qanastek/EMEA-V3 huggingface dataset:
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Basal.
Tużax 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 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.
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
516 Gruppi speċjali ta ’ pazjenti Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
Important information about some of the ingredients of Insulin Human Winthrop Basal
518 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Basal
- determine how much Insulin Human Winthrop Basal per day you will need,
- jikkalkula kemm għandek bżonn 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 għandekx tagħmel it- testijiet fuq
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insulin Human Winthrop cartridges and as recommended in the information provided by the device manufacturer.
L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- skartoċċi ta ’ Insulin Human Winthrop u kif inhu irrakkomandat fl- informazzjoni ipprovduta mill- manifattur tal- pinna.
The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
L- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa biex jitgħabba l- iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
Mix the insulin well and check it before you insert it into the pen.
Ħallat l- insulina sew u iċċekkjha qabel ma ddaħħalha fil- pinna.
Later, you must mix the insulin well again immediately before each injection.
Aktar tard, ghandek terġa ’ tħallat l- insulina sew immedjatament qabel kull injezzjoni.
Mixing is best done by gently tilting the cartridge or pen (with the cartridge in it) back and forth at least 10 times.
Dan l- aħjar li jsir billi tmil bilmod l- iskartoċċ jew il- pinna (bl- iskartoċċ ġewwa fiha) ’ l hinn u ’ l hawn għal mhux anqas minn 10 darbiet.
To assist in mixing, three tiny metal balls are present in the cartridge.
Biex jiffaċilitaw it- taħlit, hemm tliet boċċi ċkejknin tal- metall fl - iskartoċċ.
After mixing, the suspension must have a uniform milky white appearance.
Wara li titħallat, is- suspensjoni għandu jkollha dehra uniformi qisha 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 cartridge.
M’ għandhiex tintuża jekk is- suspensjoni tibqa ’ ċara jew, per eżempju, jitfaċċaw ċapep, biċċiet li jixbħu t- trofof tas- suf, partikuli jew kwalunkwe ħaġa simili fis- suspensjoni jew mal- ġnub jew il- qiegħ ta ’ l- iskartoċċ.
A new cartridge with a uniform suspension on mixing must then be used.
F’ każijiet bħal dawn, skartoċċ ġdid li jagħti suspensjoni uniformi meta titħallat għandu jintuża.
Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża skartoċċ ġdid jekk tinnota li l- kontroll taz- zokkor fid- demm qiegħed, mingħajr mistenni, jmur għall- agħar.
This is because the insulin may have lost some of its effectiveness.
Dan jista ’ jkun minħabba l- insulina tkun tilfet parti mill- qawwa 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, ħudu għand it- tabib jew l- ispiżjar tiegħekbiex jeżaminah.
Special care before injection
519 Attenzjoni speċjali qabel l- injezzjoni
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Kun żgur li la alkoħol u anqas disinfettanti jew xi sustanzi oħra ma ’ jikkontaminaw l- insulina.
- Do not mix insulin with any other medicines.
- Tħallatx l- insulina ma ’ ebda mediċini oħra.
522 Problems with the pen?
Diffikultajiet bil- pinna?
However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Madankollu, uża biss dawk is- siringi li huma magħmulin għall- qawwa ta ’ preparat ta ’ insulina ta ’ 100 IU (Unitajiet Internazzjonali) kull millilitru.
- If you have injected too much Insulin Human Winthrop Basal, your blood sugar level may
- Jekk injettajt aktar Insulin Human Winthrop Basal milli meħtieġ, il- livell taz- zokkor
If you forget to use Insulin Hun Winthrop Basal
Jekk tinsa tuża Insulin Human Winthrop Basal
Severe allergic reactions to insulin may occur which may become life-threatening.
520 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
523 Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients) • Severe allergic reaction with low blood pressure (shock) • Injection site urticaria (itchy rash)
Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
Do not use Insulin Human Winthrop Basal after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insulin Human Winthrop Basal 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).
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).
521 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 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- użu’ għandux jinżamm fi friġġ.
Do not use the cartridge after this time period.
Tużax l- iskartoċċ wara dan il- perijodu ta ’ żmien
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 jixbaħ il- ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insulin Human Winthrop Basal is supplied in cartridges containing 3 ml suspension (300 IU).
Insulin Human Winthrop Rapid huwa fornut f’ skartoċċi li fihom 3 ml ta ’ soluzzjoni (300 IU).
Packs of 3, 4, 5, 6, 9 and 10 cartridges of 3 ml are available.
Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi ta ’ 3 ml.
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
522 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
523 IPERGLIĊEMIJA U IPOGLIĊEMIJA
526 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
524 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
527 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
Tell your relatives, friends and close colleagues the following:
525 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
528 PACKAGE LEAFLET:
526 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Basal 100 IU/ml suspension for injection in a pre -filled pen Insulin human
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully, including the Instructions for Use of Insulin Human Winthrop Basal, pre-filled pen, OptiSet, before you start using this medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet għall- użu ta ’ Insulin Human Winthrop Basal, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
Insulin Human Winthrop Basal is a fluid (suspension) for injection under the skin.
Insulin Human Winthrop Basal huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
The insulin is present as tiny crystals of insulin protamine.
L- insulina hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
It comes in cartridges sealed in disposable pen injectors, OptiSet.
Dan jiġi fornut f’ skartoċċi issiġillat, li hija l- parti li tintrema, ta’ OptiSet, pinna ta ’ l- insulina.
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) għal- insulina jew għal xi wieħed mill- sustanzi l - oħra ta ’ Insulin Human Winthrop Basal.
Take special care with Insulin Human Winthrop Basal
Oqgħod attent ħafna b’ Insulin Human Winthrop Basal
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.
Segwi bil- preċiż l- istruzzjonijiet għad- dożaġġ, l- immoniterjar (testijiet tad- demm u ta ’ l- awrina), id - dieta u l- attività fiżika (xogħol fiżiku u eżerċizzju), u t- teknika ta ’ l- injezzjoni, kif spjegalek it- tabib tiegħek.
529 Travel
527 Safar
3.
529 3.
531 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
You r doctor will show you in which area of the skin you should inject your insulin.
It- tabib tiegħek ser jurik f’ liema parti tal- gilda għandek tinjetta l- insulina tiegħek.
How to handle OptiSet
Kif timmaniġġa OptiSet
Insulin Human Winthrop Basal comes in cartridges sealed in disposable pen injectors, OptiSet.
Insulin Human Winthrop Basal huwa fornut f’ skartoċċi ssiġillati f’ pinen għall- injezzjoni, OptiSet, li jintremew wara li jinħlew.
A safety test must be performed before each injection.
Uża biss labar li huma kompatibbli għall- użu ma ’ OptiSet) Test ta ’ sigurtà għandu jsir qabel kull injezzjoni.
Mix the insulin well and check it before first use.
Ħallat sew l- insulina u ċċekkjha qabel l- ewwel użu.
Later, you must mix the insulin well again immediately before each injection.
Aktar tard, għandek terġa ’ tħallat l- insulina sew immedjatament qabel kull injezzjoni.
Mixing is best done by gently tilting the pen back and forth at least 10 times.
Dan l- aħjar li jsir billi tmil bilmod l- pinna ’ l hinn u ’ l hawn għal mhux anqas minn 10 darbiet.
To assist in mixing, three tiny metal balls are present in the cartridge.
Biex jiffaċilitaw it- taħlit, hemm tliet boċċi ċkejknin tal- metall fl- iskartoċċ.
After mixing, the suspension must have a uniform milky white appearance.
Wara li thallat, is- suspensjoni għandu jkollha dehra uniformi qisha 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 cartridge in the pen.
M’ għandhiex tintuża jekk tibqa ’ ċara jew, per eżempju, jitfaċċaw ċapep, biċċiet li jixbħu t- trofof tas- suf, partikuli jew kwalunkwe ħaġa simili fis- suspensjoni jew mal- ġnub jew il- qiegħ ta ’ l- iskartoċċ fil- pinna.
A new pen with a uniform suspension on mixing must then be used.
Pinna ġdida b’ suspensjoni uniformi meta titħallat għanda mbagħad tintuża.
If you think you may have a problem with OptiSet, refer to the Questions and Answers section of the attached OptiSet Instructions for Use, or have it checked by your doctor or pharmacist.
Jekk taħseb li għandek xi problema b’ OptiSet, jekk jogħġbok, ara s- sezzjoni dwar Mistoqsijiet u Tweġibiet, ta ’ l- Istruzzjonijiet dwar l- Użu ta ’ OptiSet,, li huwa inkluż mal- pinna, jew ħudha lit- tabib jew lill- ispiżjar tiegħek biex jiċċekjahielek.
Special care before injection
530 Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Basal pre -filled pen, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Basal, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
Do not use the OptiSet if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new OptiSet has to be used.
Tużax l- OptiSet jekk hi bil- ħsara jew mhix qed taħdem sew (dovut għall- difetti mekkaniċi); din għandha tintrema u OptiSet ġdida tintuża minflok.
532 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have injected too much Insulin Human Winthrop Basal, your blood sugar level may
- Jekk injettajt aktarInsulin Human Winthrop Basal milli meħtieġ, il- livell taz- zokkor
If you forget to use Insulin Human Winthrop Basal
Jekk tinsa tuża Insulin Human Winthrop Basal
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
531 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
Keep the pre-filled pen in the outer carton in order to protect from light
Żomm il- pinna mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
In-use pens Pre-filled pens in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Pinen fl- użu Pinen mimlija għal- lest fl- użu jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin
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), mingħajr ċapep, partikuli jew trofof viżibbli.
534 Insulin Human Winthrop Basal is supplied in pre-filled pens, OptiSet, containing 3 ml suspension (300 IU).
Insulin Human Winthrop Basal huwa fornut f’ pinen mimlija għal- lest, OptiSet, li fiha 3 ml ta ’ suspensjoni (300 IU).
Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available.
Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen ta ’ 3 ml.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
533 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
534 IPERGLIĊEMIJA U IPOGLIĊEMIJA
536 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:
535 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
537 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:
536 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
538 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
Keep this leaflet for future reference each time you use OptiSet.
Żomm dan il- fuljett għax jista ’ jkollok bżonn terġa ’ taqrah kull darba li tuża OptiSet.
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (i.e. never change the dose) after injection button has been pulled out. • This pen is only for your use.
Uża biss labar li huma kompatibbli ma ’ l- użu ta ’ OptiSet. • Dejjem agħmel test ta ’ sigurtà qabel kull injezzjoni. • Jekk qed tuża OptiSet ġdida it- test inizjali ta ’ sigurtà għandu jsir bi 8 unitajiet issettjati minn qabel mill- manifattur. • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda. • Qatt m’ għandek iddawwar is- selettur tad- dożaġġ (iġifieri qatt m’ għandek tibdel id- doża) wara li l- buttun ta ’ l- injezzjoni huwa miġbud ’ il barra. • 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 OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
Taqsamhiex ma ’ ħaddieħor. • Jekk l- injezzjoni tiegħek tingħata minn persuna oħra, għandha tittieħed il- kawtela speċjali minn din il- persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u tkun trasmessa l- infezzjoni. • Qatt m’ għandek tuża OptiSet jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm OptiSet żejda f’ każ li l- OptiSet tiegħek tintilef jew jiġrilha l- hsara.
Check and mix the insulin
Iċċekkja l- insulina
Mix the insulin by turning OptiSet slowly up and down at least 10 times (do not shake the OptiSet).
Ħallat l- insulina billi ddawwar l- OptiSet bilmod ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet (iċċekċikx l- OptiSet).
Check the appearance of your insulin.
D Iċċekkja d- dehra ta ’ l- insulina tiegħek.
It must have an evenly milky white appearance.
Għandha jkollha dehra uniformi u bajda, qisha ħalib.
539 Step 2.
2
Always use a new sterile needle for each injection.
Dejjem uża labra sterili u ġdida għal- kull injezzjoni.
This helps prevent contamination, and potential needle blocks.
Dan jgħin biex telimina l- kontaminazzjoni, tnaqqas ir- riskju li tistadt il- labra.
