qanastek/EMEA-V3 huggingface dataset:
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 tieg ek.
When NovoMix 30 is used in combination with oral antidiabetic drugs the dosage should be adjusted.
Meta NovoMix 30 jintu a flimkien ma ’ medi ini antidijabeti i orali, id- do a g andu jkun a ustat.
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
I ekkja t- tikketta biex ti gura li hi t- tip korrett ta ’ insulina Dejjem u a labra dida g al kull injezzjoni sabiex tevita l- kontaminazzjoni
NovoMix 30 should not be used
94 NovoMix 30 m’ g andux jintu a
In insulin infusion pumps If FlexPen is dropped, damaged or crushed, there is a risk of leakage of insulin 92 If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 30) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (ara 6 Kif ta en NovoMix 30) Jekk l- insulina meta tit allat ma tkunx bajda u qisa alib b’ mod uniformi Jekk ikun hemm xi apep ta ’ materjal jew jekk je el xi frak abjad mal- qieg jew mal - enb ta ’ l- iskarto li jag tih dehra qisu nkesa bil - elu
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Dejjem ibdel i - ona tal - isem fejn tinjetta, biex tevita l- g oqiedi (ara 5 Effetti sekondarji li jista ’ jkollu).
If your blood sugar gets too high
95 Jekk il- livell taz- zokkor fid- demm tieg ek jitla ’
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a
Dawn jinkludu: tag mel l- awrina iktar ta ’ spiss; t ossok bil- g atx; titlef l- aptit; t ossok imqalla ’ (dardir jew rimettar); t ossok im eddel/ im edla jew g ajjien/ a; mura fil- wi, ilda xotta; alq xott u nifs li jkollu ri a ta ’ frott (acetone)).
Like all medicines, NovoMix 30 can cause side effects, although not everybody gets them.
B al kull medi ina o ra, NovoMix 30 jista ’ jkollu effetti sekondarji, g alkemm ma jidhrux fuq kul add.
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 ofor fil - ilda tieg ek jew li l - ilda qed te xien fis- sit ta ’ l- injezzjoni, g id lit- tabib tieg ek jew lill- infermier/ a, g ax dawn ir- reazzjonijiet jistg u jsiru aktar serji, jew jekk tinjetta f’ sit b al dan jistg u jbiddlu l- assorbiment ta ’ l- insulina tieg ek.
When you start taking insulin, water retention may cause swelling around your ankles and other joints.
ogi minfu in Meta tibda tie u l- insulina, i - amma ta ’ l- ilma fil - isem tista ’ tikkaw a nef a
Normally, this soon disappears.
96 madwar l- g ekiesi u ogi o rajn. afna drabi dan imur wa du.
94 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 m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, lill- infermier/ a jew lill- ispi jar tieg ek.
NovoMix 30 FlexPen that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or to near the freezer section or cooling element.
NovoMix 30 FlexPen li ma jkunx qed jintu a g andu jin a en fil- fri (2°C – 8°C), mhux fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
NovoMix 30 FlexPen that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 30 FlexPen li jkun qed jintu a jew li ser jintu a, m’ g andux jin amm fil- fri.
After removing NovoMix 30 FlexPen from the refrigerator it is recommended to mix the insulin as instructed for the first time use.
Wara li tne i NovoMix 30 FlexPen mill- fri, hu rakkomandat li t allat l- insulina kif hemm fl- istruzzjonijiet g all- ewwel u u.
See overleaf:
Ara fuq in- na a ta ’ wara:
Getting started.
Kif tibda.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 4 weeks, but any remainder must then be discarded.
Tista ’ orru mieg ek u ommu fit- temperatura ambjentali tal- kamra (mhux iktar minn 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
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 tu ah sabiex tilqa ’ mid - dawl.
NovoMix 30 FlexPen must be protected from excessive heat and sunlight.
NovoMix 30 FlexPen g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx.
What NovoMix 30 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 5 or 10 pre-filled pens of 3 ml (not all packs may be marketed).
Id- dehra ta ’ NovoMix 30 u l- kontenuti tal- pakkett Is- suspensjoni g all- injezzjoni ti i b ala suspensjoni bajda f’ pakketti ta ’ 5 jew 10 pinen mimlijin g al - lest ta ’ 3 ml (mhux il- pakketti kollha jistg u jkunu g al skop kummer jali).
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
97 Manifattur Il- manifattur jista ’ ji i identifikat permezz tan- numru tal- lott ipprintjat fuq il- kartuna u fuq it- tikketta:
Now turn over for information on how to use your FlexPen.
Issa aqleb g al informazzjoni dwar kif tu a l- FlexPen tieg ek.
This leaflet was last approved in 95 Introduction
Dan il- fuljett kien approvat l- a
Please read the following instructions carefully before using your NovoMix 30 FlexPen.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a NovoMix 30 FlexPen tieg ek.
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 or NovoTwist disposable needles up to a length of 8 mm.
B ala
As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
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.
NovoMix 30 FlexPen Pen cap
NovoMix® 30 FlexPen® G atu tal- pinna
Cartridge Residual
Membrana tal- gomma
membrane
12- il unità
units ball
Ballun Skarto tal - ie
scale
Skala ta ’ residwu
selector
Indikatur
button
Selettur Buttuna tad - ta ’ l - do a injezzjoni
Needle (example)
Labra (e empju)
Big outer
G atu l- kbir ta ’ barra tal - labra
Inner
G atu ta ’ ewwa tal - labra
needle cap needle cap
Si ill protettiv
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 ha b’ tajjara b’ di infettant.
