qanastek/EMEA-V3 huggingface dataset:
► 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 Insulatard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk l- InnoLet titwaqqa ’, ji rilha l - sara jew titg affe, hemm ir- riskju li jkun hemm xi telf ta ’ insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (see 6 Kif ta en Insulatard)
The best place to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
L- a jar postijiet minn fejn tinjetta lilek 108 innifsek huma: in- na a ta ’ quddiem ta ’ qaddek (i - aqq); il- warrani; in- na a ta ’ quddiem tal- koxox jew in- na a ta ’ fuq ta ’ dirg ajk.
103 A hypo means your blood sugar level is too low.
Ipo jfisser li l- livell taz- zokkor fid- demm tieg ek hu baxx wisq.
If you get any of these signs, test your blood sugar level and test your urine for ketones if you can.
Jekk ikollok xi wie ed minn dawn is- sinjali, i ekkja l- livell taz- zokkor fid- demm tieg ek u jekk tista ’ i ekkja l- awrina tieg ek g all- ketoni.
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
• Tkun insejt tie u l- insulina tieg ek • Li ripetutament tie u anqas insulina milli g andek b onn 109 • Ikollok infezzjoni jew deni • Tiekol aktar mis- soltu • Tag mel e er izzju fi iku anqas mis- soltu.
104 Side effects reported uncommonly (in less than 1 patient in 100)
Effetti sekondarji rrappurtati b 'mod mhux komuni (f’ inqas minn pazjent 1 minn kull 100)
Keep out of the reach and sight of children.
110 omm fejn ma jintla aqx u ma jidhirx mit- tfal.
Do not store them in or too near the freezer section or cooling element.
L- InnoLet li ma tkunx qeg da tintu a g andha tin a en fi fri (2°C - 8°C) Ta inhomx fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
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 qeg da tintu a, jew li qeda tin arr g al li jista ’ jinqala ’, m' g andiex tin amm fil - fri.
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 tkun ri t l- InnoLet mill- fri, huwa rakkomandat li t alliha til aq it- temperatura ambjentali tal- kamra qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni, kif istruwit/ a meta ti i biex tu aha g all- ewwel darba.
Always keep the pen cap on your InnoLet when you’ re not using it in order to protect it from light.
Dejjem omm l- g atu tal- pinna fuq l- InnoLet tieg ek meta ma tkunx qed tu aha sabiex tilqg alha mid- dawl.
105 Insulatard should not be disposed of via wastewater or household waste.
Insulatard m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
1 pre-filled pen contains 3 ml equivalent to 300 IU
Pinna mimlija g al- lest fiha 3 ml ekwivalenti g al 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 mimlijin g al- lest ta ’ 3 ml.
Now turn over for information on how to use your InnoLet.
Issa aqleb g al informazzjoni dwar kif tu a l- InnoLet tieg ek.
106 Information on how to use Insulatard InnoLet
111 Informazzjoni dwar kif tu a Insulatard InnoLet
Please read the following instructions carefully before using your Insulatard InnoLet.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a l- Insulatard InnoLet tieg ek.
Insulatard InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Insulatard InnoLet hija pinna mimlija g al- lest sempli i u kumpatta li kapa i tag ti minn 1 sa 50 unità f’ inkrementi ta ’ unità 1.
Insulatard InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Insulatard InnoLet hi mag mula biex tintu a ma ’ labar NovoFine S ta '8 mm jew iqsar.
The S stands for short cap.
L- S tfisser g atu qasir.
As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.
B ala mi ura prekawzjonarja, dejjem orr apparat ejjed li jkun jista ’ jag ti l- insulina, g al li jista ’ jkun l- InnoLet tieg ek tintilef jew ji rilha l - sara.
Preparing for injection
Kif tipprepara g all- injezzjoni
Take off the pen cap (as shown by the arrow).
I ekkja t- tikketta biex ti gura li l- Insulatard InnoLet tieg ek ikun fiha t- tip korrett ta ’ insulina Ne i t- tapp tal- pinna (kif muri bil- vle a).
Resuspending is easier when the insulin has reached room temperature.
Is- suspensjoni mill - did tkun e fef meta l- insulina tkun la qet it- temperatura tal- kamra.
Suspending the insulin
Kif tag mel suspensjoni ta' l- insulina
If there are less than 12 units left, use a new Insulatard 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 ’ inqas minn 12- il unità, u a Insulatard InnoLet dida aqlaq il- pinna ’ l fuq u ’ l isfel bejn il- po izzjonijiet A u B u lura biex b’ hekk il- bo a tal - • ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto (stampa 1A) g al 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.
Dan il- moviment g andu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi
Attaching the needle
al 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 Insulatard InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
Iddi infetta l- membrana tal- gomma b’ tajjara b’ di infettant • Dejjem u a labra dida g al kull injezzjoni sabiex tevita l- kontaminazzjoni • Ne i s- si ill protettiv minn fuq labra NovoFine S • Invita l- labra bi dritt u b' mod issikkat fuq Insulatard InnoLet (stampa 1B) • •
You may want to store the big outer needle cap in the compartment.
ta en l- g atu l- kbir ta ’ barra tal- labra fil- kompartiment.
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Insulatard 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.
