Buprefarm 40 mikrogram/timme Depotplåster

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Navodilo za uporabo Navodilo za uporabo (PIL)
06-11-2020
Lastnosti izdelka Lastnosti izdelka (SPC)
31-08-2020

Aktivna sestavina:

buprenorfin

Dostopno od:

Orifarm Generics A/S

Koda artikla:

N02AE01

INN (mednarodno ime):

buprenorphine

Odmerek:

40 mikrogram/timme

Farmacevtska oblika:

Depotplåster

Sestava:

buprenorfin 40 mg Aktiv substans

Tip zastaranja:

Receptbelagt

Povzetek izdelek:

Förpacknings: Påse, 1 x 1 plåster; Påse, 10 x 1 plåster; Påse, 12 x 1 plåster; Påse, 2 x 1 plåster; Påse, 3 x 1 plåster; Påse, 4 x 1 plåster; Påse, 5 x 1 plåster; Påse, 8 x 1 plåster

Status dovoljenje:

Godkänd

Datum dovoljenje:

2020-08-31

Navodilo za uporabo

                                1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUPREFARM 5 MICROGRAM/HOUR TRANSDERMAL PATCH
BUPREFARM 10 MICROGRAM/HOUR TRANSDERMAL PATCH
BUPREFARM 15 MICROGRAM/HOUR TRANSDERMAL PATCH
BUPREFARM 20 MICROGRAM/HOUR TRANSDERMAL PATCH
BUPREFARM 25 MICROGRAM/HOUR TRANSDERMAL PATCH
BUPREFARM 30 MICROGRAM/HOUR TRANSDERMAL PATCH
BUPREFARM 40 MICROGRAM/HOUR TRANSDERMAL PATCH
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 Buprefarm is and what it is used for
2.
What you need to know before you use Buprefarm
3.
How to use Buprefarm
4.
Possible side effects
5.
How to store Buprefarm
6.
Contents of the pack and other information
1.
WHAT BUPREFARM IS AND WHAT IT IS USED FOR
Buprefarm contain the active ingredient buprenorphine which belongs to
a group of medicines called
strong analgesics or ‘painkillers’. They have been prescribed for
you by your doctor to relieve
moderate, long-lasting pain that requires the use of a strong
painkiller.
Buprefarm should not be used to relieve acute pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUPREFARM
DO NOT USE BUPREFARM:
-
if you are allergic to buprenorphine or any of the other ingredients
of this medicine (listed in
section 6);
-
if you have breathing problems;
-
if you are addicted to drugs;
-
if you are taking a type of medicine known as a monoamine oxidase
inhibitor (examples
include tranylcypromide, phenelzine, isocarboxazid, moclobemide and
linezolid), or you have
taken this type of medicine in the last two weeks;
-
if you suffer from myasthenia g
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Buprefarm 5 microgram/hour transdermal patch
Buprefarm 10 microgram/hour transdermal patch
Buprefarm 15 microgram/hour transdermal patch
Buprefarm 20 microgram/hour transdermal patch
Buprefarm 25 microgram/hour transdermal patch
Buprefarm 30 microgram/hour transdermal patch
Buprefarm 40 microgram/hour transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Buprefarm 5 microgram/hour:
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.
Buprefarm 10 microgram/hour:
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.
Buprefarm 15 microgram/hour:
Each transdermal patch contains 15 mg of buprenorphine in a 18.75 cm²
area releasing a nominal 15
micrograms of buprenorphine per hour over a period of 7 days.
Buprefarm 20 microgram/hour:
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.
Buprefarm 25 microgram/hour:
Each transdermal patch contains 25 mg of buprenorphine in a 31.25 cm²
area releasing a nominal 25
micrograms of buprenorphine per hour over a period of 7 days.
Buprefarm 30 microgram/hour:
Each transdermal patch contains 30 mg of buprenorphine in a 37.5 cm²
area releasing a nominal 30
micrograms of buprenorphine per hour over a period of 7 days.
Buprefarm 40 microgram/hour:
Each transdermal patch contains 40 mg of buprenorphine in a 50 cm²
area releasing a nominal 40
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
Buprefarm 5 microgram/hour: Rectangular beige coloured patch with
rounded edges and imprinted with
“Buprenorphin” and “5 μg/h” in blue colour.
Buprefarm 10 microgram/hour: Rectangular beige coloure
                                
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