Vaqta 50
Poland
Table of Contents
Package leaflet: Information for the user
VAQTA 50, 50 U hepatitis A virus, strain CR326F/1 ml, suspension for injection
Vaccinum hepatitidis A inactivatum adsorbatum
Hepatitis A virus vaccine, inactivated, adsorbed.
For adults.
Please read all of this leaflet carefully before the vaccine is administered because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This vaccine has been prescribed for a specific individual. Do not pass it on to others. The vaccine may harm others, even if their symptoms of illness are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of the leaflet
- What VAQTA 50 vaccine is and what it is used for
- Important information before using VAQTA 50 vaccine
- How to use VAQTA 50 vaccine
- Possible side effects
- How to store VAQTA 50 vaccine
- Contents of the pack and other information
1. What VAQTA 50 vaccine is and what it is used for
The vaccine is indicated for active immunisation against infections caused by the hepatitis A virus. The vaccine is recommended for healthy adults aged 18 years and older who are at risk of infection or transmission of the disease, and in whom infection may be a life-threatening factor (e.g. individuals infected with human immunodeficiency virus (HIV) and individuals diagnosed with hepatitis C virus infection).
2. Important information before using VAQTA 50 vaccine
When not to use VAQTA 50 vaccine
- if the patient is allergic to the active substance or to any of the other ingredients of this vaccine (listed in section 6).
Warnings and precautions
Inform your doctor about any past or current illnesses and allergies.
Inform your doctor if you are pregnant or planning to become pregnant.
Since hepatitis A virus (HAV) infection may develop asymptomatically for a long time, it is possible that the vaccinated person is already infected. In such individuals, the vaccine may not prevent hepatitis A.
The container closure contains latex rubber which may cause severe allergic reactions.
VAQTA 50 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
VAQTA 50 vaccine can be administered simultaneously with yellow fever vaccine and typhoid fever vaccine.
Although data in individuals aged 18 years and older are not available, studies in children aged 12 to 23 months have shown that VAQTA may be given concurrently with measles, mumps, rubella, varicella vaccines, 7-valent conjugated pneumococcal vaccine, and inactivated poliovirus vaccine. Immunogenicity data are insufficient to confirm the possibility of simultaneous administration of VAQTA 50 with DTaP (diphtheria, tetanus, acellular pertussis vaccine).
Data on interactions with vaccines other than yellow fever and typhoid fever vaccines are not yet available; however, when vaccines are administered at separate injection sites, interactions with other vaccines are not expected.
If concomitant administration is necessary, VAQTA 50 must not be mixed in the same syringe with other vaccines and other vaccines should be administered at different sites.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before receiving this vaccine.
Pregnancy
It is not known whether VAQTA 50 vaccine administered to a pregnant woman may cause fetal harm. VAQTA 50 vaccine should be given to pregnant women only when clearly needed and when, in the opinion of the physician, the benefits outweigh the potential risks to the fetus.
Breastfeeding
Inform your doctor if you are breastfeeding. VAQTA 50 vaccine should be given to breastfeeding women only when clearly needed.
Driving and operating machinery
There is no information suggesting that the vaccine affects the ability to drive or operate machinery.
VAQTA 50 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. this medicine is considered "sodium-free".
3. How to use VAQTA 50 vaccine
The VAQTA 50 vaccine should always be used as directed by a physician or pharmacist.
If in doubt, consult a physician or pharmacist.
Primary dose
Adults aged 18 years and older should receive one dose of 1 ml (50 U) of the vaccine at the scheduled time.
Booster dose
Adults who received the primary dose at age 18 or older should receive a booster dose of the vaccine, also 1 ml (50 U), between 6 and 18 months after administration of the first dose.
Antibodies against hepatitis A virus (HAV) persist for at least 6 years after administration of the second dose (i.e. the booster dose). The duration of antibody persistence is expected to be at least 25 years.
The vaccine may be administered as a booster dose at 6–12 months after primary vaccination with another inactivated hepatitis A vaccine.
Missed administration of VAQTA 50 vaccine
If the booster dose is not administered at the recommended time, the decision on further management should be made by the physician.
Adults infected with human immunodeficiency virus (HIV)
Adults infected with HIV should receive one dose of 1 ml (50 U) of the vaccine at the scheduled time, followed by a booster dose, also 1 ml (50 U), 6 months after the first dose.
The vaccine should be administered INTRAMUSCULARLY into the deltoid muscle.
In individuals with bleeding disorders in whom intramuscular injection may pose a risk of hemorrhage (e.g. in patients with hemophilia), the vaccine may be administered subcutaneously.
The vaccine must not be administered intradermally, as this may result in a lower immunological response than expected.
The vaccine must not be administered intravenously.
4. Possible adverse reactions
Like any medicine, the VAQTA 50 vaccine may cause adverse reactions, although they do not
occur in everyone.
The vaccine is generally well tolerated.
The frequency of adverse reactions is categorized according to the following classification:
- Very common (occurring in 1 or more out of 10 vaccinated individuals);
- Common (occurring in 1 or more out of 100 and less than 1 out of 10 vaccinated individuals);
- Uncommon (occurring in 1 or more out of 1,000 and less than 1 out of 100 vaccinated individuals);
- Rare (occurring in 1 or more out of 10,000 and less than 1 out of 1,000 vaccinated individuals);
- Very rare (occurring in less than 1 out of 10,000 vaccinated individuals, including single cases).
Clinical trial data
Infections and infestations:
Uncommon: pharyngitis, upper respiratory tract infections.
Rare: bronchitis, infectious gastroenteritis.
Blood and lymphatic system disorders:
Uncommon: generalized lymphadenopathy.
Metabolism and nutrition disorders:
Rare: anorexia.
Psychiatric disorders:
Rare: apathy, insomnia.
Nervous system disorders:
Common: headache.
Uncommon: central dizziness, paresthesia (spontaneously occurring sensory sensations).
Rare: somnolence, migraine, tremor.
Eye disorders:
Rare: eye pruritus, photophobia, lacrimation.
Ear and labyrinth disorders:
Uncommon: ear pain.
Rare: labyrinthine vertigo.
Vascular disorders:
Rare: hot flushes with flushing.
Respiratory, thoracic and mediastinal disorders:
Uncommon: respiratory hyperemia, nasal hyperemia, cough.
Rare: throat swelling, sinusitis.
Gastrointestinal disorders:
Uncommon: nausea, diarrhea, flatulence, vomiting.
Rare: dry mouth, oral ulceration.
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, urticaria, erythema.
Rare: night sweats, rash, skin lesions.
Musculoskeletal and connective tissue disorders:
Common: pain in the arm (injected limb).
Uncommon: myalgia, stiffness, shoulder pain, musculoskeletal pain, back pain,
arthralgia, leg pain, neck pain, muscle weakness.
Rare: muscle cramp, elbow pain, hip pain, jaw pain, spasm.
Reproductive system and breast disorders:
Rare: menstrual disorders.
General disorders and administration site conditions:
Very common: tenderness at injection site, pain, warmth sensation, swelling, erythema.
Common: asthenia/fatigue, fever (≥38.3°C measured orally), petechiae at injection site, pain/soreness.
Uncommon: pruritus at injection site, stiffness/tension, pain, hematoma at injection site, chills, abdominal pain, malaise, induration and numbness at injection site, feeling cold, influenza-like symptoms.
Rare: burning sensation at injection site, induration (≤2.5 cm), muscle twitching, rash, abdominal distension, chest pain, flank pain, irritability.
As with any vaccine, allergic reactions may occur, which in rare cases may lead to anaphylactic shock.
Adverse reactions reported after marketing authorization
Nervous system disorders:
Very rare: Guillain-Barré syndrome (muscle weakness, abnormal sensation, tingling of arms, legs and upper body).
Blood and lymphatic system disorders:
Very rare: thrombocytopenia.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the vaccine.
5. How to store VAQTA 50 vaccine
Store in a refrigerator (2°C - 8°C).
DO NOT FREEZE.
Keep the medicine out of the sight and reach of children.
Do not use VAQTA 50 vaccine after the expiry date stated on the packaging
following: EXP.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.
6. Contents of the pack and other information
What VAQTA 50 vaccine contains
One dose of vaccine (1 ml) contains:
- The active substance of the vaccine: Hepatitis A virus, strain CR326F (inactivated) ……………50 U
Propagated in human diploid fibroblast cell culture (MRC-5).
Adsorbed onto amorphous aluminium hydroxymonosulphophosphate (0.45 mg Al).
Units defined according to the manufacturer's internal method – Merck Sharp & Dohme LLC.
- Other components: sodium tetraborate, sodium chloride, water for injections.
What VAQTA 50 vaccine looks like and contents of the pack
Available pack sizes:
1 vial containing 1 ml, in a cardboard carton.
10 vials containing 1 ml each, in a cardboard carton.
1 pre-filled syringe containing 1 ml, in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MSD Polska Sp. z o.o.
ul. Chłodna 51
00-867 Warsaw
Poland
Tel: +48 22 549 51 00
Email: [email protected]
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands