qanastek/EMEA-V3 huggingface dataset:
20 Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
20 Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz ta ’ l- inibizzjoni tas- sistema tat- trasport li tnixxi l- ketajins tat- tubuli renali.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
Għalhekk, prodotti mediċinali li huma inibituri ta ’ dan il- passaġġ attiv ta ’ l- eliminazzjoni renali, jew li jkunu mneħħija permezz ta ’ dan il- passagg, bħal cimetidine u amantadine, jistgħu jirreaġixxu ma ’ pramipexole, u dan jirrizulta fi tneħħija mnaqqsa ta ’ wieħed jew iż- żewġ prodotti mediċinali.
21 dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
21 L- aktar reazzjonijiet avversi komuni (≥5%) rapportati f’ pazjenti bil- marda ta ’ Parkinson li kienu aktar frekwenti bit- trattament b’ pramipexole milli bi plaċebo kienu dardir, diskinesja, pressjoni baxxa, sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja.
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
Reazzjoni avversa aktar frekwenti tal- mediċina flimkien ma ’ levodopa kienet diskinesja.
4.9 Overdose
22 4. 9 Doża eċċessiva
22 There is no clinical experience with massive overdose.
M’ hemm l- ebda esperjenza klinika b’ doża eċċessiva massiva.
There is no established antidote for overdose of a dopamine agonist.
M’ hemm l- ebda antidot stabbilit ghal doza eċċessiva ta ’ agonist ta ’ dopamine.
Renal excretion of unchanged pramipexole is the major route of elimination.
23 Pramipexole mhux mibdul jiġi eliminat prinċipalment mill- kliewi.
The total
Madwar 90% ta ’ doża tikkettata ta ’ 14 C hi eliminata mill- kliewi waqt li inqas minn 2% jiġi eliminat ma ’ l- ippurgar.
23 clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
It- tneħħija totali ta ’ pramipexole hi madwar 500 ml/ min u t- tneħħija mill- kliewi hi madwar 400 ml/ min.
6.6 Special precautions for disposal
24 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
24 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
EU/ 1/ 08/ 469/ 011 30 tablets:
EU/ 1/ 08/ 469/ 011 30 pillola:
EU/ 1/ 08/ 469/ 012 60 tablets:
EU/ 1/ 08/ 469/ 012 60 pillola:
EU/ 1/ 08/ 469/ 013 90 tablets:
EU/ 1/ 08/ 469/ 013 90 pillola:
EU/ 1/ 08/ 469/ 014 100 tablets:
EU/ 1/ 08/ 469/ 014 100 pillola:
Oprymea 0.7 mg tablets
Oprymea 0. 7 mg pilloli
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 0. 7 mg bażi ta ’ pramipexole (bħala 1 mg pramipexole dihydrochloride monohydrate).
0.70 mg: white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
0. 70 mg: bajda, tonda, bi truf iċċanfrati u b’ ferq fuq iż- żewġ naħat u intaljar ta ’ "P9" fuq iż- żewġ nofsijiet ta ’ naħa waħda tal- pillola.
26 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
26 Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
4.4 Special warnings and precautions for use
27 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
27 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Meta tingħata riċetta għal Oprymea f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skond kif spjegat f’ sezzjoni 4. 2.
Therefore, medicinal products
28 Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz ta ’ l- inibizzjoni tas- sistema tat- trasport li tnixxi l- ketajins tat- tubuli renali.
28 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipex ole resulting in reduced clearance of either or both medicinal products.
Għalhekk, prodotti mediċinali li huma inibituri ta ’ dan il- passaġġ attiv ta ’ l- eliminazzjoni renali, jew li jkunu mneħħija permezz ta ’ dan il- passagg, bħal cimetidine u amantadine, jistgħu jirreaġixxu ma ’ pramipexole, u dan jirrizulta fi tneħħija mnaqqsa ta ’ wieħed jew iż- żewġ prodotti mediċinali.
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
29 L- aktar reazzjonijiet avversi komuni (≥5%) rapportati f’ pazjenti bil- marda ta ’ Parkinson li kienu aktar frekwenti bit- trattament b’ pramipexole milli bi plaċebo kienu dardir, diskinesja, pressjoni baxxa, sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja.
29 reaction in combination with levodopa was dyskinesia.
Reazzjoni avversa aktar frekwenti tal- mediċina flimkien ma ’ levodopa kienet diskinesja.
4.9 Overdose
30 4. 9 Doża eċċessiva
There is no established antidote for overdose 30 of a dopamine agonist.
M’ hemm l- ebda antidot stabbilit ghal doza eċċessiva ta ’ agonist ta ’ dopamine.
Renal excretion of unchanged pramipexole is the major route of elimination.
31 Pramipexole mhux mibdul jiġi eliminat prinċipalment mill- kliewi.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
It- tneħħija totali ta ’ pramipexole hi madwar 500 ml/ min u t- tneħħija mill- kliewi hi madwar 400 ml/ min.
31 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
6.6 Special precautions for disposal
32 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
EU/ 1/ 08/ 469/ 016 30 tablets:
EU/ 1/ 08/ 469/ 016 30 pillola:
EU/ 1/ 08/ 469/ 017 60 tablets:
EU/ 1/ 08/ 469/ 017 60 pillola:
EU/ 1/ 08/ 469/ 018 90 tablets:
EU/ 1/ 08/ 469/ 018 90 pillola:
EU/ 1/ 08/ 469/ 019 100 tablets:
EU/ 1/ 08/ 469/ 019 100 pillola:
Oprymea 1.1 mg tablets
Oprymea 1. 1 mg pilloli
Each tablet contains 1.1 mg pramipexole base (as 1.5 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 1. 1 mg bażi ta ’ pramipexole (bħala 1. 5 mg pramipexole dihydrochloride monohydrate).
1.1 mg: white, round, with bevelled edges, both sides scored.
1. 1 mg: bajda, tonda, bi truf iċċanfrati u b’ ferq fuq iż- żewġ naħat.
34 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
34 Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
35 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Meta tingħata riċetta għal Oprymea f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skond kif spjegat f’ sezzjoni 4. 2.
Therefore, medicinal products
36 Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz ta ’ l- inibizzjoni tas- sistema tat- trasport li tnixxi l- ketajins tat- tubuli renali.
36 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
Għalhekk, prodotti mediċinali li huma inibituri ta ’ dan il- passaġġ attiv ta ’ l- eliminazzjoni renali, jew li jkunu mneħħija permezz ta ’ dan il- passagg, bħal cimetidine u amantadine, jistgħu jirreaġixxu ma ’ pramipexole, u dan jirrizulta fi tneħħija mnaqqsa ta ’ wieħed jew iż- żewġ prodotti mediċinali.
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
37 L- aktar reazzjonijiet avversi komuni (≥5%) rapportati f’ pazjenti bil- marda ta ’ Parkinson li kienu aktar frekwenti bit- trattament b’ pramipexole milli bi plaċebo kienu dardir, diskinesja, pressjoni baxxa, sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja.
37 reaction in combination with levodopa was dyskinesia.
Reazzjoni avversa aktar frekwenti tal- mediċina flimkien ma ’ levodopa kienet diskinesja.
4.9 Overdose
38 4. 9 Doża eċċessiva
There is no established antidote for overdose 38 of a dopamine agonist.
M’ hemm l- ebda antidot stabbilit ghal doza eċċessiva ta ’ agonist ta ’ dopamine.
Renal excretion of unchanged pramipexole is the major route of elimination.
39 Pramipexole mhux mibdul jiġi eliminat prinċipalment mill- kliewi.
39 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
6.6 Special precautions for disposal
40 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
EU/ 1/ 08/ 469/ 021 30 tablets:
EU/ 1/ 08/ 469/ 021 30 pillola:
EU/ 1/ 08/ 469/ 022 60 tablets:
EU/ 1/ 08/ 469/ 022 60 pillola:
EU/ 1/ 08/ 469/ 023 90 tablets:
EU/ 1/ 08/ 469/ 023 90 pillola:
EU/ 1/ 08/ 469/ 024 100 tablets:
EU/ 1/ 08/ 469/ 024 100 pillola:
41 ANNEX II
41 ANNESS II
Krka, d. d., Novo mesto Š marješ cesta 6 ka 8501 Novo mesto Slovenia
Krka, d. d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Is- Slovenja
The MAH must ensure that the system of pharmacovigilance, as described in version DescPhSys 000001/ 15 (13 October 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza kif deskritta f’ verżjoni DescPhSys 000001/ 15 (13 Ottubru 2008) ippreżentata f ’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq tinsab f’ postha u qed tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
The PSUR submission schedule for Oprymea tablets should follow PSURs submission schedule for the reference medicinal product.
L- iskeda ta ’ sottomissjoni ta ’ PSUR għal pilloli Oprymea għandha ssegwi l- iskeda ta ’ sottomissjoni ta ’ PSUR għal prodott mediċinali ta ’ referenza.
43 ANNEX III
43 ANNESS III
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX for blisters
KAXXA ta ’ folji
Oprymea 0.088 mg tablets Pramipexole
Oprymea 0. 088 mg pilloli Pramipexole
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 088 mg pramipexole li hi ekwivalenti għal 0. 125 mg pramipexole dihydrochloride monohydrate.
20 tablets
20 pillola
Oprymea 0.088 mg
Oprymea 0. 088 mg
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
60 tablets
60 pillola
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51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
90 tablets
90 pillola
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53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER/ (Al/ Al)
FOLJA / (Al/ Al)
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56 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Oprymea 0.18 mg tablets Pramipexole
Oprymea 0. 18 mg pilloli Pramipexole
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 18 mg pramipexole li hi ekwivalenti għal 0. 25 mg pramipexole dihydrochloride monohydrate.
Oprymea 0.18 mg
Oprymea 0. 18 mg
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
61 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
63 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
64 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
65 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
66 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
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TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1.
67 1.
Oprymea 0.35 mg tablets Pramipexole
Oprymea 0. 35 mg pilloli Pramipexole
Each tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 35 mg pramipexole li hi ekwivalenti għal 0. 5 mg pramipexole dihydrochloride monohydrate.
68 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
68 KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
Oprymea 0.35 mg
Oprymea 0. 35 mg
72 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
74 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
1.
75 1.
76 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
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Oprymea 0.7 mg tablets Pramipexole
Oprymea 0. 7 mg pilloli Pramipexole
Each tablet contains 0.7 mg pramipexole equivalent to 1 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 7 mg pramipexole li hi ekwivalenti għal 1 mg pramipexole dihydrochloride monohydrate.
79 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
Oprymea 0.7 mg
Oprymea 0. 7 mg
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
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SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICI NAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
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89 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Oprymea 1.1 mg tablets Pramipexole
Oprymea 1. 1 mg pilloli Pramipexole
Each tablet contains 1.1 mg pramipexole equivalent to 1.5 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 1. 1 mg pramipexole li hi ekwivalenti għal 1. 5 mg pramipexole dihydrochloride monohydrate.
Oprymea 1.1 mg
Oprymea 1. 1 mg
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
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93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
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95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
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99 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
99 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
101 PACKAGE LEAFLET:
101 FULJETT TA ’ TAGĦRIF:
Oprymea 0.088 mg tablets Oprymea 0.18 mg tablets Oprymea 0.35 mg tablets Oprymea 0.7 mg tablets Oprymea 1.1 mg tablets Pramipexole
Oprymea 0. 088 mg pilloli Oprymea 0. 18 mg pilloli Oprymea 0. 35 mg pilloli Oprymea 0. 7 mg pilloli Oprymea 1. 1 mg pilloli Pramipexole
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti oħra li m’ humiex
What Oprymea is and what it is used for 2.
X’ inhi Oprymea u għalxiex tintuża 2.
Before you take Oprymea 3.
Qabel ma tieħu Oprymea 3.
How to take Oprymea 4.
Kif għandek tieħu Oprymea 4.
How to store Oprymea 6.
Kif taħżen Oprymea 6.
WHAT OPRYMEA IS AND WHAT IT IS USED FOR
X’ INHI OPRYMEA U GĦALXIEX TINTUŻA
Oprymea belongs to a group of medicines known as dopamine agonists which stimulate dopamine receptors in the brain.
Oprymea hija parti mill- grupp ta ’ mediċini magħrufin bħala agonisti ta ’ dopamine li jistimulaw ir- riċettaturi ta ’ dopamine fil- moħħ.
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
L- istimulazzjoni ta ’ riċettaturi ta ’ dopamine tistimula l- impulsi tan- nervi fil- moħħ li jgħinu jikkontrollaw il- movimenti tal- ġisem.
Oprymea is used to treat the symptoms of primary Parkinson's disease.
Oprymea tintuża biex tittratta s- sintomi tal- marda primarja ta ’ Parkinson.
It can be used alone or in combination with levodopa.
Tista ’ tintuża waħedha jew flimkien ma ’ levodopa.
BEFORE YOU TAKE OPRYMEA
QABEL MA TIEĦU OPRYMEA
DO NOT take Oprymea
TIEĦUX Oprymea
- If you are allergic (hypersensitive) to pramipexole or any of the other ingredients of Oprymea
- Jekk inti allerġiku (tbati minn sensittività eċċessiva) għal pramipexole jew sustanzi oħra ta ’
"Further information").
Oprymea (ara sezzjoni 6 "Aktar tagħrif").
Take special care with Oprymea Tell your doctor if you have or have had or develop any medical conditions or symptoms, especially any of the following:
Oqgħod attent ħafna b’ Oprymea Għid lit- tabib tiegħek jekk għandek jew kellek jew jekk tiżviluppa kwalunkwe kondizzjoni medika jew sintomu, speċjalment xi wieħed minn dawn li ġejjin:
- Kidney disease.
- Mard tal- kliewi.
- Hallucinations (seeing, hearing or feeling things that are not there).
- Alluċinazzjonijiet (tara, tisma ’ jew tħoss affarijiet li mhumiex hemm).
visual.
alluċinazzjonijiet huma viżwali.
- Dyskinesia (e. g. abnormal, uncontrolled movements of the limbs).
- Diskinesja (e. g. movimenti abnormali mhux ikkontrollati tad- dirgħajn jew ir- riġlejn).
If you have advanced
Jekk inti
Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of Oprymea.
għandek mard tal- Parkinson avvanzat u qed tieħu wkoll levodopa, għandek mnejn tiżviluppa diskinesja matul tittrazzjoni ’ l fuq ta ’ Oprymea.
- Sleepiness and episodes of suddenly falling asleep.
- Irqad u episodji fejn torqod f’ daqqa.
- Behavioural changes (e. g. pathological gambling), increased libido (e. g. increased sexual
- Bidliet fl- imġieba (eż. logħob patoloġiku ta ’ l- azzard), żieda fil- libido (e. g. żieda fil- ħajra
desire), binge eating.
sesswali), tiekol bl- addoċċ.
- Psychosis (e. g. comparable with symptoms of schizophrenia).
- Psikożi (eż. komparabbli mas- sintomi ta ’ l- iskizofrenija).
- Vision impairment.
- Indeboliment fil- vista.
You should have regular eye examinations during treatment with Oprymea.
Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn waqt it- trattament
- Severe heart or blood vessels disease.
- Mard tal- qalb jew tal- vażi tad- demm.
You will need to have your blood pressure checked
Ikollok bżonn tiċċekkja l- pressjoni tad- demm tiegħek
regularly, especially at the beginning of treatment.
regolarment, speċjalment fil- bidu tat- trattament.
This is to avoid postural hypotension (a fall in blood pressure on standing up).
Dan biex tiġi evitata pressjoni posturali baxxa (il- pressjoni tad- demm taqa ’ malli tqum bil- wieqfa).
Children and adolescents Oprymea is not recommended for use in children or adolescents under 18 years.
Tfal u adoloxxenti Oprymea mhux rakkomandat għal użu fi tfal jew adoloxxenti li għandhom taħt it- 18- il sena.
This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
Dan jinkludi mediċini, taħlitiet ta ’ ħxejjex, ikel għas- saħħa jew supplimenti li int tkun ksibt mingħajr riċetta.
You should avoid taking Oprymea together with antipsychotic medicines.
Għandek tevita li tieħu Oprymea flimkien ma ’ mediċini antipsikotiċi.
Take care if you are taking the following medicines:
Oqgħod attent/ a jekk qed tieħu l- mediċini li ġejjin:
- cimetidine (to treat excess stomach acid and stomach ulcers);
- cimetidine (għal trattament ta ’ aċdu eċċessiv u ulċeri fl- istonku);
- amantadine (which can be used to treat Parkinson’ s disease).
