2010/06/24

Agrippal

AgrippalComposition, structure and packing

Suspension for a / m and s / c administration in the form of colorless, transparent liquid.

0.5 ml (1 dose) purified surface antigens of influenza viruses types A and B, grown on a culture of chick embryos, inactivated with formaldehyde, provided the following strains.

Excipients: sodium chloride, potassium chloride, potassium phosphate, disodium, sodium phosphate, disodium dvuvodny, magnesium chloride, calcium chloride, water, d / and.
hemagglutinin.
antigenic composition of the vaccine meets the WHO recommendations of the current epidemic season.

Clinico-pharmacological group: A vaccine for the prevention of influenza.

Pharmacological action

The vaccine for the prevention of influenza. Protective antibody levels are usually develops 2-3 weeks after inoculation, the duration of immunity is from 6 to 12 months.

Statement

The vaccine Agrippal S1 is designed for the prevention of influenza with 6 months of age. Immunization is particularly indicated 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, chronic anemia, congenital or acquired immunodeficiencies, diabetes and other chronic metabolic diseases;
over 60 years;
persons with high occupational risk of infection and persons who by virtue of their professional activities may be a source of infection. In times of epidemics or pandemics, it is recommended to vaccinate all groups.

Dosage regimen

The vaccine should not be installed / in! The vaccine is introduced into / m, mostly in the deltoid muscle, or deep-n / k. In younger children the vaccine can be introduced into the anterior lateral thigh. Before applying the contents of the syringe should be heated to room temperature.

Shake well.

Children from 6 months to 35 months prescribed 0.25 ml (half dose).

Children who were not previously vaccinated, we recommend double vaccinated with an interval of 4 weeks. Children from 35 months, adolescents and adults to designate 0.5 ml.

When using a syringe containing 0.5 ml of vaccine to immunize children who have shown the introduction of a half dose (0.25 ml), to remove half of its contents, pushing the plunger to the special risks. Then enter the remaining quantity of vaccine.

Vaccination should be carried out if possible before the flu season (in autumn-winter period). However depending on epidemiological situation may need it for another season. Vaccination recommended annually.

Side effect

Common (> 1 / 100, <1 / 10)

Local reactions: redness, bruising, compression, soreness and swelling at the injection site.

General reaction: fever, malaise, chills, weakness, headache, sweating, myalgia, arthralgia. These events usually take place independently in 1-2 days.

Unusual (> 1 / 1000, <1 / 100)

Dermatological reactions: common skin reactions, including pruritus, urticaria, nonspecific irritation of the skin. Rare (> 1 / 10 000, <1 / 1000)

On the part of the nervous system: neuralgia, paraesthesia (feeling of burning, numbness), convulsions.

The part of the hemopoietic system: a brief one thrombocytopenia. Allergic reactions have been noted in rare cases leading to the development of shock, symptoms of serious allergic reactions up to anaphylactic reactions: a sudden sharp drop in blood pressure, increased or decrease heart rate, unusual weakness or malaise, anxiety, nervousness, loss of consciousness, difficulty breathing and swallowing, itching (especially on the feet and hands), urticaria with or without edema often with localization on the extremities, the genital area, face (especially around the eyes and lips), rash (especially around the ears), nausea, vomiting, spastic stomach pain, diarrhea .

Very rare (1 / 10 000)

Possible vasculitis with renal dysfunction.

On the part of the nervous system: encephalomyelitis, neuritis, Guillain-Barré syndrome (acute polyneuropathy with predominant deterioration of motor function, paralysis). All of these side effects are usually short-term and transient. When they do need to consult a doctor. Patients should be informed of the need to report your doctor about any unusual adverse reactions, not described in this manual.

Contraindications
Hypersensitivity to hen's egg white;
a history of allergic reactions to other components included in the vaccine, or vaccination preceded this product.

Vaccination of persons who have suffered an acute infectious disease that is carried out 1 month after recovery. In milder forms of disease vaccination may be performed after normalization of temperature.

Pregnancy and lactation

Experience the use of the vaccine in pregnant women showed that Agrippal S1 does not have teratogenic or toxic effects on the body. The vaccine can be used with II trimester of pregnancy. Pregnant women, medically at risk for complications following influenza infection, vaccination is recommended for all stages of pregnancy. Vaccination can be conducted during the entire period of lactation (breastfeeding).

Cautions

As in the case of other injectable vaccines should always be available agents used in the case of anaphylactic reactions. The vaccine may contain residues of formaldehyde, cetyltrimethylammonium bromide and polysorbate 80, which are used in vaccine production (may cause hypersensitivity reactions). Overdose data on overdose vaccine Agrippal S1 is not available.

Drug Interactions

The use of vaccines Agrippal S1 in the calendar vaccination on epidemic indications and inactivated vaccines national calendar of vaccination may be simultaneously subject to imposition of different syringes and at different parts of the body or with an interval of one per month. This should take into account the possibility of increasing 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 by ELISA detection of antibodies against HIV (HIV1), hepatitis C, and especially against T-cell lymphotropic virus Human (HTLV1).

To avoid false positive results need to be Probed by WesternBlot. Partly false-positive results may be associated with the emergence of immunoglobulin IgM, as a response to vaccination. The vaccine Agrippal S1 should not mix with other drugs.

Terms and Conditions of storage

The vaccine should be stored protected from light, out of reach of children, at a temperature of 2 ° to 8 ° C Do not freeze. The vaccine must be transported in accordance with the joint venture 3.3.2.1248-03 in all kinds of transport at a temperature of 2 ° to 8 ° C Do not freeze.

Shelf life - 12 months. Do not use vaccine after expiration date indicated on the label and outer packaging.