qanastek/EMEA-V3 huggingface dataset:
Insuman Comb 25 comes in cartridges sealed in disposable pen injectors, OptiSet.
Insuman Comb 25 huwa fornut f’ skartoċċi ssiġillati f’ pinen għall- injezzjoni, OptiSet, li jintremew wara li jinħlew.
Special care before injection
678 Attenzjoni speċjali qabel l- injezzjoni
Insuman 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.
blood sugar level may become too high (hyperglycaemia).
tiegħek taz- zokkor fid- demm jista ’ jogħla wisq (ipergliċemija)..
If you stop using Insuman 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 Insuman 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 Insuman Comb 25 without speaking to a doctor, who will tell you what needs to be done.
Twaqqafx Insuman 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 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)
679 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
668 • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
HOW TO STORE INSUMAN COMB 25
KIF TAĦŻEN INSUMAN COMB 25 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use the pen after this time period.
Tużax il- pinna wara dan il- perijodu ta ’ żmien.
Medicines should not be disposed of via wastewater or household waste.
680 Il- mediċini m’ ghandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma l- iskart domestiku.
What Insuman Comb 25 looks like and contents of the pack After mixing, Insuman Comb 25 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Comb 25 u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Comb 25 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni), mingħajr ċapep, partikuli jew trofof viżibbli.
Insuman Comb 25 is supplied in pre-filled pens, OptiSet, containing 3 ml suspension, (300 IU).
Insuman Comb 25 huwa fornut f’ pinen mimlija għal- lest, OptiSet, li fiha 3 ml ta ’ suspensjoni (300 IU).
669 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.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
681 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
682 Jekk iz- zokkor f’ demmek huwa għoli wisq (ipergliċemija), għandu mnejn ma injettajtx biżżejjed insulina
671 HYPOGLYCAEMIA (low blood sugar levels)
IPOGLIĊEMIJA (livell baxx ta ’ zokkor fid- demm)
Warning symptoms of hypoglycaemia
683 Sintomi ta ’ twissija ta ’ ipogliċemija
If you are not
Jekk hemm bżonn, it- testijiet aktar spissi għaz- zokkor fid- demm jistgħu jgħinuk biex tintebaħ bi ġrajjiet ta ’ l- ipogliċemija ħafifa li altrimenti jista ’ jkun ma kontx tinduna bihom.
672 confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Jekk m’ intix kunfidenti li tagħraf is- sintomi ta ’ twissija, evita sitwazzjonijiet (bħal issuq karozza) fejn l- ipogliċemija tpoġġi f’ riskju lilek jew lill- oħrajn.
673 OPTISET INSTRUCTIONS FOR USE
684 STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
Check the appearance of your insulin.
685 D Iċċekkja d- dehra ta ’ l- insulina tiegħek.
674 Step 2.
Pass Nru.
675 C.
686 Ċ.
A.
687 A.
676 • If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
• Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- istixxa ikkulurita, allura hemm madwar 20 Unità t’ insulina disponibbli.
Please check section 5 – How to store Insuman Comb 25 - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insuman Comb 25 - fuq il- faċċata ta ’ wara (ta ’ l - insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
Discard your used OptiSet as required by your local regulations.
689 Armi l- OptiSet użata tiegħek kif jitolbu l- liġijiet lokali.
678 Maintenance
Manutenzjoni
679 The injection button cannot be pressed in.
Il- buttun ta ’ l - injezzjoni ma jistax
You don’t hear clicking while injecting.
690
680 PACKAGE LEAFLET:
691 FULJETT TA ’ TAGĦRIF:
Insuman Comb 25 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insuman Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
Special patient groups
692 Gruppi speċjali ta ’ pazjenti
681 Travel
Safar
Important information about some of the ingredients of Insuman Comb 25
694 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 25
683 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 25 in cartridges for OptiClik has been developed for use with OptiClik only.
Insuman Comb 25 fi skartoċċi għal OptiClik kien żviluppat għall- użu f ’ OptiClik biss.
Special care before injection
695 Attenzjoni speċjali qabel l- injezzjoni
If OptiClik does not function well, you can draw the insulin from the cartridge into an injection syringe.
Jekk OptiClik mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ b’ siringa ta ’ l- injezzjoni u tinjettha.
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.
696 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.
685 • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not put Insuman Comb 25 next to the freezer compartment or a freezer pack.
Insuman 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).
697 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).
Insuman Comb 25 comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insuman Comb 25 huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
686 This cartridge is for use with OptiClik only.
Dan l- iskartoċċ huwa għall- użu ma ’ OptiClik biss.
Insuman Comb 25 is supplied in cartridge for OptiClik containing 3 ml suspension (300 IU).
Insuman Comb 25 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
698 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
699 IPERGLIĊEMIJA U IPOGLIĊEMIJA
688 What should you do if you experience hyperglycaemia
X’ għandek tagħmel f’ każ ta ’ ipergliċemija
Hypoglycaemia is also more likely to occur if:
700 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
689 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.
Tell your relatives, friends and close colleagues the following:
701 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
690 PACKAGE LEAFLET:
702 FULJETT TA ’ TAGĦRIF:
Insuman Comb 25 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insuman 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 Insuman 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 ’ Insuman 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 Insuman Comb 25.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insuman Comb 25.
Take special care with Insuman Comb 25
Oqgħod attent ħafna b’ Insuman Comb 25:
691 Travel
703 Safar
Important information about some of the ingredients of Insuman Comb 25
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insuman Comb 25
- determine how much Insuman Comb 25 per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insuman Comb 25 kuljum,
693 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 25 is injected under the skin 30 to 45 minutes before a meal.
Insuman Comb 25 huwa injettat taħt il- ġilda 30 sa 45 minuta qabel ikla.
Do NOT inject Insuman Comb 25 into a vein.
TINJETTAX l- Insulina Comb 25 fil- vina.
To prevent the possible transmission of disease, each pen must be used by one patient only.
706 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Insuman Comb 25, pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Comb 25, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
694 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have missed a dose of Insuman Comb 25 or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Comb 25 jew ma injettajtx biżżejjed insulina, il- livell taz -
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
707 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
695 • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not use Insuman Comb 25 after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insuman 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).
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).
708 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).
Insuman Comb 25 is supplied in pre-filled pens, SoloStar, containing 3 ml suspension, (300 IU).
Insuman Comb 25 huwa fornut f’ pinen mimlija għal- lest, SoloStar, li fiha 3 ml ta ’ suspensjoni (300 IU).
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
709 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
710 IPERGLIĊEMIJA U IPOGLIĊEMIJA
698 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Hypoglycaemia is also more likely to occur if:
711 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
712 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
SoloStar.
Insuman Comb 25, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
Do not share it with anyone else. • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use SoloStar if it is damaged or if you are not sure that it is working properly. • Always have a spare SoloStar in case your SoloStar is lost or damaged.
713 • 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 infezzjoni. • Qatt m’ għandek tuża SoloStar jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm SoloStar żejda f’ każ li s- SoloStar tiegħek tintilef jew jiġrilha l- ħsara.
701 C.
Ċ.
If you are using clear insulin (Insuman Rapid), do not use this pen if the insulin is cloudy, coloured or has particles.
Jekk qed tuża insulina ċara, (Insuman Comb 25) tużax din il- pinna jekk l- insulina hija
If you are using a suspension insulin (Insuman Basal or Insuman mixtures), turn the pen up and down at least 10 times to resuspend the insulin.
mdardra, ikkulurita jew għandha xi partikuli. • Jekk qed tuża suspensjoni ta ’ l- insulina (Insuman Comb 25 jew taħlit ta ’ Insuman) l- insulina għandha titħallat billi ddawwar il- pinna ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
703 • 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.
A.