Biex tevita l- injezzjoni ta ’ l- arja u ti gura do a korrett: • Isselezzjona 2 unitajiet billi ddawwar is- selettur tad- do a lejn il- lemin omm l- Insulatard InnoLet bil- labra tipponta ’ l fuq u b’ sebg ek tektek bil- mod l - • iskarto g al xi ftit drabi, biex jekk ikun hemm xi b ie aq ta ’ l- arja dawn jin abru fin- na a ta ’ fuq ta ’ l- iskarto (stampa (stampa 1C) • Filwaqt li omm il- labra ’ l fuq, ag fas il- buttuna ta ’ l- injezzjoni u s- selettur tad- do a jirritorna fuq i - ero • Qatra insulina g andha tidher fil- ponta tal- labra.
If not, change the needle and repeat the procedure no more than 6 times.
Jekk dan ma jse x, ibdel il- labra u irrepeti l- pro edura mhux aktar minn 6 darbiet.
If a drop of insulin still does not appear, the device is defective and must not be used.
113 Jekk il- qatra ta' l- insulina tibqa ’ ma titfa ax, l- apparat hu difettu u m’ g andux jintu a.
• 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).
Isselezzjona n- numru ta ’ unitajiet li jkollok b onn billi ddawwar is- selettur tad- do a 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.
Tu ax l- iskala ta ’ kemm fadal insulina biex tkejjel id- do a ta ’ l- insulina tieg ek G andek tisma ’ klikk g al kull unità li tisselezzjona.
The dose can be corrected by turning the dial either way.
Id- do a tista ’ tkun irregolata billi • ddawwar is- selettur tad- do a f’ wa da mi - ew direzzjonijiet.
You cannot set a dose larger than the number of units left in the cartridge.
Ma tistax tissettja do a akbar min- numru ta ’ unitajiet li jkun fadal fl- iskarto.
Use the injection technique advised by your doctor • Deliver the dose by pressing the push-button fully down (picture 3).
Ag ti d- do a billi tag fas 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.
G andek tisma ’ l- klikks hekk kif is- selettur tad- do a jmur lura fuq i - ero. • Wara l- injezzjoni, il- labra g andha tin amm ta t il - ilda g al mill- anqas 6 sekondi biex ti gura li d- do a kollha tkun ing atat. • Kun gur li ma timblukkax is- selettur tad- do a waqt li tkun qed tinjetta, g ax is- selettur tad- do a jrid jit alla jmur lura fuq i - ero meta tag fas il- buttuna ta ’ l- injezzjoni.
Removing the needle
i l- labra
• Replace the big outer needle cap and unscrew the needle (picture 4).
Er a ’ po i f’ postu l- g atu l- kbir ta ’ barra tal- labra u oll il- labra (stampa 4).
Dispose of it carefully.
Armiha bl - • attenzjoni.
Remove the needle after each injection and store InnoLet without the needle attached.
Ne i l- labra wara kull injezzjoni u a en InnoLet ming ajr ma l- labra tkun imwa la.
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- sa a, qraba u nies o rajn li jie du sieb il- pazjent, g andhom isegwu l - mi uri enerali ta ’ prekawzjoni g at- tne ija u r- rimi tal- labar biex ji i eliminat ir- riskju ta ’ tingi mhux intenzjonat tal- labar.
Dispose of your used Insulatard InnoLet carefully without the needle attached.
Armi l- Insulatard InnoLet u ata tieg ek bl- attenzjoni ming ajr ma ’ l- labra tkun imwa la.
Your Insulatard InnoLet is designed to work accurately and safely.
L- Insulatard InnoLet tieg ek hi mag mula biex ta dem bi pre i joni u bla periklu.
Do not refill Insulatard InnoLet.
Timliex mill - did Insulatard InnoLet.
You can clean your Insulatard InnoLet by wiping it with a medicinal swab.
Tista ’ tnaddaf l- Insulatard InnoLet tieg ek billi timsa a b’ tajjara b’ di infettant.
110 PACKAGE LEAFLET:
115 FULJETT TA' TAG RIF:
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 b onn ter a ’ taqrah. – Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, infermier/ a tad- dijabete jew lill- ispi jar tieg ek. – Din il- medi ina iet mog tija 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 ’ tag mlilhom il - sara, anki jekk ikollhom l- istess sintomi b al tieg ek. – Jekk xi wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, l- infermier/ a tad- dijabete jew lill- ispi jar tieg ek.
How to use your FlexPen
Kif g andek tu a l- FlexPen tieg ek
111 Using other medicines
Meta tu a medi ini ohra
Talk about your insulin needs with your doctor and nurse.
Tkellem dwar il - ti ijiet tieg ek ta ’ l- insulina mat- tabib u ma ’ l- infermier/ a tad- dijabete tieg ek.
► 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 Insulatard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk il- FlexPen titwaqqa ’, ji rilha l - sara jew titg affe, hemm ir- riskju li jkun hemm xi telf ta ’ insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (see 6 Kif ta en Insulatard)
The best place to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
L- a jar postijiet minn fejn tinjetta lilek 117 innifsek huma: in- na a ta ’ quddiem ta ’ qaddek (i - aqq); il- warrani; in- na a ta ’ quddiem tal- koxox jew in- na a ta ’ fuq ta ’ dirg ajk.
If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jekk ikollok xi wie ed minn dawn is- sinjali, u pilloli tal- glukosju jew ikla afifa li fiha afna zokkor (elu, gallettini, meraq tal- frott), u mbag ad strie.
Using glucagon
Kif tu a l- glucagon
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
• Tkun insejt tie u l- insulina tieg ek • Li ripetutament tie u anqas insulina milli g andek b onn 118 • Ikollok infezzjoni jew deni • Tiekol aktar mis- soltu • Tag mel e er izzju fi iku anqas mis- soltu.
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 - ilda qieg da tit affer jew qieg da te xien, g id lit- tabib tieg ek jew lill- infermier/ a tad- dijabete, g ax dawn ir- reazzjonijiet jistg u jsiru aktar serji, jew jekk l - injezzjoni ssir f’ sit b al dan jistg u jbiddlu l- assorbiment ta ’ l- insulina tieg ek.
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 wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, lill- infermier/ a tad- dijabete jew lill- ispi jar tieg ek.
Keep out of the reach and sight of children.
119 omm fejn ma jintla aqx u ma jidhirx mit- tfal.
Do not store them in or too near the freezer section or cooling element.
Il- FlexPen li ma tkunx qeg da tintu a g andha tin a en fi fri (2C° - 8C°) Ta inhomx fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
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 qeg da tintu a, jew li qed tin arr g al li jista ’ jinqala ’, m' g andiex tin amm fil - fri.
After removing the FlexPen 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 tkun ri t il- FlexPen mill- fri, huwa rakkomandat li t alliha til aq it- temperatura ambjentali tal- kamra qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni, kif istruwit/ a meta ti i biex tu aha g all- ewwel darba.
See 3 How to use
Ara 3 Kif tu a Insulatard.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.
Tista ’ orrha mieg ek u ommha fit - temperatura ambjentali tal- kamra (mhux aktar minn 30°C) sa perjodu ta ’ 6 img at.
Always keep the pen cap on your FlexPen when you’ re not using it in order to protect it from light.
Dejjem omm l- g atu tal- pinna fuq il- FlexPen tieg ek meta ma tkunx qed tintu a sabiex tilqg alha mid- dawl.
Marketing Authorisation Holder Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id 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 g al informazzjoni dwar kif tu a il- FlexPen tieg ek.
115 Introduction
120 Introduzzjoni
Please read the following instructions carefully before using your Insulatard FlexPen.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a l- Insulatard FlexPen tieg ek.
Your FlexPen is a unique dial-a-dose insulin pen.
Il- FlexPen tieg ek hija pinna unika ta ’ l- insulina tat- tip isselezzjona- do a.
You can select doses from 1 to 60 units in increments of 1 unit.
Tista ’ tisselezzjona do i minn 1 sa 60 unità f' inkrementi ta 'unità 1.
FlexPen is designed and tested to be used with NovoFine and NovoTwist disposable needles up to a length of 8 mm.
Il- FlexPen hi mag mula biex tintu a mal- labar NovoFine u NovoTwist li jintu aw darba biss u li g andhom tul ta '8 mm jew iqsar.
As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
B ala mi ura prekawzjonarja, dejjem orr apparat ejjed li jkun jista ’ jag ti l- insulina, fil- ka li l- FlexPen tieg ek tintilef jew ji rilha l - sara.
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 tieg ek
Insulatard FlexPen Pen cap
Insulatard FlexPen G atu tal- pinna
Rubber
Membrana tal- gomma
12 units Glass
12- il Ballun unità tal - ie
Cartridge
Skarto
Residual
Skala ta ’ residwu
Push-
Selettur tad- do a
membrane
Buttuna ta ’ l - injezzjoni
ball
Labra (e empju)
scale
G atu l- kbir
selector
G atu ta ’
button
Labra
Needle (example)
Si ill protettiv
Inner
ta ’
Protective
barra tal - labra
needle cap needle cap
gewwa tal - labra
Your FlexPen is designed to work accurately and safely.
Il- FlexPen tieg ek hi mag mula biex ta dem bi pre i joni u bla periklu.
If it is dropped or crushed, there is a risk of damage and leakage of insulin.
Jekk ti i mwaqqa ’ jew mg aff a hemm ir- riskju li ji rilha l - sara u li to ro 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 tieg ek billi timsa a b’ tajjara b’ di infettant.
Do not soak it, wash or lubricate it as it may damage the pen.
M’ g andekx ixxarrabha, ta silha jew tillubrikaha g ax dan jista ’ jag mel sara lill- pinna.
Do not refill your FlexPen.
Timliex mill - did il- FlexPen tieg ek.
Preparing your Insulatard FlexPen
Kif tipprepara l- Insulatard FlexPen tieg ek
Check the label to make sure that your FlexPen contains the correct type of insulin.
I ekkja t- tikketta biex ti gura li l- FlexPen tieg ek 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 dida l- insulina trid ter a ’ ti i mag mula f’ suspensjoni:
A Let the insulin reach room temperature before you use it.
121 A
116 This makes it easier to resuspend.
alli l- insulina til aq it- temperatura tal- kamra qabel ma tu aha.
Pull off the pen cap.
Ne i l- g atu 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, aqlaq il- pinna ’ l fuq u ’ l isfel g al g oxrin darba bejn il- po izzjonijiet 1 u 2, biex b’ hekk il- bo a tal - ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto.
Repeat until the liquid appears uniformly white and cloudy.
Irrepeti, sakemm il - likwidu b’ mod uniformi 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.
G al kull injezzjoni sussegwenti, aqlaq il- pinna ’ l fuq u ’ l isfel g al mill- anqas 10 darbiet bejn il - po izzjonijiet 1 u 2 sakemm il- likwidu b’ mod uniformi jidher abjad u opak.
