Adverse reactions : תופעות לוואי

4.8    Undesirable effects

- Clinical trials

Summary of the safety profile
The safety profile presented below is based on data from more than 3500 subjects.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with INFANRIX IPV Hib with respect to the primary course.

List of adverse reactions
Frequencies per dose are defined as follows:
Very common: (≥1/10)
Common:           (≥ 1/100 to < 1/10)
Uncommon:         (≥ 1/1,000 to < 1/100)
Rare:             (≥ 1/10,000 to < 1/1,000)
Very rare:        (< 1/10,000)

Infections and infestations
Uncommon: upper respiratory tract infection
Blood and lymphatic system disorders
Uncommon: lymphadenopathy

Metabolism and nutrition disorders
Very common: appetite lost

Psychiatric disorders
Very common: crying abnormal, irritability, restlessness
Nervous system disorders
Very common: somnolence

Respiratory, thoracic and mediastinal disorders
Uncommon: bronchitis, cough, rhinorrhoea

Gastrointestinal disorders
Common: diarrhoea, vomiting
Skin and subcutaneous tissue disorders
Uncommon: urticaria, rash
Rare: pruritus, dermatitis

General disorders and administration site conditions
Very common: fever (≥38.0°C), injection site reactions such as pain and redness, local swelling at the injection site (≤50 mm)
Common: injection site reactions including induration, local swelling at the injection site (>50 mm)1 Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint1, fever2>39.5°C, fatigue

-      Post-marketing surveillance

Immune system disorders
Allergic reactions (including anaphylactic3 and anaphylactoid reactions) 
Nervous system disorders
Collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions (with or without fever)

Respiratory, thoracic and mediastinal disorders
Apnoea3 [see 4.4 for apnoea in very premature infants (≤ 28 weeks of gestation)] 
Skin and subcutaneous tissue disorders
Angioneurotic oedema3

General disorders and administration site conditions
Swelling of the entire injected limb1, injection site vesicles3

1
Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. These reactions resolve over an average of 4 days.
2 common with booster vaccination
3 reported with GSK’s DTPa containing vaccines


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.

Additionally, you should also report to GSK Israel (il.safety@gsk.com).