Tfx

Package Leaflet: Information for the User

TFX, 10 mg, powder and solvent for solution for injection

Thymostimulinum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, or if any of the side effects get serious, tell your doctor or pharmacist.

Table of Contents of the Leaflet:

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

1. What is TFX and what is it used for

TFX contains thymic factor X, which is an extract of calf thymus containing proteins and polypeptides. The active substance of the medicine has an effect similar to that of substances secreted by the human thymus, i.e. it stimulates the immune system. TFX increases the number of white blood cells - T lymphocytes, increases the body's resistance, inhibits autoaggressive processes, and reduces the adverse effects of cytostatic (anti-cancer) and immunosuppressive drugs on the hematopoietic system. The use of TFX is recommended in disease syndromes with primary and secondary immunodeficiency; as supportive treatment to stimulate the immune system in the basic therapy of cancer; in chronic, aggressive hepatitis; in some brain and spinal cord diseases; in secondary hemopoietic disorders (blood cell production), also post-drug or after X-ray irradiation.

2. Important information before using TFX

When not to use TFX

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

Warnings and precautions

Before starting treatment with TFX, discuss it with your doctor or pharmacist. When using TFX, be particularly careful:

• during pregnancy and breastfeeding;
• during the days around menstruation;
• during the period of physiological thymus activity up to the period of sexual maturation; during this period, the medicine may be used only in case of confirmed immunological deficiencies.

TFX and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take. TFX may increase the effect of some pituitary hormones (somatotropin, luteinizing hormone) and estrogens, and reduce the effect of adrenal cortex hormones, progesterone, and androgens on the lymphatic system and bone marrow.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, 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 toxic effects on the fetus. The potential risk to humans is not known.

Breastfeeding

There are no clinical data on the use of TFX during breastfeeding, therefore, it is not recommended to use the medicine during breastfeeding.

Driving and using machines

TFX has no effect on the ability to drive and use machines.

TFX contains tiomersal

The medicine contains tiomersal as a preservative and may cause allergic reactions. Inform your doctor if you have had any known allergic reactions.

3. How to use TFX

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Method of administration: Subcutaneous or intramuscular injection. Usually, 10 to 20 mg is used daily for 30 days, and then 20 to 30 mg weekly. Further use of the medicine, treatment time, and dosage depend on the achieved effect and the results of relevant tests. Method of preparation: The solution for injection should be prepared immediately before use. To do this, following the principles of aseptic procedure, dissolve the contents of the vial using the solvent contained in the ampoule. Using a syringe, take 1 ml of solvent from the ampoule and introduce it into the vial with the lyophilized substance. Mix the contents of the vial to obtain a homogeneous solution. The prepared solution is ready for subcutaneous or intramuscular injection.

Using more than the recommended dose of TFX

The risk of overdose of TFX is unlikely and limited, as thymic peptides are sensitive to the action of certain proteins (enzymes) that reduce the concentration of the medicine in the blood and do not have a direct stimulating or inhibiting effect on immune functions.

Missing a dose of TFX

Do not use a double dose to make up for a missed dose. If you miss a dose of TFX, use it as soon as possible, taking into account that longer than one-day breaks in administration may reduce the effectiveness of therapy.

Stopping the use of TFX

Sudden discontinuation of TFX reduces its effectiveness, depending on the duration of treatment, and does not pose any other adverse consequences. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, TFX can cause side effects, although not everybody gets them. Possible side effects after using TFX include: General disorders and administration site conditions. No general adverse reactions. 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 the use of the medicine for 1-2 days.

Reporting side effects

If you experience any side effects, or any other side effects not mentioned in the leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone and fax number of the Department} e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TFX

Store in a temperature below 25°C. Store in a place out of sight and reach of 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 given 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 TFX contains

• The active substance is thymic factor X (Thymostimulinum), 1 ml of solution for injection contains 10 mg of thymic factor X.
• The other ingredients are: vial: tiomersal, ampoule with solvent: sodium chloride, water for injections.

What TFX looks like and contents of the pack

10 vials with powder 10 mg + 10 ampoules with solvent 1 ml, 50 vials with powder 10 mg + 50 ampoules with solvent 1 ml. Vials and ampoules made of colorless glass in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder: TFX PHARMA Sp. z o. o., ul. Muchoborska 6, 54-424 Wrocław. Manufacturer: Przedsiębiorstwo Farmaceutyczne Jelfa S.A., Ul. Wincentego Pola 21, 58-500 Jelenia Góra.

Date of last revision of the leaflet: