Patient information leaflet for Grippol® plus: composition, indications, contraindications, administration and dosage

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Grippol® Plus

PATIENT INFORMATION LEAFLET FOR GRIPPOL® PLUS MEDICINAL PRODUCT

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Trade Name: Grippol® plus

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

Dosage form: suspension for intramuscular and subcutaneous injection

Composition per 1 dose (0.5 ml):

Active components:

Influenza type A (H1N1) virus antigen^* with 5 µg haemagglutinin content

Influenza type A (H3N2) virus antigen^* with 5 µg haemagglutinin content

Influenza type B virus antigen^* with 5 µg haemagglutinin content

Polyoxidonium® (azoximer bromide) - 500 µg

Excipients:

Phosphate-salt buffer solution - up to 0.5 ml

Preservatives-free

Appearance: Colourless or yellowish slightly opalescent liquid

Medicinal product profile: The vaccine consists of protective antigens (haemagglutinin and neuraminidase) isolated from purified influenza A and B viruses grown on chicken embryos bound to a water-soluble, high molecular weight immunoadjuvant N-oxidised poly-1,4-ethylenpiperazine derivative (Polyoxidonium®, INN: Azoximer bromide). The antigenic composition of the vaccine changes each year according to the epidemic situation and WHO recommendations.

Immunobiological properties

The vaccine induces a high level of specific immunity against influenza. The protective effect after vaccination usually comes after 8-12 days and lasts up to 12 months, including in elderly people. Antibody protective titers to influenza viruses after vaccination of individuals of different ages are detected in 75-95% of those vaccinated.

The inclusion of the Polyoxidonium® immunomodulator, which has a broad spectrum of immunopharmacological action, in the vaccine preparation provides increased immunogenicity and stability of antigens, allows increasing immunological memory, significantly reducing the vaccine dose of antigens, increasing resistance of the body to other infections through the correction of immune status.

Indications

Specific influenza prevention in children from 6 months of age, adolescents, and adults without age restriction.

Vaccine is specifically indicated to:

Persons at high risk of complications if they contract the flu:

over 60 years old;
preschool children, schoolchildren;
Adults and children with frequent acute respiratory infections, chronic somatic diseases, including: diseases and malformations of the central nervous, cardiovascular and bronchopulmonary systems, bronchial asthma, chronic kidney disease, diabetes mellitus, metabolic diseases, autoimmune diseases, allergic diseases (except chicken protein allergy); chronic anemia, congenital or acquired immune deficiency, HIV infected;

Persons who are at high risk of contracting the flu or infecting other people due to their profession:
Health care workers, employees of educational institutions, social services, transport, trade, police, military personnel, etc.

Contraindications

Allergic reactions to chicken protein and vaccine components.
Allergic reactions to previously administered influenza vaccines.
Acute febrile states or acute exacerbation of a chronic disease (vaccination should be carried out after recovery or during remission).
Non-severe ARVI, acute intestinal diseases (vaccination is performed after temperature normalization).

Precautions for use

Do not administer intravenously. Vaccination rooms must have anti-shock therapy in place. The vaccinated person must be observed by a healthcare professional for 30 minutes after immunization.

Use during pregnancy and breastfeeding

Preclinical trials have shown that the inactivated polymer-subunit influenza vaccine has no embryotoxic or teratogenic effects. The decision to vaccinate pregnant women must be made individually by a doctor, taking into account the risk of flu infection and possible complications of flu infection. Vaccination is safest in the second and third trimesters.

Breastfeeding is not a contraindication to vaccination.

Method of Administration and Dosage

Vaccinations take place annually during the autumn-winter period. Vaccination is possible at the beginning of the flu epidemic.

Children over 3 years of age, adolescents, and adults get the vaccine intramuscularly or deep subcutaneously into the upper third of the outer surface of the upper arm (deltoid muscle), infants get it intramuscularly into the anterolateral surface of the thigh.

For children aged 6 to 35 months inclusive - 0.25 ml twice with an interval of 3 to 4 weeks.

Children over 36 months old and adults are administered the vaccine once at a dose of 0.5 ml

Influenza-negative and unvaccinated children can be vaccinated twice at intervals of 3-4 weeks.

Immunocompromised patients receiving immunosuppressive therapy may be administered the vaccine twice, 0.5 ml at an interval of 3-4 weeks.

