qanastek/EMEA-V3 huggingface dataset:
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision. • Skin changes at the injection site (lipodystrophy)
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.
478 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.
Insulin that you inject in such a site may not work very well.
Bidla fis- sit tal - injezzjoni ma ’ kull injezzjoni jgħin biex dawn il- bidliet fil- ġilda ma jiġrux. • Reazzjonijiet tal- ġilda u dawk allerġiċi.
Unopened cartridges Store in a refrigerator (2°C – 8°C).
Skartoċċi mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ).
In-use cartridges Cartridges in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Skartoċċi fl- użu Skaroċċi 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 iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
The cartridge in-use must not be stored in a refrigerator.
L- iskartoċċ fl- użum’ għandux jinżamm fi friġġ.
Medicines should not be disposed of via wastewater or household waste.
475 Il- mediċini m’ ghandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma l- iskart domestiku.
100 IU (International Units) of the active substance insulin human.
100 IU (Unit Internazzjonali) tas- sustanza attiva insulina umana.
Insulin Human Winthrop Rapid comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insulin Human Winthrop Rapid huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
Packs of 3, 4, 5, 6, 9 and 10 cartridges of 3 ml are available.
Insulin Human Winthrop Rapid huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ soluzzjoni (300 IU). Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi ta ’ 3 ml.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il - pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
476 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
477 IPERGLIĊEMIJA U IPOGLIĊEMIJA
What should you do if you experience hyperglycaemia
X’ għandek tagħmel f’ każ ta ’ ipergliċemija
481 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:
478 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
- you have just begun insulin treatment or changed to ano ther insulin preparation,
- int għadek tibda t- trattament bl- insulina jew qlibt għal preparat ieħor ta ’ insulina,
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.
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.
482 The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
L- ewwel sintomi li jagħtuk indikazzjoni li ser tiżviluppa l- ipogliċemija (“ sintomi ta ’ twissija ”) jistgħu jinbidlu, jiddgħajfu jew ikunu nieqsin għal kollox, jekk:
Tell your relatives, friends and close colleagues the following:
479 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
483 PACKAGE LEAFLET:
480 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Rapid 100 IU/ml, solution for injection in a pre -filled pen Insulin human
Insulin Human Winthrop Rapid 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal - lest Insulina umana
Read all of this leaflet carefully, including the Instructions for Use of Insulin Winthrop Rapid, pre-filled pen, SoloStar, before you start using this medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Insulin Human Winthrop Rapid, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. - Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
The insulin contained in Insulin Human Winthrop Rapid is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Rapid hija magħmula bi proċess bijoteknoloġiku u hija identika għall - insulina li jagħmel il- ġisem innifsu
It comes in cartridges sealed in disposable pen injectors, SoloStar.
Dan jiġi fornut f’ skartoċċi issiġillat, li hija l- parti li tintrema, ta ’ SoloStar, pinna ta ’ l- insulina.
Special patient groups
Gruppi speċjali ta ’ pazjenti
484 Travel
481 Safar
- the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
- l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf l- ipogliċemija huma ridotti jew m’ humiex preżenti.
Important information about some of the ingredients of Insulin Human Winthrop Rapid
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insulin Human Winthrop Rapid
Based on your life -style and the results of your blood sugar (glucose) tests, your doctor will
Skond l- istil ta ’ ħajjtek u r- riżultati tat- testijiet taz- zokkor (glukożju) fid- demm, it- tabib tiegħek sejjer
486 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
See the box at the end of this leaflet for further information.
Ara l- informazzjoni f’ kaxxa li ssib fi tmiem dan il- fuljett għal aktar dettalji.
How to handle SoloStar
Kif timmaniġġa s- SoloStar
SoloStar is a pre-filled disposable pen containing human insulin.
SoloStar hija pinna mimlija għal- lest, li tintrema wara li tinħela, u fiha l- insulina umana.
Read carefully the "SoloStar Instructions for Use" included in this package leaflet.
Aqra bir- reqqa “ L- Istruzzjonijiet Dwar l- Użu ta ’ SoloStar ” li jinsabu f’ dan il- fuljett ta ’ tagħrif.
Only use needles that have been approved for use with SoloStar.
Uża biss labar li huma kompatibbli għall- użu ma ’ SoloStar).
Do not use Insulin Human Winthrop Rapid if you notice particles in it.
Tużax Insulin Human Winthrop Rapid jekk tinnota li fih l - partikuli.
Only use Insulin Human Winthrop Rapid if the solution is clear, colourless and waterlike.
Uża biss Insulin Human Winthrop Rapid jekk is- soluzzjoni hija ċara, mingħajr kulur u tixbaħ l- ilma.
If you think you have a problem with SoloStar, consult your Healthcare Professional.
Jekk taħseb li għandek xi problema b’ SoloStar, kellem lill Professjonist fil Qasam tas- Saħħa.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Kun żgur li la alkoħol u anqas disinfettanti oħra, jew xi sustanzi oħra, ma jikkontaminaw l- insulina.
Insulin Human Winthrop Rapid, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insulin Human Winthrop Rapid, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
Empty pens must not be re-filled and must be properly discarded.
484 Pinen vojta m’ għandhomx jerġgħu jimtlew u għandhom jintremew kif jixraq.
Do not use SoloStar if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new SoloStar has to be used.
Tużax s- SoloStar jekk hi bil- ħsara jew mhix qed taħdem sew, din għandha tintrema u SoloStar ġdida tintuża minflok.
487 If you forget to use Insulin Human Winthrop Rapid
Jekk tinsa tuża Insulin Human Winthrop Rapid
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)
485 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
488 • Skin and allergic reactions 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 Insulin Human Winthrop Rapid after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insulin Human Winthrop Rapid wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna.
6.
486 6.
Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available.
Insulin Human Winthrop Rapid huwa fornut f’ pinen mimlija għal- lest, SoloStar li fihom 3 ml ta ’ soluzzjoni (300 IU). Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen ta ’ 3 ml.
489 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:
Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Österreich sanofi- aventis GmbH Tel: +43 1 80 185 - 0
España sanofi-aventis, S.A.
487 España sanofi- aventis, S. A.
- your insulin pen does not work properly,
488
491 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
492 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
493 Insulin Human Winthrop Rapid solution for injection in a pre-filled pen.
Insulin Human Winthrop Rapid, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
Instructions for Use.
Struzzjonijiet dwar l- Użu.
SoloStar is a prefilled pen for the injection of insulin.
SoloStar hija pinna mimlija għal- lest, għall- injezzjoni ta ’ l- insulina.
Your healthcare professional has decided that SoloStar is right for you.
Il- professjonist tiegħek fil- qasam tas- saħħa iddeċieda li SoloStar hija tajba għalik.
Talk with your healthcare professional about proper injection technique before using SoloStar.
Kellem lill- professjonist tiegħek fil- qasam tas- saħħa dwar it- teknika korretta ta ’ l- injezzjoni qabel tuża SoloStar.
Read these instructions carefully before using your SoloStar.
Aqra dawn l- istruzzjonijiet bir- reqqa qabel tuża s- SoloStar tiegħek.
If you are not able to follow all the instructions completely on your own, use SoloStar only if you have help from a person who is able to follow the instructions.
Jekk m’ intix kapaċi issegwi l - istruzzjonijiet kollha waħdek, uża SoloStar biss jekk issib għajnuna minn persuna oħra li tista ’ ssegwi l- istruzzjonijiet.
Hold the pen as shown in this leaflet.
Żomm il- pinna kif murija f’ dan il- fuljett.
To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
490 suppost, żomm il- pinna orizzontali, bil- labra fuq ix- xellug u s- selettur tad- dożagg fuq il- lemin kif jidher fl- immaġni hawn taħt.
Follow these instructions completely each time you use SoloStar to ensure that you get an accurate dose.
Segwi għalkollox l- istruzzjonijiet kull darba li tuża s- SoloStar biex tassigura li qed tieħu id- doża preċiża.
If you do not follow these instructions completely, you may get too much or too little insulin, which may affect your blood glucose.
Jekk ma ssegwix għalkollox dawn l- istruzzjonijiet, inti tista ’ tieħu iżjed jew inqas insulina milli meħtieġ u dan jista ’ jaffettwalek il- livell taz- zokkor f’ demmek
You can set doses from 1 to 80 units in steps of 1 unit.
Int tista ’ tissettja d- doża minn Unità waħda sa 80 Unità f’ qabżiet ta ’ Unità l- waħda.
Keep this leaflet for future reference.
