There are no data from the use of encephalitis, tick borne suspension for injection in pregnant women.
It is unknown whether encephalitis, tick borne suspension for injection is excreted in human milk.
Therefore, encephalitis, tick borne suspension for injection should only be administered during pregnancy and to breastfeeding women when it is considered urgent to achieve protection against TBE infection and after careful consideration of the risk-benefit relationship.
Encephalitis, tick borne suspension for injection 0.5 ml is unlikely to affect a person’s ability to drive and use machines. It should be taken into account, however, that impaired vision or dizziness may occur.
encephalitis, tick borne suspension for injection 0.5 mL (2.4 µg)
The frequencies provided in the table below are per vaccination and have been calculated based on a pooled analysis of adverse reactions from 7 clinical studies conducted with encephalitis, tick borne suspension for injection 0.5 mL (2.4 µg) in subjects aged 16 through 65 years receiving 3 vaccinations (3512 subjects after the first vaccination, 3477 after the second vaccination, and 3274 after the third vaccination).
The ADRs listed in this section are given according to the recommended frequency convention:
Adverse Reactions from clinical trials:
| System organ class | Frequency | |||
|---|---|---|---|---|
| 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) | |
| Blood and lymphatic system disorders | Lymphadenopathy | |||
| Immune system disorders | Hypersensitivity | |||
| Nervous system disorders | Headache | Somnolence | ||
| Ear and labyrinth disorders | Vertigo1 | |||
| Gastrointestinal disorders | Nausea | Vomiting | Diarrhoea, Abdominal pain | |
| Musculoskeletal and connective tissue disorders | Myalgia, Arthralgia | |||
| General disorders and administration site conditions | Injection site reactions e.g., Injection site pain | Fatigue, Malaise | Pyrexia, Injection site hemorrhage | Injection site reactions such as: Erythema, Induration, Swelling, Pruritus, Paraesthesia, Warmth. |
Adverse reactions from post-marketing surveillance:
The following additional adverse reactions have been reported in post-marketing experience.
| System organ class | Frequency* |
|---|---|
| Rare (≥1/10,000 to <1/1,000) | |
| Infections and infestations | Herpes zoster (triggered in pre-exposed patients) |
| Immune system disorders | Precipitation or aggravation of autoimmune disorders (e.g. multiple sclerosis), anaphylactic reaction |
| Nervous system disorders | Demyelinating disorders (acute disseminated encephalomyelitis, guillain-barré syndrome, myelitis, transverse myelitis), encephalitis, convulsions, aseptic meningitis, meningism, sensory abnormalities and motor dysfunction (facial palsy/paresis, paralysis/paresis, neuritis, hypoesthesia, paresthesia), neuralgia, optic neuritis, dizziness |
| Eye disorders | Visual impairment, photophobia, eye pain |
| Ear and labyrinth disorders | Tinnitus |
| Cardiac disorders | Tachycardia |
| Respiratory, thoracic and mediastinal disorders | Dyspnea |
| Skin and subcutaneous tissue disorders | Urticaria, rash (erythematous, maculopapular), pruritus, dermatitis, erythema, hyperhidrosis |
| Musculoskeletal and connective tissue disorders | Back pain, joint swelling, neck pain, musculoskeletal stiffness (including neck stiffness), pain in extremity |
| General disorders and administration site conditions | Gait disturbance, chills, influenza-like illness, asthenia, edema, injection site joint movement impairment such as joint pain, nodule and inflammation |
* The upper limit of the 95% confidence interval of the event frequency is calculated with 3/n, with n representing the number of subjects included in all clinical trials with encephalitis, tick borne suspension for injection 0.5 ml. Therefore, the calculated frequency “rare” represents the theoretical maximum frequency for these events
In a small comparative study on the immune response after intramuscular and subcutaneous administration of encephalitis, tick borne suspension for injection 0.5 mL in healthy adults, the subcutaneous route led to a higher local reactogenicity profile, particularly in women.
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