| The following changes to Influvac Sub-unit 2010/2011 SPC have been made and are highlighted in bold and italics
1. NAME OF THE MEDICINAL PRODUCT
From:
Influvac Sub-unit 2009/2010, suspension for injection (influenza vaccine, surface antigen, inactivated).
To:
Influvac Sub-unit 2010/2011, suspension for injection (influenza vaccine, surface antigen, inactivated).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
From:
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:
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- A/Brisbane/59/2007 (H1N1)-like strain (A/Brisbane/59/2007 IVR-148 reass.)
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15 micrograms HA**
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- A/Brisbane/10/2007 (H3N2)-like strain (A/Uruguay/716/2007 NYMC X-175C reass.)
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15 micrograms HA**
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- B/ Brisbane/60/2008-like strain
(B/Brisbane/60/2008)
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15 micrograms HA**
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per 0.5 ml dose.
* propagated in fertilised hens’ eggs from healthy chicken flocks.
** haemagglutinin.
This vaccine complies with the WHO recommendation (northern hemisphere), and EU decision for the 2009/2010 season.
For a full list of excipients see section 6.1.
To:
Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*:
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-A/California/7/2009 (H1N1): derived strain used reass. virus NYMC X-181
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15 micrograms HA **
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-A/Perth/16/2009 (H3N2): like strain used reass. virus NYMC X-187 derived from A/Victoria/210/2009
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15 micrograms HA **
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-B/Brisbane/60/2008
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15 micrograms HA **
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per 0.5 ml dose
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* propagated in fertilised hens’ eggs from healthy chicken flocks.
** haemagglutinin.
This vaccine complies with the WHO recommendation (northern hemisphere), and EU decision for the 2010/2011 season.
For a full list of excipients see section 6.1.
4.1 Therapeutic indications
From:
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of Influvac Sub-unit 2009/2010 should be based on official recommendations.
To:
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of Influvac Sub-unit should be based on official recommendations.
4.2 Posology and method of administration
From:
Adults and children from 36 months: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.
For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. Immunisation should be carried out by intramuscular or deep Subcutaneous injection.
For instructions for preparation, see section 6.6.
To:
Adults and children from 36 months: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.
For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. Immunisation should be carried out by intramuscular or deep subcutaneous injection.
For instructions for preparation, see section 6.6.
4.3 Contraindications
From:
Hypersensitivity to the active substances, to any of the excipients and to residues of eggs, chicken protein (Influvac Sub-unit 2009/2010 does not contain more than 1 µg ovalbumin per dose), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.
Immunisation shall be postponed in patients with febrile illness or acute infection.
To:
Hypersensitivity to the active substances, to any of the excipients and to residues of eggs, chicken proteins (such as ovalbumin), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.
Immunisation should be postponed in patients with febrile illness or acute infection.
4.4 Special warnings and precautions for use
From:
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Influvac Sub-unit 2009/2010 should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
To:
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Influvac Sub-unit should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
4.5 Interaction with other medicinal products and other forms of interaction
From:
Influvac Sub-unit 2009/2010 may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false-positive reactions could be due to the IgM response by the vaccine.
To:
Influvac Sub-unit may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false-positive reactions could be due to the IgM response by the vaccine.
4.6 Pregnancy and lactation
From:
The limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. 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.
Influvac Sub-unit 2009/2010 may be used during lactation.
To:
The limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. 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.
Influvac Sub-unit may be used during lactation.
4.7 Effects on ability to drive and use machines
From:
Influvac Sub-unit 2009/2010 is unlikely to produce an effect on the ability to drive and use machines.
To:
Influvac Sub-unit is unlikely to produce an effect on the ability to drive and use machines.
4.8 Undesirable effects
From:
ADVERSE REACTIONS OBSERVED FROM CLINICAL TRIALS
The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 - 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.