After you have resuspended the insulin, complete all the following steps of injection without delay.
Wara li tkun er ajt g amilt l- insulina f’ suspensjoni, wettaq l- istadji kollha ta ’ l- injezzjoni li ejjin bla dewmien
• Always check there are at least 12 units of insulin left in the cartridge to allow resuspension.
• Dejjem i ekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskarto biex tippermetti li ter a ’ ssir is- suspensjoni.
If there are less than 12 units left, use a new FlexPen.
Jekk ikun baqa ’ inqas minn 12- il unità, u a FlexPen dida
Attaching a needle
Iddi infetta
Disinfect the rubber membrane with a medicinal swab.
l- membrana tal- gomma b’ tajjara medi inali
C Remove the protective tab from a new disposable needle.
C Ne i s- si ill protettiv minn labra dida li g andha tintu a darba biss.
Screw the needle straight and tightly onto your FlexPen.
Invita l- labra bi dritt u b' mod issikkat fuq il- FlexPen tieg ek.
C
122 C
D Pull off the big outer needle cap and keep it for later.
D Ne i l- g atu l- kbir ta ’ barra tal- labra u ommu g al wara
E Pull off the inner needle cap and dispose of it.
E Ne i l- g atu ta ’ ewwa tal- labra u armih
• Always use a new needle for each injection to prevent contamination.
• Dejjem u a labra dida g al kull injezzjoni sabiex tevita l- kontaminazzjoni
• Be careful not to bend or damage the needle before use.
• Oqg od attent li ma tg awwi x jew tag mel xi sara lil- labra qabel l- u u.
• 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 ball titnigge mil- labra, qatt m’ g andek ter a ’ tqieg ed lura l - g atu ta ’ ewwa tal- labra wara li tkun ne ejtu minn fuq il- labra.
Checking the insulin flow
Kif te amina l- fluss ta ’ l- insulina
Prior to each injection small amounts of air may collect in the cartridge during normal use.
Qabel kull injezzjoni waqt l- u u normali, jistg u jin emg u ammonti g ar ta ’ arja o l - iskarto.
To avoid injection of air and ensure proper dosing:
Biex tevita l- injezzjoni ta ’ l- arja u ti gura do a korrett:
F Turn the dose selector to select 2 units.
F Dawwar is- selettur tad- do a sabiex tisselezzjona 2 unitajiet.
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.
123 G omm il- FlexPen tieg ek bil- labra tipponta ’ l fuq u b’ sebg ek tektek bil- mod l- iskarto g al xi ftit drabi, biex jekk ikun hemm xi b ie aq ta ’ l- arja dawn jin abru fin- na a ta ’ fuq ta ’ l- iskarto
H Keeping the needle upwards, press the push-button all the way in.
H Filwaqt li omm il- labra ’ l fuq, ag fas il- buttuna ta ’ l- injezzjoni kollha ’ l ewwa.
The dose selector returns to 0.
Is- selettur tad- do a jirritorna fuq i - 0
A drop of insulin should appear at the needle tip.
Qatra insulina g andha tidher fil- ponta tal- labra.
If not, change the needle and repeat the procedure no more than six times.
Jekk dan ma jse pro edura sa mhux aktar minn 6 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 difettu a u g andek tu a wa da dida.
Selecting your dose
Kif tisselezzjona d- do a
Check that the dose selector is set at 0.
A erta ru ek li s- selettur tad- do a qieg ed fuq i - 0.
I Turn the dose selector to select the number of units you need to inject.
I Dawwar is- selettur tad- do a sabiex tisselezzjona n- numru ta ’ unitajiet li jkollok b onn 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- do a tista ’ tkun a ustata kemm ’ il fuq u kemm ’ l isfel billi ddawwar is- selettur tad- do a f’ direzzjoni jew o ra sakemm l- indikatur ikun fuq id- do a 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- do a, oqg od attent/ a biex ma tag fasx il- buttuna ta ’ l- injezzjoni g ax inkella to ro l - insulina.
You cannot select a dose larger than the number of units left in the cartridge.
Ma tistax tisselezzjona do a akbar min- numru ta ’ unitajiet li jkun fadal fl- iskarto.
119 I
124 I
• Do not use the residual scale to measure your dose of insulin.
• Tu ax l- iskala ta ’ residwu biex tkejjel id- do a ta ’ l- insulina tieg ek
Making the injection
Biex tag mel l- injezzjoni
Insert the needle into your skin.
Da al il- labra fil - ilda tieg ek.
Use the injection technique shown by your doctor or nurse.
U a t- teknika ta ’ l- injezzjoni kif uriek it- tabib jew l- infermier/ a tieg ek.
J Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
J Ag ti d- do a billi tag fas il- buttuna ta ’ l- injezzjoni kollha 'l ewwa sakemm l- indikatur ji i fuq i - ero.
Be careful only to push the push-button when injecting.
Oqg od attent/ a li tag fas biss il- buttuna ta ’ l- injezzjoni meta tkun qed/ a tag mel l- injezzjoni.
Turning the dose selector will not inject insulin.
Billi ddawwar is- selettur tad- do a ma tkunx qed/ a tag ti 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 omm il- buttuna ta ’ l- injezzjoni mag fusa kollha ’ l ewwa sakemm il- labra tkun in ibdet ’ il barra minn ol - ilda.
The needle must remain under the skin for at least six seconds.
Il- labra g andha tin amm ta t il - ilda g al mill- anqas sitt sekondi.
This will ensure that the full dose has been injected.
Dan ser ji gura li d- do a kollha tkun ing atat.
L Lead the needle into the big outer needle cap without touching the big outer needle cap.
L Qieg ed il- labra fl- g atu l- kbir ta ’ barra tal- labra ming ajr ma tmiss l- g atu 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 mg ottija, b’ attenzjoni imbotta l- g atu l- kbir ta ’ barra tal- labra biex jng alaq sew fuq il- pinna u imbag ad oll il- labra.
120 Dispose of it carefully and put the pen cap back on.
125 Oqg od attent kif tarmiha u er a ’ po i lura l- g atu tal- pinna
• Always remove the needle after each injection and store your FlexPen without the needle attached.
• Dejjem ne i l- labra wara kull injezzjoni u a en il- FlexPen tieg ek ming ajr ma l- labra tkun imwa la.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella, il- likwidu jista ’ jnixxi li jista ’ jwassal li tittie ed do a baljata. • • Persuni li jie du sieb il- pazjent g andhom joqog du attenti kif jimmani jaw il- labar u ati biex ma ji ux imnigg a mil- labar.
• Caregivers should be most careful when handling used needles to avoid needle sticks.
•
• Dispose of the used FlexPen carefully without the needle attached.
Armi l- FlexPen u ata tieg ek bl- attenzjoni ming ajr ma l- labra tkun imwa
• Do not share your FlexPen with anyone else.
M’ g andekx taqsam il- FlexPen tieg ek ma o rajn
Subcutaneous or intravenous use
Użu għal taħt il - ġilda jew ġol- vina
4 cartridges
4 skartoċċi
5 cartridges
5 skartoċċi
10 cartridges
10 skartoċċi
OptiSet, solution for injection
OptiSet, soluzzjoni għall- injezzjoni
cartridge (glass) in disposable pen
skartoċċ (ħġieġ) f’ pinna għall- injezzjoni, li tintrema wara li tinħela
3 pens
3 pinen
4 pens
4 pinen
10 pens
10 pinen
cartridges (glass)
skartoċċi (ħġieġ)
OptiSet, suspension for injection
OptiSet, suspensjoni għall - injezzjoni
2/ 10 EU Number
2/ 10 Numru ta ’ l- EU
3 vials
3 kunjetti
cartridge (glass) for OptiClik
skartoċċ (ħġieġ) għal Opticlik
3 cartridges
3 skartoċċi
6 cartridges
6 skartoċċi
9 cartridges
9 skartoċċi
cartridges (glass) for OptiClik
skartoċċi (ħġieġ) għal Opticlik
cartridges (glass) for OptiClik
skartoċċ (ħġieġ) għal Opticlik
5/ 10 EU Number
5/ 10 Numru ta ’ l- EU
cartridges (glass)
skartoċċ (ħġieġ)
6/ 10 EU Number
6/ 10 Numru ta ’ l- EU
OptiSet, solution for injection
OptiSet, Soluzzjoni għall- injezzjoni
6 pre-filled pens for Optiset
6 pinen
OptiSet, suspension for injection
OptiSet, Suspensjoni għall - injezzjoni
9 pre-filled pens for Optiset
9 pinen
cartridge (glass) in pre-filled pen (SoloStar)
skartoċċ (ħġieġ) f’ pinna mimlija għal- lest (SoloStar)
3 pre-filled pens
3 pinen mimlija għal- lest
4 pre-filled pens
4 pinen mimlija għal- lest
5 pre-filled pens
5 pinen mimlija għal- lest
6 pre-filled pens
6 pinen mimlija għal- lest
9 pre-filled pens
9 pinen mimlija għal- lest
10 pre-filled pens
10 pinen mimlija għal- lest
8/ 10 EU Number
8/ 10 Numru ta ’ l- EU
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a vial
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo kunjett.
Each vial contains 5 ml of solution for injection, equivalent to 500 IU insulin.
Kull ml fih 100 IU isulina umana (ekwivalenti għal 3. 5 mg) Kull kunjett fih 5 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 500 IU insulina.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
IU (Unita Internazzjonali) waħda hija ekwivalenti għal 0. 035 mg insulina umana anidru.
Insulin Human Winthrop Rapid is a neutral insulin solution (regular insulin).
Insulin Human Winthrop Rapid hija soluzzjoni newtrali ta ’ insulina (insulina regolari).
Human insulin is produced by recombinant DNA technology in Escherichia coli.
L- insulina umanaInsulin Human Winthrop hija magħmula permezz tat- teknoloġija rikombinanti tad - DNA ġo Escherichia coli.
Solution for injection in a vial.
Soluzzjoni għall- injezzjoni ġo kunjett.
Clear, colourless solution of water-like consistency.
Soluzzjoni ċara mingħajr kulur, b’ konsistenza li tixbah dik ta ’ l- ilma.
Diabetes mellitus where treatment with insulin is required.
Diabetes mellitus meta l- kura bl- insulina hija meħtieġa.
Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus.
Insulin Human Winthrop Rapid hija wkoll adatta għall- kura tal- koma ipergliċemija u l- ketoaċidożi, kif ukoll għall- kontroll stabbli f’ pazjenti b’ diabetes mellitus qabel, waqt u wara interventi kirurġiċi.
The desired blood glucose levels, the insulin preparations to be used and the insulin dosage (doses and timings) must be determined individually and adjusted to suit the patient ’ s diet, physical activity and life-style.
Il- livelli mixtieqa tal- glucose fid- demm, il- preparazzjonijiet t’ insulina li ser jintużaw, u d- dożaġġ ta ’ l - insulina (dożaġġi u l- ħinijiet) għandhom ikunu stabbiliti għal kull pazjent u aġġustati skond id- dieta tal- pazjent, l- attività fiżika u l- istil ta ’ ħajja.
Daily doses and timing of administration
Id- dożi ta ’ kuljum u l- ħin meta jingħataw
There are no fixed rules for insulin dosage.
M’ hemmx regoli fissi rigward id- dożaġġ ta ’ l- insulina.
However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day.
Madankollu, il- ħtieġa medja t’ insulina hija spiss ta ’ 0. 5 sa 1. 0 IU kull kg tal- piż tal- ġisem, kuljum.
The basal metabolic requirement is 40% to 60% of the total daily requirement.
Il- bżonn għall- metaboliżmu bażiku huwa ta ’ gminn 40 sa 60% tal- ħtieġa sħiħa ta ’ jum wieħed.
Insulin Human Winthrop Rapid is injected subcutaneously 15 to 20 minutes before a meal.
Insulin Human Winthrop Rapid hija injettata fit - tessut ta ’ taħt il- ġilda minn 15 sa 20 minuta qabel ikla.
In the treatment of severe hyperglycaemia or ketoacidosis in particular, insulin administration is part of a complex therapeutic regimen which includes measures to protect patients from possible severe complications of a relatively rapid lowering of blood glucose.
Fit- trattament ta ’ l- ipergliċemija severa, u partikolarment il- ketoaċidożi, l- użu ta ’ l- insulina huwa parti minn sistema ta ’ terapija kumplessa, li tinkludi l- miżuri biex l- pazjenti jkunu protetti mill- possibbiltà ta ’ kumplikazzjonijiet severi, dovuti għat- tnaqqis relattivament mgħaġġel fil- livelli tal- glucose fid - demm.
This regimen requires close monitoring (metabolic status, acid-base and electrolyte status, vital parameters etc.) in an intensive care unit or similar setting.
Din it- tip ta ’ kura teħtieġ moniteraġġ mill- viċinbir- reqqa (l- istatus metaboliku, il- bilanċ aċidiku- alkaliniku, l- istatus ta ’ l- elettroliti u l- parametri vitali eċċ) f’ sezzjoni tal- kura intensiva jew xi post ieħor simili.
2 Transfer to Insulin Human Winthrop Rapid
2 Kif taqleb għal Insulin Human Winthrop Rapid
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another.
Aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta jinbidel il- preparat ta ’ tip t’ insulina għal ieħor fil - pazjenti.
This applies, for example, when transferring from:
Dan japplika, per eżempju, meta wieħed jibdel minn:
- an animal insulin (especially a bovine insulin) to human insulin,
- insulina derivata mill- annimali (speċjalment l- insulina bovina) għall- insulina umana,
- one human insulin preparation to another,
- insulina umana għal preparat ieħor bħalha,
- a regimen with only regular insulin to one with a longer-acting insulin.
- sistema ta ’ kura b’ insulina regolari biss għal waħda b’ insulina li taħdem aktar fit- tul.
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
Il- ħtieġa ta ’ l- tibdil (e. ż. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
Alternatively, it may emerge gradually over a period of several weeks.
Inkella, tista ’ tiżviluppa bil- mod fuq medda ta ’ diversi ġimgħat.
Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
- were previously already controlled on rather low blood glucose levels,
- kienu minn qabel diġà ikkontrollati f’ livelli pjuttost baxxi ta ’ glucose fid- demm,
- have a tendency to hypoglycaemia,
- għandhom tendenza biex jiżviluppaw l- ipogliċemija,
- previously required high insulin doses due to the presence of insulin antibodies.
- preċedentmenet kienu jeħtieġu dożi għoljin t’ insulina dovuti għall- preżenza t’ antikorpi kontra
Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
Il- moniteraġġ metaboliku bir- reqqa huwa rrakkomandat waqt il- bidla u fl- ewwel ftit ġimgħat sussegwenti.
In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.
F’ dawk il- pazjenti li jeħtieġu dożi għoljin t’ insulina dovut għall- preżenza ta ’ l- antikorpi kontra l- insulina, il- bidla taħt is- superviżjoni medika fl- isptar jew xi faċilità simili trid tkun ikkunsidrata.
Secondary dose adjustment
Tibdil sekondarju fid- doża
Improved metabolic control may result in increased insulin sensitivity, leading to a reduced insulin requirement.
Il- kontroll metaboliku aħjar jista ’ jġib miegħu żieda fis- sensittività għall- insulina, li twassal għal ħtieġa t’ anqas insulina.
Dose adjustment may also be required, for example, if
L- tibdil tad- doża jista ’ jkun meħtieġ ukoll, per eżempju, meta
- the patient's weight changes,
- jkun hemm tibdil fil- piż tal- pazjent,
- the patient's life-style changes,
- jsiru tibdiliet f l- istil ta ’ ħajja tal- pazjent,
- other circumstances arise that may promote an increased susceptibility to hypo- or
- jokkorru ċikostanzi oħra li jwasslu għal suxxettibbiltà miżjuda għal ipogliċemja jew
hyperglycaemia (see section 4.4).
ipergliċemija (ara sezzjoni 4. 4).
