Episalvan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-07-2022
Charakterystyka produktu
(SPC)
15-07-2022
Sprawozdanie z oceny publicznego
(PAR)
15-07-2022
Składnik aktywny:
Betulae cortex
Dostępny od:
Amryt AG
Kod ATC:
D03AX13
INN (International Nazwa):
birch bark extract
Grupa terapeutyczna:
Preparations for treatment of wounds and ulcers
Dziedzina terapeutyczna:
Wounds and Injuries; Wound Healing
Wskazania:
Treatment of partial thickness wounds in adults. See sections 4.4 and 5.1 in Product Information with respect to type of wounds studied.,
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2016-01-14
Ulotka dla pacjenta
B. PACKAGE LEAFLET
15
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPISALVAN GEL
birch bark extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Episalvan is and what it is used for
2.
What you need to know before you use Episalvan
3.
How to use Episalvan
4.
Possible side effects
5.
How to store Episalvan
6.
Contents of the pack and other information
1.
WHAT EPISALVAN IS AND WHAT IT IS USED FOR
Episalvan gel is a herbal medicinal product which contains dry extract
from birch bark.
It is used in adults for the treatment of skin wounds, resulting for
example from grade 2a burn wounds
or from surgical skin graft transplantation. There is no experience of
the use of Episalvan for the
treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg
ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EPISALVAN
_ _
DO NOT USE EPISALVAN
-
if you are allergic to birch bark or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Episalvan.
Episalvan does not contain birch pollen, so it may be used by people
with birch pollen allergy.
Wound infection is a serious complication that can occur during the
healing process.
Possible signs of a wound infection are that the wound begins to drain
yellow or greenish fluid (pus),
or that the skin around the wound becomes red, warm, swollen, or
increasingly painful.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children and adolescents under 18 yea
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Episalvan gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g gel contains: 100 mg extract (as dry extract, refined) from birch
bark from
_Betula pendula_
Roth,
_Betula pubescens _
Ehrh. as well as hybrids of both species (equivalent to 0.5-1.0 g
birch bark),
corresponding to 72-88 mg betulin.
Extraction solvent: n-Heptane
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
Colourless to slightly yellowish, opalescent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of partial thickness wounds in adults. See section 4.4 and
5.1 with respect to type of
wounds studied.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The gel should be applied to the wound surface at a thickness of
approximately 1 mm and covered by
sterile wound dressing. The gel should be re-applied at each wound
dressing change, until the wound
is healed, for up to 4 weeks (see section 4.4 “wound size” and
“duration of use”).
Special populations
_Renal or hepatic impairment _
No formal studies have been conducted with Episalvan in patients with
renal or hepatic impairment.
No dose adjustment or special considerations are anticipated for
patients with renal or hepatic
impairment (see section 5.2).
_Elderly _
No dose adjustment is required.
_Paediatric population _
The safety and efficacy of Episalvan in children and adolescents under
18 years have not yet been
established. No data are available.
Method of administration
For cutaneous application.
Fresh wounds should achieve haemostasis prior to application of
Episalvan. If necessary, wounds
(accidental wounds) should be cleaned according to standard procedure,
using e.g. wound antiseptic
solution, prior to application of Episalvan.
2
Medicinal product no longer authorised
Episalvan is for single use only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to the excipient listed in
section 6.1.
4.4
SPECIAL WARNINGS AND
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