qanastek/EMEA-V3 huggingface dataset:
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Dawn ir - reazzjonijiet għall- insulina jew għas- sustanzi mhux attivi jistgħu jwasslu għal reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq
Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients) • Oedema Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles. • Injection site reactions
649 Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi • Reazzjonijiet fis- sit ta ’ l- injezzjoni
647 Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema, shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
• Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
HOW TO STORE INSULIN HUMAN WINTHROP COMB 25
KIF TAĦŻEN INSULIN HUMAN WINTHROP COMB 15
Do not use Insulin Human Winthrop Comb 25 after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insulin Human Winthrop Comb 25 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta tal- kunjett.
Do not put Insulin Human Winthrop Comb 25 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 25 m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
Opened vials Once in-use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
650 Kunjetti miftuħa Ġaladarba fl- użu, il- kunjett jista ’ jinħażen sa massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ fil- kartuna ta ’ barra u ’ l bogħod mis- sħana diretta (eż. viċin apparat li jitfa ’ s- sħana) jew mid - dawl dirett (dawl tax- xemx dirett jew viċin lampa).
Ask your pharmacist how to dispose of mediciens no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What Insulin Human Winthrop Comb 25 contains
X’ fih Insulin Human Winthrop Comb 25
One ml of Insulin Human Winthrop Comb 25 contains
Millilitru wieħed ta ’ Insulin Human Winthrop Comb 25 fih
25% of the insulin is dissolved in water; the other 75% is present as tiny crystals of insulin protamine.
25% ta ’ l- insulina hija maħlula fl- ilma; il- 75% l- oħra hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
What Insulin Human Winthrop Comb 25 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 25 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Comb 25 u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Comb 25 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Insulin Human Winthrop Comb 25 is supplied in vials containing 5 ml suspension (500 IU).
Insulin Human Winthrop Comb 25 huwa fornut f’ kunjetti ta ’ 5 ml ta ’ suspensjoni (500 IU).
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
651 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
652 IPERGLIĊEMIJA U IPOGLIĊEMIJA
Hypoglycaemia is also more likely to occur if:
653 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
654 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
652 PACKAGE LEAFLET:
655 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 25 40 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Comb 25 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
The insulin contained in Insulin Human Winthrop Comb 25 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Comb 25 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Do not use it in insulin pumps or other infusion pumps – special insulin preparations are available for use in such devices.
Tużaħx f’ pompi ta ’ l- insulina jew pompi oħra għall- infuzzjoni - hemm preparazzjonijiet apposta ta ’ insulina disponibbli għall- użu ma ’ dan l- apparat.
653 Travel
656 Safar
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti - kundizzjonijiet
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),
- pentoxifylline, propoxyphene, salicylates (bħall- aspirina, użata biex ittaffi l- uġigħ u tbaxxi d- deni)
655 3.
658 3.
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop
- jgħidlek meta j għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop
Insulin Human Winthrop Comb 25 contains 40 IU insulin per ml.
Insulin Human Winthrop Comb 25 fih 40 IU insulina kull millilitru.
Insulin Human Winthrop Comb 25 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
659 Insulin Human Winthrop Comb 25 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l - insulina.
656 Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- aventis.
If you use more Insulin Human Winthrop Comb 25 than you should
Jekk tuża Insulin Human Winthrop Comb 25 aktar milli suppost
If you forget to use Insulin HumaWinthrop Comb 25
Jekk tinsa tuża Insulin Human Winthrop Comb 25
Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients) • Oedema Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles. • Injection site reactions
660 Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi
657 Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema, shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
• Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
Opened vials Once in-use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
661 Ġaladarba fl- użu, il- kunjett jista ’ jinħażen sa massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ fil- kartuna ta ’ barra u ’ l bogħod mis- sħana diretta (eż. viċin apparat li jitfa ’ s- sħana) jew mid - dawl dirett (dawl tax- xemx dirett jew viċin lampa).
Insulin Human Winthrop Comb 25 is supplied in vials containing 10 ml suspension (400 IU).
Insulin Human Winthrop Comb 25 huwa fornut f’ kunjetti ta ’ 10 ml ta ’ suspensjoni (400 IU).
