Active ingredients: Inactivated influenza vaccine, surface antigen, adjuvanted with MF59C.1
FLUAD 2015/2016, suspension for injection in pre-filled syringe
Indications Why is Fluad used? What is it for?
Fluad is a vaccine. This vaccine helps protect you from the flu. It is used as an active immunization against influenza in the elderly (aged 65 and over), especially in those at increased risk of complications (for example, people with chronic diseases, such as diabetes. , cardiovascular and respiratory disorders).
Fluad must be used according to official recommendations.
When a person is given the Fluad vaccine, the immune system (the body's natural defense system) produces its own protective factors (antibodies) against the disease. None of the components of the vaccine can cause flu.
Influenza is a disease that can spread rapidly and is caused by different strains, which can vary each year. For this reason, it may be necessary to get vaccinated every year. The risk of contracting the flu is greater in the cold months, between October and March. . If you have not been vaccinated in the fall, you can still be vaccinated until spring because the risk of catching the flu remains until that season. Your doctor will advise you on the best time to get vaccinated.
Fluad protects you from the three viral strains contained in the vaccine starting approximately 2 to 3 weeks after injection.
Since the incubation period (the time between infection with a pathogen and the appearance of the first symptoms) of influenza is a few days, you could still contract the disease if you come into contact with the influenza virus immediately. before or after vaccination.
The vaccine does not protect against the common cold, although some symptoms are similar to flu symptoms.
Contraindications When Fluad should not be used
To make sure Fluad is right for you, it is important to tell your doctor or pharmacist if any of the following apply to you. If there is anything you do not understand, ask your doctor or pharmacist about it.
Do not use Fluad
- if you are allergic (hypersensitive) to the active substances, to any of the ingredients of Fluad, to eggs, chicken proteins such as ovalbumin, kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and barium sulphate (For information on the other ingredients of Fluad see section 6 "Contents of the pack and other information") or
- if you have experienced an anaphylactoid reaction to a previous flu vaccination.
- if you have a severe febrile illness or an acute infection, the vaccination should be postponed until you are cured.
Precautions for use What you need to know before taking Fluad
Tell your doctor before vaccination if you have a poor immune response (immunodeficiency or taking medicines that compromise the immune system).
Fainting, feeling faint or other stress-related reactions may occur, as can generally occur following needle administration. Tell your doctor or nurse if you have had such a reaction before. .
Your doctor will decide whether you should be vaccinated.
If for any reason you need to have a blood test a few days after your flu shot, please tell your doctor. This is because false positive blood test results have been observed in some recently vaccinated patients.
As with all vaccines, it is possible that Fluad does not confer complete protection on all vaccinated people.
It is possible that there is not a protective immune response in all people who have been vaccinated.
Latex sensitive individuals:
The safe use of Fluad in latex sensitive individuals has not been established; however, it is noted that the presence of natural rubber latex in the protective cap of the syringe was not found.
Interactions Which drugs or foods can modify the effect of Fluad
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If it is necessary to use Fluad at the same time as other vaccines, immunization should be performed by injection into different limbs.It should be noted that undesirable effects may be potentiated in case of concomitant administration with other vaccines.
A higher frequency of some solicited reactions has been reported in subjects vaccinated with trivalent inactivated influenza vaccine and pneumococcal vaccine compared to those who received trivalent inactivated influenza vaccine alone.
The immune response may be reduced in case of immunosuppressive treatment, for example with corticosteroids, cytotoxic drugs or radiotherapy.
Warnings It is important to know that:
Pregnancy and breastfeeding
Not relevant.
Driving and using machines
Fluad has no or negligible influence on the ability to drive or use machines.
Important information about some of the ingredients of Fluad
One dose of Fluad (0.5 ml) contains less than 1 mmol (39 mg) of potassium and less than 1 mmol (23 mg) of sodium. This means that Fluad is essentially potassium and sodium free.
Fluad contains no more than 0.2 micrograms of ovalbumin per 0.5 ml dose.
