Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Posology                                                                                                                                                                                                                                                                                                                                                Arthralgia                                                                                                                        Common a. Summary of the safety profile
Adults: 0.5 ml.                                                                                                                                                                                                                                                                                                                                                 General Disorders and Administration Site Conditions In recent clinical trials approximately 10,000 subjects from 6 months of age received VAXIGRIP.
Paediatric population                                                                                                                                                     Depending on immunization history and the age of the children, the dosage and the number of doses were different (see Paediatric population in subsection b.                          Injection site pain/tenderness, injection site erythema/redness, injection site oedema/swelling, injection                        Very common Tabulated list of adverse reactions).
Children aged 36 months onwards: 0.5 ml.                                                                                                                                  Solicited reactions usually occurred within the first 3 days following VAXIGRIP, resolved spontaneously within 1 to 3 days after onset. Most of the solicited adverse                 site induration, malaise (4), asthenia (4), injection site pruritus (4) Children aged 6 to 35 months: 0.25 ml. Clinical data are limited. See Section 6.6 for more information on administration of the 0.25 ml dose.
reactions were of mild to moderate intensity.                                                                                                                                         Fever, shivering/rigors, injection site ecchymosis                                                                                Common A 0.5 ml dose may be given, if this is required by national recommendations.
For children aged less than 9 years who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.                         The most frequently reported solicited adverse reaction within 7 days following injection of VAXIGRIP was injection site pain in all population except in children                    Flu-like syndrome            (2),   injection site warmth    (2),   injection site discomfort    (2)                              Uncommon Children aged less than 6 months: the safety and efficacy of VAXIGRIP in children aged less than 6 months have not been established. No data are available.               aged 6 to 35 months in whom irritability was the most frequently reported.
The most frequently reported solicited systemic adverse reaction within 7 days following injection of VAXIGRIP was headache in adults, elderly and children aged                     (1)   Rare in elderly                                                   (3)   Reported during clinical trials in elderly Method of administration
9 to 17 years and malaise in children aged 3 to 8 years.                                                                                                                             (2)                                                                     (4) To be administered via intramuscular or deep subcutaneous route.                                                                                                                                                                                                                                                                                                     Reported during clinical trials in adults                               Common in elderly Solicited adverse reactions were generally less frequent in elderly than in adults.
For adults and children from 36 months of age: the preferred site for intramuscular injection is the deltoid muscle.                                                                                                                                                                                                                                           (5)   Not known in adults                                               (6)   Not known in elderly For children from 12 to 35 months of age: the preferred site for intramuscular injection is the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass   b. Tabulated list of adverse reactions is adequate).                                                                                                                                                             The data below summarize the frequencies of the adverse reactions that were recorded following vaccination with VAXIGRIP during clinical trials and worldwide For children from 6 to 11 months of age: the preferred site for intramuscular injection is the anterolateral aspect of the thigh.                                                                                                                                                                                                                 Paediatric population post-marketing experience.
Precautions to be taken before handling or administering the medicinal product.
Depending on immunization history, children aged 6 months to 8 years received one or two doses of VAXIGRIP. Children aged 6 to 35 months received the 0.25 ml For instructions for preparation of the medicinal product before administration, see Section 6.6.                                                                         Adverse events are ranked under headings of frequency using the following convention: Very common (≥1/10);                                                                                                                                                    formulation, and children from 3 years of age received the 0.5 ml formulation.
4.3     Contraindications                                                                                                                                          Common (≥1/100 to <1/10);                                                                                                                                               •         Children/adolescents aged 3 to 17 years:
Hypersensitivity to the active substances, to any of the excipients listed in Section 6.1 or to any component that may be present as traces such as eggs, (ovalbu-        Uncommon (≥1/1,000 to <1/100);                                                                                                                                          The safety profile presented below is based on data from more than 300 children aged 3 to 8 years and around 70 children/adolescents aged 9 to 17 years.
Rare (≥1/10,000 to <1/1,000);
min, chicken proteins),neomycin, formaldehyde and octoxinol -9.
Very rare (<1/10,000);                                                                                                                                                  In children aged 3 to 8 years, the most frequently reported solicited reactions within 7 days following injection of VAXIGRIP were as follows: injection site pain/ten- Immunisation shall be postponed in patients with febrile illness or acute disease.                                                                                        Not known: cannot be estimated from available data.                                                                                                                     derness (56.3%), malaise (27.3%), myalgia (25.5%) and injection site erythema/redness (23.4%).
4.4     Special warnings and precautions for use                                                                                                                   Adult and elderly                                                                                                                                                       In children/adolescents aged 9 to 17 years, the most frequently reported solicited reactions within 7 days following injection of VAXIGRIP were as follows: injection
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction , although                                                                                                                                                                                  site pain/tenderness (54.5% to 70.6%), cephalalgia (22.4% to 23.6%), myalgia (12.7% to 17.6%) and injection site erythema/redness (5.5% to 17.6%).
ADVERSE REACTIONS                                            FREQUENCY VAXIGRIP during clinical trials and worldwide post-marketing experience.                                                                                                                                                                                                                                                                           Not applicable.
Blood and Lymphatic System Disorders
5.3      Preclinical safety data
Transient thrombocytopenia, lymphadenopathy                                                                   Not known Immune System Disorders                                                                                                                                Not applicable.
