Farmorubicin PFS 50 mg.

WHAT Farmorubicin PFS AND WHAT IT IS USED
Farmorubicin PFS is a cytostatic antibiotic.
Farmorubicin PFS is indicated for the treatment of breast cancer and gastric cancer.
By intravesical instillation (topical administration into the bladder).
Farmorubicin PFS is indicated for the treatment of superficial bladder cancer (transitional cell carcinoma, carcinoma in situ), and to prevent relapse after transurethral resection.
Farmorubicin PFS can also be used in combination with other medicines to combat cancer. Pomegranate. Polychemotherapy regimens.

2. BEFORE YOU USE Farmorubicin PFS
Do not use Farmorubicin PFS:
if you are allergic (hypersensitive) to epirubitsinov hydrochloride or any of the other ingredients of Farmorubicin PFS;
if you are allergic (hypersensitive) to other similar chemical structure substances (anthracyclines or anthracenediones);
if you are breastfeeding.
Do not use intravenous Farmorubicin PFS:
if you suffer from prolonged myelosuppression (suppressed bone marrow function);
if you have severe hepatic impairment;
if you have been treated with maximum cumulative doses of epirubicin and / or other similar chemical structure substances (anthracyclines and anthracenediones);
if you have severe heart disease (such as severe heart failure, recent myocardial infarction, severe arrhythmias, unstable angina, myocardiopathy);
if you suffer from acute systemic infections.
Do not use Farmorubicin PFS intravesical:
if you have a urinary tract infection;
If you suffer from inflammation of the bladder or have tumors penetrating the bladder wall;
if you suffer from hematuria (blood in urine);
there are problems in placing the catheter.
Take special care with Farmorubicin PFS:
If you are being treated or have been treated with cytostatics (anti-cancer drugs);
If you have an accompanying heart disease;
If you are treated with high doses Farmorubicin PFS or other drugs that suppress cardiac function;
If you have or have had radiation therapy to the chest;
If you have a low white blood cell count;
If you have impaired liver or kidney function;
If you notice any unusual signs of injection site Farmorubicin PFS.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Farmorubicin PFS is used mainly in combination with other anti-cancer drugs. It is extremely important to never mix more than one drug in a syringe or system.
Farmorubicin PFS should not be used in combination with other potentially cardiotoxic drugs or cardioactive substances (calcium channel blockers), unless cardiac function is closely monitored.
Doctors should avoid therapy including an anthracycline for up to 24 weeks after the termination of trastuzumab. If anthracyclines are used before this time, careful monitoring of cardiac function.
Vaccination with a live vaccine should be avoided if you use Farmorubicin PFS. Killed or inactivated vaccines may be administered, but the response to such vaccines may be reduced.
Use of cimetidine should be discontinued during treatment with Farmorubicin PFS.
If you are using paclitaxel or docetaxel Farmorubicin PFS should be used before them with a minimum 24-hour interval between the two drugs.
Deksverapamil may modify the action of Farmorubicin PFS and likely to enhance the suppressive effects on the bone marrow.
Operation of Farmorubicin PFS can be changed also by docetaxel, quinine or concomitant interferon A2b.
With concomitant use of drugs that suppress the bone marrow (eg. Cytostatics, sulfonamides, chloramphenicol, diphenylhydantoin, amidopirin derivatives, antiretroviral drugs) to be given the likelihood of violations of hematopoietic function.
Farmorubicin PFS should not be mixed with heparin due to chemical incompatibility, which may lead to the formation of a precipitate.

Pregnancy and lactation
Ask your doctor before taking any medicine.
Farmorubicin PFS can cause chromosomal damage in human spermatozoa. Men treated with Farmorubicin PFS must use effective contraceptive methods and if applicable and appropriate, seek advice on storing sperm, because of the possibility of irreversible infertility caused by therapy.
Farmorubicin PFS can cause lack of menstruation or premature menopause in premenopausal women.
It is assumed that Farmorubicin PFS may cause fetal harm when administered to a pregnant woman. If Farmorubicin PFS is used during pregnancy or if you become pregnant during treatment, you should be aware of the potential risks to the fetus. Farmorubicin PFS should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
If you are of childbearing age should exclude the possibility of pregnancy prior to treatment. Men and women treated with Farmorubicin PFS must use adequate contraception.
You should not use Farmorubicin PFS, if you are breastfeeding.

Driving and using machines
The effect of Farmorubicin PFS on ability to drive and use machines has not been systematically evaluated.

3. HOW TO USE Farmorubicin PFS
Farmorubicin PFS should be administered under the supervision of qualified professionals with experience in the use of cytotoxic agents.
Special instructions for medical staff
Following measures are recommended for safety, due to the toxic nature of this medicine:
Staff should be trained in good technique for work;
Pregnant staff should be exempt from working with this medicine;
Staff members who have contact with Farmorubicin PFS, should wear protective clothing: goggles, gowns, gloves and masks for single use;
The work surface should be protected with absorbent paper with plastic coating for single use;
All items used for administration or cleaning, including gloves, should be placed in special bags for high disposable waste for incineration at high temperature;
Scattered or spilled medicine should be treated with a dilute solution of sodium hypochlorite (1% available chlorine) preferably by soaking, and then with water;
All cleaners must be disposed of as described above;
In case of contact with skin, wash the affected area thoroughly with soap and water or sodium bicarbonate solution. However, do not rub the skin with a stiff brush;
In case of contact with the eye / eye, pull back the eyelid of the affected / affected eye / eyes, rinse with plenty of water for at least 15 minutes. Then require examination by a specialist;
After removing gloves always wash your hands with water.
Before starting treatment with Farmorubicin PFS must have recovered from acute toxicities of prior treatment with anticancer drugs.
Cardiac function should be assessed before being treated with Farmorubicin PFS and carefully monitored during treatment to minimize the risk of heart failure described for other anthracyclines. Heart failure can occur sooner or later (a few weeks, months, even years) after stopping treatment and sometimes not affected by specific treatment. Monitoring of cardiac function must be particularly strict, if you receive high cumulative doses and in patients with risk factors.
Because of the risk of damage to the heart (cardiac toxicity) a cumulative dose of 900 mg / m2 Farmorubicin PFS to be exceeded only with extreme caution.
Liver function tests should be monitored before and during each course of Farmorubicin PFS.

intravenous
The usual duration of the infusion varies between 3 and 20 minutes depending on the dose and the volume of the infusion solution.

Initial treatment with standard doses
When administered alone, the recommended standard starting dose of Farmorubicin PFS in adults is 60-120 mg / m2 body surface area per cycle. The recommended starting dose Farmorubicin PFS, when used as part of an adjuvant therapy in patients with breast cancer with positive lymph nodes is 100 to 120 mg / m2. The total initial dose per cycle can be given as a single dose or divided for 2-3 consecutive days. Each treatment cycle may be repeated every 3 to 4 weeks in the presence of normal recovery from damage caused by drug toxicity (particularly bone marrow depression and stomatitis).

Initial therapy with high doses of
The initial therapy with high doses Farmorubicin PFS can also be used in the treatment of breast cancer. When used as monotherapy in adults, the recommended starting dose higher Farmorubicin PFS rate of up to 135 mg / m2 on day 1 or in divided doses on days 1, 2, 3 every 3 to 4 weeks. In combination treatment, the recommended starting dose is high up to 120 mg / m2 on day 1 every 3 to 4 weeks.

When renal function
Because they can not give specific dosage recommendations based on limited data in patients with renal impairment in patients with severe renal impairment should be given lower initial doses.

Hepatic dysfunction
Recommended lower doses. If you have a severe liver disease should not be treated with Farmorubicin PFS.

Other special populations
If you have a severe or previous therapy with bone marrow damage caused by malignant cells should be considered lower starting doses or longer intervals between cycles. If you are elderly using standard initial doses and schedules.

intravesical administration
You should not take any liquids 12 hours before infusion. After the merger must urinate.

Superficial bladder tumors
Single entry in the bladder: A single infusion of 80-100 mg immediately after surgical removal of the prostate.

4-8-week course followed by monthly entries in the bladder: recommended infusions of 50 mg for 8 weeks. In the case of local toxicity (chemical cystitis), the dose should be reduced by 30 mg. May be administered 50 mg weekly for a period of 4 weeks, followed by monthly injections of the same dose over a period of 11 months.

If you use more than the amount Farmorubicin PFS
Acute overdosage with Farmorubicin PFS will lead to severe bone marrow suppression, gastrointestinal toxic effects and early and late cardiac complications. Should therefore be carefully monitored.

If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Farmorubicin PFS can cause side effects, although not everybody gets them.

Very common side effects (affecting more than 1 in 10 people): suppression of bone marrow function; hair loss; red colored urine for 1 to 2 days after use.

Common side effects (affecting less than 1 in 10 but more than 1 in 100 people): infection; reduced / absent appetite (anorexia), dehydration; hot flashes; inflammation of the esophagus, and the lining of the mouth, nausea, diarrhea, nausea; redness at the injection; inflammation of the lining of the bladder, sometimes with blood in the urine after intravesical administration; burning and frequent urination at intravesical administration.

Uncommon side effects (affecting less than 1 in 100 but more than 1 in 1000 people): low blood platelet count; phlebitis, thrombophlebitis.

Rare (affecting less than 1 in 1000 but more than 1 in 10,000 people): leukemias; hypersensitivity; increased levels of uric acid in the blood; dizziness; congestive heart failure, damage to the heart (cardiotoxicity), cardiac disorders; hives; absence of menstrual cycles, lack of sperm; fatigue / weakness, fever, chills; changes in liver enzymes.

Not known (from the available data can not be estimated): septic shock, sepsis, pneumonia; hemorrhage, oxygen starvation of tissues; inflammation of the conjunctiva / cornea (conjunctivitis / keratitis); shock, blood clot formation, including in the lungs; disorders of the oral mucosa, ulceration and pain in the mouth, burning sensation of the mucous membranes, bleeding lips and pigmentation; local toxicity of skin or tissue, rash, itching, skin changes, redness, hyperpigmentation of the skin and nails, sensitivity to light, hypersensitivity of irradiated skin area (reaction after radiotherapy); asymptomatic decreases in ejection fraction of the left ventricle.

If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE Farmorubicin PFS
Keep out of reach of children.
Do not use Farmorubicin PFS after the expiry date stated on the label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The solution may be stored at 2 ° C to 8 ° C. Do not freeze. Discard any unused solution.

6. FURTHER INFORMATION
What Farmorubicin PFS
The active substance is epirubitsinov hydrochloride (epirubicin hydrochloride).
The other ingredients are sodium chloride, hydrochloric acid, water for injections.

Looks Farmorubicin PFS and contents of the pack
Injection 10 mg / 5 ml
Solution for injection for intravenous and intravesical infusion 10 mg / 5ml: glass vial with chlorobutyl stopper and aluminum seal, placed in a cardboard box.
Solution for injection for intravenous and intravesical infusion 10 mg / 5ml: polypropylene vial with chlorobutyl stopper and aluminum seal, placed in a cardboard box.

Solution for injection 50 mg / 25 ml
Solution for injection for intravenous and intravesical infusion of 50 mg / 25 ml: glass vial with chlorobutyl stopper and aluminum seal, placed in a cardboard box.
Solution for injection for intravenous and intravesical infusion of 50 mg / 25 ml: polypropylene vial with chlorobutyl stopper and aluminum seal, placed in a cardboard box.