qanastek/EMEA-V3 huggingface dataset:
Take special care with Insuman Comb 15
Oqgħod attent ħafna b’ Insuman Comb 15
566 Travel
569 Safar
Using Insuman Comb 15 with food and drink
Meta tuża Insuman Comb 15 ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insuman Comb 15 in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insuman Comb 15 waqt it- tqala.
Important information about some of the ingredients of Insuman Comb 15
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 15
3.
571 3.
HOW TO USE INSUMAN COMB 15
KIF GĦANDEK TUŻA INSUMAN COMB 15
- determine how much Insuman Comb 15 per day you will need,
- jikkalkula kemm għandek bżonn Insuman Comb 15 kuljum,
- tell you when you may need to inject a higher or lower dose of Insuman Comb 15.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Comb 15,
568 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 15 is injected under the skin 30 to 45 minutes before a meal.
Insuman Comb 15 huwa injettat taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Do NOT inject Insuman Comb 15 into a vein.
TINJETTAX Insuman Comb 15 ġewwa vina.
Insuman Comb 15 contains 100 IU insulin per ml.
Insuman Comb 15 fih 100 IU insulina kull millilitru.
Insuman Comb 15 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
572 Insuman Comb 15 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.
Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- aventis.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insuman Comb 15.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insuman Comb 15.
If you use more Insuman Comb 15 than you should
Jekk tuża Insuman Comb 15 aktar milli suppost
- If you have injected too much Insuman Comb 15, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Comb 15 milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm
If you forget to use Insuman Comb 15
Jekk tinsa tuża Insuman Comb 15
- If you have missed a dose of Insuman Comb 15 or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Comb 15 jew jekk ma injettajtx biżżejjed insulina, il- livell
blood sugar level may become too high (hyperglycaemia).
tiegħek taz- zokkor fid- demm jista ’ jogħla wisq (ipergliċemija).
If you stop using Insuman Comb 15 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 15 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 15 without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insuman Comb 15 mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insuman Comb 15 can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insuman Comb 15 jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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)
573 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
570 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 15
KIF TAĦŻEN INSUMAN COMB 15
Do not use Insuman Comb 15 after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insuman Comb 15 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- kunjett.
Do not put Insuman Comb 15 next to the freezer compartment or a freezer pack.
Insuman Comb 15 m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
6.
574 6.
What Insuman Comb 15 contains
X’ fih Insuman Comb 15
One ml of Insuman Comb 15 contains 100 IU (International
Millilitru wieħed ta ’ Insuman Comb 15 fih 100 IU (Unita
15% of the insulin is dissolved in water; the other 85% is present as tiny crystals of insulin protamine.
15% ta ’ l- insulina hija maħlula fl- ilma; il - 85% l- oħra hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
What Insuman Comb 15 looks like and contents of the pack After mixing, Insuman Comb 15 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Comb 15 u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Comb 15 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Insuman Comb 15 is supplied in vials containing 5 ml suspension (500 IU).
Insuman Comb 15 huwa fornut f’ kunjetti ta ’ 5 ml ta ’ suspensjoni (500 IU).
España sanofi-aventis, S.A.
575 España sanofi- aventis, S. A.
572 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
574 PACKAGE LEAFLET:
578 FULJETT TA ’ TAGĦRIF:
Insuman Comb 15 40 IU/ml suspension for injection in a vial Insulin human
Insuman Comb 15 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
575 Travel
579 Safar
- sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to
- il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline
treat asthma),
użatgħall- kura ta ’ l- ażma),
3.
581 3.
577 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 15 contains 40 IU insulin per ml.
Insuman Comb 15 fih 40 IU insulina kull millilitru.
Insuman Comb 15 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
582 Insuman Comb 15 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.
For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Għal informazzjoni fuq il- kura ta ’ l- ipergliċemija, ara l- kaxxa li tinsab fit- tmiem ta ’ dan il- fuljett
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Dawn ir - reazzjonijiet għall- insulina jew għas- sustanzi mhux attivi jistgħu jwasslu għal Reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq.
Side effects reported 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)
583 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
579 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.
6.
584 6.