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
662 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
663 IPERGLIĊEMIJA U IPOGLIĊEMIJA
660 Warning symptoms of hyperglycaemia
Sintomi ta ’ twissija ta ’ ipergliċemija
Hypoglycaemia is also more likely to occur if:
664 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
661 The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
L- ewwel sintomi li jagħtuk indikazzjoni li ser tiżviluppa l- ipogliċemija (“ sintomi ta ’ twissija ”) jistgħu jinbidlu, jiddgħajfu jew ikunu nieqsin għal kollox, jekk:
Tell your relatives, friends and close colleagues the following:
665 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
662 PACKAGE LEAFLET:
666 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a cartridge Insulin human
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
The instructions for using the insulin pen are provided with your insulin pen.
L- istruzzjonijiet dwar l- użu tal - pinna ta ’ l- insulina huma pprovduti mal- pinna ta ’ l- insulina tiegħek.
Do not pass it on to others.
- Din il- mediċina ġiet mogħtija M’ għandekx tgħaddiha lil persuni oħra.
Insulin Human Winthrop Comb 25 is an insulin preparation with a gradual onset and long duration of action.
Insulin Human Winthrop Comb 25 huwa preparat ta ’ l- insulina li jibda jaħdem bilmod u jdum jaħdem għal żmien twil..
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
667 Gruppi speċjali ta ’ pazjenti Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
Important information about some of the ingredients of Insulin Human Winthrop Comb 25
669 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 25
Special care before injection
670 Attenzjoni speċjali qabel l- injezzjoni
666 Problems with the pen?
Diffikultajiet bil- pinna?
However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Madankollu, uża biss dawk is- siringi li huma magħmulin għall- qawwa ta ’ preparat ta ’ insulina ta ’ 100 IU (Unita Internazzjonali) kull millilitru.
If you use more Insulin Human Winthrop Comb 25 than you should
Żbalji fid- dożaġġ Jekk tuża Insulin Human Winthrop Comb 25 aktar milli suppost
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
671 fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq.
667 Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients) • Severe allergic reaction with low blood pressure (shock) • Injection site urticaria (itchy rash)
Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema, shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
• Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
HOW TO STORE INSULIN HUMAN WINTHROP COMB 25
KIF TAĦŻEN INSULIN HUMAN WINTHROP COMB 25
Do not use Insulin Human Winthrop Comb 25 after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insulin Human Winthrop Comb 25 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta ta ’ l- iskartoċċ.
In-use cartridges Cartridges in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
672 Skartoċċi fl- użu Skartoċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux ‘ il fuq minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
The cartridge in-use must not be stored in a refrigerator.
L- iskartoċċ fl- użu m’ għandux jinżamm fi friġġ.
What Insulin Human Winthrop Comb 25 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 25 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Comb 25 u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Comb 25 huwa likwidu uniformi jixbaħ il- ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insulin Human Winthrop Comb 25 is supplied in cartridge containing 3 ml suspension (300 IU).
Insulin Human Winthrop Comb 25 huwa fornut f’ skartoċċi li fihom 3 ml ta ’ suspensjoni (300 IU).
Packs of 3, 4, 5, 6, 9 and 10 cartridges of 3 ml are available.
Issibu f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi ta ’ 3 ml.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
673 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
674 IPERGLIĊEMIJA U IPOGLIĊEMIJA
670 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
675 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
671 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
Tell your relatives, friends and close colleagues the following:
676 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
672 PACKAGE LEAFLET:
677 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal - lest Insulina umana
Read all of this leaflet carefully, including the Instructions for Use of Insulin Human Winthrop Comb 25, pre-filled pen, OptiSet, before you start using this medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet għall- użu ta ’ Insulin Human Winthrop Comb 25, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
Do not pass it on to others.
M’ għandekx tghaddiha lil persuni oħra.
Insulin Human Winthrop Comb 25 is a fluid (suspension) for injection under the skin.
Insulin Human Winthrop Comb 25 Optiset huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
It comes in cartridges sealed in disposable pen injectors; OptiSet.
Dan jiġi fornut f’ skartoċċi issiġillat, li hija l- parti li tintrema, ta’ OptiSet, pinna ta ’ l- insulina.
Take special care with Insulin Human Winthrop Comb 25
Oqgħod attent ħafna b’ Insulin Human Winthrop
673 Travel
678 Safar
675 3.
680 3.
See the box at the end of this leaflet for further information.
Ara l- informazzjoni f’ kaxxa li ssib fi tmiem ta ’ dan il- fuljett 4 għal aktar dettalji
Insulin Human Winthrop Comb 25 comes in cartridges sealed in disposable pen injectors, OptiSet.
Insulin Human Winthrop Comb 25 huwa fornut f’ skartoċċi ssiġillati f’ pinen għall- injezzjoni, OptiSet, li jintremew wara li jinħlew.
To prevent the possible transmission of disease, each pen must be used by one patient only.
681 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
676 Special care before injection
Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Comb 25, pre -filled pen, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Comb 25, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
enough insulin, your blood sugar level may become too high (hyperglycaemia).
insulina, il- livell tiegħek taz- zokkor fid- demm jista ’ jogħla wisq (ipergliċemija)..
If you stop using Insulin Human Winthrop Comb 25 This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Comb 25 Dan jista ’ jwassal għall- ipergliċemija severa (zokkor għoli ħafna fid- demm) u l- ketoaċidożi (jakkumula livell għoli t’ aċidu fid- demm għax il- ġisem qiegħed jutiliżża x- xaħam minflok iz- zokkor bħala sors t’ enerġija).
Do not stop Insulin Human Winthrop Comb 25 without speaking to a doctor, who will tell you what needs to be done.
Twaqqafx Insulin Human Winthrop Comb 25 mingħajr ma tkellem tabib, li mbagħad jgħidlek x’ għandu jsir.
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Dawn ir - reazzjonijiet għall- insulina jew għas- sustanzi mhux attivi jistgħu jwasslu għalreazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq..
Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients) • Oedema Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles. • Injection site reactions
682 Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi • Reazzjonijiet fis- sit ta ’ l- injezzjoni
677 Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients) • Severe allergic reaction with low blood pressure (shock) • Injection site urticaria (itchy rash)
Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
Not in-use pens Store in a refrigerator (2°C – 8°C).
Pinen mhux fl- użu Aħżen fi friġġ (2°Ċ- 8°Ċ).
Do not put the pre -filled pen next to the freezer compartment or a freezer pack.
Tagħmilx il- pinna mimlija għal- lest viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
The pen in-use must not be stored in a refrigerator.Do not use the pen after this time period.
Tużahiex wara dan il- perijodu ta ’ żmien
What Insulin Human Winthrop Comb 25 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 25 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Comb 25 u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Comb 25 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni), mingħajr ċapep, partikuli jew trofof viżibbli.
Insulin Human Winthrop Comb 25 is supplied in pre-filled pens, OptiSet, containing 3 ml suspension, (300 IU).
Insulin Human Winthrop Comb 25 huwa fornut f’ pinen mimlija għal- lest, OptiSet, li fiha 3 ml ta ’ suspensjoni (300 IU).
Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available.
Issibu f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen ta ’ 3 ml.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
684 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
685 IPERGLIĊEMIJA U IPOGLIĊEMIJA
680 Warning symptoms of hyperglycaemia
Sintomi ta ’ twissija ta ’ ipergliċemija
Hypoglycaemia is also more likely to occur if:
686 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
681 The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
L- ewwel sintomi li jagħtuk indikazzjoni li ser tiżviluppa l- ipogliċemija (“ sintomi ta ’ twissija ”) jistgħu jinbidlu, jiddgħajfu jew ikunu nieqsin għal kollox, jekk:
Tell your relatives, friends and close colleagues the following:
687 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
682 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
683 Step 2.
2
keep
żomm
discard
armi
You may have to perform the safety test several times before insulin is seen. • If no insulin comes out, check for air bubbles and repeat the safety test two more times. • If still no insulin comes out, the needle may be blocked.
Għandu mnejn jkollok tagħmel it- test ta ’ sigurtà diversi drabi qabel ma titfaċċa l- insulina • Jekk ebda insulin ma titfaċċa, iċċekkja jekk hemmx bżieżaq ta ’ l- arja u erġa ’ irrepeti t- test ta ’ sigurtà darbtejn oħra. • Jekk xorta ma toħroġx l- insulina, il- labra tista ’ tkun miżduda.
Change the needle and try again. • If no insulin comes out after changing the needle, your OptiSet may be damaged.
Biddel il- labra u erġa ’ ipprova. • Jekk ebda l- insulina ma toħroġ wara li tibdel il- labra, l- OptiSet tiegħek tista ’ tkun bil- ħsara.
• The residual insulin scale on the transparent insulin reserv oir shows approximately how much insulin remains in the OptiSet.
• L- iskala li turi kemm fadal insulina fuq ir- riżervwar trasparenti ta ’ l- insulina turik bejn wieħed u ieħor kemm fadal insulina fl- OptiSet.
if you have selected 12 units you can inject your dose. if you have selected more than 12 units then only 12 units of your total insulin dose can be injected with this pen.
691 o jekk int għażilt 12- il Unità tista ’ tinjetta d- doża tiegħek. o Jekk int għażilt aktar minn 12- il Unità allura 12- il Unità biss mid- doża sħiħa tiegħek ta ’ l - insulina tista ’ tkun injettata b’ din il- pinna.
B.
692 B.
Please check section 5 – How to store Insulin Human Winthrop Comb 25 - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insulin Human Winthrop Comb 25 - fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
687 Maintenance
Manutenzjoni
• Difference is more than 2 units.
693 M’ hemmx biżżejjed insulina fir- riżervwar.
689 PACKAGE LEAFLET:
694 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
Take special care with Insulin Human Winthrop Comb 25
695 Oqgħod attent ħafna b’ Insulin Human Winthrop Comb 25
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
696 Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
If you are breast -feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Jekk int qed tredda ’, iddiskutiha mat- tabib tiegħek għax jista ’ jagħti l- każ li teħtieġ tibdiliet fid- dożi ta ’ l- insulina u d- dieta tiegħek.
How to handle the cartridges for OptiClik
Kif timmaniġġa l- skartoċċi għal OptiClik
Insulin Human Winthrop Comb 25 in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Comb 25 fi skartoċċi għal OptiClik kien żviluppat għall- użu f ’ OptiClik biss.
Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.
698 Dejjem uża skartoċċ ġdid jekk tinnota li l- kontroll tiegħek taz- zokkor fid- demm qiegħed bla mistenni jmur għall- agħar.
693 Problems with OptiClik?
Diffikultajiet b’ OptiClik?
If OptiClik does not function well, you can draw the insulin from the cartridge into an injection syringe for injection.
Jekk OptiClik mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ b’ siringa ta ’ l- injezzjoni u tinjettha.
However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Madankollu, uża biss dawk is - siringi li huma magħmulin għall- qawwa ta ’ preparat ta ’ insulina ta ’ 100 IU (Unitajiet Internazzjonali) kull millilitru.
If you usemore Insulin Human Winthrop Comb 25 than you should
Żbalji fid- dożaġġ Jekk tuża Insulin Human Winthrop Comb 25 aktar milli suppost
Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
699 ħsara fil- moħħ u tista ’ tkun fatali.
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Dawn ir - reazzjonijiet għall- insulina jew għas- sustanzi mhux attivi jistgħu jwasslu għal Reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq.
694 Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients) • Severe allergic reaction with low blood pressure (shock) • Injection site urticaria (itchy rash)
Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
Unopened cartridges Store in a refrigerator (2°C - 8°C).
700 Skartoċċi mhux miftuħa Aħżen fi friġġ bejn (2°Ċ- 8°Ċ).
Do not put Insulin Human Winthrop Comb 25 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 25 m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża..
In-use cartridges Cartridges in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Skartoċċi fl- użu Skartoċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux’ il fuq minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
Insulin Human Winthrop Comb 25 comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insulin Human Winthrop Comb 25 huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l - parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
Insulin Human Winthrop Comb 25 is supplied in cartridge for OptiClik containing 3 ml suspension (300 IU).
Insulin Human Winthrop Comb 25 huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ suspensjoni (300 IU).
Česká republika sanofi-aventis, s.r.o.
701 Česká republika sanofi- aventis, s. r. o.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
702 IPERGLIĊEMIJA U IPOGLIĊEMIJA
697 If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Jekk iz- zokkor f’ demmek huwa għoli wisq (ipergliċemija), għandu mnejn ma injettajtx biżżejjed insulina
- you r insulin pen does not work properly,
- int qiegħed tagħmel anqas eżerċizzju fiżiku mis- soltu, jew int qiegħed taħt stress (inkwiet,
Hypoglycaemia is also more likely to occur if:
703 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
698 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
Then eat something that has a long -acting effect in raising your blood sugar (such as bread or pasta).
Wara kul xi ħaġa li għandha effett fit- tul li tgħolli z- zokkor fid- demm (bħall- ħobż jew l- għaġin).
Tell your relatives, friends and close colleagues the following:
704 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
699 PACKAGE LEAFLET:
705 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insulin Human Winthrop Comb 25 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully, including the Instructions for Use of Insulin Human Winthrop Comb 25, pre-filled pen, SoloStar, before you start using this medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Insulin Human Winthrop Comb 25, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Comb 25.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insulin Human Winthrop Comb 25.
Take special care with Insulin Human Winthrop Comb 25
Oqgħod attent ħafna b’ Insulin Human Winthrop Comb 25:
Travel
706 Safar
700 Before travelling, consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tiegħek.
701 Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
Important information about some of the ingredients of Insulin Human Winthrop Comb 25
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insulin Human Winthrop Comb 25
3.
708 3.
- determine how much Insulin Human Winthrop Comb 25 per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insulin Human Winthrop Comb 25 kuljum,
702 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insulin Human Winthrop Comb 25 is injected under the skin 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 25 huwa injettat taħt il- ġilda 30 sa 45 minuta qabel ikla.
Do NOT inject Insulin Human Winthrop Comb 25 into a vein.
TINJETTAX l- Insulina Comb 25 fil- vina.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
709 Dejjem uża pinna ġdida jekk tinnota li l- kontroll taz- zokkor tiegħek fid- demm qiegħed imur għal agħar, bla mistenni.
Insulin Human Winthrop Comb 25, pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insulin Human Winthrop Comb 25, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
703 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have missed a dose of Insulin Human Winthrop Comb 25 or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Comb 25 jew ma injettajtx biżżejjed insulina,
Severe allergic reactions to insulin may occur which may become life-threatening.
710 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema, shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions
Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
Do not use Insulin Human Winthrop Comb 25 after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insulin Human Winthrop Comb 25 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta tal- pinna.
Not in -use pens Store in a refrigerator (2°C – 8°C).
711 Pinen mhux fl- użu Aħżen fi friġġ (2°Ċ- 8°Ċ).
705 Insulin Human Winthrop Comb 25 is supplied in pre-filled pens, SoloStar, containing 3 ml suspension, (300 IU).
Insulin Human Winthrop Comb 25 huwa fornut f’ pinen mimlija għal- lest, SoloStar, li fiha 3 ml ta ’ suspensjoni (300 IU).
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
712 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
713 IPERGLIĊEMIJA U IPOGLIĊEMIJA
707 Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
Ittestja l- livell taz- zokkor fid- demm tiegħek u fl- awrina tiegħek għall- ketoni hekk kif iseħħ xi wieħed mis- sintomi t’ hawn fuq.
Hypoglycaemia is also more likely to occur if:
714 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
708 In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem.
F’ dan il- kaz, tista ’ tiżviluppa ipogliċemija severa (u anki jħossok ħażin) qabel tintebaħ bil- problema.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
715 Huwa irrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l - glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
SoloStar.
Insulin Human Winthrop Comb 25, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
If you have any questions about SoloStar or about diabetes, ask your healthc are professional or call the local sanofi-aventis number on the front of this leaflet.
Jekk għandek xi diffikultajiet dwar l- użu ta ’ SoloStar jew id- dijabete tiegħek, saqsi lill- professjonist tiegħek fil- qasam tas- saħħa jew ċempel fuq in- numru lokali ta ’ Sanofi- Aventis, li ssib fuq il- faċċata ta ’ dan il- fuljett.
710 C.
Ċ.
B.
718 B.
712 • Do not push the injection button while turning, as insulin will come out.
• Timbuttax il- buttun ta ’ l- injezzjoni waqt li qed iddawwar, għax inkella l- insulina toħroġ.
• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Segwi l- miżuri irrakkomandati ta’ sigurtà
Follow recommended safety measures for removal and disposal of needles (e.g. contact your healthcare professional) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
719 għat- tneħħija u r- rimi tal- labar (e. ż. kellem lill- professjonist tiegħek fil- qasam tas- saħħa) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess xi mard infettiv.
713 Storage Instructions
Struzzjonijiet dwar il- ħażna
714 PACKAGE LEAFLET:
720 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 50 100 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
What Insulin Human Winthrop Comb 50 is and what it is used for 2.
X’ inhu Insulin Human Winthrop Comb 50 u għalxiex jintuża 2.
Before you use Insulin Human Winthrop Comb 50 3.
Qabel ma tuża Insulin Human Winthrop Comb 50 3.
How to use Insulin Human Winthrop Comb 50 4.
Kif għandek tuża Insulin Human Winthrop Comb 50 4.
How to store Insulin Human Winthrop Comb 50 6.
Kif taħżen Insulin Human Winthrop Comb 50 6.
WHAT INSULIN HUMAN WINTHROP COMB 50 IS AND WHAT IT IS USED FOR
X’ INHU INSULIN HUMAN WINTHROP COMB 50 U GĦALXIEX JINTUŻA
Insulin Human Winthrop Comb 50 is a fluid (suspension) for injection under the skin.
Insulin Human Winthrop Comb 50 huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il - ġilda.
The insulin contained in Insulin Human Winthrop Comb 50 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Comb 50 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insulin Human Winthrop Comb 50 is an insulin preparation with a rapid onset and moderately long duration of action.
Insulin Human Winthrop Comb 50 huwa preparat ta ’ l- insulina li jibda jaħdem malajr u jdum jaħdem għal żmien moderatament twil.
Insulin Human Winthrop Comb 50 is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Comb 50 huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil - pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSULIN HUMAN WINTHROP COMB 50
QABEL MA TUŻA INSULIN HUMAN WINTHROP COMB 50
Do not use Insulin Human Winthrop Comb 50
Tużax Insulin Human Winthrop Comb 50
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Comb 50.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insulin Human Winthrop Comb 50.
Do not inject Insulin Human Winthrop Comb 50 into a vein (blood vessel).
Tinjettax Insulin Human Winthrop Comb 50 ġewwa vina (sistema vaskulari).
Do not use it in insulin pumps or other infusion pumps – special insulin preparations are available for use in such devices.
Tużaħx f’ pompi ta ’ l - insulina jew pompi oħra għall- infuzzjoni - hemm preparazzjonijiet apposta ta ’ insulina disponibbli għall- użu ma ’ dan l- apparat.
Take special care with Insulin Human Winthrop Comb 50
Oqgħod attent ħafna b’ Insulin Human Winthrop Comb 50
715 Travel
721 Safar
Be fore travelling, consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tiegħek.
Using Insulin Human Winthrop Comb 50 with food and drink
Meta tuża Insulin Human Winthrop Comb 50 ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insulin Human Winthrop Comb 50 in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insulin Human Winthrop Comb 50 waqt it- tqala.
- you have hyperglycaemia (high blood sugar levels),
(livell għoli ta ’ zokkor fid- demm)
Important information about some of the ingredients of Insulin Human Winthrop Comb 50
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 50
717 3.
723 3.
HOW TO USE INSULIN HUMAN WINTHROP COMB 50
KIF GĦANDEK TUŻA INSULIN HUMAN WINTHROP COMB 50
- determine how much Insulin Human Winthrop Comb 50 per day you will need,
- jikkalkula kemm għandek bżonn Insulin Human Winthrop Comb 50 kuljum,
Comb 50.
Comb 50,
Insulin Human Winthrop Comb 50 is injected under the skin 20 to 30 minutes before a meal.
Insulin Human Winthrop Comb 50 huwa injettat taħt il- ġilda minn 20 sa 30 minuta qabel ikla.
Do NOT inject Insulin Human Winthrop Comb 50 into a vein.
TINJETTAX Insulin Human Winthrop Comb 50 ġewwa vina.
Insulin Human Winthrop Comb 50 contains 100 IU insulin per ml.
Insulin Human Winthrop Comb 50 fih 100 IU insulina kull millilitru.
Special care before injection
724 Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Comb 50 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
Insulin Human Winthrop Comb 50 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l - insulina.
718 Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- aventis.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insulin Human Winthrop Comb 50.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insulin Human Winthrop Comb 50.
If you use more Insulin Human Winthrop Comb 50 than you should
Żbalji fid- dożaġġ Jekk tuża Insulin Human Winthrop Comb 50 aktar milli suppost
- If you have injected too much Insulin Human Winthrop Comb 50, your blood sugar level
- Jekk injettajt aktar Insulin Human Winthrop Comb 50 milli meħtieġ, il- livell taz- zokkor
If you forget to use Insulin Human Winthrop Comb 50
Jekk tinsa tuża Insulin Human Winthrop Comb 50
- If you have missed a dose of Insulin Human Winthrop Comb 50 or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Comb 50 jew jekk ma injettajtx biżżejjed
If you stop using Insulin Human Winthrop Comb 50 This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Comb 50 Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Do not stop Insulin Human Winthrop Comb 50 without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insulin Human Winthrop Comb 50 mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insulin Human Winthrop Comb 50 can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insulin Human Winthrop Comb 50 jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients) • Oedema Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles. • Injection site reactions
725 Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi • Reazzjonijiet fis- sit ta ’ l- injezzjoni
719 Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema, shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
HOW TO STORE INSULIN HUMAN WINTHROP COMB 50
KIF TAĦŻEN INSULIN HUMAN WINTHROP COMB 50
Do not use Insulin Human Winthrop Comb 50 after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insulin Human Winthrop Comb 50 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta tal- kunjett.
Do not put Insulin Human Winthrop Comb 50 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 50 m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
Opened vials Once in use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Kunjetti miftuħa Ġaladarba fl- użu, il- kunjett jista ’ jinħażen sa massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ fil- kartuna ta ’ barra u ’ l bogħod mis- sħana diretta (eż. viċin apparat li jitfa ’ s- sħana) jew mid -
What Insulin Human Winthrop Comb 50 contains
X’ fih Insulin Human Winthrop Comb 50
One ml of Insulin Human Winthrop Comb 50 contains
Millilitru wieħed ta ’ Insulin Human Winthrop Comb 50 fih
50% of the insulin is dissolved in water; the other 50% is present as tiny crystals of insulin protamine.
50% ta ’ l- insulina hija maħlula fl- ilma; il- 50% l- oħra hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
What Insulin Human Winthrop Comb 50 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 50 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Comb 50 u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Comb 50 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Packs of 1 and 5 vials of 5 ml are available.
Insulin Human Winthrop Comb 50 huwa fornut f’ kunjetti ta ’ 5 ml ta ’ suspensjoni (500 IU). issibu f’ pakketti ta ’ kunjett wieħed u ta ’ 5 kunjetti ta ’ 5 ml.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
727 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
728 IPERGLIĊEMIJA U IPOGLIĊEMIJA
722 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
729 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar -sweetened beverage.
Immedjatament ħu madwar 10 sa 20 g zokkor, bħal glukosju, dadi taz - zokkor, jew xi xarba ħelwa li fiha z- zokkor.
Tell your relatives, friends and close colleagues the following:
730 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
724 PACKAGE LEAFLET:
731 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 50 40 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Comb 50 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
725 Travel
732 Safar
727 3.
734 3.
Insulin Human Winthrop Comb 50 contains 40 IU insulin per ml.
Insulin Human Winthrop Comb 50 fih 40 IU insulina kull millilitru.
Insulin Human Winthrop Comb 50 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
735 Insulin Human Winthrop Comb 50 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l - insulina.
728 Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- aventis.
- If you have injected too much Insulin Human Winthrop Comb 50, your blood sugar level
- Jekk injettajt aktar Insulin Human Winthrop Comb 50 milli meħtieġ,, il- livell taz- zokkor