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Key Safety Information

Contraindications:

HAVRIX may not be administered to persons with a known hypersensitivity to a component of the vaccine, or to those who have shown signs of hypersensitivity during a previous administration of HAVRIX.

Special warnings and precautions:

As in the case of other vaccines, HAVRIX will not be administered to patients with an acute febrile illness. A common infection does not constitute a contra-indication, however. HAVRIX may contain traces of neomycin. The vaccine will have to be used with caution in patients with a known hypersensitivity to this antibiotic. As with every product administered parenterally, it is recommended to prepare an appropriate medical treatment for immediate use, if an anaphylactic reaction were to occur. HAVRIX may be administered with persons who are HIV positive.

Undesirable Effects:

Very Common - Irritability, drowsiness, headache, pain and redness at injection site

For the use only of Registered Medical Practitioners or a Hospital or a Laboratory

Abbreviated Prescribing information of HAVRIX 1440 (ADULT) / 720 (JUNIOR)

Inactivated Hepatitis A Vaccine (Adsorbed) IP

ACTIVE INGREDIENT: HAVRIX1440: Each dose (1 ml) contains: Hepatitis A virus antigen (HAV) HM 175 strain, 1440 ELISA units (ELU); Aluminium (as aluminium hydroxide) 0.5 mg. HAVRIX720: Each dose (0.5 ml) contains: Hepatitis A virus antigen (HAV) HM 175 strain, 720 ELISA units (ELU); Aluminium (as aluminium hydroxide) 0.25 mg.

INDICATION: For active immunisation against infections caused by hepatitis A virus (HAV) for Children and Adolescents (from 1 year up to and including 18 years of age) and adults (from age 19 years and onwards). The booster dose may be given at any time between 6 months and 5 years, but preferably between 6 and 12 months after the primary dose.

DOSAGE AND ADMINISTRATION: Primary vaccination- Adults from age 19 years and onwards: A single dose of HAVRIX 1440 Adult (1.0 mL suspension) is used for primary immunisation. - Children and adolescents from 1 year up to and including 18 years of age: A single dose of HAVRIX 720 Junior (0.5 mL suspension) is used for primary immunisation. Booster vaccination- After primary vaccination with either HAVRIX 1440 Adult or HAVRIX 720 Junior, a booster dose is recommended in order to ensure long term protection. This booster dose should be given at any time between 6 months and 5 years, but preferably between 6 and 12 months after the primary dose. Method of Administration- HAVRIX must be injected intramuscularly only. It is recommended to inject the vaccine in the deltoid region in adults and in children. The deltoid muscle is not yet sufficiently developed in very young children, so the vaccine should be administered in the anterolateral part of the thigh. The injection must not be administered in the gluteal region subcutaneously or intradermally because the antibody response might be sub-optimal. However, the vaccine should be administered subcutaneously in patients suffering from thrombocytopoenia or subject to serious haemorrhage (e.g. haemophiliacs) because bleeding could occur after intramuscular administration in such persons. Strong pressure should be exercised at the site of the injection (without rubbing) for at least 2 minutes. The vaccine may never be administered intravascularly.

CONTRA-INDICATIONS: HAVRIX may not be administered to persons with a known hypersensitivity to a component of the vaccine or to those who have shown signs of hypersensitivity during a previous administration of HAVRIX.

SPECIAL WARNINGS and SPECIAL PRECAUTIONS: As in the case of other vaccines, HAVRIX will not be administered to patients with an acute febrile illness. A common infection does not constitute a contra-indication, however. People may already be in the incubation period of hepatitis A at the time of vaccination. In such circumstances, it is not certain that HAVRIX will prevent hepatitis A.