Preparing your NovoMix 30 FlexPen
99 Kif tipprepara NovoMix 30 FlexPen tieg ek
A Let the insulin reach room temperature before you use it.
alli l- insulina til aq it- temperatura tal- kamra qabel ma tu aha.
96 This makes it easier to resuspend.
B’ kekk ikun iktar fa li li ter a ’ ti i mag mula f’ suspensjoni..
B Roll the pen between your palms ten times – it is important that the pen is kept horizontal.
B Irrombla l- pinna bejn idejk g al g axar darbiet – huwa importanti li dejjem i omm il- pinna b’ mod orizzontali
C Then move the pen up and down ten times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
C Kif muri fl- istampa, aqlaq il- pinna ’ l fuq u ’ l isfel g al g axar darbiet bejn i - ew po izzjonijiet, biex b’ hekk il- bo a tal - ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto
Repeat rolling and moving the pen until the liquid appears uniformly white and cloudy.
Irrepeti l- irromblar u - aqlieq tal- pinna sakemm il- likwidu b’ mod uniformi jidher abjad u opak.
For every following injection move the pen up and down between the two positions 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 bejn i - ew po izzjonijiet g al mill- inqas g axar darbiet sakemm il- likwidu b’ mod uniformi jidher abjad u opak.
• Always check there are at least 12 units of insulin left in the cartridge to allow resuspension.
100 • Dejjem i ekkja li jkun fadal mill- anqas 12- il unità ta' insulina fl- iskarto biex tippermetti li ter a ’ ssir is- suspensjoni.
Attaching a needle
al labra
Disinfect the rubber membrane with a medicinal swab.
Iddi infetta l- membrana tal- gomma b’ tajjara medi inali
D Remove the protective tab from a new disposable needle.
D 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 'issikkat fuq il- FlexPen tieg ek. mod
E Pull off the big outer needle cap and keep it for later.
E Ne i l- g atu l- kbir ta ’ barra tal- labra u ommu g al wara
F Pull off the inner needle cap and dispose of it.
F Ne i l- g atu ta ’ ewwa tal- labra u armih
G Turn the dose selector to select 2 units.
G Dawwar is- selettur tad- do a sabiex tisselezzjona 2 unitajiet.
H 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.
H 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
I Keeping the needle upwards, press the push-button all the way in.
I Filwaqt li omm il- labra ’ l fuq, ag fas il- buttuna ta ’ l- injezzjoni kollha ’ l ewwa.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
a u g andek tu a wa da dida.
J Turn the dose selector to select the number of units you need to inject.
J 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.
102 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.
99 • 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
Be careful only to push the push-button when injecting.
K Ag ti d- do a billi tag fas il- buttuna ta ’ l- injezzjoni kollha 'ewwa sakemm l- indikatur ji i fuq i - 0. l Oqg od attent/ a li tag fas biss il- buttuna ta ’ l- injezzjoni meta tkun qed/ a tag mel l- injezzjoni.
L Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin.
L 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.
L
103 L
M Lead the needle tip into the big outer needle cap without touching the big outer needle cap.
M 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.
Dispose of it carefully and put the pen cap back on.
Oqg od attent kif tarmiha u er a ’ po i lura l- g atu tal- pinna
• Caregivers should be most careful when handling used needles to avoid needle sticks.
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.
• 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 la.
• Do not share your FlexPen with anyone else.
• M’ g andekx taqsam il- FlexPen tieg ek ma o rajn
100 PACKAGE LEAFLET:
104 FULJETT TA ’ TAG RIF:
NovoMix 50 FlexPen 100 U/ ml suspension for injection in a pre-filled pen Insulin aspart
Insulin aspart
What NovoMix 50 is and what it is used for 2.
X’ inhu NovoMix 50 u g alxiex jintu a 2.
Before you use NovoMix 50 3.
Qabel ma tu a NovoMix 50 3.
How to use NovoMix 50 4.
Kif g andek tu a NovoMix 50 4.
How to store NovoMix 50 7 Further information
Aktar tag rif
NovoMix 50 is a mixture of rapid-acting insulin analogue (50%) and long-acting insulin analogue (50%).
Ara l- pa na ta ’ wara g al struzzjonijiet dettaljati.
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 14-24 hours.
NovoMix 50 hu ta lita ta ’ analogu ta ’ l- insulina li ta dem malajr (50%) u analogu ta ’ l- insulina li ta dem fit- tul. (50%) Dan ifisser li jibda jbaxxi z- zokkor fid- demm tieg ek minn 10- 20 minuta wara li tie du, g andu effett massimu bejn 1 u 4 sig at, u l- effett idum sa 14- 24 sieg a.
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar).
Jekk t oss li ejja ipo (ipo hija taqsira ta ’ reazzjoni ipogli emika u hija abra ta ’ sintomi ta ’ livell baxx ta ’ zokkor fid- demm).