716 A.
704 Storage Instructions
Struzzjonijiet dwar il- ħażna
705 PACKAGE LEAFLET:
717 FULJETT TA ’ TAGĦRIF:
Insuman Comb 50 100 IU/ml suspension for injection in a vial Insulin human
Insuman Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
What Insuman Comb 50 is and what it is used for 2.
X’ inhu Insuman Comb 50 u għalxiex jintuża 2.
Before you use Insuman Comb 50 3.
Qabel ma tuża Insuman Comb 50 3.
How to use Insuman Comb 50 4.
Kif għandek tuża Insuman Comb 50 4.
How to store Insuman Comb 50 6.
Kif taħżen Insuman Comb 50 6.
WHAT INSUMAN COMB 50 IS AND WHAT IT IS USED FOR
X’ INHU INSUMAN COMB 50 U GĦALXIEX JINTUŻA
Insuman Comb 50 is a fluid (suspension) for injection under the skin.
Insuman Comb 50 huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
The insulin contained in Insuman Comb 50 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Comb 50 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insuman Comb 50 is an insulin preparation with a rapid onset and moderately long duration of action.
Insuman Comb 50 huwa preparat ta ’ l- insulina li jibda jaħdem malajr u jdum jaħdem għal żmien moderatament twil.
Insuman Comb 50 is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Comb 50 huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSUMAN COMB 50
QABEL MA TUŻA INSUMAN COMB 50
Do not use Insuman Comb 50
Tużax Insuman Comb 50
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Comb 50.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insuman Comb 50.
Do not inject Insuman Comb 50 into a vein (blood vessel).
Tinjettax Insuman 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 Insuman Comb 50
Oqgħod attent ħafna b’ Insuman Comb 50
706 Travel
718 Safar
Using Insuman Comb 50 with food and drink
Meta tuża Insuman Comb 50 ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insuman Comb 50 in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insuman Comb 50 waqt it- tqala.
Important information about some of the ingredients of Insuman Comb 50
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 50
3.
720 3.
HOW TO USE INSUMAN COMB 50
KIF GĦANDEK TUŻA INSUMAN COMB 50
- determine how much Insuman Comb 50 per day you will need,
- jikkalkula kemm għandek bżonn Insuman Comb 50 kuljum,
- tell you when you may need to inject a higher or lower dose of Insuman Comb 50.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Comb 50,
708 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 50 is injected under the skin 20 to 30 minutes before a meal.
Insuman Comb 50 huwa injettat taħt il- ġilda minn 20 sa 30 minuta qabel ikla.
Do NOT inject Insuman Comb 50 into a vein.
TINJETTAX Insuman Comb 50 ġewwa vina.
Insuman Comb 50 contains 100 IU insulin per ml.
Insuman Comb 50 fih 100 IU insulina kull millilitru.
Insuman Comb 50 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
721 Insuman 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.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insuman Comb 50.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insuman Comb 50.
If you use more Insuman Comb 50 than you should
Żbalji fid- dożaġġ Jekk tuża Insuman Comb 50 aktar milli suppost
- If you have injected too much Insuman Comb 50, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Comb 50 milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm
If you forget to use Insuman Comb 50
Jekk tinsa tuża Insuman Comb 50
- If you have missed a dose of Insuman Comb 50 or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Comb 50 jew jekk ma injettajtx biżżejjed insulina, il- livell
If you stop using Insuman 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 Insuman 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 Insuman Comb 50 without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insuman Comb 50 mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insuman Comb 50 can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insuman Comb 50 jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
710 Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk tinnota kwalunkwe waħda minn dawn l- effetti sekondarji elenkati hawn fuq jew kwalunkwe effetti mhux mixtieqa jew mhux mistennija.
HOW TO STORE INSUMAN COMB 50
KIF TAĦŻEN INSUMAN COMB 50
Do not use Insuman Comb 50 after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insuman Comb 50 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- kunjett.
Do not put Insuman Comb 50 next to the freezer compartment or a freezer pack.
Insuman Comb 50 m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
6.
723 6.
What Insuman Comb 50 contains
X’ fih Insuman Comb 50
One ml of Insuman Comb 50 contains 100 IU (International
Millilitru wieħed ta ’ Insuman Comb 50 fih 100 IU (Unita
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 Insuman Comb 50 looks like and contents of the pack After mixing, Insuman Comb 50 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Comb 50 u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Comb 50 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Insuman Comb 50 is supplied in vials containing 5 ml suspension (500 IU).
Insuman 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.
España sanofi-aventis, S.A.
724 España sanofi- aventis, S. A.
712 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
714 PACKAGE LEAFLET:
727 FULJETT TA ’ TAGĦRIF:
Insuman Comb 50 40 IU/ml suspension for injection in a vial Insulin human
Insuman Comb 50 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
715 Travel
728 Safar
- diuretics (used to treat high blood pressure or excessive fluid retention),
- id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew iż- żamma eċċessiva ta’ fluwidi),
3.
730 3.
717 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 50 contains 40 IU insulin per ml.
Insuman Comb 50 fih 40 IU insulina kull millilitru.
Insuman Comb 50 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
731 Insuman 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.
If you use more Insuman Comb 50 than you should
Jekk tuża Insuman Comb 50 aktar milli suppost
- If you have injected too much Insuman Comb 50, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Comb 50 milli meħtieġ,, il- livell taz- zokkor tiegħek fid- demm
718 If you forget to use Insuman Comb 50
Jekk tinsa tuża Insuman Comb 50
If you stop using Insuman 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 Insuman 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 Insuman Comb 50 without speaking to a doctor, who will tell you what needs to be done.
Twaqqafx Insuman Comb 50 mingħajr ma tkellem tabib, li mbagħad jgħidlek x’ għandu jsir.
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)
732 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
719 Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
It- trattament bl- insulina jista ’ jġiegħel il- ġisem jipproduċi l- antikorpi (sustanzi li jaġġixxu kontra l - insulina).
6.
733 6.
One ml of Insuman Comb 50 contains 40 IU (International
Millilitru wieħed ta ’ Insuman Comb 50 fih 40 IU (Unita
Packs of 1 and 5 vials of 10 ml are available.
Insuman 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.
España sanofi-aventis, S.A.
734 España sanofi- aventis, S. A.
723 It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Huwa irrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l - glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
724 PACKAGE LEAFLET:
737 FULJETT TA ’ TAGĦRIF:
Insuman Comb 50 100 IU/ml suspension for injection in a cartridge Insulin human
Insuman 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.
Insuman 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.
738 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.
725 Travel
Safar
Important information about some of the ingredients of Insuman Comb 50
740 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 50
727 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Special care before injection
741 Attenzjoni speċjali qabel l- injezzjoni
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. skartoċċi.
728 Mistakes in dosage
Żbalji fid- dożaġġ
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.
742 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.
729 • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjeb sew.
Do not use Insuman Comb 50 after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insuman Comb 50 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l - iskartoċċ.
Do not put Insuman Comb 50 next to the freezer compartment or a freezer pack.
Tpoġġix Insuman 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).
743 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 Insuman Comb 50 looks like and contents of the pack After mixing, Insuman Comb 50 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Comb 50 u l- kontenuti tal- pakkett Wara li jitħallat, Insuman 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.
Insuman 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.
730 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.
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
744 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
745 IPERGLIĊEMIJA U IPOGLIĊEMIJA
732 HYPOGLYCAEMIA (low blood sugar levels)
IPOGLIĊEMIJA (livell baxx ta ’ zokkor fid- demm)
Hypoglycaemia is also more likely to occur if:
746 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
733 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
747 Jekk int ma tistax tibla ’ jew jekk int mitluf minn sensik, int teħtieġ injezzjoni tal- glukosju jew tal - glukagon (mediċina li tgħolli l- livell taz- zokkor fid- demm).
734 PACKAGE LEAFLET:
748 FULJETT TA ’ TAGĦRIF:
Insuman Comb 50 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insuman 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 Insuman Comb 50, pre-filled pen, OptiSet, before you start using th is medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet dwar l- Użu ta ’ Insuman Comb 50, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
735 Travel
749 Safar
3.
