Composition, form of production and packaging
Lyophilized powder for injection 1 dose
live attenuated viruses, including:
standard measles virus (USA) 1000 TID 50 *
standard mumps virus (USA) 5000 TID 50 *
standard rubella viruses (USA) 1000 TID 50 *
Excipients: neomycin (25 Ојg per dose), sorbitol, sucrose, human albumin, calf embryo serum, gelatin hydrolyzed, sodium chloride, sodium phosphate.
The drug does not contain preservatives.
1 dose - vials (1) complete with a solvent (syringes or vials) - packs of cardboard.
1 dose - bottles (10) complete with a solvent (syringes or vials) - packs of cardboard.
The viruses that make up the vaccine are identical to the viruses used to produce Attenuvax (live measles vaccine, MSD), Mumpsvax (live mumps vaccine, MSD), Meruvax II (live rubella vaccine, MSD).
Attenuvax (live measles vaccine, MSD), a more attenuated line of measles virus, derived from an attenuated (Enders) strain of Edmonston and grown in a chick embryo cell culture.
Mumpsvax (live mumps vaccine, MSD), the Jeryl Lynn strain (level B) of mumps virus grown in chick embryo cells;
Meruvax II (live rubella vaccine, MSD), strain Wistar RA 27/3 of a live attenuated rubella virus grown in diploid cells of human pulmonary fibroblasts (WI-38).
* - TID 50 - a dose that infects 50% of cell cultures.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2005.
PHARMACHOLOGIC EFFECT
Vaccine for the prevention of rubella, measles and mumps. MMP II has high immunogenic properties.
A single injection of the vaccine causes 95% of susceptible patients to develop measles antibodies that inhibit haemagglutination, 96% have parotitic neutralizing antibodies, and 99% have anti-rubella virus antibodies that inhibit haemagglutination.
Rubella virus RA 27/3, which is part of MM-P II, determines immediately after vaccination higher titers of inhibiting hemagglutination, complement-binding and neutralizing antibodies than other strains of the rubella vaccine. It is shown that it causes the appearance of a wider range of circulating antibodies, including anti-theta and anti-iota precipitating antibodies. Rubella virus RA 27/3 immunologically simulates natural infection more than other vaccine rubella viruses. The increased level and wider spectrum of antibodies, the appearance of which is induced by the vaccine strain of the rubella virus RA 27/3, correlate with a greater resistance to subclinical reinfection with a natural virus, and with greater reliability provide long-term immunity.
Vaccination conducted by the MM-P II vaccine ensures that the level of antibodies in the patient's blood is maintained for more than 11 years.
Immunization of women of childbearing age who do not have rubella immunity protects them from rubella in pregnancy, which in turn prevents infection of the fetus and the development of lesions caused by congenital rubella.
INDICATIONS
- Conduct simultaneous vaccination of children aged 1 year and older against measles, mumps and rubella;
- immunization of children not older than 1 year who are not susceptible to rubella and who are not sick with rubella;
- immunization of women of childbearing age who do not have immunity against rubella;
-vaccination of people from high-risk groups (including students, medical workers, military personnel).
DOSING MODE
The vaccine is administered sc, preferably in the area of ​​the outer surface of the upper third of the shoulder in a dose of 0.5 ml. The dose of the vaccine is the same for patients of any age.
In children less than 15 months of age, there may be no response to the measles component of the vaccine due to the presence of a residual amount of circulating measles antibodies received from the mother, with the smaller the age of the child, the lower the likelihood of seroconversion. In geographically isolated or other inaccessible populations for which immunization programs are difficult to implement, as well as in population groups that are at high risk of being infected by the measles virus of children under the age of 15 months, a vaccine can be administered earlier. If vaccination is performed before the age of 12 months, then the booster should be given at the age of 15 months.
Rules for the preparation and administration of vaccine solutions
For injection and / or dissolution of the vaccine, a sterile syringe containing no preservatives, antiseptic and detergents should be used, as they can inactivate the live viral vaccine. Use only the vaccine supplied with the vaccine (sterile water for injection), because it does not contain preservatives and antiviral substances that can inactivate the vaccine.
Before administration, the drug should be carefully inspected for suspended particles and discoloration. Dissolved vaccine M-M-P II should be transparent and have a yellow color.
For each patient it is necessary to use separate sterile syringes and needles. It is important to follow the rules of asepsis and the proper storage of the vaccine before and after its dissolution and subsequent use.
