H EALTH ALERTS

were sold as decorations for cards, collages, mem-oryboxes, scrapbooks, invitations and giftbags. Thecharms also can be attached to necklaces andbracelets.The charmswere sold at Milchaels stores from July

2002 through February 2005, at Recollections storesfrom October 2004 through February 2005, and atHancock Fabrics stores from January 2004 throughJanuary 2005 for $3 to $4.Consumers should take these metal charms away

from chfldren and contact Hirschberg Schutz & Co.at (800) 873-5506 to receive a refund. Formore infor-mation, e-mail charmsrecall@horizongroupusa.com.

DIvO SUCkSDollar General

Corp., of Goodletts-ville, Tenn., is recall-ing 180,000 divestick packages be-cause children canfall or land on these

upright dive sticks in shallowwater and suffer imnpale-ment injuries.

The U.S. Consumer Product Safety Commissionbanned pre-weighted dive sticks in 2001.The dive sticks are hard plastic in the shape of

worms, fish and seahorses. Theywere sold at DollarGeneral stores nationwide from April throughSeptember 2004 for $1.Consumers should take these dive sticks away

from children and return them to Dollar Generalstores for a refund or discard them. For more infor-mation, contact Dollar General at (800) 678-9258or visit www.dollargeneral.com.

Musical toyrs

_|_I~~~~~~~~~~~~~~~~~~~

DollarTree Stores Inc., ofChesapeake,Va., is recall-ing 147,600 "Toy Tunes" electronic musical toysbecause the ball on the end of the drumstick soldwith these toys can break off during use, posing a

choldng hazard to young children.No incidents have been reported.The recall includes two styles ofbattery-operated,

electronic musical toys. The multicolored toys camein the shape of a drum and a xylophone, and weresold with a drumstick.The toys were sold at Dollar Tree, Only $1 and

Dollar Bills stores nationwide from March 2004through January 2005 for $1.Consumer should take these toys awayfromyotn.g

children and return the recalled toys to the storewhere purchased for a refund. For more informa-tion, call Dollar Tree Stores Inc. at (800) 876-8077.

PacMeirsTodo DollarWholesale,

of Los Angeles, Calif., isrecalling 102,000 Flash-ing Pacifier withWhistleNecklaces and FlashingPacifier Shock BabyNecklaces because thenipple can detach from

the pacifiers,psn a choking hazard to youngchildren.No injuries have been reported.The recailled pacifier necklaces consinsit of a

multicolored cord with a plastic pacifier that camein assorted colors.IThe nipple oftheWhistle Necklacepacifier is the whistle, which contains a hole at thetip to be used as a blow hole. The pacifier handleoperates as the on-off button for the flashing lighton both pacifiers.The pacifiers were sold on the Internet, from

distributors and at small retail stores from Januarythrough November 2004 for $1.

Consumners should return the pacifiers to the storewhere purchased for a refund. For more informa-tion, call Todo DollarWholesale at (866) 325-4732.

Metal charms_ ~~~~Hirschberg

Schutz & Co. Inc.,

recalling 2.8 mil-

b;=, X= ~lionmetalcharmsbecausetheycon-tain high levels oflead, posingaseri-

ous risk of lead poisoning to young children.The U.S. Consumer Product Safety Commission

has received one report of a 6-year-old girl whomouthed these charmsworn on ahomemade neck-lace. She developed elevated lead levels in her bloodthat may be related to the charms. Lead poisoningin children is associated with behavioral problems,learning disabflities, hearing problems and growthretardation.The recalled metal charms were sold under the

name "CharmIingThoughts." Mostofthe charms aresilver-colored with small silver loops and were soldin packages oftwo to 12 pieces.The metal charms are various shapes, and some

have small blue, pink or yellow stones. The charms

36 AAP News www.aapnews.org April 2005

Use booster seats to keep kids ages 4 to 8 safe in carsMotor vehicle crashes are the leading cause of death

for children of all ages, yet only about 21% of kids ages 4to 8 years ride in booster seats, according to a recent_study from the National HighwayTraffic SafetyAdministration.

