Dultavax

Package leaflet: Information for the user

DULTAVAX, suspension for injection
Diphtheria, tetanus and poliomyelitis (inactivated) adsorbed vaccine, with reduced
antigen content
Please read all of this leaflet carefully before the vaccine is administered, because it contains important information for you.

• 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 for a specific individual. Do not pass it on to others.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What DULTAVAX is and what it is used for
2. What you need to know before receiving DULTAVAX
3. How to use DULTAVAX
4. Possible side effects
5. How to store DULTAVAX
6. Contents of the pack and other information

1. What DULTAVAX is and what it is used for

DULTAVAX (Td-IPV) is a combination vaccine intended for booster vaccination in children from the age of 6 years, adolescents and adults, to provide simultaneous protection against diphtheria, tetanus and poliomyelitis.
DULTAVAX should not be used for primary vaccination against diphtheria, tetanus and poliomyelitis.
DULTAVAX should be administered according to official recommendations.

2. Important information before administration of the DULTAVAX vaccine

When not to use DULTAVAX:

• if an acute illness with or without fever is present, vaccination should be postponed,
• if there is an allergy (hypersensitivity) to any of the components of the vaccine listed in section 6, or to neomycin, streptomycin, or polymyxin B (present in trace amounts),
• if severe allergic reactions or neurological disorders occurred after previous administration of diphtheria and tetanus vaccine or poliomyelitis vaccine.

Warnings and precautions
When to exercise special caution when administering DULTAVAX:

• if a diphtheria or tetanus vaccine has been administered within the past 5 years,
• in case of impaired immune system or if the person is receiving treatment with corticosteroids, cytotoxic drugs, radiotherapy, or any other treatment that may weaken the immune system. The physician may postpone vaccination until completion of treatment,
• if after previous administration of a vaccine containing tetanus toxoid (tetanus vaccine) Guillain-Barré syndrome (unusual sensitivity, paralysis) or brachial plexus neuropathy (paralysis, diffuse pain in the arm or shoulder) occurred, the decision on re-administration of any vaccine containing tetanus toxoid will be evaluated by the physician,
• if blood disorders such as low platelet count (thrombocytopenia) or coagulation disorders are present, because there is a risk of bleeding during intramuscular injection.

Fainting may occur after, or even before, any needle injection. Therefore, you should
inform the doctor or nurse if the patient has previously experienced fainting during
injections.
DULTAVAX and other medicines
This vaccine may be administered simultaneously with other vaccines, but they should be
administered at two separate injection sites, such as the other arm or leg.
You should tell your doctor or pharmacist about all medicines currently taken or recently taken by the patient, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
Pregnancy
This vaccine is not recommended for pregnant women.
Breastfeeding
Breastfeeding is not a contraindication to vaccination.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before administration of this vaccine.
Driving and operating machinery
It is unlikely that the vaccine affects the ability to drive or operate machinery. However, no studies have been conducted in this regard.
Nevertheless, driving and operating machinery should be avoided if dizziness occurs after receiving the vaccine. Dizziness has been reported after vaccination.
DULTAVAX contains phenylalanine, sodium, potassium, and ethanol.

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

3. How to administer the DULTAVAX vaccine

Dosage
Children from the age of 6 years, adolescents and adults should receive a single injection (dose of 0.5 ml).
Method of administration
The vaccine should be administered intramuscularly. The recommended site of administration is the deltoid muscle.
The vaccine must not be administered intradermally, subcutaneously or intravenously.

4. Possible adverse reactions

Like all medicines, this vaccine may cause adverse reactions, although not everyone experiences them.

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

• Swelling of the face (facial swelling), sudden swelling of the face and neck (angioedema, Quincke's edema).
• Sudden and serious illness with low blood pressure causing dizziness and loss of consciousness, rapid heartbeat accompanied by respiratory disturbances (anaphylactic reaction and shock). These symptoms usually occur immediately after vaccination, while the person is still at the clinic or medical facility. If any of these symptoms occur after leaving the vaccination site, medical help must be sought IMMEDIATELY.

Other adverse reactions
Very common (affects more than 1 in 10 people):

• Local reactions at the injection site: pain, redness, induration (area of hardened skin), and swelling. These reactions usually occur within the first 48 hours after vaccination and last 1 to 2 days; they do not require treatment.

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

• Dizziness, headache
• Nausea, vomiting
• Fever

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

• Swollen lymph nodes
• Muscle pain
• Malaise

Rare (affects 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 plexus neuropathy (weakness, diffuse pain in the arm and shoulder)
• Transient paresthesia (tingling) or transient hypoesthesia (loss of sensation) in the arm where the vaccine was administered
• Vasovagal syncope (fainting)
• Low blood pressure
• Abdominal pain, diarrhea
• Allergy-like symptoms such as various types of rashes (skin eruptions), itching, urticaria (rash associated with itching)
• Pain in the limb where the vaccine was administered
• Aseptic abscess (non-infectious)
• Fatigue, flu-like symptoms, pallor, chills
• Large local reaction (> 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 spontaneously within 3 to 5 days.

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 of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 the Dultavax vaccine

Keep the vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the packaging following EXP.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
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 DULTAVAX contains

• The active substances are: One 0.5 ml dose contains:
  Diphtheria toxoid ……………………………………………………. not less than 2 I.U.
  Tetanus toxoid ……………………………………………………… not less than 20 I.U.
  Inactivated poliovirus (Sabin strain)
  Type 1 (Mahoney strain)* ……………………………………………. 29 antigen D units
  Type 2 (MEF-1 strain)* ………………………………………………… 7 antigen D units
  Type 3 (Saukett strain)* ……………………………………………… 26 antigen D units
  adsorbed on aluminium hydroxide, hydrated …………………................. 0.35 mg (Al)
  These antigen amounts are exactly equivalent to the previously stated 40-8-32 antigen D units, respectively for type 1, 2 and 3 viruses, measured by another appropriate immunochemical method.
  * propagated in Vero cells

• Other components are:
  Phenoxyethanol, 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 0.5 ml suspension for injection in a pre-filled syringe with needle – pack of 1 or 10, and with 1 or 2 separate needles – pack of 1 or 10.

Marketing Authorisation 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

Information intended exclusively for medical professionals

Method of administration
For prefilled syringes without attached needles, a separate needle must be securely attached to the prefilled syringe by turning it a quarter turn.