Caspofungin Orion 70 mg Pulver till koncentrat till infusionsvätska, lösning

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

kaspofunginacetat

Dostopno od:

Orion Corporation

Koda artikla:

J02AX04

INN (mednarodno ime):

kaspofunginacetat

Odmerek:

70 mg

Farmacevtska oblika:

Pulver till koncentrat till infusionsvätska, lösning

Sestava:

sackaros Hjälpämne; mannitol Hjälpämne; kaspofunginacetat 77,69 mg Aktiv substans

Tip zastaranja:

Receptbelagt

Povzetek izdelek:

Förpacknings: Injektionsflaska, 1 st

Status dovoljenje:

Godkänd

Datum dovoljenje:

2017-01-30

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CASPOFUNGIN ORION 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
CASPOFUNGIN ORION 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 any further questions, ask your doctor, pharmacist or
nurse.
-
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 Orion is and what it is used for
2.
What you need to know before you are given Caspofungin Orion
3.
How Caspofungin Orion is given
4.
Possible side effects
5.
How to store Caspofungin Orion
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN ORION IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN ORION IS
Caspofungin Orion contains a medicine called caspofungin. This belongs
to a group of medicines
called antifungals.
WHAT CASPOFUNGIN ORION IS USED FOR
Caspofungin Orion 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

Lastnosti izdelka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Caspofungin Orion 50 mg powder for concentrate for solution for
infusion
Caspofungin Orion 70 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains caspofungin acetate equivalent to 50 mg or 70 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 lyophilised
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
1
Formula). For all indications, a
single 70 mg/m
2
loading dose (not to exceed an actual dose of 70 mg) should be
administered on
Day 1, followed by 50 mg/m
2
daily thereafter (not to exc