qanastek/EMEA-V3 huggingface dataset:
If you drive or use tools or machines: watch out for signs of a hypo.
Jekk issuq jew tuża għodda jew magni: oqgħod attent/ a għal sinjali ta ’ xi ipo.
If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Jekk it- tabib tiegħek biddillek l- insulina minn tip jew marka ta ’ insulina għal oħra, jista ’ jkun li d- doża tiegħek ikollha bżonn li tiġi aġġustata mit- tabib tiegħek.
Injecting insulin
Kif tinjetta l- insulina
► Check the label to make sure it is the right type of insulin ► Always use a new needle for each injection to prevent contamination.
► Iċċekkja t- tikketta biex tiżgura li hi t- tip korrett ta ’ insulina. ► Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni
► In insulin infusion pumps ► If NovoLet is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Actrapid) ► If it does not appear water clear and colourless.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk n- NovoLet titwaqqa ’, jiġrilha l- ħsara jew titgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew kien iffriżat (ara 6 Kif taħżen Actrapid) ► Jekk ma jidhirx ċar bħall- ilma u bla kulur.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness;
Is- sinjali ta ’ twissija ta ’ ipo jistgħu jiġu għal għarrieda u jistgħu jinkludu: għaraq kiesaħ; ġilda kiesħa u pallida; uġigħ ta ’ ras; taħbit mgħaġġel tal- qalb; tħossok imqalla ’; tħoss ġuħ kbir; tibdil temporanju fil- vista; ngħas; għeja u debbulizza mhux tas- soltu; nervożità jew rogħda; tħossok ansjuż/ a; tħossok konfuż/ a; diffikultà biex tikkonċentra.
92 Side effects reported uncommonly (in less than 1 patient in 100)
Effetti sekondarji rrappurtati b’ mod mhux komuni (anqas minn pazjent 1 minn kull 100):
The NovoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
99 In- NovoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C).
The NovoLet that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
In- NovoLet li tkun qed tintuża, jew li waslet biex tintuża, jew li qeda tinġarr bħala spare, m’ għandiex tinżamm fil- friġġ.
You can carry it with you and keep it at room temperature (not above 30ºC) for up to 6 weeks.
Tista ’ ġġorrha miegħek u żżommha fit- temperatura tal- kamra (mhux aktar minn 30ºC) sa perijodu ta ’ 6 ġimgħat.
1 pre-filled pen contains 3 ml equivalent to 300 IU
Pinna mimlija għal- lest fiha 3 ml ekwivalenti għal 300 UI.
What Actrapid looks like and contents of the pack The solution for injection comes as a clear, colourless, aqueous solution.
Id- dehra ta ’ Actrapid u d- daqs tal- pakkett Is- soluzzjoni għal injezzjoni tiġi bħala soluzzjoni akweja ċara u bla kulur.
It is supplied in packs of 5 or 10 pre-filled pens of 3 ml.
Issibu f’ pakketti ta ’ 1, 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml.
Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- manifattur
94 Information on how to use Actrapid NovoLet
100 Informazzjoni dwar kif tuża Actrapid NovoLet
Please read the following instructions carefully before using your Actrapid NovoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin b’ attenzjoni qabel ma tuża l- Actrapid NovoLet tiegħek.
Actrapid NovoLet is a simple, compact pre-filled pen.
Actrapid NovoLet hi pinna mimlija għal- lest sempliċi u kumpatta.
You can dial doses from 2 to 78 units in increments of 2 units.
Tista ’ tiddajlja dożi minn 2 sa 78 unità f’ inkrementi ta ’ 2 unitajiet.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare ta ’ l- għoti ta ’ l- insulina f’ każ li l- NovoLet tiegħek tintilef jew ikollha l- ħsara.
NovoLet®
Kif tibda
Check the label to make sure that your Actrapid NovoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex tiżgura li l- Actrapid NovoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Take off the pen cap. • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Actrapid NovoLet (picture A) • Pull off the big outer needle cap and the inner needle cap.
Neħħi l- għatu tal- pinna. • Iddiżinfetta l- membrana tal- gomma b’ tajjara b’ diżinfettant • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine
Do not discard the big outer needle cap.
Tarmix l - għatu l- kbir ta ’ barra tal- labra.
Small amounts of air may collect in the needle and cartridge during normal use.
Ammonti żgħar ta ’ arja jistgħu jinġabru fil- labra u fl- iskartoċċ matul l- użu normali.
Any air bubbles will collect at the top of the cartridge • Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture B) • Still with the needle upwards, press the push-button fully down (picture C) • A drop of insulin must appear at the needle tip.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Actrapid NovoLet bil- labra tipponta ’ l fuq • Tektek l- iskartoċċ bil- mod b’ sebgħek xi ftit drabi biex kwalunkwe bżieżaq ta ’ l- arja jinġabru fin- naħa ta ’ fuq ta ’ l- iskartoċċ • Bil- labra dejjem tħares ’ il fuq, dawwar l- iskartoċċ bi klikk waħda fid- direzzjoni tal- vleġġa (stampa B) • Bil- labra għadha tipponta ’ l fuq, agħfas il- buttuna ta ’ l- injezzjoni ’ l isfel kemm tista ’ (stampa C) • Qatra insulina għandha tidher fil- ponta tal- labra.
If a drop of insulin still does not appear, the device is defective and must not be used.
Jekk il- qatra ta ’ l- insulina tibqa ’ ma titfaċċax, it- tagħmir hu difettuż u m’ għandux jintuża.
• Put the cap back on the pen, with 0 next to the dosage indicator (picture D) • Check that the push-button is fully down.
• Erġa ’ poġġi l- għatu fuq il- pinna, biż- 0 biswit l- indikatur tad- doża (stampa D) • Ivverifika li l- buttuna ta ’ l- injezzjoni hija magħfusa sa isfel nett.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Actrapid NovoLet horizontally.
