Package leaflet: Information for the user

BioThrax suspension for injection
Anthrax vaccine, adsorbed (purified cell-free filtrate)
Please read all of this leaflet carefully before this vaccine is administered.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or healthcare professional.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or healthcare professional. See section 4.

Contents of the leaflet

What BioThrax is and what it is used for
Important information before receiving BioThrax
How to use BioThrax
Possible side effects
How to store BioThrax
Contents of the pack and other information

1 WHAT BIOTHRAX IS AND WHAT IT IS USED FOR
What is BioThrax?
BioThrax is a vaccine used to prevent infection caused by the bacterium Bacillus anthracis.
What is it used for?
The vaccine is used in adults to prevent anthrax.
Anthrax is an infectious bacterial disease caused by Bacillus anthracis infection and the body's response to this infection. Vaccination with BioThrax prepares the body to fight infection by neutralizing the toxins produced during infection.

2 IMPORTANT INFORMATION BEFORE RECEIVING BIOTHRAX BY INJECTION
When not to use BioThrax vaccine:

If you are allergic to the active substance or to any of the other ingredients of this vaccine (listed in section 6).

Take special care with BioThrax
Tell your doctor if:
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I. You have a compromised immune response due to congenital or acquired immunodeficiency, or
II. You are receiving immunosuppressive therapy;
III. You experienced an allergic reaction after a previous dose of BioThrax vaccine or any of its components;
IV. You have latex allergy or sensitivity, as the vial stopper contains dry natural rubber, which may contain trace amounts of latex proteins.

Children
The safety and efficacy of BioThrax vaccine in children have not been established.

Elderly patients
The safety and efficacy of BioThrax vaccine have not been established in individuals over 65 years of age.

BioThrax and other medicines
Tell your doctor or healthcare professional if you are receiving immunosuppressive therapy, high-dose corticosteroid therapy, or cytotoxic drugs (e.g. chemotherapy).

Use of BioThrax with food and drink
No special restrictions or precautions are required regarding food or drink when receiving doses of BioThrax vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or healthcare professional before receiving any vaccine or medicine. As a precaution, pregnant or breastfeeding women should not be routinely vaccinated with anthrax vaccine.

Driving and using machines
BioThrax has no or negligible effect on the ability to drive or operate machinery. However, some of the side effects listed in section 4 may temporarily affect this ability.

3 HOW TO USE BIOTHRAX
This vaccine has been prescribed for a specific patient and will be administered by a doctor or healthcare professional. A sterile needle and syringe should be used to withdraw a 0.5 ml dose of BioThrax vaccine from the multi-dose vial. The dose will be administered by intramuscular (im.) injection into the upper arm.

Recommended vaccination schedule
To ensure protection, the recommended primary vaccination schedule is 0.5 ml intramuscularly (im.) at months 0, 1, and 6, followed by booster doses every 3 years.

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Missed injection
Contact your doctor or healthcare professional to determine the best course of action. In most cases, continuing the schedule with adjusted injection dates will be sufficient to maintain immunity.

Stopping the injections
If you have any further questions about the use of this product, consult your doctor or healthcare professional.

4 POSSIBLE SIDE EFFECTS
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
If any of the side effects worsen or if you notice any side effects not listed in this leaflet, tell your doctor or healthcare professional. Provide them with information about the symptoms, timing, date of occurrence of side effects, and the date of vaccination. They may use this information to manage your treatment and report the incident as required by law.