751 3.
HOW TO USE INSUM AN COMB 50
KIF GĦANDEK TUŻA INSUMAN COMB 50
737 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Do NOT inject Insuman Comb 50 into a vein.
TINJETTAX Insuman Comb 50 ġol vina.
Insuman Comb 50 comes in cartridges sealed in disposable pen injectors, OptiSet.
Insuman Comb 50 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.
752 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Insuman 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.
738 If you use more Insuman Comb 50 than you should
Jekk tuża Insuman Comb 50 aktar milli suppost
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
753 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
739 If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
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).
754 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 Insuman Comb 50 looks like and contents of the pack After mixing, Insuman Comb 50 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Comb 50 u l- kontenuti tal- pakkett Wara li jitħallat, Insuman 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.
Insuman 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.
740 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
755 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
756 IPERGLIĊEMIJA U IPOGLIĊEMIJA
742 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Hypoglycaemia is also more likely to occur if:
757 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
758 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
744 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
Do not share it with anyone else. • If your injection is given by ano ther 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.
745 Always use a new sterile needle for each injection.
Dejjem uża labra sterili u ġdida għal- kull injezzjoni.
Select the d ose
4 Tagħzel id- doża
In this case what should you do: • either you can inject what is remaining in the pen and complete your dose with a new OptiSet. • or use a new OptiSet for your full dose.
762 F’ każ bħal dan x’ għandek tagħmel: • jew tinjetta dak li fadal fil- pinna u tkompli tieħu li fadallek għad- doża sħiħa minn OptiSet ġdida. • jew tuża OptiSet ġdida għad- doża sħiħa.
Please check section 5 – How to storeInsuman Comb 50 - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insuman Comb 50 - fuq il- faċċata ta ’ wara (ta ’ l - insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
If your OptiSet is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature.
763 Jekk l- OptiSet tiegħek hija maħzuna fil- kesħa, oħroġha minn siegħa sa sagħtejn qabel tinjetta biex tħalliha tisħon u tilħaq it- temperatura ambjentali ta ’ ġewwa.
749 Maintenance
Manutenzjoni
750 The injection button cannot be pressed in.
Il- buttun ta ’ l -
OptiSet has been dropped or subjected to impact.
Jekk int fid- dubju jekk il- pinna hiex taħdem sew uża OptiSet ġdida.
If in any doubt whether the pen is working correctly use a new OptiSet.
L- OptiSet twaqqgħet jew ġiet soġġetta għal impatt.
751 PACKAGE LEAFLET:
765 FULJETT TA ’ TAGĦRIF:
Insuman Comb 50 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insuman Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
Special patient groups
766 Gruppi speċjali ta ’ pazjenti
752 Travel
Safar
Important information about some of the ingredients of Insuman Comb 50
768 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 50
754 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 50 in cartridges for OptiClik has been developed for use with OptiClik only.
Insuman Comb 50 fi skartoċċi għal OptiClik kien żviluppat għall- użu f ’ OptiClik biss.
Special care before injection
769 Attenzjoni speċjali qabel l- injezzjoni
If OptiClik does not function well, you can draw the insulin from the cartridge into an injection syringe.
Jekk OptiClik mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ b’ siringa ta ’ l- injezzjoni.
755 Mistakes in dosage
Żbalji fid- dożaġġ
Severe allergic reactions to insulin may occur which may become life-threatening.
770 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
756 If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not put Insuman Comb 50 next to the freezer compartment or a freezer pack.
Tpoġġix Insuman Comb 50 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).
771 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 Insuman Comb 50 looks like and contents of the pack After mixing, Insuman Comb 50 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Wara li jitħallat, Insuman Comb 50 huwa likwidu uniformi jixbaħ il- ħalib (suspensjoni għall - injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insuman Comb 50 comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insuman Comb 50 huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
757 This cartridge is for use with OptiClik only.
Dan l- iskartoċċ huwa għall- użu ma ’ OptiClik biss.
