AGRIPPAL S1

Active material: the peeled surface antigens of influenza viruses types A and B
When ATH: J07BB01
CCF: A vaccine for the prevention of influenza
ICD-10 codes (testimony): Z 15.6
Manufacturer: NOVARTIS VACCINES And DIAGNOSTICS s. r. l. (Italy)

DOSAGE FORM, COMPOSITION AND PACKAGING

Suspension for the m and s/to the introduction * as a colorless, a transparent liquid.

0.5 ml (1 dose)
the peeled surface antigens of influenza viruses types A and B, grown on a culture of chicken embryo, formaldehyde inactivated; submitted by the following strains:
A (H1N1)
15 mkgGA *
A (H3N2)15 mkgGA *
B15 mkgGA *

Excipients: sodium chloride, potassium chloride, potassium phosphate dwuzameshchenny, sodium phosphate dwuzameshchenny two-water, magnesium chloride, calcium chloride, water d / and.

* hemahhlyutynyn.
** the antigenic composition of vaccines in line with the recommendations of who the current epidemic season and annually updated according to who recommendations.

0.5 ml – glass syringes with needles (1) – blisters (1) – packs cardboard.

 

Pharmacological action

A vaccine for the prevention of influenza. A protective level of antibodies usually develops through 2-3 weeks after inoculation, duration of immunity varies from 6 to 12 Months.

 

Pharmacokinetics

 

INDICATIONS

Vaccine Agrippal S1 is designed for the prevention of influenza from 6 months of age. Immunization is particularly suitable for adults and children of the following risk groups:

— adults and children with concomitant diseases of the cardiovascular system, chronic respiratory diseases, chronic kidney disease, with diabetes and other chronic metabolic diseases, chronic anemias, congenital and acquired immunodeficiency;

-persons over 60 years;

-persons with high occupational risk of infection and persons, which, because of their professional activities can be a source of infection.

In times of epidemics or pandemics, it is recommended that vaccination of all population groups.

 

DOSAGE

The vaccine should not be administered in /!

The vaccine is injected in/m, mainly in the deltoid muscle, or deep-n/a. In young children the vaccine can be administered in front of the lateral part of the thigh.

Before use, the contents of the syringe should be brought to room temperature. Carefully shake.

Babies with 6 Months before 35 Months appointed 0.25 ml (half dose).

Babies, that have not been previously vaccinated, recommended vaccination dvukratnaya at intervals 4 of the week.

Children from 35 Months, adolescents and adults appointed 0.5 ml.

When you use a syringe, contains 0.5 ml of the vaccine for the immunization of children, which shows the introduction of half-dose (0.25 ml), you need to remove half of its content, pushing the plunger, to special risks. You then enter the remaining number of vaccines.

Vaccination should be carried out, if possible, before the start of flu season (in autumn and winter). However, depending on the epidemiological situation may need to conduct it at other times of the year. Vaccination is recommended annually.

 

SIDE EFFECT

Normal (≥1/100, <1/10)

Local reactions: redness, bruise, packing, soreness and swelling at the injection site.

Common reactions: temperature rise, malaise, chills, weakness, headache, Sweating, myalgia, arthralgia.

These side effects usually disappear on their own through the 1-2 day.

Unusual (≥1/1000, <1/100)

Dermatological reactions: General skin reactions, including itching, krapivnicu, nonspecific skin irritation.

Few (≥1/10 000, <1/1000)

From the nervous system: neuralgia, paraesthesia (burning sensation, numbness), convulsions.

From the hematopoietic system: short thrombocytopenia.

Allergic reactions were noted, in rare cases, lead to the development of shock, symptoms of a serious allergic reactions up to and including anaphylactic reaction: a sudden sharp fall in HELL, increase or drop in HEART RATE, unusual weakness or malaise, anxiety, nervousness, loss of consciousness, difficulty breathing and swallowing, itch (especially on the feet and palms), urticaria with swelling or without it, most often with the localization on the limbs, in the genital area, person (especially around the eyes and lips), rash (especially around the ears), nausea, vomiting, spasticskie stomach pain, diarrhea.

Very rare (<1/10 000)

There are Vasculitis with renal impairment.

From the nervous system: engjefalomielita, neuritis, Guillain Barre syndrome (acute polyneuropathy with deterioration of motor function, paralysis).

All of the listed side effects, usually, are intermittent and transitory nature of. If you need to consult a doctor.

The patient must be informed of the need for the message your doctor about any unusual adverse reactions, not described in this manual.

 

CONTRAINDICATIONS

-hypersensitivity to chicken egg protein;

— history of allergic reactions to other components, included in vaccines, or preceding the drug vaccination.

Vaccination of persons, survivors of acute infectious disease, is done through 1 months after convalescence. In light forms disease vaccination may be carried out after the normalization of the temperature.

 

Pregnancy and lactation

Experience of using the vaccine among pregnant women revealed, Agrippal S1 that has no teratogenic or toxic effects on the body. This vaccine can be applied from the second trimester of pregnancy.

Pregnant women, medically at risk of developing complications after influenza infection, vaccination is recommended for any pregnancy.

Vaccination may be carried out during the entire lactation period (breast-feeding).

 

Cautions

As is the case with the other injectable vaccines, should always be available funds, applicable in the case of rare anaphylactic reactions.

The vaccine may contain residual formaldehyde, cetiltrimetilammonija bromide and polisorbata 80, used in the production of vaccines (can cause hypersensitivity).

 

OVERDOSE

Data on overdose vaccine Agrippal S1 not available.

 

Drug Interactions

The application of vaccines Agrippal S1 within a calendar preventive vaccination in case and inactivated vaccines national calendar of preventive vaccination may be simultaneously subject to the introduction of different needles in different parts of the body or with an interval of one month. This should take into account the possibility of strengthening the intensity of adverse reactions. Patients, receiving immunosuppressive therapy, as well as in patients with congenital and acquired immunodeficiency vaccination may be less effective.

After influenza vaccination were marked by false positive results of antibody by ELISA against HIV infection (HIV1), hepatitis c and especially against the t-cell to grow human virus (HTLV1). To exclude false positive result it is necessary to undertake a study on the method of WesternBlot.

Transient absorption results can be linked with the advent of the immunoglobulin IgM, as a response to vaccination.

Vaccine Agrippal S1 must not be mixed with other medicinal substances.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

TERMS AND CONDITIONS OF STORAGE

The vaccine should be stored in the dark, reach of children, at a temperature of from 2 ° to 8 ° C.; Do not freeze.

The vaccine should be transported in accordance with the SP 3.3.2.1248-03 all kinds of covered transport at a temperature from 2° to 8° c; Do not freeze.

Shelf life – 12 Months. Do not use the vaccine after the expiration date, indicated on the label and outer package.