qanastek/EMEA-V3 huggingface dataset:
Before every injection: • Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
238 Qabel kull injezzjoni: • Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tifforma s - suspensjoni mill- ġdid b’ mod uniformi.
Repeat this movement at
Jekk ikun baqa ’ anqas minn 12- il unità, uża Actraphane 40 NovoLet ġdida • Mexxi l- pinna ’ l fuq u ’ l isfel bejn il- pożizzjonijiet a u b u lura (stampa A), biex b’ hekk il - boċċa tal- ħġieġ tiċċaqlaq minn tarf għall- ieħor ta ’ l- iskartoċċ għal mill- anqas 20 darba.
222 least 10 times before each injection.
Irrepeti dan il- moviment mill- anqas 10 darbiet qabel kull injezzjoni.
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • 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 Actraphane 40 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien • Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Actraphane 40 NovoLet (stampa B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Hold Actraphane 40 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Actraphane 40 NovoLet bil- labra tipponta ’ l fuq • B’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi.
Setting the dose
239 Kif tissettja d- doża
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Actraphane 40 NovoLet horizontally.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox • Żomm l- Actraphane 40 NovoLet tiegħek b' mod orizzontali.
223 • Don’ t put your hand over the push-button when you set the dose.
Ser tħoss l - għatu jikklikkja, u l- buttuna ta ’ l- injezzjoni ser titla '’ l fuq. • Tpoġġix idek fuq il- buttuna ta ’ l- injezzjoni meta tissettja d- doża.
Close your Actraphane 40 NovoLet fully with 0 next to the dosage indicator.
Agħlaq l- Actraphane 40 NovoLet tiegħek kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Actraphane 40 NovoLet carefully without the needle attached.
Armi l- Actraphane 40 NovoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Actraphane 40 NovoLet is designed to work accurately and safely.
L- Actraphane 40 NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Actraphane 40 NovoLet.
Timliex mill- ġdid Actraphane 40 NovoLet.
You can clean the exterior of your Actraphane 40 NovoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Actraphane 40 NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
225 PACKAGE LEAFLET:
241 FULJETT TA 'TAGĦRIF:
Using other medicines
242 Meta tuża mediċini ohra
226 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: inibituri ta ’ monamine oxidase (MAOI); beta- blokkanti; inibituri ta ’ l- enzima li tikkonverti l- anġjotensin (ACE- inhibitors); acetylsalicylic acid; sterojdi anaboliċi; sulphonamides; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojdi; beta- simpatomimetiċi; ormon tat- tkabbir; danazol; octreotide jew lanreotide.
227 unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
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 mhux tas- soltu u dgħjufija; nervożità jew rogħda; tħossok ansjuż/ a; tħossok konfuż/ a; diffikultà biex tikkonċentra.
228 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) Do not store them in or too near the freezer section or cooling element.
245 In- NovoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
After removing theNovoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tneħħi n- NovoLet mill- friġġ, hu rakkomandat li tħalliha tilħaq it - temperatura tal- kamra qabel ma 'terġa ’ tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl - istruzzjonijiet għall- ewwel użu.
230 Information on how to use Actraphane 50 NovoLet
246 Informazzjoni dwar kif tuża Actraphane 50 NovoLet
Please read the following instructions carefully before using your Actraphane 50 NovoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Actraphane 50 NovoLet.
Actraphane 50 NovoLet is a simple, compact pre-filled pen.
Actraphane 50 NovoLet hi pinna mimlija għal- lest sempliċi u kumpatta.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
Actraphane 50 NovoLet hi maħsuba biex tintuża mal- labar NovoFine Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare tal- forniment ta 'l - insulina f' każ li l- NovoLet tiegħek tintilef jew ikollha l- ħsara.
Check the label to make sure that your Actraphane 50 NovoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Actraphane 50 NovoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Before every injection: • Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
247 Qabel kull injezzjoni: • Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tifforma s - suspensjoni mill- ġdid b’ mod uniformi.
Repeat this movement at
Jekk ikun baqa ’ anqas minn 12- il unità, uża Actraphane 50 NovoLet ġdida • Mexxi l- pinna ’ l fuq u ’ l isfel bejn il- pożizzjonijiet a u b u lura (stampa A), biex b’ hekk il - boċċa tal- ħġieġ tiċċaqlaq minn tarf għall- ieħor ta ’ l- iskartoċċ għal mill- anqas 20 darba.
231 least 10 times before each injection.
