Mastodon

Vaqta® (Suspension) Instructions for Use

ATC Code

J07BC02 (Hepatitis A virus inactivated whole)

Active Substance

Hepatitis A vaccine (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Vaccine for the prevention of hepatitis A

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine is a mixture of inactivated purified virions adsorbed on aluminum hydroxide.

It promotes the formation of immunity against the hepatitis A virus by inducing the production of specific antibodies.

The amount of antibodies that appear after the use of the vaccine is practically no different from the amount of antibodies to the hepatitis A virus in individuals who have had this disease.

In most patients, antibodies circulate in the blood for at least 1 year after the primary vaccination course.

Indications

Prevention of viral hepatitis A in adults and children from 12 months of age.

ICD codes

ICD-10 code Indication
Z24.6 Need for immunization against viral hepatitis
ICD-11 code Indication
QC01.6 Need for immunization against viral hepatitis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the vaccine by intramuscular injection only into the deltoid muscle.

For children and adolescents aged 12 months through 18 years, administer a single 0.5 mL dose.

For adults aged 19 years and older, administer a single 1 mL dose.

Initiate the primary vaccination course with two doses.

Schedule the second dose as a booster 6 to 18 months after the first dose.

Do not administer the vaccine intravenously, subcutaneously, or intradermally.

For patients with a bleeding disorder or thrombocytopenia, administer with caution due to the risk of hematoma; consider subcutaneous administration if necessary, acknowledging a potentially suboptimal immune response.

For individuals who are immunocompromised or receiving immunosuppressive therapy, administer the vaccine as recommended; note that the immune response may be diminished.

For patients with end-stage renal disease, including those on hemodialysis, administer the vaccine as recommended.

Shake the vial or pre-filled syringe well before use to obtain a uniform, white, cloudy suspension.

Inspect the vaccine visually for particulate matter and discoloration prior to administration; do not use if the contents appear discolored or contain particulate matter.

Adverse Reactions

Possible headache, malaise, increased fatigue, fever, nausea, loss of appetite; redness, induration, swelling, pain at the injection site.

Extremely rare anaphylactic and anaphylactoid reactions.

Contraindications

Acute infectious and non-infectious diseases, exacerbations of chronic diseases, immunodeficiency states, malignant blood diseases and neoplasms, hypersensitivity to vaccine components, pregnancy, lactation period (breastfeeding).

Use in Pregnancy and Lactation

Vaccination is not recommended during pregnancy and is possible only in cases of extreme necessity.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Immunization is indicated for patients with chronic liver diseases or an increased risk of liver disease.

Use in Renal Impairment

Immunization is indicated for patients on hemodialysis.

Pediatric Use

In children, the vaccine should be used only in the form of dosage forms specifically intended for them.

Geriatric Use

Can be used according to indications.

Special Precautions

Use with caution in patients with thrombocytopenia and a tendency to hemorrhage, which is associated with an increased risk of hematoma at the injection site.

Do not administer intravenously, subcutaneously, or intradermally.

Patients on hemodialysis and patients with immune disorders require the administration of additional doses of the vaccine.

In children, the vaccine should be used only in the form of dosage forms specifically intended for them.

The correspondence of the hepatitis A vaccine used to the recommended indications should be strictly observed.

Drug Interactions

The vaccine can be administered simultaneously with immunoglobulins provided that different parts of the body are used for the injection of the vaccine and immunoglobulins.

Since this vaccine is inactivated, its combination with other inactivated vaccines does not affect the effectiveness of vaccination, provided that the vaccines are administered in different parts of the body (in particular, with the recombinant vaccine for the prevention of hepatitis B, typhoid vaccine, live vaccine for the prevention of yellow fever).

The vaccine can be used for revaccination even in cases where previous vaccination was carried out with other inactivated vaccines for the prevention of hepatitis A.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Merck Sharp & Dohme, B.V. (Netherlands)

Manufactured By

Merck Sharp & Dohme, Corp. (USA)

Dosage Form

Bottle Rx Icon Vaqta® Suspension for intramuscular administration 25 IU/0.5 ml (1 dose for children and adolescents): fl. 1, 10, 25, or 100 pcs., disposable syringe

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration slightly opalescent; upon settling, it separates into a clear colorless liquid and a white precipitate without flakes and foreign inclusions, which is easily broken up when shaken.

0.5 ml ( 1 dose for children and adolescents)
Hepatitis A virus antigen 25 IU*

Excipients : aluminum (in the form of amorphous aluminum hydroxyphosphate sulfate) – 0.225 mg, sodium borate decahydrate – 0.035 mg, sodium chloride – 4.5 mg, water for injection – 0.5 ml**.

0.5 ml – vials of colorless glass (1) – cardboard packs.
0.5 ml – vials of colorless glass (10) – cardboard packs.
0.5 ml – vials of colorless glass (25) – cardboard packs.
0.5 ml – vials of colorless glass (100) – cardboard packs.
0.5 ml – disposable syringes (1) – blister packs (1) – cardboard packs.

* – one ELISA unit corresponds to 1 ng of hepatitis A virus protein.
** – when filling vials and syringes, an excess of 0.2 ml is added to ensure the extractable volume.

Marketing Authorization Holder

Merck Sharp & Dohme, B.V. (Netherlands)

Manufactured By

Merck Sharp & Dohme, Corp. (USA)

Dosage Form

Bottle Rx Icon Vaqta® Suspension for intramuscular administration 50 IU/1 ml (1 dose for adults): fl. 1, 10, 25 or 100 pcs., disposable syringe

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration slightly opalescent; upon settling, it separates into a clear colorless liquid and a white precipitate without flakes and foreign inclusions, which is easily broken up when shaken.

1 ml (1 dose for adults)
Hepatitis A virus antigen 50 IU*

Excipients : aluminum (in the form of amorphous aluminum hydroxyphosphate sulfate) – 0.45 mg, sodium borate decahydrate – 0.07 mg, sodium chloride – 9 mg, water for injection – 1 ml**.

1 ml – vials of colorless glass (1) – cardboard packs.
1 ml – vials of colorless glass (10) – cardboard packs.
1 ml – vials of colorless glass (25) – cardboard packs.
1 ml – vials of colorless glass (100) – cardboard packs.
1 ml – disposable syringes (1) – blister packs (1) – cardboard packs.

* – one ELISA unit corresponds to 1 ng of hepatitis A virus protein.
** – when filling vials and syringes, an excess of 0.2 ml is added to ensure the extractable volume.

Table of Contents

→ TABLE OF CONTENTS