The vaccine should be brought to room temperature and shaken well before use. Remove the protective cap from the needle and deflate the syringe by holding it upright with the needle up and slowly pushing down the piston.

To immunize children for whom 0.25 ml (1/2 dose) of the vaccine is indicated, remove half of the syringe content by pushing the plunger down to the special mark on the syringe body or to the red mark on the edge of the label and inject the remaining 0.25 ml.

Open the ampoules and vials and carry out the vaccination procedure in strict compliance with aseptic and antiseptic rules: before opening the ampoule knife, the neck of the ampoule or the stopper of the vial is wiped with cotton wool moistened with 70% ethyl alcohol, the ampoule is opened or the rubber stopper of the vial is pierced with a needle, vaccine is filled into a single-use syringe, and excess air is removed from the syringe. Wipe the skin at the injection site with alcohol. Do not store the product in an open ampoule or vial.

Side effects

The vaccine is a highly purified medicinal product, well tolerated by children and adults.

Common (>1/100, <1/10). Local reactions in the form of soreness, hyperaemia, induration, and edema at the injection site. Common reactions: malaise, weakness, and low grade fever.

Uncommon (>1/1000, <1/100). Common reactions in the form of a slight runny nose, sore throat, headache, and body temperature above low grade fever. These reactions usually go away without treatment within 1-2 days.

Rare (>1/10,000, <1/1,000). Allergic reactions, including immediate ones.

Very rare (< 1/10,000)

Nervous system disorders: neuralgia, paresthesia, neurological disorders;
musculoskeletal disorders: myalgia.

The patient should be informed about the need to inform the doctor about any side effects expressed or not specified in this package leaflet.

Overdose

No overdose cases have been reported.

When administered concurrently with other medicinal products

Grippol® vaccine may be used simultaneously with inactivated and live vaccines of the National Preventive Vaccination Calendar (except for BCG and BCG-M) and inactivated vaccines under the Calendar of Preventive Immunizations for Epidemic Indications (except for antirabic vaccines). The contraindications for each of the vaccines used should be taken into account; the medicinal products should be injected into different parts of the body with different syringes.

The vaccine can be administered against a background of baseline therapy for the underlying disease. Vaccination of patients receiving immunosuppressive therapy (corticosteroids, cytotoxic medicinal products, and radiotherapy) may be less effective.

Special provisions

On the day of vaccination, vaccinated persons must be examined by a doctor (paramedic) and a thermometry must be made. When the temperature is above 37.0 °C, the vaccination is not made.

The medicinal product is not suitable for use in ampoules, vials, syringes with damaged integrity or labelling, when the physical properties (colour, transparency) have changed, with due expiry date, and if the storage conditions have been infringed upon.

The vaccine is not allowed to be administered intravenously.

Effects on car driving ability or control of machines and mechanisms

Grippol® Plus has no impact on the driving ability of the car or the control of machines and mechanisms.

Product presentation

Suspension for intramuscular and subcutaneous injection.

0.5 ml (1 dose) in disposable syringes or in ampoules or vials, hermetically sealed with rubber stoppers and crimped with aluminum caps.

1, 5 or 10 syringes in a polyvinyl chloride film coated blister pack with aluminium foil or laminated plastic-coated paper. 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.

5 ampoules or vials in a polyvinyl chloride film carton blister pack. 1 or 2 blister packs in a cardboard box together with package leaflet.

Or 5 or 10 ampoules or vials without a blister pack in a carton pack together with the package leaflet.

Storage conditions

Store in a light-protected place at a temperature between 2 °C and 8 °C.

Keep from the kids!

Do not freeze! The medicinal product that has been frozen cannot be used.

Transportation conditions

Transportation by all means of roofed transport in light-tight containers at temperatures between 2 °C and 8 °C, in a frost-free environment. Transportation is allowed at a temperature not exceeding 25 ° С for no more than 6 hours.

Expiry date

1 year. The product with due expiry date must not be used.

Dispensing conditions

By medical prescription.

Legal entity in whose name the marketing authorization is issued

Marketing Authorization Holder and Manufacturer:

NPO Petrovax Pharm LLC

Legal address/Address for filing consumer claims:

1, Sosnovaya st., Pokrov village, Podolsk district, Moscow region, 142143, Russia

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

e-mail: info@petrovax.ru.

^*Influenza virus antigen strains - in accordance with WHO recommendations for the current epidemic season.