Caspofungin 70 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Caspofungin

Available from:

Macarthys Laboratories Limited

ATC code:

J02AX; J02AX04

INN (International Name):

Caspofungin

Dosage:

70.00 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

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:

2017-05-12

Patient Information leaflet

PREGNANCY AND BREAST-FEEDING
Ask your doctor for advice before taking any medicine, if you are
pregnant or breast-feeding or think you are pregnant.
• Caspofungin has not been studied in pregnant women. It
should be used in pregnancy only if the potential benefit
justifies the potential risk to the unborn baby.
• Women given Caspofungin should not breast-feed.
DRIVING AND USING MACHINES
There is no information to suggest that Caspofungin affects your
ability to drive or operate machinery.
3. HOW TO USE CASPOFUNGIN
Caspofungin will always be prepared and given to you by a
healthcare professional.
You will be given Caspofungin:
• once each day
• by slow injection into a vein (intravenous infusion)
• over about 1 hour.
Your doctor will determine the duration of your treatment and how
much Caspofungin you will be given each day. Your doctor will
monitor how well the medicine works for you. If you weigh more
than 80 kg, you may need a different dose.
CHILDREN AND ADOLESCENTS
The dose for children and adolescents may differ from the adult
dose.
IF YOU HAVE BEEN GIVEN MORE CASPOFUNGIN THAN YOU SHOULD
Your doctor will decide how much Caspofungin you need and for
how long each day. If you are worried that you may have been
given too much Caspofungin, tell your doctor or nurse straight
away.
If you have any further questions on the use of this medicine, ask
your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
TELL YOUR DOCTOR OR NURSE STRAIGHT AWAY IF YOU NOTICE ANY OF
THE FOLLOWING SIDE EFFECTS – YOU MAY NEED URGENT MEDICAL
TREATMENT:
• rash, itching, feeling warm, swelling of your face, lips or throat
or difficulty breathing - you may be having a histamine reaction
to the medicine.
• difficulty breathing with wheezing or a rash that gets worse -
you may be having an allergic reaction to the medicine.
• cough, serious breathing difficulties - if you are an adult and
have invasive aspergillosis you may be exp

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin 70 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Caspofungin 70 mg powder for concentrate for solution for infusion
Each vial contains 70 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of
concentrate contains 7.2 mg of Caspofungin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Before reconstitution, the powder 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, MostellerFormula). 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 b