One ml of Insuman Comb 15 contains 40 IU (International
Millilitru wieħed ta ’ Insuman Comb 15 fih 40 IU (Unita
Insuman Comb 15 is supplied in vials containing 10 ml suspension (400 IU).
Insuman Comb 15 huwa fornut f’ kunjetti ta ’ 10 ml ta ’ suspensjoni (400 IU).
España sanofi-aventis, S.A.
585 España sanofi- aventis, S. A.
Tel: +39 02 393 91
Tel; +39 02 393 91
581 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
583 PACKAGE LEAFLET:
588 FULJETT TA ’ TAGĦRIF:
Insuman Comb 15 100 IU/ml suspension for injection in a cartridge Insulin human
Insuman Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
It comes in cartridges designed for use in an injection device of the OptiPen series.
Huwa disponibbli f’ skartoċċi magħmulin għall- użu f’ sistema ta ’ injezzjoni fis- serje ta ’ l - OptiPen.
Special patient groups
589 Gruppi speċjali ta ’ pazjenti
584 Before travelling, consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tiegħek.
585 Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu:
Important information about some of the ingredients of Insuman Comb 15
591 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 15
586 Frequency of administration
Kemm- il darba jingħata
Special care before injection
592 Attenzjoni speċjali qabel l- injezzjoni
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.
593 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.
Changing the injection site with each injection may help to prevent such skin changes. • Skin and allergic reactions 588 Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur.
Reazzjonijiet oħrajn ħfief fis- sit ta ’ l- injezzjoni (bħal ħmura fis- sit ta ’ l- injezzjoni, uġigħ qawwi mhux tas- soltu fis- sit ta ’ l- injezzjoni wara li din tingħata, ħakk, nefħa jew infjammazzjoni post ta ’ l - injezzjoni), jistgħu jiġru..
Do not use Insuman Comb 15 after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insuman Comb 15 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l - iskartoċċ.
Do not put Insuman Comb 15 next to the freezer compartment or a freezer pack.
Insuman Comb 15 m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża..
Keep the cartridge in the outer carton in order to protect from light.
594 Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
What Insuman Comb 15 looks like and contents of the pack After mixing, Insuman Comb 15 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Comb 15 u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Comb 15 huwa likwidu uniformi jixbaħ il- ħalib (suspensjoni għall - injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insuman Comb 15 is supplied in cartridges containing 3 ml suspension (300 IU).
Insuman Comb 15 huwa fornut f’ skartoċċi li fihom 3 ml ta ’ suspensjoni (300 IU).
589 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
595 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
596 IPERGLIĊEMIJA U IPOGLIĊEMIJA
If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or o thers 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.
Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.Caution:
Immedjatament ħu madwar 10 sa 20 g zokkor, bħal glukosju, dadi taz - zokkor, jew xi xarba ħelwa li fiha z- zokkor.
592 Tell your relatives, friends and close colleagues the following:
598 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
593 PACKAGE LEAFLET:
599 FULJETT TA ’ TAGĦRIF:
Insuman Comb 15 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insuman Comb 15 100 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 15, pre-filled pen, OptiSet, before you start using this medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet dwar l- Użu ta ’ Insuman Comb 15, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
BEFORE YOU USE INSUMAN COMB 15
QABEL MA TUŻA INSUMAN COMB 15 OPTISET
594 Travel
600 Safar
3.
602 3.
596 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
OptiSet delivers insulin in increments of 2 units. up to a maximum single dose of 40 units.
OptiSet tagħti l- insulina f’ zidiet ta ’ 2 unitajiet, sa massimu ta ’ 40 unità f’ doża waħda.
Insuman Comb 15 comes in cartridges sealed in disposable pen injectors, OptiSet.
Insuman 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.
603 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Insuman Comb 15, pre-filled pen, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Comb 15, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
597 If you use more Insuman Comb 15 than you should
Jekk tuża Insuman Comb 15 aktar milli suppost
- If you have injected too much Insuman Comb 15, your blood sugar level may become too low
- Jekk injettajt aktarInsuman Comb 15 milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm
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
604 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
598 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 15
KIF TAĦŻEN INSUMAN COMB 15 OPTISET
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).
605 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 Insuman Comb 15 looks like and contents of the pack After mixing, Insuman Comb 15 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Comb 15 u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Comb 15 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni), mingħajr ċapep, partikuli jew trofof viżibbli.
Insuman Comb 15 is supplied in pre-filled pens, OptiSet, containing 3 ml suspension, (300 IU).
Insuman Comb 15 huwa fornut f’ pinen mimlija għal- lest, OptiSet, li fiha 3 ml ta ’ suspensjoni, (300 IU).
599 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
606 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
607 IPERGLIĊEMIJA U IPOGLIĊEMIJA
601 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Hypoglycaemia is also more likely to occur if:
608 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
609 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
603 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
604 Step 2.
Pass Nru.
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.
613 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.
Storage Instructions
614 Struzzjonijiet dwar il- ħażna
Please check section 5 - How to store Insuman Comb 15 - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insuman Comb 15 - fuq il- faċċata ta ’ wara (ta ’ l - insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
608 Maintenance
Manutenzjoni
If the safety test is successful OptiSet is ready for use.
Jekk it- test ta sigurtà rnexxa l- OptiSet hija lesta għall- użu.
• Difference is more than 2 units.
615 M’ hemmx biżżejjed insulina fir- riżervwar.
609 The injection button cannot be pressed in.
Il- buttun ta ’ l - injezzjoni ma jistax
610 PACKAGE LEAFLET:
616 FULJETT TA ’ TAGĦRIF:
Insuman Comb 15 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insuman Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
Insuman Comb 15 is an insulin preparation with a gradual onset and long duration of action.
Insuman Comb 15 huwa preparat ta ’ l- insulina li jibda jaħdem b’ mod gradwali u jdum jaħdem għal żmien twil..
Do not use it in insulin pumps or other infusion pumps - special insulin preparations are available for use in such devices.
Tużahx f’ pompi ta ’ l- insulina jew pompi oħra għall- infuzzjoni - hemm preparazzjonijiet apposta ta ’ l- insulina disponibbli għall- użu ma ’ dan l - apparat.
Special patient groups
617 Gruppi speċjali ta ’ pazjenti
611 Travel
Safar
Important information about some of the ingredients of Insuman Comb 15
619 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 15
613 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Special care before injection
620 Attenzjoni speċjali qabel l- injezzjoni
614 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have missed a dose of Insuman Comb 15or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Comb 15 jew jekk ma injettajtx biżżejjed insulina, il- livell
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.
621 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.
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Jekk qed tbati minn retinopatija proliferattiva (marda ta ’ l- għajnejn relatata mad- dijabete) attakki severi ta ’ l- ipogliċemija jistgħu jirriżultaw f’ telf temporanju tal- vista. • Tibdiliet fil- ġilda fis- sit tal- injezzjoni (lipodistrofija) Jekk tinjetta l- insulina spiss wisq fl- istess sit tal- ġilda, t- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jogħlob jew jeħxien.
615 • 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.
Keep the cartridge in the outer carton in order to protect from light.
Insuman Rapid m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża. 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).
622 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 15 comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insuman Comb 15 huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
616 This cartridge is for use with OptiClik only.
Dan l- iskartoċċ huwa għall- użu ma ’ OptiClik biss.
Insuman Comb 15 is supplied in cartridges for OptiClik containing 3 ml suspension (300 IU).
Insuman Comb 15 huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ suspensjoni (300 IU).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
623 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
624 IPERGLIĊEMIJA U IPOGLIĊEMIJA
618 What should you do if you experience hyperglycaemia
X’ għandek tagħmel f’ każ ta ’ ipergliċemija
Hypoglycaemia is also more likely to occur if:
625 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
619 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:
626 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
620 PACKAGE LEAFLET:
627 FULJETT TA ’ TAGĦRIF:
Insuman Comb 15 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insuman Comb 15 100 Unità/ 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 15, 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 15, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
It comes in cartridges sealed in disposable pen injectors, SoloStar.
Dan jiġi fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, tas - SoloStar, pinna ta ’ l- insulina.
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Comb 15.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insuman Comb 15.
Take special care with Insuman Comb 15
Oqgħod attent ħafna b’ Insuman Comb 15:
621 Travel
628 Safar
Important information about some of the ingredients of Insuman Comb 15
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insuman Comb 15
- determine how much Insuman Comb 15 per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insuman Comb 15 kuljum,
623 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 15 is injected under the skin 30 to 45 minutes before a meal.
Insuman Comb 15 huwa injettat taħt il- ġilda 30 sa 45 minuta qabel ikla.
Do NOT inject Insuman Comb 15 into a vein.
TINJETTAX l- Insulina Comb 15 fil- vina.
To prevent the possible transmission of disease, each pen must be used by one patient only.
631 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Insuman Comb 15, pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Comb 15, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
624 If you use more Insuman Comb 15 than you should
Jekk tuża Insuman Comb 15 aktar milli suppost
- If you have missed a dose of Insuman Comb 15 or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Comb 15 jew ma injettajtx biżżejjed insulina, il- livell taz -
blood sugar level may become too high (hyperglycaemia).
zokkor f’ demmek jista ’ jogħla ħafna (ipergliċemija).
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
632 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
625 • 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 15 after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insuman Comb 15 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).
633 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 15 is supplied in pre-filled pens, SoloStar, containing 3 ml suspension, (300 IU).
Insuman Comb 15 huwa fornut f’ pinen mimlija għal- lest, SoloStar, li fiha 3 ml ta ’ suspensjoni (300 IU).
626 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
634 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
635 IPERGLIĊEMIJA U IPOGLIĊEMIJA
628 HYPOGLYCAEMIA (low blood sugar levels)
IPOGLIĊEMIJA (livell baxx ta ’ zokkor fid- demm)
Hypoglycaemia is also more likely to occur if:
636 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
629 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
Tell your relatives, friends and close colleagues the following:
637 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
SoloStar.
638 Insuman Comb 15, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
631 C.
Ċ.
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.
Iċċekkja d- dehera ta ’ l- insulina tiegħek. • Jekk qed tuża insulina ċara (Insuman Comb 15), tużax din il- pinna jekk l- insulina hija mdardra, ikkulurita jew għandha xi partikuli. • Jekk qed tuża suspensjoni ta ’ l- insulina (Insuman Comb 15 jew taħlit ta ’ Insuman) l- insulina għandha titħallat billi ddawwar il- pinna ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
633 • Do not push the injection button while turning, as insulin will come out.
641 • Timbuttax il- buttun ta ’ l- injezzjoni waqt li qed iddawwar, għax inkella l- insulina toħroġ.
Follow recommended safety measures for removal and disposal of needles (e.g. contact your healthcare professional) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri irrakkomandati ta’ sigurtà għat- tneħħija u r- rimi tal- labar (e. g. kellem lill- professjonist tiegħek fil- qasam tas- saħħa) biex
634 Storage Instructions
Struzzjonijiet dwar il- ħażna
635 PACKAGE LEAFLET:
643 FULJETT TA ’ TAGĦRIF:
Insuman Comb 25 100 IU/ml suspension for injection in a vial Insulin human
Insuman Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
What Insuman Comb 25 is and what it is used for 2.
X’ inhu Insuman Comb 25 u għalxiex jintuża 2.
Before you use Insuman Comb 25 3.
Qabel ma tuża Insuman Comb 25 3.
How to use Insuman Comb 25 4.
Kif għandek tuża Insuman Comb 25 4.
How to store Insuman Comb 25 6.
Kif taħżen Insuman Comb 25 6.
WHAT INSUMAN COMB 25 IS AND WHAT IT IS USED FOR
X’ INHU INSUMAN COMB 25 U GĦALXIEX JINTUŻA
Insuman Comb 25 is a fluid (suspension) for injection under the skin.
Insuman Comb 25 huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
The insulin contained in Insuman Comb 25 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Comb 25 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu (“ insulina umana ”).
Insuman Comb 25 is an insulin preparation with a gradual onset and long duration of action.
Insuman Comb 25 huwa preparat ta ’ l- insulina li jibda jaħdem b’ mod gradwali u jdum jaħdem għal żmien twil.
Insuman Comb 25 is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Comb 25 huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSUMAN COMB 25
QABEL MA TUŻA INSUMAN COMB 25
Do not use Insuman Comb 25
Tużax Insuman Comb 25
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) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insuman Comb 25.
Do not inject Insuman Comb 25 into a vein (blood vessel).
Tinjettax Insuman Comb 25 ġewwa vina (sistema vaskulari).
Take special care with Insuman Comb 25
Oqgħod attent ħafna b’ Insuman Comb 25
636 Travel
644 Safar
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti kundizzjonijiet
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 recognise 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 Insuman Comb 25 with food and drink
Meta tuża Insuman Comb 25 ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insuman Comb 25 in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insuman Comb 25 waqt it- tqala.
Important information about some of the ingredients of Insuman Comb 25
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Comb 25
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium- free’.
Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e tista ’ tgħid li huwa ‘ nieqes minn sodium ’..
3.
646 3.
HOW TO USE INSUMAN COMB 25
KIF GĦANDEK TUŻA INSUMAN COMB 25
- determine how much Insuman Comb 25 per day you will need,
- jikkalkula kemm għandek bżonn Insuman Comb 25 kuljum,
- tell you when you may need to inject a higher or lower dose of Insuman Comb 25.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Comb 25,
638 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 minn 30 sa 45 minuta qabel ikla.
Do NOT inject Insuman Comb 25 into a vein.
TINJETTAX Insuman Comb 25 ġewwa vina.
Insuman Comb 25 contains 100 IU insulin per ml.
Insuman Comb 25 fih 100 IU insulina kull millilitru.
Insuman Comb 25 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
647 Insuman Comb 25 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l- insulina.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insuman Comb 25.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insuman Comb 25.
If you use more Insuman Comb 25 than you should
Jekk tuża Insuman Comb 25 aktar milli suppost
- If you have injected too much Insuman Comb 25, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Comb 25 milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm
639 If you forget to use Insuman Comb 25
Jekk tinsa tuża Insuman Comb 25
- 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 jekk ma injettajtx biżżejjed insulina, il- livell
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 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 25 without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insuman Comb 25 mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insuman Comb 25 can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insuman Comb 25 jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Dawn ir - reazzjonijiet għall- insulina jew għas- sustanzi mhux attivi jistgħu jwasslu għal reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq
Side effects reported 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)
648 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
640 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).
HOW TO STORE INSUMAN COMB 25
KIF TAĦŻEN INSUMAN COMB 15
Do not use Insuman Comb 25 after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insuman Comb 25 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- kunjett.
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.
6.
649 6.
What Insuman Comb 25 contains
X’ fih Insuman Comb 25
One ml of Insuman Comb 25 contains 100 IU (International
Millilitru wieħed ta ’ Insuman Comb 25 fih 100 IU (Unita
25% of the insulin is dissolved in water; the other 75% is present as tiny crystals of insulin protamine.
25% ta ’ l- insulina hija maħlula fl- ilma; il - 75% l- oħra hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
What 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) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Insuman Comb 25 is supplied in vials containing 5 ml suspension (500 IU).
Insuman Comb 25 huwa fornut f’ kunjetti ta ’ 5 ml ta ’ suspensjoni (500 IU).
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:
España sanofi-aventis, S.A.
650 España sanofi- aventis, S. A.
642 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
652 Ezempji ta ’ sintomi li jindikaw livell baxx taz- zokkor fil- moħħ:: uġigħ ta ’ ras, ġuħ kbir, dardir, remettar, għeja, ngħas, disturbi fl- irqad, nuqqas ta ’ kwiet, komportament aggressiv, nuqqas ta ’ attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid- diskors, (xi drabi it- telf komplet tad- diskors), indeboliment tal- vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir- reġjun tal- ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t- telf mis- sensi.
644 PACKAGE LEAFLET:
653 FULJETT TA ’ TAGĦRIF:
Insuman Comb 25 40 IU/ml suspension for injection in a vial Insulin human
Insuman Comb 25 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
The insulin contained in Insuman Comb 25 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Comb 25 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
645 Travel
654 Safar
Before travelling consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tiegħek.
3.
656 3.
- tell you when you may need to inject a higher or lower dose of Insuman Comb 25.
- jgħidlek meta j għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Comb 25,
647 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Comb 25 contains 40 IU insulin per ml.
Insuman Comb 25 fih 40 IU insulina kull millilitru.
Insuman Comb 25 may be mixed with all Sanofi -Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
Insuman Comb 25 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l- insulina.
Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
657 It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- aventis.
If you forget to use Insuman Comb 25
Jekk tinsa tuża Insuman Comb 25
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.
658 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.
649 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.
One ml of Insuman Comb 25 contains 40 IU (International
Millilitru wieħed ta ’ Insuman Comb 25 fih 40 IU (Unita
Insuman Comb 25 is supplied in vials containing 10 ml suspension (400 IU).
Insuman Comb 25 huwa fornut f’ kunjetti ta ’ 10 ml ta ’ suspensjoni (400 IU).
España sanofi-aventis, S.A.
660 España sanofi- aventis, S. A.
651 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
653 PACKAGE LEAFLET:
663 FULJETT TA ’ TAGĦRIF:
Insuman Comb 25 100 IU/ml suspension for injection in a cartridge Insulin human
Insuman Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
It may harm them, even if their
Tista ’ tagħmlilhom il -
symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
Insuman Comb 25 is an insulin preparation with a gradual onset and long duration of action.
Insuman Comb 25 huwa preparat ta ’ l- insulina li jibda jaħdem bilmod u jdum jaħdem għal żmien twil..
Special patient groups
664 Gruppi speċjali ta ’ pazjenti
654 Travel
Safar
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
665 Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or operating machinery).
666 Żomm din il- problema f’ moħħok f’ kull sitwazzjoni fejn tista ’ tpoġġi lilek innifsek jew lil ħaddieħor f’ riskju (bħal fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
656 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
After mixing, the suspension must have a uniform milky white appearance.
667 Wara li titħallat, is- suspensjoni għandu jkollha dehra uniformi qisha ħalib.
If you use more Insuman Comb 25 than you should
Żbalji fid- dożaġġ Jekk tuża Insuman Comb 25 aktar milli suppost
As with all insulin therapy, the most frequent side effect is hypoglycaemia (low blood sugar).
668 Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- aktar effett sekondarju frekwenti huwa l- ipogliċemija (livell baxx ta ’ zokkor fid- demm).
658 • 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.
5.
669 5.
HOW TO STORE INSUMAN COMB 25
KIF TAĦŻEN INSUMAN COMB 25
Do not use Insuman Comb 25 after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insuman Comb 25 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).
Skartoċċi mhux miftuħa Aħżen fi friġġ bejn (2°Ċ- 8°Ċ).
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 jixbaħ il- ħalib (suspensjoni għall - injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insuman Comb 25 is supplied in cartridge containing 3 ml suspension (300 IU).
Insuman Comb 25 huwa fornut f’ skartoċċi li fihom 3 ml ta ’ suspensjoni (300 IU).
659 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.
Česká republika sanofi-aventis, s.r.o.
670 Česká republika sanofi- aventis, s. r. o.
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
671 IPERGLIĊEMIJA U IPOGLIĊEMIJA
661 HYPOGLYCAEMIA (low blood sugar levels)
IPOGLIĊEMIJA (livell baxx ta ’ zokkor fid- demm)
662 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).
673 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).
663 PACKAGE LEAFLET:
674 FULJETT TA ’ TAGĦRIF:
Insuman Comb 25 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insuman Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully including the Instructions for use of Insuman Comb 25, pre-filled pen, OptiSet, before you start using this medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet dwar l- Użu ta ’ Insuman Comb 25, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
Insuman Comb 25 is a fluid (suspension) for injection under the skin.
Insuman Comb 25 Optiset huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
The insulin contained in Insuman Comb 25 is made by a biotechnology process and is identical with the body's own insulin.
L - insulina li hemm f’ Insuman Comb 25 hija magħmula bi proċess bijoteknoloġiku u hija identika għall - insulina li jagħmel il- ġisem innifsu.
Take special care with Insuman Comb 25
Oqgħod attent ħafna b’ Insuman
664 Travel
Safar
Before travelling, consult your doctor.
675 Qabel tivvjaġġa kellem lit- tabib tiegħek.
3.
677 3.
666 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.