Fluvoxin: instructions for use. Chinese flu vaccine Fluvaxin - instructions for use Fluvaxin instructions for use

The only effective way to prevent the body from becoming infected with the influenza virus is to get the appropriate vaccination on time. There are many different drugs that have the desired effect. One of them is Fluvaxin. This product is very affordable, quite effective and safe.

Manufacturer, composition and release form

Fluvaxin is developed and produced by the Chinese corporation Changchun Changsheng Life Sciences. The product has been present on the Russian market since 2009.

The drug is available in ampoules containing 0.5 milliliters of inactivated, split, cultured on chicken embryos. Active against influenza viruses type A and B.

The active ingredients of the vaccine include hemagglutinin of three types of influenza virus:

  1. A (strain H1N1);
  2. A (strain H3N2);

The following excipients are used: sodium (chloride and hydrogen phosphate), potassium (chloride and dihydrogen phosphate), water and a small amount of otrxinol-9 and formaldehyde.

The composition of the product absolutely meets the WHO requirements established for the Western Hemisphere.

The antigenic components of the vaccine change annually in accordance with WHO recommendations and the epidemic situation.

Indications and contraindications for use

Fluvaxin is a drug used to prevent serious health problems that occur when the influenza virus enters the body. Vaccination is strongly recommended for persons who are predisposed to frequent colds and respiratory viral diseases (3-4 times during the winter and off-season).

The vaccine is indicated for people who are forced to come into contact with potential carriers of influenza:

  1. employed in the service sector;
  2. teachers in kindergartens, teachers of educational institutions, etc.

The flu vaccine is given in early autumn, before outbreaks of infection are likely to occur, so that immunity has time to develop.

Fluvaxin has several contraindications, in the presence of which a person should not administer this drug:

  • hypersensitivity to any components;
  • period of illness, which is accompanied by fever.

Medical withdrawal during the course of a chronic or acute disease is due to the fact that at the appropriate time the person’s immunity is greatly weakened. Vaccination is not recommended until 14 days have passed since complete recovery.

At the moment, there is no information that this drug has a negative effect on a woman’s body and/or on the fetus she is carrying. But still, doctors recommend getting vaccinated either in the second or third semester.

However, of course, this issue is resolved by the doctor. As for breastfeeding, this is not a contraindication.

Instructions for use of Fluvaxin

There are two ways to administer the Fluvaxin vaccine:

  1. intramuscularly;
  2. deep subcutaneously.

The first method is most often used. The specific dosage of the drug depends on the age of the vaccinee.

So, children who have reached 6 months are administered 0.25 milliliters. For those who have crossed the threshold of 3 years, as well as adults, the dosage is 0.5 ml. At the same time, children who have not previously had the flu are most often vaccinated twice, dividing the volume of the injected product in half.

The interval between injections is 1 month. The contents of the ampoule should be shaken before use. If its appearance does not correspond to the nominal (for example, the color is changed or foreign particles are present), the unit of the drug should be discarded.

When only 0.25 milliliters is used (dosage for children under 3 years of age), the syringe should be drawn up full and then the excess volume should be removed from it. Residues should not be used under any circumstances - they must be destroyed.

Intravenous administration of this vaccine is absolutely unacceptable. Also, the specialist administering the vaccine must be aware of the patient’s current condition, as well as what treatment he has received recently.

To prevent the occurrence of side effects, the doctor also needs to know about the medications used by the vaccinated person (including those available without a prescription).

Like many others, this vaccine can provoke a state of shock. Therefore, in the office where vaccination is carried out, all means must be present to prevent corresponding reactions.

A decrease in the effectiveness of the vaccine can be caused by immunodeficiency conditions, as well as by simultaneous vaccination and immunosuppressive therapy.

Side effects and complications

Fluvaxin is tolerated normally by most patients.

In some cases, one or more side effects may develop after vaccination:

  • increase in body temperature;
  • general malaise and fatigue;
  • increased sweating;
  • the appearance of compaction and redness at the injection site.

The above is a specific immune reaction to the components of the drug. The body adapts to them in about a day.

Therefore, these manifestations disappear without the use of special techniques and means in 1-2 days.

