Wegovy

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-10-2023
Public Assessment Report Public Assessment Report (PAR)
09-06-2023

Active ingredient:

semaglutide

Available from:

Novo Nordisk A/S

ATC code:

A10BJ06

INN (International Name):

semaglutide

Therapeutic group:

Preparazzjonijiet ta 'kontra l-ossessjoni, esklużi prodotti tad-dieta

Therapeutic area:

Obesity; Overweight

Therapeutic indications:

Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to.

Product summary:

Revision: 4

Authorization status:

Awtorizzat

Authorization date:

2022-01-06

Patient Information leaflet

                                67
B. FULJETT TA’ TAGĦRIF
68
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
WEGOVY 0.25 MG SOLUZZJONI GĦALL-INJEZZJONI F’PINNA MIMLIJA
GĦAL-LEST
WEGOVY 0.5 MG SOLUZZJONI GĦALL-INJEZZJONI F’PINNA MIMLIJA
GĦAL-LEST
WEGOVY 1 MG SOLUZZJONI GĦALL-INJEZZJONI F’PINNA MIMLIJA GĦAL-LEST
WEGOVY 1.7 MG SOLUZZJONI GĦALL-INJEZZJONI F’PINNA MIMLIJA
GĦAL-LEST
WEGOVY 2.4 MG SOLUZZJONI GĦALL-INJEZZJONI F’PINNA MIMLIJA
GĦAL-LEST
semaglutide
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA DIN IL-MEDIĊINA
PERESS LI FIH
INFORMAZZJONI IMPORTANTI GĦALIK.
–
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
–
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar jew
lill-infermier tiegħek.
–
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anke jekk għandhom l-istess sinjali ta’
mard bħal tiegħek.
–
Jekk ikollok xi effett sekondarju kellem lit-tabib, lill-ispiżjar jew
lill-infermier tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Wegovy u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Wegovy
3.
Kif għandek tuża Wegovy
4.
Effetti sekondarji possibbli
5.
Kif taħżen Wegovy
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU WEGOVY U GĦALXIEX JINTUŻA
X’INHU WEGOVY
Wegovy huwa mediċina għal tnaqqis fil-piż u ż-żamma tal-piż li
fiha s-sustanza attiva semaglutide.
Huwa simili għal ormon naturali msejjaħ
_glucagon-like peptide_
-1 (GLP-1) li tirrilaxxa l-musrana wara
ikla. Jaħdem billi jaġixxi fuq miri (riċetturi) fil-moħħ li
jikkontrollaw
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti tal-kura tas-saħħa
huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata. Ara
sezzjoni 4.8 dwar kif
għandhom jiġu rrappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
Wegovy 0.25 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Wegovy 0.5 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Wegovy 1 mg soluzzjoni għall-injezzjoni f’pinna mimlija għal-lest
Wegovy 1.7 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Wegovy 2.4 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Wegovy 0.25 mg FlexTouch soluzzjoni għall-injezzjoni f’pinna
mimlija għal-lest
Wegovy 0.5 mg FlexTouch soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Wegovy 1 mg FlexTouch soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Wegovy 1.7 mg FlexTouch soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Wegovy 2.4 mg FlexTouch soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Pinna mimlija għal-lest, doża waħda
_Wegovy 0.25 mg soluzzjoni għall-injezzjoni_
Kull pinna mimlija għal-lest b’doża waħda fiha 0.25 mg
semaglutide* f’soluzzjoni ta’ 0.5 mL. mL
wieħed ta’ soluzzjoni fih 0.5 mg ta’ semaglutide*.
_Wegovy 0.5 mg _
_soluzzjoni għall-injezzjoni_
Kull pinna mimlija għal-lest b’doża waħda fiha 0.5 mg
semaglutide* f’soluzzjoni ta’ 0.5 mL. mL
wieħed ta’ soluzzjoni fih 1 mg ta’ semaglutide*
_Wegovy 1 mg soluzzjoni għall-injezzjoni_
Kull pinna mimlija għal-lest b’doża waħda fiha 1 mg semaglutide*
f’soluzzjoni ta’ 0.5 mL. mL
wieħed ta’ soluzzjoni fih 2 mg ta’ semaglutide*.
_Wegovy 1.7 mg _
_soluzzjoni għall-injezzjoni_
Kull pinna mimlija għal-lest b’doża waħda fiha 1.7 mg
semaglutide* f’soluzzjoni ta’ 0.75 mL. mL

                                
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Active ingredient semaglutide

semaglutide

ATC code A10BJ06

A10BJ06

Marketed by Novo Nordisk A/S

Novo Nordisk A/S

INN (International Name) semaglutide

semaglutide

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Patient Information leaflet Patient Information leaflet Bulgarian 13-10-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-10-2023
Public Assessment Report Public Assessment Report Bulgarian 09-06-2023
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Summary of Product characteristics Summary of Product characteristics Spanish 13-10-2023
Public Assessment Report Public Assessment Report Spanish 09-06-2023
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Public Assessment Report Public Assessment Report Czech 09-06-2023
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Public Assessment Report Public Assessment Report Danish 09-06-2023
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Public Assessment Report Public Assessment Report German 09-06-2023
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Public Assessment Report Public Assessment Report Estonian 09-06-2023
Patient Information leaflet Patient Information leaflet Greek 13-10-2023
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Public Assessment Report Public Assessment Report Greek 09-06-2023
Patient Information leaflet Patient Information leaflet English 13-10-2023
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Public Assessment Report Public Assessment Report English 09-06-2023
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