Caspofungin Teva Pdr/Conc/Soln for Infus 70mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CASPOFUNGIN ACETATE

Available from:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN ACETATE 70 mg

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CASPOFUNGIN ACETATE 70 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2016-05-18

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN TEVA 70 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
Caspofungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Caspofungin Teva is and what it is used for
2.
What you need to know before you take Caspofungin Teva
3.
How to take Caspofungin Teva
4.
Possible side effects
5.
How to store Caspofungin Teva
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN TEVA IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN TEVA IS
Caspofungin Teva contains a medicine called caspofungin. This belongs
to a group of medicines
called antifungals.
WHAT CASPOFUNGIN TEVA IS USED FOR
Caspofungin Teva 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 syst

Summary of Product characteristics

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Caspofungin Teva 70 mg Powder for Concentrate for Solution for
Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 70 mg caspofungin (as acetate).
After reconstitution (see section 6.6), each ml of the concentrate
contains 7.2 mg of caspofungin.
Excipients with known effect: Each vial contains approximately 0.38 mg
– 1.24 mg sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
The powder is a lyophilized white to off white colour powder, free of
visible evidence of
contamination..
pH
:
5.6 -7.0
Osmolality: approx. 275 mOsmol/Kg
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 Teva 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
1
Formula). Fo