qanastek/EMEA-V3 huggingface dataset:
Gently pinch up the skin surrounding the site of injection and hold firmly with the other hand.
Bil- mod agħfas ’ il fuq il- ġilda madwar il- post fejn ha tingħata l- injezzjoni u żommha sew bl- id l- oħra.
Hold the syringe as you would hold a pencil, insert the needle completely into the skin at an angle of about 45 degree.
Żomm is- siringa isek qed iżomm lapes, daħħal il- labra kompletament fil- ġilda f’ anglu ta ’ madwar 45 gradi.
Once the needle has been inserted completely, release your grasp of the skin.
Hekk kif il- labra tkun iddaħħlet kompletament, eħles il- qabda tiegħek tal- ġilda.
Pull back gently the plunger of the syringe.
Ibbota bil- mod il- parti ta ’ wara tas- siringa.
If blood appears continue as described in step 14.
Jekk joħroġ id- demm, kompli kif deskritt fl- 14- il pass.
If no blood appears, inject the solution slowly by pushing the plunger gently forward.
Jekk ma joħroġx demm, injetta t- taħlita bil- mod billi tibbotta l- parti ta ’ wara tas- siringa ġentilment ‘ il quddiem.
After all of the solution is injected, withdraw the needle slowly, applying gentle pressure with the alcohol swab on the skin where the needle was inserted.
Wara li tkun injettajt t- taħlita kollha, oħroġ is- siringa bil- mod, u bil - mod agħfas iċ- ċaruta bl- alkoħol fuq il- ġilda fejn tkun daħħalt il- labra.
Withdraw the needle at the same angle as it was inserted.
Oħroġ il- labra bl- istess anglu li tkun daħħaltha.
If blood appears, withdraw the needle with the syringe and gently apply pressure to the injection site.
Jekk joħroġ id- demm, neħħi l- labra mas- siringa u bil- mod agħmel ftit pressjoni fuq il- post fejn ingħatat l- injezzjoni.
Do not use this solution but empty the syringe in a sink.
Tużax it- taħlita iżda battal is- siringa f’ sink.
Start again with step 1.
Erġa ’ ibda mill- ewwel pass.
Use the syringe and needles only once.
Uża s- siringa u l- labar darba biss.
Dispose of the syringe and needles immediately after use (put the covers on the needles to avoid injury).
(poġġi l - għotjin fuq il- labar biex tevita li xi ħadd iwegga ’).
If you use more Cetrotide than you should
Jekk tieħu Cetrotide aktar milli suppost għandek:
Overdosage of Cetrotide 0.25 mg may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
Doża eċċessiva ta ’ Cetrotide 0. 25 mg tista ’ ttawwal il- perjodu ta ’ azzjoni iżda m’ għandiex tkun marbuta ma ’ effetti tossiċi akuta.
Therefore, in case of overdosage no specific measures are required.
Għalhekk, f’ każ ta ’ doża eċċessiva l- ebda miżuri speċifiċi m’ huma meħtieġa.
If you forget to take Cetrotide:
Jekk tinsa tieħu Cetrotide:
Do not take a double dose to make up for a forgotten dose, please contact your doctor.
Tieħux doża doppja biex tpatti għad- doża li nsejt tieħu, jekk jogħġbok agħmel kuntatt mat - tabib tiegħek
Ideally Cetrotide 0.25 mg should be administered at 24 hours intervals.
Preferibilment Cetrotide 0. 25 mg għandu jingħata fi spazju ta ’ 24 siegħa.
But if you missed to administer Cetrotide 0.25 mg at the right time it is no problem to administer this dose at a different time of the same day.
Iżda jekk ma tkunx ħadt Cetrotide 0. 25 mg fil- ħin li jkun immissek mhemmx problema li tieħu din id- doża f’ ħin differenti ta ’ l - istess ġurnata.
POSSIBLE SIDE EFFECTS
EFFETTI OĦRA LI JISTA ’ JKOLLU
Like all medicines, Cetrotide can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Cetrotide jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd
Mild and transient reactions may occur at the injection site like reddening, itching, and swelling.
Rejazzjonijiet moderati u li ma jdumux jistgħu jseħħu fil- post fejn tingħata l- injezzjoni bħal ħmura, ħakk u nfieħ.
These problems may affect between 1 and 10 patients out of 100 treated.
Dawn il- problemi jistgħu jaffetwaw bejn 1 u 10 pazjienti f’ 100 li ġew ittratti.
Rare cases of severe generalised allergic reactions have also been reported (less than 1 in 1000 patients).
Każi rari ta ’ reazzjonijiet allerġiċi ġeneralizzati qawwijin kienu rrapurtati wkoll (inqas minn 1 f’ 1000 pazjienti).
Occasionally systemic side effects, like nausea and headache have been reported (less than 1 in 100 patients).
Xi kultant, xi effetti mhux mixtieqa sistematiċi, bħal nawsja u wġigħ ta ’ ras kienu rrapurtati (inqas minn 1 f’ 100)..
In addition, a single case of pruritus has been reported during treatment with Cetrorelix.
Barra minn dan, kien irrapurtat każ wieħed ta ’ ħakk matul il- kura b’ Cetrorelix.
Occasionally, stimulation of ovaries with gonadotropins (hormones promoting egg maturation) may lead to a so-called ovarian hyperstimulation syndrome (OHSS).
Xi kultant, l- istimulazzjoni ta ’ l- ovarji bil- gonadotropini (ormoni li jippromwovu l- maturazzjoni tal - bajd) jistgħu jikkaġunaw dak li hu magħruf bħala sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS).
Symptoms like abdominal pain, tension, nausea, vomiting, diarrhoea and breathing difficulties may indicate an OHSS.
Sintomi bħal uġigħ addominali, tensjoni, nawsja, vomitu, dijareja u diffikultajiet fin- nifs jistgħu jindikaw l- OHSS.
Please inform your doctor immediately, if you feel such symptoms.
Jekk jogħġbok informa lit- tabib mill- ewwel jekk tħoss dawn is- sintomi.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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 CETROTIDE
KIF TAĦŻEN CETROTIDE
Do not store above 25°C.
Taħżinx f’ temperatura ‘ l fuq minn 25°C.
Keep the vial in the outer carton in order to protect from light.
Aħżen il- kontenitur fil- kartuna ta ’ barra sabiex tipproteġi mid- dawl.
Do not use Cetrotide after the expiry date which is stated on the vial after EXP.
Tużax Cetrotide wara id- data ta ’ skadenza, li tidher fuq il- vjala wara JIS.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal l- ahhar ġurnata ta ’ dik ix- xahar.
The Cetrotide 0.25 mg powder in the vial and the solvent in the pre-filled syringe have the same expiry date.
It- trab ta ’ Cetrotide 0. 25 mg fil- fjala u s- solvent fis- siringa mimlija lesta jiskadu fl- istess ġurnata.
It is printed on the labels and on the carton.
Din hi stampata fuq it- tikketti u fuq il- kartuna.
The solution should be used immediately after preparation.
It- taħlita għandha tintuża mill- ewwel wara li titħallat.
31 Do not use Cetrotide if the white pellet in the vial has changed in aspect or colour, or if the solvent solution in the vial is no longer clear and colourless or if it contains particles.
Tużax Cetrotide jekk il- pelitt abjad fil- vjal inbidel fl- aspett jew kulur tiegħu, jew inkella jekk is - solvent tat- taħlita mhuwiex izjed ċar u minghajr kulur, jew jekk fih il- biċċiet.
If you have any further questions please consult your doctor or pharmacist.
Jekk għandek xi mistoqsijiet oħra jekk jogħġbok ikkonsulta lit- tabib jew spiżjar tiegħek.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjient.
FURTHER INFORMATION
GĦALL- AKTAR TAGĦRIF
What Cetrotide contains
X’ fih Cetrotide
The active substance is cetrorelix acetate 0.26 – 0.27 mg, equivalent to 0.25 mg cetrorelix.
Is- sustanż attiv huwa cetrorelix acetate 0. 26 – 0. 27 mg, ekwivalenti għall- 0. 25 mg cetrorelix.
The other ingredient is mannitol.
L- igredjient l- ieħor huwa mannitol.
The solvent is Water for Injections.
Is- solvent huwa ilma għall- injezzjoni.
What Cetrotide looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
Cetrotide 0.25 mg is a powder for solution for injection.
Cetrotide 0. 25 mg hu trab għal soluzzjoni għall- injezzjoni.
It is available in packs of one or seven vials.
Dan jinstab f’ pakketti ta ’ fjala waħda jew seba ’ fjali.
Additionally, for each vial the packs contain
Barra minn dan, kull pakkett jinkludi
• one pre-filled syringe with solvent (water for injections) for parenteral use for dissolving the powder in the vial • one injection needle with a yellow mark for injecting the water into the vial and withdrawing the solution from the vial • one injection needle with a grey mark for injecting the solution • two alcohol swabs for cleaning purposes.
• siringa waħda mimlija lesta bis- solvent (ilma għall- injezzjonijiet) għall- użu parenterali biex it - trab jinħall fil- fjala • labra waħda għall- injezzjoni b’ marka safra għall- injezzjoni ta ’ l- ilma fil- fjala u biex tinħareġ it - taħlita mill- fjala • labra waħda għall- injezzjoni b’ marka griża għall- injezzjoni tat- taħlita • żewġ ċraret bl- alkoħol għal skopijiet ta ’ tindif tal- ġilda.
Marketing Authorisation Holder
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom
Serono Europe Limited, 56 Marsh Wall, Londra E14 9TP, Renju Unit.
Manufacturer
33 Manifattur:
Baxter Oncology GmBH, Kantstrasse 2, D-33790 Halle, Germany.
Baxter Oncology GmbH, Kantstrasse 2, D- 33790 Halle, Ġermanja.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal aktar tagħrif dwar il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizazzjoni għall- Kummerċ.
Luxembourg/ Luxemburg Serono Benelux BV Esplanade Heysel - b11 B - 1020 Bruxelles/ Brüssel Belgique/ Belgien Tél. / Tel.: +32 2 48175 80
Luxembourg/ Luxemburg België/ Belgique/ Belgien Serono Benelux BV Serono Benelux BV Esplanade Heysel - b11 Esplanade Heysel - b11 B - 1020 Bruxelles/ Brüssel B - 1020 Bruxelles/ Brüssel Belgique/ Belgien Belgique/ Belgien Tél. / Tel.: +32 2 48175 80 Tél. / Tel.: +32 2 48175 80
Þverholti 14 IS-105 Reykjavík Sími: +354-568-8533
Þverholti 14 IS- 105 Reykjavík Lynghálsi 13 IS- 110 Reykjavík Tel: +354- 568- 8533
INFORMATION FOR THE USER
35 FULJETT TA ’ TAGĦRIF Cetrotide 3mg trab u solvent għal soluzzjoni għall- injezzjoni
Read all of this leaflet carefully before you start using this medicine.
Aqra dan il- fuljett kollu qabel ma tibda tuża din il- mediċina
- If any of the side effects gets serious, or you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
Possible side effects 5 How to store Cetrotide 6.
5.
Further information
Kif taħżen Cetrotide 6.
Cetrotide 3 mg inhibits the effects of a natural hormone, called luteinising hormone releasing hormone (LHRH).
Cetrotide 3 mg iwaqqaf l- effetti ta ’ ormon naturali, magħruf bħala ormon li jistimula l- produzzjoni ta ’ l- ormon ta ’ lutejinazzjoni (LHRH).
Cetrotide 3 mg inhibits premature ovulation which is undesirable during hormone treatment for ovarian stimulation as only mature egg cells are suitable for fertilisation.
Cetrotide 3 mg iwaqqaf l - ovulazzjoni prematura li mhiex mixtieqa matul it- trattament ta ’ stimulazzjoni ta ’ l- ovarji bl- ormoni minħabba li ċelloli tal- bajd matur biss huma tajbin għall- fertilizzazzjoni.
Cetrotide 3 mg is used to prevent premature ovulation during a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
Cetrotide 3 mg jintuża fil- prevenzjoni ta ’ ovulazzjoni prematura f’ pazjenti li għaddejjin minn stimulazzjoni kontrollata ta ’ l- ovarji, segwita minn ġbir ta ’ l- ooċit u minn teknika ta ’ riproduzzjoni assistita.
In clinical trials Cetrotide 3 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle stimulating hormone (FSH) suggested similar efficacy.
F’ eżamijiet kliniċi Cetrotide 3 mg kien użat mal- gonadotropina umana tal- menopawża (HMG), iżda l - esperjenza limitata mal- FSH rikombinanti tissuġġerixxi effiċjenza simili.
