Menjugate (Lyophilisate) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Trading, JSC (Russia)

Manufactured By

GSK Vaccines, GmbH (Germany)

Manufactured By

GlaxoSmithKline Vaccines, S.r.l. (Italy)

ATC Code

J07AH (Meningococcal vaccines)

Active Substance

Meningococcal group C conjugate vaccine (Ph.Eur.)

Dosage Form

Menjugate

Lyophilisate for the preparation of suspension for intramuscular administration: fl.

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of a suspension for intramuscular administration white in color.

Excipients: sodium dihydrogen phosphate monohydrate 0.092 mg, sodium hydrogen phosphate heptahydrate 0.48 mg, mannitol 7.3 mg.

Solvent composition: aluminum hydroxide 1.2 mg, sodium chloride 4.2 mg, water for injections up to 0.6 ml.

Vials (1) in a kit with a syringe with solvent (1 pc.) and needles (2 pcs) – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of diseases caused by meningococci

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Standardized serological parameters correlating with the achievement of a protective immune response for conjugated meningococcal group C vaccines are absent.

Data from clinical studies on double vaccination of infants in the first year of life comparing the administration schedule at 2, 3, and 4 months and the administration schedule at 2 and 4 months conducted in 241 children showed that 1 month after completion of the primary vaccination, serum bactericidal antibodies at a titer of 1:8 and higher were detected in 100% and 98% of vaccinated individuals, respectively.

The immune response developing after administration of the Menjugate vaccine in young children, children, and adolescents is superior to that when using polysaccharide meningococcal vaccines and is comparable to the immune response in adults.

Unlike non-conjugated meningococcal polysaccharide vaccines, Menjugate induces the formation of immunological memory. The duration of protective immunity has not been established.

Indications

• Specific prophylaxis of meningococcal group C infection caused by Neisseria meningitidis in children from 2 months of age, adolescents, and adults.

ICD codes

Dosage Regimen

A single dose is 0.5 ml for all ages.

The lyophilisate must be dissolved with the solvent (0.6 ml) supplied in the package immediately before use. Before administration, the solution must be gently shaken. After dissolution: an opaque whitish suspension without foreign inclusions. The dissolved vaccine must not be stored and must be used immediately.

Before dissolution, the syringe containing the solvent with aluminum hydroxide should be shaken gently. The syringe tip is removed and replaced with an appropriate needle. The full volume of the solution (0.6 ml) is withdrawn from the syringe and used to dissolve the vaccine lyophilisate in the vial.

The vial with the solution is gently shaken until the vaccine is completely dissolved (which ensures binding of the antigen to the adjuvant). Using a second needle of suitable diameter, the dissolved vaccine is drawn into the syringe.

The drug is administered intramuscularly into the deltoid muscle, or into the anterolateral part of the thigh in young children.

Menjugate should not be mixed in the same syringe with other vaccines.

The vaccine must not be administered intravenously or subcutaneously.

Primary vaccination

For children from 2 to 12 months inclusive, the vaccine is administered twice with a 2-month interval. For children over 12 months, adolescents, and adults, the vaccine is administered once.

Revaccination

For children who received the vaccination course in the first year of life, a single revaccination is carried out if necessary no earlier than 1 year after completion of the vaccination course.

Adverse Reactions

When assessing the adverse effects of the drug, the following frequency criteria were used: very common (≥10%), common (from 1% to 10%), occasional (from 0.1% to 1%), rare (from 0.01% to 0.1%), very rare (< 0.01%, including isolated cases).

Adverse reactions were recorded daily for 6 days.

Adverse effects noted in all age groups, identified during clinical studies.

Local and systemic reactions

Very common: reactions at the injection site (redness, swelling, induration, and pain).

Common: body temperature increase above 38°C (100.4°F).

Adverse effects noted in infants (first year of life) and children under 2 years.

Gastrointestinal disorders

Very common: diarrhea and anorexia, vomiting (in children under 1 year).

Common: vomiting (in children under 2 years).

General reactions

Very common: irritability, drowsiness, sleep disorders.

Common: crying.

Adverse effects noted in older children and adults

General and systemic reactions

Very common: malaise, headache (in younger schoolchildren).
Common: headache (in older schoolchildren).

Gastrointestinal disorders

Very common: nausea (in adults).

Musculoskeletal system disorders

Very common: myalgia and arthralgia.

Adverse effects noted during post-marketing studies (in all age groups).

The most common reactions were: dizziness, fever, headache, nausea, vomiting, and fainting.

The frequency of adverse effects provided below is based on summarized data obtained from the report on spontaneous adverse effects when using Menjugate and other meningococcal vaccines.

Nervous system disorders.

Very rare: dizziness, seizures including febrile seizures, fainting, hypersensitivity, hypotension.

