Xiapex
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
02-03-2020
Charakterystyka produktu
(SPC)
02-03-2020
Sprawozdanie z oceny publicznego
(PAR)
02-03-2020
Składnik aktywny:
collagenase Clostridium histolyticum
Dostępny od:
Swedish Orphan Biovitrum AB
Kod ATC:
M09AB02
INN (International Nazwa):
collagenase Clostridium histolyticum
Grupa terapeutyczna:
Other drugs for disorders of the musculo-skeletal system
Dziedzina terapeutyczna:
Dupuytren Contracture
Wskazania:
, 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.
Podsumowanie produktu:
Revision: 20
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-02-28
Ulotka dla pacjenta
37
B. PACKAGE LEAFLET
Medicinal product no longer authorised
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
XIAPEX 0.9 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
collagenase
_clostridium histolyticum _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xiapex is and what it is used for
2.
What you need to know before you are given Xiapex
3.
How Xiapex is used
4.
Possible side effects
5.
How to store Xiapex
6.
Contents of the pack and other information
1.
WHAT XIAPEX IS AND WHAT IT IS USED FOR
Xiapex is used for the treatment of two different conditions:
DUPUYTREN’S CONTRACTURE IN ADULT
PATIENTS WITH A PALPABLE CORD
and
PEYRONIE’S DISEASE IN ADULT MEN
.
DUPUYTREN’S CONTRACTURE
This is a disease that causes your finger(s) to bend inward. This
bending is called a contracture and is
caused by the abnormal formation of a cord containing collagen under
your skin. For many people, a
contracture causes significant difficulties with performing everyday
tasks like driving, shaking hands,
playing sports, opening jars, typing or holding objects.
PEYRONIE’S DISEASE
This is a condition where adult men have a ‘plaque’ that can be
felt and a curve to their penis. The
disease can cause a change in the shape of the erect penis due to the
abnormal build-up of scar tissue,
known as a plaque, within the stretchy fibres of the penis. The plaque
may interfere with the ability to
get a straight erection because the plaque will not stretch as much as
the rest of the penis. Men with
Peyronie’s disease may have an erection that is curved or bent.
The ac
tive substance in Xiapex is collagenase
_clostridium histolyticum_
, and this collagenase is
produced using the microorganism
_Clostri
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Xiapex 0.9 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 0.9 mg of collagenase
_clostridium histolyticum_
*.
*A formulation of two collagenase enzymes co-expressed and harvested
from anaerobic fermentation
of a phenotypically selected strain of C
_lostridium histolyticum _
bacterium.
Excipients with known effect
Sodium injected per joint in the treatment of Dupuytren’s
contracture:
Metacarpophalangeal (MP) joints: 0.9 mg.
Proximal interphalangeal (PIP) joints: 0.7 mg.
Sodium injected per plaque in the treatment of Peyronie’s disease:
0.9 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is a white lyophilised powder.
The solvent is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xiapex 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 (see sections
4.2 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dupuytren’s contracture _
Xiapex must be administered by a physician appropriately trained in
the correct administration of the
medicinal product and experienced in the diagnosis and management of
Dupuytren’s disease.
Posology
The recommended dose of Xiapex is 0.58 mg per injection into a
palpable Dupuytren’s cord. The
volume of solvent required and the volume of reconstituted Xiapex to
be administered into the
Dupuytren’s cord differs depending on the type of joint being
treated (for the reconstitution
instructions, see section 6.6, Table 14).
•
For cords affecting MP joints each dose is administered in an
injection volume of 0.25 ml.
•
For cords affecting PIP joints, each dose is admini
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