Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about TachoSil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine.
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you having TachoSil against the benefits they expect it will have for you.
If you have any concerns about receiving this medicine, ask your doctor.
Keep this leaflet.
You may need to read it again.

What TachoSil is used for

This medicine is used during surgery to stop local bleeding (haemostasis).
This medicine contains the two active ingredients fibrinogen and human thrombin, which are proteins normally found in the blood.
When the sponge comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the human thrombin are activated and form a fibrin network.
This means that the sponge sticks to the tissue surface, the blood coagulates and the tissue is sealed.
In the body, TachoSil will dissolve and disappear completely.
Ask your doctor if you have any questions about why this medicine has been recommended for you.
Your doctor may have prescribed it for another reason.
There is not enough information to recommend the use of this medicine for children under the age of 18 years.

Before you receive TachoSil

When you must not have it

• any medicine containing fibrinogen or human thrombin

• any of the ingredients listed at the end of this leaflet.

• shortness of breath

• wheezing or difficulty breathing

• swelling of the face, lips, tongue or other parts of the body

• rash, itching or hives on the skin.

Before you start to have it

Taking other medicines

How TachoSil is given

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
The surgeon treating you will administer TachoSil during surgery.
The sponge will be placed on the internal organ to stop the bleeding.
The sponge will disappear and dissolve completely over time.

How much will be given

After you have received TachoSil

Things you must do

Side effects

Tell your doctor as soon as possible if you do not feel well after you have been given TachoSil.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor to answer any questions you may have.
Tell your doctor as soon as possible if you notice any of the following:

• fever

• changes in the way your heart beats.

• shortness of breath, wheezing or difficulty breathing

• swelling of the face, lips, tongue or other parts of the body

• rash, itching or hives on the skin

• fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain

• pain in your abdomen or bowels

Product description and storage

Storage

What it looks like

• 1 sponge of 9.5 cm x 4.8 cm

• 2 sponges of 4.8 cm x 4.8 cm

• 1 sponge of 3.0 cm x 2.5 cm

• 5 sponges of 3.0 cm x 2.5 cm

Ingredients

• collagen

• albumin

• riboflavine

• sodium chloride

• sodium citrate dihydrate

• arginine hydrochloride.

Manufacturer and Supplier

1 Name of Medicine

Fibrinogen and human thrombin.

2 Qualitative and Quantitative Composition

Each TachoSil sponge contains approximately 5.5 mg of fibrinogen and 2.0 IU of human thrombin per cm² as the active ingredients.
Other inactive ingredients include riboflavine, collagen, albumin, sodium chloride, sodium citrate dihydrate and arginine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

TachoSil is a biodegradable, highly flexible, hygroscopic surgical medicated sponge. The active side of the sponge, which is coated with fibrinogen and human thrombin, is marked by a yellow colour.
TachoSil is available in three presentations, which differ in the size of the sponge, but not in the composition of the sponge and the coating (see Section 6.5 Nature and Contents of Container).

4 Clinical Particulars

4.9 Overdose

No case of overdose has been reported.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Studies to determine the genotoxicity of TachoSil have not been performed.
Carcinogenicity. Long-term animal studies to evaluate the carcinogenic potential of TachoSil have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Fibrinogen is a soluble plasma glycoprotein with a molecular weight of approximately 340 kDa, and circulates in plasma as a precursor of fibrin. The native molecule is a homo-dimer, in which both subunits consist of three different polypeptide chains (Aα, Bβ, and γ). All three polypeptide chains of the subunits as well as the dimer are linked with disulfide bonds. Thrombin is a serine protease with a molecular weight of approximately 39 kDa and consists of 295 amino acids. It is formed by two peptide chains of 36 and 259 amino acids respectively, linked by disulfide bonds.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

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