Zubsolv

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
10-10-2023
Public Assessment Report Public Assessment Report (PAR)
12-01-2018

Active ingredient:

Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate

Available from:

Accord Healthcare S.L.U.

ATC code:

N07BC51

INN (International Name):

buprenorphine, naloxone

Therapeutic group:

Andre narkotika stoffer

Therapeutic area:

Opioid-relaterede lidelser

Therapeutic indications:

Substitutionsbehandling for opioidlægemiddelafhængighed inden for rammerne af medicinsk, social og psykologisk behandling. Intentionen med naloxon-komponenten er at afskrække intravenøs misbrug. Behandlingen er beregnet til brug hos voksne og unge over 15 år, som har accepteret at blive behandlet for afhængighed.

Product summary:

Revision: 10

Authorization status:

autoriseret

Authorization date:

2017-11-10

Patient Information leaflet

                                41
B. INDLÆGSSEDDEL
42
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
ZUBSOLV 0,7 MG/0,18 MG SUBLINGUALE RESORIBLETTER
ZUBSOLV 1,4 MG/0,36 MG SUBLINGUALE RESORIBLETTER
ZUBSOLV 2,9 MG/0,71 MG SUBLINGUALE RESORIBLETTER
ZUBSOLV 5,7 MG/1,4 MG SUBLINGUALE RESORIBLETTER
ZUBSOLV 8,6 MG/2,1 MG SUBLINGUALE RESORIBLETTER
ZUBSOLV 11,4 MG/2,9 MG SUBLINGUALE RESORIBLETTER
buprenorphin/naloxon
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT TAGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
-
Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor
være med at give medicinen
til andre. Det kan være skadeligt for andre, selvom de har de samme
symptomer, som du har.
-
Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger,
herunder bivirkninger, som
ikke er nævnt i denne indlægsseddel. Se punkt 4.
Se den nyeste indlægsseddel på www.indlaegsseddel.dk
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at tage Zubsolv
3.
Sådan skal du tage Zubsolv
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Zubsolv indeholder de aktiver stoffer buprenorphin og naloxon. Zubsolv
bruges til at behandle
afhængighed af opioider (narkotika), såsom heroin eller morfin hos
stofmisbrugere, som har indvilliget
i at blive behandlet for deres afhængighed. Zubsolv bruges til voksne
og unge over 15 år, som får
medicinsk, social og psykologisk støtte.
SÅDAN VIRKER ZUBSOLV
Resoribletten indeholder buprenorphin, som har til opgave at behandle
afhængigheden af opioider
(narkotika). Den indeholder ligeledes naloxon, som bruges til at
hindre intravenøst misbrug af
produktet.
2.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ZUBSOLV
_ _
TAG IKKE ZUBSOLV,
hvis du:
-
er allergisk over for buprenorphin, naloxon eller et af de øvrige
indholdsstoffer i Zubsolv
(angivet i punkt 6)
-
har
ALV
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Zubsolv 0,7 mg/0,18 mg sublinguale resoribletter
Zubsolv 1,4 mg/0,36 mg sublinguale resoribletter
Zubsolv 2,9 mg/0,71 mg sublinguale resoribletter
Zubsolv 5,7 mg/1,4 mg sublinguale resoribletter
Zubsolv 8,6 mg/2,1 mg sublinguale resoribletter
Zubsolv 11,4 mg/2,9 mg sublinguale resoribletter
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Zubsolv 0,7 mg/0,18 mg sublinguale resoribletter
Hver sublingual resoriblet på 0,7 mg/0,18 mg indeholder 0,7 mg
buprenorphin (som hydrochlorid) og
0,18 mg naloxon (som hydrochloriddihydrat).
Zubsolv 1,4 mg/0,36 mg sublinguale resoribletter
Hver sublingual resoriblet på 1,4 mg/0,36 mg indeholder 1,4 mg
buprenorphin (som hydrochlorid) og
0,36 mg naloxon (som hydrochloriddihydrat).
Zubsolv 2,9 mg/0,71 mg sublinguale resoribletter
Hver sublingual resoriblet på 2,9 mg/0,71 mg indeholder 2,9 mg
buprenorphin (som hydrochlorid) og
0,71 mg naloxon (som hydrochloriddihydrat).
Zubsolv 5,7 mg/1,4 mg sublinguale resoribletter
Hver sublingual resoriblet på 5,7 mg/1,4 mg indeholder 5,7 mg
buprenorphin (som hydrochlorid) og
1,4 mg naloxon (som hydrochloriddihydrat).
Zubsolv 8,6 mg/2,1 mg sublinguale resoribletter
Hver sublingual resoriblet på 8,6 mg/2,1 mg indeholder 8,6 mg
buprenorphin (som hydrochlorid) og
2,1 mg naloxon (som hydrochloriddihydrat).
Zubsolv 11,4 mg/2,9 mg sublinguale resoribletter
Hver sublingual resoriblet på 11,4 mg/2,9 mg indeholder 11,4 mg
buprenorphin (som hydrochlorid) og
2,9 mg naloxon (som hydrochloriddihydrat).
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Sublingual resoriblet
Zubsolv 0,7 mg/0,18 mg sublinguale resoribletter
En hvid til råhvid, oval tablet, længde 6,8 mm og bredde 4,0 mm,
præget med “.7” på den ene side.
Zubsolv 1,4 mg/0,36 mg sublinguale resoribletter
En hvid til råhvid, trekantet tablet, bund 7,2 mm og højde 6,9 mm,
præget med “1.4” på den ene side.
Zubsolv 2,9 mg/0,71 mg sublinguale resoribletter
En hvid til råhvid, D-formet tablet, højde 7,3 mm og bredde 5,65 m
                                
                                Read the complete document

Similar products

Active ingredient Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate

Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate

ATC code N07BC51

N07BC51

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) buprenorphine, naloxone

buprenorphine, naloxone

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-10-2023
Public Assessment Report Public Assessment Report Bulgarian 12-01-2018
Patient Information leaflet Patient Information leaflet Spanish 10-10-2023
Summary of Product characteristics Summary of Product characteristics Spanish 10-10-2023
Public Assessment Report Public Assessment Report Spanish 12-01-2018
Patient Information leaflet Patient Information leaflet Czech 10-10-2023
Summary of Product characteristics Summary of Product characteristics Czech 10-10-2023
Public Assessment Report Public Assessment Report Czech 12-01-2018
Patient Information leaflet Patient Information leaflet German 10-10-2023
Summary of Product characteristics Summary of Product characteristics German 10-10-2023
Public Assessment Report Public Assessment Report German 12-01-2018
Patient Information leaflet Patient Information leaflet Estonian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Estonian 10-10-2023
Public Assessment Report Public Assessment Report Estonian 12-01-2018
Patient Information leaflet Patient Information leaflet Greek 10-10-2023
Summary of Product characteristics Summary of Product characteristics Greek 10-10-2023
Public Assessment Report Public Assessment Report Greek 12-01-2018
Patient Information leaflet Patient Information leaflet English 10-10-2023
Summary of Product characteristics Summary of Product characteristics English 10-10-2023
Public Assessment Report Public Assessment Report English 12-01-2018
Patient Information leaflet Patient Information leaflet French 10-10-2023
Summary of Product characteristics Summary of Product characteristics French 10-10-2023
Public Assessment Report Public Assessment Report French 12-01-2018
Patient Information leaflet Patient Information leaflet Italian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Italian 10-10-2023
Public Assessment Report Public Assessment Report Italian 12-01-2018
Patient Information leaflet Patient Information leaflet Latvian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Latvian 10-10-2023
Public Assessment Report Public Assessment Report Latvian 12-01-2018
Patient Information leaflet Patient Information leaflet Lithuanian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 10-10-2023
Public Assessment Report Public Assessment Report Lithuanian 12-01-2018
Patient Information leaflet Patient Information leaflet Hungarian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 10-10-2023
Public Assessment Report Public Assessment Report Hungarian 12-01-2018
Patient Information leaflet Patient Information leaflet Maltese 10-10-2023
Summary of Product characteristics Summary of Product characteristics Maltese 10-10-2023
Public Assessment Report Public Assessment Report Maltese 12-01-2018
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Summary of Product characteristics Summary of Product characteristics Dutch 10-10-2023
Public Assessment Report Public Assessment Report Dutch 12-01-2018
Patient Information leaflet Patient Information leaflet Polish 10-10-2023
Summary of Product characteristics Summary of Product characteristics Polish 10-10-2023
Public Assessment Report Public Assessment Report Polish 12-01-2018
Patient Information leaflet Patient Information leaflet Portuguese 10-10-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 10-10-2023
Public Assessment Report Public Assessment Report Portuguese 12-01-2018
Patient Information leaflet Patient Information leaflet Romanian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Romanian 10-10-2023
Public Assessment Report Public Assessment Report Romanian 12-01-2018
Patient Information leaflet Patient Information leaflet Slovak 10-10-2023
Summary of Product characteristics Summary of Product characteristics Slovak 10-10-2023
Public Assessment Report Public Assessment Report Slovak 12-01-2018
Patient Information leaflet Patient Information leaflet Slovenian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 10-10-2023
Public Assessment Report Public Assessment Report Slovenian 12-01-2018
Patient Information leaflet Patient Information leaflet Finnish 10-10-2023
Summary of Product characteristics Summary of Product characteristics Finnish 10-10-2023
Public Assessment Report Public Assessment Report Finnish 12-01-2018
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Summary of Product characteristics Summary of Product characteristics Swedish 10-10-2023
Public Assessment Report Public Assessment Report Swedish 12-01-2018
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Summary of Product characteristics Summary of Product characteristics Norwegian 10-10-2023
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Summary of Product characteristics Summary of Product characteristics Icelandic 10-10-2023
Patient Information leaflet Patient Information leaflet Croatian 10-10-2023
Summary of Product characteristics Summary of Product characteristics Croatian 10-10-2023
Public Assessment Report Public Assessment Report Croatian 12-01-2018

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