Żomm dan il- fuljett għax għandek mnejn tkun tixtieq terġa ’ taqrah ’ il quddiem.
If you have any questions about SoloStar or about diabetes, ask your healthcare professional or call the local sanofi-aventis number on the front of this leaflet.
Jekk għandek xi diffikultajiet dwar l- użu ta ’ SoloStar jew id- dijabete tiegħek, saqsi lill- professjonist tiegħek fil- qasam tas- saħħa jew ċempel fuq in- numru lokali ta ’ Sanofi- Aventis, li ssib fuq il- faċċata ta ’ dan il- fuljett.
Important information for use of SoloStar:
Tagħrif importanti dwar l- użu ta ’ SoloStar:
Only use needles that have been approved for use with SoloStar. • Always perform the safety test before each injection (see Step 3). • This pen is only for your use.
3). • Din il- pinna hija għall- użu tiegħek biss.
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.
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 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.
Check the insulin
Tiċċekkja l- insulina
Check the label on your SoloStar to make sure you have the correct insulin.
Iċċekkja t- tikketta tas- SoloStar tiegħek biex tassigura ruħek li għandek l- insulina korretta.
Insulin Human Winthrop SoloStar is white with a colour on the injection button.
L - Insulin Human Winthrop SoloStar hija ta ’ kulur abjad b’ kulur fuq il- buttun ta ’ l- injezzjoni.
The injection button colour will vary based on the formulation of Insulin Human Winthrop insulin used.
Il - kulur tal- buttun ta ’ l- injezzjoni jista ’ jvarja skond il- formulazzjoni tal- insulina Insulin Human Winthrop.
The pictures below are for illustrative purposes only.
L- istampi hawn taħt huma biss għall- għanijiet illustrattivi.
Take off the pen cap.
Neħħi l- kappa mill- pinna.
494 C.
Ċ.
Check the appearance of your insulin.
Iċċekkja d- dehera ta ’ l- insulina tiegħek.
If you are using clear insulin (Insulin Human Winthrop Rapid), do not use this pen if the insulin is cloudy, coloured or has particles.
Jekk qed tuża insulina ċara, (Insulin Human Winthrop Rapid) tużax din il- pinna jekk l -
If you are using a suspension insulin (Insulin Human Winthrop Basal or Insulin Human Winthrop mixtures), turn the pen up and down at least 10 times to resuspend the insulin.
insulina hija mdardra, ikkulurita jew għandha xi partikuli. • Jekk qed tuża suspensjoni ta ’ l- insulina (Insulin Human Winthrop Basal jew taħlit ta ’ Insulin Human Winthrop) l- insulina għandha titħallat billi ddawwar il- pinna ’ il fuq u ’ l isfel għal
Turn the pen gently to avoid foaming in the cartridge.
Il- pinna għandha tiġi mdawwra bilmod biex tevita r- ragħwa fl - iskartoċċ.
After mixing check the appearance of your insulin.
Iċċekkja d- dehera ta ’ l- insulina tiegħek wara li tħallat.
Insulin suspensions must have an evenly milky-white appearance.
Is- suspenzjoni ta ’ l- insulina għandha jkollha dehera uniformi tixbaħ lil dik tal- ħalib.
Step 2.
2
Attach the needle
Twaħħal il- labra
Before use of needle, carefully read the “Instructions for Use” accompanying the needles.
Qabel l- użu tal- labra, aqra bir- reqqa “ L- istruzzjonijiet dwar l- Użu ” li jiġu mal- labar.
Please note:
Oqgħod attent:
The needles shown are for illustrative purposes only.
Il- labar huma biss għall- għanijiet illustrattivi.
If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
• Jekk il- labra ma tinżammx dritta waqt li qed tqabbadha, din tista ’ tagħmel ħsara l- woxer tal - lastku, u bħala riżultat ta ’ dan, il- pinna tibda tqattar, jew il- labra tinkiser.
Perform a safety test
Tagħmel test ta ’ sigurtà
This ensures that you get an accurate dose by: • ensuring that pen and needle work properly • removing air bubbles
Dan jiżgura li d- doża tkun preċiza għax: • tkun żgur li l- pinna u l- labra qed jaħdmu sew. • tneħħi l- bżieżaq ta ’ l- arja.
Select a dose of 2 units by turning the dosage selector.
Agħżel doża ta ’ 2 unitajiet billi ddawwar is- selettur tad- dożaġġ.
Take off the outer needle cap and keep it to remove the used needle after injection.
Neħħi l- kappa ta ’ barra tal- labra u żommha biex tkun tista ’ tneħħi l- labra użata biha, wara l - injezzjoni.
Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Taptap ir- riżervwar ta ’ l- insulina biex jekk hemm xi bżieżaq ta ’ l- arja dawn jitilgħu ’ l fuq lejn il- labra.
Check if insulin comes out of the needle tip.
Iċċekkja li l- insulina qed toħroġ mill- ponta tal - labra.
• If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them. • If still no insulin comes out, the needle may be blocked.
Għandu mnejn ikollok tagħmel it- test ta ’ sigurtà diversi drabi qabel ma titfaċċa l- insulina. • Jekk ebda insulina ma toħroġ, iċċekkja għall- preżenza ta ’ bżieżaq ta ’ l- arja u irrepeti t- test ta ’ sigurtà darbtejn jew aktar biex tneħħihom. • Jekk xorta ma toħroġx l- insulina, l- labra tista ’ tkun miżduda.
Change the needle and try again. • If no insulin comes out after changing the needle, your SoloStar may be damaged.
Biddel il- labra u erġa ’ pprova. • Jekk ebda insulina ma toħroġ wara li tibdel il- labra, s- SoloStar tiegħek tista ’ tkun bil- ħsara.
Do not use this SoloStar.
Tużax din is- SoloStar.
You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Tista ’ tissettja d- doża f’ qabżiet ta ’ Unità l- waħda, minn minimu ta ’ Unità waħda sa massimu ta ’ 80 Unità.
If you need a dose greater than 80 units, you should give it as two or more injections.
Jekk tinħtieġ doża akbar minn 80 Unità, trid tehodha f’ żewġ injezzjonijiet jew aktar.
Check that the dose window shows “0” following the safety test.
Iċċekkja li t- tieqa tad- dożaġġ turi “ 0 ” wara li tkun għamilt it- test ta ’ sigurtà.
Select your required dose (in the example below, the selected dose is 30 units).
Agħżel id- doża meħtieġa (fl- eżempju hawn taħt, id- doża magħżula hija 30 Unità).
If you turn past your dose, you can turn back down.
Jekk tiskorri d- doża tiegħek waqt li qed iddawwar, tista ’ terġa tiġi lura.
496 • 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.
• You cannot turn the dosage selector past the number of units left in the pen.
• Ma tistax iddawwar is- selettur tad- dożaġġ ’ l hinn minn numru ta ’ unitajiet li fadal fil- pinna.
Do not force the dosage selector to turn.
Tisforzax is- selettur tad- dożaġġ billi ddawwru.
In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
F’ dan il- każ, jew tista ’ tinjetta dak li fadal fil - pinna u tkompli bid- doża tiegħek b’ pinna ġdida SoloStar, jew tuża SoloStar ġdida għad- doża sħiha.
Step 5.
493 Pass Nru. 5
Use the injection method as instructed by your healthcare professional.
Uża l- metodu ta ’ l- injezzjoni li urik il- professjonist tiegħek fil- qasam tas- saħħa.
Deliver the dose by pressing the injection button in all the way.
Ħu d- doża billi tagħfas il- buttun ta ’ l- injezzjoni it- tul kollu.
The number in the dose window will return to “0” as you inject.
In- numru fit- tieqa li turi d- doża għandu jerġa ’ lura għal “ 0 ” waqt li tinjetta.
Keep the injection button pressed all the way in.
Żomm il- buttun ta ’ l- injezzjoni magħfus sa ġewwa.
Slowly count to 10 before you withdraw the needle from the skin.
Għodd bil- mod sa 10 qabel ma tiġbed il - labra lura u barra mill- ġilda.
This ensures that the full dose will be delivered.
Dan jiżgura li tkun ħadt id- doża sħiħa.
The pen plunger moves with each dose.
Il- planġer tal- pinna tiċċaqlaq ma ’ kull doża.
The plunger will reach the end of the cartridge when the total of 300 units of insulin have been used.
Il- planġer jasal sat- tarf ta ’ l- iskartoċċ meta jintuża t- total ta ’ 300 unitajiet ta ’ insulina.
Always remove the needle after each injection and store SoloStar without a needle attached.