ADVERSE REACTIONS                                                     FREQUENCY Urticaria                                                                                                     Not known                                6           PHARMACEUTICAL PARTICULARS Blood and Lymphatic System Disorders
Allergic reactions such as pruritus, rash erythematous, dyspnoea, angioedema, shock                           Not known                                    6.1      List of excipients Lymphadenopathy (5)                                                                                                   Uncommon Metabolism and nutrition Disorders                                                                                                                     Buffer solution: Transient thrombocytopenia                                                                                            Not known                                                                                                                                                                                                   •   Sodium chloride Decreased appetite, anorexia           (1)                                                                    Very common                              •   Potassium chloride Immune System Disorders
Psychiatric Disorders                                                                                                                                  •   Disodium phosphate dihydrate Urticaria   (5)                                                                                                       Uncommon                                                                                                                                                                                                    •   Potassium dihydrogen phosphate Crying abnormal, irritability                                                                                 Very common                              •   Water for injections Allergic reactions such as pruritus, rash erythematous, dyspnoea, angioedema, shock                                   Not known Insomnia     (1)                                                                                              Common                                       6.2      Incompatibilities Nervous System Disorders
Cephalalgia                                                                                                           Very common                                          Nervous System Disorders                                                                                                                               In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Dizziness (2)                                                                                                         Common                                               Drowsiness                                                                                                    Very common                                  6.3      Shelf life Neuralgia, paresthesia, convulsions, neurological disorders, such as encephalomyelitis, neuritis and                  Not known                                            Paresthesia, convulsions, neurological disorders such as encephalomyelitis                                    Not known                                1 year.
Guillain Barré syndrome                                                                                                                                                    Vascular disorders                                                                                                                                         6.4      Special precautions for storage Vascular disorders                                                                                                                                                         Vasculitis such as Henoch-Schonlein purpura, with transient renal involvement in certain cases                Not known                                Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.
Vasculitis such as Henoch-Schonlein purpura, with transient renal involvement in certain cases                        Not known                                            Gastrointestinal Disorders                                                                                                                                 6.5      Nature and contents of container Gastrointestinal Disorders                                                                                                                                                 Diarrhoea     (1)                                                                                             Very common                              0.5 ml of suspension in prefilled syringe (type I glass) with attached needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl or bromo- Diarrhoea     (1)                                                                                                     Uncommon                                             Vomiting                                                                                                      Common                                   butyl) – pack size of 1, 10, 20 or 50.
0.5 ml of suspension in prefilled syringe (type I glass) without needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl or bromobutyl) Musculoskeletal and Connective Tissue Disorders                                                                                                                            General Disorders and Administration Site Conditions                                                                                                   and a tip cap (chlorobromobutyl) – pack size of 1, 10, 20 or 50.
Myalgia                                                                                                               Very common Injection site pain/tenderness, injection site erythema/redness, injection site oedema/swelling, injection    Very common                                  6.6      Special precautions for disposal and other handling General Disorders and Administration Site Conditions                                                                                                                       site induration, fever Any unused product and or waste material should be disposed of in accordance with local requirements.
Injection site pain/tenderness, injection site erythema/redness, injection site oedema/swelling, injection            Very common                                          Injection site pruritus   (1)   , injection site ecchymosis (1)                                               Common                                   The vaccine should not be used if foreign particles are present in the suspension.
site induration (3), malaise                                                                                                                                                                                                                                                                                                      The vaccine should be brought to reach room temperature before use.
(1)                                                                                                                                                     Shake before use. Inspect visually prior to administration.
Fever, shivering/rigors   (4)   , injection site ecchymosis, injection site discomfort (2), injection site pruritus   Common                                                    Reported within 3 days after injection of VAXIGRIP Instructions for the administration of a dose of 0.25 ml in children aged 6 to 35 months Injection site warmth   (3)   , injection site haemorrhage (1)                                                        Uncommon                               c. Other special populations                                                                                                                                         When one dose of 0.25 ml is indicated, in order to eliminate half of the volume of the 0.5 ml syringe: the syringe should be held in an upright position and the Although only a limited number of subjects with co-morbidities were enrolled, studies conducted in renal transplant patients, asthmatic patients, or children aged   plunger stopper should be pushed until it reaches the fine black line printed on the syringe. The remaining volume of 0.25 ml should be injected. See also Section 6 months to 3 years with medical conditions being at especially high risk of developing serious flu-related complications showed no major differences in terms of    4.2.
(1)   Reported during clinical trials in children aged 3 to 8 years                                                                                                           safety profile of VAXIGRIP in these populations.
(2)   Reported during clinical trials in children/adolescents aged 9 to 17 years (3)   Common in children/adolescents aged 9 to 17 years                                                                                                                       Reporting of suspected adverse reactions                                                                                                                             Manufacturer: (4)   Very common in children/adolescents aged 9 to 17 years                                                                                                                                                                                                                                                                                       SANOFI PASTEUR SA 2, avenue Pont Pasteur 69007 Lyon, France (5)                                                                                                                                                                           Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the Not known in children/adolescents aged 9 to 17 years                                                                                                                                                                                                                                                                                         License Holder: medicinal product.
Medici Medical Ltd., 3 Hamachshev St., Netanya
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulatorybyusinganonlineform http://forms.gov.il/globaldata/ The format of this leaflet was determined by the Ministry of Health and its content was checked and approved at June 2016.
getsequence/getsequence.aspx?formType=AdversEffectMedic@moh. gov.il
•            Children aged 6 to 35 months: PI-124.06