Very common (more than 1 in 10)
Pain, tenderness, redness, bruising, itching, swelling, or warmth at the injection site
Limited mobility in the injected arm
Hardening at the injection site
A burning sensation may occur immediately after vaccination and may last about one minute
Muscle pain, fatigue, or headache

Common (less than 1 in 10, or greater than or equal to 1 in 100)
Discomfort in the armpit (axillary lymph node)
Chills, fever, dizziness, insomnia, nausea, or indigestion (dyspepsia)
Cough, nasal/sinus infection, or lower respiratory tract infection
Rash, itching
Joint, back, or neck pain

Uncommon (less than 1 in 100, or greater than or equal to 1 in 1,000)
Numbness/tingling at the injection site
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Influenza-like illness, nasal congestion, shortness of breath, sneezing, shingles ( herpes zoster )
Malaise
Increased heart rate
Joint or muscle stiffness, limb (arm) pain
Eye allergy
Skin redness (including rashes)
Fainting
Upper abdominal pain, vomiting, menstrual cramps (dysmenorrhea)

Rare (less than 1 in 1,000, or greater than or equal to 1 in 10,000)
Severe allergic reaction. Signs of a severe allergic reaction include difficulty breathing, weakness, hoarseness, wheezing, rapid heartbeat, hives, dizziness, paleness, or swelling of the throat, lips, or face.
Invasive breast cancer
Increased intracranial pressure (pseudotumor cerebri)
Narrowing of the canal leading to increased fluid in the brain (aqueductal stenosis)
Rotator cuff injury
Cold sweats

Very rare (less than 1 in 10,000)
Severe, potentially life-threatening allergic reaction (anaphylactic reactions)

Side effects reported after marketing authorization include:
I. Guillain-Barré syndrome (a condition in which the immune system attacks nerves), seizures, brachial neuritis, somnolence
II. Rhabdomyolysis (a condition involving breakdown of muscle cells)
III. Deep skin swelling (angioedema), hair loss (alopecia), eczema, dry skin
IV. Slow heart rate, palpitations
V. Speech difficulties (dysphonia)
VI. Diarrhea, sensation of tight throat (dysphagia)
VII. Enlarged axillary lymph node
VIII. Hives at the injection site

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If you experience any unusual symptoms such as difficulty breathing, weakness, hoarseness, wheezing, rapid heartbeat, hives, dizziness, paleness, or swelling of the throat, lips, or face within minutes after vaccination or within minutes to one hour after injection, inform your doctor or healthcare professional immediately, as this may be a sign of a severe reaction.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects 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.: 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.

Reporting side effects helps to provide more information on the safety of this vaccine.

5 HOW TO STORE BIOTHRAX
Keep this medicine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the label.
Do not use more than 28 days after first opening.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original packaging to protect from light.

6 CONTENTS OF THE PACK AND OTHER INFORMATION
What BioThrax contains
One dose (0.5 ml) contains:

Anthrax antigen from filtrate: 50 micrograms
Adsorbed on hydrated aluminium hydroxide (0.6 mg aluminium per dose)
Benzethonium chloride
Formaldehyde
Sodium chloride
Water for injections

The product is sterile and contains no live or dead bacteria.

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The container of this medicinal product contains latex rubber. It may cause severe allergic reactions.

What BioThrax looks like and contents of the pack
BioThrax is a milky-white suspension (after mixing) contained in a clear glass vial. The vial is closed with a stopper (chlorobutyl) and sealed with an aluminium cap. The product is sterile, and one vial contains enough vaccine for 10 injections of 0.5 ml each.

Marketing Authorization Holder
Emergent Sales and Marketing Germany GmbH
Vichystraße 14
76646 Bruchsal, Germany
Telephone: 0049 7251 32197031
Facsimile: 0049 7251 32197010
e-mail: [email protected]

Manufacturer
Emergent Sales and Marketing Germany GmbH
Vichystr. 14
76646 Bruchsal, Germany
Telephone: 0049 7251 32197031
Facsimile: 0049 7251 32197010
e-mail: [email protected]

For more detailed information, contact the local representative of the marketing authorization holder:
For product quality or safety concerns, please contact:
Emergent BioSolutions, Inc
Telephone: 0049 7251 32197031
Facsimile: 0049 7251 32197010
E-Mail: [email protected]

This medicinal product is authorized for marketing in the European Economic Area (EEA) and in Great Britain (Northern Ireland)
under the following names:
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Germany, the Netherlands, Great Britain (Northern Ireland), Poland, Italy: BioThrax
France: BaciThrax
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