Savene

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

dexrazoxane hydrochloride

Beschikbaar vanaf:

Clinigen Healthcare B.V.

ATC-code:

V03AF02

INN (Algemene Internationale Benaming):

dexrazoxane

Therapeutische categorie:

All other therapeutic products

Therapeutisch gebied:

Extravasation of Diagnostic and Therapeutic Materials

therapeutische indicaties:

Savene is indicated for the treatment of anthracycline extravasation.

Product samenvatting:

Revision: 14

Autorisatie-status:

Authorised

Autorisatie datum:

2006-07-27

Bijsluiter

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SAVENE 20 MG/ML POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
Dexrazoxane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Savene is and what it is used for
2.
What you need to know before you use 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 SAVENE IS AND WHAT IT IS USED FOR
Savene contains the active substance dexrazoxane, which acts as an
antidote to anti-cancer medicines
called anthracyclines.
Most anti-cancer medicines are administered intravenously (into a
vein). Occasionally an accident
occurs and the medicine is infused outside the vein and into the
surrounding tissue or leaks from the
vein into the surrounding tissue. This event is called extravasation.
It is a serious complication as it
can cause severe tissue damage.
Savene is used to treat anthracyline extravasation in adults. It can
reduce the amount of tissue damage
caused by anthracycline extravasation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE 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 to become pregnant and do not use adequate
contraceptive measures
-
If you are breast-feeding
-
If you are given yellow-fever vaccine
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Savene:
-
Savene should only be given to you if you have an extravasation in
connection with
anthracycline-containing chemotherapy.
-
During treatment with Savene the area where the extravasation has
occurred will be examined
on a regula

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Savene 20 mg/ml powder and solvent for concentrate for solution for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane
hydrochloride).
Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml
of Savene solvent.
Excipients with known effects:
Solvent bottle:
Potassium 98 mg/500 ml or 5.0 mmol/l
Sodium 1.61 g/500 ml or 140 mmol/l
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for concentrate for solution for infusion.
Powder vial:
White to off-white lyophilisate.
Solvent bottle:
Clear isotonic solution (295 mOsml/l, pH approx. 7.4).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Savene is indicated in adults for the treatment of anthracycline
extravasation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Savene must be administered under the supervision of a physician
experienced in the use of anti-
cancer medicinal products.
Posology
Treatment should be given once daily for 3 consecutive days. The
recommended dose is:
Day 1:
1000 mg/m
2
Day 2:
1000 mg/m
2
Day 3:
500 mg/m
2
The first infusion should be initiated as soon as possible, within the
first six hours after the accident.
Treatment Day 2 and Day 3 should start at the same hour (+/- 3 hours)
as Day 1.
For patients with a body surface area of more than 2 m
2
the single dose should not exceed 2000 mg.
_Renal impairment _
In patients with moderate to severe renal impairment (creatinine
clearance <40 mL/min) the Savene
dose should be reduced by 50% (see section 4.4 and 5.2).
3
_Hepatic impairment _
Dexrazoxane has not been studied in patients with impaired hepatic
function and its use in such
patients is not recommended (see section 4.4).
_Elderly _
Safety and efficacy have not been evaluated in the elderly and the use
of dexrazoxane in such patients
is not recommended.
_Paediatric population _
The safety and efficacy of Savene in children below the age of 18
years hav