Cancidas 70mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Caspofungin acetate

Available from:

Merck Sharp & Dohme Ltd

ATC code:

J02AX04

INN (International Name):

Caspofungin acetate

Dosage:

70mg

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: 05020400; GTIN: 5013945000474

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CANCIDAS
® 70 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Caspofungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE GIVEN
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU._ _

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, nurse or
pharmacist.

If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Cancidas is and what it is used for
2. What you need to know before you are given Cancidas
3. How to use Cancidas
4. Possible side effects
5. How to store Cancidas
6. Contents of the pack and other information
1. WHAT CANCIDAS IS AND WHAT IT IS USED FOR_ _
WHAT CANCIDAS IS
Cancidas contains a medicine called caspofungin. This belongs to a
group of medicines called anti-
fungals.
WHAT CANCIDAS IS USED FOR
Cancidas is used to treat the following infections in children,
adolescents and adults:

serious fungal infections in your tissues or organs (called 'invasive
candidiasis'). This infection
is caused by fungal (yeast) cells called Candida._ _
People who might get this type of infection include those who have
just had an operation or
those whose immune systems are weak. Fever and chills that do not
respond to an antibiotic are
the most common signs of this type of infection.

fungal infections in your nose, nasal sinuses or lungs (called
'invasive aspergillosis') if other
anti-fungal treatments have not worked or have caused side effects.
This infection is caused by a
mould called Aspergillus.
People who might get this type of infection include those having
chemotherapy, those who have
had a transplant and those whose immune systems are weak.

suspected fungal infections if you have a fever and a low white cell
count that have not
improved on treatment with an antibiotic. People who are at risk of
getting a fungal infection
include th

Summary of Product characteristics

OBJECT 1
CANCIDAS 50 MG (FORMERLY CASPOFUNGIN MSD)
Summary of Product Characteristics Updated 25-Jul-2016 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
CANCIDAS
®
50 mg powder for concentrate for solution for infusion
CANCIDAS
®
70 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
CANCIDAS 50 mg powder for concentrate for solution for infusion:
Each vial contains 50 mg caspofungin (as acetate).
Excipients with known effect:
Each 50 mg vial contains 35.7 mg of sucrose.
CANCIDAS 70 mg powder for concentrate for solution for infusion:
Each vial contains 70 mg caspofungin (as acetate).
Excipients with known effect:
Each 70 mg vial contains 50.0 mg of sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
Before reconstitution, the powder is a white to off-white compact,
powder.
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of invasive candidiasis in adult or paediatric patients.
• Treatment of invasive aspergillosis in adult or paediatric
patients who are refractory to or intolerant of
amphotericin B, lipid formulations of amphotericin B and/or
itraconazole. Refractoriness is defined as
progression of infection or failure to improve after a minimum of 7
days of prior therapeutic doses of
effective antifungal therapy.
• Empirical therapy for presumed fungal infections (such as Candida
or Aspergillus) in febrile,
neutropaenic adult or paediatric patients.
4.2 Posology and method of administration
Caspofungin should be initiated by a physician experienced in the
management of invasive fungal
infections.
Posology
_Adult patients_
A single 70 mg loading dose should be administered on Day-1, followed
by 50 mg daily thereafter. In
patients weighing more than 80 kg, after the initial 70 mg loading
dose, caspofungin 70 mg daily is
recommended (see section 5.2). No dosage adjustment is necessary based
on gender or race (see section
5.2).
_Paediatric patients (12 m