Xiaflex

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Collagenase clostridium histolyticum 900ug;  

Beschikbaar vanaf:

Janssen-Cilag (New Zealand) Ltd

INN (Algemene Internationale Benaming):

Collagenase clostridium histolyticum 900 µg

Dosering:

900 mcg

farmaceutische vorm:

Powder for injection

Samenstelling:

Active: Collagenase clostridium histolyticum 900ug   Excipient: Hydrochloric acid Sucrose Trometamol Calcium chloride dihydrate Sodium chloride Water for injection

Prescription-type:

Prescription

Geproduceerd door:

Lonza Ltd

therapeutische indicaties:

XIAFLEX is indicated for the treatment of Dupuytren's contracture in adult patients with palpable cord.

Product samenvatting:

Package - Contents - Shelf Life: Combination pack, - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 4 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 1 hours reconstituted (not refrigerated), no storage statement needed. at 20 to 25 deg C - Vial, glass, active component - 0.9 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, diluent - 3 mL - 48 months from date of manufacture stored at or below 30°C. do not freeze

Autorisatie datum:

2014-01-15

Bijsluiter

XIAFLEX

_ _
_(Zi a flex) _
Collagenase clostridium histolyticum – 900 micrograms powder and
diluent for solution for
injection.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE
PROFESSIONALS ONLY:
DUPUYTREN’S CONTRACTURE
INSTRUCTIONS FOR USE AND HANDLING
1. PREPARATION - RECONSTITUTION PROCEDURE
The single dose vial containing XIAFLEX powder and
the single dose vial containing the diluent for solution
for
injection
for
reconstitution
must
be
refrigerated.
Prior to use, the vial containing XIAFLEX powder and
the
vial
containing
the
diluent
for
solution
for
reconstitution must be removed from the refrigerator
and allowed to stand at room temperature for at least
15 minutes and no longer than 60 minutes.
Each
vial
of
XIAFLEX
and
sterile
solvent
for
reconstitution should only be used for a single injection.
If two cords of affected joints on the same hand are to
be treated during a treatment visit, separate vials and
syringes should be used for each reconstitution and
injection.
Confirm the joint(s) to be treated (metacarpophalangeal
[MP] or proximal interphalangeal [PIP]) as the volume
of diluent required for reconstitution is determined by
the type of joint(s).
Using an aseptic technique, the following procedure for
reconstitution must be followed:
1.
Confirm
the
joint(s)
to
be
treated
(metacarpophalangeal [MP] or proximal interphalangeal
[PIP])
as
the
volume
of
diluent
required
for
reconstitution is determined by the type of joint (PIP
joint requires a smaller volume for injection).
2. Remove the flip-off plastic caps the vials and
swab the rubber stopper and surrounding surface of the
vial containing XIAFLEX powder and the vial containing
the diluent for reconstitution with sterile alcohol (no
other antiseptics must be used).
3. Use only the supplied diluent for reconstitution; it
contains calcium which is required for the activity of
XIAFLEX powder. Using a sterile syringe calibrated
with 0.01 mL graduations, withdraw the APPROPRIATE
AMOUNT
OF
DILUENT supplied
in
order
to
deliver
as
follow

Productkenmerken

XIAFLEX NEW ZEALAND DATA SHEET
XIAFLEX (190531) ADS
Page 1 of 33
1 PRODUCT NAME
XIAFLEX collagenase clostridium histolyticum.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 900 micrograms of collagenase Clostridium
histolyticum. Also refer to
Section 6.1 Excipients.
CAS: Clostridium histolyticum gene colG isoenzyme AUX-I: 955089-04-0
CAS: Clostridium histolyticum gene colH isoenzyme AUX-II: 955089-06-2
XIAFLEX is a lyophilised product for intralesional administration.
XIAFLEX contains purified collagenase
clostridium histolyticum, consisting of two microbial collagenases in
a defined mass ratio, Collagenase
AUX-I and Collagenase AUX-II, which are isolated and purified from the
fermentation of Clostridium
histolyticum bacteria. A collagenase is an enzyme that recognises and
binds to collagen in its native
conformation and cleaves the peptide bonds resulting in collagen
breakdown. Collagenase AUX-I is a
single polypeptide chain consisting of approximately 1000 amino acids
of known sequence. It has an
observed molecular weight of 114 kiloDaltons (kDa). It belongs to the
class I Clostridium histolyticum
collagenases. Collagenase AUX-II is a single polypeptide chain
consisting of approximately 1000 amino
acids of known sequence. It has an observed molecular weight of 113
kDa. It belongs to the class II
Clostridium histolyticum collagenases.
3 PHARMACEUTICAL FORM
XIAFLEX is supplied as a sterile lyophilised powder (white cake)
intended for reconstitution with the
provided diluent.
The XIAFLEX diluent is a clear colourless solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
XIAFLEX is indicated for the treatment of Dupuytren’s contracture in
adult patients with a palpable
cord.
The treatment of adult men with Peyronie’s disease with a palpable
plaque and curvature deformity
of at least 30 degrees at the start of therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dupuytren’s Contracture
XIAFLEX is only to be administered by qualified doctors who are
experienced in the diagnosis of
Dupu