Vaccine against measles, mumps and rubella, live attenuated (lyophilized), Lyophilisate for preparing a solution for subcutaneous administration. Mumps-measles vaccine cultural live Vaccine measles rubella mumps domestic instructions

The vaccine for the prevention of measles and mumps stimulates the formation of antibodies to these viruses, therefore, after vaccination, the patient develops immunity to these diseases.

Composition and release form

The drug is produced both in vials and in ampoules, which contain one dose of lyophilized powder and a solvent is attached to it. The vaccine contains the measles and mumps virus; in addition, auxiliary compounds are added in the form of sorbitol and gelatin stabilizer.

The container with the vaccine indicates the expiration date; after its expiration, the drug must be disposed of; if it is expired, it is contraindicated to use it.

pharmachologic effect

The vaccine for the prevention of measles and mumps has the ability to stimulate in a person the production of special antibodies to both measles and mumps viruses, as a result of which these infectious diseases do not occur in the patient.

Indications for use

The drug is used to prevent measles and mumps, while primary vaccination is carried out in children aged one to six years who have not suffered from these diseases.

Emergency vaccination is carried out for children over one year of age and adults who have been in contact with sick patients, and it is recommended to carry it out no later than 72 hours after direct contact, in the absence of possible contraindications.

Contraindications for use

I will list the conditions under which vaccination is contraindicated:

Hypersensitivity to vaccine components;
In the presence of primary immunodeficiency;
In the presence of malignant diseases;
In the presence of a pronounced reaction, in particular with hyperthermia exceeding forty degrees, with hyperemia and swelling with a diameter of more than eight centimeters at the immediate injection site;
During pregnancy;
In case of complications from the previous administration of this vaccine.

In addition, the presence of acute infectious diseases, as well as non-infectious diseases, is considered a contraindication.

Application and dosage

The vaccine should be injected subcutaneously directly under the shoulder blade or into the shoulder area; the injection is carried out once in a dose of 0.5 milliliters. Vaccination should be carried out by an experienced specialist.

Side effects

From four to eighteen days after vaccination, the following side effects may appear: hyperthermia up to 39 degrees, catarrhal phenomena in the form of rhinitis and redness of the pharynx are added. For a short time, the parotid salivary glands may become enlarged, as well as a measles-like rash and general malaise.

Local reactions are also possible, they will be as follows: slight hyperemia of the skin and swelling of the soft tissues, while the symptoms disappear quite quickly, within a day or two without any treatment.

Rarely, allergic reactions may occur; they usually appear on the first or second day. After two weeks or a month, the development of serous meningitis, which occurs in a benign form, is possible.

Drug overdose

Currently, there are no cases of vaccine overdose reported.

special instructions

If the patient has HIV infection, vaccination cannot be performed. In mild forms of ARVI, in acute intestinal diseases, the drug can be administered immediately after the temperature has normalized.

Vaccination can be carried out on the same day as other calendar vaccinations, or no earlier than a month after the previous vaccination. Persons who are temporarily exempt from vaccination must be vaccinated after the removal of existing contraindications.

If in the post-vaccination period the patient develops a fever, as well as febrile convulsions, it is necessary to prescribe antipyretic medications.

Immediately before using the drug, it is recommended to dilute the vaccine with a special solvent at the rate of 0.5 milliliters of solvent per vaccination dosage, and it should dissolve completely after three minutes.

You cannot use a vaccine that is in a container with compromised integrity, except when its physical properties change, when the color and transparency of the drug changes. In addition, it is contraindicated to use a product that has expired.

The opening of the ampoules, as well as the vaccination technique itself, must be carried out under aseptic conditions. It is recommended to treat containers with the vaccine, as well as the solvent at the site of the direct incision, with alcohol, after which they are carefully broken off; ethanol must not be allowed to get inside the ampoule.

After that, the required volume of a special solvent is drawn into the syringe and carefully transferred to the ampoule with the vaccine. Next, the product is drawn up with a new needle and vaccination is carried out.

The dissolved vaccine cannot be stored for any period of time, even for an hour; it should be used for its intended purpose immediately after preparation. It is necessary to register the vaccination performed on medical records, indicating in the journal the date of vaccination, the patient's reaction to vaccination, and the series number.