- amantadine (li jista ’ jintuża għal trattament tal- marda ta ’ Parkinson).
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Oprymea.
Jekk qed tieħu levodopa, hu rakkomandat li d- doża ta ’ levodopa titnaqqas meta tibda t- trattament b’ Oprymea.
Take care if you are using any medicines that calm you down (have a sedative effect) or if you drink alcohol.
Oqgħod attent/ a jekk qed tieħu xi mediċini biex jikkalmawk (għandhom effett sedattiv) jew jekk tixrob l- alkoħol.
In this cases Oprymea may effect your ability to drive and operate machinery.
F’ dawn il- każijiet Oprymea jista ’ jaffettwa l- ħila tiegħek biex issuq u tħaddem magni.
Taking Oprymea with food and drink You should be cautious while drinking alcohol during treatment with Oprymea.
Meta tieħu Oprymea ma ’ l- ikel u max- xorb Għandek toqgħod attent/ a meta tixrob l- alkoħol matul it- trattament b’ Oprymea.
Oprymea can be taken with or without food.
Oprymea jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
The tablets should be taken with water.
Il- pilloli għandhom jittieħdu ma ’ l- ilma.
Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.
Għid lit- tabib tiegħek jekk inti tqila, jekk taħseb li inti tqila jew jekk għandek il- ħsieb li tohroġ tqila.
Your doctor will then discuss with you if you should continue to take Oprymea.
It- tabib tiegħek imbagħad ser jiddiskuti miegħek jekk għandekx tibqa ’ tieħu Oprymea.
The effect of Oprymea on the unborn child is not known.
L- effett ta ’ Oprymea fuq it- tarbija mhux imwielda mhuwiex magħruf.
Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.
Għalhekk, tieħux Oprymea jekk inti tqila ħlief jekk it- tabib tiegħek jgħidlek mod ieħor.
Oprymea is not recommended during breast-feeding.
Oprymea mhix rakkomandata waqt it- treddigħ.
Oprymea can reduce the production of breast milk.
Oprymea tista ’ tnaqqas il- produzzjoni tal- ħalib ta ’ l- omm.
Also, it can pass into the breast milk and can reach your baby.
Ukoll, hi tista ’ tgħaddi fil- ħalib ta ’ l- omm sabiex tilħaq it- tarbija tiegħek.
If treatment with Oprymea is unavoidable, breast-feeding must be stopped.
Jekk trattament b’ Oprymea hu inevitabbli, it- treddigħ għandu jitwaqqaf.
Driving and using machines Oprymea can cause hallucinations (seeing, hearing or feeling things that are not there).
Sewqan u tħaddim ta ’ magni Oprymea jista ’ jikkawza alluċinazzjonijiet (tara, tisma ’ jew tħoss affarijiet li mhumiex hemm).
If affected, do not drive or use machines.
Jekk tkun affettwat issuqx jew tuża magni.
Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’ s disease.
Oprymea kien assoċjat ma ’ rqad u episodji ta ’ rqad li jiġu f’ daqqa, partikolarment f’ pazjenti bil- marda ta ’ Parkinson.
If you experience these side effects, you must not drive or operate machinery.
Jekk ikollok dawn l- effetti sekondarji, inti m’ għandekx issuq jew tħaddem inġenji.
Please tell your doctor if this occurs.
Jekk jogħġbok għid lit- tabib tiegħek jekk dan iseħħ.
HOW TO TAKE OPRYMEA
KIF GĦANDEK TIEĦU OPRYMEA
Always take Oprymea exactly as your doctor has told you.
Dejjem għandek tieħu Oprymea skond il- parir tat- tabib.
Parkinson’ s disease The daily dose is to be taken divided into 3 equal doses.
Mard ta ’ Parkinson Id- doża ta ’ kuljum għandha tinqasam fi tliet dożi ugwali.
103 During the first week, the usual dose is 1 tablet Oprymea 0.088 mg three times a day (equivalent to 0.264 mg daily):
103 Matul l- ewwel ġimgħa, id- doża li ġeneralment tingħata hi ta ’ pillola waħda ta ’ Oprymea 0. 088 mg tliet darbiet kuljum (ekwivalenti għal 0. 264 mg kuljum):
1st week Number of tablets Total daily dose (mg)
l- 1 ġimgħa Numru ta ’ pilloli
1 tablet Oprymea 0.088 mg three times a day 0.264
Pillola 1 ta ’ Oprymea 0. 088 mg tliet darbiet kuljum
This will be increased every 5 – 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Din tkun miżjuda kull 5 – 7 jiem kif istruwit mit- tabib tiegħek sakemm is- sintomi huma kontollati (doża ta ’ manteniment).
2nd week
It- 2 ġimgħa
3rd week
It- 3 ġimgħa
1 tablet Oprymea 0.18 mg three times a day OR 2 tablets Oprymea 0.088 mg three times a day
Pillola Oprymea ta ’ 0. 18 mg tliet darbiet kuljum JEW 2 pilloli Oprymea ta ’ 0. 088 mg tliet darbiet kuljum
1 tablet Oprymea 0.35 mg three times a day OR 2 tablets Oprymea 0.18 mg three times a day
Pillola Oprymea ta ’ 0. 35 mg tliet darbiet kuljum JEW 2 pilloli Oprymea ta ’ 0. 18 mg tliet darbiet kuljum
The usual maintenance dose is 1.1 mg per day.
Id- doża normali ta ’ manteniment hi ta ’ 1. 1 mg darba kuljum.
However, your dose may have to be increased even further.
Madankollu, id- doża tieghek għandha mnejn ikollha tiżdied aktar.
If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day.
Jekk ikun meħtieġ, it- tabib tiegħek jista ’ jżid id- doża tal- pillola tiegħek sa massimu ta ’ 3. 3 mg ta ’ pramipexole kuljum.
A lower maintenance dose of three Oprymea 0.088 mg tablets a day is also possible.
Doża ta ’ manteniment iżgħar ta ’ tliet pilloli Oprymea ta ’ 0. 088 mg kuljum hi possibbli wkoll.
Lowest maintenance dose
L- inqas doża ta ’ manteniment
Highest maintenance dose
L- ogħla doża ta ’ manteniment
1 tablet Oprymea 0.088 mg three times a day
Pillola Oprymea ta ’ 0. 088 mg tliet darbiet kuljum
1 tablet Oprymea 1.1 mg three times a day
Pillola Oprymea 1. 1 mg tliet darbiet kuljum
You can take Oprymea with or without food.
Tista ’ tieħu Oprymea kemm ma ’ l- ikel jew mingħajru.
Patients with kidney disease If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Pazjenti bil- mard tal- kliewi Jekk għandek mard moderat jew sever tal- kliewi, it- tabib tiegħek ser jagħtik riċetta għal doża aktar baxxa.
In this case, you will have to take the tablets only once or twice a day.
F’ dan il- każ inti ser ikollok tieħu l- pilloli darba jew darbtejn kuljum biss.
If you have moderate kidney disease, the usual starting dose is 1 tablet Oprymea 0.088 mg twice a day.
Jekk għandek mard tal- kliewi moderat, id- doża li ġeneralemnt tibda biha hi ta ’ pillola waħda Oprymea ta ’ 0. 088 mg darbtejn kuljum.
In severe kidney disease, the usual starting dose is just 1 tablet Oprymea 0.088 mg a day.
F’ mard tal- kliewi severi, id- doża li ġeneralment tibda biha hi ta ’ pillola waħda ta ’ Oprymea ta ’ 0. 088 mg kuljum.
If you take more Oprymea than you should If you accidentally took too many tablets:
Jekk tieħu Oprymea aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda
- Contact your doctor or nearest hospital casualty department immediately for advice.
- Ikkuntattja lit- tabib tiegħek jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament għal
- You may experience vomiting, restlessness, or any of the side effects as described in section 4.
- Jista ’ jkollok remettar, irrikwitezza, jew kwalunkwe effett oħra ieħor kif deskritt f’ sezzjoni 4.
"Possible side effects".
"Effetti sekondarji li jista ’ jkollu".
If you forget to take Oprymea Do not worry.
Jekk tinsa tieħu Oprymea Tinkwetax.
Simply leave out that dose completely and then take your next dose at the right time.
Sempliċiment ħalli barra dik id- doża kompletament imbagħad ħu d- doża tiegħek li jmiss fil- ħin tagħha.
If you stop taking Oprymea Do not stop taking Oprymea without first talking to your doctor.
Jekk tieqaf tieħu Oprymea Tieqafx tieħu Oprymea mingħajr ma ’ l- ewwel titkellem mat- tabib tiegħek.
If you have to stop taking this medicine, your doctor will reduce the dose gradually.
Jekk ikollok tieqaf tieħu din il- mediċina, it- tabib tiegħek ser inaqqas id- doża gradwalment.
104
104 Jekk tbati mill- marda ta ’ Parkinson inti m’ għandekx twaqqaf it- trattament b’ Oprymea minnufih.
- fever,
- deni,
- unstable blood pressure,
- pressjoni tad- demm mhux stabbli,
- tachycardia (increased heart rate),
- takikardja (żieda fit- taħbit tal- qalb),
- depressed level of consciousness (e. g. coma).
- livell baxx ta ’ koxjenza (eż. koma).
Evaluation of these side effects is based on the following frequencies:
Bħal kull mediċina oħra, Oprymea jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Not known:
L- evalwazzjoni ta dawn l- effetti oħra hi msejsa fuq il- frekwenzi li ġejjin:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from available data
jaffettwa aktar minn pazjent 1 f’ 10 trattati Komuni ħafna: jaffettwa minn minn pazjent 1 sa 10 f’ 100 trattati Komuni: jaffettwa minn pazjent 1 sa 10 f’ 1, 000 trattati Mhux komuni: jaffettwa pazjent 1sa 10 f’ 10, 000 trattati Rari: jaffettwa inqas minn pazjent 1 f’ 10, 000 trattati Rari ħafna:
You may experience the following side effects (regardless of indication):
Inti jista ’ jkollok l- effetti oħra li ġejjin (irrispettivament mill- indikazzjoni):
- Dyskinesia (e. g. abnormal, uncontrolled movements of the limbs)
- Diskinesja (e. g. movimenti abnormali mhux ikkontrollati tad- dirgħajn jew ir- riġlejn)
- Nausea (sickness)
- Dardir
- Hypotension (low blood pressure)
- Pressjoni baxxa (pressjoni tad- demm baxxa)
- Hallucinations (seeing, hearing or feeling things that are not there)
- Alluċinazzjonijiet (tara, tisma ’ jew tħoss affarijiet li ma jkunux hemm)
- Confusion
- Konfużjoni
- Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
- Bidliet fir- ritmu ta ’ l- irqad, bħal nuqqas ta ’ rqad (insomnja) u ngħas
- Excess of fluid, usually in the legs (peripheral oedema)
- Aktar fluwidu milli suppost, ġeneralment fir- riġlejn (edema periferali)
- Abnormal dreams
- Ħolm abnormali
- Paranoia (e. g. excessive fear for one’ s own well-being)
- Paranoja (eż. biża ’ eċċessiv għal benesseri tiegħu/ tagħha)
- Excessive daytime sleepiness and suddenly falling asleep
- Irqad eċċessiv matul il- jum u rqad għall- għarrieda
- Hyperkinesia (increased movements and inability to keep still)
- Iperkinesja (żieda fil- movimenti u nuqqas ta ’ ħila biex toqgħod kwiet)
- Increased sexual desire (e. g. increased libido)
- Żieda fil- ħajra sesswali (eż. żieda fil- libido)
Unknown frequency:
Frekwenza mhix magħrufa:
- Pathological gambling, especially in patients with Parkinson’ s disease taking high doses of
- Logħob patoloġiku ta ’ l- azzard, speċjalment f’ pazjenti bil- marda tal- Parkinson li qed jieħdu
Oprymea
dożi għoljin ta ’ Oprymea
- Abnormal behaviour
- Imġieba abnormali
- Increased eating (binge eating, hyperphagia)
- Żieda fl- ammont ta ’ ikel li jittiekel (tiekol bl- addoċċ, iperfaġjia)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
105 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE OPRYMEA
KIF TAĦŻEN OPRYMEA
Do not use Oprymea after the expiry date which is stated on the packaging.
Tużax Oprymea wara d- data ta ’ skadenza li tidher fuq il- pakkett.
What Oprymea contains
X’ fih Oprymea
- The active substance is pramipexole.
- Is- sustanza attiva hi pramipexole.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg
Kull pillola fiha 0. 088 mg, 0. 18 mg, 0. 35 mg, 0. 7 mg jew 1. 1
or 1.1 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 1.5 mg pramipexole dihydrochloride monohydrate, respectively.
mg pramipexole as 0. 125 mg, 0. 25 mg, 0. 5 mg, 1 mg jew 1. 5 mg pramipexole dihydrochloride monohydrate, rispettivament.
- The other ingredients are mannitol, maize starch, pregelatinised maize starch, povidone K25,
- Is- sustanzi l- oħra huma mannitol, maize starch, pregelatinised maize starch, povidone K25,
colloidal anhydrous silica and magnesium stearate.
colloidal anhydrous silica u magnesium stearate.
What Oprymea looks like and contents of the pack Tablets of 0.088 mg are white, round, with bevelled edges and imprint "P6" on one side of the tablet.
Id- Dehra ta ’ Oprymea u l- kontenuti tal- pakkett Il- pilloli ta ’ 0. 088 mg huma bojod, tondi, bi truf iċċanfrati u b’ intaljar ta ’ "P6" fuq naħa waħda tal - pillola.
Tablets of 0.18 mg are white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
Il- pilloli ta ’ 0. 18 mg huma bojod, ovali, bi truf iċċanfrati u b’ ferq fuq iż- żewġ naħat, u b’ intaljar ta ’ "P7" fuq iż- żewġ nofsijiet tal- pillola.
Tablets of 0.35 mg are white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
Il- pilloli ta ’ 0. 35 mg huma bojod, ovali, bi truf iċċanfrati u b’ ferq fuq iż- żewġ naħat, u b’ intaljar ta ’ "P8" fuq iż- żewġ nofsijiet tal- pillola.
Tablets of 0.70 mg are white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
Il- pilloli ta ’ 0. 70 mg huma bojod, tondi, bi truf iċċanfrati u b’ ferq fuq iż- żewġ naħat, u b’ intaljar ta ’ "P9" fuq iż- żewġ nofsijiet ta ’ naħa waħda tal- pillola.
Tablets of 1.1 mg are white, round, with bevelled edges, both sides scored.
Pilloli ta ’ f 1. 1 mg huma bojod, tondi, bi truf iċċanfrati u b’ ferq fuq iż- żewġ naħat.
Boxes of 20, 30, 60, 90 and 100 tablets in blisters of 10 tablets are available.
Kaxex ta ’ 20, 30, 60, 90 u 100 pillola f’ folji ta ’ 10 pilloli huma disponibbli.
Marketing Authorisation Holder and Manufacturer KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
Česká republika KRKA Č s.r.o.
106 Česká republika KRKA ČR, s. r. o.
Polska KRKA Polska Sp.z.o.o
Polska KRKA Polska Sp. z. o. o Tel.: + 48 (0) 22 573 7500
România KRKA, d.d., Novo mesto Reprezentanţpentru România a Tel: + 402 (0)1 310 66 05
România KRKA, d. d., Novo mesto Reprezentanţa pentru România Tel: + 402 (0) 1 310 66 05
Κύ ρς πο Sverige KRKA, d.d., Novo mesto Τ λ+ 30 (0)210 9581143 (EL)
Κύπρος KRKA, d. d., Novo mesto Τηλ: + 30 (0) 210 9581143 (EL)
Tel: + 46 (0)8 643 67 66 (SE)
Sverige KRKA Sverige AB Tel: + 46 (0) 8 643 67 66 (SE)
What is Optaflu?
X' inhu Optaflu?
Optaflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Optaflu hu vaċċin li jiġi bħala sospensjoni għall- injezzjoni f' siringa mimlija minn qabel.
The vaccine contains the inactivated ‘ surface antigen ’ from three different strains (types) of influenza (flu) virus as active substances (A/ Solomon Islands/ 3/ 2006, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
Il- vaċċin fih l - 'antiġene tas- superfiċje' mhux attivat minn tliet razez (tipi) tal- vajrus ta 'l- influwenza bħala sustanzi attivi (A/ Solomon Islands/ 3/ 2006, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
What is Optaflu used for?
Għal xiex jintuża Optaflu?
Optaflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease.
Optaflu jintuża fit- tilqim ta 'l- adulti kontra l- influwenza, speċjalment dawk li jkollhom riskju akbar li jiżviluppaw komplikazzjonijiet tal- marda.
How is Optaflu used?
Kif jintuża Optaflu?
Optaflu is given as one injection of 0.5 ml into the muscle at the top of the arm.
Optaflu jingħata bħala injezzjoni ta '0. 5 ml fil- muskolu fin- naħa ta' fuq tad- driegħ.
How does Optaflu work?
Kif jaħdem Optaflu?
Optaflu is a vaccine.
Optaflu hu vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi 'jgħallmu' lis- sistema immunitarja (id- difiżi naturali tal - ġisem) kif tiddefendi lilha nnifisha kontra l- mard.
Optaflu contains fragments from the surface of three different strains of flu virus.
Optaflu fih frak fuq is- superfiċje ta 'tliet razez differenti tal- vajrus ta' l- influwenza.
When a person is given the vaccine, the immune system recognises the virus fragments as ‘ foreign’ and makes antibodies against them.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf il - frammenti tal- vajrus bħala 'barranin' u tipproduċi antikorpi kontrihom.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Fil- futur, is- sistema immunitarja tkun tista 'tipproduċi antikorpi iktar malajr meta tkun esposta għal kwalunkwe minn dawn ir- razez.
The antibodies will then help to protect against the disease caused by these strains of the flu virus.
L- antikorpi mbagħad jipproteġu kontra l- mard ikkawżat minn dawn ir- razez tal- vajrus ta 'l - influwenza.
Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season, and these virus strains need to be included in Optaflu before the vaccine can be used.
Kull sena, l- Organizzazzjoni Dinjija tas- Saħħa (WHO) tagħmel rakkomandazzjonijiet fuq liema razez għandhom jiġu inklużi fil- vaċċini għall- istaġun li jkun imiss ta 'l- influwenza u jeħtieġ li dawn ir- razez ta' vajrus jiddaħħlu f' Optaflu qabel ma jkun jista 'jintuża l- vaċċin.
Optaflu currently contains fragments of the virus strains that are expected to cause flu in the 2007/ 2008 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU).
Attwalment, Optaflu fih frammenti tar- razez tal- vajrus li mistennija jikkawżaw l- influwenza fl- istaġun 2007/ 2008, skond ir - rakkomandazzjonijiet mid- WHO għall- emisfera tat- tramuntana u mill- Unjoni Ewropea (UE).
The virus strains in Optaflu will be need to be replaced again before the vaccine can be used in subsequent seasons.
Jeħtieġ li r- razez f' Optaflu jiġu sostitwiti għal darb' oħra qabel ma jkun jista 'jintuża l- vaċċin fl- istaġuni sussegwenti.
The viruses used in Optaflu are grown in mammal cells, unlike those in other flu vaccines, which are grown in hen’ s eggs.
Il- vajrusijiet użati f' Optaflu jitkabbru f' ċelloli tal- mammiferi, kuntrarjament għal dawk użati f' vaċċini oħra ta 'l- influwenza, li jitkabbru fil- bajd tat- tiġieġ.
(44-20) 74 18 84 00 Fax (44-20) E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu © European Medicines Agency, 2007.
How has Optaflu been studied?
Kif ġie studjat Optaflu?
The effects of Optaflu were first tested in experimental models before being studied in humans.
L- effetti ta 'Optaflu għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil - bniedem.
The effectiveness of Optaflu was first assessed using a formulation of the vaccine that included the virus strains expected to cause flu in the 2004/ 2005 season.
L- effikaċja ta 'Optaflu ġiet għall- ewwel valutata bl- użu ta' formulazzjoni ta 'vaċċin li inkluda r- razez ta' vajrus mistennija li jikkawżaw influwenza fl- istaġun 2004/ 2005.
The vaccine’ s effectiveness was assessed in one main study involving 2,654 adults, around half of whom were elderly (over 60 years of age).
L- effikaċja tal- vaċċin ġie valutat fi studju ewlieni wieħed li fih ħadu sehem 2, 654 adult, li kważi nofshom kienu anzjani ('il fuq minn 60 sena).
The effects of Optaflu were compared to those of a similar flu vaccine that was made in eggs.
L- effetti ta 'Optaflu tqabblu ma' dawk ta 'vaċċin ta' l- influewnza simili għal dak ta 'vaċċin magħmul fil- bajd.
The study compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), by comparing antibody levels before injection and three weeks afterwards.
L- istudju qabbel il- kapaċità taż- żewġ vaċċini li jistimulaw il- produzzjoni ta 'antikorpi (immunoġeneċità), billi qabbel il- livelli ta' l- antikorpi qabel l- injezzjoni ma 'dawk ta' tliet ġimgħat wara.
The immunogenicity of the current formulation of the vaccine has been confirmed in 135 adults, around half of whom were elderly.
L- immunoġeniċità tal- formulazzjoni attwali tal- vaċċin ġiet ikkonfermata f' 135 adult, li kważi nofshom kienu anzjani.
What benefit has Optaflu shown during the studies?
X' benefiċċji ta 'Optaflu intwerew f' dawn l- istudji?
In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the Committee for Medicinal Products for Human Use (CHMP) for flu vaccines produced in cell culture.
