qanastek/EMEA-V3 huggingface dataset:
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 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 50 without speaking to a doctor, who will tell you what needs to be done.
Twaqqafx Insulin Human Winthrop Comb 50 mingħajr ma tkellem tabib, li mbagħad jgħidlek x’ għandu jsir.
729 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.
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 - dawl dirett (dawl tax- xemx dirett jew viċin lampa).
It is recommended that the date of the first use be noted on the label.
Huwa rrakkomandat li d- data ta ’ l- ewwel użu titniżżel fuq it- tikketta
730 6.
737 6.
Packs of 1 and 5 vials of 10 ml are available.
Insulin Human Winthrop Comb 50 huwa fornut f’ kunjetti ta ’ 10 ml ta ’ suspensjoni (400 IU). Issibu f’ pakketti ta ’ kunjett wieħed u ta ’ 5 kunjetti ta ’ 10 ml.
731 España sanofi-aventis, S.A.
738 España sanofi- aventis, S. A.
732 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
733
740
734 PACKAGE LEAFLET:
741 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 50 100 IU/ml suspension for injection in a cartridge Insulin human
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
It comes in cartridges designed for use in an injection device of the OptiPen series.
Insulin Human Winthrop Comb 50 huwa preparat ta ’ l- insulina li jibda jaħdem malajr u jdum jaħdem għal żmien moderatament twil Huwa disponibbli f’ skartoċċi magħmulin għall- użu f’ sistema ta ’ injezzjoni fis- serje ta ’ l- OptiPen.
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
742 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 50
744 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 50
Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.
745 Dejjem uża skartoċċ ġdid jekk tinnota li l- kontroll tiegħek taz- zokkor fid- demm qiegħed bla mistenni jmur għall- agħar.
- Do not mix insulin with any other medicines.
- Terġax timla u terġa ’ tuża l- skartoċċi vojta
- Do not re-fill and re-use empty cartridges.
- Iżżidx xi insulina oħra fl- iskartoċċ.
- Do not add any other insulin to the cartridge.
- Tħallatx l- insulina ma ’ ebda mediċini oħra..
738 Problems with the pen?
Diffikultajiet bil- pinna?
If you forget to use Insulin HumaWinthrop Comb 50
Jekk tinsa tuża Insulin Human Winthrop Comb 50
Severe allergic reactions to insulin may occur which may become life-threatening.
746 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
739 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
Do not use Insulin Human Winthrop Comb 50 after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insulin Human Winthrop Comb 50 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta ta ’ l- iskartoċċ.
Unopened cartridges Store in a refrigerator (2°C - 8°C).
747 Skartoċċi mhux miftuħa Aħżen fi friġġ bejn (2°Ċ- 8°Ċ).
Do not put Insulin Human Winthrop Comb 50 next to the freezer compartment or a freezer pack.
Tpoġġix Insulin Human Winthrop Comb 25 viċin il- kumpartiment tal- friża jew maġenb pakk 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).
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 jixbaħ il- ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Packs of 3, 4, 5, 6, 9 and 10 cartridges of 3 ml are available.
Insulin Human Winthrop Comb 50 huwa fornut f’ skartoċċi ta ’ 3 ml ta ’ suspensjoni (300 IU). Issibu f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi ta ’ 3 ml.
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
749 IPERGLIĊEMIJA U IPOGLIĊEMIJA
742 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
750 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
743 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
Tell your relatives, friends and close colleagues the following:
751 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
744 PACKAGE LEAFLET:
752 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 50 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insulin Human Winthrop Comb 50 100 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 50, pre-filled pen, OptiSet, before you start using th is medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet għall- użu ta ’ Insulin Human Winthrop Comb 50, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
Special patient groups
753 Gruppi speċjali ta ’ pazjenti
745 Travel
Safar
Important information about some of the ingredients of Insulin Human Winthrop Comb 50
755 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 50
Do NOT inject Insulin Human Winthrop Comb 50 into a vein.
TINJETTAX Insulin Human Winthrop Comb 50 ġol vina.
