Caspofungin 70mg powder for concentrate for solution for infusion vials

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Caspofungin acetate

Disponible depuis:

Wockhardt UK Ltd

Code ATC:

J02AX04

DCI (Dénomination commune internationale):

Caspofungin acetate

Dosage:

70mg

forme pharmaceutique:

Powder for solution for infusion

Mode d'administration:

Intravenous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 05020400; GTIN: 5012727913100

Notice patient

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
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 the active substance 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 ris

Résumé des caractéristiques du produit

OBJECT 1
CASPOFUNGIN 70 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 16-Nov-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Caspofungin 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 for solution
for infusion 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/m
2
loading dose (no