Adverse reactions : תופעות לוואי

ADVERSE REACTIONS
Clinical Trial AdverseADVERSE
ReactionsREACTIONS
Clinical Trial Adverse Reactions
Because clinical trials   are conducted
Because           clinical trials  underare     widely       varying under conducted              conditions,   widely   adverse varying   reaction conditions,rates adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may trials of another vaccine and may not reflect rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.
In a randomized, controlled clinical trial conducted in Canada, 339 infants were immunized with PEDIACEL® at 2, 4 and 6 months of age. In addition, 301 of these children were immunized as toddlers at 18 months. Injection site reactions were generally mild. Up to one third of children receiving PEDIACEL® experienced some degree of redness, swelling or tenderness around the injection site. The frequency of solicited injection site and systemic reactions observed in a clinical trial within 24 hours of any dose of PEDIACEL® given at 2, 4, 6 and 18 months of age are presented below.
Very Common: ≥10%
Common:             ≥1% and <10%
Gastrointestinal Disorders
Common: Diarrhea, vomiting.
General Disorders and Administration Site Conditions
Very Common: Injection site tenderness, swelling, redness, fever (≥38.0°C), crying, eating less, fussiness, less active.
Data from Post-Marketing Experience
The following additional adverse events have been spontaneously reported during the post- marketing use of PEDIACEL® worldwide. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Immune System Disorders
Hypersensitivity, anaphylactic reaction (such as urticaria, angioedema).
Psychiatric Disorders
Irritability , screaming.
Nervous System Disorders
Convulsion (with or without fever), prolonged or unusual high-pitched crying, hypotonic hyporesponsive episode (infant appears pale, hypotonic [limp] and unresponsive to parents).
To date, this condition has not been associated with any permanent sequelae Somnolence Vascular Disorders
Pallor
Respiratory, Thoracic and Mediastinal Disorders
Apnea
Skin and Subcutaneous Tissue Disorders
Erythema, rash.
Musculoskeletal, Connective Tissue and Bone Disorders
Pain in vaccinated limb.
General Disorders and Administration Site Conditions
High fever (>40.5°C), injection site mass, , asthenia, and listlessness.
Large injection site reactions (>50 mm) including extensive limb swelling which may extend from the injection site beyond one or both joints, have been reported in children following PEDIACEL® administration. These reactions usually start within 24 - 72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3 to 5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.
Edematous reactions affecting one or both lower limbs have occurred following vaccination with H. influenza type b containing vaccines. When this reaction occurs, it does so mainly after primary injections and is observed within the first few hours following vaccination. Associated symptoms may include cyanosis, redness, transient purpura and severe crying. All events resolved spontaneously without sequelae within 24 hours.
DRUG INTERACTIONS
Vaccine-Drug Interactions
Immunosuppressive treatments may interfere with the development of the expected immune response. (See WARNINGS AND PRECAUTIONS.)
Concomitant Vaccine Administration
Administering the most widely used live and inactivated vaccines during the same patient visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately. Vaccines administered simultaneously should be given using separate syringes at separate sites. Simultaneous administration is suggested, particularly when there is concern that a person may not return for subsequent vaccination.
PEDIACEL® should not be mixed in the same syringe with other parenterals.
Vaccine-Laboratory Test Interactions
Antigenuria has been detected in some instances following administration of a vaccine containing Hib antigen. Therefore, urine antigen detection may not have definite diagnostic value in suspected H. influenzae type b disease within two weeks of immunization.