Analogs

Priorix is ​​an analogue.

Conclusion

We talked about how the Measles-Mumps vaccine is used, we studied the instructions for use, the composition, indications, contraindications, and effect of the drug. Vaccination should be carried out in a medical facility, taking into account contraindications to its use. If side effects develop, it is recommended to report your symptoms to your doctor.

Latest update of the description by the manufacturer 31.07.2003

Filterable list

Active substance:

ATX

Pharmacological group

Nosological classification (ICD-10)

Composition and release form

1 dose of lyophilized powder for preparing a solution for subcutaneous administration contains measles virus not less than 1000 TCD 50, mumps virus not less than 20,000 TCD 50 and gentamicin sulfate not more than 25 mcg; in ampoules of 1 dose, in a cardboard box 10 ampoules.

Characteristic

Homogeneous porous mass of pink color, hygroscopic.

pharmachologic effect

Stimulates the production of antibodies to measles and mumps viruses, reaching maximum levels 3-4 weeks and 6-7 weeks after vaccination, respectively.

Indications of the drug Mumps-measles cultural live vaccine

Planned and emergency prevention of measles and mumps.

Contraindications

Hypersensitivity (including to aminoglycosides, quail egg white), severe reaction or complication to the previous dose, primary immunodeficiency conditions, malignant blood diseases, neoplasms, pregnancy.

Use during pregnancy and breastfeeding

Contraindicated during pregnancy.

Directions for use and doses

S.C., immediately before use, mix the vaccine with the solvent (0.5 ml of solvent per 1 vaccination dose of the vaccine), inject 0.5 ml under the shoulder blade or into the shoulder area (at the border between the lower and middle third of the shoulder, on the outside). Routine vaccinations are carried out twice at the ages of 12 months and 6 years for children who have not had measles and mumps.

Emergency prophylaxis is carried out for children aged 12 months, adolescents and adults who have had contact with a patient with measles or mumps, who have not had these infections and have not been vaccinated against them in accordance with the vaccination calendar (the vaccine is administered no later than 72 hours after contact with the patient) .

Precautionary measures

Vaccination can be carried out after the end of acute manifestations of infectious and non-infectious diseases, exacerbations of chronic diseases; after normalization of body temperature in mild forms of ARVI or acute intestinal diseases; 3-6 months after immunosuppressive therapy. After the administration of human immunoglobulin preparations, vaccinations against measles and mumps are carried out no earlier than 2 months later. After the administration of the mumps-measles vaccine, immunoglobulin preparations are administered no earlier than 2 weeks later. If it is necessary to use immunoglobulin earlier than this period, vaccination against measles and mumps should be repeated.

J.07.B.D.52 Measles virus in combination with mumps and rubella viruses - live, attenuated

J.07.B.D Vaccine to prevent measles

Excipients: stabilizer - a mixture of 0.08 ml of an aqueous solution of LS-18* and 0.02 ml of a 10% gelatin solution; - no more than 20 mcg.

1 dose - ampoules (10) - cardboard packs.

* Composition of the aqueous solution of LS-18: sucrose - 250 mg, lactose - 50 mg, sodium glutamic acid - 37.5 mg, - 25 mg, L-proline - 25 mg, Hanks dry mixture with phenol red - 7.15 mg, water for injection - up to 1 ml.

pharmachologic effect

It is a lyophilized mixture of liquid semi-finished measles and mumps vaccines prepared by cultivating attenuated strains of measles virus L-16 and mumps virus L-3 on a primary cell culture of quail embryos

Stimulates the production of antibodies to measles and mumps viruses in seronegative vaccinated individuals, reaching maximum values ​​after 3-4 weeks. and 6-7 weeks. after vaccination, respectively.

Indications

Prevention of measles and mumps starting at 12 months of age.

In accordance with the National Preventive Vaccination Calendar, vaccination is carried out twice at the ages of 12 months and 6 years for children who have not had measles and mumps.