To use M-M-P II in a vial containing 1 dose, it is necessary to completely add the solvent to a sterile syringe, introduce all the solvent into the vial of the lyophilized vaccine and mix thoroughly. Type the entire contents of the vial into the syringe and completely enter the s / c.
The vaccine and solvent do not contain preservatives, so the potential for contamination should be avoided and special precautions should be taken to ensure the sterility of the preparation. It is recommended that the vaccine be used as soon as possible after dissolution.
SIDE EFFECT
When using the MM-P II vaccine, the same adverse reactions were observed as when monovalent or combination vaccines were administered.
Local reactions: often - rapid burning and / or soreness at the injection site; rarely - erythema, denseness and sensitivity of the skin.
Dermatological reactions: rarely - a rash (usually minor, but sometimes generalized, occurs between 5 and 12 days).
From the digestive system: rarely - mumps, nausea, vomiting, diarrhea.
From the hemopoietic system: rarely - thrombocytopenia, thrombocytopenic purpura.
From the side of the lymphatic system: rarely - regional lymphadenopathy.
Allergic reactions: rarely skin reactions such as blisters or hyperemia at the injection site, anaphylactic and anaphylactoid reactions, angioedema (including peripheral edema and edema of the face), bronchospasm, urticaria.
From the musculoskeletal system: rarely - arthralgia and / or arthritis (usually transient, in some cases, chronic), myalgia.
When vaccinating children, reactions from the joints are not typical and usually short-lived. The incidence of arthritis in women is usually higher than in children and is 12-20% and 0-3%, respectively, and the reactions are generally more pronounced and prolonged.
Articular syndrome in women tends to more severe and prolonged course, the symptoms can persist for several months, and in rare cases - even for years. In adolescent girls, the frequency of reactions from the joints is higher than in children, but lower than in adult women. Even in older women (35-45 years), these reactions are usually well tolerated and do not affect normal vital activity.
From the side of the central nervous system and the peripheral nervous system: rarely - febrile seizures in children, convulsions not associated with fever, headache, dizziness, irritability, paresthesia, polyneuritis, polyneuropathy, Guillain-Barre syndrome, ataxia, subacute sclerosing encephalitis, various variants of neuritis of the optic Nerve, including retrobulbar rhinitis, papillitis; paralysis of the eye nerves, deafness associated with neuritis.
Single cases of encephalitis / encephalopathy with a frequency of 1 per 3 million doses are described. In no case has the actual association of these reactions with vaccination been proved. The risk of developing such serious neurological disorders after the introduction of live measles vaccine remains significantly lower than the risk of encephalitis and encephalopathy in measles (1 in 2,000 reported cases).
From the sense organs: rarely - otitis media, conjunctivitis.
From the respiratory system: rarely - pneumonia, cough, rhinitis.
On the part of the reproductive system: rarely - orchitis.
Other: rarely - fever (38.8 В° C or more, usually occurs between 5 and 12 days), sore throat, malaise, mitigated measles, syncope.
Very rarely reported deaths from various and in some cases unknown causes after the introduction of the vaccine against measles, mumps and rubella, but the relationship with vaccination has not been established. When observing a wide clinical application involving 1.5 million children and adults vaccinated with M-M-R II during 1982-1993, there are no reports of fatalities or long-term complications.
CONTRAINDICATIONS
-anafilactic or anaphylactoid reactions to neomycin in the anamnesis;
-anaphylactic or anaphylactoid reactions to eggs in the anamnesis;
-theft of the respiratory system, accompanied by fever;
- Acute infections accompanied by fever;
-cured tuberculosis in the active phase;
-cancerous diseases of the blood and lymphatic system, other malignant tumors affecting the bone marrow;
Primary and secondary immunodeficiencies (including AIDS or other clinical manifestations of HIV infection); violation of cellular immunity;hypogammaglobulinemia or disgammaglobulinemia;
-implementation of immunosuppressive therapy (with the exception of substitution therapy with corticosteroids, for example, about Addison's disease);
- the presence of congenital or hereditary immunodeficiency in a family history (until the state of the patient's immune system is established);
-pregnancy;
-increased sensitivity to any component of the vaccine, including gelatin.
In accordance with the prospectus for Merck Sharp & Dohme doctors for this drug, people who have anamnestic anaphylactic, anaphylactoid and other immediate-type hypersensitivity reactions (eg urticaria, mucous membrane swelling of the mouth and pharynx, difficulty breathing, hypotension or shock) , associated with the use of eggs, have an increased risk of developing an immediate type of hypersensitivity reaction after administration of a vaccine containing traces of chicken embryo antigens. In such cases, before vaccination it is necessary to carefully evaluate the ratio of potential risks and benefits. Such patients should be vaccinated in exceptional cases and in the presence of all medicines needed in the event of an allergic reaction.
PREGNANCY AND LACTATION
The MM-P II vaccine is contraindicated in pregnancy.
It is not known whether the MM-P II vaccine can have a damaging effect on the fetus in the case of a pregnant woman's vaccination.
However, in case of unintentional vaccination during pregnancy or pregnancy within 3 months after vaccination, it should be borne in mind that in a 10-year study, more than 700 pregnant women vaccinated against rubella for 3 months before or after conception (189 of them received the strain Wistar RA 27/3), none of the newborns showed congenital defects characteristic of congenital rubella syndrome. With parotitis infection in the first trimester of pregnancy, an increased risk of spontaneous abortion is possible. It is shown that the mumps vaccine virus can infect the placenta and fetus, but there is no evidence that it can cause congenital malformations in humans. There are reports that a natural infection of measles during pregnancy increases the risk to the fetus. An increase in the frequency of spontaneous abortions, stillbirths, birth defects and premature birth was observed in cases of measles during pregnancy. Adequate studies of the attenuated vaccine strain of measles virus in pregnant women have not been conducted. However, the assumption that the vaccine strain of the virus is also capable of damaging the fetus is justified.
Caution should be given to the MM-P II lactating mother during lactation. It is not known whether vaccine viruses of measles and mumps are excreted in breast milk.Recent studies have shown that when immunizing women during lactation with a live attenuated rubella vaccine, the virus can be detected in breast milk and transmitted to the newborn. Cases of severe disease in neonates with serological signs of rubella infection were not found, but one child developed a typical acquired rubella of a mild course.
Women of childbearing age are recommended to be protected from pregnancy within 3 months after vaccination. They should be informed about the possibility of frequent occurrence of transient arthralgias and / or arthritis in 2-4 weeks after vaccination. Conducting serological tests to determine susceptibility to rubella followed by vaccination of seronegative patients is desirable, but not mandatory.
It is believed that in many cases it is justified to vaccinate women susceptible to rubella, immediately after childbirth.
APPLICATION FOR CHILDREN
In children less than 15 months of age, there may be no response to the measles component of the vaccine due to the presence of a residual amount of circulating measles antibodies received from the mother, with the smaller the age of the child, the lower the likelihood of seroconversion. In geographically isolated or other inaccessible populations for which immunization programs are difficult to implement, as well as in population groups that are at high risk of being infected by the measles virus of children under the age of 15 months, a vaccine can be administered earlier. If vaccination is performed before the age of 12 months, then the booster should be given at the age of 15 months.
SPECIAL INSTRUCTIONS
The vaccine is not given IV.
Given the possibility of anaphylactic and anaphylactoid reactions, the necessary medications, including epinephrine for injection (1: 1000), should be prepared before the introduction of the vaccine.
There is evidence that in children immunized at the age of 1 year, re-vaccination at a later date does not always lead to a prolonged retention of antibodies, so the benefits of early immunization should be correlated with the possibility of an inadequate response to a re-inoculation.
Vaccination of people in contact with a measles patient can provide some protection if the vaccine is introduced within the first 72 hours after contact. If the vaccine was introduced a few days before infection, then in this case a high preventive effect will be achieved. Convincing data on the preventive effect of vaccination of persons in contact with patients with mumps and rubella are absent.
There have been reports that cases of encephalitis, pneumonia and deaths have developed in patients with severe impairment of immunity after the random introduction of measles vaccine as a result of disseminated infection caused by the vaccine virus.
With extreme caution, vaccination should be given to patients who have a history of seizures (including relatives), brain tissue damage, and any other conditions in which body temperature should be avoided.
Patients with thrombocytopenia after vaccination may develop more severe thrombocytopenia. In addition, in patients with thrombocytopenia after the first vaccination with M-M-P II (or a vaccine included in its composition), thrombocytopenia may develop with the administration of subsequent doses. In the latter case, an assessment of specific immunity should be made to determine the need for a re-vaccination. In such cases, before vaccination it is necessary to carefully evaluate the ratio of potential risks and benefits.
Children and adolescents infected with human immunodeficiency virus, but without obvious clinical signs of immunosuppression, can be vaccinated. In such cases, vaccination may be less effective than in uninfected persons.
M-M-R II should be given 1 month before or 1 month after the introduction of other vaccines.
In most patients, within 7-28 days after vaccination, small amounts of live attenuated rubella virus from the nose and pharynx were noted. The possibility of transmission of the virus in this way from vaccinated to other people has not been proven. With close personal contact, this possibility should theoretically be taken into account, however, its risk is insignificant.
There are no reports on transmission of live attenuated measles or mumps virus from vaccinated to susceptible persons.
There are reports that live measles, mumps and rubella vaccines administered separately may lead to a temporary decrease in skin sensitivity to tuberculin. Therefore, if necessary, tuberculin samples should be taken before or simultaneously with the MM-P II vaccine.
Children who are receiving TB treatment, there was no worsening of the disease after the introduction of a live vaccine against measles. Reports of research on the effects of live measles vaccine for untreated tuberculosis in children are absent.
Arthralgia and / or arthritis (usually transient and rarely chronic), and polyneuritis are characteristic of natural rubella and can vary in frequency and severity, depending on age and sex, being most pronounced in adult women and the least - in children in prepubertal age. When natural rubella chronic arthritis may occur related to the persistence of the virus and / or viral antigen excreted from the body tissue. The vaccinated persons chronic symptoms of the joints is rare.
Investigation of wide clinical use for more than 200 Mill. Doses of M-M and M-R-M-R II worldwide for over 25 years (1971-1996) suggests that reports of serious adverse events such as encephalitis and encephalopathy They remain rare. cases of subacute sclerosing panencephalitis have been described (SSPE) in children without a history of measles, but received measles vaccine. Some of them cause disease may have been unrecognized measles in the first year of life or measles vaccination. Given the estimated incidence of measles vaccination, the potential risk of SSPE at its carrying out is about 1 case per 1 million. Doses of the vaccine. This is significantly less than with measles - 6-22 cases of SSPE per million cases of measles. It is believed that measles vaccination in general warns SSPE,reducing the incidence of measles in which the high risk of this complication.
There are rare reports of the occurrence of panniculitis after the introduction of the measles vaccine.
Vaccination should be carried out 2 weeks before or 3 months after the administration of human immunoglobulin, as well as blood or plasma transfusions.
As with any other vaccine, MM-P II does not provide protection against the disease in 100% of vaccinated.
Note that each dose dissolved MM-P II vaccine contains about 25 ug neomycin.
Use in Pediatrics
The safety and efficacy of measles vaccine in children under the age of 6 months has not been established. The safety and effectiveness of vaccines against mumps and rubella in children under 1 year has not been established.
OVERDOSE
Rare cases of overdose are not accompanied by serious adverse reactions.
DRUG INTERACTION
Simultaneous administration of M-M-R II and immunoglobulins may impair the expected immune response.
M-M-R II used simultaneously with the immunization against chickenpox and Haemophilus influenzae B infection conducted different syringes at different sites. Thus it was not detected violations immune response to antigens administered, and the nature, frequency and severity of adverse reactions were similar to those when administered monotherapies.
The massive use of DTP and / or live polio vaccine simultaneously with vaccines against measles, mumps and rubella is not recommended due to limited data on the outcome of the combined application of these antigens.
However, these published studies relating to the simultaneous administration of commercial polyvalent vaccines (e.g., DTP, OPV, M-M-R vaccine against Haemophilus influenzae type B infections and hepatitis B vaccine) do not indicate any interaction therebetween.
TERMS AND CONDITIONS OF STORAGE
Before dissolving vaccine M-M-R II must be stored at a temperature of from 2 В° to 8 В° C in a dark place. It is necessary to protect the vaccine from light, becauseinactivation of the virus is possible. The solvent can be refrigerated with the lyophilized vaccine or separately at room temperature. The shelf life of the vaccine - 3 years, solvent - 5 years. Do not use after the expiration date.
It is recommended to use the vaccine as soon as possible after the dissolution; It is stored in the dark at 2-8 В° C no more than 8 hours.
To ensure the safety of the vaccine when transporting properties necessary that the vaccine is at a temperature of 10 В° C or lower. Freezing during shipment will not affect the quality of the drug.
Conditions of leave from pharmacies
Vaccine prescription.
