WHO PACKAGE INSERT. GlaxoSmithKline Biologicals FluLaval. Dossier First - Chapter 1 to 10 for WHO

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1 77 WHO PACKAGE INSERT 11 Chapter 4_Annex 4.4-1_ WHO leaflet_en - Page 1

2 78 1. NAME OF THE MEDICINAL PRODUCT, suspension for injection Influenza vaccine (split virion, inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION is an inactivated influenza vaccine (split virion), containing antigens (propagated in embryonated eggs) equivalent to the following types and subtypes: A/Solomon Islands/3/2006 (H1N1)-like strain [variant A/Solomon Islands/03/2006 (IVR-145)]; A/Wisconsin/67/2005 (H3N2)-like strain [variant A/Wisconsin/67/2005 (NYMCX-161-B)]; B/Malaysia/2506/2004-like strain [variant B/Malaysia/2506/2004]. This vaccine complies with the WHO recommended strains (Northern Hemisphere) for the season 2007/2008. Each 0.5 ml vaccine dose ( ) contains 15 µg haemagglutinin of each of the recommended strains. meets the WHO requirements for biological substances and influenza vaccines and the US Pharmacopoeia requirements for influenza vaccines. 3. PHARMACEUTICAL FORM Suspension for injection. is a colourless to slightly opalescent suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications is indicated for active immunisation of adults from 18 years of age against influenza disease caused by influenza virus types A and B contained in the vaccine. should be administered before the beginning of the influenza season or as required by the epidemiological situation. Vaccination should be repeated every year with vaccine of updated antigen composition. 4.2 Posology and method of administration should be administered as a single 0.5 ml injection by the intramuscular route preferably into the deltoid muscle of the upper arm. 4.3 Contraindications should not be administered to subjects with known hypersensitivity to the active substances, to any of the excipients or to any of the residues such as egg proteins and formaldehyde. should not be administered to subjects with known hypersensitivity reaction after previous administration of influenza vaccines. 21 Chapter 4_Annex 4.4-1_ WHO leaflet_en - Page 2

3 Special warnings and precautions for use Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. As with all injectable vaccines, appropriate medical treatment should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. As with other vaccines, the administration of should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As for other vaccines administered intramuscularly, should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. No data are available on subcutaneous administration of. should under no circumstances be administered intravascularly. The expected immunological response may not be obtained after vaccination of immunosuppressed patients such as HIV infected patients or patients receiving immunosuppressive therapy. is not effective against all possible strains of influenza virus. is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains. A protective immune response may not be elicited in all vaccinees. 4.5 Interaction with other medicinal products and other forms of interaction Data have not been generated on the concomitant administration of and other vaccines. If is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites. As with other vaccines it may be expected that, in patients receiving immunosuppressive therapy, an adequate response may not be achieved. 4.6 Pregnancy and lactation Pregnancy Animal reproduction studies have not been conducted with. Limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine is recommended from the second trimester of pregnancy in healthy women. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Lactation may be used during lactation. 31 Chapter 4_Annex 4.4-1_ WHO leaflet_en - Page 3

4 Effects on ability to drive and use machines The vaccine is unlikely to produce an effect on the ability to drive and use machines. 4.8 Undesirable effects Clinical trials The safety profile presented below is based on data from clinical trials. Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows: 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) Infections and infestations Uncommon: upper respiratory infection Nervous system disorders Very common: headache Uncommon: dizziness Eye disorders Common: reddened eyes Respiratory, thoracic and mediastinal disorders Common: pharyngolaryngeal pain, sore throat*, cough* Gastrointestinal disorders Uncommon: nausea Skin and subcutaneous tissue disorders Uncommon: facial swelling* Musculoskeletal and connective tissue disorders Very common: myalgia Common: arthralgia General disorders and administration site conditions Very common: pain and redness at the injection site, fatigue Common: swelling at the injection site, fever, malaise, chills, chest tightness *These symptoms can be associated to the oculorespiratory syndrome (ORS). ORS consists of the following signs and symptoms: bilateral red eyes and/or respiratory symptoms (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat) and/or facial swelling. Although not explicitely identified as ORS during the clinical trials, these symptoms were solicited to detect possible cases of that syndrome. 41 Chapter 4_Annex 4.4-1_ WHO leaflet_en - Page 4

5 81 Post-marketing surveillance: Immune system disorders Allergic reactions including anaphylactic and anaphylactoid reactions Skin and subcutaneous tissue disorders Angioedema, urticaria 4.9 Overdose Insufficient data are available 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmaco-therapeutic group: viral vaccines, ATC code: J07BB02 provides active immunisation against 3 influenza virus strains anticipated to circulate in the Northern Hemisphere during the upcoming winter season. Annual revaccination is necessary because immunity wanes during the year after vaccination, and because the antigens displayed on the surface of influenza virus strains, which are the targets of the protective immune response, may change from year to year a process called antigenic drift. Although multiple immune mechanisms, including cellular immunity, may contribute to vaccine-induced protection against influenza, the humoral component of the immune response, in particular antibodies against virus hemagglutinin (HA) and neuraminidase antigens is best understood. Specific levels of vaccine-induced HAI antibodies that protect against naturally occurring influenza disease have not been established in randomised, controlled trials. A haemagglutinin inhibition titre equal to or greater than 1:40 in the serum is associated with reductions in influenza illness. Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccination immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months. The seroprotection and seroconversion rates of for the influenza vaccine season were assesesd in clinical trials. The seroprotection rate was defined as a day-21 HAI reciprocal titer 40 and the seroconversion rate as a 4-fold increase on day 21 post-immunisation in reciprocal HAI antibody titer or an increase in reciprocal titers from undetectable (<10) to 40. The seroprotection rates following vaccination were in excess of these requirements. 5.2 Pharmacokinetic properties Evaluation of pharmacokinetic properties is not required for vaccines. 5.3 Preclinical safety data has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients 51 Chapter 4_Annex 4.4-1_ WHO leaflet_en - Page 5

6 82 Sodium chloride, potassium chloride, sodium phosphate dibasic heptahydrate, potassium phosphate monobasic, thiomersal and water for injections 6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 Shelf life The expiry date of the vaccine is indicated on the label and packaging. 6.4 Special precautions for storage Store at +2 C to +8 C (in a refrigerator). Do not freeze. Store in the original packaging in order to protect from light. 6.5 Nature and contents of container 5 ml of suspension in a vial (type I glass) for 10 doses pack size of Special precautions for disposal and other handling is a colourless to slightly opalescent suspension. The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine. Multidose vials of from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met (as described in the WHO policy statement: The use of opened multidose vials in subsequent immunization sessions. WHO/V&B/00.09): The expiry date has not passed; The vaccines are stored under appropriate cold chain conditions; The vaccine vial septum has not been submerged in water; Aseptic technique has been used to withdraw all doses; The vaccine vial monitor (VVM), if attached, has not reached the discard point. A separate sterile syringe and needle should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and should not be recapped. Any unused product of waste material should be disposed of in accordance with local requirements. Presentations For further information, please contact the manufacturer. is a trademark. 61 Chapter 4_Annex 4.4-1_ WHO leaflet_en - Page 6