Isolated reports of seizure development after vaccination with Menjugate have been received. Reports of seizures were received during vaccination of children with existing epilepsy. In infants, seizures were usually associated with fever, most likely febrile seizures.

In very rare cases, after vaccination with the meningococcal group C conjugate vaccine, the development of visual disturbances and photophobia has been reported. As a rule, such adverse reactions were associated with other neurological symptoms, such as headache and dizziness.

Respiratory system disorders: apnea in premature infants (gestation less than 28 weeks).

Gastrointestinal disorders

Very rare: nausea, vomiting, and diarrhea.

Skin manifestations

Very rare: rash, urticaria, itching, purpura, exudative multiforme erythema, Stevens-Johnson syndrome.

Disorders of muscular, connective tissues, and skeletal system

Very rare: lymphadenopathy, hypersensitivity reactions, including bronchospasm, facial edema, angioedema, anaphylactic shock.

A report was received of a relapse of nephrotic syndrome associated with vaccination with the conjugate vaccine against meningococcal group C infection.

Contraindications

• Hypersensitivity to any component of the vaccine, including diphtheria toxoid;
• Hypersensitivity reactions to previous administration of Menjugate.

Immunization with the Menjugate vaccine should be postponed in patients with acute infectious and non-infectious diseases or exacerbation of chronic diseases until complete recovery.

Use in Pregnancy and Lactation

Pregnancy

Data on the use of the Menjugate vaccine in pregnant women are absent. A study in rabbits with administration of the Menjugate vaccine at various stages of pregnancy did not reveal any risk to the fetus. Taking into account the severity of meningococcal group C infection, it is not recommended to postpone vaccination in cases where there is a high risk of infection with this infection.

Lactation

Information on the safety of using the Menjugate vaccine during breastfeeding is absent. To make a decision on vaccination during the lactation period, it is necessary to determine the ratio of the benefit from vaccination and the possible risk of infection.

Pediatric Use

The vaccine is used in children from 2 months of age and adolescents.

Special Precautions

Menjugate does not protect against diseases of meningococcal etiology caused by other serogroups of meningococci (A, B, 29-E, H, I, K, L, W₁₃₅ , X, Y, or Z, including non-typable).

Data on the possibility of using this vaccine to control an epidemic outbreak of meningococcal infection during post-exposure prophylaxis are absent.

In individuals suffering from humoral immunity deficiency, vaccination may not ensure the development of sufficient protective immunity. HIV infection is not a contraindication for immunization, but a special study of the effectiveness of Menjugate in individuals with immunodeficiencies has not been conducted. In individuals suffering from complement system deficiency and individuals with functional or anatomical asplenia, the degree of protection and effectiveness have not been established.

The protein CRM₁₉₇ included in the Menjugate vaccine does not replace vaccination against diphtheria. Therefore, the administration schedules for vaccines containing diphtheria toxoid should not be altered.

Acute infectious and non-infectious diseases are grounds to postpone vaccination with Menjugate, except in cases where, in the opinion of the attending physician, a delay in vaccination entails a much higher health risk. As a rule, minor health disorders without an increase in body temperature, such as mild upper respiratory tract infections, are not a contraindication to vaccination.

During primary immunization of premature infants (gestation less than 28 weeks) and children with previously observed respiratory complications, the potential risk of apnea and the need for respiratory monitoring for 48-72 hours after vaccination should be taken into account. When deciding on vaccination in these cases, the possible risk and benefit must be assessed.

The use of the Menjugate vaccine in individuals with thrombocytopenia or bleeding disorders has not been specifically studied. When deciding on intramuscular vaccination of individuals at risk of bleeding, the possible risk and benefit must be assessed.

Parents or guardians must be informed about the immunization schedule used for this vaccine, advised on the possibility of using antipyretic drugs, and emphasized the need to report the development of any adverse reactions.

The syringe cap contains 10% natural rubber and although in this case the risk of developing an allergic reaction to latex is very small, physicians administering the vaccination should assess the risk before vaccinating individuals with existing hypersensitivity to latex.

Drug Interactions

Administration of Menjugate simultaneously with the following vaccines (in different body sites) does not reduce the immune response to any of the listed antigens:

• Poliomyelitis vaccine (inactivated or live);
• Diphtheria and tetanus toxoids and DTP vaccine (whole-cell or acellular);
• Haemophilus influenzae type b (Hib) conjugate vaccine;
• Hepatitis B vaccine (mono or associated);
• Combined measles-mumps-rubella vaccines and corresponding monovaccines;
• 7-valent pneumococcal conjugate vaccine;
• Hexavalent vaccine (DTP-Hepatitis B-Polio-Hib).

Storage Conditions

Store in a light-protected place at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Transport at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.