Caspofungin 50mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Caspofungin acetate

Available from:

Mylan

ATC code:

J02AX04

INN (International Name):

Caspofungin acetate

Dosage:

50mg

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: 5016695007748

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN 50 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 Caspofungin is and what it is used for
2.
What you need to know before you are given Caspofungin
3.
How to use Caspofungin
4.
Possible side effects
5.
How to store Caspofungin
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN IS
Caspofungin belongs to a group of medicines called antifungals.
WHAT CASPOFUNGIN IS USED FOR
Caspofungin 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

Summary of Product characteristics

OBJECT 1
CASPOFUNGIN 50 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 18-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Caspofungin 50 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 50 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of
concentrate contains 5.2 mg caspofungin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
Before reconstitution, the product 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 months to 17 years)_
In paediatric patients (12 months to 17 years of age), dosing should
be based on the patient's body surface
area (see Instructions for Use in Paediatric Patients, Mosteller
Formula). For all indications, a single 70-
mg/m
2
loading dose (not to excee