M-M-P II

General characteristics. Structure:

Active ingredient: the live attenuarovany viruses including _{1000 TID50} * standard viruses of measles (USA), _{5000 TID50} * standard viruses of parotitis (USA), _{1000 TID50} * standard viruses of a rubella (USA).

Excipients: Neomycinum (25 mkg on each dose), sorbitol, sucrose, albumine of the person, serum of an embryo of a calf, the gelatin hydrolyzed sodium chloride, sodium phosphate. Drug does not contain preservatives.

The viruses which are a part of a vaccine are identical to the viruses used for production Attenuvax (a live clumsy vaccine, MSD), Mumpsvax (a live vaccine against parotitis, MSD), Meruvax II (a live vaccine against a rubella, MSD).

Attenuvax (live clumsy vaccine, MSD), more attenuirovanny line of a virus of measles received from an attenuirovanny (Enders) strain of Edmonston and grown up in culture of cells of a chicken embryo.

Mumpsvax (live vaccine against parotitis, MSD), a strain of Jeryl Lynn (level B) of a virus of the parotitis which is grown up in culture of cells of a chicken embryo;
Meruvax II (live vaccine against a rubella, MSD), a strain of Wistar RA 27/3 of the live attenuated virus of a rubella which is grown up in culture of diploid cells of pulmonary fibroblasts of the person (WI-38).

* - _TID50 - the dose infecting with 50% of cultures of cells.

Pharmacological properties:

Pharmacodynamics. A vaccine for prevention of a rubella, measles and parotitis. M-M-P II has high immunogene properties.

Single introduction of a vaccine causes emergence in 95% of susceptible patients of the clumsy antibodies inhibiting hemagglutination in 96% - parotitis neutralized antibodies and in 99% - the antibodies against a virus of a rubella inhibiting hemagglutination.

The virus strain of a rubella of RA 27/3 which is a part of M-M-P II defines directly after vaccination higher credits inhibiting hemagglutination, complement-linked and neutralized antibodies, than other strains of a vaccine against a rubella. It is shown that it causes emergence of wider range of the circulating antibodies, including an anti-theta and anti-иота precipitant antibodies. RA 27/3 rubella virus strain immunological imitates a natural infection more than other vaccinal viruses of a rubella. The increased level and wider range of antibodies which emergence is induced by a vaccinal virus strain of a rubella of RA 27/3 correlate with bigger resistance to subclinical reinfection a natural virus, and with bigger reliability provide life-long immunity.

The vaccination which is carried out by the vaccine M-M-P II provides preservation of level of antibodies in the patient's blood more than 11 years.

Immunization of the women of childbearing age who do not have immunity against a rubella protects them from a disease of a rubella at pregnancy that in turn prevents infection of a fruit and development of the defeats caused by an inborn rubella.

Indications to use:

— performing simultaneous vaccination of children at the age of 1 year is also more senior against measles, parotitis and a rubella;

— carrying out immunization neimmunizirovanny against a rubella and the children who did not have a rubella is more senior 1 years which pregnant mothers are susceptible to a rubella;

— carrying out immunization of the women of childbearing age who do not have immunity against a rubella;

— vaccination of persons from groups of the increased risk (including pupils, health workers, the military personnel).

Route of administration and doses:

The vaccine is entered п / to preferably into the area of an outside surface of an upper third of a shoulder in a dose of 0.5 ml. The dose of a vaccine is identical to patients of any age.

Children at the age of less than 15 months can have no response on clumsy a vaccine component owing to existence of residual quantity of the circulating clumsy antibodies received from mother, at the same time the age of the child is less, the probability of seroconversion is lower. In geographically isolated or other inaccessible populations for which implementation of programs of immunization presents difficulties and also in population groups in which the risk of natural infection with a virus of measles of children aged up to 15 months is high, introduction of a vaccine to earlier terms is possible. If vaccination is carried out aged to 12 months, then the revaccination should be carried out at the age of 15 months.

Rules of preparation and administration of solutions of a vaccine. For an injection and/or dissolution of a vaccine it is necessary to use the sterile syringe which is not containing preservatives, antiseptic and detergents as they can inactivate a live virus vaccine. It is necessary to use only the solvent delivered with a vaccine (sterile water for injections) since it does not contain preservatives and antiviral substances which can inactivate a vaccine.

Before introduction drug should be examined carefully on existence of suspended particles and discoloration. The dissolved vaccine M-M-P II has to be transparent and have yellow color.

For each patient it is necessary to use separate sterile syringes and needles. Observance of rules of an asepsis and the correct storage of a vaccine before its dissolution and the subsequent use are important.

