Buprenorfine Sandoz pleister 5 microgram/uur, pleister voor transdermaal gebruik

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

BUPRENORFINE

Dostopno od:

Sandoz B.V.

Koda artikla:

N02AE01

INN (mednarodno ime):

BUPRENORPHINE

Farmacevtska oblika:

Pleister voor transdermaal gebruik

Sestava:

BLAUWE INKT ; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT (75,0), BUTYLACRYLAAT (15,0), ACRYLZUUR (5,0), VINYLACETAAT (5,0) MET ALUMINIUMACETYLACETONAAT ALS CROSSLINKINGAGENT ; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT, GLYCIDYLMETHACRYLAAT, HYDROXYETHYLACRYLAAT, VINYLACETAAT ; LEVULINEZUUR ; OLEYLOLEAAT ; POLYESTER ; POLYETHYLEENTEREPHTHALAAT ; POLYETHYLEENTEREPHTHALAAT, GESILICONEERD ; POVIDON K 90 (E 1201),

Pot uporabe:

Transdermaal gebruik

Terapevtsko območje:

Buprenorphine

Povzetek izdelek:

Hulpstoffen: BLAUWE INKT; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT, GLYCIDYLMETHACRYLAAT, HYDROXYETHYLACRYLAAT, VINYLACETAAT; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT (75,0), BUTYLACRYLAAT (15,0), ACRYLZUUR (5,0), VINYLACETAAT (5,0) MET ALUMINIUMACETYLACETONAAT ALS CROSSLINKINGAGENT; LEVULINEZUUR; OLEYLOLEAAT; POLYESTER; POLYETHYLEENTEREPHTHALAAT; POLYETHYLEENTEREPHTHALAAT, GESILICONEERD; POVIDON K 90 (E 1201);

Datum dovoljenje:

2017-01-19

Navodilo za uporabo

Sandoz B.V.
Page 1/11
Buprenorfine Sandoz 5, 10, 20 microgram/uur, pleister
voor transdermaal gebruik
RVG 118909-10-11
1313-V3
1.3.1.3 Bijsluiter
April 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPRENORFINE SANDOZ
® PLEISTER 5 MICROGRAM/UUR, PLEISTER VOOR TRANSDERMAAL GEBRUIK
BUPRENORFINE SANDOZ
® PLEISTER 10 MICROGRAM/UUR, PLEISTER VOOR TRANSDERMAAL GEBRUIK
BUPRENORFINE SANDOZ
® PLEISTER 20 MICROGRAM/UUR, PLEISTER VOOR TRANSDERMAAL GEBRUIK
buprenorphine
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] contains the active substance
buprenorphine which belongs to a group of
medicines called strong analgesics or ‘painkillers’. It has been
prescribed for you by your doctor 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);

have breathing problems;

are addicted to drugs;

are taking a type

Lastnosti izdelka

Sandoz B.V.
Page 1/13
Buprenorfine Sandoz 5, 10, 20 microgram/uur, pleister
voor transdermaal gebruik
RVG 118909-10-11
1311-V3
1.3.1.1 Samenvatting van de Productkenmerken
April 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Buprenorfine Sandoz pleister 5 microgram/uur, pleister voor
transdermaal gebruik
Buprenorfine Sandoz pleister 10 microgram/uur, pleister voor
transdermaal gebruik
Buprenorfine Sandoz pleister 20 microgram/uur, pleister voor
transdermaal gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[5 micrograms/h:]
Each transdermal patch contains 5 mg of buprenorphine in a 6.25 cm²
area releasing a nominal
5 micrograms of buprenorphine per hour over a period of 7 days.
[10 micrograms/h:]
Each transdermal patch contains 10 mg of buprenorphine in a 12.5 cm²
area releasing a nominal
10 micrograms of buprenorphine per hour over a period of 7 days.
[20 micrograms/h:]
Each transdermal patch contains 20 mg of buprenorphine in a 25 cm²
area releasing a nominal
20 micrograms of buprenorphine per hour over a period of 7 days.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch
[5 micrograms/h:]
Rectangular beige coloured patch with rounded edges and imprinted with
“Buprenorphin” and “5 μg/h” in
blue colour.
[10 micrograms/h:]
Rectangular beige coloured patch with rounded edges and imprinted with
“Buprenorphin” and “10 μg/h” in
blue colour.
[20 micrograms/h:]
Rectangular beige coloured patch with rounded edges and imprinted with
“Buprenorphin” and “20 μg/h ” in
blue colour.
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
Sandoz B.V.
Page 2/13
Buprenorfine Sandoz 5, 10, 20 microgram/uur, pleister
voor transdermaal gebruik
RVG 118909-10