Vimkunya · 4.8 Undesirable effects · 1

HOS-099709 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common local adverse reaction at the injection site after vaccine administration was injection site pain (24.0%). The most common systemic adverse reactions observed after vaccination were fatigue (17.8%), headache (16.7%) and myalgia (16.5%) (Table 1). Tabulated list of adverse reactions The tabulated summary of the adverse reactions following administration of VIMKUNYA (Table 1) is based on an analysis of the pooled safety data gathered from three completed phase 2 studies and two completed phase 3 studies on 3 522 participants ≥ 12 years old who received VIMKUNYA. Of these, 3 141 individuals received a single 40 micrograms dose of VIMKUNYA. These participants were followed up for serious adverse events over the entire study period of 182 days. Adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class. The adverse reactions reported are listed according to the following 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 - Very rare < 1/10 000 Table 1: Adverse reactions reported following administration of VIMKUNYA MedDRA system organ class Adverse reaction Frequency Injection site pain Very common Fatigue Very common Chills Common General disorders and administration site Malaise Common conditions Injection site redness Uncommon Injection site swelling Uncommon Pyrexia Uncommon Injection site bruising Uncommon Headache Very common Nervous system disorders Dizziness Uncommon Paraesthesia Rare Myalgia

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099705 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-099704 · has-indication-information · PDF-Seite 2

VIMKUNYA is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. The use of this vaccine should be in accordance with official recommendations.

HOS-099707 · has-interaction-information · PDF-Seite 4

No interaction studies with other medicinal products have been performed. Concomitant administration of VIMKUNYA with other vaccines has not been studied.

HOS-099708 · has-pregnancy-information · PDF-Seite 4

Pregnancy In animal studies, no vaccine-related adverse effects on embryofetal development were observed in rats and rabbits; some postnatal effects of unknown clinical relevance were seen only in rabbits (see section 5.3). There is limited amount of data from the use of VIMKUNYA in pregnant women. These data are not sufficient to conclude on the absence of potential effects of VIMKUNYA on pregnancy, embryo- foetal development, parturition and post-natal development. Decisions to administer VIMKUNYA during pregnancy should take into consideration the individual’s risk of exposure to wild-type CHIKV, gestational age, and risks to the foetus or neonate. Breast-feeding It is unknown if VIMKUNYA is excreted in human milk. A risk to the breastfed child cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIMKUNYA and any potential adverse effects on the breastfed child from VIMKUNYA. 4 Fertility No specific studies have been performed on fertility. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).

HOS-099706 · has-warning-information · PDF-Seite 3

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. Hypersensitivity and anaphylaxis Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of VIMKUNYA. Immunocompromised individuals The safety and efficacy of VIMKUNYA has not been assessed in patients with immunodeficiency and patients using systemic immunosuppressive therapies. It is not known whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressive therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen. Anxiety-related reactions As with all injectable vaccines, anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution to individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular injection in these individuals. 3 Limitations of vaccine effectiveness As with any vaccine, protection may not be elicited after vaccination in all persons. It is recommended to continue personal protection measures against mosquito bites after vaccination. Excipients Potassium This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’. Sodium This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.