Rx Item-Adacel Syringe 5X0.5 ml Tdap Diph Pertuss(Acell) Tet Vac/Pf Intram By Sa

Clinical Information
Gen. Code and Des.
63901 diph,pertuss(acell),tet vac/PF INTRAMUSC SYRINGE 2-2.5-5/.5
Strength
2 Lf unit-(2.5-5-3-5 mcg)-5 Lf unit/0.5 mL
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC



sanofi pasteur Package Insert 306 Adacel Clean Confidential/ Proprietary info. Page of 27 Item info. These highlights do not include ll the info. neeeded to use Adacel safely and effectively. ee full prescribing info. for Adacel. Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Suspension for Intramuscular Injection Initial US Approval: 2005 - INDICATIONS AND USAGE Adacel is vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use as single dose in persons 11 through 64 years of age. 1) DOSAGE AND ADMINISTRATION A single Intramuscular injection of 0.5 mL. 2.1) -DOSAGE FORMS AND STRENGTHS - Single-dose vials and prefilled syringes containing 0.5-mL suspension for injection. 3) CONTRAINDICATIONS Severe allergic reaction (eg, anaphylaxis) to any component of Adacel or any other diphtheria toxoid, te tanus toxoid and pertussis antigen containing vaccine. 4.1) ncephalopathy (e.g., coma, decreas ed level of consciousness, prolonged seizures) within days of administration of previous pertussis antigen-containing vaccine. 4.2) WARNINGS AND PRECAUTIONS The tip caps of the Adacel prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals.( 5.2, 17) If Guillain-Barr? syndrome occurred within weeks of receipt of prior vaccine containing tetanus toxo id, the risk for Guillain-Barr? syndrome may be increased following subsequent dose of Adacel vaccine.( 5.3) Pr ogressive or unstable neurologic conditions are reasons to defer Adacel vaccination 5.4) Persons who experienced an Art hus-t ype hypersensitivity reaction following prior dose of tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine. 5.5) ADVERSE REACTIONS The most common solicited injection site reactions occuring within 0-14 days following vaccination with Adacel were For Adolescents 11-17 years of age: pain (77.8%), swelling (20.9%), erythema (20.8%). For Adults 18-64 years of age: pain (65.7%), swelling (21.0%), erythema (24.7%) 6.1). The most common solicited system ic reactions occurring within 0-14 days following vaccination with Adacel were: For Adolescents 11-17 years of age: headache (43.7%), body ache or muscle weakness (30.4%), tiredness (15.1%). For Adults 18-64 years of age: headache (33.9%), body ache or muscle weakness (21.9%) 6.1). To report SU SPECTED ADVERSE REACTIONS, contact Pharmacovigilance Department, Sa nofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800- VACCINE) or VAERS at 1-800-822-7967 or https://vaers.hhs.gov. DRUG INTERACTIONS When Adacel vaccine was admini stered concomitantly with trivalent inactivated influenza vaccine (TIV) to subjects 19-64 years of age, lower antibody response was observed for pertactin antigen as compared to Adacel vaccine administered alone. 7.1, 14.4) Im munosuppressive therapies may reduce the immune response to Adacel. 7.2 Do not mix Adacel vaccine with any other vaccine in the same syringe or vial. USE IN SPECIFIC POPULATIONS -- Safety and effectiveness of Adacel vaccine have not been established in pregnant women 8.1) Pregnancy Surveillance Registry: contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE) 8.1) See 17 PATIENT COUNSELING info. Revised: [February 2012

Rx Item-Adacel Syringe 5X0.5 m
Rx Item-Adacel Syringe 5X0.5 ml Tdap Diph Pertuss(Acell) Tet Vac/Pf IM Item No.:RX770818/A, Item No. RX770818, 770818, Box NDC No.: 49281-0400-20, 49281-400-20, 4928140020, 49281040020, 0400-20, 0400

Rx Item-Adacel Syringe 5X0.5 m
Rx Item-Adacel Syringe 5X0.5 ml Tdap Diph Pertuss(Acell) Tet Vac/Pf IM Item No.:RX770818/A, Item No. RX770818, 770818, Box NDC No.: 49281-0400-20, 49281-400-20, 4928140020, 49281040020, 0400-20, 0400

Rx Item-Adacel Syringe 5X0.5 ml Tdap Dip
NDC No.49281-0400-20 49281-400-20 UPC/GTIN No.3-49281-40015-5 MPN No. 40015 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Ph

DIPH,PERTUSS(ACELL),TET V
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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