Dosage and method of use How to use Fluad: Dosage
Dose
One 0.5 ml dose.
Route (s) and / or method of administration
Your doctor will give you the recommended dose of the vaccine by injection into the upper arm (deltoid muscle). If you have any questions about the use of this vaccine, consult your doctor or pharmacist.
Overdose What to do if you have taken too much Fluad
Not relevant.
Side Effects What are the side effects of Fluad
Like all medicines, Fluad can cause side effects, although not everybody gets them.
A higher incidence of moderate reactions compared to non-adjuvanted influenza vaccines has been reported following immunization with Fluad.
The following undesirable effects were observed in clinical studies. Their frequency was defined as common (1 to 10 cases in 100):
- headache
- sweating
- muscle pain (myalgia), joint pain (arthralgia)
- fever, general feeling of being unwell, chills, tiredness
- local reactions: redness, swelling, pain at the injection site, bruising (bruising), induration around the injection site of the vaccine.
Most reactions are mild or moderate in severity and resolve spontaneously within 1-2 days.
In addition to the common side effects already mentioned, the following side effects occurred after the vaccine was placed on the market:
- allergic reactions: - which in rare cases have caused an emergency situation, with the inability of the circulatory system to maintain adequate blood flow to the various organs (shock); - in very rare cases more evident swelling of the head and neck, including face, lips, tongue, throat, or any other part of the body (angioedema);
- skin reactions that can spread all over the body, including itching, hives, rash
- inflammation of blood vessels, which can cause skin rashes (vasculitis) and, in very rare cases, transient kidney problems.
- severe rash (exudative erythema multiforme)
- pain along the course of a nerve (neuralgia), abnormal perception of touch, pain, heat and cold (paraesthesia), fits (convulsions), fainting, feeling faint, neurological disorders which can cause neck stiffness, confusion , numbness, pain and weakness in the limbs, loss of balance, loss of reflexes, paralysis of parts of the body or the whole body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
- reduction in the number of certain blood particles called platelets; a low number of platelets can cause too many bruising or bleeding (thrombocytopenia); swollen glands in the neck, armpits or groin (lymphadenopathy).
- asthenia, flu-like syndrome (ILI),
- pain in extremities, muscle weakness
- injection site swelling, pain and redness that affect an area greater than 10 cm and last for more than a week (injection site cellulite-like reaction);
- extensive swelling in the injected limb that lasts for more than a week
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep out of the sight and reach of children.
Do not use Fluad after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. Keep the syringe in the outer carton to protect the medicine from light.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Fluad contains
The active substances are influenza virus surface antigens (hemagglutinin and neuraminidase), of the following strains *:
A / California / 7/2009 (H1N1) pdm09 - equivalent strain (A / California / 7/2009, NYMC X-181) 15 micrograms HA **
A / Switzerland / 9715293/2013 (H3N2) - equivalent strain (A / Switzerland / 9715293/2013, NIB-88) 15 micrograms HA **
B / Brisbane / 9/2014 (wild type) 15 micrograms HA **
For each 0.5 ml dose
* grown in embryonated hen eggs from healthy chicken farms and adjuvanted with MF59C.1
** hemagglutinin
The vaccine complies with WHO (World Health Organization) recommendations (Northern Hemisphere) and EU decision for the 2015/2016 season.
The adjuvant is MF59C.1 containing: 9.75 mg of squalene; 1.175 mg of polysorbate 80; 1.175 mg of sorbitan trioleate; 0.66 mg of sodium citrate; 0.04 mg of citric acid and water for injections.
The other excipients are:
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
What Fluad looks like and contents of the pack
The vaccine comes as a suspension for injection in a 0.5 ml pre-filled syringe in packs of 1 or 10 units, with or without a needle.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FLUAD SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
(2015-2016 SEASON)
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Surface antigens (haemagglutinin and neuraminidase) of influenza virus, strains *:
A / California / 7/2009 (H1N1) pdm09 - equivalent strain (NYMC X-181)
15 mcg HA **
A / Switzerland / 9715293/2013 (H3N2) - equivalent strain (NIB-88)
15 mcg HA **
B / Brisbane / 9/2014 (wild type)
15 mcg HA **
* grown in embryonated chicken eggs from healthy chicken farms and adjuvanted with MF59C.1
** hemagglutinin
Adjuvant: MF59C.1 which is a proprietary adjuvant containing: 9.75 mg of squalene; 1.175 mg of polysorbate 80; 1.175 mg of sorbitan trioleate; 0.66 mg of sodium citrate; 0.04 mg of citric acid and water for injections.
For each 0.5 ml dose
The vaccine complies with the recommendations of the World Health Organization (for the Northern Hemisphere) and the decisions of the European Union for the 2015/2016 season.
Fluad may contain traces of eggs such as ovalbumin or chicken protein, kanamycin and neomycin sulfate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and barium sulfate which are used during the manufacturing process (see section 4.3).
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine comes as a milky white suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Active immunization against influenza in the elderly (65 years of age and older), especially in individuals with an increased risk of associated complications (eg people with chronic diseases such as diabetes, cardiovascular and respiratory disorders).
Fluad must be used according to official recommendations.
04.2 Posology and method of administration
Dosage
A single 0.5 ml dose should be administered by intramuscular injection into the deltoid muscle. Given the presence of the adjuvant, the injection should be performed using a 25 mm needle.
Method of administration
For preparation instructions, see section 6.6.
04.3 Contraindications
Hypersensitivity to the active ingredients, to the components of the adjuvant, to the excipients, to residues (eg eggs or chicken proteins, such as ovalbumin); the vaccine is also contraindicated in anyone who has experienced an anaphylactoid reaction to a previous anti-influenza vaccination .
The vaccine may contain residues of the following substances: kanamycin and neomycin sulfate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and barium sulfate.
Immunization should be postponed in patients with febrile illnesses or acute infections.
04.4 Special warnings and appropriate precautions for use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in the event of an anaphylactic reaction following the administration of the vaccine.
Fluad should under no circumstances be administered intravascularly or subcutaneously.
Following, or even before, any vaccination, anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions, may occur as a psychogenic response to needle administration. This phenomenon can be accompanied by various neurological disorders. such as transient visual disturbances, paraesthesia and tonic-clonic movements of the limbs during the recovery phase It is important to adopt procedures to avoid damage resulting from fainting.
The antibody response may be insufficient in patients with endogenous or iatrogenic immunodeficiency.
A protective response may not be produced in all vaccinated people.
Latex sensitive individuals:
The safe use of Fluad in latex sensitive individuals has not been established; however, it is noted that the presence of natural rubber latex in the protective cap of the syringe was not found
04.5 Interactions with other medicinal products and other forms of interaction
No clinical data are available on concomitant administration with other vaccines.
If Fluad is to be administered concomitantly with other vaccines, immunization should be performed in different limbs. It is understood that concomitant administration may intensify adverse reactions.
A higher frequency of some solicited reactions has been reported in subjects vaccinated with trivalent inactivated influenza vaccine and pneumococcal vaccine compared to those who received trivalent inactivated influenza vaccine alone.
The immunological response may be reduced if the patient is being treated with immunosuppressive drugs.
False positive results in serological tests have been observed following influenza vaccination to identify antibodies to HIV1, Hepatitis C and especially HTLV1 using the ELISA method. The Western Blot technique allows the identification of false positive ELISA results. These false positive reactions could be due to the IgM response to the vaccine.
04.6 Pregnancy and lactation
Not relevant.
04.7 Effects on ability to drive and use machines
Fluad has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
A higher incidence of moderate reactions has been reported following immunization with Fluad compared to non-adjuvanted influenza vaccines.
