Regranex
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
15-08-2012
Fachinformation
(SPC)
15-08-2012
Öffentlichen Beurteilungsberichts
(PAR)
15-08-2012
Wirkstoff:
becaplermin
Verfügbar ab:
Janssen-Cilag International NV
ATC-Code:
D03AX06
INN (Internationale Bezeichnung):
becaplermin
Therapiegruppe:
Preparations for treatment of wounds and ulcers
Therapiebereich:
Wound Healing; Skin Ulcer
Anwendungsgebiete:
Regranex is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
Produktbesonderheiten:
Revision: 18
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
1999-03-29
Gebrauchsinformation
B. PACKAGE LEAFLET
13
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
REGRANEX 0.01% GEL.
Becaplermin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What REGRANEX is and what it is used for
2.
Before you use REGRANEX
3.
How to use REGRANEX
4.
Possible side effects
5.
How to store REGRANEX
6.
Further information
1.
WHAT REGRANEX IS AND WHAT IT IS USED FOR
The name of your medicine is REGRANEX. It contains a substance called
becaplermin. Becaplermin
is a human recombinant Platelet Derived Growth Factor (rhPDGF).
REGRANEX is used to help the growth of normal tissue in order to heal
skin ulcers. It is used with
other good wound care measures to help with the healing of the ulcers.
Good wound care measures include:
•
Your doctor or healthcare professional removing dead skin/debris from
the wound whenever
necessary
•
Keeping weight off your feet, perhaps by wearing special orthopaedic
shoes or by other methods
•
Your doctor or healthcare professional treating any infection of the
wound - treatment with
REGRANEX should be stopped if the wound becomes infected
•
Continuing to visit your doctor or healthcare professional and
following your treatment plan
REGRANEX is used for skin ulcers that:
•
Are not more than 5 square centimetres (see diagram opposite) and have
a good blood supply
•
Are due to complications of diabetes.
_Insert diagram of size (circle measuring 2.524 cm in diameter) _
By using REGRANEX, it is more likely that your skin ulcers will heal
quickly and completely.
2.
BEFORE YOU USE REGRANEX
DO NOT USE REGRANEX:
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Fachinformation
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
REGRANEX 0.01% gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 100
μ
g of becaplermin*.
* Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB)
produced in
_Saccharomyces cerevisiae _
by recombinant DNA technology.
Excipients:
Each gram contains E218 (methyl parahydroxybenzoate) 1.56 mg and E216
(propyl
parahydroxybenzoate) 0.17 mg, see section 4.4.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
REGRANEX is a clear colourless to straw-coloured gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REGRANEX is indicated, in association with other good wound care
measures, to promote
granulation and thereby the healing of full-thickness, neuropathic,
chronic, diabetic ulcers less than
or equal to 5 cm
2
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with REGRANEX should be initiated and monitored by
physicians (specialists or non-
specialists) who are experienced in the management of diabetic wounds.
REGRANEX should always be used in conjunction with good wound care
consisting of initial
debridement (to remove all the necrotic and/or infected tissue),
additional debridement as necessary
and a non-weight-bearing regimen to alleviate pressure on the ulcer.
REGRANEX should be applied as a continuous thin layer to the entire
ulcerated area(s) once daily using
a clean application aid. The site(s) of application should then be
covered by a moist saline gauze dressing
that maintains a moist wound-healing environment. REGRANEX should not
be used in conjunction with
occlusive dressings.
-
A tube of REGRANEX should be used on a single patient only.
-
Care should be taken during use to avoid microbial contamination and
spoilage.
-
Hands should be washed thoroughly before applying REGRANEX.
-
The tip of the tube should not come into contact with the wound or any
other surface.
-
The use of a clean application aid is recommended and contac
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