Irrepeti dan il- moviment mill- anqas 10 darbiet qabel kull injezzjoni.
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • 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 Actraphane 50 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien • Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Actraphane 50 NovoLet (stampa B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Hold Actraphane 50 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Actraphane 50 NovoLet bil- labra tipponta ’ l fuq • B’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi.
Setting the dose
248 Kif tissettja d- doża
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Actraphane 50 NovoLet horizontally.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox • Żomm l- Actraphane 50 NovoLet tiegħek b' mod orizzontali.
232 • Don’ t put your hand over the push-button when you set the dose.
Ser tħoss l - għatu jikklikkja, u l- buttuna ta ’ l- injezzjoni ser titla '’ l fuq. • Tpoġġix idek fuq il- buttuna ta ’ l- injezzjoni meta tissettja d- doża.
Close your Actraphane 50 NovoLet fully with 0 next to the dosage indicator.
Agħlaq l- Actraphane 50 NovoLet tiegħek kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Actraphane 50 NovoLet carefully without the needle attached.
Armi l- Actraphane 50 NovoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Actraphane 50 NovoLet is designed to work accurately and safely.
L- Actraphane 50 NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Actraphane 50 NovoLet.
Timliex mill- ġdid Actraphane 50 NovoLet.
You can clean the exterior of your Actraphane 50 NovoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Actraphane 50 NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
234 PACKAGE LEAFLET:
250 FULJETT TA 'TAGĦRIF:
How to use your InnoLet
Kif għandek tuża InnoLet
Using other medicines
251 Meta tuża mediċini ohra
235 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: inibituri ta ’ monamine oxidase (MAOI); beta- blokkanti; inibituri ta ’ l- enzima li tikkonverti l- anġjotensin (ACE- inhibitors); acetylsalicylic acid; sterojdi anaboliċi; sulphonamides; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojdi; beta- simpatomimetiċi; ormon tat- tkabbir; danazol; octreotide jew lanreotide.
► 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 Actraphane) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk InnoLet titwaqqa ’, jiġrilha l- ħsara jew titgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Actraphane) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
236 unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
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 mhux tas- soltu u dgħjufija; nervożità jew rogħda; tħossok ansjuż/ a; tħossok konfuż/ a; diffikultà biex tikkonċentra.
They must not give you any food or drink as it could choke you. ► If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death ► If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
M' għandhomx jagħtuk ikel jew xorb, għax tista ’ tifga. ► Jekk ipogliċemija severa ma tkunx ikkurata, din tista ’ tikkawża ħsara fil- moħħ (temporanja jew permanenti) u anki l- mewt ► Jekk ikollok ipo li ġġiegħlek tintilef minn sensik, jew ħafna ipos, kellem lit- tabib tiegħek.
237 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)
Painful neuropathy (nerve related pain).
Newropatija bl- uġigħ (uġigħ marbut man- nervaturi).
The InnoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
254 L- InnoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
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 qeda tintuża, li waslet biex tintuża, jew li qeda tinġarr bħala spare, m' għandiex tinżamm fil- friġġ.
After removing the InnoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tneħħi l- InnoLet mill- friġġ, hu rakkomandat li tħalliha tilħaq it- temperatura tal- kamra qabel ma 'terġa ’ tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.
Tista ’ ġġorrha miegħek u żżommha fit - temperatura tal- kamra (mhux aktar minn 30°C) sa perjodu ta ’ 6 ġimgħat.
Always keep the pen cap on your InnoLet when you’ re not using it in order to protect it from light.
Dejjem żomm l- għatu tal- pinna fuq l- InnoLet tiegħek meta ma tkunx qed tużaha sabiex tilqgħalha mid- dawl.
It is supplied in packs of 1, 5 or 10 pre-filled pens of 3 ml.
Id- dehra ta 'Actraphane u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja opaka u bajda Issibu f’ pakketti ta ’ 1, 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml.
Now turn over for information on how to use your InnoLet.
Issa aqleb għal informazzjoni dwar kif tuża l- InnoLet tiegħek.
239 Information on how to use Actraphane 30 InnoLet
255 Informazzjoni dwar kif tuża Actraphane 30 InnoLet
Please read the following instructions carefully before using your Actraphane 30 InnoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Actraphane 30 InnoLet.
Actraphane 30 InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Actraphane 30 InnoLet hi pinna mimlija għal- lest sempliċi u kumpatta li hi kapaċi tforni minn 1 sa 50 unità f' inkrementi ta 'unità 1.
Actraphane 30 InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Actraphane 30 InnoLet hi maħsuba biex tintuża mal- labar NovoFine S ta '8 mm jew iqsar.
Look for an S on the needle box.
Fittex S fuq il- kaxxa tal- labar.
The S stands for short cap.
L- S tfisser għatu qasir.
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.
Big outer needle cap
Kif tipprepara għall- injezzjoni
Check the label to make sure that your Actraphane 30 InnoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Actraphane 30 InnoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Take off the pen cap (as shown by the arrow).
Neħħi l- għatu tal- pinna (kif muri mill- vleġġa).
Suspending the insulin
Kif tagħmel suspensjoni ta 'l- insulina
Before every injection: • Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
Qabel kull injezzjoni: • Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tifforma s - suspensjoni mill- ġdid b’ mod uniformi.
If there are less than 12 units left, use a new Actraphane 30 InnoLet • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Jekk ikun baqa ’ anqas minn 12- il unità, uża Actraphane 30 InnoLet ġdida. • Mexxi l- pinna ’ l fuq u ’ l isfel bejn il- pożizzjonijiet A u B u lura biex b’ hekk il- boċċa tal- ħġieġ tiċċaqlaq minn tarf għall- ieħor ta ’ l- iskartoċċ (stampa 1A) għal mill- anqas 20 darba.
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay.
256 • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien
Attaching the needle
Kif twaħħal il- labra
• 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 Actraphane 30 InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
• Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine S • Invita l- labra bi dritt u b' mod issikkat fuq Actraphane 30 InnoLet (stampa 1B) • Neħħi 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
Preparazzjoni biex tneħħi l- arja
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Actraphane 30 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 1C). • 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.
Is - selettur tad- doża jirritorna fuq iż- żero • 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.
257 Jekk il- qatra ta 'l- insulina tibqa ’ ma titfaċċax, it- tagħmir hu difettuż u m’ għandux jintuża.
Setting the dose
Kif tissettja d- doża
• 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. • Iddajlja n- numru ta ’ unitajiet li jkollok bżonn billi ddawwar is- selettur tad- doża lejn il- lemin (stampa 2).
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 residwa biex tkejjel id- doża ta ’ l- insulina tiegħek • Għandek tisma ’ klikk għal kull unità li tisselezzjona.
The dose can be corrected by turning the dial either way.
Id- doża tista ’ tkun irregolata billi ddawwar is- selettur tad- doża f’ waħda miż- żewġ direzzjonijiet.
You cannot set a dose larger than the number of units left in the cartridge.
Ma tistax tissettja doża akbar min- numru ta ’ unitajiet li jkun fadal fl- iskartoċċ.
Use the injection technique advised by your doctor • Deliver the dose by pressing the push-button fully down (picture 3).
Uża t- teknika ta ’ l- injezzjoni kif tak parir it- tabib tiegħek. • Agħti d- doża billi tagħfas il- buttuna ta ’ l- injezzjoni, ’ l isfel kemm tista ’ (stampa 3).
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 qed/ a 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).
Dispose of it carefully.
Armiha bl - attenzjoni.
Remove the needle after each injection and store InnoLet without the needle attached.
Neħħi l- labra wara kull injezzjoni u aħżen Innolet mingħajr ma l- labra tkun imwaħħla.
Dispose of your used Actraphane 30 InnoLet carefully without the needle attached.
Armi l- Actraphane 30 InnoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Actraphane 30 InnoLet is designed to work accurately and safely.
L- Actraphane 30 InnoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Actraphane 30 InnoLet.
Timliex mill- ġdid Actraphane 30 InnoLet.
You can clean your Actraphane 30 InnoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Actraphane 30 InnoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
This may damage the mechanism.
Dan jista ’ jagħmel ħsara lill- mekkaniżmu.
243 PACKAGE LEAFLET:
259 FULJETT TA 'TAGĦRIF:
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, jekk jogħġbok 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 mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib lill- infermier/ a jew lill- ispiżjar tiegħek.
How to use your FlexPen
Kif għandek tuża l- FlexPen tiegħek
Using other medicines
260 Meta tuża mediċini ohra
244 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: inibituri ta ’ monamine oxidase (MAOI); beta- blokkanti; inibituri ta ’ l- enzima li tikkonverti l- anġjotensin (ACE- inhibitors); acetylsalicylic acid; sterojdi anaboliċi; sulphonamides; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojdi; beta- simpatomimetiċi; ormon tat- tkabbir; danazol; octreotide jew lanreotide.
Talk about your insulin needs with your doctor and nurse.
Tkellem dwar il- ħtiġijiet tiegħek ta ’ l- insulina mat- tabib u ma ’ l- infermier/ a tiegħek.
► 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 Actraphane) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk FlexPen titwaqqa ’, jiġrilha l- ħsara jew titgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Actraphane) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
4.
261 4.
245 unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
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 mhux tas- soltu u dgħjufija; nervożità jew rogħda; tħossok ansjuż/ a; tħossok konfuż/ a; diffikultà biex tikkonċentra.
If you get any of these signs. eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jekk ikollok xi wieħed minn dawn is- sinjali, kul pilloli tal- glukosju jew ikla ħafifa li fiha ħafna zokkor (ħelu, gallettini, meraq tal- frott), u mbagħad strieħ.
246 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 li- fis- sit ta ’ l- injezzjoni l- ġilda qiegħda titħaffer jew qiegħda teħxien, għid lit- tabib tiegħek jew lill- infermier/ a, għax dawn ir- reazzjonijiet jistgħu jsiru aktar serji, jew jekk l- injezzjoni ssir 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 mhumiex 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) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
263 Il- FlexPen li tkun qeda tintuża, li waslet biex tintuża, jew li qeda tinġarr bħala spare, m' għandiex tinżamm fil- friġġ.
After removing theFlexPen from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tneħħi l- FlexPen mill- friġġ, hu rakkomandat li tħalliha tilħaq it- temperatura tal- kamra qabel ma 'terġa ’ tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
Always keep the pen cap on your FlexPen when you’ re not using it in order to protect it from light.
Dejjem żomm l- għatu tal- pinna fuq il- FlexPen tiegħek meta ma tkunx qed tużaha sabiex tilqgħalha mid- dawl.
It is supplied of 1, 5 or 10 pre-filled pens of 3 ml.
Id- dehra ta 'Actraphane u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja opaka u bajda Issibu f’ pakketti ta ’ 1, 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml.
Marketing Authorisation Holder Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label: – If the second and third characters are W5, S6, P5, K7, or ZF Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark is the manufacturer
- Jekk it- tieni u t- tielet karattri huma W5, S6, P5, K7 jew ZF, il- manifattur huwa, Novo Nordisk
– If the second and third characters are H7 or T6 Novo Nordisk Production SAS, 45 Avenue d’ Orléans, F-28002 Chartres, France is the manufacturer.
Jekk it- tieni u t- tielet karattri huma H7 jew T6, il- manifattur huwa, Novo Nordisk Production SAS, 45, Avenue d’ Orléans, F- 28002 Chartres, Franza
Now turn over for information on how to use your FlexPen.
Issa aqleb għal informazzjoni dwar kif tuża l- FlexPen tiegħek.
248 Introduction
264 Introduzzjoni
Please read the following instructions carefully before using your Actraphane FlexPen.
Jekk jogħġbok aqra sew l- istruzzjonijiet li ġejjin qabel ma tuża l- Actraphane FlexPen tiegħek.
Your FlexPen is a unique dial-a-dose insulin pen.
Il- FlexPen tiegħek hija pinna unika ta ’ l- insulina tat- tip isselezzjona- doża.
You can select doses from 1 to 60 units in increments of 1 unit.
Tista ’ tisselezzjona dożi minn 1 sa 60 unità f' inkrementi ta 'unità 1.
FlexPen is designed and tested to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm.
Il- FlexPen hi magħmula u ttestjata biex tintuża mal- labar NovoFine jew NovoTwist li jintużaw darba biss u li għandhom tul ta 'mhux iżjed minn 8 mm.
As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
Bħala miżura prekawzjonarja, dejjem ġorr apparat żejjed li jkun jista ’ jagħti l- insulina, fil- każ li l- FlexPen tiegħek tintilef jew jiġrilha l- ħsara.
The colour of the pen in the illustrations differs from your FlexPen.
Il- kulur tal- pinna f’ dawn l- istampi huwa differenti minn dak tal- FlexPen tiegħek
Actraphane 30 FlexPen Pen cap
Actraphane 30 FlexPen Għatu tal- pinna
12 units Glass
12- il
Cartridge
Boċċa Skartoċċ
Residual
Skala ta ’
Pointer
Indikatur
Dose
Selettur
Push-
Buttuna
membrane
tal- gomma
ball
unità
scale
tal - ħġieġ
selector
residwu
button
tad - doża
Needle (example)
tal - injezzjoni
Big outer
Labra (eżempju)
Inner
Għatu l- kbir ta ’ barra tal - labra
Needle
Għatu ta ’ ġewwa tal - labra
Protective
Labra
needle cap needle cap
Siġill protettiv
Your FlexPen is designed to work accurately and safely.
Il- FlexPen tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
If it is dropped or crushed, there is a risk of damage and leakage of insulin.
Jekk tiġi mwaqqa ’ jew mgħaffġa hemm ir- riskju li jiġrilha l- ħsara u li toħroġ l- insulina.
You can clean the exterior of your FlexPen by wiping it with a medicinal swab.
Tista ’ tnaddaf il- parti ta ’ barra tal- FlexPen tiegħek billi timsaħha b’ tajjara b’ diżinfettant.
Do not soak it, wash or lubricate it as it may damage the pen.
M’ għandekx ixxarrabha, taħsilha jew tillubrikaha għax dan jista ’ jagħmel ħsara lill- pinna.
Do not refill your FlexPen.
Timliex mill- ġdid il- FlexPen tiegħek.
Preparing your Actraphane FlexPen
Kif tipprepara l- Actraphane FlexPen tiegħek
Check the label to make sure that your FlexPen contains the correct type of insulin.
Iċċekkja t- tikketta biex tiżgura li l- FlexPen tiegħek ikun fiha t- tip korrett ta ’ insulina.
Before your first injection with a new FlexPen you must resuspend the insulin:
Qabel l - ewwel injezzjoni b’ FlexPen ġdida l- insulina trid terġa ’ tiġi magħmula f’ suspensjoni:
249 A Let the insulin reach room temperature before you use it.
Ħalli l- insulina tilħaq it- temperatura tal- kamra qabel ma tużaha.
This makes it easier to resuspend.
B’ kekk ikun iktar faċli li terġa ’ tiġi magħmula f’ suspensjoni..
Pull off the pen cap.
Neħħi l- għatu tal- pinna.
B Move the pen up and down twenty times between position 1 and 2 as shown, so the glass ball moves from one end of the cartridge to the other.
B Kif muri fl- istampa, ċaqlaq il- pinna ’ l fuq u ’ l isfel għal għoxrin darba bejn il- pożizzjonijiet 1 u 2, biex b’ hekk il- boċċa tal- ħġieġ tiċċaqlaq minn tarf għall- ieħor ta ’ l- iskartoċċ.
Repeat until the liquid appears uniformly white and cloudy.
Irrepeti, sakemm b’ mod uniformi, il- likwidu jidher abjad u opak.
For every following injection move the pen up and down between position 1 and 2 at least ten times until the liquid appears uniformly white and cloudy.
Għal kull injezzjoni sussegwenti, ċaqlaq il- pinna ’ l fuq u ’ l isfel għal mill- anqas 10 darbiet bejn il - pożizzjonijiet 1 u 2 sakemm b’ mod uniformi, il- likwidu jidher abjad u opak.
After you have resuspended the insulin, complete all the following steps of injection without delay.
Wara li tkun erġajt għamilt l- insulina f’ suspensjoni, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla dewmien
• Always check there are at least 12 units of insulin left in the cartridge to allow resuspension.
• Dejjem iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tippermetti li terġa ’ ssir is- suspensjoni.
If there are less than 12 units left, use a new FlexPen.
Jekk ikun baqa ’ inqas minn 12- il unità, uża FlexPen ġdida
Attaching a needle
Kif twaħħal labra
Disinfect the rubber membrane with a medicinal swab.
Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali
C Remove the protective tab from a new disposable needle.
C Neħħi s- siġill protettiv minn labra ġdida li għandha tintuża darba biss.
Screw the needle straight and tightly onto your FlexPen.
Invita l- labra bi dritt u b' mod issikkat fuq il- FlexPen tiegħek.
D Pull off the big outer needle cap and keep it for later.
266 D Neħħi l- għatu l- kbir ta ’ barra tal- labra u żommu għal wara
E Pull off the inner needle cap and dispose of it.
E Neħħi l- għatu ta ’ ġewwa tal- labra u armih
• Always use a new needle for each injection to prevent contamination.
• Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni
• Be careful not to bend or damage the needle before use.
• Oqgħod attent li ma tgħawwiġx jew tagħmel xi ħsara lil- labra qabel l- użu.
• To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when you have removed it from the needle.