The following undesirable effects have been observed during clinical trials with the following frequencies:
very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
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Organ class
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Very common
≥1/10
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Common
≥1/100, <1/10
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Uncommon
≥1/1,000, <1/100
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Rare
≥1/10,000, <1/1,000
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Very rare
<1/10,000
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Nervous system disorders
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Headache*
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Skin and Subcutaneous tissue disorders
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Sweating*
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Musculoskeletal and connective tissue disorders
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Myalgia, arthralgia*
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General disorders and administration site conditions
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fever, malaise, shivering, fatigue
Local reactions: redness, swelling, pain, ecchymosis induration*
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* these reactions usually disappear within 1-2 days without treatment
Adverse reactions reported from post-marketing surveillance
Adverse reactions reported from post marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:
Blood and lymphatic system disorders:
Transient thrombocytopenia, transient lymphadenopathy
Immune system disorders:
Allergic reactions, in rare cases leading to shock, angioedema
Nervous system disorders:
Neuralgia, paraesthesia, febril convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Vascular disorders:
Vasculitis associated in very rare cases with transient renal involvement
Skin and Subcutaneous tissue disorders:
Generalised skin reactions including pruritus, urticaria or non-specific rash
To:
ADVERSE REACTIONS OBSERVED FROM CLINICAL TRIALS
The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 - 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.
The following undesirable effects have been observed during clinical trials with the following frequencies:
very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports.
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Organ class
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Very common
≥ 1/10
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Common
≥ 1/100,
< 1/10
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Uncommon
≥ 1/1,000,
< 1/100
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Rare
≥ 1/10,000,
< 1/1,000
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Very rare
< 1/10,000
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Nervous system disorders
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Headache*
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Skin and Subcutaneous tissue disorders
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Sweating*
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Musculoskeletal and connective tissue disorders
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Myalgia, arthralgia*
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General disorders and administration site conditions
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fever, malaise, shivering, fatigue
Local reactions: redness, swelling, pain, ecchymosis induration*
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* These reactions usually disappear within 1-2 days without treatment
Adverse reactions reported from post-marketing surveillance
Adverse reactions reported from post marketing surveillance are, in addition to the reactions which have also been observed during the clinical trials, the following:
Blood and lymphatic system disorders:
Transient thrombocytopenia, transient lymphadenopathy
Immune system disorders:
Allergic reactions, in rare cases leading to shock, angioedema
Nervous system disorders:
Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Vascular disorders:
Vasculitis associated in very rare cases with transient renal involvement
Skin and Subcutaneous tissue disorders:
Generalised skin reactions including pruritus, urticaria or non-specific rash
5.1 Pharmacodynamic properties
From:
Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02.
Seroprotection is generally obtained within 2 to 3 weeks. The duration of post-vaccinal immunity to homologuous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
To:
Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02.
Seroprotection is generally obtained within 2 to 3 weeks. The duration of post-vaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
6.1 List of excipients
From:
Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride, magnesium chloride hexahydrate and water for injections.
To:
Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.
6.2 Incompatibilities
From:
In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.
To:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.4 Special precautions for storage
From:
Influvac Sub-unit 2009/2010 should be stored in a refrigerator (+2°C to +8°C).
Do not freeze.
Protect from light.
To:
Influvac Sub-unit should be stored in a refrigerator (+2°C to +8°C).
Do not freeze.
Protect from light.
6.6 Special precautions for disposal and other handling
From:
Unused vaccine and other waste material should be disposed of in compliance with local rules for the disposal of products of this nature.
Influvac Sub-unit 2009/2010 should be allowed to reach room temperature before use.
Shake before use.
For administration of a 0.25 ml dose from a syringe, push the front side of the plunger exactly to the edge of the hub (the knurled polypropylene ring); a reproducible volume of vaccine remains in the syringe, suitable for administration. See also section 4.2.
To:
Influvac Sub-unit should be allowed to reach room temperature before use.
Shake before use.
For administration of a 0.25 ml dose from a syringe, push the front side of the plunger exactly to the edge of the hub (the knurled polypropylene ring); a reproducible volume of vaccine remains in the syringe, suitable for administration. See also section 4.2.
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
From:
Solvay Healthcare Limited
Mansbridge Road
West End
Southampton
SO18 3JD
To:
Abbott Healthcare Products Limited
Mansbridge Road
West End
Southampton
SO18 3JD
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
From:
February 1998 / December 2007
To:
March 1998 / December 2007
10 DATE OF REVISION OF THE TEXT
From:
02/09/2009
To:
06 /08/ 2010
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