Caspofungin 50mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Caspofungin acetate

Available from:

Dr Reddy's Laboratories (UK

ATC code:

J02AX04

INN (International Name):

Caspofungin acetate

Dosage:

50mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020400; GTIN: 5036072006836

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN 50 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 Caspofungin is and what it is used for
2. What you need to know before you are given Caspofungin
3. How to use Caspofungin
4. Possible side effects
5. How to store Caspofungin
6. Contents of the pack and other information
1. WHAT CASPOFUNGIN IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN IS
Caspofungin
contains
a
medicine
called
caspofungin.
This belongs to a group of medicines called antifungals.
WHAT CASPOFUNGIN IS USED FOR
Caspofungin 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 fun

Summary of Product characteristics

OBJECT 1
CASPOFUNGIN DR. REDDY'S 50 MG POWDER FOR
CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 24-Jan-2018 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Caspofungin Dr. Reddy's 50 mg Powder For Concentrate For Solution For
Infusion
2. Qualitative and quantitative composition
Each 50 mg vial contains 50 mg caspofungin (as acetate).
The concentration of the reconstituted vials is 5.2 mg/ml.
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,
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
administer