Adverse reactions detected in clinical trials
The following undesirable effects were observed during clinical trials with the following frequencies:
Very common (≥1 / 10); common (≥1 / 100,
Nervous system disorders
Common (≥1 / 100,: headache
Skin and subcutaneous tissue disorders
Common (≥1 / 100,: sweating
Musculoskeletal and connective tissue disorders
Common (≥1 / 100,: myalgia, arthralgia
General disorders and administration site conditions
Common (≥1 / 100,: fever, malaise, chills, fatigue
Local reactions: redness, swelling, pain at the injection site, bruising, induration
Most reactions are mild or moderate in severity and resolve spontaneously within 1-2 days.
Adverse reactions detected by post-marketing surveillance
Adverse reactions from post-marketing surveillance, in addition to reactions observed during clinical trials, are as follows:
Disorders of the blood and lymphatic system
Thrombocytopenia (some very rare cases were severe with platelet counts below 5000 per mm3), lymphadenopathy.
Disorders of the immune system
Allergic reactions which, in rare cases, have led to shock, angioedema.
Nervous system disorders
Neuralgia, paraesthesia, convulsions, syncope, pre-syncope.
Neurological disorders such as encephalomyelitis, neuritis and Guillain-Barré syndrome.
Vascular pathologies
Vasculitis with transient renal involvement and exudative erythema multiforme.
Skin and subcutaneous tissue disorders
Generalized skin reactions including itching, hives or non-specific rash.
Musculoskeletal and connective tissue disorders
Pain in extremities, muscle weakness
General disorders and administration site conditions
Asthenia, flu-like syndrome (ILI)
Cellulite-like reaction at the injection site (some cases of swelling, pain and redness affecting an area greater than 10 cm and lasting for more than a week), extensive swelling in the injection site limb that lasts for more than a week .
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Overdose is unlikely to have any undesirable effects.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: influenza vaccine, ATC code: J07BB02
Seroprotection is usually achieved in 2-3 weeks. The duration of post-vaccination immunity to homologous or closely related strains to those contained in the vaccine varies, but is usually 6-12 months.
Although no comparative clinical efficacy studies have been performed, the antibody response to Fluad is enhanced when compared to the response to non-adjuvanted vaccines, particularly with regard to influenza B and A / H3N2 antigens.
The increase in the immune response is more noticeable in elderly subjects with low pre-immunization titers and in subjects suffering from chronic diseases (diabetes, cardiovascular and respiratory diseases) who run a higher risk of complications associated with influenza. A similar immunogenic profile is obtained after a second and third immunization with Fluad.
A significant increase in antibody titer after immunization with Fluad has also been demonstrated with respect to heterovariant strains, antigenically different from those present in the vaccine.
05.2 Pharmacokinetic properties
Not relevant.
05.3 Preclinical safety data
Studies on repeated dose toxicity, local tolerance and sensitization did not reveal any specific risk for humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Adjuvant: see section 2.
Other excipients: sodium chloride, potassium chloride, potassium dihydrogen phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
06.2 Incompatibility
In the absence of compatibility studies, Fluad must not be mixed with other medicinal products.
06.3 Period of validity
1 years
06.4 Special precautions for storage
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. Keep the syringe in the outer carton to protect the medicine from light.
06.5 Nature of the immediate packaging and contents of the package
Pre-filled syringe with or without needle (Type I glass) containing 0.5 ml of suspension.
Pack of 1, with or without needle.
Pack of 10 x, with or without needle.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Bring Fluad to room temperature before administering it. Shake gently before use.
After shaking, Fluad appears as a milky white suspension.
Visually examine the contents of each pre-filled syringe of Fluad for any particulate matter or discoloration prior to administration. If particulate matter or discoloration is present, do not use the contents.
Do not use the product if the vaccine has been frozen.
Unused vaccine and waste derived from this vaccine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Novartis Vaccines Influenza S.r.l., Via Fiorentina 1, 53100 Siena, Italy.
08.0 MARKETING AUTHORIZATION NUMBER
031840034 (pack of 1, with needle)
031840059 (pack of 1, without needle)
031840046 (pack of 10, with needle)
031840061 (pack of 10x, without needle)
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
15/05/1997
06/10/2010
10.0 DATE OF REVISION OF THE TEXT
09/2015
