Cardioxane 500mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexrazoxane

Available from:

Clinigen Healthcare Ltd

ATC code:

V03AF02

INN (International Name):

Dexrazoxane

Dosage:

500mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010000; GTIN: 8714023000603

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARDIOXANE 500 MG POWDER FOR SOLUTION FOR INFUSION
Dexrazoxane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Cardioxane is and what it is used for
2.
What you need to know before you are given Cardioxane
3.
How Cardioxane is given
4.
Possible side effects
5.
How to store Cardioxane
6.
Contents of the pack and other information
1.
WHAT CARDIOXANE IS AND WHAT IT IS USED FOR
Cardioxane contains a substance called dexrazoxane. This substance
belongs to a group of medicines
which protect the heart (cardioprotective medicines).
Cardioxane is used to prevent heart damage when medicines called
anthracyclines (such as
doxorubicin or epirubicin) are used during breast cancer treatment in
adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CARDIOXANE
YOU MUST NOT BE GIVEN CARDIOXANE

If you are under 18 years old and your planned dose of anthracycline
is considered low – talk to
your doctor about this.

If you are allergic (hypersensitive) to dexrazoxane.

If you are breast-feeding (see also “Pregnancy and
breast-feeding”).

If you are given yellow-fever vaccine.
If any of the above apply, you must not be given this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
Cardioxane:

If you have or have had liver or kidney problems.

If you have or have had a heart attack, heart failure, uncontrolled
chest pain and heart valve
problems.

If you are pregnant or plan to become pregnant (see also “Pregnancy
and breast-feeding”).

If you are allergic to dexrazoxane.
3
YOU SHOULD ALSO BE AWARE THAT:

Yo

Summary of Product characteristics

OBJECT 1
CARDIOXANE 500MG POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 21-Feb-2018 | Clinigen
Healthcare Ltd
1. Name of the medicinal product
CARDIOXANE 500 mg powder for solution for infusion.
2. Qualitative and quantitative composition
One vial of powder contains 500 mg of dexrazoxane as its hydrochloride
salt.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
Sterile, pyrogen free, white to off-white, lyophilised powder.
4. Clinical particulars
4.1 Therapeutic indications
Cardioxane is indicated in adults for the prevention of chronic
cumulative cardiotoxicity caused by
anthracycline use in advanced and/or metastatic breast cancer patients
who have received a prior
cumulative dose of 300 mg/m
2
of doxorubicin or a prior cumulative dose of 540 mg/m
2
of epirubicin
when further anthracycline treatment is required.
4.2 Posology and method of administration
Posology
Cardioxane is administered by a short intravenous infusion (15
minutes), approximately 30 minutes prior
to anthracycline administration at a dose equal to 10 times the
doxorubicin-equivalent dose and 10 times
the epirubicin-equivalent dose.
Thus it is recommended that Cardioxane is given at a dose of 500 mg/m
2
when the commonly used
dosage schedule for doxorubicin of 50 mg/m
2
is employed or 600 mg/m
2
when the commonly used
dosage schedule for epirubicin of 60 mg/m
2
is employed.
_Paediatric population_
The safety and efficacy of Cardioxane in children aged 0 to 18 years
have not been established. Currently
available data are described in section 4.3, 4.4, 4.8, 5.1 and 5.2.
_Renal impairment_
In patients with moderate to severe renal impairment (creatinine
clearance < 40 ml/min) the dexrazoxane
dose should be reduced by 50% (see section 4.4).
_Hepatic impairment_
The dosage ratio should be kept, i.e. if the anthracycline dose is
reduced the dexrazoxane dose should be
reduced accordingly.
Method of administration
Intravenous use
For instructions on reconstitution a