Your need for insulin may change If you have an infection, fever or have had an operation you may need more insulin than usual If you suffer from diarrhoea, vomiting or eat less than usual you may need less insulin than usual 101 If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Jekk tbati mid- dijarea, rimettar jew jekk tiekol inqas mis- soltu, jista ’ jkollok b onn inqas
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 if it has been frozen (see 6 How to store NovoMix 50) If the insulin is not uniformly white and cloudy when it’ s mixed 102 If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (ara 6 Kif ta en NovoMix 50) Jekk l- insulina meta tit allat ma tkunx bajda u qisa alib b’ mod uniformi Jekk ikun hemm xi apep ta ’ materjal jew jekk je el xi frak abjad mal- qieg jew mal - enb ta ’ l- iskarto li jag tih dehra qisu nkesa bil - elu
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
107 bil- g atx; titlef l- aptit; t ossok imqalla ’ (dardir jew rimettar); t ossok im eddel/ im edla jew g ajjien/ a; mura fil- wi, ilda xotta; alq xott u nifs li jkollu ri a ta ’ frott (acetone)).
103 These may be signs of a very serious condition called diabetic ketoacidosis.
Dawn jistg u jkunu sinjali ta ’ kundizzjoni serja afna li tissejja ketoa idosi dijabetika.
Normally, this soon disappears.
ogi minfu in Meta tibda tie u l- insulina, i - amma ta ’ l- ilma fil - isem tista ’ tikkaw a nef a madwar l- g ekiesi u ogi o rajn. afna drabi dan imur wa du.
Painful neuropathy.
108 Newropatija bl- u ig.
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 m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, lill- infermier/ a jew lill- ispi jar tieg ek.
NovoMix 50 FlexPen that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or to near the freezer section or cooling element.
NovoMix 50 FlexPen li ma jkunx qed jintu a g andu jin a en fil- fri (2°C – 8°C), mhux fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
NovoMix 50 FlexPen that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 50 FlexPen li jkun qed jintu a jew li ser jintu a, m’ g andux jin amm fil- fri.
After removing NovoMix 50 FlexPen from the refrigerator it is recommended to mix the insulin as instructed for the first time use.
Wara li tne i NovoMix 50 FlexPen mill- fri, hu rakkomandat li t allat l- insulina kif hemm fl- istruzzjonijiet g all- ewwel u u.
See overleaf.
Ara fuq in- na a ta ’ wara:
You can carry it with you and keep it at room temperature (not above 30ºC) for up to 4 weeks, but any remainder must then be discarded.
Tista ’ orru mieg ek u ommu fit- temperatura ambjentali tal- kamra (mhux iktar minn 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
NovoMix 50 FlexPen must be protected from excessive heat and sunlight.
NovoMix 50 FlexPen g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx.
What NovoMix 50 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 1, 5 or 10 pre-filled pens of 3 ml (not all packs may be marketed).
Id- dehra ta ’ NovoMix 50 u l- kontenuti tal- pakkett Is- suspensjoni g all- injezzjoni ti i b ala suspensjoni bajda f’ pakketti ta ’ 1, 5 jew 10 pinen mimlijin g al- lest ta ’ 3 ml (mhux il- pakketti kollha jistg u jkunu g al skop kummer jali).
105 Introduction
109 Introduzzjoni
Please read the following instructions carefully before using your NovoMix 50 FlexPen.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a NovoMix 50 FlexPen tieg ek.
NovoMix 50 FlexPen Pen cap
NovoMix® 50 FlexPen® G atu tal- pinna
Preparing your NovoMix 50 FlexPen
110 Kif tipprepara NovoMix 50 FlexPen tieg ek
This makes it easier to resuspend.
B’ kekk ikun iktar fa li li ter a ’ ti i mag mula f’ suspensjoni..
106 Pull off the pen cap.
Ne i l- g atu tal- pinna.
If the moving procedure alone is not enough to give a uniformly white and cloudy liquid, repeat the rolling and moving procedures (see B and C) until the liquid does appear uniformly white and cloudy
Jekk il- pro edura ta - aqliq wa idha ma tkunx bi ejjed sabiex b’ mod uniformi l- likwidu jidher abjad u opak, irrepeti l - pro eduri ta ’ l- irrumblar u - aqliq (ara B u C) sakemm b’ mod uniformi l- likwidu jidher proprju abjad u opak.
C
111 C
• 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.
Checking the insulin flow
112 Kif te amina l- fluss ta ’ l- insulina
108 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.
H 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
I
113 I
K
114 K
111 PACKAGE LEAFLET:
115 FULJETT TA ’ TAG RIF:
NovoMix 70 FlexPen 100 U/ ml suspension for injection in a pre-filled pen Insulin aspart
Insulin aspart
What NovoMix 70 is and what it is used for 2.
X’ inhu NovoMix 70 u g alxiex jintu a 2.
Before you use NovoMix 70 3.
Qabel ma tu a NovoMix 70 3.
How to use NovoMix 70 4.
Kif g andek tu a NovoMix 70 4.
How to store NovoMix 70 7 Further information
Aktar tag rif
NovoMix 70 is a mixture of rapid-acting insulin analogue (70%) and long-acting insulin analogue (30%).
Ara l- pa na ta ’ wara g al struzzjonijiet dettaljati.
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 14-24 hours.
NovoMix 70 hu ta lita ta ’ analogu ta ’ l- insulina li ta dem malajr (70%) u analogu ta ’ l- insulina li ta dem fit- tul. (30%) Dan ifisser li jibda jbaxxi z- zokkor fid- demm tieg ek minn 10- 20 minuta wara li tie du, g andu effett massimu bejn 1 u 4 sig at, u l- effett idum sa 14- 24 sieg a.
Your need for insulin may change If you have an infection, fever or have had an operation you may need more insulin than usual
Il - tie a tieg ek g all- insulina tista ’ tinbidel Jekk g andek infezzjoni, deni, jew kellek xi operazzjoni, jista ’ jkollok b onn iktar insulina mis- soltu.
