Sci-Bi-Vac (Suspension) Instructions for Use

Marketing Authorization Holder

Pharmsintez PJSC (Russia)

Manufactured By

Scivac, Ltd. (Israel)

ATC Code

J07BC01 (Hepatitis B virus purified antigen)

Dosage Form

Sci-Bi-Vac

Suspension for intramuscular administration 10 mcg/1 ml: fl. 1 ml 1 or 25 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration white or white with a grayish tint, homogeneous, upon settling separates into 2 layers: upper layer – colorless transparent liquid; lower layer – white or white with a grayish tint sediment; upon shaking the suspension should easily resuspend.

Excipients* aluminum hydroxide as a 2% aqueous solution – 1500 mcg, sodium chloride – 8450 mcg, potassium chloride – 20 mcg, disodium hydrogen phosphate – 380 mcg, potassium dihydrogen phosphate – 20 mcg, water for injections – 1 ml.

* 10M sodium chloride solution or 6M hydrochloric acid solution – if necessary to achieve pH 7.50±0.05.

1 ml (1 dose) – glass bottles with a capacity of 4 ml (1) – cardboard packs.
1 ml (1 dose) – glass bottles with a capacity of 4 ml (25) – cardboard boxes with dividers.

Clinical-Pharmacological Group

Vaccine for the prevention of hepatitis B

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Hepatitis B vaccine, obtained using recombinant DNA technology in Chinese hamster ovary (CHO) cell culture. The vaccine consists of particles isolated and purified from the culture medium. The particles contain all three antigenic determinants of the hepatitis B surface antigen (HBsAg), namely, the S, Pre-S1, and Pre-S2 proteins, in their glycosylated and non-glycosylated forms, embedded in a phospholipid matrix, thereby mimicking genuine HBsAg viruses from plasma. The antigen is formed by adsorption onto aluminum hydroxide. The vaccine does not contain any known animal viruses, bacteria, or mycoplasmas. Each dose may contain residual amounts of CHO cell proteins (up to 5 ng/dose).

CHO cell DNA (up to 20 pg/dose), bovine serum albumin (up to 5 ng/dose), and formaldehyde (up to 1 mcg/dose) from the manufacturing process.

This vaccine induces antibodies to HBsAg. Antibody concentrations ≥10 mIU/ml against HBsAg are considered to provide protection against infection caused by the hepatitis B virus.

Indications

• Active prevention of infection caused by the hepatitis B virus (HBV) in adults over 18 years of age.

ICD codes

Dosage Regimen

The vaccine is administered intramuscularly into the deltoid muscle.

It is not recommended to administer the vaccine intramuscularly into the gluteal region.

Administration of the drug intravenously is strictly prohibited.

Subcutaneous or intradermal administration of the vaccine is not recommended due to a possible decrease in vaccine efficacy.

The vaccination schedule for all vaccinated individuals consists of three (3) doses of the vaccine according to the following schedule

• First dose at a selected time;
• Second dose 1 month after the first dose;
• Third dose 6 months after the first dose: (0-1-6 months).

The duration of the protective effect of the hepatitis B vaccine is currently unknown.

Adverse Reactions

Blood and lymphatic system disorders uncommon – lymphadenopathy.

Gastrointestinal disorders common – diarrhea, nausea, abdominal pain.

Nervous system disorders very common – headache; common – dizziness.

Musculoskeletal and connective tissue disorders very common – myalgia; uncommon – arthralgia.

Skin and subcutaneous tissue disorders uncommon – urticaria, pruritus; common – rash.

Contraindications

• Hypersensitivity to any component of the vaccine;
• Symptoms of hypersensitivity to a previous administration of hepatitis B vaccine;
• Acute infectious and non-infectious diseases are temporary contraindications for vaccination;
• Age under 18 years (data on efficacy and safety are lacking).

With caution

• Individuals with complicated cardiopulmonary status;
• Individuals with a significant risk of systemic reaction.

Use in Pregnancy and Lactation

The safety of use during pregnancy has not been established. The effect of the vaccine on the fetus and reproductive function has not been studied. Data on use during pregnancy are lacking. The possibility of vaccinating a pregnant woman may be considered only in cases of extremely high risk of infection, when the expected benefit for the mother outweighs the potential risk to the fetus.

Data on use during breastfeeding are lacking. It is unknown whether the vaccine antigen or antibodies pass into breast milk. The possibility of vaccinating a breastfeeding woman may be considered only in cases of extremely high risk of infection. In this case, based on the doctor’s decision and taking into account the benefits of breastfeeding for the child and the benefits of vaccination for the mother, either breastfeeding should be discontinued or vaccination should be refrained from.

Special Precautions

Due to the long incubation period of the hepatitis B virus, early infection of the patient may not be detected at the time of vaccination. In such a case, vaccination may be ineffective against the hepatitis B virus. The vaccine does not prevent the development of infectious diseases associated with other hepatitis viruses – A, C, E, or other infectious liver diseases.

In case of exacerbation of chronic diseases, vaccination is carried out 2-4 weeks after recovery or during convalescence or remission; for mild acute respiratory viral infections or acute intestinal diseases, vaccinations are carried out immediately after temperature normalization.

Vaccination with Sci-Bi-Vac is recommended for the adult population, including those individuals who have or may have an increased risk of hepatitis B virus infection in the future.

During vaccination, medications for emergency care must be available in case the patient develops an anaphylactic reaction.

Effect on ability to drive vehicles and machinery

There is no information regarding the effect of this vaccine on reaction speed when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. However, some of the adverse reactions described above, such as fatigue, headache, dizziness, may temporarily affect the ability to drive a car or operate machinery.

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.