Clodivac

Package Leaflet: Information for the User

Clodivac,suspension for injection
Vaccine against diphtheria and tetanus, adsorbed, with reduced antigen content
Not less than 40 IU of tetanus toxoid and not less than 5 IU of diphtheria toxoid/0.5 ml;
1 dose (0.5 ml)

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

• Keep this package 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Clodivac vaccine and what is it used for
• 2. Important information before using Clodivac vaccine
• 3. How to use Clodivac vaccine
• 4. Possible side effects
• 5. How to store Clodivac vaccine
• 6. Contents of the pack and other information

1. What is Clodivac vaccine and what is it used for

Clodivac is a vaccine that protects against two diseases: tetanus and diphtheria (caused by tetanus and diphtheria bacteria). The active substances of the vaccine are tetanus and diphtheria toxoids (non-infectious components derived from bacteria). After administration of the vaccine, the body produces antibodies that protect against the disease.
The vaccine is used for active immunization of children who have completed their 7th year of life, adolescents, and adults against tetanus and diphtheria.
Primary vaccination

• persons who have completed their 7th year of life and have not received primary vaccination against diphtheria and tetanus (i.e., mandatory vaccination according to the Immunization Program).

Booster vaccination

• children who have completed their 7th year of life and have not received a booster dose of DTPa at 6 years of age (in case of contraindications to pertussis vaccination),
• adolescents at 14 and 19 years of age,
• adults who have received a complete primary vaccination cycle against tetanus and diphtheria (booster dose every 10 years).

Vaccination against tetanus in injured persons
Clodivac vaccine may be administered in case of injury, according to the Immunization Program.
Adequate protection against infection is achieved after administration of all vaccine doses, according to the Immunization Program, which contains information about these vaccinations.
Study results have confirmed both the safety and high efficacy of Clodivac vaccine.

2. Important information before using Clodivac vaccine

When not to use Clodivac vaccine:

If there are any contraindications to vaccination with Clodivac vaccine, the doctor should assess the risk of administering the vaccine in relation to the risk of infection.

Warnings and precautions

Before starting to use Clodivac vaccine, discuss it with your doctor or nurse if you have experienced any side effects or other worrying reactions after the previous dose of the vaccine.
Vaccination should be preceded by a medical examination and interview about the patient's general health and previously performed and recorded vaccinations. This approach allows for predicting the risk of side effects after vaccine administration.

For safety reasons, after vaccination, you should remain under medical observation for 30 minutes.

Clodivac vaccine and other medicines

Clodivac vaccine can be administered at the same time as other vaccines, if this is indicated by the Immunization Program, and with immunoglobulins, if necessary.
Different vaccines and immunoglobulins administered at the same time should be injected into different parts of the body using separate syringes and needles.
In patients undergoing immunosuppressive therapy (inhibiting the activity of the immune system) or with immune deficiencies, the response to the vaccine may be reduced.
In such cases, the doctor may decide to postpone vaccinations until the end of therapy and determine the level of antibodies after vaccination.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Guidelines for recommended vaccinations for pregnant women are presented in the Immunization Program.
Breastfeeding is not a contraindication to vaccination.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this vaccine.

Driving and using machines

The vaccine has no influence or negligible influence on the ability to drive and use machines.

3. How to use Clodivac vaccine

Clodivac vaccine will be administered by a nurse or doctor deep subcutaneously. The vaccine should never be administered intravenously.

Dosing in primary and booster vaccination

Primary vaccination
Primary vaccination consists of three doses of the vaccine:

• two doses of the vaccine at an interval of 4 weeks (primary vaccination)
• a third dose of the vaccine after 6-12 months from the administration of the second dose (booster vaccination).

Booster vaccination
One dose of the vaccine:

• children who have completed their 7th year of life and have not received a booster dose of DTPa at 6 years of age (in case of contraindications to pertussis vaccination)
• adolescents at 14 years of age (second booster dose)
• adolescents at 19 years of age (third booster dose)
• adults with completed primary vaccination, every 10 years.

Dosing in case of injury

In case of injury, the doctor decides on the administration of the vaccine and the dosing regimen.
Detailed information can be found at the end of the package leaflet in the section "Information intended exclusively for healthcare professionals."

Dosing during pregnancy

Guidelines for recommended vaccinations are presented in the Immunization Program.

Administration of a higher dose of Clodivac vaccine than recommended

Overdose is unlikely, as the packaging is single-dose.
In case of doubt, consult a doctor.

Discontinuation of Clodivac vaccine

In case of any further doubts about the use of this vaccine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

Very common (occurring in more than 1 in 10 patients):

general side effects: fever, feeling unwell
local side effects: reaction, pain

Frequency not known (frequency cannot be estimated from the available data):

• decreased platelet count, which increases the risk of bleeding and bruising
• enlargement, tenderness of local lymph nodes
• allergy symptoms (including generalized or localized rash, itching, facial swelling, and laryngeal spasm) up to anaphylactic shock
• central and peripheral nervous system disorders
• headache, dizziness
• non-febrile seizures
• fainting, loss of consciousness, decreased muscle tone
• weakness of the limb into which the vaccine was administered, which may be a sign of paralysis or brachial plexus inflammation
• Guillain-Barré syndrome (polyneuritis that may manifest as sensory disturbance, weakness, and paralysis of limbs)
• gastrointestinal disorders (nausea, vomiting, abdominal pain),
• limited mobility, pain, swelling, and warmth of the joint of the limb into which the vaccine was administered
• muscle pain
• renal failure
• general reaction: fever, chills, excessive sweating, malaise. These symptoms occur very rarely and usually resolve within 24-48 hours
• local reaction: redness, painful swelling, and itching at the injection site. A pruritic lymphatic infiltrate may also appear. Such reactions occur most frequently in persons vaccinated multiple times. Subcutaneous nodules - granulomas may develop, which sometimes transform into aseptic abscesses (1:100,000). Granulomas that do not resolve within 6 weeks may be a sign of hypersensitivity to aluminum.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301, fax: 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 this medicine.

5. How to store Clodivac vaccine

Store upright, in a refrigerator (2°C - 8°C).
Do not freeze; if frozen, the vaccine should be discarded.
Store ampoules in the outer packaging to protect from light.
Store the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
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. Contents of the pack and other information

What Clodivac vaccine contains

The active substances of the vaccine are:
Tetanus toxoid
not less than 40 IU
Diphtheria toxoid
not less than 5 IU
adsorbed on hydrated aluminum hydroxide
not more than 0.5 milligrams of Al
The other ingredients of the vaccine are: sodium chloride and water for injections.

What Clodivac vaccine looks like and contents of the pack

After shaking, the vaccine is a white or almost white, homogeneous suspension in glass ampoules.
During storage, a white sediment forms at the bottom of the ampoule, and a clear supernatant (liquid) above it.
The pack contains 1 or 15 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Instytut Biotechnologii Surowic i Szczepionek BIOMED Spółka Akcyjna
Al. Sosnowa 8
30-224 Kraków
tel.: +48 12 37 69 200
e-mail: informacjanaukowa@biomed.pl
Date of last revision of the package leaflet:
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Information intended exclusively for healthcare professionals

Administration of Clodivac vaccine

Before use, shake the vaccine to obtain a homogeneous suspension.
Visually inspect the vaccine for any foreign particles or changes in appearance. If any changes are observed, do not use the vaccine.
Measure the dose of 0.5 ml and administer deep subcutaneously.
The recommended injection site is the deltoid muscle.
Do not administer intravenously!
Make sure the needle is not inserted into a blood vessel.
Note: Due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room should be equipped with a standard emergency kit.
If there are contraindications to administration of the diphtheria vaccine, only the tetanus vaccine (T) should be administered.
Clodivac vaccine may be administered in case of injury - guidelines for specific tetanus prevention in injured persons are presented in the Immunization Program.
To improve the identifiability of biological medicinal products, clearly record the name and batch number of the administered product.