AMBISOME 50MG/VIAL POWDER FOR CONCENTR.FOR LIPOSOMAL DISPERS.FOR INF.

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

AMPHOTERICIN B

Διαθέσιμο από:

GILEAD SCIENCES IRELAND UC (0000009744) IDA BUSINESS & TECHNOLOGY PARK, COUNTY CORK, CARRIGTOHILL, T45 DP77

Φαρμακολογική κατηγορία (ATC):

J02AA01

INN (Διεθνής Όνομα):

AMPHOTERICIN

Δοσολογία:

50MG/VIAL

Φαρμακοτεχνική μορφή:

POWDER FOR CONCENTR.FOR LIPOSOMAL DISPERS.FOR INF.

Σύνθεση:

AMPHOTERICIN B (0001397893) 50MG

Οδός χορήγησης:

INTRAVENOUS USE

Τρόπος διάθεσης:

Ειδική άδεια άρθρο 126A

Θεραπευτική περιοχή:

AMPHOTERICIN

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή; 10 VIALS X 50MG (SINGLE DOSE) (27S003301) 10 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS
ONLY:
READ THIS ENTIRE SECTION CAREFULLY BEFORE BEGINNING RECONSTITUTION.
AMBISOME IS NOT INTERCHANGEABLE WITH OTHER AMPHOTERICIN PRODUCTS.
AMBISOME MUST BE RECONSTITUTED USING STERILE WATER FOR INJECTION
(WITHOUT A BACTERIOSTATIC AGENT) AND DILUTED IN DEXTROSE SOLUTION
(5%, 10% OR 20%) FOR INFUSION ONLY.
The use of any solution other than those recommended, or the presence
of a bacteriostatic agent (e.g. benzyl alcohol) in the solution, may
cause
precipitation of AmBisome.
AmBisome is NOT compatible with saline and must not be reconstituted
or diluted with saline or administered through an intravenous line
that has
previously been used for saline unless first flushed with dextrose
solution (5%,10% or 20%) for infusion. If this is not feasible,
AmBisome should be
administered through a separate line.
Do NOT mix AmBisome with other drugs or electrolytes.
Aseptic technique must be observed in all handling, since no
preservative or bacteriostatic agent is present in AmBisome, or in the
material specified for
reconstitution and dilution.
Vials of AmBisome Containing 50 mg of Amphotericin B are Prepared as
Follows:
1. Add 12 ml of Water for Injection to each AmBisome vial, to yield a
preparation containing 4 mg/ml amphotericin B.
Step 1
12 ML OF
WATER FOR
INJECTION
= 4 MG/ML
liposomal amphotericin B
2. IMMEDIATELY after the addition of water, SHAKE THE VIAL VIGOROUSLY
for 30 seconds to completely disperse the AmBisome. After
reconstitution
the concentrate is a translucent, yellow dispersion. Visually inspect
the vial for particulate matter and continue shaking until complete
dispersion is
obtained. Do not use if there is evidence of precipitation of foreign
matter.
Step 2
liposomal amphotericin B
liposomal amphotericin B
liposomal amphotericin B
SOLUTION
FREE OF
PARTICULATE
MATTER
VISUAL
INSPECTION
3. Calculate the amount of reconstituted AmBisome (4 mg/ml) to be
further diluted (see table below).
4. The infusion solution is obtained by dilution of the