112 If you suffer from diarrhoea, vomiting or eat less than usual you may need less insulin than usual If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Jekk ser issiefer: li tivvja a bejn oni tal - in differenti, jista ’ jaffettwa l - ti ijiet tieg ek ta ’ l - insulina u l - in meta tie u l- injezzjonijiet.
Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Iddiskuti mat- tabib tieg ek jekk g andekx issuq jew t addem magni jekk ikollok episodji frekwenti ta ’ ipos jew jekk issibha issibha diffi li biex tag raf l- ipos.
In insulin infusion pumps If FlexPen is dropped, damaged or crushed, there is a risk of leakage of insulin 113 If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 70) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (ara 6 Kif ta en NovoMix 70) Jekk l- insulina meta tit allat ma tkunx bajda u qisa alib b’ mod uniformi Jekk ikun hemm xi apep ta ’ materjal jew jekk je el xi frak abjad mal- qieg jew mal - enb ta ’ l- iskarto li jag tih dehra qisu nkesa bil - elu
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a
Dawn jinkludu: tag mel l- awrina iktar ta ’ spiss; t ossok
114 fruity (acetone) smell of the breath.
118 bil- g atx; titlef l- aptit; t ossok imqalla ’ (dardir jew rimettar); t ossok im eddel/ im edla jew g ajjien/ a; mura fil- wi, ilda xotta; alq xott u nifs li jkollu ri a ta ’ frott (acetone)).
Painful neuropathy.
119 Newropatija bl- u ig.
115 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 m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, lill- infermier/ a jew lill- ispi jar tieg ek.
NovoMix 70 FlexPen that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or to near the freezer section or cooling element.
NovoMix 70 FlexPen li ma jkunx qed jintu a g andu jin a en fil- fri (2°C – 8°C), mhux fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
NovoMix 70 FlexPen that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 70 FlexPen li jkun qed jintu a jew li ser jintu a, m’ g andux jin amm fil- fri.
After removing NovoMix 70 FlexPen from the refrigerator it is recommended to mix the insulin as instructed for the first time use.
Wara li tne i NovoMix 70 FlexPen mill- fri, hu rakkomandat li t allat l- insulina kif hemm fl- istruzzjonijiet g all- ewwel u u.
Getting Started.
Kif tibda.
NovoMix 70 FlexPen must be protected from excessive heat and sunlight.
NovoMix 70 FlexPen g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx.
What NovoMix 70 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 1, 5 or 10 pre-filled pens of 3 ml (not all packs may be marketed).
Id- dehra ta ’ NovoMix 70 u l- kontenuti tal- pakkett Is- suspensjoni g all- injezzjoni ti i b ala suspensjoni bajda f’ pakketti ta ’ 1, 5 jew 10 pinen mimlijin g al- lest ta ’ 3 ml (mhux il- pakketti kollha jistg u jkunu g al skop kummer jali).
116 Introduction
120 Introduzzjoni
Please read the following instructions carefully before using your NovoMix 70 FlexPen.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a NovoMix 70 FlexPen tieg ek.
NovoMix 70 FlexPen Pen cap
NovoMix® 70 FlexPen® G atu tal- pinna
12 Glass Cartridge Residual
Membrana tal- gomma
Protective
Si ill protettiv
needle cap needle cap
G atu l- kbir ta ’ barra tal - labra
tab
G atu ta ’ ewwa tal - labra
Preparing your NovoMix 70 FlexPen
Kif tipprepara NovoMix 70 FlexPen tieg ek
117 Pull off the pen cap.
Ne i l- g atu tal- pinna.
• Always check there are at least 12 units of insulin left in the cartridge to allow resuspension.
122 • Dejjem i ekkja li jkun fadal mill- anqas 12- il unità ta' insulina fl- iskarto biex tippermetti li ter a ’ ssir is- suspensjoni.
G
123 G
119 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.
H 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
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.
124 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.
L
125 L
What is NovoNorm?
X' inhu NovoNorm?
NovoNorm is a medicine that contains the active substance repaglinide.
NovoNorm huwa mediċina li fiha s- sustanza attiva repaglinide.
It is available as round tablets (white:
Huwa disponibbli f' pilloli tondi (bojod:
0.5 mg; yellow:
0. 5 mg; sofor:
1 mg; peach:
1 mg; lewn il- ħawħ:
What is NovoNorm used for?
Għal xiex jintuża NovoNorm?
NovoNorm is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Novonorm jintuża fit- trattament ta 'pazjenti adulti li jbatu mid- dijabete tat- tip 2 (dijabete mhux dipendenti mill- insulina).
It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Jintuża flimkien ma ’ dieta u eżerċizzju biex ibaxxi l- livell ta ’ glukożju (zokkor) fid- demm f’ pazjenti li jkollhom ipergliċemija (livelli għoljin ta ’ glukożju fid- demm) li ma tkunx tista ’ tiġi kkontrollata minn dieta, tnaqqis fil- piż u eżerċizzju.
NovoNorm may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
NovoNorm jista ’ jintuża wkoll mal- metformina (mediċina oħra kontra d- dijabete) f’ pazjenti b’ dijabete tat- tip 2 li jkollhom livelli ta ’ glukożju fid- demm li ma jkunux ikkontrollati biżżejjed bl- użu tal- metformina waħedha.
