Buprenorfine Sandoz 40 microgram/uur 7 dagen, pleister voor transdermaal gebruik

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

BUPRENORFINE 40 mg/stuk

INN (International Name):

BUPRENORFINE 40 mg/stuk

Pharmaceutical form:

Pleister voor transdermaal gebruik

Composition:

COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT (75,0), BUTYLACRYLAAT (15,0), ACRYLZUUR (5,0), VINYLACETAAT (5,0) MET ALUMINIUMACETYLACETONAAT ALS CROSSLINKINGAGENT ; LEVULINEZUUR ; OLEYLOLEAAT ; POLYETHYLEENTEREPHTHALAAT ; POLYETHYLEENTEREPHTHALAAT, GESILICONEERD ; POLYURETHAAN NIET-GEWEVEN MEDICINAAL TAPE ; POVIDON K 90 (E 1201) ; ZWARTE INKT

Administration route:

Transdermaal gebruik

Authorization date:

1900-01-01

Patient Information leaflet

Sandoz B.V.
Page 1/12
Buprenorfine Sandoz
®
25, 30, 40microgram/uur 7 dagen,
pleister voor transdermaal gebruik
RVG 128363, 128364,128366
1313-v1
1.3.1.3 Bijsluiter
Maart 2022
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
Buprenorfine Sandoz 25 microgram/uur 7 dagen, pleister voor
transdermaal gebruik
Buprenorfine Sandoz 30 microgram/uur 7 dagen, pleister voor
transdermaal gebruik
Buprenorfine Sandoz 40 microgram/uur 7 dagen, pleister voor
transdermaal gebruik
buprenorfine
For use in adults
_ _
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 pharmacist.
•
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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What {[Nationally completed name]} is and what it is used for
2.
What you need to know before you use {[Nationally completed name]}
3.
How to use {[Nationally completed name]}
4.
Possible side effects
5.
How to store {[Nationally completed name]}
6.
Contents of the pack and other information
1.
WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
{[Nationally completed name]} transdermal patches contain the active
substance buprenorphine,
which belongs to a group of medicines called strong analgesics or
‘painkillers’.
{[Nationally completed name]} is used in adults to relieve moderate,
long-lasting pain that requires
the use of a strong painkiller.
{[Nationally completed name]} should not be used to relieve acute
pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE {[NATIONALLY COMPLETED NAME]}
_ _
DO NOT USE {[NATIONALLY COMPLETED NAME]} IF YOU
•
are allergic to buprenorphine or any of the other ingredients of this
medicine (listed in section 6)
•
h

Summary of Product characteristics

Sandoz B.V.
Page 1/15
Buprenorfine Sandoz 25, 30, 40 microgram/uur 7 dagen,
pleister voor transdermaal gebruik
RVG 128363, 128364, 128366
1311-v1
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2022
1.
NAAM VAN HET GENEESMIDDEL
Buprenorfine Sandoz 25 microgram/uur 7 dagen, pleister voor
transdermaal gebruik
Buprenorfine Sandoz 30 microgram/uur 7 dagen, pleister voor
transdermaal gebruik
Buprenorfine Sandoz 40 microgram/uur 7 dagen, pleister voor
transdermaal gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[Nationally completed name] 25 microgram/hour transdermal patch}:
Each transdermal patch contains 25 mg of buprenorphine per 31.25 cm
2
, releasing 25 micrograms of
buprenorphine per hour.
{[Nationally completed name] 30 microgram/hour transdermal patch}:
Each transdermal patch contains 30 mg of buprenorphine per 37.5 cm
2
, releasing 30 micrograms of
buprenorphine per hour.
{[Nationally completed name] 40 microgram/hour transdermal patch}:
Each transdermal patch contains 40 mg of buprenorphine per 50 cm
2
, releasing 40 micrograms of
buprenorphine per hour.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
The medicinal product is composed of a transdermal patch containing
the active substance integrated
with an oversized pale yellowish-brown cover patch without any active
substance. The shape of the
transdermal patch is rectangular with rounded edges. The transdermal
patch contains the following
imprint:
‘Buprenorphinum 25 µg/h’
‘Buprenorphinum 30 µg/h’
‘Buprenorphinum 40 µg/h’
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of non-malignant pain of moderate intensity when an opioid
is necessary for obtaining
adequate analgesia.
[Nationally completed name] is not suitable for the treatment of acute
pain.
[Nationally completed name] is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
[Nationally completed name] should be administered every 7th day.
_ _
_Patients aged 18 years and over _
Sandoz B.V.
Page 2/15
Bu