Dultavax

Package Leaflet: Information for the User

DULTAVAX,suspension for injection
Tetanus, diphtheria and poliomyelitis (inactivated) vaccine, adsorbed, with reduced antigen content

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed specifically for you. Do not pass it on to others.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is DULTAVAX and what is it used for
• 2. Important information before using DULTAVAX vaccine
• 3. How to use DULTAVAX vaccine
• 4. Possible side effects
• 5. How to store DULTAVAX vaccine
• 6. Package contents and other information

1. What is DULTAVAX and what is it used for

DULTAVAX (Td-IPV) is a combined vaccine for booster vaccination in children from the age of 6 years, adolescents and adults to prevent tetanus, diphtheria and poliomyelitis simultaneously.
DULTAVAX should not be used for primary vaccination against tetanus, diphtheria and poliomyelitis.
DULTAVAX should be administered in accordance with official recommendations.

2. Important information before using DULTAVAX vaccine

When not to use DULTAVAX vaccine:

• if you have a fever or other acute illness, vaccination should be postponed,
• if you are allergic (hypersensitive) to any of the vaccine components listed in section 6 or to neomycin, streptomycin or polymyxin B (present in trace amounts),
• if you have had severe allergic reactions or neurological disorders after previous administration of tetanus and diphtheria vaccine or poliomyelitis vaccine.

Warnings and precautions

When to exercise special caution when using DULTAVAX vaccine:

• if you have received tetanus or diphtheria vaccine in the last 5 years,
• in case of impaired immune system or if you are receiving treatment with corticosteroids, cytotoxic drugs, radiation therapy or any other treatment that may weaken the immune system. Your doctor may postpone vaccination until the end of treatment,
• if you have had Guillain-Barré syndrome (unusual sensitivity, weakness) or brachial neuropathy (weakness, diffuse arm or shoulder pain) after previous administration of tetanus toxoid-containing vaccine, the decision to administer the vaccine again will be assessed by your doctor,
• if you have bleeding disorders such as thrombocytopenia or coagulation disorders, as there is a risk of bleeding during intramuscular administration.

Fainting can occur after, or even before, any needle injection. Therefore, you should inform your doctor or nurse if you have fainted during previous injections.

DULTAVAX vaccine and other medicines

This vaccine can be used at the same time as other vaccines, but they should be administered at different injection sites, such as the other arm or leg.
Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to use.

Pregnancy and breastfeeding

Pregnancy

This vaccine is not recommended for pregnant women.

Breastfeeding

Breastfeeding is not a contraindication to vaccination.
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice before using this vaccine.

Driving and using machines

It is unlikely that the vaccine will affect your ability to drive or use machines. However, no studies have been conducted in this regard.
Do not drive or use machines if you experience dizziness after receiving the vaccine. Dizziness has been reported after vaccination.

DULTAVAX vaccine contains phenylalanine, sodium, potassium and ethanol.

• DULTAVAX vaccine contains 10 micrograms of phenylalanine per 0.5 ml dose, which corresponds to 0.17 micrograms/kg for a person weighing 60 kg. Phenylalanine may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body because the body cannot remove it properly.
• DULTAVAX vaccine contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, i.e. the vaccine is considered "potassium-free" and "sodium-free".
• DULTAVAX vaccine contains 2 milligrams of alcohol (ethanol) per 0.5 ml dose. The small amount of alcohol in this vaccine will not cause any noticeable effects.

3. How to use DULTAVAX vaccine

Dosage

Children from the age of 6 years, adolescents and adults will receive one injection (0.5 ml dose).

Method of administration

The vaccine should be administered intramuscularly. The recommended injection site is the deltoid muscle.
The vaccine must not be administered subcutaneously, intradermally or intravenously.

4. Possible side effects

Like all medicines, the vaccine can cause side effects, although not everybody gets them.

Severe allergic reactions

Severe allergic reactions, although rare, can occur after vaccination. These reactions may include:

• Facial swelling (facial edema), sudden swelling of the face and neck (angioedema, Quincke's edema).
• Sudden and severe malaise with a drop in blood pressure causing dizziness and loss of consciousness, rapid heartbeat with accompanying respiratory disorders (anaphylactic reaction and shock). These symptoms usually occur immediately after vaccination when the person is still in the clinic or doctor's office. If any of these symptoms occur after leaving the vaccination site, contact your doctor immediately.

Other side effects

Very common (affect more than 1 in 10 people):

• Local reactions at the injection site: pain, redness, induration (area of hard skin) and swelling. These reactions usually occur within the first 48 hours after vaccination and resolve on their own within 1 to 2 days, without requiring treatment.

Common (affect less than 1 in 10 people but more than 1 in 100 people):

• Dizziness, headache
• Nausea, vomiting
• Fever

Uncommon (affect less than 1 in 100 people but more than 1 in 1,000 people):

• Enlarged lymph nodes
• Muscle pain
• Malaise

Rare (affect less than 1 in 1,000 people but more than 1 in 10,000 people):

• Joint pain

Frequency not known:

• Seizures
• Guillain-Barré syndrome (unusual sensitivity, weakness)
• Brachial neuropathy (weakness, diffuse arm or shoulder pain)
• Transient paresthesia (tingling) or transient numbness (loss of sensation) in the arm where the vaccine was administered
• Vasovagal syncope (loss of consciousness)
• Low blood pressure
• Abdominal pain, diarrhea
• Allergic-type reactions such as various rashes (eruptions), itching (pruritus), hives (urticaria)
• Pain in the limb where the vaccine was administered
• Aseptic abscess (uninfected)
• Fatigue, flu-like symptoms, pallor, chills
• Large reaction at the injection site (> 50 mm), including limb swelling. This reaction may be accompanied by redness, warmth or pain at the injection site. These reactions occur within 24 to 72 hours after vaccination and resolve on their own within 3 to 5 days.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the vaccine.

5. How to store DULTAVAX vaccine

Store the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the packaging after EXP.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
Medicines should 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. Package contents and other information

What DULTAVAX contains

• Active substances are: One 0.5 ml dose contains: Diphtheria toxoid ……………………………………………………. not less than 2 IU Tetanus toxoid …………………………………………………… not less than 20 IU Inactivated poliomyelitis virus Type 1 (Mahoney strain)* ……………………………………………. 29 antigen units D Type 2 (MEF-1 strain)* ……………………………………………… 7 antigen units D Type 3 (Saukett strain)*…………………………………………….. 26 antigen units D adsorbed on hydrated aluminum hydroxide …………………................. 0.35 mg (Al ) these antigen amounts are exactly the same as previously expressed as 40-8-32 antigen units D, respectively for virus type 1, 2 and 3, measured by another suitable immunochemical method * grown in Vero cells
• Other ingredients are: Phenoxylethanol, anhydrous ethanol, formaldehyde, acetic acid (for pH adjustment), sodium hydroxide (for pH adjustment), Hanks' 199 medium (a mixture containing amino acids, including phenylalanine, mineral salts, vitamins, polysorbate 80, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and other substances) and water for injections.

What DULTAVAX looks like and contents of the pack

DULTAVAX is available as a suspension for injection in 0.5 ml pre-filled syringe with needle – pack of 1 or 10, and with 1 or 2 separate needles – pack of 1 or 10.

Marketing authorization holder

Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon, France

Manufacturer

Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon, France
Sanofi-Aventis Zrt.
Building DC5
Campona utca 1.
Budapest, 1225
Hungary
Date of last revision of the leaflet: May 2023
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Information intended for healthcare professionals only

Method of administration

Regarding pre-filled syringes without attached needles, a separate needle must be firmly attached to the pre-filled syringe by rotating it a quarter turn.