SAVENE 20 mg /Ml Инфузионный Раствор

Содержание инструкции

1. Savene 20 mg/ml powder and solvent for concentrate for solution for infusion
   1. What is Savene and what is it used for
   2. What you need to know before using Savene
   3. How to use Savene
   4. Possible side effects
   5. How to store Savene
   6. Contents of the pack and other information
   7. FORMULATION
   8. RECOMMENDATIONS FOR SAFE HANDLING
   9. 2 Dilution of the concentrate
   10. 2 After reconstitution and dilution
   11. DISPOSAL OF THE PRODUCT

Savene 20 mg/ml powder and solvent for concentrate for solution for infusion

Dexrazoxane

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is Savene and what is it used for

Savene contains the active substance dexrazoxane which acts as an antidote to the group of anticancer drugs called anthracyclines.
Most anticancer drugs are administered intravenously (into a vein).
Sometimes, accidentally, it may happen that the drug is injected outside the vein, or
leaks from the vein, and comes into contact with the surrounding tissue. This episode is called
extravasation. This is a serious complication because it can cause severe damage to the tissues.
Savene is used for the treatment of anthracycline extravasations in adults. It can reduce the
amount of damage to the tissues caused by anthracycline extravasation.

2. What you need to know before using Savene

Do not use Savene:

• if you are allergic to dexrazoxane or any of the other ingredients of this medicine (listed in section 6)
• if you are planning a pregnancy and are not using effective contraceptive measures
• if you are breastfeeding
• if you are being given the yellow fever vaccine

Warnings and precautions
Talk to your doctor or nurse before using Savene:

• Savene should only be used in case of extravasation associated with anthracycline-based chemotherapy.
• During treatment with Savene, the area where the extravasation occurred must be examined regularly and the patient must be regularly subjected to blood tests to check blood cells.
• In case of liver problems, the doctor will need to monitor liver function during therapy.
• In case of kidney problems, the doctor must perform checks to identify any signs of changes in blood cells.

Children and adolescents
Savene should not be given to children under 18 years of age.

Other medicines and Savene
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor or nurse if you are taking or might take any of the following
medicines:

• vaccines: you should not use Savene if you are being given the yellow fever vaccine and the use of Savene should be avoided if you are taking a vaccine containing live virus particles;
• a product called DMSO (which is a cream for treating some skin diseases);
• phenytoin (a treatment for convulsions), Savene may reduce the effectiveness of this medicine;
• anticoagulants (blood thinners), it may be necessary to monitor blood levels more frequently;
• cyclosporine or tacrolimus (both used for immunosuppression and to prevent organ rejection after a transplant);
• myelosuppressive medicines (reduce the production of white blood cells, red blood cells and platelets).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
Savene must not be used if you are pregnant.
Do not breastfeed during treatment with Savene.
If you are sexually active, it is recommended to use effective contraceptive methods to prevent
pregnancy during treatment and for six months after treatment, whether you are male or female
(see section 2 “Do not use Savene”).
Information about the effect of Savene on fertility is limited; if you have any doubts, talk to your
doctor.

Driving and operating machinery
Dizziness, fatigue and sudden fainting have been observed in a small number of patients
treated with Savene. Treatment is considered to have a limited effect on the ability to drive
vehicles and operate machinery.

Savene contains potassium and sodium
Savene solvent contains 98 mg of potassium per 500 ml vial, which may be harmful to
people who are on a low potassium diet or who have kidney problems. If you are at risk due to high levels of potassium in the blood, your doctor will monitor these levels.
Savene solvent also contains 1.61 g of sodium (the main component of common table salt)
per 500 ml vial. This amount is equivalent to 81% of the maximum recommended daily intake of sodium
in the diet of an adult.

3. How to use Savene

Savene will be administered under the supervision of a doctor experienced in the use of treatments against
cancer.

Recommended dose
The dose depends on the patient's height, weight and kidney function. The doctor must calculate
your body surface area in square meters (m²) to determine the dose you need to take. The recommended dose for adult patients (with normal kidney function) is:
Day 1: 1000 mg/m²
Day 2: 1000 mg/m²
Day 3: 500 mg/m²
The doctor may reduce your dose if you have kidney problems.
Savene is administered by infusion into a vein. The infusion lasts 1 or 2 hours.

Frequency of administration
The infusion should be given once a day for 3 consecutive days. The first infusion will be
administered as soon as possible and within the first six hours after extravasation of an anthracycline.
The Savene infusion will be administered at the same time each day of treatment.
Savene will not be used again during the next anthracycline cycle, except in the event of
another extravasation.

If you receive more Savene than you should
If you are given more Savene than intended, you will be closely monitored with particular
attention to: blood cells, possible gastro-intestinal symptoms, skin reactions and hair loss.
If Savene comes into contact with the skin, the affected area must be immediately and
thoroughly rinsed with water.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention
In patients treated with Savene, the following serious side effects have been observed (frequency not
known):

• allergic reactions including itching, rash, swelling of face/throat, wheezing, shortness of breath or difficulty breathing, changes in levels of consciousness, hypotension, sudden fainting.

If you experience any of the above symptoms, seek medical advice immediately.
Other possible side effects are as follows:
Very common: may affect more than 1 in 10 people

• Nausea
• Reactions at the injection site (pain, redness, swollen or painful at the injection site, hardening at the injection site)
• Decreased white blood cells and platelets
• Infection (following surgery or other infections)

Common: may affect up to 1 in 10 people

• Vomiting
• Diarrhea
• Feeling tired, drowsiness, dizziness, sudden fainting
• Decreased any of the senses (sight, smell, hearing, touch, taste)
• Fever
• Inflammation of the blood vessel in which the treatment is administered (phlebitis)
• Inflammation of a blood vessel just below the skin, often with a small blood clot
• Blood clot in a vein, usually in an arm or leg
• Inflammation of the oral cavity
• Dry mouth
• Hair loss
• Itching
• Weight loss, loss of appetite
• Muscle pain, tremor (involuntary muscle movements)
• Vaginal bleeding
• Difficulty breathing
• Pneumonia (lung infection)
• Swelling of arms or legs (edema)
• Wound complications
• Changes in liver function (observable in test results)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the
national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Savene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack, on the label of the
vial containing the powder and on the label of the solvent vial after “EXP”. The expiry date refers to the last day of that month.
Store at a temperature below 25 °C.
Keep the vials with the powder and the vials with the solvent in the outer packaging to protect the
medicine from light.

6. Contents of the pack and other information

What Savene contains

• The active ingredient is dexrazoxane. Each vial contains 500 mg of dexrazoxane as 589 mg of dexrazoxane hydrochloride.
• The other ingredients are: the solvent containing Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Sodium gluconate, Sodium hydroxide and water for injections.

Description of the appearance of Savene and contents of the emergency kit
The Savene kit consists of Savene, powder for concentrate (powder of colour from white to off-white)
and Savene solvent. An emergency kit contains 10 vials of Savene powder and 3 vials of
Savene solvent, together with 3 vial hangers.
The concentration of dexrazoxane after reconstitution with 25 ml of Savene solvent is 20 mg/ml.
The concentrate is slightly yellow.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
CNX Therapeutics Ireland Limited
5th Floor Rear, Connaught House
1 Burlington Road
Dublin 4, Dublin
Ireland

Manufacturer
Cenexi-Laboratoires Thissen SA
Rue de la Papyrée 2-4-6
B-1420 Braine-L’Alleud
Belgium

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency http://www.ema.europa.eu.
The following information is intended exclusively for healthcare professionals.

Instructions for preparing Savene 20 mg/ml powder and solvent for concentrate for
infusion solution
Before starting the preparation of Savene, it is important to read the entire contents of the
procedure.

1. FORMULATION

Savene is supplied in the form of:

• 1. Savene Powder for concentrate
• 2. Solvent for Savene

Before administration, Savene powder must be reconstituted in 25 ml of Savene solvent
to obtain a concentrate which must be further diluted with the remaining Savene solvent.

2. RECOMMENDATIONS FOR SAFE HANDLING

Savene is an antineoplastic agent. It is therefore necessary to adopt the normal procedures provided for the
correct handling and disposal of antineoplastic drugs, in particular:

• Personnel must be adequately trained to perform the operations for reconstituting the drug
• Pregnant personnel must be excluded from work with this drug
• Personnel handling this drug during reconstitution must wear protective clothing including a mask, protective glasses and gloves
• In case of accidental contact with the skin or eyes, immediate action must be taken and wash thoroughly with plenty of water

3. PREPARATION FOR INTRAVENOUS USE

3.1 Reconstitution of Savene powder to prepare the concentrate

• 3.1.1 Using a syringe with the needle inserted, aseptically draw 25 ml from the Savene solvent vial.
• 3.1.2 Inject the entire contents of the syringe into the vial containing Savene powder.
• 3.1.3 Remove the syringe with the needle inserted and manually mix by inverting several times until the powder is completely dissolved. Do not shake.
• 3.1.4 Let the vial with the concentrate rest for 5 minutes at room temperature and check that the solution is homogeneous and transparent. The concentrated solution is slightly yellow. The concentrated solution contains 20 mg of dexrazoxane/ml and must be used immediately for further dilutions. It does not contain antibacterial preservatives.
• 3.1.5 Keep and store the open solvent vial under aseptic conditions, as it is necessary for diluting the concentrate.

3.2 Dilution of the concentrate

• 3.2.1 To obtain the required dose for the patient, up to four vials of Savene concentrate may be necessary. Depending on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume containing 20 mg of dexrazoxane/ml from the required number of vials containing the concentrate. Use a graduated syringe with the needle inserted.
• 3.2.2 Re-inject the required reconstituted volume into the opened vial of Savene solvent (see section 3.1.5). Do not mix the solution with other medicinal products.

• 3.2.3 Mix the solution by gently shaking the infusion bag.
• 3.2.4 Savene must be administered in aseptic conditions by infusion over 1 or 2 hours, at room temperature and under normal light conditions.
• 3.2.5 As with all parenteral products, before administration, the Savene concentrate solution and the infusion solution must be visually inspected for the absence of particles and colour changes. Solutions containing a precipitate must be discarded.

4. STORAGE

4.1 Before reconstitution and dilution

• Store at a temperature below 25 °C.
• Keep the vials and bottles in the outer packaging to protect the medicinal product from light.

4.2 After reconstitution and dilution

• Chemical and physical stability during use has been demonstrated for 4 hours if the preparation is stored at a temperature between 2 and 8 °C.
• To avoid possible microbial contamination of the medicine, the product must be used immediately.
• If not used immediately, the product must be stored in a refrigerator at a temperature between 2 and 8 °C, for no more than 4 hours.

5. DISPOSAL OF THE PRODUCT

All components necessary for preparation, administration or cleaning, including gloves, and
liquid residues, must be disposed of in accordance with local legal requirements.