Do not use Cetrotide:
Tużax Cetrotide:
• if you are allergic (hypersensitive) to cetrorelix acetate, exogenous peptide hormones (medicines similar to Cetrotide 3 mg), or any of the other ingredients. • if you are pregnant or breast-feeding • if you have already reached your menopause • if you have a moderate or severe kidney or liver disease.
• jekk int allerġiku (sensittività eċċessiva) għal cetrorelix acetate, ormoni esoġeni tal- peptide (mediċini simili għal Cetrotide 3 mg) jew xi ingredienti oħra. • jekk int tqila jew qed tredda ’ • jekk diġà wasalt fil- menopawża • jekk għandek mard moderat jew serju fil- kliewi jew fil- fwied.
Take special care with Cetrotide:
37 Oqgħod attent ħafna b’ Cetrotide:
36 During or following hormonal stimulation of the ovaries an ovarian hyperstimulation syndrome can occur.
Matul jew wara l- istimulazzjoni ormonali ta ’ l- ovarji jista ’ jseħħ is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji.
For symptoms and suitable measures please refer to the Patient Information Leaflet of the gonadotropin-containing medicine prescribed for you.
Għas- sintomi u miżuri xierqa jekk jogħġbok irreferi għall- Pakkett ta ’ Informazzjoni għall- Pazjent tal- mediċina li fiha tinkludi l- gonadotropina li ġiet mgħotija lilek b’ riċetta tat- tabib.
There is limited experience up to now with the administration of Cetrotide 3 mg during a repeated ovarian stimulation procedure.
Hemm esperjenza limitata s’ issa fl- ingħatar ta ’ Cetrotide 3 mg matul proċedura ta ’ stimulazzjoni ta ’ l - ovarji ripetuta.
Therefore you should use Cetrotide 3 mg in repeated cycles only after a careful risk/ benefit evaluation by your doctor.
Għalhekk għandek tuża Cetrotide 3 mg f’ ċikli ripetuti biss wara evalwazzjoni dettaljata ta ’ riski/ benefiċċji mit- tabib tiegħek.
Experimental investigations have shown that interactions are unlikely with medications that are metabolised in the liver.
Jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċina oħra, anki mhux bir- riċetta.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Investigazzjonijiet sperimentali wrew li mhux suppost li jkun hemm interazzjonijiet ma ’ medikamenti li huma metabolizzati fil- fwied.
Pregnancy and breast-feeding:
Tqala u jekk qed tredda ’:
You should not use Cetrotide 3 mg if you are already pregnant, or suspect that you might be pregnant, or if you are breast-feeding.
M’ għandekx tuża Cetrotide 3 mg jekk int diġà tqila, jew għandek suspett li tista ’ tkun tqila, jew jekk qed tredda ’.
Always use cetrtide exactly as your doctor has told you.
Dejjem uża Cetrotide eżatt kif jghidlek it- tabib.
The following statements apply to Cetrotide 3 mg unless otherwise prescribed by your doctor.
L- informazzjoni segwenti tapplika għal Cetrotide 3mg sakemm ma jkunx ordnat mod ieħor mit- tabib tiegħek.
Please observe these instructions for use, otherwise you will not fully benefit from Cetrotide 3 mg.
Jekk jogħġbok osserva dawn l- istruzzjonijiet għall- użu, inkella ma tkunx tista ’ tibbenefika bis- sħiħ minn Cetrotide 3 mg.
The contents of 1 vial (3 mg cetrorelix) are to be administered on day 7 of ovarian stimulation (approximately 132 to 144 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins.
Il- kontenut kollu ta ’ fjala waħda (3 mg Cetrorelix) għandu jingħata fis- 7 ġurnata ta ’ l- istimulazzjoni ta ’ ovarji (madwar 132 sa 144 siegħa wara l- bidu ta ’ l- istimulazzjoni ta ’ l- ovarji) permezz ta ’ gonadotropini urinarji jew rikombinanti.
A single dose of Cetrotide 3 mg results in a duration of action of at least 4 days.
Doża waħda ta ’ Cetrotide 3 mg tirriżulta f’ perjodu ta ’ azzjoni ta ’ mill- inqas erbat ijiem.
If the follicle growth does not allow ovulation induction on the fifth day after injection of Cetrotide 3 mg, additionally 0.25 mg cetrorelix (Cetrotide 0.25 mg) should be administered once daily beginning 96 hours after the injection of Cetrotide 3 mg until the day of ovulation induction.
Jekk it- tkabbir tal- follikuli ma jippermettix induzzjoni ta ’ l- ovulazzjoni fil- ħames ġurnata wara l- injezzjoni ta ’ Cetrotide 3 mg, 0. 25 mg cetrorelix (Cetrotide 0. 25 mg) ieħor għandu jingħata darba kuljum 96 siegħa wara l- injezzjoni ta ’ Cetrotide 3 mg sal- ġurnata li fiha jkun hemm l- induzzjoni ta ’ l- ovulazzjoni.
Route of administration
Kif għandu jingħata Cetrotide?
Cetrotide is intended for subcutaneous use, that means given by injection just under the skin.
Cetrotide 3 mg għandu jingħata b’ injezzjoni taħt il- ġilda.
It is for single use only.
Huwa ghal- użu singlu.
You can carry out the following injections yourself as long as you have been made aware by your doctor of the symptoms that may indicate allergy, the consequences of such a reaction and the need for immediate treatment.
Int tista ’ tieħu dawn l- injezzjonijiet waħdek sakemm it- tabib ikun infurmak bis- sintomi li jistgħu jindikaw allerġija, il- konsegwenzi ta ’ reazzjoni tali u l- bżonn għall- kura immedjata.
Cetrotide 3 mg is for injection under the skin of the lower abdominal wall, preferably around the navel.
38 Cetrotide 3 mg għandu jingħata b’ injezzjoni taħt il- ġilda fil- parti t’ isfel tal- membrana ta ’ l- addome, preferibilment madwar iż- żokra.
37 Dissolve Cetrotide 3 mg powder only with the water contained in the pre-filled syringe.
Ħoll it- trab ta ’ Cetrotide 3 mg biss bl- ilma li jinstab fis- siringa mimlija lesta.
Do not use a Cetrotide 3 mg solution if it contains particles or if it is not clear.
Tużax it- taħlita ta ’ Cetrotide 3 mg jekk fiha xi frak jew mhix ċara.
Lay out on a clean surface everything you need (one vial, one pre-filled syringe, one injection needle with a yellow mark, one injection needle with a grey mark and two alcohol swabs).
Poġġi kull ma għandek bżonn fuq wiċċ nadif (fjala waħda, siringa mimlija lesta, labra għall - injezzjoni b’ marka sfara, labra għall- injezzjoni b’ labra griża u żewġ ċraret ta ’ l- alkoħol).
Flip off the plastic cover of the vial.
Neħħi l- għatu tal- plastika tal- fjala.
Put the needle on the syringe and remove the cover of the needle.
Poġġi l- labra fuq is- siringa u neħħi l- l- għatu tal- labra.
Take the injection needle with the grey mark and remove its wrapping.
Aqbad il- labra ta ’ l- injezzjoni bil- marka l- griża u neħħilha l- għatu.
Invert the syringe and push the plunger until all air bubbles have been expelled.
Aqleb is- siringa u ibbota l- parti ta ’ wara sakemm il- bżieżaq ta ’ l- arja jkunu tneħħew kollha.
Choose an injection site at the lower abdominal wall, preferably around the navel.
Agħżel il- post ta ’ l- injezzjoni fil- parti t’ isfel tal- membrana ta ’ l- addome, preferibilment madwar iż- żokra.
Take the second alcohol swab and clean the skin at the injection site.
Aqbad it- tieni ċaruta ta ’ l- alkoħol u naddaf il- ġilda fil- post fejn ħa tingħata l - injezzjoni.
Gently pinch up the skin surrounding the site of injection and hold firmly with the other hand.
Bil- mod agħfas ’ il fuq il- ġilda madwar il- post fejn ħa tingħata l- injezzjoni u żommha sew bl- id l- oħra.
If no blood appears, inject the solution slowly by pushing the plunger gently forward.
Jekk ma joħroġx demm, injetta t- taħlita bil- mod billi tibbotta l- parti ta ’ wara ġentilment ‘ il quddiem.
After all of the solution is injected, withdraw the needle slowly, applying gentle pressure with the alcohol swab on the skin where the needle was inserted.
Wara li tkun injettajt t- taħlita kollha, oħroġ is- siringa bil- mod, u bil- mod agħfas iċ - ċaruta bl- alkoħol fuq il- ġilda fejn tkun daħħalt il- labra.
Dispose of the syringe and needles immediately after use (put the covers on the needles to avoid injury).
(poġġi l - għotjin fuq il- labar biex tevita li xi ħadd iweġġa ’).
38 If you use more Cetrotide than you should
Jekk tuża Cetrotide aktar milli suppost għandek:
Overdosage of Cetrotide 3 mg may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
Doża eċċessiva ta ’ Cetrotide 3 mg tista ’ ttawwal il- perjodu ta ’ azzjoni iżda m’ għandiex tkun marbuta ma ’ effetti tossiċi akuta.
Do not take a double dose to make up for a forgotten dose, please contact your doctor.
Tieħux doża doppja biex tpatti għad- doża li nsejt tieħu, jekk jogħġbok agħmel kuntatt mat - tabib tiegħek.
POSSIBLE SIDE EFFECTS
EFFETTI OĦRA LI JISTGĦU JINĦASSU
Like all medicines, Cetrotide can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Cetrotide jista ’ jkollu effetti oħra għalkemm ma jidhrux fuq kulħadd.
Mild and transient reactions may occur at the injection site like reddening, itching, and swelling.
Reazzjonijiet moderati u li ma jdumux jistgħu jseħħu fil- post fejn ħa tingħata l- injezzjoni bħal ħmura, ħakk u nfieħ.
Occasionally systemic side effects, like nausea and headache have been reported (less than 1 patient in 100).
Xi kultant, xi effetti mhux mixtieqa sistematiċi, bħal nawsja u wġigħ ta ’ ras kienu rrapurtati (inqas minn 1 f’ 100).
Symptoms like abdominal pain, tension, nausea, vomiting, diarrhoea and breathing difficulties may indicate an OHSS.
Sintomi bħal uġigħ addominali, tensjoni, nawżea, vomitu, dijarea u diffikultajiet fin- nifs jistgħu jindikaw l- OHSS.
If you notice any side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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.
Keep out of the reach and sight of children.
Żomm fejn ma ’ jintlaħaqx u ma jidhirx mit- tfal.
Do not store above 25°C.
Taħżinx f’ temperatura ta ’ ‘ l fuq minn 25°C.
Keep the vial in the outer carton in order to protect from light.
Aħżen il- kontenitur fil- kartuna ta ’ barra sabiex tipproteġi l- prodott mid- dawl.
Do not use Cetrotide after the expiry date which is stated on the vial after EXP.
Tużax Cetrotide wara id- data ta ’ skadenza, li hija miktuba fuq il- vjala wara JIS.
The Cetrotide 3 mg powder in the vial and the solvent in the pre-filled syringe have the same expiry date.
It- trab ta ’ Cetrotide 3mg fil- fjala u s- solvent fis- siringa mimlija lesta jiskadu fl- istess ġurnata.
Do not use Cetrotide if the white pellet in the vial has changed in aspect or colour, or if the solvent solution in the vial is no longer clear and colourless or if it contains particles.
Tużax Cetrotide jekk il- pelitt abjad fil- vjal inbidel fl- aspett jew kulur tiegħu, jew inkella jekk is - solvent tat- taħlita mhuwiex izjed ċar u minghajr kulur, jew jekk fih il- biċċiet.
If you have any further questions please consult your doctor or pharmacist.
36 Jekk għandek xi mistoqsijiet oħra jekk jogħġbok ikkonsulta lit- tabib jew spiżjar tiegħek.
These measures will help protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjient.
The active substance is cetrorelix acetate 3.12 – 3.24 mg, equivalent to 3 mg cetrorelix.
Is- sustanż attiv huwa cetrorelix acetate 3. 12 – 3. 24mg, ekwivalenti għall- 3 mg cetrorelix.
What Cetrotide looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Cetrotide 3mg is a powder for solution for injection.
Cetrotide 3 mg hu trab għal soluzzjoni għall- injezzjoni.
It is available in a pack with one vial.
Dan jinstab f’ pakketti ta ’ fjala waħda jew seba ’ fjali.
Marketing Authorisation Holder
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Manufacturer
Manifattur:
Baxter Oncology GmBH, Kantstrasse 2, D-33790 Halle, Germany. For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Baxter Oncology GmbH, Daimlerstrsse 2, D- 33790 Halle, Ġermanja.
België/ Belgique/ Belgien Serono Benelux BV Heizel Esplanade Heysel - b11 B -1020 Brussel/ Bruxelles/ Brüssel Tel. / Tél.: +32 2 481 75 80
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizazzjoni għall- Kummerċ.
Slovenská republika Serono Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Viedeň Rakúsko Tel: + 43 1 6047690
Slovenská republika Serono Austria GmbH Floridsdorfer Hauptstraße 1
EU Number
Għamla
Invented name
Mnejn jingħata
Strength
Numru ta ’ l- EU
Pharmaceutical Form
Isem inventat
Route of Administration
farmaċewtika
0.5 mg 1.0 mg 0.5 mg and 1.0 mg
0. 5 mg 1. 0 mg 0. 5 mg u 1. 0 mg
Film-coated tablet Film-coated tablet Film-coated tablet
Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita
Oral use Oral use Oral use
Użu orali Użu orali Użu orali
bottle (HDPE) bottle (HDPE) blister (Aclar/ PVC/ alu) in a card
Flixkun (HDPE) Flixkun (HDPE) Folja (Aclar/ PVC/ alu) f’ kartuna
56 tablets 56 tablets 11 x 0.5 mg + 14 x 1 mg tablets
56 pilloli 56 pilloli 11 x 0. 5 mg + 14 x 1 mg pilloli
1.0 mg 1.0 mg 0.5 mg 0.5 mg 0.5 mg and 1.0 mg
1. 0 mg 1. 0 mg 0. 5 mg 0. 5 mg 0. 5 mg u 1. 0 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita
Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali
blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a carton
Folja (Aclar/ PVC/ alu) f’ kartuna Folja (Aclar/ PVC/ alu) f’ kartuna Folja (Aclar/ PVC/ alu) f’ kartuna Folja (Aclar/ PVC/ alu) f’ kartuna Folja (Aclar/ PVC/ alu) f’ kartuna
28 tablets 56 tablets 28 tablets 56 tablets 11 x 0.5 mg + 14 x 1 mg tablets
28 pilloli 56 pilloli 28 pilloli 56 pilloli 11 x 0. 5 mg + 14 x 1 mg pilloli
1.0 mg 1.0 mg 1.0 mg 0.5 mg and 1.0 mg
1. 0 mg 1. 0 mg 1. 0 mg 0. 5 mg u 1. 0 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita Pilloli miksija b’ rita
Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali
blister (Aclar/ PVC/ alu) in a carton blister (Aclar/ PVC/ alu) in a carton blister (Aclar/ PVC/ alu) in a carton blister (Aclar/ PVC/ alu) in a card
Folja (Aclar/ PVC/ alu) f’ kartuna Folja (Aclar/ PVC/ alu) f’ kartuna Folja (Aclar/ PVC/ alu) f’ kartuna Folja (Aclar/ PVC/ alu) f’ kartuna
28 tablets 56 tablets 112 tablets 11 x 0.5 mg + 14 x 1 mg tablets plus 28 x 1mg tablets
28 pilloli 56 pilloli 112 pilloli 11 x 0. 5 mg + 14 x 1 mg pilloli ma ’ 28 x 1mg pilloli
CHAMPIX 0.5 mg film-coated tablets
CHAMPIX 0. 5 mg pilloli miksijin b' rita
Each film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Kull pillola miksija b' rita fiha 0. 5 mg ta 'varenicline (bħala tartrat).
Film-coated tablet
Pillola miksija b' rita
0.5 mg film-coated tablets:
Pilloli ta '0. 5 mg miksijin b' rita:
White, capsular-shaped, biconvex tablets debossed with “ Pfizer ” on one side and “ CHX 0.5” on the other side.
Pilloli bojod bikonvessi forma ta 'kapsula bi “ Pfizer ” imnaqqax fuq naħa u “ CHX 0. 5 ” fuq in- naħa l- oħra.
CHAMPIX is indicated for smoking cessation in adults.
CHAMPIX huwa indikat għat- twaqqif tat- tipjip f' persuni adulti.
Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
It- terapiji għal waqfien mit- tipjip huma aktar probabbli li jirnexxu għal pazjenti li jkunu motivati biex jaqtgħu t- tipjip u li jkunu pprovduti parir u appoġġ addizzjonali.
CHAMPIX is for oral use.
CHAMPIX huwa għal użu orali biss.
The recommended dose is 1 mg varenicline twice daily following a 1- week titration as follows:
Id- doża rakkomandata hi 1 mg varenicline darbtejn kuljum wara ġimgħa titrazzjoni kif ġej:
Days 1 – 3:
Jum 1 - 3:
Days 4 – 7:
Jum 4 - 7:
Day 8 – End of treatment:
Jum 8 - Tmiem tal- kura:
0.5 mg once daily 0.5 mg twice daily 1 mg twice daily
1 mg darbtejn kuljum
The patient should set a date to stop smoking.
biex jieqaf mit- tipjip.
CHAMPIX dosing should start 1-2 weeks before this date.
Id- dożi ta 'CHAMPIX għandhom jibdew 1- 2
Patients who cannot tolerate adverse effects of CHAMPIX may have the dose lowered temporarily or permanently to 0.5 mg twice daily.
Pazjenti li ma jistgħux jittolleraw l- effetti avversi ta 'CHAMPIX jista' jkollhom id- doża mnaqqsa b' mod temporanju jew permanenti għal 0. 5 mg darbtejn kuljum.
CHAMPIX tablets should be swallowed whole with water.
Il- pilloli CHAMPIX għandhom jinbelgħu sħaħ bl- ilma.
CHAMPIX can be taken with or without food.
CHAMPIX jista 'jittieħed ma' l- ikel jew waħdu.
Patients should be treated with CHAMPIX for 12 weeks.
Il- pazjenti għandhom jiġu kkurati b' CHAMPIX għal 12- il ġimgħa.
For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered (see section 5.1).
Fil- każ tal- pazjenti li jkunu qatgħu b' suċċess it- tipjip fit- tmiem tat- 12 - il ġimgħa, jista 'jiġi kkunsidrat kors addizzjonali ta' 12- il ġimgħa kura b' CHAMPIX b' doża ta '1 mg darbtejn kuljum (ara sezzjoni 5. 1).
No data are available on the efficacy of an additional 12 weeks course of treatment for patients who do not succeed in stopping smoking during initial therapy or who relapse after treatment.
M' hemmx informazzjoni disponibbli dwar l- effikaċja ta 'kors ta' kura addizzjonali ta '12- il ġimgħa għal pazjenti li ma rnexxilhomx jaqtgħu t- tipjip matul it- terapija inizjali jew li jirkadu wara l- kura.