Dejjem neħħi l- labra wara kull injezzjoni u aħżen SoloStar mingħajr labra fil- post.
This helps prevent: • Contamination and/or infection • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Dan jgħin biex telimina: • Il- kontaminazzjoni u/ jew l- infezzjoni • Id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u li l- insulina tqattar mill- pinna, li jistgħu jikkawżaw dożaġġ ineżatt.
• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
• Jekk l- injezzjoni tiegħek ser tingħata minn persuna oħra, għandha tittieħed attenzjoni speċjali minn din il- persuna waqt li tneħħi u tarmi l- labra.
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. ż. kellem lill- professjonist tiegħek fil- qasam tas- saħħa) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess xi mard infettiv.
Dispose of the needle safely.
Armi l- labra mingħajr periklu.
Always put the pen cap back on the pen, then store the pen until your next injection.
Qiegħed il- kappa tal- pinna lura f’ postha, u wara aħżen il- pinna sa l- injezzjoni li jmissek tieħ
497 Storage Instructions
Struzzjonijiet dwar il- ħażna
Please check the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
Jekk jogħġbok ara l- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ SoloStar.
If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up.
Jekk is- SoloStar tiegħek hija maħzuna fil- kesħa, oħroġha minn siegħa sa sagħtejn qabel tinjetta biex tħalliha tisħon u tilħaq it- temperatura ta ’ ġewwa.
Discard your used SoloStar as required by your local authorities.
494 Armi s- SoloStar użata tiegħek kif jitolbu l- awtoritajiet lokali.
Protect your SoloStar from dust and dirt.
Żomm is- SoloStar tiegħek ’ il bogħod mit- trab u l- ħmieġ.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Tista ’ tnaddaf is- SoloStar tiegħek minn barra billi timsaħha b’ ċaruta niedja.
Do not soak, wash or lubricate the pen as this may damage it.
Ixxarrabx, taħsilx u anqas m’ għandek tillubrika l- pinna għax dawn jistgħu jagħmlulha ħsara.
Your SoloStar is designed to work accurately and safely.
Is- SoloStar tiegħek hija magħmula biex taħdem bi preċiżjoni u sigurtà.
It should be handled with care.
Għandha tkun immaniġġata bir- reqqa.
If you are concerned that your SoloStar may be damaged, use a new one.
Jekk int qed tinkwieta li s - SoloStar tiegħek seta ’ ġralha xi ħsara, armiha u uża waħda ġdida.
498 PACKAGE LEAFLET:
495 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Basal 100 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu, qabel tibda tuża din il- mediċina.
What Insulin Human Winthrop Basal is and what it is used for 2.
X’ inhu Insulin Human Winthrop Basal u għalxiex jintuża 2.
Before you use Insulin Human Winthrop Basal 3.
Qabel ma tuża Insulin Human Winthrop Basal 3.
How to use Insulin Human Winthrop Basal 4.
Kif għandek tuża Insulin Human Winthrop Basal 4.
Possible side effects 5.
Effetti sekondarji jista ’ jkollha 5.
How to store Insulin Human Winthrop Basal 6.
Kif taħżen Insulin Human Winthrop Basal 6.
WHAT INSULIN HUMAN WINTHROP BASAL IS AND WHAT IT IS USED FOR
X’ INHU INSULIN HUMAN WINTHROP BASAL U GĦALXIEX JINTUŻA
Insulin Human Winthrop Basal is a fluid (suspension) for injection under the skin.
Insulin Human Winthrop Basal huwa likwidu (suspensjoni) għall- injezzjoni taħt il- ġilda.
The insulin contained in Insulin Human Winthrop Basal is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li tinsab f ’ Insulin Human Winthrop Basal, hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina tal - ġisem stess.
Insulin Human Winthrop Basal is an insulin preparation with a gradual onset and long duration of action.
Insulin Human Winthrop Basal hija preparat ta ’ l- insulina li tibda taħdem bil- mod u ddum taħdem għal żmien twil.
The insulin is present as tiny crystals of insulin protamine.
L- insulina tikkonsisti f’ kristalli ċkejknin ta ’ l- insulina protamine.
Insulin Human Winthrop Basal is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Basal hija użata biex tbaxxi l- livell għoli taz- zokkor fid- demm tal- pazjenti li qed ibatu minn diabetes mellitus.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Id- dijabete mellitus hija marda meta ġismek ma jistax jipproduċi biżżejjed insulina biex jikkontrolla l- livell taz- zokkor fid- demm.
BEFORE YOU USE INSULIN HUMAN WINTHROP BASAL
QABEL MA TUŻA INSULIN HUMAN WINTHROP BASAL
Do not use Insulin Human Winthrop Basal
Tużax Insulin Human Winthrop Basal:
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Basal.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insulin Human Winthrop Basal.
Do not inject Insulin Human Winthrop Basal into a vein (blood vessel).
Tinjettax Insulin Human Winthrop Basal fil- vina (sistema vaskulari).
Do not use it in insulin pumps or other infusion pumps - special insulin preparations are available for use in such devices.
Tużahiex fil- pompi għall - insulina jew pompi oħra għal- infużjoni – hemm preparazzjonijiet apposta t’ insulina disponibbli għall - użu ma ’ dan l- apparat.
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Oqgħod attent ħafna b ’ Insulin Human Winthrop Basal Segwi sew l- istruzzjonijiet fuq id- dożaġġ, il- moniteraġġ (permezz ta ’ analiżi tad- demm u ta ’ l- awrina), id- dieta, u l- eżerċizju fiżiku (xogħol fiżiku u eżerċizju), kif diskuss mat- tabib tiegħek.
499 Travel
496 Safar
Using Insulin Human Winthrop Basal with food and drink
Meta tuża Insulin Human Winthrop Basal ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insulin Human Winthrop Basal in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insulin Human Winthrop Basal waqt it- tqala.
If you are breast - feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Jekk int qed tredda ’, iddiskutiha mat- tabib tiegħek għax jista ’ jagħti l- każ li teħtieġ tibdiliet fid- dożi ta ’ l- insulina u d- dieta tiegħek.
You r ability to concentrate or react may be reduced if:
L- abbiltà tiegħek biex tikkonċentra u tirreaġixxi tista ’ tonqos jekk:
- you have problems with your sight.
- għandek problemi bil- vizta tiegħek.
Important information about some of the ingredients of Insulin Human Winthrop Basal
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Basal
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.
498 3.
HOW TO USE INSULIN HUMAN WINTHROP BASAL
KIF GĦANDEK TUŻA INSULIN HUMAN WINTHROP BASAL
- determine how much Insulin Human Winthrop Basal per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insulin Human Winthrop Basal kuljum,
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- jġħidlek meta teżamina l- livell taz- zokkor f’ demmek, u jekk għandek bżonn tagħmel analiżi ta ’
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop Basal.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop Basal,
501 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insulin Human Winthrop Basal is injected under the skin 45 to 60 minutes before a meal.
Insulin Human Winthrop Basal huwa injettat taħt il- ġilda 45 sa 60 minuta qabel ikla.
Do NOT inject Insulin Human Winthrop Basal into a vein.
TINJETTAX Insulin Human Winthrop Basal fil- vina.
Insulin Human Winthrop Basal contains 100 IU insulin per ml.
Insulin Human Winthrop Basal fih 100 IU insulina kull millilitru.
Only injection syringes designed for this insulin concentration (100 IU per ml) must be used.
Għandhom jintużaw biss dawk is - siringi għall- injezzjoni li huma magħmulin għall- qawwa ta ’ din l- insulina (100 IU kull ml).
The injection syringes must not contain any other medicines or traces of medicines (such as traces of heparin).
Is- siringi ta ’ l- injezzjoni m’ għandhomx ikollhom ebda mediċini oħrajn jew xi traċċi tagħhom (bħal traċċi ta ’ eparina).
Before the first withdrawal of insulin you must remove the safety tear-off cap on the vial.
Qabel ittella ’ l- ewwel doża ta ’ l- insulina għandek tneħħi l- għatu ta ’ sigurtà tal- kunjett billi ċċarrtu.
Mix the insulin well immediately before each injection.
Ħallat l- insulina sew immedjatament qabel kull injezzjoni.
This is best done by rolling the vial tilted between the palms of the hands.
Dan l- aħjar li jsir billi bil- kunjett immejjel iddawru bejn il- pali ta ’ l- idejn.
Do not shake the vial vigorously as this could damage the insulin and cause froth to form.
Iċċekċikx il- kunjett bil- qawwa għax dan jista ’ jagħmel ħsara lill - insulina u jikkaġuna r- ragħwa.