If symptoms persist for more than two days or cause severe discomfort, you should consult your doctor.

Sometimes, after administration of Fluvaxin, vaccine recipients develop additional symptoms. In particular, the following may develop: anaphylactic shock, convulsions, neuralgia, vasculitis, etc. This happens if a person has contraindications.

In these cases, immediate medical attention is needed. But since the vaccinated person is always left in a specially equipped room for half an hour after vaccination, these manifestations, if they arise, are quickly and professionally eliminated.

Price and analogues

Fluvaxin is one of the cheapest flu medications. The cost of this drug is only 230-250 rubles. There are many drugs that have similar effects.

Vaccines Influvac and Grippol plus

In Russia the following are most often used:

  • Begrivak;
  • Flu;
  • Influvac;

The difference between them lies in both the composition and cost of the product.

The film-coated tablet contains:

fluvoxamine maleate 50 mg or 100 mg;

excipients: mannitol, pregelatinized starch, microcrystalline cellulose, starch, colloidal silicon dioxide, sodium stearyl fumarate, opadry YS-1-12526A yellow.

Description

Film-coated tablets, 50 mg:

Slightly biconvex oblong tablets, yellow film-coated, with a line on one side.

Film-coated tablets, 100 mg:

Round, slightly biconvex, yellow film-coated tablets

colors, with a dividing line on one side.

pharmachologic effect

The active ingredient of the drug Fluvoxin - fluvoxamine maleate - has the property of selective inhibition of serotonin reuptake by neurons of the brain and is characterized by a minimal effect on the adrenergic system: it has a weak ability to bind to a- and b-adrenergic receptors, as well as histamine, m-cholinergic receptors, dopamine and serotonin receptors .

Pharmacokinetics

After oral administration, fluvoxamine is completely absorbed from the gastrointestinal tract, Cmax in blood plasma is reached after 3-8 hours. The state of equilibrium in plasma is achieved after 10-14 days of taking the drug. Blood protein binding is about 77%.

Fluvoxamine is metabolized in the liver primarily by oxidative demethylation.

After taking a single dose, the half-life T1/2 is 13-15 hours, with repeated doses it increases slightly and is 17-22 hours.

Fluvoxamine is excreted by the kidneys in the form of metabolites.

Indications for use

  • depression of various origins;
  • treating symptoms of obsessive-compulsive disorder.

Contraindications

  • severe liver dysfunction;
  • simultaneous use of MAO inhibitors (the interval between discontinuation of MAO inhibitors and the start of treatment with fluvoxamine should be at least 2 weeks);
  • children's age (depending on indications);
  • pregnancy and lactation;
  • hypersensitivity to fluvoxamine and other ingredients of the drug.

Directions for use and doses

At treatment depression The recommended starting dose is 50 mg or 100 mg 1 time

per day in the evening. The dose should be increased gradually. The effective dose, usually 100 mg per day, is selected individually depending on the patient's response to treatment. The daily dose can reach 300 mg.

Doses of more than 150 mg per day should be divided into several doses.

For prevention of relapse of depression fluvoxamine is prescribed to adults in a dose

100 mg 1 time per day.

Fluvoxamine is not recommended for children and adolescents under 18 years of age.

During treatment obsessive-compulsive disorders The recommended starting dose is 50 mg per day for 3-4 days. The dose should be increased gradually until an effective daily dose is reached, which is usually 100-300 mg. Maximum effective dose for adults is 300 mg per day. Doses up to 150 mg per day can be taken in one dose, preferably in the evening. Doses of more than 150 mg per day are recommended to be divided into 2-3 doses.

For children over 8 years old and adolescents, the initial dose is 25 mg per day at a time, the maintenance dose is 50-200 mg per day, the maximum daily dose is 200 mg. Doses over 100 mg per day should be divided into 2-3 doses.

At liver and kidney failure treatment should begin with the lowest dose under the strict supervision of a physician.

Side effect

From the digestive system: nausea, vomiting, constipation, anorexia, dyspepsia, diarrhea, discomfort in the epigastric region, dry mouth; rarely - increased activity of liver enzymes.

From the side of the central nervous system: possible drowsiness, dizziness, headache, insomnia, anxiety, psychomotor agitation, fear, tremor.

From the cardiovascular system: possible slight decrease in heart rate, palpitations, tachycardia.

Dermatological reactions: Possible increased sweating.

Some of these side effects may be symptoms of depression and are not due to fluvoxamine.

Overdose

Symptoms: The most common symptoms are nausea, vomiting, diarrhea, drowsiness, and dizziness. There are reports of cardiac dysfunction (tachycardia, bradycardia, arterial hypotension), liver dysfunction, convulsions, coma.

Treatment: gastric lavage, which should be performed as soon as possible after taking the drug; taking activated carbon, symptomatic therapy. There is no specific antidote.

Forced diuresis and hemodialysis are inappropriate.

Interaction with other drugs

When used simultaneously with tizanidine, a significant and prolonged decrease in blood pressure may be observed, leading to drowsiness, weakness, and inhibited psychomotor reactions.

Fluvoxamine may slow the elimination of drugs metabolized by oxidation in the liver. A clinically significant interaction is possible with drugs characterized by a narrow dose-effect relationship (for example, warfarin, phenytoin, theophylline, clozapine, carbamazepine). When combined with warfarin, a significant increase in plasma warfarin concentrations and prolongation of prothrombin time were observed for 2 weeks. Thus, when fluvoxamine is combined with anticoagulants, prothrombin time should be monitored and the dose of the anticoagulant should be adjusted.

With the use of fluvoxamine, a slight increase in plasma concentrations of benzodiazepines, which are metabolized in the liver by oxidation, is possible.

Lithium salts (and possibly tryptophan) enhance the serotonergic effects of fluvoxamine; cases of the development of neuroleptic malignant syndrome have been described when using this combination, so such combination therapy should be prescribed with caution.

Precautionary measures

With depression, there is usually a high likelihood of attempting suicide, which may persist until sufficient remission is achieved.

Prescribe with caution to patients with a history of seizures. If an epileptic seizure develops, treatment with fluvoxamine should be discontinued.

Dosage form:  

suspension for intramuscular and subcutaneous administration

Compound:

0.5 ml of the drug contains:

active substances: influenza viruses, cultured on chicken embryos, inactivated, cleaved, represented by strains equivalent to the following:

A(H1N1) strain* 15 µg hemagglutigin

A (H 3 N 2) strain* 15mcg hemagglutigin

In strain* 15mcg hemagglutigin

*The strains used for this epidemic season are indicated.

Excipients: thiomersal (preservative), sodium chloride, potassium chloride, potassium dihydrogen phosphate, sodium hydrogen phosphate, water for injection. trace amounts: formaldehyde, otoxynol-9.

Description: Colorless, slightly opalescent liquid Pharmacotherapeutic group: MIBP - ATX vaccine:  

J.07.B.B.01 Influenza virus - inactivated whole virus

J.07.B.B Vaccine to prevent influenza

Pharmacodynamics:Immunological properties

Fluvaxin forms specific resistance to influenza viruses in 80-95% of vaccinated people. Specific antibodies in a protective titer are produced 10-15 days after vaccination and persist for at least 1 year. High efficiencyb vaccine is ensured by the presence of both surface and internal antigens.

Indications:

Prevention of influenza in adults and older children 6 months People who are at high risk of developing post-influenza complications (suffering from chronic somatic diseases, often suffering from acute respiratory infections) or who, by the nature of their work, have extensive public contacts - medical personnel, teachers, service workers, transport workers - are vaccinated first. Vaccination is carried out annually in early autumn. Vaccination is allowed at the beginning of an epidemic rise in influenza disease.

Contraindications:

Hypersensitivity (including to chicken protein), severe allergic reactions to vaccines in the anamnesis. Diseases accompanied by an increase in body temperature (including acute manifestations of an infectious disease), exacerbation of chronic diseases. In these cases, vaccination should be postponed until recovery (remission). Against the background of mild ARVI and acute intestinal diseases, vaccination is carried out after normalization of body temperature.

Pregnancy and lactation:

The decision to vaccinate pregnant women should be made by a doctor

individually, taking into account the risk of influenza infection and possible complications of influenza infection. Vaccination is safest in the 2nd and 3rd trimesters of pregnancy. There is currently no data indicating a possible risk to the fetus or impairment of fertility when using the vaccine for the first time. 8 weeks of pregnancy, however, the advisability of vaccination during this period should be assessed by a doctor. Breastfeeding is not a contraindication for vaccination.

Directions for use and dosage:

The vaccine is administered intramuscularly or deeply subcutaneously once to adults and children over 3 years of age in a dose of 0.5 ml, for children: with 6 months to 3 years at a dose of 0.25 ml. Children up to 8 years inclusive, who have not previously had the flu and are being vaccinated against influenza for the first time, it is recommended to administer the vaccine twice with an interval of 4 weeks. Before use, the vaccine must be brought to room temperature and shaken. The vaccine should not be used if coloring or foreign particles are present.

When using a vial containing 0.5 ml of vaccine to immunize children for whom 0.25 ml is indicated, it is necessary to draw the entire contents into a syringe with the appropriate graduation and remove 0.25 ml of vaccine. Any remaining vaccine must be destroyed immediately. A syringe containing 0.5 ml of vaccine is not used to immunize children for whom administration of 0.25 ml is indicated.

Side effects:

General reactions: increased body temperature, malaise, chills, feeling tired, headache, sweating, myalgia, arthralgia. Local reactions: hyperemia, swelling, pain, bruising, compaction at the injection site. These reactions occur frequently, but usually resolve within 1-2 days without special treatment. In rare cases, neuralgia (pain along the nerve), paresthesia, convulsions, and short-term thrombocytopenia may occur; allergic reactions including the development of anaphylactic shock; vasculitis with short-term involvement of the kidneys (in extremely rare cases); neurological disorders.

Interaction:

Glucocorticosteroids and immunosuppressants reduce the immune response to the vaccine. Fluvaxin can be administered on the same day with other vaccines (in different parts of the body) with the exception of BCG.

Special instructions:

Intravascular administration is not allowed. The physician should be informed about any treatment that coincides with vaccination, or about recent use of any medications (including over-the-counter medications), as well as about the patient's immunodeficiency, allergies, or unusual reaction to a previous vaccination.

In the rooms where vaccination is carried out, it is necessary to have medications for anti-shock measures and relief of anaphylactic reactions. The vaccinated person should be under the supervision of a health care worker for 30 minutes after immunization.

Release form/dosage:

Suspension for intramuscular and subcutaneous administration.

Package: 0.5 ml in a bottle, sealed with a stopper under an aluminum rim and closed on top with a safety plastic cap. 0.25 ml and 0.5 ml in a syringe, which is sealed in a blister made of glass foil.

5 bottles or 1 syringe in a cardboard box with instructions for use.

Storage conditions:

Conditions of transportation and storage.

A drug Fluvaxin- inactivated vaccine for the prevention of influenza.
Fluvaxin forms specific resistance to influenza viruses in 80-95% of vaccinated people.
Specific antibodies in a protective titer are produced 10-15 days after vaccination and persist for at least 1 year. The high effectiveness of the vaccine is ensured by the presence of both surface and internal antigens.

Indications for use:
Vaccine Fluvaxin intended for the prevention of influenza in adults and children over 6 months.
People who are at high risk of developing post-influenza complications (suffering from chronic somatic diseases, often suffering from acute respiratory infections) or who, by the nature of their work, have extensive public contacts - medical personnel, teachers, service workers, transport workers - are vaccinated first. Vaccination is carried out annually in early autumn. Vaccination is allowed at the beginning of an epidemic rise in influenza disease.

