Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-Polio-Haemophilus Influenzae type b Conjugate Combined Vaccine Biological Page (DTaP-IPV-Hib-HB)

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1 Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-Pli-Haemphilus Influenzae type b Cnjugate Cmbined Vaccine Bilgical Page (DTaP-IPV-Hib-HB) Sectin 7: Bilgical Prduct Infrmatin Standard #: Created by: Apprved by: Prvince-wide Immunizatin Prgram Standards and Quality Prvince-wide Immunizatin Prgram Standards and Quality Apprval Date: September 1, 2016 Revised: February 1, 2017 Manufacturer Bilgical Classificatin Indicatins fr Prvincially Funded Vaccine Nte: Fr questins related t Travel and r Fr Sale vaccine refer t AHS Travel Health and Cntracted Immunizatin Services resurces. Schedule GlaxSmithKline Inc. Inactivated Primary immunizatin fr children tw mnths up t and including 23 mnths f age when diphtheria, tetanus, acellular pertussis, pli, Hib and hepatitis B vaccines are indicated fr nn-hyprespnsive individuals. Nte: Hepatitis B vaccine indicated fr: Infants brn t hepatitis B infected mthers r whse primary caregiver is hepatitis B infected (acute cases r carriers) Infants wh are husehld cntacts f a hepatitis B carrier Infants whse families have immigrated t Canada frm areas where there is a high prevalence (8% r higher) f hepatitis B. See Hepatitis B Endemic Cuntries List Primary series fr high risk infants wh have received HBIG and/r hepatitis B vaccine at birth. Exceptin: D nt administer INFANRIX hexa t high risk infants weighing less than 2000g wh received Hepatitis B vaccine and/r HBIG at birth. These infants shuld cntinue t receive the separate Hepatitis B vaccine accrding t the schedule utlined in the Hepatitis B Vaccine Bilgical Page (#07.234). Nte: INFANRIX hexa cntains nly a regular strength dse f Hepatitis B Vaccine and is nt indicated fr infants and children requiring a duble dse f Hepatitis B vaccine. Children 2 mnths up t and including 23 mnths f age: Dse 1: 2 mnths f age Dse 2: 4 mnths f age Dse 3: 6 mnths f age Ntes: Third dse shuld nt be given t infants befre 6 mnths (24 weeks r 168 days) f age. Spacing recmmendatin fr ff schedule children is 2 mnths (8 weeks) between dses hwever, minimum intervals respecting all f the fllwing may be used: Minimum f 4 weeks between the first and secnd dse AND, Minimum f 8 weeks between the secnd and third dse AND Minimum f 4 mnths (16 weeks r 112 days) between the first and third dse. Immunizatin Prgram Standards Manual Page 1 f 5 Ppulatin, Public and Indigenus Health

2 Preferred Use Dse Rute Cntraindicatins/ Precautins N/A Where a dse f hepatitis B vaccine is given at birth, INFANRIX hexa can be used fr the subsequent dses as per the schedule indicated abve. An infant in this case wuld receive a ttal f 4 dses f hepatitis B vaccine. Where a dse f hepatitis B vaccine is given at birth, INFANRIX hexa can be used fr the secnd dse frm the age f six weeks. This spacing wuld nly be used if early immunizatin is required due t increased risk f expsure t antigens ther than Hepatitis B cntained in the vaccine. The first three dses f an immunizatin series shuld be cmpleted with the same cmbinatin prduct whenever pssible. If this is nt pssible an alternative cmbinatin may be used. Ideally a series started with INFANRIX hexa will be cmpleted with INFANRIX hexa. A series started with separate DTaP-IPV-Hib and Hepatitis B vaccine shuld be cmpleted with the separate vaccines. Exceptin as detailed abve is infants given a dse f hepatitis B vaccine at birth. The schedule and spacing cnsideratins fr this vaccine vary slightly frm thse f the individual HBV and DTaP-IPV-Hib vaccines. Ensure the apprpriate schedule is fllwed fr the vaccine(s) that are being used. The rutine 18 mnth dse will be cmpleted with a DTaP-IPV-Hib cntaining vaccine. Children wh have had pertussis infectin shuld cntinue t receive pertussis-cntaining vaccines. Children in whm invasive Hib disease develps befre 24 mnths f age shuld receive Hib vaccine as recmmended because natural disease may nt induce prtectin. Children 7 mnths up t and including 23 mnths f age wh are starting a primary series r wh have an incmplete primary series f INFANRIX hexa shuld cntinue t receive INFANRIX hexa as indicated abve. These children may need fewer dses f the Hib cmpnent; hwever, it is acceptable t give the additinal dses f Hib vaccine in this cmbinatin vaccine fr cnvenience f administratin. Individuals travelling t cuntries currently exprting and/r infected with pli may need special immunizatin dcumentatin verifying pli immunizatin. These individuals shuld cnsult with a Travel Clinic t determine what dcumentatin is required. 0.5 ml Nte: Once recnstituted, withdraw the entire cntents f the vial. IM Cntraindicatins: Knwn severe hypersensitivity t any cmpnent f INFANRIX hexa. The plunger stpper f pre-filled syringe may cntain latex. Anaphylactic reactin t a previus dse f vaccine cntaining diphtheria, tetanus, pertussis, pli, Hib r hepatitis B antigens. Encephalpathy (eg. cma, decreased level f cnsciusness, prlnged seizures) within seven days f a previus dse f a pertussis-cntaining vaccine nt attributable t anther identifiable cause. Precautins: Child Hematpietic Stem Cell Transplant (HSCT) Recipients and Children Immunizatin Prgram Standards Manual Page 2 f 5 Ppulatin, Public and Indigenus Health

3 Pssible Reactins Pregnancy Lactatin Cmpsitin Pre and Pst Slid Organ Transplant shuld nt receive INFANRIX hexa as INFANRIX hexa cntains a regular strength dse f Hepatitis B vaccine. D nt administer INFANRIX hexa t high risk infants weighing less than 2000g wh received Hepatitis B vaccine and/r HBIG at birth. These infants shuld cntinue t receive the separate Hepatitis B vaccine accrding t the schedule utlined in the Hepatitis B Vaccine Bilgical Page (#07.234). Capsular plysaccharide antigen (Hib antigen) can be detected in the urine f vaccine recipients fr up t tw weeks fllwing immunizatin with cnjugate vaccines. This phenmenn culd be cnfused with antigenuria assciated with invasive Hib infectins. Hib vaccines shuld never be given t a child yunger than six weeks f age. Data suggest that Hib cnjugate vaccines given befre six weeks f age may induce immunlgic tlerance (reduced respnse t subsequent dses). Children with neurlgic cnditins shuld be assessed carefully. If Guillain-Barré Syndrme (GBS) ccurred within eight weeks f immunizatin with a previus dse f vaccine cntaining tetanus txid, it is prudent t withhld subsequent dses f tetanus-cntaining vaccine. Thse wh develp GBS utside f this interval r have an alternative cause identified may receive subsequent dses f tetanus-cntaining vaccine. Cmmn: Apprximately 10% r mre f children receiving INFANRIX hexa will experience pain, redness, swelling at the injectin site, lss f appetite, fatigue, irritability, abnrmal crying, restlessness and fever f 38 C r greater. Apprximately 1-10% f children receiving INFANRIX hexa will experience nervusness, vmiting, diarrhea, lcal swelling at the injectin site (>50 mm), fever >39.5 C (when given at the same time as pneumcccal cnjugate vaccine), pruritus and injectin site reactins, including induratin. Rare: Upper respiratry tract infectin, smnlence, swelling f the injected limb, brnchitis, rash, dermatitis, brnchspasm. Apnea in very premature infants ( 28 weeks gestatin), thrmbcytpenia, allergic reactins, anaphylaxis, nervus system disrders, angineurtic edema, petichiae/purpura, injectin vesicles, swelling f the limb and peripheral edema. As with any immunizatin, unexpected r unusual side effects can ccur. Refer t the prduct mngraph fr mre detailed infrmatin. Nt intended fr use in adults. Nt intended fr use in adults. Each 0.5 ml dse cntains: Active Ingredients: Diphtheria txid 25 Lf Tetanus txid 10 Lf Acellular pertussis: Pertussis txid (PT) 25 mcg Filamentus haemagglutinin (FHA) 25 mcg Pertactin 8 mcg Hepatitis B 10 mcg Inactivated plimyelitis vaccine Type 1-40 DU Immunizatin Prgram Standards Manual Page 3 f 5 Ppulatin, Public and Indigenus Health

4 Bld/Bld Prducts Bvine/Prcine Prducts Latex Interchangeability Administratin with Other Prducts Appearance Type 2 8 DU Type 3 32 DU Purified plyribsyl-ribitlphsphate capsular plysaccharide (PRP) f Haemphilus influenzae type b cvalently bund t tetanus txid 10 mcg Nn-medical Ingredients: lactse sdium chlride aluminum salts water fr injectin Manufacturing residuals: Frmaldehyde Plysrbate 20 and 80 M199 (as a stabilizer) Ptassium chlride Disdium phsphate Mnptassium phsphate Glycine Nemycin sulphate Plymyxin B sulphate Aluminum phsphate 5% yeast prtein Des nt cntain human bld r bld prducts. Des nt cntain bvine r prcine prducts. Latex in plunger stpper f pre-filled syringe. The first three dses f the immunizatin series shuld be cmpleted, whenever pssible, with the same cmbinatin prduct. Hwever, if the riginal vaccine is nt knwn r nt available an alternate cmbinatin prduct may be used t cmplete the primary series, with a separate dse f Hepatitis B vaccine. Either Pediacel r Infanrix -IPV/Hib may be used interchangeably fr the furth dse. INFANRIX hexa can be given cncmitantly with pneumcccal cnjugate, MenC cnjugate, MenACWY cnjugate, rtavirus, measles, mumps, rubella and varicella vaccines. Data have shwn n clinically relevant interference in the antibdy respnse t each f the individual antigens in INFANRIX hexa Can be given at the same time as ther inactivated and live vaccine using a separate needle and syringe fr each vaccine. The same limb may be used if necessary, but different sites n the limb must be chsen The Hib cmpnent will appear as a lyphilized white pwder. The DTaP-HB-IPV cmpnent is supplied as a turbid white suspensin. The recnstituted vaccine presents as a slightly mre cludy suspensin than the liquid cmpnent alne. Strage Stre at +2 0 C t +8 0 C. D nt freeze. D nt use beynd the labeled expiry date. Stre in riginal packaging when pssible t prtect frm light. Vaccine Cde DTaP-IPV-Hib-HB Immunizatin Prgram Standards Manual Page 4 f 5 Ppulatin, Public and Indigenus Health

5 Antigen Cde Licensed fr Tetanus T Diphtheria D Acellular pertussis P Hepatitis B HB Inactivated pli vaccine POL Haemphilus influenzae type b - Hib Children six weeks up t tw years f age. Ntes: INFANRIX hexa became available September 1, 2016 fr the rutine Alberta Immunizatin Prgram. Related Resurces: Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Pli and Haemphilus influenzae type b Cnjugate Vaccine Infrmatin Sheet (September 1, 2016). References: Alberta Health. (2016, March 16). Alberta Immunizatin Plicy. Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-Pli-Haemphilus influenzae type b Cnjugate Cmbined Vaccine: INFANRIX hexa. Alberta Health, Health System Accuntability and Perfrmance Divisin. GlaxSmithKline. (2016, April 25). Prduct Mngraph. INFANRIX hexa : Cmbined diphtheria and tetanus txids, acellular pertussis, hepatitis B (recmbinant), inactivated plimyelitis and adsrbed cnjugated Haemphilus influenzae type b vaccine. Natinal Advisry Cmmittee n Immunizatin. (2016). Canadian Immunizatin Guide (Evergreen Editin). Ottawa, ON: Public Health Agency f Canada. Immunizatin Prgram Standards Manual Page 5 f 5 Ppulatin, Public and Indigenus Health

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