Biothrax

Package Leaflet: Information for the User

BioThrax Suspension for Injection

Anthrax vaccine, adsorbed (purified cell-free extract)

Read the package leaflet carefully before using the medicine.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1 WHAT IS BIOTHRAX AND WHAT IS IT USED FOR

What is BioThrax?

BioThrax is a vaccine used to prevent infections caused by the bacterium Bacillus anthracis.

What is it used for?

The vaccine is used in adults to prevent the occurrence of anthrax.
Anthrax is an infectious bacterial disease caused by infection with Bacillus anthracisand the body's reaction to this infection. Vaccination with BioThrax prepares the body to fight the infection by blocking the toxins produced during the infection.

2 IMPORTANT INFORMATION BEFORE RECEIVING BIOTHRAX

INJECTION

When not to use BioThrax vaccine:

Special warnings and precautions for use

Tell your doctor if:
I.
the patient has an immune system disorderdue to congenital or acquired immune deficiency or
II.
the patient is receiving immunosuppressive treatment;
III.
the patient has had an allergic reactionafter a previous dose of BioThrax vaccine or any of its components;
IV.
the patient has an allergy or hypersensitivity to latex, as the vial stopper contains a dry mixture of 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

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

BioThrax and other medicines

Tell your doctor or healthcare professional about immunosuppressive treatment or corticosteroid treatment at high doses or the use of cytotoxic drugs (e.g. chemotherapy).

Using BioThrax with food and drink

No special restrictions or precautions are required when taking doses of BioThrax vaccine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or healthcare professional for advice before using any vaccine or medicine. As a precaution, pregnant or breastfeeding women should not be routinely vaccinated against anthrax.

Driving and using machines

BioThrax vaccine has no or negligible influence on the ability to drive and use machines. However, some of the side effects mentioned in section 4 may temporarily affect the ability to drive or use machines.

3 HOW TO USE BIOTHRAX

The vaccine has been prescribed for a specific patient and will be administered by a doctor or healthcare professional. To administer, use a small sterile needle and syringe, draw up a 0.5 ml dose of BioThrax vaccine from the multidose vial. The dose will be administered by intramuscular(im) injection into the upper arm.

Recommended vaccination schedule

To ensure protection, the recommended initial vaccination schedule is 0.5 ml intramuscularly (im) at months 0, 1, and 6, followed by booster doses every 3 years.
Page 2 of 7

Missed injection

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

Discontinuation of injections

If you have any further questions about using this product, ask 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional. They will need information about the symptoms, time, and date of the side effects, as well as the date of vaccination. They can then use this information to treat you and report the incident as required by law.
Very common (more than 1 in 10)
Pain, redness, swelling, itching, or warmth at the injection site
Limited mobility in the injected arm
Induration at the injection site
A burning sensation may occur immediately after injection and may last for about a 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 area (axillary lymph node)
Chills, fever, dizziness, insomnia, nausea, or indigestion (dyspepsia)
Cough, infection of the nasal passages/sinuses or respiratory tract at another level
Rash, itching
Joint pain, back pain, or neck pain
Uncommon (less than 1 in 100, or greater than or equal to 1 in 1000)
Numbness/tingling at the injection site
Flu-like illness, respiratory congestion, shortness of breath, sneezing, shingles (herpes zoster)
Malaise
High heart rate
Stiffness of joints or muscles, arm pain (limb pain)
Allergic reaction in the eye area
Redness of the skin (including rash)
Fainting
Abdominal pain, vomiting, menstrual cramps (dysmenorrhea)
Rare (less than 1 in 1000, or greater than or equal to 1 in 10000)
Severe allergic reaction. Signs of a severe allergic reaction include difficulty breathing, weakness, hoarseness or wheezing, rapid heartbeat, hives, dizziness, paleness, or swelling of the throat, lips, or face).
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 10000)
Severe, potentially life-threatening allergic reaction (anaphylactic reactions)

Side effects reported after marketing authorization

I.
Guillain-Barré syndrome (a disorder in which the immune system attacks the nerves), seizures, brachial neuritis, somnolence
II.
Rhabdomyolysis (a condition in which muscle cells break down)
III.
Deep vein thrombosis, alopecia, eczema, dry skin
IV.
Low heart rate, palpitations
V.
Speech difficulties (dysphonia)
VI.
Diarrhea, feeling of a constricted throat (dysphagia)
VII.
Enlarged axillary lymph node
VIII.
Hives at the injection site
Page 4 of 7
If you experience any unusual symptoms, such as difficulty breathing, weakness, hoarseness, or wheezing, rapid heartbeat, hives, dizziness, paleness, or swelling of the throat, lips, or face within a few minutes of vaccination or within a few minutes to an hour after injection, inform your doctor or healthcare professional immediately, as this may be a sign of a severe reaction.
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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 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 BIOTHRAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label.
Do not use for more than 28 days after first opening.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package to protect from light.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What BioThrax contains

One dose (0.5 ml) contains:

• Anthrax antigen from cell-free extract: 50 micrograms
• Adsorbed on aluminum hydroxide, hydrated (0.6 mg aluminum per dose)
• Benzethonium chloride
• Formaldehyde
• Sodium chloride
• Water for injections The product is sterile and does not contain any living or dead bacteria.

Page 5 of 7
The container of this medicinal product contains latex. 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 aluminum cap.
The product is sterile, and one vial contains enough vaccine for 10 injections of 0.5 ml.

Marketing Authorization Holder

Emergent Sales and Marketing Germany GmbH
Vichystraße 14
76646 Bruchsal, Germany
Phone: 0049 7251 32197031
Fax: 0049 7251 32197010
e-mail: medicalinformation@ebsi.com

Manufacturer

Emergent Sales and Marketing Germany GmbH
Vichystr. 14
76646 Bruchsal, Germany
Phone: 0049 7251 32197031
Fax: 0049 7251 32197010
e-mail: medicalinformation@ebsi.com
To obtain more detailed information, please contact your local representative of the marketing authorization holder:
For questions about the quality or safety of products, please contact:
Emergent BioSolutions, Inc
Phone: 0049 7251 32197031
Fax: 0049 7251 32197010
E-Mail: medicalinformation@ebsi.com

This medicinal product is authorized in the Member States of the

European

Economic Area (EEA) and in the United Kingdom (Northern Ireland) under the following names:

Page 6 of 7
Germany, Netherlands, United Kingdom (Northern Ireland), Poland, Italy: BioThrax
France: BaciThrax
Date of last revision of the leaflet:
Page 7 of 7