For use of M-M-P II in the bottle containing 1 dose it is necessary to gather completely solvent in the sterile syringe, to enter all solvent into a bottle with the lyophilized vaccine and to mix carefully. To gather all contents of a bottle in the syringe and to enter completely п / to.

The vaccine and solvent do not contain preservatives therefore it is necessary to exclude potential threat of pollution and to take special precautionary measures for ensuring sterility of drug. It is recommended to use a vaccine as soon as possible after dissolution.

Features of use:

Use at pregnancy and feeding by a breast. The vaccine M-M-P II is contraindicated to use at pregnancy.

It is unknown whether the vaccine M-M-P II can have the damaging effect on a fruit in case of vaccination of the pregnant woman.

However in case of inadvertent vaccination during pregnancy or approach of pregnancy within 3 months after vaccination it is necessary to consider that in a 10-year research more than 700 pregnant women vaccinated against a rubella within 3 months to or after conception (189 of them received a strain of Wistar RA 27/3), at one of newborns are not revealed the inborn defects characteristic of a syndrome of an inborn rubella. At a parotitis infection in the I trimester of pregnancy increase in risk of spontaneous abortion is possible. It is shown that the virus of a vaccine against parotitis can infect a placenta and a fruit, however data that it can cause inborn defects in the person are absent. There are messages that natural infection with measles during pregnancy increases risk for a fruit. Increase in frequency of spontaneous abortions, still births, inborn defects and premature births was observed in a case of measles during pregnancy. Adequate researches of action of an attenuirovanny vaccinal virus strain of measles at pregnant women were not conducted. However the assumption that the vaccinal virus strain is also capable to have the damaging effect on a fruit is justified.

With care it is necessary to enter M-M-P of the II nursing mother in the period of a lactation. It is unknown whether vaccinal viruses of measles and parotitis with breast milk are allocated. Recent researches showed that at immunization of women in the period of a lactation the virus can be defined by a live attenuirovanny vaccine against a rubella in breast milk and be transferred to newborns. Cases of a severe disease with serological signs of infection with a virus of a rubella did not occur at newborns, however at one child the typical acquired rubella of an easy current developed.

Women of childbearing age are recommended to be protected from pregnancy within 3 months after vaccination. They should be informed on a possibility of frequent emergence of passing arthralgias and/or arthritis in 2-4 weeks after vaccination. Carrying out serological researches for the purpose of definition of a susceptibility to a rubella with the subsequent inoculation of seronegative patients is desirable, but not obligatory.

Believe that in many cases vaccination of the women susceptible to a rubella, right after childbirth is justified.

Use for children. Children at the age of less than 15 months can have no response on clumsy a vaccine component owing to existence of residual quantity of the circulating clumsy antibodies received from mother, at the same time the age of the child is less, the probability of seroconversion is lower. In geographically isolated or other inaccessible populations for which implementation of programs of immunization presents difficulties and also in population groups in which the risk of natural infection with a virus of measles of children aged up to 15 months is high, introduction of a vaccine to earlier terms is possible. If vaccination is carried out aged to 12 months, then the revaccination should be carried out at the age of 15 months.

Special instructions. The vaccine is not entered in / century. Considering a possibility of anaphylactic and anaphylactoid reactions, before introduction of a vaccine it is necessary to prepare necessary remedies, including adrenaline for injections (1:1000).

Are available this, testimonial that at children, immunizirovanny aged till 1 year, revaccination in later terms not always leads to long preservation of antibodies therefore advantages of early immunization need to be correlated to a possibility of the inadequate answer to revaccination.

Vaccination of the persons which are in contact with the patient with measles can provide a certain protection if the vaccine is entered into the first 72 h after contact. If the vaccine was entered some days before infection, then in this case the high preventive effect will be reached. Convincing data on preventive effect of vaccination of the persons which are in contact with patients with parotitis and a rubella no.

There are messages that at patients with heavy disturbances of immunity after accidental introduction of a clumsy vaccine as a result of the disseminated infection caused by a vaccinal virus cases of encephalitis, pneumonia and lethal outcomes developed.

With extra care it is necessary to carry out vaccination of patients at whom in the anamnesis spasms were observed (including at relatives), damage of tissue of brain and any other states at which it is necessary to avoid fervescence.

At patients with thrombocytopenia after vaccination development of heavier thrombocytopenia is possible. Besides, at persons with thrombocytopenia after the first vaccination of M-M-P II (or the vaccine which is its part) thrombocytopenia can develop at introduction of the subsequent doses. In the latter case for definition of need of revaccination it is necessary to carry out assessment of specific immunity. In similar cases before vaccination it is necessary to estimate carefully a ratio of potential risk and advantage.

The children and teenagers infected with a human immunodeficiency virus, but without strong clinical signs of immunosuppression, can be vaccinated. In similar cases vaccination can be less effective, than at not infected persons.

M-M-P II should appoint 1 month to or in 1 month after introduction of other vaccines.

At most of patients within 7-28 days after vaccination allocation of small amounts of the live weakened rubella virus from a nose and a throat was noted. The possibility of transfer of a virus from vaccinated to other people is not proved in such way. At close personal contact such opportunity theoretically should be considered, however its risk is insignificant.

Messages on transfer of a live attenuated virus of measles or parotitis from vaccinated to susceptible persons are absent.

There are messages that the live vaccines against measles, parotitis and a rubella entered separately can lead to temporary decrease in skin sensitivity to tuberculine. Therefore, if it is necessary, tuberkulinovy tests should be carried out to or along with introduction of the vaccine M-M-P II.

At the children receiving antitubercular therapy the aggravation of a course of a disease after introduction of a live vaccine against measles was not noted. Messages on researches of influence of a live clumsy vaccine on the course of not treated tuberculosis at children are absent.

The arthralgia and/or arthritis (usually passing and seldom chronic) and a polyneuritis are characteristic of a natural rubella and can vary on the frequency and weight depending on age and a floor, being the most expressed at adult women and least - at children at prepubertatny age. At a natural rubella there can be chronic arthritis connected with a persistention of the virus and/or a viral antigen allocated from body tissues. At the vaccinated persons chronic symptoms from joints develop seldom.

The research of a wide clinical use of more than 200 million doses of M-M-P and M-M-P II around the world within 25 years (1971-1996) demonstrates that messages on the serious undesirable phenomena, such as encephalitis and encephalopathy, remain rare. Cases of a subacute sclerosing panencephalitis (PSPE) at the children who did not have measles, but received a clumsy vaccine were described. Some of them a cause of illness, perhaps, had not recognizable measles within the first year of life or vaccination against measles. Considering settlement prevalence of vaccination against measles, the possible risk of development of PSPE at its carrying out makes about 1 case on 1 million doses of a vaccine. It is much less, than at a disease of measles - 6-22 cases of PSPE on one million cases of measles. Believe that vaccination against measles in general warns PSPE, reducing incidence of measles at which the risk of this complication is high.

There are rare messages on emergence of a panniculitis after introduction of a clumsy vaccine.

Vaccination should be carried out in 2 weeks prior to or in 3 months after administration of human immunoglobulin, and also hemotransfusion or plasma.

As well as any other vaccine, M-M-P II does not provide protection against a disease at 100% vaccinated.

It is necessary to consider that each dose of the dissolved vaccine M-M-P II contains about 25 mkg of Neomycinum.

Use in pediatrics. Safety and efficiency of a clumsy vaccine at children aged up to 6 months is not established. Safety and efficiency of vaccines against parotitis and a rubella at children aged till 1 year is not established.

Side effects:

At use of the vaccine M-M-P II the same side reactions were observed, as at introduction of the monovalent or combined vaccines.

Local reactions: often - quickly taking place burning and/or morbidity in the place of an injection; seldom - an erythema, consolidation and sensitivity of skin.

Dermatological reactions: seldom - rash (usually insignificant, but sometimes generalized; appears between 5 and 12 days).

From the alimentary system: seldom - parotitis, nausea, vomiting, diarrhea.

From system of a hemopoiesis: seldom - thrombocytopenia, a Werlhof's disease.

From lymphatic system: seldom - a regional limfoadenopatiya.

Allergic reactions: seldom - skin reaction like blisters or a hyperemia in the place of an injection, anaphylactic and anaphylactoid reactions, a Quincke's disease (including peripheral hypostases and a face edema), a bronchospasm, a small tortoiseshell.

From a musculoskeletal system: seldom - arthralgias and/or arthritises (usually passing, in some cases chronic), mialgiya.

At vaccination of children of reaction from joints are not characteristic and usually short-term. Frequency of arthritises at women is usually higher, than at children and makes, respectively 12-20% and 0-3%, and reactions are usually more expressed and long.

The joint syndrome at women tends to heavier and long current, symptoms can remain within several months, and in rare instances - even years. At girls of teenage age the frequency of reactions from joints is higher, than at children, but below, than at adult women. Even at women of more advanced age (35-45 years) these reactions are usually well transferred and do not influence normal life activity.

From TsNS and peripheral nervous system: seldom - febrile spasms at children, the spasms which are not connected with fever, a headache, dizziness, irritability, paresthesias, a polyneuritis, a polyneuropathy, a syndrome to Giyena-Barra, an ataxy, subacute sclerosing encephalitis, various options of an optic neuritis including retrobulbar rhinitis, a papillitis; paralysis of optic nerves, the deafness connected with neuritis.

Isolated cases of encephalitis/encephalopathy with a frequency of 1 on 3 million doses are described. In one case the valid communication of these reactions with vaccination was not proved. The risk of development of such serious neurologic violations after introduction of a live vaccine against measles remains to much lower, than risk of encephalitis and encephalopathies at a disease of measles (1 on 2000 described cases).

From sense bodys: seldom - average otitis, conjunctivitis.

From respiratory system: seldom - pneumonia, cough, rhinitis.

From a reproductive system: seldom - an orchitis.

Others: seldom - fever (38,8 °C and more; usually appears between 5 and 12 days), a pharyngalgia, an indisposition, mitigirovanny measles, a syncope.

Very seldom messages on death from various and in certain cases the unknown reasons after introduction of a vaccine against measles, parotitis and a rubella arrived, however the interrelation with vaccination was not established. At the observation of a wide clinical use including 1.5 million children and the adults vaccinated by M-M-P II during 1982-1993 there are no messages on deaths or long complications.

Interaction with other medicines:

At simultaneous introduction of M-M-P II and immunoglobulins disturbance of the expected immune response is possible.

M-M-P II was applied along with the chicken pox and hemophilic B infection inoculations which are carried out by different syringes to different body parts. At the same time disturbances of an immune response on the entered antigens were not revealed, and character, frequency and expressiveness of side reactions were similar to those at administration of monodrugs.

Mass use of AKDS and/or live poliomyelitic vaccines along with vaccines against measles, parotitis and a rubella is not recommended in connection with limited data on results of the combined use of these antigens.

However, the data of the published researches concerning simultaneous introduction of commercial polyvalent vaccines (for example, AKDS, OPV, M-M-R, a vaccine against hemophilic B infection and a vaccine against hepatitis B) do not indicate any interaction between them.

Contraindications:

— anaphylactic or anaphylactoid reactions to Neomycinum in the anamnesis;

— anaphylactic or anaphylactoid reactions to eggs in the anamnesis;

— the diseases of respiratory system which are followed by fever;

— the acute infections which are followed by fever;

— not treated tuberculosis in an active phase;

— malignant diseases of blood and lymphatic system, other malignant new growths affecting marrow;

— primary and secondary immunodeficiences (including AIDS or other clinical manifestations of infection of HIV); disturbance of cellular immunity; hypogammaglobulinemia or dysgammaglobulinemia;

— performing immunodepressive therapy (except for replacement therapy by corticosteroids, for example, concerning Addison's disease);

— existence of a congenital or hereditary immunodeficiency disorder in the family anamnesis (until the condition of immune system of the patient is established);

— pregnancy;

— hypersensitivity to any component of a vaccine, including gelatin.

According to the prospectus for doctors of the Merck Sharp & Dohme company on this drug of the person who in the anamnesis have anaphylactic, anaphylactoid and other reactions of immediate hypersensitivity (for example, urticaria, hypostasis of a mucous membrane of a mouth and throat, breath difficulty, arterial hypotension or shock) connected with the use of eggs have the increased risk of development of reaction of immediate hypersensitivity after introduction of the vaccine containing traces of antigens of a chicken embryo. In similar cases before vaccination it is necessary to estimate carefully a ratio of potential risk and advantage. Such patients should be vaccinated in exceptional cases and in the presence of all medicines necessary in case of allergic reaction.

Overdose:

Exceptional cases of overdose were not followed by serious undesirable reactions.

Storage conditions:

Before dissolution vaccine M-M-P II should be stored at a temperature from 2 °C to 8 °C in the dark place. It is necessary to protect a vaccine from light since the inactivation of viruses is possible. Solvent can be stored in the refrigerator together with the lyophilized vaccine or separately at the room temperature. A vaccine period of validity - 3 years, solvent - 5 years. Not to apply after expiry date. It is recommended to use a vaccine as soon as possible after dissolution; storage in the dark place at a temperature of 2-8 °C no more than 8 h is allowed. When transporting it is necessary for ensuring safety of properties of a vaccine that the vaccine was at a temperature of 10 °C or below. Freezing when transporting does not influence quality of drug.

Issue conditions:

According to the recipe

Packaging:

1 dose - bottles (1) complete with solvent (syringes or bottles) - packs cardboard.
1 dose - bottles (10) complete with solvent (syringes or bottles) - packs cardboard.