Froth can make it difficult for you to measure the correct dose.
Ir- ragħwa tista ’ tfixklek fil- miżura korretta tad- doża.
After mixing, the suspension must have a uniform milky white appearance.
Wara r- ridistribuzzjoni tal- partiċelli, il- likwidu għandu jkollu dehera uniformi tixbaħ lil dik tal- ħalib.
It must not be used if it remains clear or if, for example, clumps, flakes, particles or anything similar are in the suspension or on the sides or bottom of the vial.
Jekk dan jibqa ’ ċar, jew per eżempju, jitfaċċaw xi ċapep, laqx, partikoli jew xi ħaġa oħra simili fil - likwidu, jew mal- ġenb jew il- qiegħ tal- kunjett, l- insulina ma tistax tintuża.
A new vial with a uniform suspension on mixing must then be used.
Imbagħad, kunjett ġdid li juri l- partiċelli żgħar mqassmin b’ mod uniformi meta jitħallat jrid jintuża.
Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża kunjett ġdid jekk tinnota li l- kontroll tal- livell taz- zokkor f’ demmek qed imur għall- agħar mingħajr m’ hu mistenni.
This is because the insulin may have lost some of its effectiveness.
Dan għaliex l- insulina tista ’ tkun tilfet parti mill- effikaċja tagħha.
If you think you may have a problem with your insulin, have it checked by your doctor or pharmacist.
Jekk taħseb li għandek problema bl- insulina tiegħek, staqsi lit- tabib tiegħek jew l- ispiżjar biex jiċċekkjahielek.
Insulin Human Winthrop Basal may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
Insulin Human Winthrop Basal 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 -
Also, it must NOT be mixed with animal source insulins or insulin analogues.
Jeħtieġ ukoll li M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- Aventis.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insulin Human Winthrop Basal.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insulin Human Winthrop Basal.
Inject as soon as you have mixed them.
Injetta hekk kif tħallathom.
Do not mix insulins of different strengths (for example 100 IU per ml and 40 IU per ml).
Tħallatx insulini ta ’ qawwa differenti (per eżempju insulina ta ’ 100 IU kull millilitru ma ’ waħda ta ’ 40 IU kull millilitru).
If you use more Insulin Human Winthrop Basal than you should
Jekk tuża aktar Insulin Human Winthrop Basal milli suppost
- If you have injected too much Insulin Human Winthrop Basal, your blood sugar level may
- Jekk injettajt Insulin Human Winthrop Basal aktar milli meħtieġ, il- livell taz- zokkor
502 If you forget to use Insulin Han WinthropBasal
Jekk tinsa tuża Insulin Human Winthrop Basal
- If you have missed a dose of Insulin Human Winthrop Basal or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Basal jew ma injettajtx biżżejjed insulina, il -
If you stop using Insulin Human Winthrop Basal This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Basal Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Do not stop Insulin Human Winthrop Basal without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insulin Human Winthrop Basal mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insulin Human Winthrop Basal can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insulin Human Winthrop Rapid 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)
500 Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema, shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
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.
503 • Skin and allergic reactions 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..
HOW TO STORE INSULIN HUMAN WINTHROP BASAL
KIF TAĦŻEN INSULIN HUMAN WINTHROP BASAL
Do not use Insulin Human Winthrop Basal after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insulin Human Winthrop Basal wara d- data ta ’ skadenza li hija murija fuq il- kaxxa u fuq it - tikketta tal- kunjett.
Do not put Insulin Human Winthrop Basal next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Basal m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
Opened vials Once in-use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Kunjetti miftuħa Ġaladarba fl- użu, - kunjett jista jinħażen sa massimu ta ’ 4 ġimgħat, 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).
Do not use the vial after this time period.
Tużax il- kunjett wara dan il- perijodu ta ’ żmien.
It is recommended that the date of the first use be noted on the label.
Huwa rakkomandat li d- data ta ’ l- ewwel użu titniżżel fuq it- tikketta.
6.
501 6.
What Insulin Human Winthrop Basal contains
X’ fih Insulin Human Winthrop Basal
One ml of Insulin Human Winthrop Basal contains
Millilitru wieħed ta ’ Insulin Human Winthrop Basal fih
- The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium
- Is- sustanzi l- oħra huma: protamine sulphate, meta- cresol, phenol, zinc chloride, sodium
dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment) and water for injections.
dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall - aġġustament tal- pH), u ilma għall- injezzjonijiet.
What Insulin Human Winthrop Basal looks like and contents of the pack After mixing, Insulin Human Winthrop Basal is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Basal u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Basal huwa likwidu uniformi qisu ħalib (suspensjoni għall - injezzjoni) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Insulin Human Winthrop Basal is supplied in vials containing 5 ml suspension (500 IU).
Insulin Human Winthrop Basal huwa fornut f’ kunjetti ta ’ 5 ml ta ’ suspensjoni (500 IU).
Packs of 1 and 5 vials of 5 ml are available.
Huwa disponibbli f’ pakketti ta ’ kunjett wieħed u ta ’ 5 kunjetti ta ’ 5 ml.
504 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.
502 España sanofi- aventis, S. A.
Serious hypoglycaemia may cause a heart attack or brain damage and may be life -threatening.
Jekk il- livell taz- zokkor fid- demm tiegħek jinżel wisq tista ’ tintilef minn sensik. Ipogliċemija serja tista ’ tkun il- kawża ta ’ attakk ta ’ qalb jew ta ’ ħsara fil- moħħ u tista ’ tkun fatali.
506 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
507 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija?
508 PACKAGE LEAFLET:
505 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Basal 40 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Basal 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
509 Travel
506 Safar
3.
508 3.
511 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insulin Human Winthrop Basal contains 40 IU insulin per ml.
Insulin Human Winthrop Basal fih 100 IU insulina kull millilitru.
Only injection syringes designed for this insulin concentration (40 IU per ml) must be used.
Għandhom jintużaw biss dawk is - siringi għall- injezzjoni li huma magħmulin għall- qawwa ta ’ din l- insulina (100 IU kull ml).
Insulin Human Winthrop Basal may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
509 Insulin Human Winthrop Basal 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 Insulin Human Winthrop Basal than you should
Jekk tuża Insulin Human Winthrop Basal aktar milli suppost
- If you have injected too much Insulin Human Winthrop Basal, your blood sugar level may
- Jekk injettajt aktar Insulin Human Winthrop Basal, il- livell taz- zokkor tiegħek fid- demm
become too low (hypoglycaemia).
jista ’ jitbaxxa wisq (ipogliċemija).
512 If you forget to use Insulin Human Winthrop Basal
Jekk tinsa tuża Insulin Human Winthrop Basal
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)
510 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
513 • Skin and allergic reactions 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..
Opened vials Once in-use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Kunjetti miftuħa Ġaladarba fl- użu, tista ’ żżomm il- kunjett għal mhux aktar minn 4 ġimgħat, 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).
It is recommended that the date of the first use be noted on the label.
Huwa rakkomandat li tniżżel fuq it- tikketta d - data ta ’ meta ħadt l- ewwel doża mill- kunjett.
6.
511 6.
40 IU (International Units) of the active substance insulin human.
40 IU (Unita Internazzjonali) tas- sustanza attiva insulina umana.
Insulin Human Winthrop Basal is supplied in vials containing 10 ml suspension (400 IU).
Insulin Human Winthrop Basal huwa fornut f’ kunjetti ta ’ 10 ml ta ’ suspensjoni (400 IU).
Packs of 1 and 5 vials of 10 ml are available.
Huwa disponibbli f’ pakketti ta ’ kunjett wieħed u ta ’ 5 kunjetti ta ’ 10 ml.
514 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.
512 España sanofi- aventis, S. A.
516 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
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.
514 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.
517 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
518 PACKAGE LEAFLET:
515 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Basal 100 IU/ml suspension for injection in a cartridge Insulin human
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
The insulin contained in Insulin Human Winthrop Basal is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Basal hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insulin Human Winthrop Basal is an insulin preparation with a gradual onset and long duration of action.
Insulin Human Winthrop Basal huwa preparat ta ’ l- insulina li jibda jaħdem bilmod u jdum jaħdem għal żmien twil.
It comes in cartridges designed for use in an injection device of the OptiPen series.
L- insulina hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine. Huwa disponibbli f’ skartoċċi magħmulin għall- użu f’ sistema ta ’ injezzjoni fis- serje ta ’ l- OptiPen.
Insulin Human Winthrop Basal is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Basal huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete mellitus.