Fl- istudju ewlieni oriġinali, kemm Optaflu kif ukoll il- vaċċin li tqabbel miegħu wasslu għal livelli adegwati ta 'antikorpi għall- protezzjoni kontra t- tliet razez ta' l- influwenza, kif definiti mill- kriterji stipulati mill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) għal vaċċini prodotti u kkultivati fiċ- ċelloli.
The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly.
Iż- żewġ vaċċini kienu jixxiebhu fl- istimolu tal- produzzjoni ta 'l - antikorpi, kemm f' persuni ta' 60 sena jew inqas, kif ukoll fl- anzjani.
The current formulation of Optaflu for the 2007/ 2008 season brought about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study.
Il- formulazzjoni attwali ta 'Optaflu għall- istaġun 2007/ 2008 wasslet għal risponsi simili mill- antikorpi kontra t- tliet razez ta' l- influwenza inklużi fil- vaċċin ma 'dawk osservati fl- istudju ewlieni.
What is the risk associated with Optaflu?
X' inhu r- riskju assoċjat ma 'Optaflu?
The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, erythema (reddening of the skin), pain, malaise (feeling unwell) and fatigue (tiredness).
L- aktar effetti sekondarji komuni tat- teħid ta 'Optaflu (li dehru f' pazjent minn kull għaxra) huma uġigħ ta' ras, eritema (ħmura fil- ġilda), uġigħ, il- pazjent ma jħossux f' siktu u għejja.
These side effects usually disappear within one to two days without treatment.
Dawn l- effetti sekondarji ġeneralment jisparixxu wara jum jew tnejn wara li jitwaqqaf it- trattament.
For the full list of all side effects reported with Optaflu, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati ma' Optaflu, ara l- Fuljett ta 'Tagħrif.
Optaflu should not be used in people who may be hypersensitive to the active substances or any of the other ingredients.
Optaflu ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi għas- sustanzi attivi jew għal xi sustanza oħra minn tiegħu.
People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Il- vaċċin ma għandux jingħata lil persuni li jkollhom id- deni jew infezzjoni akuta (li tgħaddi malajr) sakemm dawn ma jkunux irkupraw.
Why has Optaflu been approved?
Għaliex ġie approvat Optaflu?
The CHMP decided that Optaflu’ s benefits are greater than its risks for the prophylaxis of influenza for adults, especially those who run an increased risk of associated complications.
Is- CHMP iddeċieda li l- benefiċċju ta 'Optaflu fil- prevenzjoni ta' l- influwenza fl- adulti, speċjalment dawk li jkollhom riskju akbar ta 'kumplikazzjonijiet marbuta magħha, jisbqu r- riskji tiegħu.
The Committee recommended that Optaflu be given marketing authorisation.
Il- Kumitat irrakkomanda li Optaflu jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Optaflu:
Tagħrif ieħor dwar Optaflu:
The European Commission granted a marketing authorisation valid throughout the EU for Optaflu to Novartis Vaccines and Diagnostics GmbH & Co.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Optaflu valida fl- UE kollha lil Novartis Vaccines and Diagnostics GmbH & Co.
KG on 1 June 2007.
KG fl- 1 ta 'Ġunju ta' l- 2007.
The full EPAR for Optaflu can be found here.
L- EPAR sħiħ għal Optaflu jista 'jinstab minn hawn.
Suspension for injection in pre- filled syringe
Suspensjoni għall - injezzjoni f’ siringa mimlija għal- lest
Intramuscular use
Użu għal ġol - muskoli
1 pre-filled syringe (Luer Cone)
Siringa 1 mimlija għal- lest (Luer Cone)
10 pre-filled syringes (Luer Cone)
10 siringi mimlijin għal- lest (Luer Cone)
2 x 10 pre-filled syringes (Luer Cone)
2 x 10 siringi mimlijin għal - lest (Luer Cone)
1 pre-filled syringe (Luer Cone) + 1 needle
Siringa 1 mimlija għal- lest (Luer Cone) + labra 1
10 pre-filled syringes (Luer Cone) + 10 needles
10 siringi mimlijin għal- lest (Luer Cone) + 10 labriet
2 x 10 pre-filled syringes (Luer Cone) + 20 needles
2 x 10 siringi mimlijin għal - lest (Luer Cone) + 20 labra
1 pre-filled syringe (Luer Lock)
Siringa 1 mimlija għal- lest (Luer Lock)
10 pre-filled syringes (Luer Lock)
10 siringi mimlijin għal- lest (Luer Lock)
2 x 10 pre-filled syringes (Luer Lock)
2 x 10 siringi mimlijin għal - lest (Luer Lock)
1/ 2 1 Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
1 Antiġeni tal- wiċċ tal- virus ta ’ l- influwenza (haemagglutinin u neuraminidase) *, inattivati, tar- razez li ġejjin:
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR-145) A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005, NYMC X161B) B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004)
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR- 145) A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005, NYMC X161B) B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004)
15 micrograms HA** 15 micrograms HA** 15 micrograms HA** per 0.5 ml dose
15 – il mikrogramma HA ** 15 – il mikrogramma HA ** 15 – il mikrogramma HA ** F’ kull doża ta ’ 0. 5 ml
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
* ippropagati fiċ- ċelluli Madin Darby Canine Kidney (MDCK)
Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Optaflu suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest Tilqima ta ’ l- influwenza (antiġen tal- wiċċ, inattivata, ippreparata f’ kolturi taċ- ċelluli)
(2007/ 2008 season)
(Staġun 2007/ 2008)
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Antiġeni tal- wiċċ tal- virus ta ’ l- influwenza (haemagglutinin u neuraminidase) *, inattivati, tar- razez li ġejjin: