Intanza - summary of medicine characteristics

Summary of medicine characteristics - Intanza

1. NAME OF THE MEDICINAL PRODUCT

INTANZA 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Influenza virus (inactivated, split) of the following strains*:

A/Michigan/45/2015 (H1N1)pdm09 – like strain (A/Michigan/45/2015, NYMC X-275).............................................................................................................................15 micrograms

A/Hong Kong/4801/2014 (H3N2) – like strain (A/Hong Kong/4801/2014, NYMC X-263B.............................................................................................................................15 micrograms HA

B/Brisbane/60/2008 – like strain (B/Brisbane/60/2008, wild type)

ms HA

isphere) and EU decision for

Per 0.1 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks

** haemagglutinin

This vaccine complies with the WHO recommendations (No the 2017/2018 season.

For the full list of excipients, see section 6.1.

INTANZA may contain residues of eggs such and octoxinol 9, which are used during the manufacturing process (see section 4.3).

min and residues of neomycin, formaldehyde

3. PHARMACEUTICAL F

Suspension for injection.

Colourless and opalescent suspension.

4. CLINICAL PARTICULARS

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4.1 Therapeutic indications of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.

The use of INTANZA should be based on official recommendations.

4.2 Posology and method of administration

Posology

Individuals 60 years of age and over: 0.1 ml.

Paediatric population

INTANZA is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.

Method of administration

Immunisation should be carried out by intradermal route.

The recommended site of administration is the region of the deltoid.

Precautions to be taken before handling or administering the medicinal product

For instructions on preparation of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.

Immunisation shall be postponed in subjects with febrile illness or acute infection

4.4 Special warnings and precautions for useays be

As with all injectable vaccines, appropriate medical treatment and supervision sho readily available in case of an anaphylactic event following the administration of the vaccine (see section 4.8).

INTANZA should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

Very limited data in immunocompromised patients are available for INTANZA.

In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.

Interference with serological testing: See section 4.5.

4.5 Interaction with other medicinal products and other forms of interaction

INTANZA 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.

ertility, pregnancy and lactation

This vaccine is intended for individuals 60 years of age and over. Therefore, this information is not applicable.

4.7 Effects on ability to drive and use machines

INTANZA has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

a. Summary of the safety profile

The safety of INTANZA has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of INTANZA.

Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up for 2,974 subjects (population of two out of the three clinical trials).

The most common reactions occurring after vaccine administration were local reactions at injecti site.

Apparent local reactions after intradermal administration were more frequent than after intramus administration of an adjuvanted or non-adjuvanted comparator vaccine.

Most reactions resolved spontaneously within 1 to 3 days after onset.

Systemic safety profile of INTANZA is similar to the comparator vaccine, adjuvanted or non-adjuvanted, administered intramuscularly.

o the previous injections.

After repetitive yearly injections the safety profile of INTANZA is si

b. Tabulated summary of adverse reactions

The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data).

Organ class	Very common	Common	Uncommon	Rare	Very rare	Not known
Immune system disorders						Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedem r. shock
Nervous system disorders	Headache			Paresthesia, neuritis
Skin and subcutaneous tissue disorders			Sweating	Pruritus, rash
Musculoskeletal and connective tissue disorders	Myalgia		Arthralgia
General disorders and administration site conditions	Local reactions: redness*, induration swelling, pruritus, pain	Malaise, shivering, fever, Local reactions: ecchymosis r?	Fatigue \C

*In some cases, local redness lasted up to

c. Potential adverse events

Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, the following events may be reported:

Blood and lymphatic system disorders

Transient thrombocytopenia, transient lymphadenopathy

Nervous system disorders

Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré syndrome

Vascular disorders

Vasculitis associated in very rare cases with transient renal involvement

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued 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 listed in

4.9 Overdose

Overdose is unlikely to have any untoward effect.

5. PHARMACOLOGICAL PROPERTIES5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02

Immunogenicity

Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immun homologous strains or to strains closely related to the vaccine strains varies but is usually 6–12 months.

In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years o 0.1 ml of INTANZA by intradermal route and 1,089 subjects over 60 years of a trivalent inactivated influenza vaccine administered by intramuscular route.

eived

eceived 0.5 ml of a

In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.

Data were as follows (values in brackets show the 95% confidence intervals):

	Intradermal 15gg
	A/H1N1	A/H3N2	B
	A/New Caledonia/ 20/99	A/Wisconsin/ 67/2005	B/Malaysia/ 2506/2004
	N = 2,585	N = 2,586	N = 2,582
Geometric mean of titre (1/dil)	81.7 y (78.0 ; 85.6)	298.0 (282 ; 315)	39.9 (38.3 ; 41.6)
Seroprotection rate (%) *	77.0 (75.3 ; 78.6)	93.3 (92.3 ; 94.3)	55.7 (53.8 ; 57.6)
Seroconversion or significant increase rate (%)	38.7 (36.8 ; 40.6)	61.3 (59.3 ; 63.1)	36.4 (34.5 ; 38.3)
Geometric mea a of titre ratio ♦ < (gmtr)	3.97 (3.77 ; 4.18)	8.19 (7.68 ; 8.74)	3.61 (3.47 ; 3.76)

*Seroprotection = HI titre > 40

Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre > 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre).

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety datae was significant transient local ecause theseon in females have

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients6.2 IncompatibilitiesIn the absence of compatib medicinal products.1 year6.46.3 Shelf-lifel precautions for storageNature and contents of containerdies, this medicinal product must not be mixed with otherin a refrigerator (2°C-8°C). Do not freeze.the syringe in the outer carton in order to protect from light.

6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

The vaccine should be allowed to reach room temperature before use.

The vaccine should not be used if foreign particles are present in the suspension.

It is not necessary to shake the vaccine before use.

The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.

The needle shielding system is designed to cover the micro-needle after use.

Micro-Injection System

INSTRUCTIONS FOR USE

Please read the instruction before use

1/ REMOVE NEEDLE CAP

Do not purge through the needle.

2/ HOLD MICRO-INJECTION SYSTEM

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Remove the needle cap from the Micro-Injection System.

Hold the system by placing the thumb an middle finger only on the finger pads; he index finger r emains free.

Do not place fingers indows.

4/ INJECT USING THE INDEX FINGER

3/ INSERT NEEDLE RAPIDLY

PERPENDICULAR TO THE SKIN

Insert the needle perpendicular to the skin, in the region of the deltoid, in a short, quick movement.

Once the micro-needle has been inserted, maintain a light pressure on the surface of the skin and inject using the index finger to push on the plunger. The vein test is unnecessary.

BY PUSHING FIRMLY ON PLUNGER

5/ ACTIVATE NEEDLE SHI

Remove the needle from the skin.

Orient the needle away from you and others.

With the same hand, push very firmly with the thumb on the plunger to activate the needle shield.

You hear a click and a shield comes out to cover the needle.

Immediately dispose of the system in the nearest sharps collector.

Injection is considered successful whether or not the presence of a wheal is observed.