Posology : מינונים

4.2     Posology and method of administration                                                                                                                                                                                                                                                                                                            Myalgia                                                                                                                           Very common
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.