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Drug Interactions: No data are available on the immune response to LYMErix when administered
concurrently with other vaccines As with other intramuscular injections, do not give LYMErix to individuals on anticoagulant therapy, unless potential benefit clearly outweighs risk of administration Carcinoganasis, Mutagenesis, Impairment of Fertility: LYMErix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility
Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproductive studies have not been conducted with LYMErix. It is also r.ot known whether LYMErix can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity Give LYMEnx to a pregnant woman only if clearly needed Health care providers are encouraged
to register pregnant women who receive LYMEnx (Lyme Disease Vaccine (Recombinant
OspA)l in the SmithKIine Beecham Pharmaceuticals vaccination pregnancy regie try by calling 1 800-366-8900. ext 5231 Nursing Mothers: It is not known whether LYMErix is excreted in human milk. Because many drugs are excreted in human milk, use caution when LYMErix is administered to a nursing woman Pediatric Use: Safety and efficacy in pediatric subjects younger than 15 years of age have not been evaluated Therefore, the vaccine is not indicated for this age group at this time ADVERSE REACTIONS: During clinical trials involving 6.478 individuals receiving a total of 18,047 doses. LYMErix has been generally well tolerated Subjects with the following conditions chronic joint or neurologic illness related to Lyme disease, diseases associated with joint swelling (including rheumatoid arthritis) or diffuse musculoskeletal pain; secondor third-degree atrioventricular block or a pacemaker were excluded from the efficacy trial because such conditions could interfere with the assessment of Lyme disease m the trial Therefore, data are limited regarding the safety of the vaccine in subjects with these conditions (see below) Unsolicited Adverse Events The most frequently reported (01 %) unsolicited adverse.events within 30 days of vaccination for all subjects receiving at least one dose (n* 10,936) in the double-blind, placebo-controlled efficacy trial are shown in Table 1 Table 1. Incidence (01%) of Unsolicited Adverse Events Occurring Within 30 Days
Following Each Dose* and Overall (after Doses 1, 2 or 3)_ IN-SMI) (N-SM7I i % % I-OI7) (N-S417) <N-M % %% I (N-SM7) % 2137* 1 54*» 891 091 2 03 1 96 135* 091 188 166 122 172 090 142 278 205* 386 2 58* 283 254* 112 225 073 342 161 2 45 166 104 Afltakjia 322 267 7& 172 311 260 152* 0 98 678 606 1J0 155 4 83* 2 94 111fry*1*
101 561 108 508 110 150 128 146
55.6%