Contraindications

Anaphylactic reactions or severe forms of allergic reactions to aminoglycosides (since the drug may contain), chicken and/or quail eggs; primary immunodeficiency, malignant blood diseases and neoplasms; severe reaction (hyperthermia above 40°C, hyperemia or swelling more than 8 cm in diameter at the site of vaccine administration) or complication of previous administration of mumps or measles vaccines; acute diseases or exacerbation of chronic diseases; pregnancy, breastfeeding period.

Dosage

SC under the shoulder blade or shoulder area (on the border between the lower and middle third of the shoulder from the outside), once in a single dose.

Side effects

Often: from 5 to 15 days - a short-term slight increase in body temperature, catarrhal symptoms from the nasopharynx (mild hyperemia of the pharynx, rhinitis). With mass use of the vaccine, an increase in body temperature above 38.5°C should not occur in more than 2% of vaccinated people. An increase in body temperature above 38.5°C in the post-vaccination period is an indication for the prescription of antipyretics.

Infrequently: from 5 to 18 days - coughing, conjunctivitis, measles-like rash, lasting 1-3 days.

Rarely: in the first 48 hours after vaccination, local reactions, expressed in skin hyperemia and mild swelling at the site of vaccine administration, which resolve without treatment; from 5 to 42 days - a short-term slight increase in the parotid salivary glands, lasting 2-3 days; anxiety, lethargy, sleep disturbance.

Very rarely: in the first 24-48 hours - allergic reactions that occur in persons with altered reactivity; after 6-10 days - convulsive reactions that occur after vaccination against a background of high temperature; after 2-4 weeks - benign serous meningitis, each case of which requires differential diagnosis; development of encephalitis, each case of which requires differential diagnosis; , abdominal syndrome; painful short-term swelling of the testicles.

Drug interactions

Vaccination can be carried out simultaneously (on the same day) with DTP and ADS vaccines, live and inactivated polio vaccine, vaccine against rubella, influenza, and Haemophilus influenzae, provided it is administered to different parts of the body. Other live viral vaccines are administered at intervals of at least 1 month.

If it is necessary to perform a tuberculin test, it should be carried out either simultaneously with vaccination or 6 weeks after it, since the measles (and possibly mumps) vaccination process can cause a temporary decrease in the sensitivity of the skin to tuberculin, which will cause a false negative result.

After administration of human drugs, vaccinations should be carried out no earlier than 2 months later. After administration of the mumps-measles vaccine, immunoglobulin preparations can be administered no earlier than 2 weeks later; If it is necessary to use immunoglobulin earlier than this period, vaccination against mumps and measles should be repeated.

special instructions

In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccinated person with mandatory thermometry.

Vaccination with the mumps-measles vaccine is not recommended during periods of increased incidence of serous meningitis.

HIV infection is not a contraindication for vaccination.

Considering the possibility of developing immediate allergic reactions (anaphylactic shock, Quincke's edema, urticaria) in particularly sensitive individuals, vaccinated persons must be provided with medical supervision for 30 minutes.

Vaccination sites must be provided with anti-shock therapy.

Vaccination is carried out after acute infectious and non-infectious diseases, after exacerbation of chronic diseases - after the end of acute manifestations of the disease; for mild ARVI, acute intestinal diseases and other conditions - immediately after the temperature normalizes; after immunosuppressive therapy, vaccination is carried out 3-6 months after the end of treatment.

Persons temporarily exempt from vaccination should be monitored and vaccinated after contraindications are lifted

The vaccination carried out is registered in the established registration forms, indicating the name of the drug, date of vaccination, dose, manufacturer, batch number, date of manufacture, expiration date, reaction to the vaccine.

Pregnancy and lactation

During pregnancy and breastfeeding, vaccination with this vaccine is contraindicated.

Instructions for medical use

medicine

Tradename

Live attenuated lyophilized vaccine against measles, mumps and rubella

International nonproprietary name

Dosage form

Lyophilisate for the preparation of solution for subcutaneous administration

1 dose in a bottle complete with 0.5 ml solvent in an ampoule

Compound

One dose (0.5 ml) contains

active substances: measles virus not less than 1000 TCD 50, mumps virus not less than 5000 TCD 50, rubella virus not less than 1000 TCD 50,

Excipients: partially hydrolyzed gelatin, sorbitol, histidine, L-alanine, tricine, L-arginine hydrochloride,

lactabumine hydrolyzate.