Parents may not realize that children who are notprop-__erly restrained in an accident can be hurled out of the carmuch like a missile.A booster seat helps elevate children so the car's safety

beltfits snugly atthe shoulder and pelvis. Studies showthatyouthswho ride in boosters are 59% less likelyto be injuredin a crash than children improperly restrained.A belt-positioning booster seat should be used once a

child has reached the top weight or height allowed for his forward-facing child safety seat, his shoulders are above thehamess slots or his ears have reached the top of his car safety seat (around age 4 and when he weighs at least 40 pounds),according to the American Academy of Pediatrics.When checking the fit of a booster, remember to position the belt across a child's shoulders and hips, not the

abdomen. Be sure the shoulder belt crosses your child's shoulder and does not cut across the neck. The lap beft shouldbe low and snug across the thighs. The child should fit against the vehicle's seat back with his or her feet hanging downwhen the legs are bent at the knees.

Although boosters with shields may meet federal standards for use by children who weigh 30 to 40 pounds, theAcademydoes not recommend their use.

The Academy advises that a child no longer needs a booster seat when the vehicle's seat belts fit the child correctly.The shoulder belt should lie across the chest, not the neck or throat. The lap belt must be low and snug across thethighs, not the stomach. In addition, the child should be tall enough to sit against the vehicle seat back with her legs bentat the knees and feet hanging down. An aduft seat beft usually will fit a child when he or she reaches about 4-feet, 9-inches tall and is 8 to 12 years of age.

The Academy and other organizations offer the following advice on booster seat usage to parents and caregivers:* Properly restrain children on every trip, including when children ride in cars driven by out-of-home caregivers.* Always use the appropriate restraint -properly fitted and installed -for a child's age and size.* Children under age 13 should sit in the back seat.

H EALTH ALERTS

front or back of the walker.Toy and juvenile product stores nationwide sold

the walkers for $15 to $25. Model 9026 walkerswere sold from June 1998 through December 2002,and all other models were sold from December 2003through December 2004.

Consumers should return the walkers to theretailer where purchased for a refund. For moreinformation, call Big Save International Corp. at (800)626-9393.

Baby outerwear

The stuffed bunny wears a skirt or overall shortsin various colors, including purple, turquoise andpink. The skirt and overall shorts are decorated withheart and flower buttons. The eyes are round blackbeads.The toys were sold at discount and dollar stores

from February 2002 through March 2003 for $1.Consumers should take the toy away from young

children and return it the store where purchased fora refund. For more information, call Ocean DesertSales at (800) 252-1931.

Electric scootersSpartan Sports, of t

King of Prussia, Pa., is r5frecalling 4,300 electric l:scooters because aknob can loosen andcause the handlebar to _detach from the _scooter. Additionally,_the folding joint lock on the model FS-101 scootercan break, causing the handlebars to release fromthe upright position. Both hazards can cause therider to lose control and fall.The company has received 28 reports involving

the scooters' handlebars, including one report of achild who suffered a broken arm after falling.The recall involves models FS-101 and FS-102

Spartan Sports electric scooters, which are poweredby 250-watt electric motors and made of steel. Themodel numbers do not appear on the product butare on the users' manual. The scooters haveadjustable handlebars, collapsible parts and a

stepping plate and kick stand attached to the base.The scooters were sold in black and blue with a

black kick plate throughWeb sites operated by GSICommerce Solutions from October 2002 throughJune 2004 for $240 (Model FS-10O1) and $194 (ModelFS- 102) .

Consumers should stop using the product and call(866) 316- 4812 to receive a free repair kit.

Denim jumpersHIS International, t0

of New York, iS- _X

re call1i ng 6,7 0 0 -;denim jumper setsmbecause the paint on 3the buttons containsexcessive lead levels, -posing a lead poisoning hazard to young children.No injuries have been reported.The recalled denimjumper sets are made of I100%

cotton and were sold in three styles. Style number2814X is a long sleeve body suit with a flower applique'jumper. Style number 2817X is a striped turtleneckwith aheart pocketjumper, and style number2818Xis a long sleeve body suit with a patchwork jumper.The jumper sets were sold at Kmart Stores nation-wide from July to November 2004 for $13.

Consumers should return thejumper sets to Krnartfor a refund or replacement. For more information,call HIS International at (888) 467-3990 or visitwww,nokidding-his.com.

See Health Alerts, page 44

|||_ g W W X Wal-Mvart Stores* %1-; LDx_r_L\Inc., of Bentonville,^_ ~~~~~Ark., is recalling

0{_ ~~~~54,260 Reef Rocker| | ~~~~~infant toys because08 tx ~~~~~the seam on the plas-

tic balls can separate,releasing the small toy inside and posing a chokinghazard to young children.No injuries have been reported.The recalled Baby Connection Reef Rocker is a

floor toy intended for children ages 3 months andolder. The toy's water-filled dome and four toy ballshave colorful sea creatures inside. Lights and musicare activated when the toy is shaken.The toys were sold at Wal-Mart stores nation-

wide from May 2004 through January 2005 for $8 to$10.Consumers should take the toy away from small

children and return it to Wal-Mart for a refund. Formore information, callWal-Mart at (800) 925-6278.

Baby hammocksPlaytex Products Inc., of

Westport, Conn., is re- _calling 32,000 Hip _Hammocksbecausethe_shoulder strap support_can detach from the harn-_mock, causing the baby to _fall.

__ ~~~~~Lands'End,_ 5 _ ~~~~~ofDodgeville,

n -0 _ ~~~~Wis., is recalling_ . ~~~~~_ 24,000infantand_ vSia t~~oddler jackets,

. * _ ~~~~snowsuits and_ ffi > bibs~ibecause the

rubber zipperpull-tab can be bitten off, posing a choking risk toyoung children.The company has received four reports of tabs

being chewed off, without injury.The recall includes the following garments and

style nurnbers: infant squall parkas, style 94648; infanthooded sport squall, style 94650; infant squall snow-suit, style 94654; infant squall bib, style 94652; tod-dler squall parka, style 94649; toddler hooded sportsquall, style 94651; toddler squall snowsuit, style94655; and toddler squall bib, style 94653.The outerwear was sold through Lands' End cat-

alogs and via the Internet from August throughDecember 2004 for $54.50 to $79.50.

Consumers should cut off the fabric zipper pulland throw it away. For more information, call Lands'End at (800) 200-6212 or visit www.landsend.com.

Plate set

The company has received two reports of shoul-der straps detaching from the infant carrier. Noinjuries have been reported.The recalled infant carriers include model num-

bers 05300, basic blackHip Hammock; 05301, deluxeblack Hip Hammock; and 05302, deluxe navy blueHip Hammock.The hammocks were sold at juvenile product and

discount stores nationwide as well as through cata-logs and Internet sites from June 2004 throughFebruary 2005. The basic model sold for $40 and thedeluxe model for $60.

Consumers should stop using the carrier and con-tact Playtex Products Inc., at (800) 522-8230 or

www.playtexbaby.com, for instructions on return-ing the carrier for a replacement.

Baby walkersBig Save Inter-

national Corp., of Los_ ~~~~~~~Angeles, Calif., is recall-_ ~~~~~~ing12,000 baby walk-_ ~~~~~~ersbecause thewalkers__ ~~~~~fitthrough a standard

doorway and are notdesigned to stop at theedge of a step. Ad-

ditionally, these walkers can tip over. Babies usingthese walkers can be seriously injured or killed.No injuries have been reported.Big Save babywalkers with model numbers 9026,

9028, 9090, 90110 and 90111 are included in thisrecall. The model number is printed as the final dig-its on a bar code number and may appear on the

g i ~~~~~~~~GiftcoInc.,ofVernonHills,Ill., is recalling

<>.".¢>Wv 0- ~26,157 Winnie__ ~~~~~~~thePooh plate_ " _ ~~~~~~~~setswith plas-

tic forks andspoons because the plastic fork prongs can break,posing a choking hazard to young children.The companyhas received three reports ofthe fork

prongs breaking with one child choking on a pieceof the fork, without injury.The plate sets were sold at school holiday shops.

