Caspofungin Teva 50 mg Powder for Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Caspofungin acetate

Available from:

Teva B.V.

ATC code:

J02AX; J02AX04

INN (International Name):

Caspofungin acetate

Dosage:

50 milligram(s)

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antimycotics for systemic use; caspofungin

Authorization status:

Not marketed

Authorization date:

2016-08-12

Patient Information leaflet

1
11-5-16
WA
INDESIGN CS6
Body: Syntax roman/bold/
Italic 9pts
Med info: 8pts
Subhead: Univers 65 Bld 11pts
Header: Univers 65 Bld 13pts
44410
CASPOFUNGIN 70MG POWDER
FOR CONC. FOR SOL. FOR INF. 1 VIAL
(GODOLLO) TEI HOSP
10-5-16
268 x 414mm
WA
Leafl et
CUTTER GUIDE
PMS PROCESS BLACK
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Y
Y
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN TEVA 70 MG POWDER FOR
CONCENTRATE FOR SOLUTION FOR INFUSION
CASPOFUNGIN
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leafl et. 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 leafl et. See Section 4.
WHAT IS IN THIS LEAFL ET
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
‘invasiv

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Teva 50 mg Powder for Concentrate for Solution for
Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg caspofungin (as acetate).
After reconstitution (see section 6.6), each ml of the concentrate
contains 5.2 mg of caspofungin.
Excipients with known effect: Each vial contains approximately 0.28 mg
- 0.90 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. 211 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). For all indications, a single 70