Insuman Comb 50 is supplied in cartridges for OptiClik containing 3 ml suspension, (300 IU).
Insuman 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
772 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
773 IPERGLIĊEMIJA U IPOGLIĊEMIJA
759 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:
774 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
If you are not confident
Jekk hemm bżonn, it- testijiet aktar spissi għaz- zokkor fid- demm jistgħu jgħinuk biex tintebaħ bi ġrajjiet ta ’ l- ipogliċemija ħafifa li altrimenti jista ’ jkun ma kontx tinduna bihom.
760 about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Jekk m’ intix kunfidenti li tagħraf is- sintomi ta ’ twissija, evita sitwazzjonijiet (bħal issuq karozza) fejn l- ipogliċemija tpoġġi f’ riskju lilek jew lill- oħrajn.
Tell your relatives, friends and close colleagues the following:
775 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
761 PACKAGE LEAFLET:
776 FULJETT TA ’ TAGĦRIF:
Insuman Comb 50 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insuman 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 Insuman 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 ’ Insuman Comb 50, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
Insuman Comb 50 is an insulin preparation with a rapid onset and moderately long duration of action.
Insuman 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 Insuman Comb 50.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insuman Comb 50.
Take special care with Insuman Comb 50
Oqgħod attent ħafna b’ Insuman Comb 50:
762 Travel
777 Safar
Important information about some of the ingredients of Insuman Comb 50
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insuman Comb 50
- determine how much Insuman Comb 50 per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insuman Comb 50 kuljum,
764 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 50 is injected under the skin 20 to 30 minutes before a meal.
Insuman Comb 50 huwa injettat taħt il- ġilda 30 sa 45 minuta qabel ikla.
Do NOT inject Insuman 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.
780 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Insuman Comb 50, pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Comb 50, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
765 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have missed a dose of Insuman Comb 50 or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Comb 50 jew ma injettajtx biżżejjed insulina, il- livell taz -
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
781 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
766 • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not use Insuman Comb 50 after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insuman Comb 50 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna.
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).
782 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).
Insuman Comb 50 is supplied in pre-filled pens, SoloStar, containing 3 ml suspension, (300 IU).
Insuman Comb 50 huwa fornut f’ pinen mimlija għal- lest, SoloStar, li fiha 3 ml ta ’ suspensjoni (300 IU).
767 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.
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
783 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
784 IPERGLIĊEMIJA U IPOGLIĊEMIJA
770 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
Tell your relatives, friends and close colleagues the following:
786 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
SoloStar.
Insuman Comb 50, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
Do not share it with anyone else. • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use SoloStar if it is damaged or if you are not sure that it is working properly. • Always have a spare SoloStar in case your SoloStar is lost or damaged.
787 • 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 infezzjoni. • Qatt m’ għandek tuża SoloStar jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm SoloStar żejda f’ każ li s- SoloStar tiegħek tintilef jew jiġrilha l- ħsara.
772 C.
Ċ.
If you are using clear insulin (Insuman Rapid), do not use this pen if the insulin is cloudy, coloured or has particles.
Jekk qed tuża insulina ċara, (Insuman Comb 50) tużax din il- pinna jekk l- insulina hija
If you are using a suspension insulin (Insuman Basal or Insuman mixtures), turn the pen up and down at least 10 times to resuspend the insulin.
mdardra, ikkulurita jew għandha xi partikuli. • Jekk qed tuża suspensjoni ta ’ l- insulina (Insuman Comb 50 jew taħlit ta ’ Insuman) l- insulina għandha titħallat billi ddawwar il- pinna ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
774 • 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.
This helps prevent: • Contamination and/or infection • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
790 • Id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u li l- insulina tqattar mill- pinna, li jistgħu jikkawżaw dożaġġ ineżatt.
775 Storage Instructions
Struzzjonijiet dwar il- ħażna
776 PACKAGE LEAFLET:
791 FULJETT TA ’ TAGĦRIF: