14.8 -
`Add 1 mLIMFERON lor ""ch 6 kJ.l IJOdy wt1lpht 10 provide lor tho replonlshmcnt of
`Iron stores to a maximum of H ml.
`For weight In pounds use lhe factor 0.0216.
`
`Children 5•15 kg (11-33 pounds):
`See Dosage Table.
`All.omatlvely the I01a1 dose may be oalcuJatod.
`IMFERON should not normally bo given In fho first four months of Ille.
`If t11e child's body weigh! In kilograms Is W and homoglobln lnvet Is ti Qldl:
`Dose ol lMFERON required In ml = 0.0476 X W x (t2 - H) + Iron slDres.
`Add I ml IMFERON for each 5 kg bDily wolghl to provldo for Iha roplenlshmonl
`DI Iron stores lo a maximum of 14 mL
`For weight in pounds use the factor 0.0216.
`II . Iron Roplacrimonr for 8/aod Lass
`Somo Individuals sustain blood losm on an Intermittent or repetlliva basis. Such
`blood losses may occur pertodlC11lly in patient• with hemorrhagic dlolhoses (lamlllal
`telanglectasla; hemophllla; gastrolnte,UnBI bleeding) and on a repetitive basis
`from prooedures such as renal homodlalysls·.
`Iron tllorapy In these patients should be directed toward replacem·ent ol the
`oqulvalant amounl of Iron ropresonlod In the lest brood. The table and lormula
`presented undor Iron doffclenoy anemia are no/ applicable ror simple Iron reptaco(cid:173)
`ment valuos.
`Ouonlltative estlmales of tho Individual's periodic blood loss and hematocrll during
`tho bleeding episode provide a convenient method for 1he calculaUon of the
`required Iron dose.
`The foflTIUI~ shown below is based on the approximation that 1 ml of normocytic,
`normochromic red coils contains 1 mg of elemental Iron:
`Replacement Iron Qn mg) = Blood loss (In ml) x hematocrlt
`Example: Blood loss of 500 ml wfth 20% hernatocril
`Replacement Iron = 500 x O .20 = 100 mg
`IMFERON dose = 100 mg= 2 inl
`w-
`.
`Admlnlatrallon
`The lotal amount ol lMFERON required for the treatment of Iron dellcloncy anom/a
`or . Iron ropJacomonr for blood loss is determined from lhe table or appropriate
`form4ta. (Seo Dongo.)
`I. fnlrovenous Infection
`Prior lo rooe/ving lholr llrsl intravenous IMFERON therapeullc dose, ell patienls
`st,ould be olvon an Intravenous /es/ dose of 0.5 ml. AIU1ouoh anapIIylacllc
`rcacUoo s known to occur following IMFEAON _administration are. llSUally evldMt
`within a few minutes, er soonor It Is reoommended that a l)Oriod ol an hour or
`longer efap"' bolore tho remainder al the lnllial therapeuUo dose i1l given.
`Individual doses of 2 ml or less may be given on, daity-baals until the Clllculat•d
`total amount required has been reached. IMFERON is given undiluted and slowly
`.
`(1 ml or loss por minute).
`fl. lntnunuscu/ar lnjMJr/on
`Prior to rrlC!llvlng their first intramuscular IMFERON therapoullc doso, all patlants
`should be given ;n lnlramuseular lost dose of Q.5 ml, administered In tho same
`be(ow. Although
`recommon~ed lost site and by
`anaphylactl~ roacllons known
`usually evident within a few m
`an hour or long or ela~e hefore the remain .er ol lhe nH!el thorapeulk: doie le given.
`IMFEROfl can·be given according to tho
`II no advorse reactions are obse,wd
`followtng schodulo unlll the calculatod total amount required has been roached .
`Each doy's· dose should ordlnarllv not cxC!led 0.5 ml (25 mg·or Iron) for lnfanl6
`undar 5 ko (J1 lbs .J; 1.0 iol 150 mg ol lron) lor children under 10 kg (22 lbs,):
`and 2.0 ml too mg of Iron) lor olher patienls.
`Dally doses larger than those have been associated with an lncroa5ed number ol
`roports of delay•d reactions and should be utlllzod only In those s11uatlons wh,ero
`the potential benefits ctaarly outweigh the Increased risk. A dally dose of S ml
`.
`should not be exceeded.
`IMFEAON should be Injected only Into lhe muscle mass olthe upperouIerquadranl
`and should be
`never lnlo the arm or other exposed areas -
`of the bullock -
`Injected deeply, IYllh a 2-lnch or 3,lnch 19 or 20 gauge needle. If lhe patient Is
`standing, ho/she should be bearing hls/hor wolght on the leg opposite the ln}eotlon
`site, or If In bed, he/she should bo In tho lateral posltlor with lnlectlon site
`uppermost, To avoid in/oellon or leakage Into the suboutaneous llssuo, a Z-track
`toctinlquo (dlsplacemen of the skin lalerally prlorlll lnjeotlon) Is recommended.
`NOTE: Do not mix IMFERDN with olher medications or add to parenteral nutrition
`solutions for Intravenous Infusion.
`HOW SUPPLIED:
`For Intramuscular or Intravenous use:
`~Bel D~g:'~5~f6es of to:
`For Intramuscular use ONLY:
`10 ml muIUpIo doso viol containing
`g•J~ ~i~~2~Mrescrvalive. boxes of 2:
`
`·
`
`CAUTION: Federal la"". prohibits dispensing wilhout prescrlpflon.
`Store at room temperature, preferably below 86°F. Do not freeze. Keep out of
`the reach of children.
`
`f ,so~a~aceuticals
`
`Rochester, NY 14623 USA
`IMFEAON and FISONS are Registered Trade Marks
`.
`of FISONS pie
`C> Fisons pie 1987, 1989
`
`Made in England
`
`Revised 5/89
`RF 042
`
`