Package leaflet: Information for the user

TFX, 10 mg, powder and solvent for solution for injection
Thymostimulinum
Please read all of this leaflet before using this medicine because it contains important
information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Table of contents:

What TFX is and what it is used for
Important information before using TFX
How to use TFX
Possible side effects
How to store TFX
Contents of the package and other information

1. What TFX is and what it is used for

TFX contains thymic factor X, an extract from calf thymus glands containing proteins and polypeptides. The active substance of the medicine exhibits activity similar to substances secreted by the human thymus gland, thus exerting an immunostimulatory effect. TFX increases the number of white blood cells – T lymphocytes, enhances body immunity, suppresses autoimmune processes, and reduces the adverse effects of cytostatic (anticancer) and immunosuppressive drugs on the haematopoietic system.
TFX is recommended for diseases associated with primary and secondary immunodeficiency; as supportive treatment to stimulate the immune system during basic therapy of malignant diseases; in chronic aggressive hepatitis; in certain diseases of the brain and spinal cord; and in secondary disorders of haemopoiesis (blood cell formation), including those caused by drugs or X-ray irradiation.

2. Important information before using TFX medicine

When not to use TFX

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with TFX, discuss this with your doctor or pharmacist.
Exercise special caution when using TFX:

during pregnancy and breastfeeding;
during the perimenstrual period;
during the period of physiological thymus activity up to sexual maturity, inclusive; during this period, the medicine should be used only if clear immunological deficiencies are diagnosed.

TFX and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
TFX may enhance the action of certain pituitary hormones (somatotropin, luteinizing hormone) and estrogens, and may reduce the effects of adrenal cortex hormones, progesterone, and androgens with regard to their influence on the lymphatic system and bone marrow.

Pregnancy, breastfeeding, and effects on fertility
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult your doctor or pharmacist before using this medicine.

Pregnancy
There are insufficient data on the use of thymic factor X in pregnant women. Animal studies have shown embryotoxic effects. The potential risk for humans is unknown.

Breastfeeding
There are no clinical data on the use of TFX during breastfeeding; therefore, the use of the medicine is not recommended in breastfeeding women.

Driving and operating machinery
TFX has no influence on the ability to drive or operate machinery.

TFX contains thiomersal
The medicine contains thiomersal as a preservative and may cause allergic reactions. Inform your doctor if you have a history of, or currently experience, known allergic reactions.

3. How to use TFX medicine

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Method of administration:
Subcutaneous or intramuscular injection
Typically, 10 to 20 mg is administered daily for 30 days, followed by 20 to 30 mg weekly.
Further use of the medicine, as well as duration of treatment and dosage, depend on the therapeutic
effect achieved and results of appropriate tests.
Preparation method:
The injection solution should be prepared immediately before use. While following aseptic
technique, dissolve the contents of the vial using the solvent contained in the ampoule. Using a
syringe, withdraw 1 mL of solvent from the ampoule and transfer it into the vial containing the
lyophilized substance. Mix the contents of the vial until a uniform solution is obtained.
The prepared solution is ready for subcutaneous or intramuscular injection.
Use of a higher than recommended dose of TFX medicine
The risk of overdosing on TFX medicine is unlikely and limited, because thymus peptides
are sensitive to certain proteins (enzymes) that reduce the drug concentration in blood
and do not have a direct stimulating or inhibiting effect on immune functions.
Missed dose of TFX medicine
Do not administer a double dose to make up for a missed dose.
If a dose of TFX medicine is missed, administer it as soon as possible, bearing in mind that
interruptions longer than one day may reduce the effectiveness of therapy.
Stopping treatment with TFX medicine
Sudden discontinuation of TFX medicine may reduce treatment efficacy depending on the duration
of therapy, but does not pose a risk of any other adverse consequences.
If you have any further doubts regarding the use of this medicine, consult your doctor.
4. Possible side effects
Like all medicines, this product may cause side effects, although not everyone experiences them.
Possible side effects after administration of TFX medicine include:
General disorders and injection site reactions
No general adverse symptoms reported.
Local reaction: redness and slight pain may occur at the injection site.
Immune system disorders
Skin allergic reactions may occur: redness, itching, skin rash.
If the above symptoms occur, discontinue administration of the medicine for 1–2 days.
Reporting side effects
If any adverse effects occur, including any unlisted side effects in this leaflet, inform your
doctor or nurse. Adverse 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
{current address, telephone and fax number of the above Department}
e-mail: [email protected]
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store the medicine TFX

Store below 25°C.
Store in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What TFX medicinal product contains

The active substance is thymic factor X (Thymostimulinum); 1 ml of injection solution contains 10 mg of thymic factor X.
Other ingredients:
vial: thiomersal
solvent ampoule: sodium chloride, water for injections

What TFX looks like and contents of the pack
10 vials with 10 mg powder + 10 solvent ampoules with 1 ml
50 vials with 10 mg powder + 50 solvent ampoules with 1 ml
Vials and ampoules made of colorless glass, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TFX PHARMA Sp. z o.o.
Muchoborskiej Street 6
54-424 Wrocław, Poland

Manufacturer
Jelfa Pharmaceutical Company S.A.
Wincentego Pola Street 21
58-500 Jelenia Góra, Poland