Mode of application:
Vaccine Fluvaxin administered intramuscularly or deep subcutaneously once to adults and children over 3 years of age at a dose of 0.5 ml, for children from 6 months to 3 years at a dose of 0.25 ml.
For children under 8 years of age inclusive, who have not previously had influenza and are being vaccinated against influenza for the first time, it is recommended to administer the vaccine twice with an interval of 4 weeks.
Before use, the vaccine must be brought to room temperature and shaken. The vaccine should not be used if coloring or foreign particles are present.
When using a vial containing 0.5 ml of vaccine to immunize children for whom 0.25 ml is indicated, it is necessary to draw the entire contents into a syringe with the appropriate graduation and remove 0.25 ml of vaccine.
Any remaining vaccine must be destroyed immediately. A syringe containing 0.5 ml of vaccine is not used to immunize children for whom administration of 0.25 ml is indicated.

Side effects:
General reactions: increased body temperature, malaise, chills, feeling tired, headache, sweating, myalgia, arthralgia. Local reactions: hyperemia, swelling, pain, bruising, compaction at the injection site. These reactions occur frequently, but usually resolve within 1-2 days without special treatment. In rare cases, neuralgia (pain along the nerve), paresthesia, convulsions, and short-term thrombocytopenia may occur; allergic reactions including the development of anaphylactic shock; vasculitis with short-term involvement of the kidneys (in extremely rare cases); neurological disorders.

Contraindications:
Contraindications to the use of the vaccine Fluvaxin are: hypersensitivity (including to chicken protein), a history of severe allergic reactions to the administration of vaccines. Diseases accompanied by an increase in body temperature (including acute manifestations of an infectious disease), exacerbation of chronic diseases. In these cases, vaccination should be postponed until recovery (remission). Against the background of mild ARVI and acute intestinal diseases, vaccination is carried out after normalization of body temperature.

Pregnancy:
Vaccination decision Fluvaxin Pregnant women should be taken individually by a doctor, taking into account the risk of contracting influenza and possible complications of influenza infection. Vaccination is safest in the 2nd and 3rd trimesters of pregnancy. Currently, there is no data indicating a possible risk to the fetus and fertility problems when using the vaccine in the first 8 weeks of pregnancy, however, the advisability of vaccination during this period should be assessed by a physician. Breastfeeding is not a contraindication for vaccination.

Interaction with other drugs:
Glucocorticosteroids and immunosuppressants reduce the immune response to the vaccine.
Fluvaxin can be administered on the same day with other vaccines (in different parts of the body) with the exception of BCG.

Storage conditions:
Transport and store in a dry place, protected from light at a temperature of 2 °C to 8 °C. Keep out of the reach of children.

Release form:
Fluvaxin - suspension for intramuscular and subcutaneous administration.
0.5 ml in a bottle, sealed with a stopper under an aluminum rim and closed on top with a safety plastic cap. 0.25 ml and 0.5 ml in a syringe, which is sealed in a blister made of glass foil.
5 bottles or 1 syringe in a cardboard box with instructions for use.

Compound:
Fluvaxin contains active ingredient: Influenza vaccine (inactivated).

Additionally:
Intravascular administration is not allowed. The physician should be informed about any treatment that coincides with vaccination, or about recent use of any medications (including over-the-counter medications), as well as about the patient's immunodeficiency, allergies, or unusual reaction to a previous vaccination.
In the rooms where vaccination is carried out, it is necessary to have medications for anti-shock measures and relief of anaphylactic reactions. The vaccinated person should be under the supervision of a health care worker for 30 minutes after immunization.

1. Allergic reactions to chicken protein or other components of the vaccine.
2. Severe post-vaccination reactions (temperature above 40°C, swelling at the injection site, hyperemia over 8 cm in diameter) or post-vaccination complications (collapse, non-febrile convulsions, anaphylaxis) to the previous administration of influenza vaccine.
3. Pregnancy (when using a vaccine with a preservative).
4. Age up to 18 years (when using a vaccine with a preservative).
5. Age up to 6 months.
Temporary contraindications.
1. Acute febrile conditions, acute infectious and non-infectious diseases, including the period of convalescence. Vaccination is usually carried out 2-4 weeks after recovery.
2. Chronic diseases in the acute stage. Vaccination is carried out during the period of remission. The possibility of vaccination of persons suffering from chronic diseases is determined by the attending physician, based on the patient’s condition.
3. For mild forms of acute respiratory viral and intestinal infections, vaccination is carried out after the temperature has normalized and/or the acute symptoms of the disease have disappeared.
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