Jekk m’ hijiex, dawwar l - għatu sakemm il- buttuna ta ’ l- injezzjoni hija magħfusa s’ isfel nett. • Żomm l- Actrapid NovoLet tiegħek b’ mod orizzontali.
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture E) to set the right dose.
Ser tħoss l - għatu jikklikkja, u l- buttuna li tingħafas ser titla ’. • Tqegħidx idejk fuq il- buttuna ta ’ l- injezzjoni meta tissettja d- doża.
You’ ll feel the cap clicking, and the push-button will rise up
Jekk il- buttuna ta ’ l - injezzjoni ma tistax titla ’ liberament, xi ftit mill- insulina tiegħek se tiġi imbuttata ’ l barra mil - labra.
If the push-button cannot rise freely, some of your insulin will be pushed out of the needle • The scale on the cap shows 0, 2, 4, 6, 8, 10, 12, 14, 16 and 18 units.
102 • L- iskala fuq l- għatu turi 0, 2, 4, 6, 8, 10, 12, 14, 16 u 18- il unità.
For every click you feel when you turn the cap, you set 2 units more.
Għal kull klikk li tħoss meta ddawwar l- għatu, int tissettja 2 unitajiet aktar.
The push-button also rises as you turn the cap • The scale under the push-button shows 20, 40 and 60 units.
Il- buttuna ta ’ l- injezzjoni titla ’ wkoll hekk kif iddawwar l- għatu • L- iskala taħt il- buttuna ta ’ l- injezzjoni turi 20, 40 u 60 unità.
Turn the cap until 8 is opposite the dosage indicator; four clicks To select 26 units:
Dawwar l- għatu sakemm in- numru 8 ikun fil- pożizzjoni opposta ta ’ l- indikatur tad- doża; erba ’ klikks Biex tagħżel 26 unità:
Turn the cap round 1 full turn, so 0 is opposite the dosage indicator again.
Dawwar l- għatu dawra waħda kompleta, b’ tali mod li ż- 0 ikun mill- ġdid fil- pożizzjoni opposta ta ’ l - indikatur tad- doża.
Keep turning the cap until 6 is opposite the dosage indicator.
Kompli dawwar l- għatu sakemm in- numru 6 ikun fil- pożizzjoni opposta ta ’ l- indikatur tad- doża.
On the push-button scale you’ ll see a 20- line.
Fuq l- iskala tal- buttuna ta ’ l- injezzjoni, għandek tara sinjal ta ’ 20.
Add the 6 from the dosage indicator to the 20 on the push-button scale.
Għodd is- 6 mill- indikatur tad- doża ma ’ l- 20 fuq l- iskala tal- buttuna ta ’ l- injezzjoni.
There, you’ ve set 26 units (picture F).
Issa għadek kemm issettjajt 26 unità (stampa F).
To check a dose you set • Note the figure on the cap next to the dosage indicator • Note the highest figure you can see on the push-button scale • Add the two together to show the dose you set • If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
Biex tiċċekkja d- doża li tissettja • Innota n- numru fuq l- għatu biswit l- indikatur tad- doża • Innota l- ogħla numru li tista ’ tara fuq l- iskala tal- buttuna ta ’ l- injezzjoni • Għodd iż- żewġ numri biex turi d- doża li tkun issettjat • Jekk tkun issettjajt id- doża ħażin, sempliċement dawwar l- għatu ’ l quddiem jew lura sakemm tissettja n- numru korrett ta ’ unitajiet.
Turn the cap back as far as you can.
Dawwar l- għatu lura kemm tista ’.
Turn it till the push-button is fully down and you can feel resistance.
Dawru sakemm il- buttuna li tingħafas tkun ’ l isfel għal kollox u tkun tista tħoss ir- reżistenza.
Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator.
Imbagħad neħħi l- għatu u erġa ’ poġġih f’ postu, u agħmel iż- 0 biswit l- indikatur tad- doża.
Remember that 78 units is the maximum dose
Ftakar li 78 unità hi d- doża massima
97 • After the dose is set, remove the cap to inject the insulin.
103 • Wara li d- doża tkun issettjata, neħħi l- għatu biex tinjetta l- insulina.
Go straight on to section Injecting the insulin.
Mur dritt għas- sezzjoni Kif tinjetta l- insulina.
Be careful only to push the push- button when injecting • Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin.
Oqgħod attent/ a biex tagħfas il- buttuna ta ’ l- injezzjoni meta tkun qed tinjetta biss • Żomm il- buttuna ta ’ l- injezzjoni magħfusa ’ l isfel għal kollox wara l- injezzjoni sakemm il - labra tkun inġibdet ’ il barra minn ġol- ġilda.
The needle must remain under the skin for at least 6 seconds.
Il- labra għandha tinżamm taħt il- ġilda għal mill - anqas 6 sekondi.
Subsequent injections • Always check that the push-button is completely down.
Injezzjonijiet sussegwenti • Dejjem iċċekkja li l- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox.
If not, turn the cap until the push- button is fully depressed, then proceed as described in Getting started • You may hear a clicking sound when you press the push-button.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox, imbagħad kompli kif deskritt fis- sezzjoni Kif tibda • Tista ’ tisma ’ ħoss ta ’ klikk meta tagħfas il- buttuna ta ’ l- injezzjoni.
Don’ t use this to set or check your dose; it may not be accurate • You can’ t set a dose higher than the number of units left in the cartridge • You can use the insulin level indicator to estimate how much is left, but you can’ t use it to set or select your dose.
Tużahiex biex tissettja jew biex tiċċekkja d- doża tiegħek; din tista ’ ma tagħtikx informazzjoni preċiża • Ma tistax tissettja doża akbar min- numru ta ’ unitajiet li jkun fadal fl- iskartoċċ. • Tista ’ tuża l- indikatur tal- livell ta ’ l- insulina biex tagħmel stima ta ’ kemm baqa ’ insulina, iżda ma tistax tużah biex tissettja jew tagħżel id- doża.
Dispose of it carefully.
• Erġa ’ poġġi f’ postu l- għatu l- kbir ta ’ barra tal- labra u ħoll il- labra Armiha b’ attenzjoni.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella, il - likwidu jista ’ jnixxi ’ l barra li tista ’ tkun il- kawża ta ’ teħid ta ’ doża żbaljata.
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
Professjonisti fil- qasam tas- saħħa, qraba u nies oħrajn li jieħdu ħsieb il- pazjent, għandhom isegwu l - miżuri ġenerali ta ’ prekawzjoni għat- tneħħija u r- rimi tal- labar biex jiġi eliminat ir- riskju ta ’ tingiż mhux intenzjonat tal- labar.
Close your Actrapid NovoLet fully with 0 next to the dosage indicator.
Agħlaq l- Actrapid NovoLet kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Actrapid NovoLet carefully without the needle attached.
Armi l- Actrapid NovoLet użata tiegħek b’ attenzjoni mingħajr ma l- labra tkun imwaħħla.
Your Actrapid NovoLet is designed to work accurately and safely.
L- Actrapid NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
It must be handled with care.
Għandha tkun immaniġġjata b’ attenzjoni.
Do not refill Actrapid NovoLet.
Timliex mill- ġdid Actrapid NovoLet.
You can clean the exterior of your Actrapid NovoLet by wiping it with a medicinal swab.
Tista ’ tnaddaf in- naħa ta ’ barra ta ’ l- Actrapid NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
Do not soak it, wash or lubricate it.
Tgħaddashiex jew taħsilha jew tillubrikha.
Actrapid InnoLet 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid InnoLet 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Look out for the signs of allergy in 5 Possible side effects ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Oqgħod attent/ a għas- sinjali ta ’ l- allerġija f’ 5 Effetti sekondarji li jista ’ jkollu. ► Jekk tħoss li ġejja ipo (ipo hija taqsira għal reazzjoni ipogliċemika u hija ġabra ta ’ sintomi ta ’ livell baxx ta ’ zokkor fid- demm).
Using other medicines
105 Meta tuża mediċini oħra
99 Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Il- ħtieġa tiegħek għall- insulina tista ’ tinbidel jekk inti tieħu wkoll: prodotti mediċinali kontra d - dijabete li jittieħdu mill- ħalq; inibituri ta ’ monoamine oxidase (MAOI),), sustanzi li jibblukkaw ir - riċetturi beta, inibituri ta ’ l- enzima li tikkonverti l- angjotensin (ACE), acetylsalicylic acid; sterojdi anaboliċi; sulfonamidi; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojde; beta - simpatomimetiċi; ormon tat- tkabbir, danazol; octreotide jew lanreotide.
It is recommended that you measure your blood glucose regularly.
Hu rakkomandat li tiċċekkja l- livell tal- glukosju fid- demm tiegħek regolarment.
► Check the label to make sure it is the right type of insulin ► Always use a new needle for each injection to prevent contamination.
► Iċċekkja t- tikketta biex tiżgura li hi t- tip korrett ta ’ insulina ► Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni
► In insulin infusion pumps ► If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Actrapid) ► If it does not appear water clear and colourless.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk l- InnoLet titwaqqa ’, jiġrilha l- ħsara jew titgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew kien iffriżat (ara 6 Kif taħżen Actrapid) ► Jekk ma jidhirx ċar bħall- ilma u bla kulur.
101 Side effects reported uncommonly (in less than 1 patient in 100)
Effetti sekondarji rrappurtati b’ mod mhux komuni (anqas minn pazjent 1 minn kull 100):
The InnoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
108 L- InnoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C).
The InnoLet that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
L- InnoLet li tkun qed tintuża, jew li waslet biex tintuża, jew li qeda tinġarr bħala spare, m’ għandiex tinżamm fil- friġġ.
1 pre-filled pen contains 3 ml equivalent to 300 IU
Millilitru fih 100 UI ta ’ insulina umana. Pinna mimlija għal- lest fiha 3 ml ekwivalenti għal 300 UI.
It is supplied in packs of 1, 5 or 10 pre-filled pens of 3 ml.
Issibu f’ pakketti ta ’ 1, 5 jew 10 pinen mimlija għal- lest ta ’ 3 ml.
103 Information on how to use Actrapid InnoLet
109 Informazzjoni dwar kif tuża Actrapid InnoLet
Please read the following instructions carefully before using your Actrapid InnoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin b’ attenzjoni qabel ma tuża l- Actrapid InnoLet tiegħek.
Actrapid InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Actrapid InnoLet hi pinna mimlija għal- lest sempliċi u kumpatta li kapaċi tforni minn 1 sa 50 unità f’ inkrementi ta ’ unità 1.
Actrapid InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Actrapid InnoLet hi maħsuba biex tintuża ma ’ labar NovoFine S ta ’ 8 mm jew iqsar.
As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.
Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare tal- forniment ta ’ l - insulina f’ każ li l- InnoLet tiegħek tintilef jew ikollha l- ħsara.
Push-button
Kif tipprepara għall- injezzjoni
Dose Selector dial Residual scale Dose scale
Iċċekkja t- tikketta biex tiżgura li l- Actrapid InnoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
cartridge
Neħħi t- tapp tal- pinna (kif muri bil- vleġġa).
needle cap
Kif twaħħal il- labra
Preparing for injection
• Iddiżinfetta l- membrana tal- gomma b’ tajjara b’ diżinfettant
• Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S needle • Screw the needle straight and tightly onto Actrapid InnoLet (picture 1A) • Pull off the big outer needle cap and the inner needle cap.
110 • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine S • Issikka l- labra bi dritt u b’ mod marsus fuq Actrapid InnoLet (stampa 1A) • Iġbed ’ il barra l- għatu l- kbir ta ’ barra tal- labra u l- għatu ta ’ ġewwa tal- labra.
You may want to store the big outer needle cap in the compartment.
Jista ’ jkun li tkun trid taħżen l- għatu l- kbir ta ’ barra tal- labra fil- kompartiment.
Priming to expel air
Kif tħejji biex tneħħi l- arja
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Actrapid InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1B) • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin must appear at the needle tip.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Iddajlja 2 unitajiet billi ddawwar is- selettur tad- doża lejn il- lemin • Żomm Actrapid InnoLet bil- labra tipponta ’ l fuq u tektek l- iskartoċċ bil- mod b’ sebgħek xi ftit drabi, biex iġġiegħel kwalunkwe bżieżaq ta ’ l- arja jinġabru fin- naħa ta ’ fuq ta ’ l- iskartoċċ (stampa 1B) • Filwaqt li żżomm il- labra ’ l fuq, agħfas il- buttuna ta ’ l- injezzjoni u s- selettur tad- doża jirritorna fuq iż- żero • Qatra insulina għandha tidher fil- ponta tal- labra.
• Always check that the push-button is fully depressed and the dose selector is set at zero • Dial the number of units required by turning the dose selector clockwise (picture 2).
• Dejjem iċċekkja li l- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox u li s - selettur tad- doża jkun issettjat fuq iż- żero.
Do not use the residual scale to measure your dose of insulin • You will hear a click for every single unit dialled.
Tużax l- iskala ta ’ kemm fadal insulina biex tkejjel id- doża ta ’ l- insulina tiegħek • Għandek tisma ’ klikk għal kull unità li tiddajlja.
The dose can be corrected by turning the dial either way.
Id- doża tista ’ tkun irregolata billi ddawwar id- dajal f’ waħda miż- żewġ direzzjonijiet.
You will hear clicks as the dose selector returns to zero • After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button • Remove the needle after each injection.
Għandek tisma ’ l- klikks hekk kif is- selettur tad- doża jmur lura fuq iż- żero. • Wara l- injezzjoni, il- labra għandha tinżamm taħt il- ġilda għal mill- anqas 6 sekondi biex tiżgura li d- doża kollha tkun ingħatat. • Kun żgur li ma timblukkax is- selettur tad- doża waqt li tkun tinjetta, għax is- selettur tad - doża jrid jitħalla jmur lura fuq iż- żero meta tagħfas il- buttuna ta ’ l- injezzjoni. • Neħħi l- labra wara kull injezzjoni.
• Replace the big outer needle cap and unscrew the needle (picture 4).
• Erġa ’ poġġi f’ postu l- għatu l- kbir ta ’ barra tal- labra u ħoll il- labra (stampa 4).
Use a new needle for each injection.
112 Uża labra ġdida għal kull injezzjoni.
Remove the needle after each injection and store InnoLet without a needle attached.
Neħħi l- labra wara kull injezzjoni u aħżen InnoLet mingħajr ma l- labra tkun imwaħħla.
Dispose of your used Actrapid InnoLet carefully without the needle attached.
Armi l- Actrapid InnoLet użata tiegħek b’ attenzjoni mingħajr ma l- labra tkun imwaħħla.
Your Actrapid InnoLet is designed to work accurately and safely.
L- Actrapid InnoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Actrapid InnoLet.
Timliex mill- ġdid Actrapid InnoLet.
You can clean your Actrapid InnoLet by wiping it with a medicinal swab.
Tista ’ tnaddaf l- Actrapid InnoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
This may damage the mechanism.
M’ għandekx ixxarrabha, taħsilha jew tillubrikha. Dan jista ’ jagħmel ħsara lill- mekkaniżmu.
107 PACKAGE LEAFLET:
113 FULJETT TA ’ TAGĦRIF:
Actrapid FlexPen 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid FlexPen 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. – Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lill- infermier/ a jew lill- ispiżjar tiegħek. – Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or your pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. – Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib lill- infermier/ a jew lill - ispiżjar tiegħek.
Using other medicines
114 Meta tuża mediċini oħra
108 Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Il- ħtieġa tiegħek għall- insulina tista ’ tinbidel jekk inti tieħu wkoll: prodotti mediċinali kontra d - dijabete li jittieħdu mill- ħalq; inibituri ta ’ monoamine oxidase (MAOI),), sustanzi li jibblukkaw ir - riċetturi beta, inibituri ta ’ l- enzima li tikkonverti l- angjotensin (ACE), acetylsalicylic acid; sterojdi anaboliċi; sulfonamidi; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojde; beta - simpatomimetiċi; ormon tat- tkabbir, danazol; octreotide jew lanreotide.
► In insulin infusion pumps ► If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Actrapid) ► If it does not appear water clear and colourless.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk il- FlexPen titwaqqa ’, jiġrilha l- ħsara jew titgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew kien iffriżat (ara 6 Kif taħżen Actrapid) ► Jekk ma jidhirx ċar bħall- ilma u bla kulur.
110 Side effects reported uncommonly (in less than 1 patient in 100)
Effetti sekondarji rrappurtati b’ mod mhux komuni (anqas minn pazjent 1 minn kull 100):
If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Jekk tinnota ħofor fil- ġilda tiegħek jew li l- ġilda qed teħxien fis- sit ta ’ l- injezzjoni, għid lit- tabib tiegħek jew lill- infermier/ a, għax dawn ir- reazzjonijiet jistgħu jsiru aktar serji, jew jekk tinjetta f’ sit bħal dan jistgħu jbiddlu l- assorbiment ta ’ l- insulina tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib, lill- infermier/ a jew lill- ispiżjar tiegħek.
The FlexPen that is not being used is to be stored in a refrigerator (2°C - 8°C).
Il- FlexPen li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C).
Do not freeze.
117 Tagħmilhomx fil- friża.
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
Il- FlexPen li tkun qed tintuża, jew li waslet biex tintuża, jew li qeda tinġarr bħala spare, m’ għandiex tinżamm fil- friġġ.
Not all packs may be marketed.
Issibu f’ pakketti ta ’ 1, 5 jew 10 pinen mimlija għal- lest ta ’ 3 ml Mhux il- pakketti kollha jistgħu jkunu għal skop kummerċjali.
Marketing Authorisation Holder Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka
Now turn over for information on how to use your FlexPen.
Issa aqleb għal informazzjoni dwar kif tuża il- FlexPen tiegħek.
112 Introduction
118 Introduzzjoni
Please read the following instructions carefully before using your Actrapid FlexPen.
Jekk jogħġbok aqra sew l- istruzzjonijiet li ġejjin qabel ma tuża l- Actraphane FlexPen tiegħek.
Actrapid FlexPen Pen cap
Actrapid FlexPen Għatu tal- pinna
12 units
12- il
scale
unità
selector
tad - doża
button
tal - injezzjoni
Needle (example)
Labra (eżempju)
Big outer
Għatu l- kbir ta ’ barra tal - labra
Inner
Għatu ta ’ ġewwa tal - labra
Protective
Siġill protettiv
needle cap needle cap
Manutenzjoni
Maintenance Your FlexPen is designed to work accurately and safely.
Il- FlexPen tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Preparing your Actrapid FlexPen
Kif tipprepara l- Actrapid FlexPen tiegħek
A Pull off the pen cap.
Neħħi l- għatu tal- pinna.
Disinfect the rubber membrane with a medicinal swab.
119 Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali.
B Remove the protective tab from a new disposable needle.
B Neħħi s- siġill protettiv minn labra ġdida li għandha tintuża darba biss.
C Pull off the big outer needle cap and keep it for later.
C Neħħi l- għatu l- kbir ta ’ barra tal- labra u żommu għal wara
D Pull off the inner needle cap and dispose of it.
D Neħħi l- għatu ta ’ ġewwa tal- labra u armih
E Turn the dose selector to select 2 units.
E Dawwar is- selettur tad- doża sabiex tisselezzjona 2 unitajiet.
114 E
120 E
2 units- select ed
Isselezzjonati 2 unitajiet
F Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
F Żomm il- FlexPen tiegħek bil- labra tipponta ’ l fuq u b’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi, biex jekk ikun hemm xi bżieżaq ta ’ l- arja dawn jinġabru fin- naħa ta ’ fuq ta ’ l- iskartoċċ
G Keeping the needle upwards, press the push-button all the way in.
G Filwaqt li żżomm il- labra ’ l fuq, agħfas il- buttuna ta ’ l- injezzjoni kollha ’ l ġewwa.
H Turn the dose selector to select the number of units you need to inject.
H Dawwar is- selettur tad- doża sabiex tisselezzjona n- numru ta ’ unitajiet li jkollok bżonn tinjetta
You cannot select a dose larger than the number of units left in the cartridge.
121 Ma tistax tisselezzjona doża akbar min- numru ta ’ unitajiet li jkun fadal fl- iskartoċċ.
5 units select ed
Isselezzjonati 5 unitajiet
24 unit s select ed
Isselezzjonati 24 unità
I Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
I Agħti d- doża billi tagħfas il- buttuna ta ’ l- injezzjoni kollha 'l ġewwa sakemm l- indikatur jiġi fuq iż - żero.
J Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin.
J Wara l- injezzjoni żomm il- buttuna ta ’ l- injezzjoni magħfusa kollha ’ l ġewwa sakemm il- labra tkun inġibdet ’ il barra minn ġol- ġilda.
K Lead the needle into the big outer needle cap without touching the big outer needle cap.
K Qiegħed il- labra fl- għatu l- kbir ta ’ barra tal- labra mingħajr ma tmiss l- għatu l- kbir ta ’ barra tal- labra.
When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
Meta l- labra tkun mgħottija, b’ attenzjoni imbotta l- għatu l- kbir ta ’ barra tal- labra biex jngħalaq sew
• Always remove the needle after each injection otherwise the liquid may leak out which can cause inaccurate dosing.
• Dejjem neħħi l- labra wara kull injezzjoni u aħżen il- FlexPen tiegħek mingħajr ma l- labra tkun imwaħħla.
117
123
What is Adenuric?
X' inhu Adenuric?
Adenuric is a medicine containing the active substance febuxostat.
Adenuric hu mediċina li fiha s- sustanza attiva febuxostat.
It is available as yellow, capsule- shaped tablets (80 and 120 mg).
Jiġi bħala pilloli sofor, f' forma ta 'kapsula (80 u 120 mg).
What is Adenuric used for?
Għal xiex jintuża Adenuric?
Adenuric is used to treat chronic (long-term) hyperuricaemia (high levels of uric acid or ‘ urate ’ in the blood).
Adenuric jintuża fit- trattament ta 'l- iperuriċemija (livelli għoljin ta' aċidu uriku jew 'urat' fid- demm) kronika (fit- tul).
Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
L- iperuriċemija tista 'twassal għall- formazzjoni u l- akkumulu ta' kristalli ta 'urat fil - ġogi u fil- kliewi.
When this happens in the joints and causes pain, it is known as ‘ gout’.
Meta dan iseħħ fil- ġogi u jikkawża wġigħ dan ikun magħruf bħala 'gotta'.
Adenuric is used in patients who already have signs of a build-up of crystals, including arthritis (pain and inflammation in the joints) or tophi (‘ stones ’, larger deposits of urate crystals that can cause joint and bone damage).
Adenuric jintuża f' pazjenti li diġà jkollhom sinjali ta 'akkumulu ta' kristalli, fosthom l- artrite (uġigħ u infjammazzjoni fil- ġogi) jew tofi (tophi, 'ġebliet', depożiti akbar ta 'kristalli ta' l- urat li jistgħu jikkawżaw ħsara fil- ġogi u fl- għadam).
How is Adenuric used?
Kif jintuża Adenuric?
The recommended dose of Adenuric is 80 mg once a day.
Id- doża rakkomandata ta 'Adenuric hi 80 mg darba kuljum.
It can be taken with or without food.
Tista 'tittieħed ma' l- ikel jew mingħajru.
Adenuric usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain above 6 mg per decilitre after two to four weeks.
Ġeneralment, Adenuric inaqqas il- livelli ta 'l- aċidu uriku fi żmien ġimagħtejn, iżda d- doża tista' tiżdied għal 120 mg darba kuljum jekk il- livelli ta 'aċidu uriku fid- demm jibqgħu iktar minn 6 mg kull deċilitru wara bejn ġimagħtejn u erba' ġimgħat.
Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric.
L- attakki tal- gotta xorta jistgħu jseħħu matul l- ewwel ftit xhur ta 'trattament, u għalhekk huwa rakkomandat li l- pazjenti jieħdu mediċini oħra biex jipprevjenu l- attakki tal- gotta għal ta' l- anqas l- ewwel sitt xhur ta 'trattament b' Adenuric.
Adenuric treatment should not be stopped if an attack happens.
It- trattament b' Adenuric ma għandux jitwaqqaf jekk ikun hemm attakk.
The safety and effectiveness of Adenuric have not been studied in patients with severe kidney or liver problems.
Is- sigurtà u l- effikaċja ta 'Adenuric ma ġewx studjati f' pazjenti bi problemi severi fil- kliewi jew fil - fwied.
It is not recommended for use in children or in patients who have had an organ transplant because it has not been studied in these groups.
Mhux rakkomandat li jintuża fit- tfal jew fil- pazjenti li jkunu għaddew minn trapjant ta 'l- organi minħabba li ma ġiex studjat f' dawn il- gruppi.
How does Adenuric work?
Kif jaħdem Adenuric?
The active substance in Adenuric, feboxustat, reduces the formation of uric acid.
Is- sustanza attiva f' Adenuric, feboxustat, tnaqqas il- formazzjoni ta 'l- aċidu uriku.
It works by blocking an enzyme called ‘ xanthine oxidase’, which is needed to make uric acid in the body.
Jaħdem billi jimblokka enzim magħruf bħala 'xantina ossidażi' ('xanthine oxidase'), li huwa meħtieġ biex il- ġisem jipproduċi l- aċidu uriku fil- ġisem.
By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Bit- tnaqqis fil- produzzjoni ta 'l- aċidu uriku, Adenuric jista' jbaxxi l - livelli ta 'aċidu uriku fid- demm u jżommhom baxxi, u jwaqqaf il- kristalli milli jakkumulaw.
This can reduce the symptoms of gout.
Dan jista 'jnaqqas is- sintomi tal- gotta.
Keeping uric acid levels low for long enough can also shrink tophi.
Jekk il- livelli ta 'aċidu uriku jinżammu baxxi għal żmien twil biżżejjed, dan jista' jċekken id- daqs tat- tofi.
How has Adenuric been studied?
Kif ġie studjat Adenuric?
The effects of Adenuric were first tested in experimental models before being studied in humans.
L- effetti ta 'Adenuric għall- ewwel ġew ittestjati f' mudelli sperimentali qabel ma ġew studjati fil - bnedmin.
The effectiveness of Adenuric has been studied in two main studies involving a total of 1,834 patients with hyperuricaemia and gout.
L- effikaċja ta 'Adenuric ġiet studjata f' żewġ studji ewlenin li fihom b' kollox ħadu sehem 1, 834 pazjent li jbatu minn iperuriċemija u gotta.
The first study, carried out in 1,072 patients, compared the effectiveness of three doses of Adenuric (80, 120 and 240 mg once a day) with that of placebo (a dummy treatment) and of allopurinol (another medicine used to treat hyperuricaemia).
L- ewwel studju, li fih ħadu sehem 1, 072 pazjent, qabbel l- effikaċja ta 'tliet dożi ta' Adenuric (80, 120 u 240 mg darba kuljum) ma 'dik tal- plaċebo (trattament finta) u ta' allopurinol (mediċina oħra użata fit- trattament ta 'l- iperuriċemija).
The study lasted six months.
L- istudju dam għaddej sitt xhur.
The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.
It- tieni studju qabbel żewġ dożi ta 'Adenuric (80 u 120 mg kuljum) ma' allopurinol fuq perjodu ta 'sena f' 762 pazjent.
In both studies, allopurinol was used at a dose of 300 mg once a day, except for patients with kidney problems, who took 100 mg.
Fiż- żewġ studji, allopurinol intuża f' doża ta '300 mg darba kuljum, ħlief għal pazjenti bi problemi fil - kliewi, li ħadu 100 mg.
The main measure of effectiveness was the number of patients whose final three blood uric acid levels were below 6 mg/ dl.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien l- għadd ta' pazjenti li l- aħħar tliet livelli ta 'aċidu uriku fid- demm tagħhom kienu inqas minn 6 mg/ dl.
Blood uric acid levels were measured every month.
Il- livelli ta 'aċidu uriku fid- demm tkejlu kull xahar.
What benefit has Adenuric shown during the studies?
Liema benefiċċju wera Adenuric waqt l- istudji mwettqa?
Adenuric was more effective than allopurinol and placebo in reducing blood uric acid levels.
Adenuric kien iktar effikaċi minn allopurinol u mill- plaċebo fit- tnaqqis tal- livelli ta 'aċidu uriku fid - demm.
In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/ dl in the final three measurements.
Fl- ewwel studju, 48% tal- pazjenti li jieħdu 80 mg Adenuric darba kuljum (126 minn 262) u 65% tal - pazjenti li jieħdu 120 mg darba kuljum (175 minn 269) kellhom livelli ta 'aċidu uriku inqas minn 6 mg/ dl fl- aħħar tliet testijiet.
This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo.
Tnaqqis bħal dan deher biss fi 22% tal- pazjenti li kienu qed jieħdu allopurinol (60 minn 268) u fl- ebda mill- 134 pazjent li kienu qed jieħdu l- plaċebo.
Similar results were seen in the second study after a year.
Dehru riżultati simili fit- tieni studju wara sena.
What is the risk associated with Adenuric?
X' inhu r- riskju assoċjat ma 'Adenuric?
The most common side effects with Adenuric (seen in between 1 and 10 patients in 100) are headache, diarrhoea, nausea (feeling sick), rash and abnormal liver test results.
L- iktar effetti sekondarji komuni ma 'Adenuric (li dehru f' bejn pazjent wieħed u għaxra minn kull 100) huma wġigħ ta' ras, dijarrea, nawżea (dardir), raxx u anomaliji tat- testijiet tal- fwied.
There may also be an increased risk of certain side effects affecting the heart and blood vessels, particularly in patients with a history of heart problems.
Jista 'jkun hemm ukoll żieda fir- riskju ta' ċerti effetti sekondarji li jaffettwaw lill- qalb u lill- arterji u l- vini, partikolarment f' pazjenti bi storja ta 'problemi tal- qalb.
For the full list of all side effects reported with Adenuric, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappuratati ma' Adenuric, ara l- Fuljett ta 'Tagħrif.
Adenuric should not be used in people who may be hypersensitive (allergic) to feboxustat or any of the other ingredients.
Adenuric m' għandux jintuża f' persuni li jistgħu jkunu allerġiċi għal feboxustat jew għal xi sustanza oħra tiegħu.
Why has Adenuric been approved?
Għaliex ġie approvat Adenuric?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Adenuric was more effective than allopurinol at lowering blood uric acid levels, but that it could carry a greater risk of side effects affecting the heart and blood vessels.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li Adenuric kien iktar effikaċi minn allopurinol fit- tnaqqis tal- livelli ta 'aċidu uriku fid- demm, iżda li jista' jkollu riskju ikbar ta 'effetti sekondarji li jaffettwaw il- qalb u l- arterji u l- vini.
The Committee decided that Adenuric’ s benefits are greater than its risks for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred.
Il- Kumitat iddeċieda li l- benefiċċji ta 'Adenuric huma ikbar mir- riskji għat- trattament ta' iperuriċemija kronika f' kundizzjonijiet fejn id - depożitu ta 'urat diġà jkun seħħ.
The Committee recommended that Adenuric be given marketing authorisation.
Il- Kumitat irrakkomanda li Adenuric jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Adenuric:
Informazzjoni oħra dwar Adenuric:
The European Commission granted a marketing authorisation valid throughout the European Union for Adenuric on 21 April 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- swieq ta ’ l- Unjoni Ewropea kollha għal Adenuric fil 21 April 2008.
The marketing authorisation holder is Beaufour Ipsen Pharma.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq hu Beaufour Ipsen Pharma.
The full EPAR for Adenuric can be found here.
L- EPAR sħiħ għal Adenuric jista 'jiġi kkonsultat hawn.
Oral use Oral use Oral use Oral use
Għall- użu orali Għall- użu orali Għall- użu orali Għall- użu orali
Blister (PVC/ Aclar/ Alu) Blister (PVC/ Aclar/ Alu) Blister (PVC/ Aclar/ Alu) Blister (PVC/ Aclar/ Alu)
Folja ċara (Aclar/ PVC/ Aluminju) Folja ċara (Aclar/ PVC/ Aluminju) Folja ċara (Aclar/ PVC/ Aluminju) Folja ċara (Aclar/ PVC/ Aluminju)
28 tablets 84 tablets 28 tablets 84 tablets
28 pillola miksija b’ rita 84 pillola miksija b’ rita 28 pillola miksija b’ rita 84 pillola miksija b’ rita
ADENURIC 80 mg film-coated tablets
ADENURIC 80 mg pilloli miksija b’ rita
Each tablet contains 80 mg of febuxostat.
Kull pillola fiha 80 mg ta ’ febuxostat.
Each tablet contains 76.50 mg of lactose monohydrate
Kull pillola fiha 76. 50 mg ta ’ lactose monohydrate
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “ 80 ” on one side.
Pilloli forma ta ’ kapsula, sofor ċari sa sofor, miksija b’ rita, minquxa b ’ “ 80 ” fuq naħa waħda.
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/ or gouty arthritis).
Kura ta ’ iperuriċimja kronika f’ kundizzjonijiet fejn diġà seħħet depożizzjoni ta ’ urate (inkluż passat, jew preżenza ta ’ artrite tofus u/ jew tal- gotta).
The recommended oral dose of ADENURIC is 80 mg once daily without regard to food.
Id- doża orali rrakkomandata ta ’ ADENURIC hija 80 mg darba kuljum mingħajr każ ta ’ l- ikel.
If serum uric acid is > 6 mg/ dl (357 µmol/ l) after 2-4 weeks, ADENURIC 120 mg once daily may be considered.
Jekk wara 2- 4 ġimgħat il- uric acid fis- serum huwa > 6 mg/ dl (357 µmol/ l), jista ’ jiġi kkunsidrat ADENURIC 120 mg darba kuljum.
ADENURIC works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
ADENURIC jaħdem malajr biżżejjed biex jippermetti li jerġa jsir test tal- uric acid fis- serum wara ġimagħtejn.
The therapeutic target is to decrease and maintain serum uric acid below 6 mg/ dl (357μ mol/ l).
Il- mira terapewtika hija li l- uric acid fis- serum jitnaqqas u jinżamm taħt 6 mg/ dl (357μmol/ l).
Gout flare prophylaxis of at least 6 months is recommended (see section 4.4).
Profilassi għall- irkadar tal- gotta hija rrakkomandata għal ta ’ l- inqas 6 xhur (ara sezzjoni 4. 4).
Renal insufficiency No dosage adjustment is necessary in patients with mild or moderate renal impairment.
Insuffiċjenza renali L- ebda aġġustament fid- doża ma huwa meħtieġ f’ pazjenti b’ insuffiċjenza renali ħafifa jew moderata.
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/ min, see section 5.2).
L- effikaċja u s- sigurtà ma ġewx stmati għal kollox f’ pazjenti b’ indeboliment renali sever (tneħħija ta ’ krejatinina < 30 ml/ min, ara sezzjoni 5. 2).
Hepatic impairment The recommended dosage in patients with mild hepatic impairment is 80 mg.
Indeboliment epatiku Id- dożaġġ irrakkomandat f’ pazjenti b’ indeboliment epatiku ħafif huwa 80 mg.
The efficacy and safety
Huwa disponibbli tagħrif limitat f’ pazjenti b’ indeboliment epatiku moderat.
2 of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
L- effikaċja u s- sigurtà ta ’ febuxostat ma ġewx studjati f’ pazjenti b’ indeboliment epatiku sever (Child Pugh Klassi Ċ).
Elderly No dose adjustment is required in the elderly (see section 5.2).
Anzjani L- ebda aġġustament fid- doża ma huwa meħtieġ fl- anzjani (ara sezzjoni 5. 2).
Children and adolescents As there has been no experience in children and adolescents, the use of febuxostat in such patients is not recommended.
2 Tfal u adoloxxenti Peress li ma kienx hemm esperjenza fit- tfal u l- adoloxxenti, l- użu ta ’ febuxostat f’ dawn il- pazjenti mhux irrakkomandat.
Organ transplant recipients As there has been no experience in organ transplant recipients, the use of febuxostat in such patients is not recommended (see section 5.1).
Pazjenti li jirċievu trapjant ta ’ organu Peress li ma kienx hemm esperjenza f’ riċevituri ta ’ trapjant ta ’ organu, l- użu ta ’ febuxostat f’ dawn il - pazjenti mhux irrakkomandat.
Hypersensitivity to the active substance or to any of the excipients (see section 4.8).
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 4. 8).
Cardio-vascular disorders Treatment with febuxostat in patients with ischaemic heart disease or congestive heart failure is not recommended (see section 4.8).
Disturbi kardjovaskulari Kura b’ febuxostat f’ pazjenti b’ mard iskemiku tal- qalb jew b’ insuffiċjenza tal- qalb konġestiva mhux irrakkomandata (ara sezzjoni 4. 8).
Acute gouty attacks (gout flare) Febuxostat treatment should not be started until an acute attack of gout has completely subsided.
Attakki ta ’ gotta akuta (rkadar tal- gotta) Kura b’ febuxostat m’ għandiex tinbeda qabel jgħaddi għal kollox attakk akut tal- gotta.
As with other urate lowering medicinal products, gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits.
Bħal bi prodotti mediċinali oħra li jbaxxu l- urate, jista ’ jseħħ irkadar tal- gotta waqt il- bidu tal- kura minħabba tibdil fil - livelli ta ’ uric acid fis- serum li jwassal għal mobilizzazzjoni ta ’ urate mid- depożiti fit- tessut.
At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended.
Fil- bidu tal- kura b’ febuxostat hija rrakkomandata profilassi ta ’ l- irkadar b’ NSAID jew colchicine għal ta ’ l - inqas 6 xhur.
If a gout flare occurs during febuxostat treatment, it should not be discontinued.
Jekk ikun hemm irkadar tal- gotta waqt kura b’ febuxostat, dan m’ għandux jitwaqqaf.
The gout flare should be managed concurrently as appropriate for the individual patient.
Irkadar tal- gotta għandu jiġi mmaniġġjat fl- istess ħin kif xieraq għall- pazjent individwali.
Continuous treatment with febuxostat decreases frequency and intensity of gout flares.
Kura kontinwa b’ febuxostat tnaqqas il- frekwenza u l- intensità ta ’ l- irkadar tal- gotta.
Xanthine deposition As with other urate lowering medicinal products, in patients in whom the rate of urate formation is greatly increased (e. g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
Depożizzjoni ta ’ xanthine Bħal bi prodotti mediċinali oħra li jbaxxu l- urate, f’ pazjenti li għandhom ir- rata ta ’ formazzjoni ta ’ urate miżjuda ħafna (e. ż. mard malinn u l- kura tiegħu, sindrome Lesch- Nyhan) il- konċentrazzjoni assoluta ta ’ xanthine fl- awrina tista ’, f’ każijiet rari, tiżdied biżżejjed biex tħalli depożizzjoni fl- apparat ta ’ l- awrina.
As there has been no experience with febuxostat, its use in these populations is not recommended.
Minħabba li ma kienx hemm esperjenza b’ febuxostat, l- użu tiegħu f’ dawn il - popolazzjonijiet mhux irrakkomandat.
Mercaptopurine/ azathioprine Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/ azathioprine (see section 4.5).
Mercaptopurine/ azathioprine L- użu ta ’ febuxostat mhux irrakkomandat f’ pazjenti kkurati fl- istess waqt b’ mercaptopurine/ azathioprine (ara sezzjoni 4. 5).
Theophylline Febuxostat should be used with caution in patients concomitantly treated with theophylline and theophylline levels should be monitored in patients starting febuxostat therapy (see section 4.5).
Theophylline Febuxostat għandu jintuża b’ attenzjoni f’ pazjenti kkurati fl- istess waqt b’ theophylline u l- livelli ta ’ theophylline għandhom jiġu sorveljati f’ pazjenti li bdew terapija b’ febuxostat (ara sezzjoni 4. 5).