Use in specific patient groups
L- użu fi gruppi speċifiċi ta ’ pazjenti
In patients with hepatic or renal impairment as well as in the elderly, insulin requirements may be diminished (see section 4.4).
F’ pazjenti li għandhom mard tal- fwied jew tal- kliewi, kif ukoll fl- anzjani, il- bżonn ta ’ l- insulina jista ’ jonqos (ara sezzjoni 4. 4).
Insulin Human Winthrop Rapid contains 100 IU of insulin per ml solution.
Insulin Human Winthrop Rapid fiħ 100 IU t’ insulina kull ml f ’ soluzzjoni.
Only injection syringes designed for this strength of insulin (100 IU per ml) are to be used.
Dawk is- siringi ta ’ l - injezzjoni biss li huma magħmulin għal din il- konċentrazzjoni t’ insulina (100 IU kull ml) għandhom jintużaw.
The injection syringes must not contain any other medicinal product or residue (e. g. traces of heparin).
Is- siringi ta ’ l- injezzjoni m’ għandhomx ikollhom ebda prodott mediċinali ieħor jew xi residwi (e. ż. traċċi ta ’ ħeparina).
Insulin Human Winthrop Rapid is administered subcutaneously.
Insulin Human Winthrop Rapid għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insulin absorption and hence the blood glucose lowering effect of a dose may vary from one injection area to another (e. g. the abdominal wall compared with the thigh).
L- assorbiment ta ’ l- insulina u, għalhekk, l- effett ta ’ doża fuq it- tnaqqis tal- livell tal- glucose fid- demm jista ’ jvarja minn sit t’ injezzjoni għal oħra (e. ż. il- qafas taż- żaqq meta mqabbel mal- koxxa).
Injection sites within an injection area must be rotated from one injection to the next.
Is- siti ta ’ l- injezzjoni, f’ erja partikolari, għandhom jinbiddlu minn titqiba għall- oħra.
Insulin Human Winthrop Rapid may also be administered intravenously.
Insulin Human Winthrop Rapid tista ’ tingħata fil- vina.
Intravenous insulin therapy must generally take place in an intensive care unit or under comparable monitoring and treatment conditions (see "Daily doses and timing of administration").
It- terapija ta ’ l- insulina intravenuża għandha normalment issir fil- qasam tal- kura intensiva jew fejn hemm faċilitajiet komparabbli għall- moniteraġġ u l- kura (ara “ Id- dożi ta ’ kuljum u l- ħin meta jingħataw ”).
For further details on handling, see section 6.6.
Għal aktar informazzjoni dwar immaniġġar, ara sezzjoni 6. 6.
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita ’ eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Insulin Human Winthrop Rapid must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing.
Insulin Human Winthrop Rapid m’ għandhux jintuża f’ pompi ta ’ l- insulina, kemm dawk esterni kif ukoll dawk imdaħħla fil- ġisem, jew f’ pompi peristaltiċi b’ tubi ta’ silikon.
Patients hypersensitive to Insulin Human Winthrop Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
Pazjenti b’ sensittivita ’ eċċessiva għal Insulin Human Winthrop Rapid, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u, fejn hemm bżonn, flimkien ma ’ trattament kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Rapid, since they may experience immunological cross-reactions.
F’ pazjenti li huma allerġiċi għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir analiżi għar- reazzjonijiet allerġiċi b’ injezzoni żgħira fil- ġilda, qabel ma ssir il- bidla għal Insulin Human Winthrop Rapid, għax dawn jistgħu jiżviluppaw kontro- reazzjonijiet immunoloġiċi kontriha.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Fl- anzjani, l- aggravament progressiv tal- funzjoni tal- kliewikliewi jista ’ jwassal għat- tnaqqis sostanzjali fil- bżonn ta ’ l- insulina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti li għandhom mard tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil - kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ ta ’ nuqqas adegwat tal- kontroll tal- livell tal- glucose, jew f’ każ ta ’ tendenza biex jokkorru attakki ta ’ l- ipergliċemija jew l- ipogliċemja, għandha ssir rievalwazzjoni ta ’ kemm il- pazjent qiegħed jieħu t- trattament preskritt, is- siti ta ’ l- injezzjoni, it- teknika korretta ta ’ kif qed issir l- injezzjoni u kull fattur ieħor rilevanti, qabel ma tkun ikkunsidrata l- tibdil tad- doża.
Hypoglycaemia
L- Ipogliċemija
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemja tista ’ sseħħ meta d- doża ta ’ l- insulina hija għolja wisq, meta mqabbla mal- ħtieġa attwali ta ’ l- ammont t’ insulina.
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Il- kawtela trid tkun eżerċitata, u l- immoniterjar intensiv tal- livelli tal- glucose fid- demm huwa irrakkomandat f’ dawk il- pazjenti li jiżviluppaw attakki t’ ipogliċemija, u li jkunu t’ importanza klinika patikolarment rilevanti, bħal ngħidu aħna, pazjenti bi djuq sinifikanti ta ’ l- arterji koronarji jew ta ’ l - arterji li jissupplixxu d- demm lill- moħħ (riskju ta ’ kumplikazzjonijiet kardijaċi u ċerebrali dovuti għall- ipogliċemja), kif ukoll dawk il- pazjenti li għandhom retinopatija proliferattiva, speċjalment jekk mhumiex ittrattati b’ photocoagulation (u b’ hekk għandhom ir- riskju li jiżviluppaw amawrosi li tgħaddi wara l- ipogliċemja,).
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Il- pazjenti għandhom ikunu konxji ta ’ dawk iċ- ċirkostanzi meta s- sintomi ta ’ twissija ta ’ l- ipogliċemja huma mnaqqsin.
The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups.
Is- sintomi ta ’ twissija ta ’ l- ipogliċemja jistgħu jinbidlu, jinħassu anqas, jew ikunu nieqsa f’ ċerti gruppi ta ’ pazjenti f’ riskju.
These include patients:
Dawn jinkludu pazjenti:
- in whom glycaemic control is markedly improved,
- fejn il- kontroll taz- zokkor fid- demm qaleb ħafna għall- aħjar,
- in whom hypoglycaemia develops gradually,
- fejn l- ipogliċemja tiżviluppa bil- mod,
- who are elderly,
- li huma anzjani,
- after transfer from animal insulin to human insulin,
- wara l- bidla minn insulina derivata mill- annimali għall- insulina umana,
- in whom an autonomic neuropathy is present,
- li għandhom newropatija awtonomika,
- with a long history of diabetes,
- li għandhom storja twila ta ’ dijabete,
- suffering from a psychiatric illness,
- li qegħdin ibatu minn mard psikjatriku,
- receiving concurrent treatment with certain other medicinal products (see section 4.5).
- li qegħdin jieħdu trattament konkomittanti b’ ċerti prodotti mediċinali oħra (ara sezzjoni 4. 5).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Sitwazzjonijiet bħal dawn jistgħu jirriżultaw f’ ipogliċemja severa (u possibbilment it- telf mis- sensi) qabel ma ’ l- pazjent jintebaħ bl- ipogliċemija.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
4 Jekk ikun hemm livelli normali jew imnaqqsa ta’ emoglobina glikata, il- possibbiltà t’ attakki ta ’ ipogliċemja rikurrenti, u dawk fejn il- pazjent ma jintebaħx bihom (speċjalment matul il- lejl), trid tkun ikkunsidrata.
4 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Biex jitnaqqas ir- riskju ta ’ l- ipogliċemja huwa essenzjali li l- pazjent iżomm mad- dożaġġ u l- kura bid - dieta, it- teħid korrett ta ’ l- insulina, u li l- pazjent ikun konxju tas- sintomi ta ’ l- ipogliċemja.
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Il- fatturi li jżidu s- suxxettibbiltà għas- sintomu tal- ipogliċemja jeħtieġu partikolarment l- moniteraġġ mill- qrib u jistgħu jirrikjedu tibdil tad- l- aġġustament fid- doża.
These include:
Dawn jinkludu:
- change in the injection area,
- bidla fis- sit fejn issir l- injezzjoni,
- improved insulin sensitivity (by, e. g., removal of stress factors),
- sensittività akbar għall- insulina (e. ż. permezz tat- tneħħija ta ’ fatturi li jikaġunaw tensjoni),
- unaccustomed, increased or prolonged physical activity,
- attività fiżika mhux tas- soltu, żieda fl- attività fiżika, jew dik imtawwla,
- intercurrent illness (e. g. vomiting, diarrhoea),
- mard li jitfaċċa minn żmien għall- ieħor (e. ż. rimettar, dijarrea),
- inadequate food intake,
- ammont inadegwat t’ ikel,
- missed meals,
- ikliet maqbuża,
- alcohol consumption,
- konsum ta ’ l- alkoħol,
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- disturbi fil- glandoli endokrini mhux ikkompensati (e. ż. ipotijrojdiżmu, l- insuffiċjenza tal- parti
adrenocortical insufficiency),
anterjura tal- pitwitarja u l- insuffiċjenza adrenokortikali),
- concomitant treatment with certain other medicinal products.
- trattament konkomittanti ma ’ xi prodotti oħra mediċinali.
Intercurrent illness
Mard kurrenti Il- mard kurrenti jirrikjedi l- moniteraġġ metaboliku aktar intensiv.
In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet l- analiżi ta ’ l - awrina għall- ketones huma ndikati, u ta ’ spiss ikun neċessarju li d- doża ta ’ l- insulina tiġi aġġustata.
The insulin requirement is often increased.
Il - ħtieġa għall- insulina normalment tiżdied.
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Pazjenti li għandhom id- dijabete tip I għandhom ikomplu jieklu mqar ammont żgħir ta ’ karboidrati fuq bażi regolari, anke jekk jistgħu jieklu ftit jew ebda ikel, jew qegħdin jirremettu eċċ, u m’ għandhom qatt iwaqqfu l- insulina għal kollox.
A number of substances affect glucose metabolism and may require dose adjustment of human insulin.
Hemm numru ta ’ sustanzi li jeffetwaw il- metaboliżmu tal- glucose u b’ hekk ikun meħtieġ tibdil tad - doża ta ’ l- insulina umana.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Is- sustanzi li jistgħu jżidu l- effett fuq it- tnaqqis tal- livell tal- glucose fid- demm, u jżidu s - suxxettibbiltà għall- ipogliċemja, jinkludu sustanzi antidijabetiċi orali, inibituri ta ’ l- enzima li tikkonverti anġiotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monoamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates u l- antibijotiċi sulphonamide.