Insulin Human Winthrop Comb 50 comes in cartridges sealed in disposable pen injectors, OptiSet.
Insulin Human Winthrop Comb 50 huwa fornut f’ skartoċċi ssiġillati f’ pinen għall- injezzjoni, OptiSet, li jintremew wara li jinħlew.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
756 Dejjem uża pinna ġdida jekk tinnota li l- kontroll taz- zokkor fid- demm mar għall- agħar mingħajr mistenni.
748 Special care before injection
Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Comb 50, pre-filled pen, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Comb 50, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
If you use more Insulin Human Winthrop Comb 50 than you should
Jekk tuża Insulin Human Winthrop Comb 50 aktar milli suppost
Severe allergic reactions to insulin may occur which may become life-threatening.
757 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
749 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)
Do not use Insulin Human Winthrop Comb 50 after the expiry date which isstated on the carton and on the label of the cartridge.
Tużax Insulin Human Winthrop Comb 50 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta ta ’ l- iskartoċċ.
In-use pens Pre-filled pens in use 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).
758 Pinen fl- użu Pinen mimlija għal- lest fl- użu jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
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), mingħajr ċapep, partikuli jew trofof viżibbli.
Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available.
Insulin Human Winthrop Comb 50 huwa fornut f’ pinen mimlija għal- lest, OptiSet, li fiha 3 ml ta ’ suspensjoni (300 IU). Issibu f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen ta ’ 3 ml.
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
759 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
760 IPERGLIĊEMIJA U IPOGLIĊEMIJA
752 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
761 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
753 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
762 Huwa irrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l - glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
754 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
Do not share it with anyone else. • If your injection is given by ano the r person, special caution must be taken by this person to avoid accidental needle injury and transm ission of infection. • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
Taqsamhiex ma ’ ħaddieħor. • Jekk l- injezzjoni tiegħek tingħata minn persuna oħra, għandha tittieħed attenzjoni speċjali minn din il- persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u titrasmetti xi l- infezzjoni. • Qatt m’ għandek tuża OptiSet jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm OptiSet żejda f’ każ li l- OptiSet tiegħek tintilef jew jiġrilha l- hsara.
755 Step 2.
2
Select the d ose
Tagħzel id- doża
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.
766 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.
767 B.
Please check section 5 – How to store Insulin Human Winthrop Comb 50 - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insulin Human Winthrop Comb 50 - fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
759 Maintenance
Manutenzjoni
• Difference is more than 2 units.
768 M’ hemmx biżżejjed insulina fir- riżervwar.
761 PACKAGE LEAFLET:
769 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 50 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
It comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Dan jiġi fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l - parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
Special patient groups
770 Gruppi speċjali ta ’ pazjenti
762 If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
- 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 -
You r 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 50
772 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 50
Insulin Human Winthrop Comb 50 in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Comb 50 fi skartoċċi għal OptiClik kien żviluppat għall- użu f ’ OptiClik biss.
The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
L- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa għal biex iddaħħal l- iskartoċċ, twaħħal il- labra, u tagħti l- injezzjoni ta ’ l- insulina.
Special care before injection
773 Attenzjoni speċjali qabel l- injezzjoni
765 Problems with OptiClik?
Diffikultajiet b’ OptiClik?
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
Jekk OptiClik bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi), għandha tintrema u OptiClik ġdida għandha tintuża minflok.
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.
Severe allergic reactions to insulin may occur which may become life-threatening.
774 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
766 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
Do not put Insulin Human Winthrop Comb 50 next to the freezer compartment or a freezer pack.
Tpoġġix Insulin Human Winthrop Comb 50 viċin il- kumpartiment tal- friża jew maġenb pakk tal- friża.
Keep the cartridge in the outer carton in order to protect from light.
775 Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
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).
One mlof Insulin Human Winthrop Comb 50 contains
Millilitru wieħed ta ’ Insulin Human Winthrop Comb 50 fih
Insulin Human Winthrop Comb 50 comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insulin Human Winthrop Comb 50 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 50 is supplied in cartridges for OptiClik containing 3 ml suspension, (300 IU).
