Casokan 70mg powder for concentrate for solution for infusion

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

CASPOFUNGIN ACETATE

থেকে পাওয়া:

Heaton k.s. Na Pankraci 14, 140 00 Praha 4, Czech Republic

এটিসি কোড:

J02AX04

INN (International Name):

CASPOFUNGIN ACETATE 70 mg

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

রচনা:

CASPOFUNGIN ACETATE 70 mg

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

অনুমোদন অবস্থা:

Withdrawn

অনুমোদন তারিখ:

2017-09-12

তথ্য লিফলেট

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CASOKAN 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 Casokan is and what it is used for
2.
What you need to know before you are given Casokan
3.
How to use Casokan
4.
Possible side effects
5.
How to store Casokan
6.
Contents of the pack and other information
1.
WHAT CASOKAN IS AND WHAT IT IS USED FOR
WHAT CASOKAN IS
Casokan contains the active substance caspofungin. This belongs to a
group of medicines called
antifungals.
WHAT CASOKAN IS USED FOR
Casokan 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 those who hav

পণ্য বৈশিষ্ট্য

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Casokan 70 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 70 mg caspofungin (as acetate). After
reconstitution each ml concentrate contains
7.2 mg caspofungin.
Excipient with known effect
Sodium less than 1 mmol (23 mg) per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
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,
neutropenic 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
1
Formula). For all indications,
a single 70-mg/m² loading dose (not to exceed an actual dose of 70
mg) should be administered on
1
Mosteller RD. Simplified Calculation of Body Surface Area.