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Drug Interactions: No data are available on the immune response to LYMErix when administered
concurrently with other vaccines As witn other intramuscular injections, do not give
LYMErix to individuals on anticoagulant therapy, unless potential benefit clearly outweighs risk of administration Carcinogenesis, Mutagenesis, Impairment of Fertility LYMErix has not been evaluated
♦or 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 not known whether LYMErix can cause
fetal harm when administered to a pregnant woman or can affect reproductive capacity Give
LYMErix to a pregnant woman only if clearly needed Health care providers are encouraged
to register pregnant women who receive LYMErix |Lyme Disease Vaccine (Recombinant
OspA)| in the Smith Kline Beecham Pharmaceuticals vaccination pregnancy registry by calling
1-800-366^900. 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
PadUtite 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
M7VERSE 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 in 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 (21 %) 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
1. incidence (2:1%) of Unsolicited Adverse Events Occurring Within 30 Days
ring Each Dose* and Overall (after Poses 1, 2 or 3)_ (N.S4M IN-M7I (N-SB7) IN.5417] (N-MM) (N-SMI (N-MHI (N-M7) % % % _%_| % %_% ^action sit unction 17 9* 490 b if 21 8* IS4° 691 091 CMfc/Rpn t«igue frfoctnnwrai frfiurus-Hkc 203 1 96 135* 091 181 IN 144* OS 122 172 090 142 279 20* 3 06 25* 2 83 25* 112 225 073 342 161 2.45 166 104 322 26* 267 172 311 152* 260 OS 678 605 IS 156 48* 2 94 OS 1.21 2 96 236 101 ill 109 509 Cougrxng 110 IS 428 146
57.0%