• Sabiex tnaqqas ir- riskju li bi żball titniggeż mil- labra, qatt m’ għandek terġa ’ tqiegħed lura l - għatu ta ’ ġewwa tal- labra wara li tkun neħħejtu minn fuq il- labra.
Checking the insulin flow
Kif teżamina l- fluss ta ’ l- insulina
Prior to each injection small amounts of air may collect in the cartridge during normal use.
Waqt l- użu normali jistgħu jinġemgħu ammonti żgħar ta ’ arja ġo l- iskartoċċ qabel kull injezzjoni.
To avoid injection of air and ensure proper dosing:
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett:
F Turn the dose selector to select 2 units.
F Dawwar is- selettur tad- doża sabiex tisselezzjona 2 unitajiet.
2 units- selected
2 unitaj ie t - isselezzjonati
G 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.
G 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
267 G
251 H Keeping the needle upwards, press the push-button all the way in.
H Filwaqt li żżomm il- labra ’ l fuq, agħfas il- buttuna ta ’ l- injezzjoni kollha ’ l ġewwa.
The dose selector returns to 0.
Is- selettur tad- doża jirritorna fuq iż- 0
A drop of insulin should appear at the needle tip.
Qatra insulina għandha tidher fil- ponta tal- labra.
If not, change the needle and repeat the procedure no more than six times.
Jekk dan ma jseħħx, ibdel il- labra u rrepeti l - proċedura sa mhux aktar minn sitt darbiet.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
Jekk il- qatra ta 'l- insulina tibqa ’ ma tidhirx, il- pinna hija difettuża u għandek tuża waħda ġdida.
Selecting your dose
Kif tisselezzjona d- doża
Check that the dose selector is set at 0.
Aċċerta ruħek li s- selettur tad- doża qiegħed fuq iż- 0.
I Turn the dose selector to select the number of units you need to inject.
I Dawwar is- selettur tad- doża sabiex tisselezzjona n- numru ta ’ unitajiet li jkollok bżonn tinjetta
The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer.
Id- doża tista ’ tkun aġġustata kemm ’ il fuq u kemm ’ l isfel billi ddawwar is- selettur tad- doża f’ direzzjoni jew oħra sakemm l- indikatur ikun fuq id- doża li tkun trid.
When turning the dose selector be careful not to push the push- button as insulin will come out.
Waqt li tkun qed/ a ddawwar is - selettur tad- doża, oqgħod attent/ a biex ma tagħfasx il- buttuna ta ’ l- injezzjoni għax inkella toħroġ l - insulina.
You cannot select a dose larger than the number of units left in the cartridge.
Ma tistax tisselezzjona doża akbar min- numru ta ’ unitajiet li jkun fadal fl- iskartoċċ.
I
268 I
5 units selected
Isselezzjonati 5 unitajiet
24 units selected
Isselezzjonati 24 unità
• Do not use the residual scale to measure your dose of insulin.
• Tużax l- iskala ta ’ residwu biex tkejjel id- doża ta ’ l- insulina tiegħek
Making the injection
Biex tagħmel l- injezzjoni
Insert the needle into your skin.
Daħħal il- labra fil- ġilda tiegħek.
Use the injection technique shown by your doctor or nurse.
Uża t- teknika ta ’ l- injezzjoni kif uriek it- tabib jew l - infermier/ a tiegħek.
252 J Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
J Agħti d- doża billi tagħfas il- buttuna ta ’ l- injezzjoni kollha 'l ġewwa sakemm l- indikatur jiġi fuq iż - żero.
Be careful only to push the push-button when injecting.
Oqgħod attent/ a li tagħfas il- buttuna ta ’ l- injezzjoni biss meta tkun qed/ a tagħmel l- injezzjoni.
Turning the dose selector will not inject insulin.
Billi ddawwar is- selettur tad- doża ma tkunx qed/ a tagħti l- insulina.
K Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin.
K Wara l- injezzjoni żomm il- buttuna ta ’ l- injezzjoni magħfusa kollha ’ l ġewwa sakemm il- labra tkun inġibdet ’ il barra minn ġol- ġilda.
The needle must remain under the skin for at least six seconds.
Il- labra għandha tinżamm taħt il- ġilda għal mill- anqas sitt sekondi.
This will ensure that the full dose has been injected.
Dan ser jiżgura li d- doża kollha tkun ingħatat.
L Lead the needle into the big outer needle cap without touching the big outer needle cap.
L 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 u mbagħad ħoll il- labra.
Dispose of it carefully and put the pen cap back on.
Oqgħod attent kif tarmiha u erġa ’ poġġi lura l- għatu tal- pinna
L
269 L
• Always remove the needle after each injection and store your FlexPen without the needle attached.
• Dejjem neħħi l- labra wara kull injezzjoni u aħżen il- FlexPen tiegħek mingħajr ma l- labra tkun imwaħħla.
• Caregivers should be most careful when handling used needles to avoid needle sticks.
Inkella, il- likwidu jista ’ jnixxi li jista ’ jwassal li tittieħed doża żbaljata. • • Persuni li jieħdu ħsieb il- pazjent għandhom joqogħdu attenti kif jimmaniġġjaw il- labar użati biex ma jiġux imniggża mil- labar.
• Dispose of the used FlexPen carefully without the needle attached.
• Armi l- FlexPen użata tiegħek bl- attenzjoni mingħajr ma l- labra tkun imwaħħla.
• Do not share your FlexPen with anyone else.
• M’ għandekx taqsam il- FlexPen tiegħek ma oħrajn
253
270
EMEA/ H/ C/ 424
EMEA/ H/ C/ 441
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ aktar informazzjoni abbażi tar- rakkommandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Actrapid?
X’ inhu Actrapid?
Actrapid is a solution for injection.
Actrapid huwa soluzzjoni għall- injezzjoni.
It is available in a vial, a cartridge (PenFill) or in a prefilled pen (NovoLet, FlexPen or InnoLet).
Huwa disponibbli fi fjal, cartridge (PenFill), jew pinna mimlija minn qabel (NovoLet, FlexPen u InnoLet).
Actrapid contains the active substance insulin human (rDNA).
Actrapid fih is- sustanza attiva insulina umana (rDNA).
What is Actrapid used for?
Għal xiex jintuża Actrapid?
Actrapid is used in patients who have diabetes.
Actrapid jintuża f’ pazjenti bid- dijabete.
How is Actrapid used?
Kif jintuża Actrapid?
Actrapid is administered subcutaneously (under the skin) by injection, usually into the abdominal wall (tummy).
Actrapid jingħata b’ injezzjoni taħt il- ġilda, ġeneralment fil- ħajt addominali (iż- żaqq).
The thigh, the deltoid region (shoulder) or the gluteal region (buttocks) may also be used.
Tista ’ tintuża wkoll il- koxxa, fir- reġjun tad- deltoid (fl- ispalla) jew fir- reġjun gluteali (fil- warrani).
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Il- glukożju (zokkor) fid- demm tal- pazjent għandu jiġi ttestjat regolarment biex tinstab l- iżgħar doża effettiva.
The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
Id - doża normali hija bejn 0. 3 u 1. 0 unità internazzjonali (IU) għal kull kilogramma tal- piż tal- ġisem kuljum.
Actrapid is given 30 minutes before a meal.
Actrapid jingħata 30 minuta qabel l- ikel.
Actrapid is a fast-acting insulin and may be used with long-acting insulins.
Actraprid hija insulina li taħdem malajr u tista ’ tintuża ma ’ insulini li jaħdmu fit- tul.
Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.
Actrapid jista ’ jingħata wkoll fil- vina iżda biss minn tabib jew infirmiera.
How does Actrapid work?
Kif jintuża Actrapid?
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Id- dijabete hi marda li biha l- ġisem ma jipproduċix biżżejjed insulina biex jikkontrolla z- zokkor fid - demm.
Actrapid is a replacement insulin that is identical to the insulin made by the pancreas.
Actrapid hu insulina li tissostitwixxi u hi identika għall- insulina magħmula mill- frixa.
The active substance in Actrapid, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Is - sustanza attiva f’ Actrapid, l- insulina umana (rDNA), hi prodotta b’ metodu magħruf bħala ‘ teknoloġija rekombinanti ’: l- insulina hi magħmula minn ħmira li tkun irċeviet ġene (DNA), li b’ hekk tkun tista ’ tipproduċi l- insulina.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
L- insulina ta ’ sostituzzjoni taġixxi bl- istess mod bħall- insulina prodotta naturalment u tgħin lill- glukożju jidħol fiċ- ċelloli mid- demm.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Bil- kontroll tal- glukożju fid- demm, is - sintomi u l- kumplikazzjonijiet tad- dijabete jitnaqqsu.
How has Actrapid been studied?
Kif ġie studjat Actrapid?