Consumers should return just the fork or the entireplate set to Giftco for a full refund. For more infor-mation, call Giftco at (888) 448-6728.

Stuffed yarn bunnya.j, #

Ocean Desert Sales:: <SSv ; ::3 Inc. of Philadelphia,

j 0; S ~~~isrecalling 18,500_ E b ~~~~~stuffed yarn bunnies

because the eyes and| _ o~~~~~ecorations can de-

_ ~~~~~~tach,posing a chok-ing hazard to young children.No incidents have been reported.

April 2005 www.aapnews.org AAPNews 37

Infant tov

Health Alerts Continuedfrom page 37

inadeqtuate to accept or rejec a causal relation betilee these corddions and vaccines containing tetanus and/ordiphtheria toxoids.' In the differential diagnosis of polyadicuoneuropathies fdoHowng admrinistration of a vaccirnecontaining letanus toxoid, tetanus toxoid should be cDnsidered as a possible etiohogy.7POSTMARKETiNG REPORTS Additional adverse events reported between 1998-2003 during post-approval use ofTetanus ard Diphthena Toxoids Adsorbed! For Adutt Use, mnanufactured by Aventis Pasteur Irn- irilude bcal reactionat in,ection sfte (ie, swfelling. redness, warnth. oeOubffis). rnyalgia, arthrakgia, muscle sffHness, nausea. vomiting, paraes-thesia, dizziness, convulsions anbd rash. Events were indoded in thi lis because of the seriousness or frquency ofreporting. Because these events are repDrted voluntarily from) a population of uncertain size, it is not always possible toreliably estimate their frequencies or to estabsh a causal relationiship to cornponents of Tetanus and Diphtheria ToxoidsAdsorbed. ForAduR Use, manufactured by Aventis Pasteur inc.'

