PATIENT INFORMATION LEAFLET FOR GRIPPOL® QUADRIVALENT MEDICINAL PRODUCT

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Trade Name: Grippol® Quadrivalent

Quadrivalent inactivated subunit adjuvanted influenza vaccine

Group name: Influenza Prevention Vaccine [Inactivated] + Azoximer Bromide

Dosage form: solution for intramuscular and subcutaneous injection

Composition per 1 dose (0.5 ml):

Active ingredients:

Serotype A (H1N1)^* influenza virus antigen with concentration of hemagglutinin - 5 μg

Serotype A (H3N2)^* influenza virus antigen with concentration of hemagglutinin - 5 μg

Type B influenza virus antigen (Yamagata line)^* with concentration of hemagglutinin - 5 μg

Type B influenza virus antigen (Victoria line)^* with concentration of hemagglutinin - 5 μg

Polyoxidonium®, freeze-dried substance^** (Azoximer bromide) - 500 μg

Excipients:

PBS - phosphate-buffered saline - up to 0,5 мл

Thimerosal^*** - 50 μg

Appearance:

Colorless or white off slightly opalescent fluid.

Characteristics of the preparation:

The vaccine is protective antigens (hemagglutinin and neuraminidase) of epidemically actual strains of subtypes A (H1N1), A(H3N2) of type A and type B Yamagata line and Victoria line influenza viruses, isolated from virus-containing chick-embryo allantoic fluid in combination with immunoadjuvant Polyoxidonium® (INN: Azoximer bromide).

The strain composition of vaccine is updated annually in accordance with epidemic situations and guidelines of WHO for the Northern hemisphere.

Pharmacotherapeutic group:

MIBP-vaccine

ATC code: J07BB02

Immunological properties

The vaccine induces formation of high level of specific immune response against influenza. The protective effect post vaccination generally develops after 8-12 days and preserves till 12 months.

Addition of immunoadjuvant Polyoxidonium® with wide range of immunopharmacological action into the vaccine, ensures increased immunogenicity and antigen stability, allows to increase immunologic memory, to decrease substantially antigen vaccine dose.

Indications

Specific flu prevention for children and adults aged 6 to 60 years.

Vaccine is specifically indicated to:

Individuals at high risk for influenza-associated complications:

individuals, who frequently fall ill with ARD, suffering from chronic somatic diseases, including: diseases and congenital anomalies of central nervous system, cardiovascular and broncho-pulmonary system, bronchial asthma, chronic kidney diseases, diabetes mellitus, metabolic diseases, autoimmune diseases, allergic diseases (except for allergy to chicken proteins); chronic anemia, hereditary or acquired immunodeficiency, HIV-associated;

Individuals with high occupational risk of influenza infection or influenza contamination of other individuals:
medical staff, citizens who are subject to call-up for military service, employees of educational institutions, social service sphere, transport, trade, police, individuals, engaged in poultry industry, members of the military etc.

Contraindications

Allergic reaction to chicken protein and vaccinal components, including thiomersal, contained in multidose vials.
Allergic reactions to previously administered influenza vaccines.
Strong reaction (temperature is above 40 °C, edema and hyperemia at injection site over 8 cm in diameter) or history of complications to previous administration of influenza vaccines. Acute febrile conditions or exacerbation of chronic disease (vaccination is performed after recovery or during remission).
In non-severe ARVI, acute intestinal diseases the vaccination is performed after normalization of temperature.
Age below 6 years.
Pregnancy (using the vaccine, containing preservative thiomersal).

With caution

Not for intravenous injection! Antishock medicinal products should be envisaged in rooms, where vaccination is performed. A vaccinated person should be under follow-up with healthcare provider for 30 min post immunization.

Use during pregnancy and lactation

The decision concerning immunization of pregnant women should be taken individually by a physician considering a risk of influenza infection and possible complications of influenza infection. The immunization is most safe at the second and third trimester. Breastfeeding is not a contraindication for immunization.

Dosage and Administration

The vaccination is performed annually in the autumn-winter period. The vaccination is possible at the beginning of epidemic raise of flu morbidity.

The vaccine is administered intramuscularly or deep subcutaneously in the upper third of external surface of the upper arm (into the deltoid).

Dosage for adults: 0.5 mL as a single injection.

The vaccine should be kept till room temperature and mix well before use.

Using a syringe it is necessary to take off a protective cap from the needle and remove the air out of syringe, holding it in the vertical position with the needle upwards and slowly pressing to a plunger.

The opening of multidose vial is executed in strict compliance with aseptic and antiseptic regulations. Ahead of opening of a vial wipe out the external surface of its stopper with cotton wool, soaked with 70% alcohol, withdraw the vaccine into a disposable syringe and remove the air excess out of the syringe. A new sterile syringe with a new sterile needle should be used for each collected dose for each patient. Within the intervals between collections of doses and not later than 5 min after the last collection, it is necessary to place the vial into a fridge (but not into a freezer) for storage at temperature 2 to 8 °C. The medicinal product in opened multidose vial may be used within a working day in compliance of appropriate storage conditions.

It is necessary to immediately dispose a partially utilised multidose vial in cases as follows:

if it is impossible to assure sterility of withdraw of the vaccine;
probable or actual contamination;
change of appearance and presence of impurities.

The vaccine in multidose vial should be kept for all storage period in accordance with manufacture's recommendations, specified in patient information leaflet. After use all residues of the vaccine and package should be disposed using safe method in according to local regulations.

Side effects

The vaccine is a highly purified product and well-tolerated.

The rate of adverse events, registered during conduction of clinical trials, is presented in accordance with the ADR WHO classification.

The rate of adverse events across the WHO classification: very frequent (>1/10), frequent (>1/100 and <1/10), infrequent (>1/1000 and <1/100), rare (>1/10000 and <1/1000), very rare (<1/10000).

Blood and lymphatic system disorders: rare - increased lymph nodes.

Nervous system disorders: frequent - head ache.

Respiratory, thoracic and mediastinum-related disorders: frequent - runny nose, throat hyperemia, infrequent - sore throat.

Musculoskeletal and connective tissue disorders: infrequent - myalgia, arthralgia.

General disorders and administration site conditions:

general disorders: frequent - malaise;
administration site conditions: very frequent - pain, redness, formation of indurations (infiltration) and swelling at administration site, frequent - itch at administration site.

Investigations: infrequent - increased body temperature.

Most reactions are generally resolved spontaneously within 2-3 days.

Although there are no clinical findings, it is impossible to eliminate the possibility of the development of neurological disorders and allergic reactions (including immediate reactions, to chicken protein and other vaccinal components) characteristic for influenza vaccines.

Patient should be informed that it is necessary to report his/her physician on any apparent or not specified in this instruction adverse events.

Overdosage

No case of overdoses registered.

Interactions

Grippol® Quadrivalent vaccine against influenza quadrivalent inactivated subunit adjuvant may be administered concomitantly with inactivated and live vaccines according to National Immunization Schedule (excluding BCG and BCG-M) and inactivated vaccines from Immunization Schedule by epidemic indications (excluding antirabic vaccines). However contraindications to each of the used vaccine should be taken into account; the medicinal products should be administered in different parts of the body using different syringes.

The vaccine should be administered on basis therapy, available in vaccinated disease. The immunization of patients, receiving immunosuppressive therapy (glucocorticosteroids, cytostatic preparations, radiotherapy) may be less effective.

Special precautions

On day of vaccination the individuals being vaccinated should be examined by a physician (physician assistant) with compulsory thermometry. The vaccination is not performed at temperature over 37.0 °C

The medicinal product in syringes with disturbed integrity and labeling, with changed physical properties (color, clarity), with expired date, impaired requirements for storage is not suitable for use.

The incompliance of technique of collection of doses out of multidose vial may reflect in properties of the medicinal product. Therefore the manufacture is responsible for its quality for 24 hours after the first procedure of collection only at storage condition in fridge in accordance with manufacturer's guidelines.

Multidose vials Grippol® Quadrivalent contain small quantity of thiomersal as a preservative, which may be a reason of allergic reaction.

Effect on ability to drive and use machines

Grippol® Quadrivalent vaccine against influenza quadrivalent inactivated subunit adjuvant causes no effect of ability to drive and use machines.

Product presentation

Solution for intramuscular and subcutaneous injection.

0.5 ml (1 dose) in disposable glass syringes.

5.0 ml (10 doses) with preservative in glass vials, hermetically sealed with rubber stoppers and crimped with aluminium caps.

1, 5 or 10 syringes in a blister pack made of polyvinyl chloride film, coated with polymer-coated aluminum foil.

Per 1 (containing 1 or 5 syringes or 10 syringes) or 2 (containing 5 syringes) blister packs in a cardboard box together with package leaflet.

1 vial in a cardboard pack together with the package leaflet.

20 or 50 vials per cardboard pack with cardboard insert, together with the package leaflet.

Storage conditions

Protect from light. Store at 2°C to 8°C. Do not freeze. The medicinal product that has been frozen cannot be used.

Keep out of the reach of children.

Transportation conditions

Protect from light. Store at 2°C to 8°C. Do not freeze. Transportation is allowed at a temperature not exceeding 25 ° С for no more than 24 hours.

Expiry date

1 year. Don’t use after the expiry date.

Dispensing conditions

Pack containing 1 syringe is available with a prescription.

Packs containing 5 or 10 syringes, 1, 20, or 50 vials are delivered to healthcare institutions.

Manufacturer

NPO Petrovax Pharm LLC

Legal address: 1 Sosnovaya ul., Pokrov village, Podolsk city, Moscow region, 142143, Russian Federation.

Tel./fax: +7 (495) 730-75-45,

e-mail: info@petrovax.ru.

Marketing authorization holder and organization receiving claims:

NPO Petrovax Pharm LLC

Legal address and manufacturing address: Legal address: 1 Sosnovaya ul., Pokrov village, Podolsk city, Moscow region, 142143, Russian Federation.

Tel./fax: +7 (495) 730-75-45,

e-mail: info@petrovax.ru.

^* strains of influenza virus antigen - in accordance with the guidelines of WHO for the current epidemic season for the Northern hemisphere;

^** equivalent to active ingredient Azoximer bromide, excipients - mannitol, povidone;

^*** preservative thiomersal - only for multidose vial (10 doses - 5 mL in vial).