Ixiaro · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-154398 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 5,021 healthy adults (from non-endemic countries) and 1,559 children and adolescents (mostly from endemic countries). Approximately 40% of treated subjects experienced systemic adverse reactions and approximately 54% experienced injection site reactions. They usually occur within the first three days after vaccination, are 5 usually mild and resolve within a few days. No increase in the number of adverse reactions was noted between first and second doses or following a booster dose in adults. Most commonly reported adverse reactions in adults included headache (20% of subjects), myalgia (13%), injection site pain (33%), injection site tenderness (33%) and fatigue (12.9%). Most commonly reported adverse reactions in children and adolescents included pyrexia, diarrhoea, influenza like illness, irritability, injection site pain, injection site tenderness, and injection site redness (see table 1). Adverse reactions are listed according to the following frequencies: 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 Adult and older adults (>65 years) population Blood and lymphatic system disorders Uncommon: lymphadenopathy Rare: thrombocytopenia Nervous system disorders Very common: headache Uncommon: migraine, dizziness Rare: paraesthesia, neuritis, dysgeusia, syncope* Eye disorders Rare: eyelid oedema Ear and labyrinth disorders Uncommon: vertigo Cardiac disorders Rare: palpitations, tachycardia Respiratory, thoracic and mediastinal disorders Rare: dyspnoea Gastrointestinal disorders Common: nausea Uncommon: vomiting, diarrhoea, abdominal pain Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis Rare: urticaria, erythema Musculoskeletal and connective tissue disorders Very common: myalgia Uncommon: musculoskeletal stiffness, arthralgia Rare: pain in extremity General disorders and administration site conditions Very common: injection site pain, injection site tenderness, fatigue Common: influenza like illness, pyrexia, other injection site reactions e.g. redness, hardening, swelling, itching Uncommon: chills, malaise, asthenia Rare: oedema peripheral 6 Investigations Uncommon: hepatic enzymes increased *reported also from post-marketing ex

Auszug; vollständigen Abschnitt im Original lesen.

HOS-154394 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite (see section 2.), host cell protein. Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose. Administration must be postponed in persons with acute severe febrile conditions.

HOS-154393 · has-indication-information · PDF-Seite 2

IXIARO is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.

HOS-154396 · has-interaction-information · PDF-Seite 5

Concomitant administration of IXIARO with other vaccines: Concomitant administration of IXIARO with inactivated hepatitis A vaccine and with inactivated rabies vaccine in two different schedules has been evaluated in clinical studies. There was no interference with the immune response to Japanese encephalitis virus (JEV) or to hepatitis A or rabies virus vaccines (see section 5.1). The safety profiles of IXIARO and the other studied vaccines were not compromised when administered concomitantly. In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may not be obtained. Paediatric population No interaction studies have been performed in children and adolescents.

HOS-154397 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are limited amount of data from the use of IXIARO in pregnant women. In animal studies findings of unclear clinical relevance have been identified (see section 5.3). As a precautionary measure, the use of IXIARO during pregnancy should be avoided. Breast-feeding It is unknown whether IXIARO is excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to IXIARO is negligible. However, in the absence of data and as a precautionary measure the use of IXIARO during lactation should be avoided. Fertility A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.

HOS-154395 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine. Under no circumstances should IXIARO be administered intravascularly. 4 As with any other vaccine, vaccination with IXIARO may not result in protection in all cases. IXIARO will not protect against encephalitis caused by other micro-organisms. Like other intramuscular injections, this vaccine should not be administered intramuscularly to persons with thrombocytopenia, haemophilia or other bleeding disorders (see section 4.2). In adults a seroconversion rate of 29.4 % has been observed 10 days after the first i.m. vaccination, and 97.3 % one week after the second i.m. vaccination in the conventional schedule. After immunisation with the rapid schedule a seroconversion rate of 99% has been observed 7 days after the second i.m. vaccination. Hence, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV). Protection against Japanese Encephalitis is not ensured until the second dose has been received.