In patients undergoing haemodialysis and in subjects with a deficient immune system, the anti-HAV (hepatitis A virus) may remain insufficient after a primo-vaccination; in such patients, additional doses of the vaccine may have to be administered to attain an adequate antibody count. HAVRIX may contain traces of neomycin. The vaccine will have to be used with caution in patients with a known hypersensitivity to this antibiotic. As with every product administered parenterally, it is recommended to prepare an appropriate medical treatment for immediate use, if an anaphylactic reaction were to occur after the administration of the vaccine. For this reason, the vaccinated persons should remain under medical supervision for half an hour after vaccination. Syncope (fainting) can occur after any vaccination, or even before with adolescents in particular, as a psychogenic reaction to injection. This can be accompanied by several neurological signs such as a transient disturbance in vision, paraesthesia and tonic clonic movements of the limbs during the recovery phase. It is important that caution be set up to avoid injuries in the event of fainting. HAVRIX may be administered with persons who are HIV positive. Vaccination is not justified in subjects with anti-hepatitis A IgG.

This vaccine contains less than 1 mmol of sodium (23 mg) per dose, it is therefore essentially ‘sodium-free’. This vaccine contains potassium, less than 1 mmol (39 mg) per dose, it is therefore essentially ‘potassium-free’.

ADVERSE EFFECTS:

Clinical Trials: Frequencies, per dose, are defined as follows: Very common: ≥ 1/10, Common: ≥ 1/100 to < 1/10, Uncommon: ≥1/1000 to < 1/100, Rare: ≥1/10000 to < 1/1000, Very rare: < 1/10000.

Undesirable effects reported with HAVRIX Junior 720

Infections and infestations Uncommon: rhinitis. Metabolism and nutrition disorders Common: loss of appetite. Psychiatric disorders Very common: irritability. Nervous system disorders Common: drowsiness, headaches Very rare: neuritis, including Guillain-Barré syndrome and transverse myelitis. Gastrointestinal disorders_Common: nausea Uncommon: diarrhoea, vomiting Skin and subcutaneous tissue disorders Uncommon: rash General disorders and administrative site conditions Very common: pain and redness at injection site Common: swelling, malaise, fever (> 37.5°C) Uncommon: reaction at the injection site (induration)

Undesirable effects reported with HAVRIX 1440

Infections and infestations: Uncommon: upper respiratory tract infection, rhinitis Metabolism and nutrition disorders: Common: loss of appetite Nervous system disorders: Very common: headaches Uncommon: dizziness Rare: hypoaesthesia, paraesthesia Very rare: neuritis, including Guiliain-Barré syndrome and transverse myelitis. Gastrointestinal disorders: Common: gastrointestinal syndromes, diarrhoea, nausea Uncommon: vomiting Skin and subcutaneous tissue disorders Rare: pruritis Musculoskeletal and systemic disorders: Uncommon: myalgia, musculoskeletal stiffness General disorders and administrative site conditions: Very common: pain and redness at injection site, fatigue Common: swelling, malaise, fever (>37.5°C), reaction at the injection site (induration) Uncommon: influenza like illness Rare: shivering

Post-marketing surveillance

Immune system disorders: Anaphylactic reactions, allergic reactions, including anaphylactoid reactions and serum sickness like disease. Nervous system disorders: Convulsions Vascular disorders: Vasculitis Skin and subcutaneous tissue disorders: Angioneurotic oedema, urticaria, erythema multiforme Musculoskeletal and connective tissue disorders: Arthralgia

Version: HAX/API/IN/2025/02 v02 dated 03 Jul 2025

Registered medical practitioners can refer company website http://india-pharma.gsk.com/en-in/products/prescribing-information/ for full Product Information.

Please report adverse events with any GSK product to the company at india.pharmacovigilance@gsk.com

For the use only of a registered medical practitioner or a hospital or a laboratory. Trademarks are owned by or licensed to the GSK group of companies. Refer to full prescribing information before use. Registered medical practitioners can refer company website: india-pharma.gsk.com/en-in/products/prescribing-information/ for Full Product Information. Please report adverse events with any GSK product to the company at india.pharmacovigilance@gsk.com. ©2026 GSK group of companies or its licensor. For more information, please contact: GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Worli, Mumbai – 400030 (India).