Savene 500mg powder for concentrate and solvent for solution for infusion vials

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Dexrazoxane

Disponibbli minn:

Clinigen Healthcare Ltd

INN (Isem Internazzjonali):

Dexrazoxane

Dożaġġ:

500mg

Għamla farmaċewtika:

Powder and solvent for solution for infusion

Rotta amministrattiva:

Intravenous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 08010000; GTIN: 5060229220240

Karatteristiċi tal-prodott

OBJECT 1
SAVENE 20 MG/ML POWDER FOR CONCENTRATE AND
DILUENT FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 21-Feb-2018 | Clinigen
Healthcare Ltd
1. Name of the medicinal product
Savene 20 mg/ml powder for concentrate and diluent 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 diluent.
Excipients with known effects:
Diluent 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 for concentrate and diluent for solution for infusion.
Powder vial:
White to off-white lyophilisate.
Diluent 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).
_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
n