The studies compared Actrapid to a human insulin analogue (insulin aspart) over six months by measuring the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Actrapid ġie studjat f’ pazjenti bid- dijabete ta ’ l- ewwel tip, li fiha l- frixa ma tkunx tista ’ tipproduċi insulina (żewġ studji bil- parteċipazzjoni ta ’ 1, 954 pazjent), u dijabete tat- tieni tip, meta l- ġisem ma jkunx jista ’ juża l- insulina effettivament (żewġ studji li fihom ħadu sehem 182 pazjent).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- istudji qabblu Actrapid ma ’ sustanza analoga għall- insulina tal- bniedem (insulina aspart), fuq medda ta ’ sitt 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Actrapid shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged xhur billi ġie mkejjel il- livell ta ’ sustanza fid- demm magħrufa bħala emoglobina glikosalata (glycosylated haemoglobin) (HbA1c), li tagħti indikazzjoni ta ’ kemm il- glukożju fid- demm ikun ikkontrollat.
HbA1c levels remained fairly steady over the six months of treatment with Actrapid.
Il- livelli ta ’ HbA1c baqgħu pjuttost stabbli matul perjodu ta ’ sitt xhur ta ’ trattament b’ Actrapid.
What is the risk associated with Actrapid?
X’ inhu r- riskju assoċjat ma ’ Actrapid?
As with all insulins, Actrapid may cause hypoglycaemia (low blood glucose).
Bħal kull insulina oħra, Actrapid jista ’ jikkawża ipogliċemija (livell baxx ta ’ glukożju fid- demm).
For the full description of all side effects reported with Actrapid, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Actrapid, ara l- Fuljett ta ’ Tagħrif.
Actrapid should not be used in people who may be hypersensitive to insulin human (rDNA) or any of the other ingredients.
Actrapid m’ għandux jingħata lil persuni allerġiċi għall- insulina tal- bniedem (rDNA) jew għal kwalunkwe mill- ingredjenti l- oħra.
Actrapid doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Id- dożi ta ’ Actrapid jista ’ wkoll ikollhom jiġu aġġustati meta jingħata ma ’ għadd ta ’ mediċini oħra li jistgħu jaffettwaw il- glukożju fid- demm.
The full list is available in the Package Leaflet.
Il- lista sħiħa tinsab fil- Fuljett ta ’ Tagħrif.
Why has Actrapid been approved?
Għaliex ġie approvat Actrapid?
The Committee for Medicinal products for Human Use (CHMP) decided that Actrapid’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Actrapid fit- trattament tad- dijabete mellitus huma ikbar mir- riskji tiegħu.
The Committee recommended that Actrapid be given marketing authorisation.
Il- Kumitat irrakkomanda li Actrapid jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Actrapid:
Tagħrif ieħor dwar Actrapid:
The European Commission granted a marketing authorisation valid throughout the European Union for Actrapid to Novo Nordisk A/ S on 7 October 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Actrapid valida fl- Unjoni Ewropea kollha lil Novo Nordisk A/ S fis- 7 ta ’ Ottubru 2002.
The marketing authorisation was renewed on 7 October 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 7 ta ’ Ottubru 2007.
The full EPAR for Actrapid can be found here.
L- EPAR sħiħ għal Actrapid jinsab hawnhekk.
This summary was last updated in 10-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' 10- 2007.
Actrapid 40 IU/ ml solution for injection in a vial.
Actrapid 40 UI/ ml soluzzjoni għall- injezzjoni f’ kunjett
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Insulina umana, rDNA (magħmula permezz tat- teknoloġija tad- DNA rikombinanti f’ Saccharomyces cerevisiae).
1 vial contains 10 ml equivalent to 400 IU.
Kunjett fih 10 ml ekwivalenti għal 400 UI.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
UI waħda (Unità Internazzjonali) tikkorrispondi għal 0. 035 mg ta ’ insulina umana anidra.
Solution for injection in a vial.
Soluzzjoni għall- injezzjoni f’ kunjett.
Clear, colourless, aqueous solution.
Soluzzjoni akweja, ċara u mingħajr kulur.
Actrapid is a fast-acting insulin and may be used in combination with long-acting insulin products.
Actrapid hu insulina li taħdem malajr u jista ’ jintuża flimkien ma ’ prodotti ta ’ l- insulina li jaħdmu fit - tul.
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Il- ħtieġa individwali ta ’ l - insulina normalment hi ta ’ bejn 0. 3 u 1. 0 UI/ kg/ kuljum.