Insulin Human Winthrop Comb 50 huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ suspensjoni (300 IU).
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
776 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
769 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
777 IPERGLIĊEMIJA U IPOGLIĊEMIJA
770 Hypoglycaemia is also more likely to occur if:
778 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
779 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
771 PACKAGE LEAFLET:
780 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 50 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insulin Human Winthrop Comb 50 100 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 50, pre-filled pen, SoloStar, before you start using th is medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Insulin Human Winthrop Comb 50, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
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 b’ mod gradwali u jdum jaħdem għal żmien twil.
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) għall- insulina jew għal xi sustanzi oħra ta ’ Insulin Human Winthrop Comb 50.
Take special care with Insulin Human Winthrop Comb 50
Oqgħod attent ħafna b’ Insulin Human Winthrop Comb 50:
772 Travel
781 Safar
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
774 3.
783 3.
HOW TO USE INSULIN HUM AN 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 tieħu Insulin Human Winthrop Comb 50 kuljum,
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 30 sa 45 minuta qabel ikla.
Do NOT inject Insulin Human Winthrop Comb 50 into a vein.
TINJETTAX l- Insulina Comb 50 fil- vina.
To prevent the possible transmission of disease, each pen must be used by one patient only.
784 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
775 Special care before injection
Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Comb 50, pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insulin Human Winthrop Comb 50, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
- 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 ma injettajtx biżżejjed insulina,
Severe allergic reactions to insulin may occur which may become life-threatening.
785 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
776 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
Do not use Insulin Human Winthrop Comb 50 after the expiry date which isstated on the carton and on the label of the pen.
Tużax Insulin Human Winthrop Comb 50 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).
786 Pinen mhux fl- użu Aħżen fi friġġ (2°Ċ- 8°Ċ).
In-use pens Pre-filled pens in use 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).
Pinen fl- użu Pinen mimlija għal- lest fl- użu jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed 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 50 is supplied in pre-filled pens, SoloStar, containing 3 ml suspension, (300 IU).
Insulin Human Winthrop Comb 50 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
787 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
788 IPERGLIĊEMIJA U IPOGLIĊEMIJA
779 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
780 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
790 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 50, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
782 C.
Ċ.
784 • Do not push the injection button while turning, as insulin will come out.
793 • Timbuttax il- buttun ta ’ l- injezzjoni waqt li qed iddawwar, għax inkella l- insulina toħroġ.
785 Storage Instructions
Struzzjonijiet dwar il- ħażna
786 PACKAGE LEAFLET:
795 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Infusat 100 IU/ml solution for injection in a vial Insulin human
Insulin Human Winthrop Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana
What Insulin Human Winthrop Infusat is and what it is used for 2.
X’ inhu Insulin Human Winthrop Infusat u għalxiex jintuża 2.
Before you use Insulin Human Winthrop Infusat 3.
Qabel ma tuża Insulin Human Winthrop Infusat 3.
How to use Insulin Human Winthrop Infusat 4.
Kif għandek tuża Insulin Human Winthrop Infusat 4.
How to store Insulin Human Winthrop Infusat 6.
Kif taħżen Insulin Human Winthrop Infusat 6.
WHAT INSULIN HUMAN WINTHROP INFUSAT IS AND WHAT IT IS USED FOR
X’ INHU INSULIN HUMAN WINTHROP INFUSAT U GĦALXIEX JINTUŻA
Insulin Human Winthrop Infusat is a solution to be given under the skin.
Insulin Human Winthrop Infusat huwa soluzzjoni biex tingħata fit- tessut ta ’ taħt il- ġilda.
The insulin contained in Insulin Human Winthrop Infusat is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Infusat hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insulin Human Winthrop Infusat is an insulin preparation with a rapid onset and short duration of action.
Insulin Human Winthrop Infusat huwa preparat ta ’ l- insulina li jibda jaħdem malajr u jdum jaħdem għal żmien qasir.
In sulin Human Winthrop Infusat must only be used in insulin pumps suitable for this insulin.
Insulin Human Winthrop Infusat għandu jintuża biss f’ pompi ta ’ l- insulina adattati għal din l- insulina.
Insulin Human Winthrop Infusat is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Infusat huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil - pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSULIN HUMAN WINTHROP INFUSAT
QABEL MA TUŻA INSULIN HUMAN WINTHROP INFUSAT
Do not use Insulin Human Winthrop Infusat
Tużax Insulin Human Winthrop Infusat
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Infusat.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insulin Human Winthrop Infusat.
Do not use Insulin Human Winthrop Infusat in peristaltic pumps with silicone tubing.
Tużax Insulin Human Winthrop Infusat f’ pompi peristaltiċi b’ tubi tas- silikown.
Situations in which you must not start or continue to use insulin pumps are described in the operating manuals for these pumps.
Sitwazzjonijiet meta m’ għandekx tibda jew tkompli tuża pompi ta ’ l- insulina huma deskritti fil- manwali ta ’ l- operat ta ’ dawn il- pompi.
Take special care with Insulin Human Winthrop Infusat
Oqgħod attent ħafna b’ Insulin Human Winthrop Infusat
787 Special patient groups
796 Gruppi speċjali ta ’ pazjenti
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recogn ise a hypoglycaemia.
L- imblokkaturi tar- riċetturi beta, bħall- mediċini oħra simpatolitiċi, (bħal clonidine, guanethidine, u reserpine) jistgħu jdgħajjfu jew jaħbu kompletament l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf xi ipogliċemija.
Using Insulin Human Winthrop Infusat with food and drink
Meta tuża Insulin Human Winthrop Infusat ma ’ l- ikel u max- xorb
How ever, there is no experience with the use of Insulin Human Winthrop Infusat in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insulin Human Winthrop Infusat waqt it- tqala.
789 3.
798 3.
HOW TO USE INSULIN HUMAN WINTHROP INFUSAT
KIF GĦANDEK TUŻA INSULIN HUMAN WINTHROP INFUSAT
- determine how much Insulin Human Winthrop Infusat per day you will need, how much of this
- kemm għandek bżonn tieħu Insulin Human Winthrop Infusat kuljum, kemm minnu jingħata
is infused continuously ("basal rate") and how much and when you need additional insulin as an "insulin boost" ("bolus dose"),
bħala infuzzjoni kontinwa (“ rata bażika ”), u kemm u meta tinħtieġ insulina addizzjonali bħala “ boost t’ insulina ” (“ doża bolus ”)
- tell you when you may need to use a higher or lower dose of Insulin Human Winthrop Infusat.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop
Your doctor will show you how and in which area of the skin you should infuse your insulin and how often you must change the puncture site within the particular area of skin where you are infusing the insulin.
It- tabib tiegħek ser jurik kif u f’ liema parti tal- ġilda tista ’ tieħu l- infuzzjoni ta ’ l- insulina, u kemm spiss għandek tibdel is- sit tal- puntura fiż- żona partikulari tal- ġilda li int qed tieħu l- infuzzjoni ta ’ l - insulina.
Speak to your doctor before you change the area of skin that you are infusing.
Kellem lit- tabib tiegħek qabel tibdel iż- żona tal- ġilda fejn qed tieħu l- infuzzjoni.
In sulin Human Winthrop Infusat has been developed for use in Hoechst Infusor and H-Tron.
Insulin Human Winthrop Infusat kien żviluppat għall- użu ma ’ Hoechst Infusor u H- Tron.
It must only be used in insulin pumps suitable for this insulin.
Għandu jintuża biss f’ pompi ta ’ l- insulina adattati għal din it- tip ta ’ insulina.
Only tetrafluoroethylene or polyethylene catheters must be used for infusion.
Kateters tat- tetrafluoroethylene jew polyethylene biss għandhom jintużaw għall- infuzzjoni.
The operating manual provided with the pump will tell you how to use it.
Il- manwal ta ’ kif tħaddem il- pompa ipprovdut mal- pompa jgħidlek kif tużha.
Insulin Human Winthrop Infusat must only be used if the solution is clear, colourless, with no solid particles visible, and has a water-like consistency.
Insulin Human Winthrop Infusat għandu jintuża biss jekk is- soluzzjoni hija cara, mingħajr kulur, u bla ebda partikuli solidi u viżibbli, u jekk tixbaħ id- dehra ta ’ l- ilma.
The insulin cartridge of the pump must be sterile and must be used once only.
L- iskartoċċ ta ’ l- insulina tal- pompa għandu jkun sterili u għandu jintuża darba biss.
After filling the cartridge of the pump keep it at room temperature for 1 to 2 hours before using it, so that you can see and remove any air bubbles which form during warming-up.
Wara li timla l - iskartoċċ tal- pompa, żommu fit- temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn qabel tużah, ħalli tkun tista ’ tara jekk hemmx xi bżieżaq ta ’ l- arja li ifformaw sa kemm saħan u tneħħihom.
Special care before injection
Attenzjoni speċjali qabel l- infużjoni
Before starting the infusion remove any air bubbles.
Qabel ma tibda l- infuzzjoni neħħi l- bżieżaq ta ’ l- arja li jista ’ jkun hemm.
Insulin Human Winthrop Infusat must NOT be mixed with any other insulin preparations.
Insulin Human Winthrop Infusat M’ GĦANDUX jitħallat ma ’ ebda preparazzjonijiet oħra ta ’ l- insulina.
Insulin pump faults
Ħsarat fil- pompa ta ’ l- insulina
You should always consider the possibility of a technical problem if, in order to achieve the desired blood sugar levels,
Għandek dejjem tikkunsidra l- possibbiltà ta ’ problema teknika jekk, biex tikseb il- livelli meħtieġa taż - zokkor fid- demm,
- you need additional insulin ("bolus doses") at larger doses or more often than usual, or
- tinħtieg insulina addizzjonali (“ dożi bolus ”) f’ dożi akbar jew aktar spissi mis- soltu, jew
- you need additional insulin ("bolus doses") at smaller doses or less often than usual.
- tinħtieġ insulina addizzjonali (“ dożi bolus ”) f’ dożi iżgħar jew anqas spissi mis- soltu.
For details on safety precautions in the use of insulin pumps see the operating manual.
Għad- dettalji dwar il- miżuri ta ’ sigurtà fl- użu tal- pompi ta ’ l- insulina ara l- manwal tal- pompa.
If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe for injection.
799 Jekk il- pompa mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ ġewwa siringa ta ’ l- injezzjoni.
Therefore, keep injection syringes and injection needles as well.
Għalhekk, żomm is- siringi u l- labar għall- injezzjoni wkoll.
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 ta ’ l - injezzjoni li huma magħmulin ghal qawwa ta ’ insulina ta ’ 100 IU (Unitajiet Internazzjonali) kull millilitru.
790 Mistakes in dosage
Żbalji fid- dożaġġ
If you use more Insulin Human Winthrop Infusat than you should
Jekk tuża Insulin Human Winthrop Infusat aktar milli suppost
- If you have injected too much Insulin Human Winthrop Infusat, your blood sugar level may
- Jekk injettajt aktar Insulin Human Winthrop Infusat milli meħtieġ, il- livell taz- zokkor
If you forget to use Insulin Human Winthrop Infusat
Jekk tinsa tuża Insulin Human Winthrop Infusat
- If you have missed a dose of Insulin Human Winthrop Infusat or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Infusat jew jekk ma injettajtx biżżejjed
If you stop using Insulin Human Winthrop Infusat 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 Infusat 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 Infusat without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insulin Human Winthrop Infusat mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insulin Human Winthrop Infusat can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insulin Human Winthrop Infusat jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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.
800 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 INFUSAT
KIF TAĦŻEN INSULIN HUMAN WINTHROP INFUSAT
Do not use Insulin Human Winthrop Infusat after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insulin Human Winthrop Infusat wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- kunjett.
Do not put Insulin Human Winthrop Infusat 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..
Once in the pump, Insulin Human Winthrop Infusat may be kept for up to 2 weeks.
Ġaladarba fil- pompa, Insulin Human Winthrop Infusat jista ’ jinżamm sa ġimgħatejn.
6.
801 6.
What Insulin Human Winthrop Infusat contains
X’ fih Insulin Human Winthrop Infusat
One ml of Insulin Human Winthrop Infusat contains
Millilitru wieħed ta ’ Insulin Human Winthrop Infusat fih
- The other ingredients are: phenol, zinc chloride, trometamol, poloxamer 171, glycerol,
- Is- sustanzi l- oħra huma: phenol, zinc chloride, trometamol, poloxamer 171, glycerol,
hydrochloric acid (for pH adjustment) and water for injections.
hydrochloric acid (għall- aġġustament tal- pH), u ilma għall- injezzjonijiet.
792 What Insulin Human Winthrop Infusat looks like and contents of the pack Insulin Human Winthrop Infusat is a clear, colourless solution for injection, with no solid particles visible, and of water-like consistency.
Id- Dehra ta ’ Insulin Human Winthrop Infusat u l- kontenuti tal- pakkett Insulin Human Winthrop Infusat huwa soluzzjoni għall- injezzjoni ċara, minghajr kulur, bla ebda partikuli solidi u viżibbli, u tixbaħ l- ilma.
Insulin Human Winthrop Infusat is supplied in vials containing 10 ml solution (1000 IU).
Insulin Human Winthrop Infusat huwa fornut f’ kunjetti ta ’ 10 ml ta ’ soluzzjoni (1000 IU).
Pack of 3 vials of 10 ml is available.
Issibu f’ pakketti ta ’ 3 kunjetti ta ’ 10 ml.
France sanofi-aventis France Tél:
802 France sanofi- aventis France Tél:
- you r insulin pump does not work properly,
- int qiegħed tagħmel anqas eżerċizzju fiżiku mis- soltu, jew int qiegħed taħt stress (inkwiet,
794 Warning symptoms of hyperglycaemia
803 Sintomi ta ’ twissija ta ’ ipergliċemija
Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
X’ għandek tagħmel f’ każ ta ’ ipergliċemija Ittestja l- livell taz- zokkor fid- demm tiegħek u fl- awrina tiegħek għall- ketoni hekk kif iseħħ xi wieħed mis- sintomi t’ hawn fuq.
795 The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
804 L- ewwel sintomi li jagħtuk indikazzjoni li ser tiżviluppa l- ipogliċemija (“ sintomi ta ’ twissija ”) jistgħu jinbidlu, jiddgħajfu jew ikunu nieqsin għal kollox, jekk:
Stop your insulin infusion (if necessary, by withdrawing the needle) at least until you feel that you are fully alert again.
Tinjettax l- insulina.
796 PACKAGE LEAFLET:
805 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Infusat 100 IU/ml solution for injection in a cartridge Insulin human
Insulin Human Winthrop Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ Insulina umana
The insulin contained in Insulin Human Winthrop Infusat is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Infusat hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu (“ insulina umana ”).
It comes in cartridges designed for use in Hoechst Infusor and H-Tron (insulin pumps).
Huwa fornut f’ skartoċċi magħmulin għall- użu ma ’ Hoechst Infusor u H- Tron (pompi ta ’ l- insulina).
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Infusat.
Jekk int allerġiku/ a( tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insulin Human Winthrop Infusat.
797 Special patient groups
806 Gruppi speċjali ta ’ pazjenti
799 3.
808 3.
- determine how much Insulin Human Winthrop Infusat per day you will need, how much of this
- jikkalkula kemm għandek bżonn tieħu Insulin Human Winthrop Infusat kuljum, kemm minnu
is infused continuously ("basal rate") and how much and when you need additional insulin as an "insulin boost" ("bolus dose"),
jingħata bħala infuzzjoni kontinwa (“ rata bażika ”), u kemm u meta tinħtieġ insulina addizzjonali bħala “ boost t’ insulina ” (“ doża bolus ”)
- tell you when you may need to use a higher or lower dose of Insulin Human Winthrop Infusat.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop Infusat,
In sulin Human Winthrop Infusat comes in cartridges designed for use in Hoechst Infusor and H-Tron.
Insulin Human Winthrop Infusat huwa fornut f’ skartoċċi magħmulin għall- użu ma ’ Hoechst Infusor u H- Tron.
Only tetrafluoroethylene or polyethylene catheters must be used for infusion.
Kateters tat - tetrafluoroethylene jew polyethylene biss għandhom jintużaw għall- infuzzjoni.
Keep the cartridge at room temperature 1 to 2 hours before inserting it in the pump so that you can see and remove any air bubbles which form during warming-up.
Żomm l- iskartoċċ fit- temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn qabel tużah, ħalli tkun tista ’ tara jekk hemmx xi bżieżaq ta ’ l- arja li ifformaw sa kemm saħan u tneħħihom.
Do not re-fill and re-use empty cartridges.
Terġax timla jew tuża l- skartoċċi vojta.
If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe for injection.
809 Jekk il- pompa mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ ġewwa siringa ta ’ l- injezzjoni.
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 ta ’ l - injezzjoni li huma magħmulin ghal qawwa ta ’ insulina ta ’ 100 IU (Unitajiet Internazzjonali) kull ml.
800 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have injected too much Insulin Human Winthrop Infusat, your blood sugar level may
- Jekk injettajt aktar Insulin Human Winthrop Infusat, milli meħtieġ il- livell taz- zokkor
If you stop using Insulin Human Winthrop Infusat 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 Infusat 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 Infusat without speaking to a doctor, who will tell you what needs to be done.
Twaqqafx Insulin Human Winthrop Infusat mingħajr ma tkellem tabib, li mbagħad jgħidlek x’ għandu jsir.
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.
810 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 Infusat after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insulin Human Winthrop Infusat wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l- iskartoċċ.
Do not put Insulin Human Winthrop Infusat next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Infusat m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
What Insulin Human Winthrop Infusat looks like and contents of the pack Insulin Human Winthrop Infusat is a clear, colourless solution for injection, with no solid particles visible, and of water-like consistency.
811 Id- Dehra ta ’ Insulin Human Winthrop Infusat u l- kontenuti tal- pakkett Insulin Human Winthrop Infusat huwa soluzzjoni għall- injezzjoni ċara, minghajr kulur, bla ebda partikuli solidi u viżibbli, u tixbaħ l- ilma.
Insulin Human Winthrop Infusat is supplied in cartridges containing 3.15 ml solution (315 IU).
Insulin Human Winthrop Infusat huwa fornut f’ skartoċċi li fihom 3. 15 ml ta ’ soluzzjoni (315 IU).
Pack of 5 cartridges of 3.15 ml is available.
Issibu f’ pakkett ta ’ 5 skartoċċi ta ’ 3. 15 ml.
8 02 Marketing Authorisation Holder and Manufacturer Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Il- Ġermanja.
Ísland Vistor hf.
812 Ísland Vistor hf.
What should you do if you experience hyperglycaemia
813 X’ għandek tagħmel f’ każ ta ’ ipergliċemija
804 HYPOGLYCAEMIA (low blood sugar levels)
IPOGLIĊEMIJA (livell baxx ta ’ zokkor fid- demm)
805 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.
806
815
INSUMAN RAPID ISUMAN BASAL INSUMAN COMB (15, 25, 50) INSUMAN INFUSAT
INSUMAN RAPID, INSUMAN BASAL, INSUMAN COMB (15, 25, 50), INSUMAN INFUSAT
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettq sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is Insuman?
X’ inhu Insuman?
Insuman is a range of insulin solutions and suspensions for injection.
Insuman jiġi f’ varjetà ta ’ soluzzjonijiet u sospensjonijiet tal- insulina għall- injezzjoni.
It is supplied in vials, cartridges, or pre-filled disposable pens (OptiSet and SoloStar).
Huwa ipprovdut bħala kunjetti, skrataċ jew pinen mimlija minn qabel (OptiSet u SoloStar).
Insuman contains the active substance insulin human.
Insuman fih is- sustanza attiva insulina umana.
The Insuman range is comprised of fast-acting insulin solutions (Insuman Rapid and Insuman Infusat) that contain soluble insulin, an intermediate- acting insulin suspension (Insuman Basal) that contains isophane insulin, and combinations of fast- and intermediate-acting insulins in various proportions (Insuman Comb): • Insuman Comb 15:
Il- varjetajiet ta ’ Insuman jinkludu soluzzjonijiet ta ’ insulina li jaħdmu malajr (Insuman Rapid u Insuman Infusat) u li fihom insulina solubbli (li tinħall), sospensjoni ta ’ l- insulina li taħdem b’ mod intermedju (Insuman Basal) u li fiha insulina isofana (isophane), u taħlitiet ta ’ proporzjonijiet diversi ta ’ insulina li taħdem malajr u dik li taħdem b’ mod intermedju. • Insuman Comb 15:
15% soluble insulin and 85% crystalline protamine insulin; • Insuman Comb 25:
15% ta ’ insulina solubbli u 85% ta ’ insulina kristallina tal- protamina; • Insuman Comb 25:
25% soluble insulin and 75% crystalline protamine insulin; • Insuman Comb 50:
25% ta ’ insulina solubbli u 75% ta ’ insulina kristallina tal- protamina; • Insuman Comb 50:
50% soluble insulin and 50% crystalline protamine insulin.
50% ta ’ insulina solubbli u 50% ta ’ insulina kristallina tal- protamina;
What is Insuman used for?
Għal xiex jintuża Insuman?
Insuman is used in patients with diabetes who need treatment with insulin.
Insuman jintuża fuq pazjenti bid- dijabete li għandhom bżonn trattament bl- insulina.
Insuman Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation.
Insuman Rapid jista ’ wkoll jintuża għat- trattament ta ’ koma ipergliċemika (koma kkawżata minn eċċess ta ’ glukożju [zokkor] fid- demm u ketoaċidożi (livelli għoljin ta ’ ketoni [aċidi] fid- demm), u sabiex jikkontrolla l- glukożju fid- demm, matul jew wara operazzjoni.
How is Insuman used?
Kif jintuża Insuman?
Insuman is given by injection under the skin, generally in the abdominal wall (tummy) or the thigh, according to the doctor’ s recommendations.
Insuman jingħata permezz ta 'injezzjoni taħt il- ġilda, ġeneralment fil- parti addominali (żaqq) jew il - koxxa skont ir- rakkomandazzjonijiet tat- tabib.
The injection site is changed for each injection.
Is- sit ta ’ l- injezzjoni jinbidel għal kull injezzjoni.
The desired blood glucose levels, type of Insuman to be used, and the dose and timing of injections are determined by the doctor for each patient individually, and are adjusted to suit the patient ’ s diet, physical activity and lifestyle.
Il - livelli mixtieqa ta ’ glukożju fid- demm, it- tip ta ’ Insuman li għandu jintuża, id- doża u l- intervalli ta ’ żmien bejn l- injezzjonijiet huma determinati mit- tabib tiegħek fuq bażi individwali għal kull pazjent u huma adattati sabiex ikunu jaqblu mad- dieta, l- attività fiżika u l- istil ta ’ ħajja tal- persuna.
The patient ’ s blood glucose should be tested regularly to find the lowest effective dose.
Il- livell ta ’ glukożju fid- demm tal- pazjent għandu jiġi ttestjat b’ mod regolari sabiex tinsab l- aktar doża baxxa li tkun effikaċi.
Insuman should be given before meals.
Insuman għandu jingħata qabel l- ikel.
See the Package Leaflet for exact timings.
Ara l- Fuljett ta ’ Tagħrif għall- ħinijiet eżatti meta għandha tittieħed il- mediċina.
Insuman Rapid may also be given into a vein, but only in hospital where the patient can be closely monitored.
Insuman Rapid jista ’ wkoll jingħata fil- vina, iżda biss fl- isptar fejn il- pazjent ikun jista ’ jiġi ssorveljat mill- qrib.