How is NovoNorm used?
Kif jintuża NovoNorm?
NovoNorm is taken before meals, normally up to 15 minutes before each main meal.
NovoNorm jingħata qabel l- ikel, is- soltu sa 15- il minuta qabel kull ikla prinċipali.
The dose is adjusted to give the best control.
Id- doża hija aġġustata sabiex tagħti l- aqwa kontroll.
A doctor should regularly test the patient ’ s blood glucose to find the lowest effective dose.
Tabib għandu jittestja l- glukożju fid- demm tal- pazjent regolarment biex isib id- doża effikaċi l- iktar baxxa.
NovoNorm can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
NovoNorm jista ’ jintuża wkoll għal pazjenti b’ dijabete tat- tip 2 li l- livelli ta ’ glukożju fid- demm tagħhom is- soltu jiġu kkontrollati sew b’ dieta, iżda li qegħdin jitilfu kontroll tal- glukożju fid- demm għal perjodu temporanju.
The recommended starting dose is 0.5 mg.
Id- doża tal- bidu rakkomandata hija 0. 5 mg.
This dose may need to be increased after one or two weeks.
Jista ’ jkun li din id- doża jkollha tiżdied wara ġimgħa jew ġimagħtejn.
If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
Jekk pazjenti qalbu minn mediċina kontra d- dijabete oħra, id- doża inizjali rakkomandata hija 1 mg.
NovoNorm is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
NovoNorm mhux rakkomandat sabiex jintuża f’ pazjenti ta ’ inqas minn 18- il sena minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja f’ dan il- grupp.
How does NovoNorm work?
Kif jaħdem NovoNorm?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Id- dijabete tat- tip 2 hija marda li minħabba fiha, il- frixa (pankreas) ma tipproduċix biżżejjed insulina biex tikkontrolla l- livell ta 'glukożju fid- demm jew meta l- ġisem ma jkunx jista' juża l- insulina b' mod effikaċi.
NovoNorm helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
NovoNorm jgħin lill- frixa tipproduċi iktar insulina f’ ħin l- ikel u jintuża biex jikkontrolla dijabete tat- tip 2.
The main studies compared NovoNorm with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide).
L- istudji ewlenin qabblu NovoNorm ma ’ mediċini oħra użati f’ dijabete tat- tip 2 (glibenclamide, glipizide jew gliclazide).
Another study looked at the effect of adding NovoNorm to metformin.
Studju ieħor ħares lejn l- effett taż- żieda ta ’ NovoNorm ma ’ metformin.
The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
Dan il - livell jagħti indikazzjoni ta ’ kemm hu kkontrollat tajjeb il- glukożju fid- demm.
What benefit has NovoNorm shown during the studies?
Liema benefiċċju wera NovoNorm waqt l- istudji li twettqu?
In all studies, NovoNorm led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines.
Fl- istudji kollha, NovoNorm wassal għal tnaqqis fil- livell ta ’ HbA1c, li wera li l- livelli tal- glukożju fid- demm ġew ikkontrollati għal livell simili għal dak misjub fil- mediċini ta ’ tqabbil.
In the study where NovoNorm was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
Fl- istudju fejn NovoNorm ġie miżjud mal- metformina, l- effetti taż- żewġ mediċini kienu talanqas addittivi (ekwivalenti għall- effetti taż- żewġ mediċini mħalltin flimkien).
NovoNorm produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal.
NovoNorm ipproduċa rispons tajjeb ta ’ insulina għal ikla fi żmien 30 minuta minn meta ngħata lil pazjenti b’ dijabete tat- tip 2, li wassal għal tnaqqis tal- glukożju fid- demm matul l- ikla.
The raised insulin levels returned to normal after the meal.
Il- livelli ta ’ insulina li kienu telgħu, reġgħu għan- normal wara l- ikla.
What is the risk associated with NovoNorm?
X’ inhu r- riskju assoċjat ma ’ NovoNorm?
The most common side effects with NovoNorm (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea.
L- effetti sekondarji l- iktar komuni b’ NovoNorm (li dehru f’ bejn 1 u 10 pazjenti minn kull 100) huma ipogliċemija (livelli baxxi ta ’ glukożju fid- demm), uġigħ addominali (taż- żaqq) u dijarrea.
For the full list of all side effects reported with NovoNorm, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b' NovoNorm, ara l- Fuljett ta ’ Tagħrif.
NovoNorm should not be used in people who may be hypersensitive (allergic) to repaglinide or any of the other ingredients.
NovoNorm m’ għandux jintuża f’ persuni ipersensittivi (allerġiċi) għal repaglinide jew għal xi ingredjenti oħra tiegħu.
It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘ C-peptide ’ in their blood (a marker of type 1 diabetes).
M’ għandux jintuża wkoll f’ pazjenti b’ dijabete tat- tip 1 (dipendenti fuq l - insulina) li ma jkollhomx ‘ C- peptide ’ fid- demm (indikatur ta ’ dijabete tat- tip 1).
It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels).
M’ għandux jintuża wkoll f’ pazjenti b’ ketoaċidożi dijabetika (livelli għoljin ta ’ ketoni [aċidi] fid- demm), f’ pazjenti bi problemi severi fil- fwied jew f’ pazjenti li jkunu qegħdin jieħdu wkoll gemfibrozil (mediċina użata biex tnaqqas il- livelli ta ’ xaħam fid- demm).
NovoNorm doses may also need to be adjusted when given with some medicines used in heart conditions, and to treat pain, asthma and other conditions.
Jista ’ jkun li jiġu aġġustati d- dożi ta ’ NovoNorm meta jingħata ma ’ xi mediċini użati f’ kondizzjonijiet tal- qalb, u biex jittrattaw l- uġigħ, ażma u kondizzjonijiet oħra.
The full list of these medicines is available in the Package Leaflet.
Il- lista sħiħa ta ’ dawn il- mediċini tista ’ tiġi kkonsultata fil- Fuljett ta ’ Tagħrif.
Why has NovoNorm been approved?
Għaliex ġie approvat NovoNorm?
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoNorm’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li NovoNorm għandu iktar benefiċċji milli riskji fit- trattament tad- dijabete tat- tip 2.
The Committee recommended that NovoNorm be given marketing authorisation.
Il- Kumitat irrakkomanda li NovoNorm jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about NovoNorm:
Tagħrif ieħor dwar NovoNorm:
The European Commission granted a marketing authorisation valid throughout the European Union for NovoNorm to Novo Nordisk A/ S on 17 August 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal NovoNorm lil Novo Nordisk A/ S fis- 17 ta ’ Awwissu 1998.
The marketing authorisation was renewed on 17 August 2003 and on 17 August 2008.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fis- 17 ta ’ Awwissu 2003 u fis- 17 ta ’ Awwissu 2008.
The full EPAR for NovoNorm is available here.
L- EPAR sħiħ dwar NovoNorm jista ’ jiġi kkonsultat hawn.
NovoNorm 0.5 mg tablets
NovoNorm 0. 5 mg pilloli
Each tablet contains 0.5 mg of repaglinide.
0. 5 mg ta ’ repaglinide
Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull).
Il- pilloli ta ’ repaglinide huma bojod, tondi u konvessi u inċiżi bil- logo Novo Nordisk (Apis bull).
Repaglinide is indicated in patients with type 2 diabetes (Non Insulin-Dependent Diabetes Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.
Repaglinide huwa indikat f' pazjenti li għandhom id- dijabete tat- tip 2 (Dijabete Mellitus li mhux Dipendenti fuq l- insulina (NIDDM)) fejn l- ipergliċemija tagħhom ma tistax tiġi kkontrollata b' mod aktar sodisfaċenti b' dieta, bi tnaqqis fil- piż u b' eżerċizzju.
Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Repaglinide huwa wkoll indikat flimkien ma 'metformin f' pazjenti li għandhom id- dijabete tat- tip 2 li m' humiex ikkontrollati b' mod sodisfaċenti b’ metformin biss.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Il- kura għandha tinbeda bħala żieda mad- dieta u l- eżerċizzju biex jitbaxxa l- glucose fid- demm li jkun ġej mill- ikel.
Repaglinide is given preprandially and is titrated individually to optimise glycaemic control.
Repaglinide jingħata qabel l- ikel u d- doża tiegħu tiġi kkalkulata individwalment biex ikun hemm l - aħjar kontroll gliċemiku.
In addition to the usual self-monitoring by the patient of blood and/ or urinary glucose, the patient ’ s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Flimkien mas- soltu monitoraġġ tal- glucose fid- demm u/ jew fl- awrina min - naħa tal- pazjent stess, kull tant żmien, il- glucose fid- demm tal- pazjent għandu jiġi ċċekkjat mit- tabib biex tiġi determinata l- inqas doża effettiva għall- pazjent.
Glycosylated haemoglobin levels are also of value in monitoring the patient’ s response to therapy.
Il- livelli ta 'l- emoglobina glikosilata jistgħu wkoll jiġu użati biex jiġi eżaminat ir- rispons tal- pazjent għat- terapija.
Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i. e. primary failure) and to detect loss of adequate blood glucose- lowering response after an initial period of effectiveness (i. e. secondary failure).
Monitoraġġ perjodiku huwa neċessarju biex jiġu identifikati dawk il- każijiet fejn ma jkunx hemm tnaqqis adegwat fil- livelli tal - glucose fid- demm minkejja li tkun nghatat l- ogħla doża rakkomandata (jiġifieri falliment primarju) u biex jiġu identifikati dawk il- każijiet fejn ikun hemm nuqqas fil- kapaċità li jiġi kkontrollat b’ mod adegwat il- livell ta’ glucose fid- demm wara perijodu inizjali ta 'effikaċja (jiġifieri falliment sekondarju).
Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic patients usually controlled well on diet.
It- teħid ta ’ repaglinide għal żmien qasir jista 'jkun biżżejjed waqt perijodi ta ’ nuqqas temporanju fil - kontroll tal- livelli tal- glucose fid- demm f' pazjenti li għandhom id- dijabete tat- tip 2 li s- soltu tiġi kkontrollata tajjeb b' dieta.
Repaglinide should be taken before main meals (i. e. preprandially).
Repaglinide għandu jittieħed qabel l- ikliet prinċipali.
Doses are usually taken within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal (i. e. preprandially 2, 3, or 4 meals a day).
Normalment id- dożi jittieħdu fiż- żmien 15- il minuta qabel l- ikel iżda l- ħin jista ’ jvarja minn eżatt qabel l- ikel sa daqs 30 minuta qabel l- ikel (jiġifieri qabel 2, 3 jew 4 ikliet kuljum).
Patients who skip a meal (or add an extra meal) should be instructed to skip (or add) a dose for that meal.
Pazjenti li jaqbżu ikla (jew jieħdu ikla żejda) għandhom jiġu mgħarrfa biex jaqbżu (jew jżidu) doża għal dik l- ikla.
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess the dosage.
F’ każ ta ’ użu fl- istess ħin ta ’ sustanzi attivi oħra irreferi għal sezzjonijiet 4. 4 u 4. 5 biex tiċċekkja d - dożaġġ.
Initial dose The dosage should be determined by the physician, according to the patient’ s requirements.
2 Doża inizjali Id- doża għandha tiġi determinata mit- tabib, skond il- ħtiġijiet tal- pazjent.
The recommended starting dose is 0.5 mg.
Huwa rakkomandat li l- kura għandha tibda b’ doża ta ’ 0. 5 mg.
If patients are transferred from another oral hypoglycaemic agent the recommended starting dose is
Bejn il- perijodi ta ’ aġġustament fid - doża għandhom jgħaddu minn ġimgħa sa ġimagħtejn (kif determinat mir- rispons gliċemiku).
2 1 mg.
Jekk pazjenti jiġu trasferiti minn sustanza orali oħra li tbaxxi l- livell ta ’ glucose fid- demm, huwa rakkomandat li l- kura għandha tibda b’ doża ta ’ 1 mg.
Maintenance The recommended maximum single dose is 4 mg taken with main meals.
Manteniment Il- massimu ta ’ doża waħda rakkomandata hija 4 mg meħuda ma 'ikliet prinċipali.
The total maximum daily dose should not exceed 16 mg.
Id- doża massima ta 'kuljum m' għandhiex tkun aktar minn 16 mg.
Specific patient groups Repaglinide is primarily excreted via the bile and excretion is therefore not affected by renal disorders.
Gruppi ta 'pazjenti speċifiċi Repaglinide jiġi eliminat primarjament permezz tal- bile u għalhekk l- eliminazzjoni ma tiġix affettwata minn disturbi renali.
Eight percent of one dose of repaglinide is excreted through the kidneys and total plasma clearance of the product is decreased in patients with renal impairment.
Tmienja fil- mija ta ’ doża waħda ta ’ repaglinide tiġi eliminata mill- kliewi u t- tneħħija totali tal- prodott mill- plażma jonqos f' pazjenti li għandhom indeboliment renali.
As insulin sensitivity is increased in diabetic patients with renal impairment, caution is advised when titrating these patients.
Minħabba li s- sensittività għall - insulina togħla f' pazjenti dijabetiċi b’ indeboliment renali, huwa importanti li f’ dawn il- pazjenti l - aġġustament fid- doża jsir b’ attenzjoni.
No clinical studies have been conducted in patients > 75 years of age or in patients with hepatic insufficiency (see section 4.4).
(ara sezzjoni 4. 4).
Repaglinide is not recommended for use in children below age 18 due to a lack of data on safety and/ or efficacy.
Minħabba n- nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja, Repaglinide mhux rakkomandat għall- użu fit- tfal taħt it- 18- il sena.
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful dose titration is required to avoid hypoglycaemic reactions.
F' pazjenti indeboliti jew neqsin minn ikel sustanzjuż id- doża inizjali u ta 'manteniment għandha tkun konservattiva u l- aġġustament fid- doża għandu jsir b' attenzjoni sabiex jiġu evitati reazzjonijiet ipogliċemiċi.
Patients receiving other oral hypoglycaemic agents (OHAs) Patients can be transferred directly from other oral hypoglycaemic agents to repaglinide.
Pazjenti li qed jieħdu sustanzi ipogliċemiċi orali oħra (OHAs) Pazjenti jistgħu jiġu trasferiti direttament minn sustanzi ipogliċemiċi orali oħra għal repaglinide.
However, no exact dosage relationship exists between repaglinide and the other oral hypoglycaemic agents.
Madankollu, ma teżistix relazzjoni eżatta fid- dożaġġ bejn repaglinide u sustanzi oħra ipogliċemiċi li jittieħdu mill- ħalq.
The recommended maximum starting dose of patients transferred to repaglinide is 1 mg given before main meals.
Fil- bidu tal- kura d- doża massima rakkomandata għall- pazjenti trasferiti għal repaglinide hija ta ’ 1 mg mogħtija qabel l- ikliet prinċipali.
Repaglinide can be given in combination with metformin, when the blood glucose is insufficiently controlled with metformin alone.
Repaglinide jista 'jingħata flimkien ma' metformin, meta l- glucose fid- demm ma jkunx ikkontrollat b' mod suffiċjenti b’ metformin waħdu.
In this case, the dosage of metformin should be maintained and repaglinide administered concomitantly.
F' dan il- każ, id- doża ta 'metformin għandha tibqa ’ l- istess u repaglinide għandu jittieħed miegħu.
The starting dose of repaglinide is 0.5 mg, taken before main meals; titration is according to blood glucose response as for monotherapy.
Fil- bidu tal- kura d- doża ta ’ repaglinide hija ta ’ 0. 5 mg, meħuda qabel l- ikliet prinċipali; l- aġġustament fid- doża għandu jsir skond ir- rispons gliċemiku bħal ma jsir meta repaglinide jingħata waħdu.
• Hypersensitivity to repaglinide or to any of the excipients in NovoNorm • Type 1 diabetes (Insulin-Dependent Diabetes Mellitus:
• Sensittività eċċessiva għal repaglinide jew għal xi sustanzi mhux attivi ta ’ NovoNorm. • Dijabete tat- tip 1 (Dijabete Mellitus li Tiddependi fuq l- insulina:
IDDM), C-peptide negative • Diabetic ketoacidosis, with or without coma • Severe hepatic function disorder • Concomitant use of gemfibrozil (see section 4.5).
IDDM), C- peptide negattiv • Ketoaċidożi dijabetika, b' koma jew mingħajr koma. • Problemi serji fil- funzjoni tal- fwied • Użu konkomitanti ta 'gemfibrozil (ara sezzjoni 4. 5)
General Repaglinide should only be prescribed if poor blood glucose control and symptoms of diabetes persist despite adequate attempts at dieting, exercise and weight reduction.
Ġenerali Għandha tinkiteb riċetta għal repaglinide biss jekk minkejja tentattivi adegwati ta 'dieta, eżerċizzju u tnaqqis fil- piż, jippersistu kemm kontroll gliċemiku fqir kif ukoll sintomi tad- dijabete.
Repaglinide like other insulin secretagogues, is capable of producing hypoglycaemia.
Repaglinide bħas- sustanzi l- oħra li jikkawżaw is- sekrezzjoni ta ’ l- insulina, jista 'jikkawża ipogliċemija.
The blood glucose-lowering effect of oral hypoglycaemic agents decreases in many patients over time.
3 L- effett ta 'sustanzi ipogliċemiċi, orali, li jbaxxu l- glucose fid- demm maż- żmien jonqos f' ħafna pazjenti.
This may be due to progression of the severity of the diabetes or to diminished responsiveness to the product.
Dan jista 'jigri jew minħabba li d- dijabete issir iżjed gravi jew minħabba tnaqqis fir- rispons għall- mediċina.
This phenomenon is known as secondary failure, to distinguish it from primary failure, where the drug is ineffective in an individual patient when first given.
Dan il- fenomenu huwa magħruf bħala falliment sekondarju biex jiġi distint minn falliment primarju, fejn il- mediċina ma tkunx effettiva f' pazjent individwali mill- ewwel darba li tingħata.
Adjustment of dose and adherence to diet and exercise should be assessed before classifying a patient as a secondary failure.
Qabel ma pazjent jiġi kklassifikat bħala falliment sekondarju, għandha tiġi aġġustata d- doża u wieħed għandu jivverifika li l- pazjent kien qed josserva d- dieta u jagħmel l- eżerċizzju.
Repaglinide acts through a distinct binding site with a short action on the β -cells.
Repaglinide jaġixxi permezz ta ’ sit speċifiku ta ’ rabta b' azzjoni qasira fuq ċ- ċelloli β.
Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
L- użu ta ’ repaglinide f' każ ta 'falliment sekondarju għal sustanzi li jikkawżaw s- sekrezzjoni ta ’ l- insulina ma ġiex investigat fi studji kliniċi.
Trials investigating the combination with other insulin secretagogues and acarbose have not been
Ma sarux studji kliniċi li jinvestigaw t- teħid tal- prodott flimkien ma 'prodotti oħra li jikkawżaw s- sekrezzjoni ta ’ l- insulina u ma ’ acarbose.
Trials of combination therapy with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones have been performed.
Ġew magħmula studji ta 'terapija kombinata ma' insulina Neutral Protamine Hagedorn (NPH) jew ma ’ thiazolidinediones.
However, the benefit risk profile remains to be established when comparing to other combination therapies.
Madankollu l- profil tal- benefiċċju riskju għad irid jiġi stabbilit meta mqabbel ma ’ terapiji kombinati oħra.
Combination treatment with metformin is associated with an increased risk of hypoglycaemia.
Kura bil- prodott flimkien ma 'metformin hija assoċjata ma' żieda fir- riskju ta 'ipogliċemija.
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Meta pazjent stabbilizzat fuq xi sustanza ipogliċemika orali jiġi espost għal xi tip ta ’ strss bħal deni, trawma, infezzjoni jew kirurġija, jista 'jkun hemm telf fil- kontroll gliċemiku.
At such times, it may be necessary to discontinue repaglinide and treat with insulin on a temporary basis.
Meta jiġri hekk, jista 'jkun neċessarju illi jitwaqqaf repaglinide u tikkura b' insulina fuq bażi temporanja.
The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e. g. myocardial infarction) (see sections 4.8 and 5.1).
L- użu ta ’ repaglinide jista ’ jkun assoċjat ma ’ żieda fl- inċidenza tas- sindromu koronarju akut (eż. infart mijokardjali). (ara sezzjonijiet 4. 8 u 5. 1).
Concomitant use Repaglinide should be used with caution or be avoided in patients receiving drugs which influence repaglinide metabolism (see section 4.5).
Użu konkomitanti Repaglinide għandu jintuża b’ kawtela jew jiġi evitat f’ pazjenti li qed jirċievu mediċini li jaffettwaw il - metaboliżmu ta ’ repaglinide (ara sezzjoni 4. 5).
If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.
Jekk l- użu fl- istess ħin ikun meħtieġ, għandu jsir monitoraġġ bir- reqqa tal- glucose fid- demm u monitoraġġ kliniku mill- qrib.
Specific patient groups No clinical studies have been conducted in patients with impaired hepatic function.
Gruppi ta 'pazjenti speċifiċi Ma sarux studji kliniċi fuq pazjenti li għandhom indeboliment fil- funzjoni epatiku.