Solvent - water for injection 0.5 ml.

Description

A homogeneous, porous mass of yellowish-white color, hygroscopic. After dissolution, a clear, colorless or light yellow liquid.

Solvent: transparent colorless liquid.

Pharmacotherapeutic group

Antiviral vaccines. Measles virus in combination with mumps and rubella viruses - live, weakened.

ATX code J07BD52

Pharmacological properties

Pharmacokinetics

Vaccines do not require pharmacokinetic evaluation.

Pharmacodynamics

The vaccine is a combination preparation containing live attenuated strains of the Edmonston-Zagreb measles virus, the Leningrad-Zagreb (L-Z) mumps virus and the Wistar RA 27/3 rubella virus. Measles and rubella viruses are grown on human diploid cells (HDC), and mumps virus is grown on chicken fibroblasts obtained from SPF (specific pathogen free) eggs. The vaccine forms active immunity against the measles, mumps and rubella viruses by inducing the synthesis of measles, mumps and rubella IgG antibodies, which develops within 15 days after vaccination and persists for at least 16 years. Seroconversion occurs in 95-100% of vaccinated patients. When conducting a serological test, the result is considered positive when the dilution is at least 1/20 (in RTGA): in this case, the patient is regarded as having specific immunity and vaccination is not required for him. If the dilution is less than 1/20, the result is considered negative.

The vaccine meets the requirements of the World Health Organization.

Indications for use

Prevention of measles, mumps and rubella

Primary vaccination

Active immunization against measles, mumps and rubella in children aged 12-15 months

Revaccination

Children first immunized at 12-15 months of age should be immunized again at 4-6 years of age.

In cases where primary vaccination was not effective (protective titer less than 1/20)

Directions for use and doses

The vaccine must be diluted only with the supplied diluent (sterile water for injection) using a sterile syringe. The dry vaccine dissolves easily with gentle shaking. The vaccine must be used immediately after dilution. A single dose of the drug (0.5 ml) is administered only deep subcutaneously in the anterolateral upper part of the thigh in newborns and in the shoulder in older children.

The supplied solvent is specially made for this vaccine. Only use the supplied solvent. Do not use solvents with other types of vaccines or measles, mumps, and rubella (MMR) vaccines from other manufacturers. The use of inappropriate solvents may result in altered vaccine properties and severe reactions in recipients.

Before administering the drug, a visual inspection of the diluent and diluted vaccine should be performed to determine the presence of flakes and/or abnormalities in physical characteristics. If visual inspection results are unsatisfactory, diluent or diluted vaccine should not be used.

Side effects

Determination of the frequency of side effects: very common (≥1/10, more than 10%); frequent (≥1/100, but<1/10, более 1%, но менее 10%); нечастые (≥1/1,000, но <1/100, более 0,1%, но менее 1%); редкие (≥1/10,000, но <1/1,000, более 0,01%, но менее 0,1%); очень редкие (<1/10,000, менее 0,01%), включая единичные сообщения

Often

Moderate increase in temperature on days 7-12 after vaccination lasting 1-2 days

Moderate pain at the injection site within 24 hours after vaccination, in most cases goes away on its own within 2-3 days

Arthralgia and arthritis in adolescent girls and adult women due to the rubella component, which last from several days to 2 weeks

Often

Rash on day 7-10 and disappearing after 2 days

Arthralgia and arthritis in children and men due to the rubella component, occurring 1-3 weeks after vaccination and lasting from 1 day to 2 weeks. These transient reactions are characteristic only of unimmunized individuals, for whom vaccination with this vaccine is of great importance.

Rarely

Lymphadenopathy

Myalgia and paresthesia

Very rarely

Mumps and orchitis due to the mumps component (0.008%)

Aseptic meningitis on days 15-35 after immunization due to the mumps component, resolves without treatment within a week and does not cause complications

Encephalitis due to measles component (1:1000000)

Thrombocytopenia (less than 1:30000)

Anaphylactic shock

Contraindications

Hypersensitivity to vaccine components (neomycin and egg white)

Feverish state

Acute infectious diseases

Pregnancy and lactation

Leukemia

Severe anemia and other severe blood diseases, including malignant ones

Severe renal impairment

Heart diseases in the stage of decompensation

Malignant neoplasms

Immunodeficiency conditions with damage to cellular immunity

Pre-vaccination use of corticosteroids, immunosuppressants or radiation therapy

Pre-vaccination use of gammaglobulins or blood transfusion

History of anaphylactic or anaphylactoid reactions to vaccine administration

Drug interactions

It is possible to administer the vaccine simultaneously (on the same day) with vaccines against whooping cough, diphtheria, and tetanus; diphtheria and tetanus; tetanus toxoid; polio vaccine (live and inactivated); vaccine against Haemophilus influenzae type b; hepatitis B virus vaccine without the risk of complications or reduced effectiveness. In this case, vaccines are injected into different parts of the body using different syringes.

The MMR vaccine should not be administered earlier than 3 months after the administration of immunoglobulins and blood products containing them (whole blood, plasma), since inactivation of the vaccine may occur. For the same reason, immunoglobulins should not be prescribed within 2 weeks after vaccination. Individuals receiving corticosteroids experience an insufficient immune response.

special instructions

ATTENTION!

1. The vaccine must be administered deep subcutaneously. Because any component of the vaccine may cause anaphylactic reaction, a solution of adrenaline (1:1000) should be ready for intradermal or intramuscular injection. For the treatment of severe anaphylaxis, the initial dose of epinephrine is 0.1-0.5 mg (0.1-0.5 ml injection 1:1000) and administered intramuscularly or subcutaneously. A single dose should not exceed 1 mg (1 ml). For infants and children, the recommended dose of epinephrine is 0.01 mg/kg (0.01 ml/kg injection 1:1000). A single pediatric dose should not exceed 0.5 mg (0.5 ml). This will help effectively eliminate anaphylactic shock/anaphylactic reaction. Adrenaline should be administered at the first suspicion of the onset of anaphylactic shock.

2. The person receiving the vaccine must be under the supervision of medical personnel for 30 minutes after administration of the vaccine, which is necessary for the timely recognition of immediate allergic reactions. The vaccination site should have prednisolone and/or other injectable antihistamines available, as well as other equipment: oxygen breathing apparatus, etc.

HIV infection

The live MMR vaccine can be prescribed to children with HIV infection without clinical manifestations.

Pregnancy and lactation

It is prohibited to administer the vaccine during pregnancy!

No studies have been conducted on the effect of the vaccine on lactation.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There is no evidence that the MMR vaccine affects the ability to drive vehicles or operate machinery.

Overdose

There were no cases of overdose.

Release form and packaging

Vaccine. 1 dose of vaccine in brown glass bottles. 50 bottles each with instructions for medical use in the state and Russian languages ​​in a cardboard box.

Solvent. 0.5 ml in an ampoule made of colorless transparent glass of 1 hydrolytic group. 50 ampoules with instructions for medical use in the state and Russian languages ​​in a cardboard box or 10 ampoules in a blister pack (blister) made of polyamide/aluminum PVC composite material and printed-varnished aluminum foil; 5 contour blister packs (blisters) with instructions for medical use in the state and Russian languages ​​in a cardboard box.

Storage conditions

Vaccine. Store in a place protected from light at a temperature between

2 °C to 8 °C. Do not freeze.

Solvent. Store at temperatures between 5°C and 30°C.

Do not freeze.

Reconstituted vaccine cannot be stored.

Keep out of the reach of children!

Shelf life

Vaccine - 2 years

Solvent - 5 years

Do not use after expiration date.

Conditions for dispensing from pharmacies

By prescription (for medical institutions)

Manufacturer

Serum Institute of India Ltd

Registration Certificate Holder

Serum Institute of India Ltd

212/2, Hadapsar, Pune 411 028, India

Address of the organization receiving complaints from consumers regarding the quality of the drug in the territory of the Republic of Kazakhstan

Albedo LLP, Republic of Kazakhstan, 050035, Almaty, 10 microdistrict-on,

32, tel. +7 727 303 21 00, +7 727 303 06, fax +7 727 303 21 03,

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