2 In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
2 Fit- terapija għal waqfien mit- tipjip, ir- riskju ta 'rikaduta għat- tipjip huwa għoli fil- perjodu immedjatament wara t- tmiem tal- kura.
In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).
Fil- każ ta 'pazjenti b' riskju għoli ta' rikaduta, jista 'jiġi kkunsidrat tnaqqis fid- doża (ara sezzjoni 4. 4).
Patients with renal insufficiency No dosage adjustment is necessary for patients with mild (estimated creatinine clearance > 50 ml/ min and ≤ 80 ml/ min) to moderate (estimated creatinine clearance ≥ 30 ml/ min and ≤ 50 ml/ min) renal impairment.
Pazjenti b' insuffiċjenza tal- kliewi M' hemmx bżonn aġġustament fid- doża għal pazjenti b' indeboliment tal- kliewi ħafif (clearance stmata tal- kreatinina > 50 ml/ min u ≤80 ml/ min) għal moderat (clearance stmata tal- kreatinina ≥30 ml/ min u ≤50 ml/ min).
For patients with moderate renal impairment who experience adverse events that are not tolerable, dosing may be reduced to 1 mg once daily.
Għall- pazjenti b' indeboliment moderat tal- kliewi li jesperjenzaw episodji avversi li ma jkunux tollerabbli, id- doża tista 'titnaqqas għal 1 mg darba kuljum.
For patients with severe renal impairment (estimated creatinine clearance < 30 ml/ min), the recommended dose of CHAMPIX is 1 mg once daily.
Għall- pazjenti b' indeboliment akut tal- kliewi (clearance stmata tal- kreatinina < 30 ml/ min), id- doża rakkomandata ta 'CHAMPIX hi 1 mg darba kuljum.
Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily.
Id- doża għandha tibda b' 0. 5 mg darba kuljum għall- ewwel 3 ijiem u mbagħad tiżdied għal 1 mg darba kuljum.
Based on insufficient clinical experience with CHAMPIX in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).
Fuq il- bażi ta 'esperjenza klinika insuffiċjenti b' CHAMPIX f' pazjenti b' mard tal- kliewi ta' l- aħħar stadju, mhix rakkomandata kura f' din il- popolazzjoni ta 'pazjenti.
Patients with hepatic impairment No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Pazjenti b' indeboliment tal- fwied Mhux meħtieġ aġġustament fid- doża għal pazjenti b' indeboliment tal- fwied (ara sezzjoni 5. 2).
Dosing in elderly patients No dosage adjustment is necessary for elderly patients (see section 5.2).
Dożaġġ f' pazjenti anzjani Mhux meħtieġ aġġustament fid- doża għal pazjenti anzjani (ara sezzjoni 5. 2).
Because elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient.
Billi l- pazjenti anzjani huma aktar probabbli li jkollhom funzjoni tal- kliewi mnaqqsa, min jordna l- mediċina għandu jikkunsidra l- istat tal- kliewi ta 'pazjent anzjan.
Paediatric patients CHAMPIX is not recommended for use in children or adolescents below 18 years of age due to insufficient data on safety and efficacy (see section 5.2).
Pazjenti pedjatriċi CHAMPIX mhux irrakkomandat għall- użu fit- tfal jew l- adoloxxenti ta 'taħt it- 18 - il sena peress li m' hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva gћas- sustanza attiva jew gћal xi sustanzi mhux attivi.
Effect of smoking cessation:
Effett tal- waqfien mit- tipjip:
Physiological changes resulting from smoking cessation, with or without treatment with CHAMPIX, may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin).
Il- bidliet fiżjoloġiċi li jirriżultaw minn waqfien mit- tipjip, bi jew mingħajr kura b' CHAMPIX, jistgħu jibdlu l- farmakokinetiċi jew il- farmakodinamiċi ta 'xi prodotti mediċinali, li għalihom jista' jkun meħtieġ aġġustament fid- doża (eżempji jinkludu t- theophylline, il - warfarin u l- insulina).
As smoking induces CYP1A2, smoking cessation may result in an increase of plasma levels of CYP1A2 substrates.
Billi t- tipjip jinduċi CYP1A2, waqfien mit- tipjip jista 'jirriżulta f' żieda fil- livelli tas- sottostrati ta' CYP1A2 fil- plasma.
Depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with Champix in the post-marketing experience.
Dipressjoni, ideat u atteġġamenti ta ’ suwiċidju u attentati ta ’ suwiċidju, ġew irrappurtati f’ pazjenti li jkunu qed jippruvaw jieqfu jpejpu b’ Champix waqt l- esperjenza bil- prodott wara t- tqegħid fis- suq.
Not all patients had stopped smoking at the time of onset of symptoms and not all patients had known pre-existing psychiatric illnesss.
Mhux il- pazjenti kollha kienu waqqfu mit- tipjip fiż- żmien li bdew jidhru is- sintomi u mhux il- pazjenti kollha kellhom xi mard psikjatriku ġa eżistenti.
Clinicians should be aware of the possible emergence of significant depressive symptomatology in patients undergoing a smoking cessation attempt, and should advise patients accordingly.
L- ispeċjalisti kliniċi għandhom ikunu konxji li jista ’ jkun hemm sintomatoloġija dipressiva sinifikanti f ’ pazjenti li qed jippruvaw jieqfu jpejpu, li jkunu jeħtieġu pariri xierqa skond il- każ.
Champix should be discontinued immediately if agitation, depressed mood or changes in behaviour that are of concern for the doctor, the patient, family or caregivers are observed, or if the patient develops suicidal ideation or suicidal behaviour.
Għandu jiġi mwaqqaf ukoll jekk il- pazjent jiżviluppa ideat ta ’ suwiċidju jew atteġġamenti ta ’ suwiċidju.
Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal.
Burdati dippressivi, li rarament jinkludu ideat ta ’ suwiċidju u attentati ta ’ suwiċidju, jisgħu ikunu sintomu ta ’ twaqqif tan- nikotina.
In addition, smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e. g. depression).
Dipressjoni).
3 The safety and efficacy of Champix in patients with serious psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder has not been established.
3 Is- sigurta ’ u l- effikaċja ta ’ Champix f’ pazjenti b’ mard psikjatriku serju, bħal skizofrenija, episodji ta ’ manija jalternaw ma ’ burdati dipressivi (bipolar disorder), u marda ta ’ dipressjoni akuta ma ġewx stabilizzati.
Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
Dawn il - pazjenti għandhom jiġu avżati skond il- każ.
There is no clinical experience with CHAMPIX in patients with epilepsy.
M' hemmx esperjenza klinika b' CHAMPIX f' pazjenti li jbatu minn epilessija.
At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/ or insomnia in up to 3% of patients.
Fit- tmiem tal- kura, it- twaqqif ta 'CHAMPIX ġie assoċjat ma' żieda fl- irritabilita ', xenqa ta' tipjip, depressjoni, u/ jew nuqqas ta 'rqad f' sa 3% tal- pazjenti.
The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering.
Min jordna l- mediċina għandu jinforma lill - pazjent f' dak ir- rigward u jiddiskuti jew jikkunsidra l- ħtieġa li titnaqqas id- doża.
Based on varenicline characteristics and clinical experience to date, CHAMPIX has no clinically meaningful drug interactions.
Fuq il- bażi tal- karatteristiċi ta 'varenicline u l- esperjenza klinika sa issa, CHAMPIX m' għandux interazzjonijiet kliniċi importanti ma' mediċini oħra.
No dosage adjustment of CHAMPIX or co-administered medicinal products listed below is recommended.
Mhux rakkomandat aġġustament fid- doża ta 'CHAMPIX jew tal- prodotti mediċinali mogħtija miegħu elenkati hawn taħt.
In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Studji in vitro jindikaw li varenicline mhux probabbli li jibdel il- farmakokinetiċi ta 'komposti li jiġu metabolizzati primarjament minn enzimi taċ- ċitokromu P450.
Furthermore since metabolism of varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of varenicline (see section 5.2) and therefore a dose adjustment of CHAMPIX would not be required.
Barra minn hekk, billi l- metaboliżmu ta 'varenicline jirrappreżenta anqas minn 10% tal- clearance tiegħu, sustanzi attivi magħrufa li jaffettwaw is- sistema taċ- ċitokromu P450 mhumiex probabbli li jbiddlu l- farmakokinetiċi ta' varenicline (ara sezzjoni 5. 2) u għalhekk m' għandux ikun meħtieġ aġġustament fid- doża ta 'CHAMPIX.
In vitro studies demonstrate that varenicline does not inhibit human renal transport proteins at therapeutic concentrations.
Studji in vitro juru li varenicline ma jinibixxix il- proteini tat- trasport renali uman f' konċentrazzjonijiet terapewtiċi.
Therefore, active substances that are cleared by renal secretion (e. g. metformin - see below) are unlikely to be affected by varenicline.
Għalhekk, sustanzi attivi li jiġu eliminati permezz ta 'sekrezzjoni renali (p. e. metformin - ara taħt) mhumiex probabbli li jiġu affettwati b' varenicline.
Varenicline did not affect the pharmacokinetics of metformin.
Varenicline ma affettwax il- farmakokinetiċi ta 'metformin.
Metformin had no effect on varenicline pharmacokinetics.
Metformin ma kellux effett fuq il- farmakokinetiċi ta 'varenicline.
Cimetidine:
Cimetidine:
Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance.
L- amministrazzjoni ta 'cimetidine ma' varenicline żiedet l- espożizzjoni sistemika ta 'varenicline b' 20% minħabba tnaqqis fil- clearance renali ta' varenicline.
No dosage adjustment is recommended based on concomitant cimetidine administration in subjects with normal renal function or in patients with mild to moderate renal impairment.
Mhux rakkomandat aġġustament fid- doża bbażat fuq l- amministrazzjoni konkomitanti ta 'cimetidine f' suġġetti b' funzjoni tal- kliewi normali jew f' pazjenti b' indeboliment tal- kliewi ħafif għal moderat.
In patients with severe renal impairment, the concomitant use of cimetidine and varenicline should be avoided.
F' pazjenti b' indeboliment akut tal- kliewi, l- użu f' daqqa ta 'cimetidine u varenicline għandu jiġu evitat.
Varenicline did not alter the steady-state pharmacokinetics of digoxin.
Varenicline ma bidilx il- farmakokinetiċi fissi ta 'digoxin.
Varenicline did not alter the pharmacokinetics of warfarin.
Varenicline ma bidilx il- farmakokinetiċi ta 'warfarin.
Prothrombin time (INR) was not affected by varenicline.
Varenicline ma affettwax il- ħin li jieħu d- demm biex jagħqad (INR).
Smoking cessation itself may result in changes to warfarin pharmacokinetics (see section 4.4).
Il- waqfien mit- tipjip innifsu jista 'jwassal għal bidliet fil - farmakokinetiċi ta' warfarin (ara sezzjoni 4. 4).
Alcohol:
Alkoħol:
There is limited clinical data on any potential interaction between alcohol and varenicline.
Hemm tagħrif kliniku limitat dwar kwalunkwe interazzjoni potenzjali bejn l- alkoħol u varenicline.
Use with other therapies for smoking cessation:
Użu ma 'terapiji oħra għal waqfien mit- tipjip:
Varenicline did not alter the steady-state pharmacokinetics of bupropion.
Varenicline ma biddilx il- farmakokinetiċi fissi ta 'bupropion.
Nicotine replacement therapy (NRT):
Terapija ta 'sostituzzjoni tan- nikotina (NRT):
When varenicline and transdermal NRT were co-administered to smokers for 12 days, there was a statistically significant decrease in average systolic blood pressure (mean 2.6 mmHg) measured on the final day of the study.
F' dan l- istudju, l- inċidenza
In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
4 tad- dardir, uġigħ ta 'ras, rimettar, sturdament, dispepsja, u għeja kienet akbar għall- kombinazzjoni milli għan- NRT waħedha.
Safety and efficacy of CHAMPIX in combination with other smoking cessation therapies have not been studied.
Is- sigurta 'u l- effikaċja ta' CHAMPIX ma 'terapiji oħra għal waqfien mit- tipjip ma ġewx studjati.
There are no adequate data from the use of CHAMPIX in pregnant women.
M' hemmx tagħrif adegwat mill- użu ta 'CHAMPIX f' nisa tqal.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq l- annimali wrew tossiċita 'tas - sistema riproduttiva (ara sezzjoni 5. 3).
CHAMPIX should not be used during pregnancy.
CHAMPIX m' għandux jintuża waqt it- tqala.
It is unknown whether varenicline is excreted in human breast milk.
Mhux magħruf jekk varenicline jitneħħiex fil- ħalib uman.
Animal studies suggest that varenicline is excreted in breast milk.
L- istudji fuq l- annimali jissuġġerixxu li varenicline jitneħħa fil- ħalib uman.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with CHAMPIX should be made taking into account the benefit of breast-feeding to the child and the benefit of CHAMPIX therapy to the woman.
Deċiżjoni dwar jekk it- treddigħ jissoktax/ jitwaqqaf jew jekk it - terapija b' CHAMPIX tissoktax/ titwaqqaf għandha tittieħed billi jiġi kkunsidrat il- benefiċċju tat - treddigħ għat- tarbija u l- benefiċċju tat- terapija b' CHAMPIX għall- mara.
CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
CHAMPIX jista 'jkollu effett żgħir jew moderat fuq il- ħila biex issuq u tħaddem magni.
CHAMPIX may cause dizziness and somnolence and therefore may influence the ability to drive and use machines.
CHAMPIX jista 'jikkawża sturdament u ngħas u għalhekk jista' jaffettwa l- ħila biex issuq u tħaddem magni.
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Il - pazjenti huma mogħtija parir biex ma jsuqux, ma jħaddmux makkinarju kumpless u ma jinvolvux ruħhom f' attivitajiet oħra li jistgħu jkunu perikolużi sakemm ikun magħruf jekk dan il- prodott mediċinali jaffettwax il- ħila tagħhom biex iwettqu dawn l- attivitajiet.
Smoking cessation with or without treatment is associated with various symptoms.
Il- waqfien mit- tipjip bi jew mingħajr kura huwa assoċjat ma 'diversi sintomi.
For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; decreased heart rate; increased appetite or weight gain have been reported in patients attempting to stop smoking.
Pereżempju, burdata disforika jew depressa; nuqqas ta 'rqad, irritabilita', frustrazzjoni jew rabja; ansjeta '; diffikulta' biex tikkonċentra; irrekwitezza; ritmu tal- qalb imnaqqas; żieda fl- aptit jew żieda fil- piż ġew irrapportati f' pazjenti li ppruvaw jaqtgħu t- tipjip.
No attempt has been made in either the design or the analysis of the CHAMPIX studies to distinguish between adverse events associated with study drug treatment or those possibly associated with nicotine withdrawal.
Ma sar l- ebda tentattiv fit- tfassil jew fl- analiżi ta 'l- istudji b' CHAMPIX biex issir distinzjoni bejn l- episodji avversi marbuta mal- kura bil- mediċina taħt studju jew dawk possibbilment assoċjati mat- twaqqif tan- nikotina.
Clinical trials included approximately 4,000 patients treated with CHAMPIX for up to 1 year (average exposure 84 days).
Il- provi kliniċi kienu jinkludu madwar 4, 000 pazjent ikkurati b' CHAMPIX għal perjodi li kienu jlaħħqu sa sena (espożizzjoni medja 84 jum).
In general, when adverse reactions occurred, onset was in the first week of therapy; severity was generally mild to moderate and there were no differences by age, race or gender with regard to the incidence of adverse reactions.
Ġeneralment, meta seħħew reazzjonijiet avversi, il- bidu kien fl- ewwel ġimgħa tat- terapija; is- severita 'ġeneralment kienet ħafifa għal moderata u ma kienx hemm differenzi bl- eta', razza jew sess tal- persuna fir- rigward ta 'l- inċidenza tar- reazzjonijiet avversi.
In patients treated with the recommended dose of 1mg BID following an initial titration period the adverse event most commonly reported was nausea (28.6%).
Fil- pazjenti kkurati bid- doża rakkomandata ta '1mg BID wara perjodu ta' titrazzjoni inizjali, l- episodju avvers li ġie rrapportat l- aktar kien id- dardir (28. 6%).
In the majority of cases nausea occurred early in the treatment period, was mild to moderate in severity and seldom resulted in discontinuation.
Fil- maġġoranza tal- każijiet id- dardir seħħ kmieni fil- perjodu ta 'kura, kien ta' severita 'ħafifa għal moderata u rari wassal għal twaqqif tal- kura.
The treatment discontinuation rate due to adverse events was 11.4% for varenicline compared with 9.7% for placebo.
Ir- rata tat- twaqqif tal- kura minħabba episodji avversi kienet 11. 4% għal varenicline meta mqabbla ma '9. 7% għall- plaċebo.
In this group, the discontinuation rates for the most common adverse events in varenicline treated patients were as follows: nausea (2.7% vs.
F' dan il- grupp, ir- rati tat- twaqqif għall- aktar episodji avversi komuni f' pazjenti kkurati b' varenicline kienu kif ġej: dardir (2. 7% vs.
0.6% for placebo), headache (0.6% vs.
0. 6% għall- plaċebo), uġigħ ta 'ras (0. 6% vs.
1.0% for placebo), insomnia (1.3% vs.
1. 0% għall- plaċebo), nuqqas ta 'rqad (1. 3% vs.
1.2% for placebo), and abnormal dreams (0.2% vs.
1. 2% għall- plaċebo), u ħolm abnormali (0. 2% vs.
0.2% for placebo).
0. 2% għall- plaċebo).
In the table below all adverse reactions, which occurred at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100) and rare (≥ 1/ 10,000 to < 1/ 1,000)). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Ir- reazzjonijiet avversi kollha fit- tabella ta 'hawn taħt, li seħħew b' inċidenza akbar mill- plaċebo huma elenkati bis- sistema tal- klassifika ta' l- organi u l- frekwenza (≥1/ 10), komuni (≥1/ 100 to < 1/ 10), mhux komuni (≥1/ 1, 000 to < 1/ 100) u rari (≥1/ 10, 000 to < 1/ 1, 000)).
Infections and Infestations Uncommon
F' kull sezzjoni ta 'frekwenza, l- effetti mhux mixtieqa huma ppreżentati skond is- serjetà tagħhom.
Metabolism and nutrition disorders Common Uncommon
L- effetti li huma l- aktar serji huma mniżżlin l- ewwel, segwiti minn dawk inqas serji.
5
5 Sistema tal - Klassifika ta 'l - Organi
System Organ Class
Reazzjonijiet Avversi għall- Mediċina
Adverse Drug Reactions
Infezzjonijiet u Infestazzjonijiet Mhux komuni
Psychiatric disorders Very common Uncommon
Bronkite, rinofarinġite, sinożite, infezzjoni fungali, infezzjoni virali
Abnormal dreams, insomnia Panic reaction, bradyphrenia, thinking abnormal, mood swings
Żieda fl- aptit Anoreksja, tnaqqis fl- aptit, polydipsia