DOSAGE AND ADMINISTRAI,ION Parenteral drug products should be inspected visually for extraneous particulatematter and/or dfiscohoration prior to administration, whenever solution and container permit. (See DESCRIPTIONsection.) It these conditions exist, the vaccine should riot be administered.SHAKE SYRINGE WELL before si&vinistering the vacdirw. The vaccine. after shaking, is a turbid liquid, whitish-grayin color. Discard syringe containing vaccine if the vaccine cannot be resuspenlded.Before injection. the skin over the site to be injected should be cleansed with a suitable germicide.Inject 0.5 mL intramusculariy in the area of the vastus lateralis (mid-thigh laterally) or deltoid. The vaccine should notbe injected into the gluteal area or areas where there may be a major nerve trunk.Do not administer this product intravenously or subcutaneously.The needle length should be suffcient to deliver the vaccine intramuscularly. but not so long as lo involveunderlying nerves and blood vessels or bone. The health-care professional should determine the appropniate sizeand length of the needle for individual patients.PRIMARY iMMUNIZATION DECAVAC vaccine is approved for administration in persons 7 years of age and okWerwho have not been immunized previously against tetanus and diphtheria, as a prmary immunization se-ries of three0.5 mL doses. Fof primary immunization with Td vaccines, the intervals between doses recommended by theAdVisory Commitee on Immunization Practices (ACIP) are 4 to 8 weeks between the first anwd second dose, and 6to 12 months between the second and third dose.2DECAVAC vaocine may be used to complete the primary immunization series for tetanus and diphtheria in children7 years of age or older who have received one or two doses of whoe-cell pertussis DTP, DTaP and,'or DT vaccinte.However, the safety and efficacy of DECAVAC vaccine in such chlAdren have not been evaluated.Inteffuption of the recomrnended schectule with a delay between doses should not intetfere with the final immunityachieved with DECAVAC vaccine. There is no need to start the series over again. regardHess of the time elapsedbetween doses.'RiOUTINE BOOSTER IMMUNIZATION DECAVAC vaccne is approved for booster immunization in persons 7 yearsof agte and older who have completed primary immunization against tetanus and criphtheria.A booster dose of Td is recommended by the ACIP in persons 11-12 years of age if at least 5 years have elapsedsince the last dose of tetanus and diphtheria toxoid-containing vaccine.' Subsequent routine boosters with Td arerecomrnended every 10 years.'- 9 If a dose is given sooner than 10 years, as part of wound managernent ot onexposure to diphtheria, the next booster is not needed for 10 years thereafter.;MlORE FREOUENT BOOSTER DOSES ARE NOT RECOMMENDED AND MAY BE ASSOCIATED WITHINCREASED INCIDENCE AND SEVERITY OF ADVERSE REACTIONS!- I (See WARNINGS secfion.)DIPHTHERIA PROPHYLAXIS FOR CASE CONtACTS The ACIP has published recornmendations on vaccination fordiphtheria prophylaxis in individuals who have had contact with a person with confirrned or suspected diphtheria.'TETANUS PROPHYLAXIS iN WOUND MANAGEMENTThe need for active immunizahon with a tetanus toxoid-con-taining preparation. with or without passive immunization with TIG (Human) depends on both the concitionl of thewound and the patient's vaccination history (Table 1).A thorough attempt must be made to determnine whether a patient has completed pnimary immunization. Individualswho have completed primary immunization against tetanus, and who sustain wounds which are minor anduncontaminated, should receive a booster dose of a tetanus toxoid-containing preparabon only it they have notreceiveid tetanus toxoid within the preceding 10 years. For tetanus prone wounds (eg, wounds contaminated withdirt. feces, soil, and saliva; puncture wountds; avulsions; and wounds resulhng from misslRes, crushing, bums, andfrostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within thepreceding 5 years. If a booster dose is given soonter than 10 years as paft of wound managemnent, the next routinebooster should not be given for 10 years thereafter.Individuals who have not coDmplete p,mary immunization against letanus, or whose immunization historyis unknown or uncertain, should be immtrunized with a tetanus toxoid-containing product. Com,oletion of primaryimmunization thereafter should be ensured. In addibon, it these inctividuals have sustained a tetanus-prone wound.,the use of TIG (Human) is recommended. TIG (Human) should be administered at a separate site, with a separateneedle and syrnge! accorcing to the manufacturer's package insert. If a contraindication to using tetanus toxoid-containing prepatations exists in a person who has not completed a pnmary immunizing course of Meanus toxoidand other than a clean, rninor wound is sustained, only passive immunization with TIG (Human) should be given,'Td is the recommended preparation for active tetanus immunization in wound management of patients 27 yearsof age.7 In such persons. a preparation coDntaining tetanus and diphtheria toxoids Is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection. DECAVIAC vaccine is approved for wound managernent inpatients 7 years of age and older,

TABLE 12 SUMMARY GUIDE TO TETANUS PROPHYLAXIS IN ROUTINEWOUND MANAGEMENT FOR PERSONS 7 YEARS OF AGE OR OLDER*

History of Adsorbed Clean, Minor All OtherTetanus Toxoid (doses) Wounds Wounds**

Td5 TIG TdS TIGUnknown or < thfee Yes No Yes Yes2Threel Not No Not No

*Imporlant details are in the text of the DOSAGE AND ADMIINISTRATION section. " Such as, but not limited to,wounds coDntaminated with dirt. feces. soil, and saliva; puncture wounds: avulsions; and wounlds resulting from mis-siles, crushing, burns, and frostbite. I If only three doses of fluid tetanus toxoid have been received. then a fourthdose of toxoid, preferably an adsorbed toxoid should be given. t Yes, if >10 years sintce last dose. $ Yes, if >5 yearssince last dose. (More frequent boosters are not needed and can accentuate side effects.) § DECAVAC vaccine isapproved for wound management in persons 7 years of age or okWe.STORAGEStore between 2' BC (35' - 46'F). DO NOT FREEZE. Do not use vaccine after expiratin date,REFERENCES: 1. CDC. RecDmrnended childhood and adolescent immunization schedule-United States, 2003.MMWR 2003: 52(04) Q1-04. 2. Recommendations of the Immunization Practices Advisor Committee (ACIP).Diphtheria. Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR40:1991 ,No.RR-10. 3. CDC. Update: Vaccinle side effects, adverse reactions, contraindications, and precautions rec-ommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996; 45(RR-12): 22-31.4. CDC. General recommendations on immunization: Recommendations of the Advisory Committee on ImmunizationPractices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002; 51 (RR-2): 1-35. 5. CDC.Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 1993; 42(RR 04): 1 -9.6. Myers MG, et aL. Primary immunizatin with tetanus and diphtheria toxoids. IAMA 248:19812; 2478-2480. 7. Institueof Medicine (US), Stratton KR, et al, eds. Adverse events associated wth childhood vaccines: evidence bearing oncausality Washington (DC): National Academy Press. 1994:.67-117. 8. Data on file, 030104. 9. Food and DrugAdministration. New reporting requiremnents for vaccine adverse events. FDA Dnug Bull 18 (2): 1988; 16-18B.

Teether raffle The company has received one March 2004 for $150.NewEnglandSterling, ofAttleboro, reportofafarmanimalfigurethatwas Consumers can return the prod-

Mass., forTiffany and Co. ofNewYork, found in a 7-month-old child's mouth. uct to Tiffany and Co. for a refund,is recalling 3,700 teether rattles The childwasnotinjured. creditoranewrattle.Formore infor-

because a metal bar on the rattle can The recalled Farm Teether Rattle is mation, contact Tiffany at (800) 464-

break off, releasing small beads and a hollow sterling silver ring designed 5000.smallfarm animalfigures, which chil- for children ages 3 months and up.dren can swallow. The breakage also Tiffany and Co. sold the rattles in its Toy carscan create ragged edges on the ring, retail stores and from its catalogs and New StarToys & Gifts Inc., ofVernon,posing a laceration hazard. Web site from November 2002 through Calif., is recalling 1,200 toycars because

small parts_can breakioff duringuse, pos-ing a chok-ing hazardto youngchildren.No injuries have been reported.The recall includes two styles of

toy cars. The Funny Puzzle Car or

"Funny Game Car" has a frog buttonon one side and lettered buttons on

the other. They were sold with fourshape blocks that can be inserted inthe windows of the car. The FunnyCartoon Car or "Beautiful Music Car"is a six-wheel truck with 15 spinningblocks on one side showing Spanishwords, a plastic abacus on the otherside and a play clock on the back. Bothproducts have a yellow pull-string inthe front.The cars were sold at toy, depart-

ment and discount stores nationwidefrom September through December2004 for $4 to $6.Consumers should take these toys

away from young children and returnthe recalled toys to the storewhere pur-chased for a refund. For more infor-mation, callNewStar at (888) 647-0051.

Drinking cupsCharles Products, ofBethesda, Md.,

is recalling 720 toddler drinking cupsbecause a container inside the cupholds petroleum distillates, which canleak and pose a poisoning hazard tochildren.

_ ~~~~~Thecom-pany has

| _ ~~~received| ~~~~~one report~~~~~of the pe-

troleum_ ~~~~~distillates

I~~~~~~~e,_,.in~~~~from thebottom of

the cup. No injuries were reported.The toddler cups are made of clear

plastic with two handles and have ablue lid with a spout. The containerinside the cup contains blue and clearliquid, along with two toy dolphins.The cups were sold at the Maui

Ocean Center in Wailuku Maui,Hawaii, from June 2003 throughSeptember 2004 for $10.Consumers should take these cups

away from young children and returnthem to the store where purchasedfor a refund. For more information,call Charles Products at (800) 242-7537.

Produtd inforrnationas of March 2004

Printed in USA4935 493

44 AAPNews www.aapnews.org April 2005

AHFS Category: 80:08

Tetanus and DiphtheriaToxoids Adsorbed For Adult Use R.onlyDECAVACT

Brle SummarySee full prescribing infontioINDi CATIONS AND USAGE DECAVAC va ocine is indicated for active immunization of persons 7 years of age or olderfor pzrevention of tetanus and diphtheria. For immunization of infants and children younger than 7 years of age againsttetanus and diphtheria, refer to the manufacturers' packagie inserts for Diphtheria and Tetanus Toxoids and AcelularPertussis Vaccine Adsorbed (DTaP) and for Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT).If pzassive protection aggainst tetanus is required, Tetanus Irnmune Globulin (Human) (TIG) may be adrninistered ata sepoarate site wlth a separate needle and syringe. (See DOSAGE AND ADMtiPSTRATiON section, and TETANUSPROPHYLAXIS IN WOUND MANAGEMENT subsection.)Persons who have had tetanus or diphthera should still be immunized since these clinical infections do not alwaysconfer immunity. As with any vaccine, vaccination with DECAVAC vaccine may not protect I100% of individuals.CONTRAiNiDICATIONS Hypersensitivity to any component of the vaccine is a contraindicatlon to receipt of DECAVACvaccine. (See DESCRIPTION section.)It is a contraindication to use DECAVAC vaccine after anaphylaxis or other serious al3ergic reaction following a previ-ous dose of this vaccine, any other tetanus or diphtheria toxoid containing vaccine, or any component of this vaccine.i3ecause of uncertainty as to which component of the vaccine may be responsibbe. no turther vaccination with diph-theria or tetanus coDmponents should be cwrie out. Altematively, such individuals may be referred to an allergist torevaluation if further immnunizations are to be consideed.WARNINGS A booster dose of Td is recommended at 11 -12 years of age if at least 5 years have elapsed since thelast dose of tetanus and diphtheria-toxoid containing vaccine.' Subseqiuent routine boosters with Td are recom-mended every 10 years (see iDOSAGE AND ADMINISTRATION).' More krequent administrafion of Td is not rec-ommnended except under circumstances of wound management or diptheria perophylaxis (see DOSAGE AiNDADMtINISTRATION) since it may be associated with increased ircidence and severity of adverse reactions.!Persons who experienced Artu-type hypersensitiit reactions or a temperature of >103-F (>39.4zCQ follwing a priordose of tetanus toxoid uksually have high serum tetanus antiSoxin levels and stiould not be given even emefgency dosesof DECAVAC vaccine more freqiuently than every 10 years, even if they have a wound that is rneither cian nor minor.2If Guillain-Barre Syndrome occurred within 6 weeks of receipt of a prior vaccine containinxg tetanus toxoid, thedecision to give subsequent doses of DECAVAC vaocine or any vaccine containing tetanus toxoid should be basedon careful consideration of the potential benefis and possible risks.4Because of the risk of hernorrhage, DECAVAC vaccine should not be given to persons with any bleeding disorder,such as hemophilia or thrombocytopzenia, or to persons on anticoagulant therapy unless the potential benefit cleardyoutweighs the risk of administration. If the decision is made to administer DECAVAC vaccine in such persons, it shouldbe given with caution, with steps taken to avoid the risk of bleeding and hematoma formation following injection? I

The Advisory Committee on Immunization Practices (ACIP) has published guideiines for vaccination of persons withrecent or acute illness-'PRECAUTIONSGENERAL Care is to be taken by the health-we provider for the safe and effective use of DECAVAC vaccine.EPINEPHRINE INJECTION (1:1000) AND OTHEFI APPROPRIATE AGENTSAND E()iJPMENT MUST BE IMMEDIATELYAVAIltABLE SHOULD AN ACUTE ANAPHYLACTIC REACTIONt OCCUR DUE TOANY COMPONENT OFTHE VACCtNE.Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. Thisinchides a review of the patient's previous immunizafion history, the presence of any contraindications toimrnunization, the cuffent health status, and history conceming possible sensitivity to thte vacine of similar vaccine.(See CONTRAINDICATIONS section.)Special care should be taken to ensure that the injeton does not enter a bloo vessel,Immurnocomnpromnised persons (whether from disease or treatrnenl) may not obtain the expected immune responseto DECAVAC vaccine.Administration of Td vaccines is not contraindicated in immunocompromised persons.'A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to preventtransmission of blood borne infecious agents. Needles should not be recapped and should be disposed ofaccording to biohazarct waste guidelines.DRUG INTERACTIO1YS Immunosuppressive therapies, including irradiation, antimetabolftes, atkylating agents,cytotoxic drugs and corticosteroids (used in greater than physioloJgic doses), may reduce the immune response tovaccines (see PRECAUTIONS - GENERAL section). No information is available regarding concomitant admninistra-tion of DECAVAC vaccine with other US licensed vaccines.

CARCINOGENESIS. MUTAGENESIS. IMPAIRMENT OF FERTILITY No studies have been performed wnthDECAVAC vaccine to evaluate carcinogenicity. mutagenic potential, or impact on fertility.PREGNANCY CATEGORY C Animal reproduction studies have not been r,onducted with DECAVAC vaccdne, It is alsonot known whlether DECAVAC vaccine can cause fetal harm when administered to a pregnant woman or can affectreproduction capaciy. DECAVAC vaccine should b)e given to a pregnant wornan only if cleary needed. The ACIP haspub ished recommendations for use of Tetanus and Diphthera Toxokis Adsorbed, For Adult Use, in pregnant women.'NURSING MOTHERS It is not known whether DECAVAC vaccine is excreted in human mfilk. Because many drugs areexcreted in huffan mrilk, caution should bze exercised when DECAVAC vaccine is administered to a nursing woman.PEDIATRIC USE DECAVAC vaccine is not indicated for infants and children younger than 7 years of age. For immu-nization of infants and chiidren younrger than 7 years of age against tetanus and diphthefia, refer to the manufac-turers'package inserts for Diphttleia and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and forDiphthena and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT).GERIATRIC USE Clinical studies of DECAVAC vaccine did not include subjects aged 59 years and over to deter-mine whether they respond differently than younger subjects.ADVERSE REACTIONS Because clinical trials are conducted urnder widely varying conditions, adverse reactionrates obsefved in the clinical trias of a vaccine cannot be directly compared to rates in the c6nicai trials of anothervaccine and may not reflect the rates observedJ in practice. The adverse reaction informaxtion from clinical trials doeshowever, provide a basis for identifying the adverse events that appear to be relater3 to vaccine use and for approx-imating rates,

In a clinical study involving 58 individuals 6 years of age and older, 19% of the individuals noted local reactions con-sisting of erythema. tendernes and induration at the injection site and 2Y1. systemic reactions coDnsisting ofheadache, malaise and temperature elevations.'ADDITIONAL ADVERSE REACTIONS Additional adverse reactions, included in this section. have been reported inconjunction with reoeipt of vaccines containing tetanus toxoid and/or diphtheria toxoid.Arthus-type hypersensitivity reactions. characterized by severe local reactions (generally starting 2-8 hours after aninjection), may follow receipt of tetanus toxoid. Such reacfions may be associated with high levels of circulatingantitoxin in persons who have had overly frequent injections of tetanus toxoid. (See WARNINGS.)'Persistent nodules at the site of injeton have been reported following the use of adsorbed products."Cases of aPergc or anaphylactic reaction (ie, hives, swelling of the mrouth, difficulty breathing, hypotensbon, or shock)have been reported after receiving some preparations containing diphtheria ard/or tetanus toxoid.1 Death folowingvaccine-caused anaphylaxis has been reported.'Certain neurological conditions have been reported in ternporal assciation with sorne tetanu toxoid-oDntaining vaccinesor tetaus and ciphtheria tDxoid-contaiing vaccines, A review by fth Insfilte of Medicre (IOM) concluded that fthevidence favors acceptance of a causal relafion between tetanus toxoid anld both brachial neuntis and Guiban-Barr6Syndrome.7 Othe neumohgial cdrfions that have been reported7 indude: dernyelinatbng diseases of the centralnervous systemn, peripheral mnooneuropatties, aanial rnononewopathies, and EEG diustrnoes with enpeaioathy(with or withut permanent intellecual arKVor rnotor huncfion irnpairment). The IOM has concluded that the evidence is

Manufactured by:Sanofl Pasteur Inc.Swiftwater PA 18370 USA

MKT9574