Remove the protective seal from a new needle.
A Neħħi s- siġill protettiv mil- labra l- ġdida.
Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
B Iddritta l- labra fuq il- pinna, u żommha dritta waqt li qed tqabbadha (bil- kamin jew b’ għafsa, skond it- tip ta ’ labra).
• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or the needle can be bent.
• 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 titgħawweġ.
Select the dose for the Safety Test. • New and unused OptiSet: a dose of 8 units is already preset by the manufacturer for the first safety test. • In-use OptiSet: select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2.
Agħżel id- doża għat- Test tas- Sigurtà. • Għal OptiSet ġdida u mhux użata: doża ta ’ 8 unitajiet diġa tkun issettjata mill- manifattur għall - ewwel test ta ’ sigurtà.
discard
armi żomm
You may have to perform the safety test several times before insulin is seen. • If no insulin comes out, check for air bubbles and repeat the safety test two more times. • If still no insulin comes out, the needle may be blocked.
Biddel il- labra u erġa ’ ipprova.
Change the needle and try again. • If no insulin comes out after changing the needle, your OptiSet may be damaged.
539 • Jekk ebda l- insulina ma toħroġ wara li tibdel il- labra, l- OptiSet tiegħek tista ’ tkun bil- ħsara.
Pull out the injecti on button completely in order to load the dose.
Iġbed il- buttun ta ’ l- injezzjoni kompletament ’ il barra biex b’ hekk ittella ’ d- doża.
Note that the injection button only goes out as far as the amount of insulin that is left in the reservoir. • The injection button must be held out under tension during this check. • The last thick line visible on the injection button shows the amount of insulin loaded.
Innota li l- buttun ta ’ l- injezzjoni joħroġ ’ il barra sa l - ammont t’ insulina li fadal fir- riżervwar. • Waqt li qed isir dan l- iċċekkjar il- buttun ta ’ l- injezzjoni għandu jinżamm miġbud ’ il barra. • L- aħħar linja ħoxna viżibbli fuq il- buttun ta ’ l- injezzjoni turi l- ammont t’ insulina li telgħet.
When the injection button is held out only the top part of this thick line can be seen. • In this example, 12 units are loaded.
Meta l- buttun ta ’ l- injezzjoni jkun miġbud ’ il barra l- parti ta ’ fuq biss ta ’ din il- linja ħoxna tkun tidher. • Nieħdu eżempju fejn 12- il Unità ttellgħet.
if you have selected 12 units you can inject your dose. if you have selected more than 12 units then only 12 units of your total insulin dose can be injected with this pen.
540 jekk int għażilt 12- il Unità tista ’ tinjetta d- doża tiegħek. o Jekk int għażilt aktar minn 12- il Unità allura 12- il Unità biss mid- doża sħiħa o tiegħek ta ’ l- insulina tista ’ tkun injettata b’ din il- pinna.
Always remove the needle after each injection and store OptiSet without a needle attached.
Dejjem neħħi l- labra wara kull injezzjoni u aħżen l- OptiSet mingħajr labra fis- sit.
Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri rakkomandati ta ’ sigurtà għat - tneħħija u r- rimi tal- labar (e. g. tintuża id waħda biex tpoġġi l- kappa lura fuq il- labra) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess l- mard infettiv.
Please check section 5 – How to store Insulin Human Winthrop Basal - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insulin Human Winthrop Basal - fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
543 Maintenance
Manutenzjoni
Questions and Answers
Mistoqsijiet u Tweġibiet
Press the injection button completely in and discard the insulin.
Agħfas il- buttun ta ’ l- injezzjoni ’ l ġewwa kompletament u armi l- insulina.
If the safety test is successful OptiSet is ready for use.
Jekk it- test ta sigurtà rnexxa l- OptiSet hija lesta għall- użu. ’ il ġewwa, mingħajr ma twaħħlet labra.
If test is not successful, the pen might be damaged.
Jekk it- test ta sigurtà ma rnexxiex, il- pinna tista ’ tkun bil- ħsara.
The dosage selector does not turn.
Is- selettur tad- dożaġġ ma jdurx.
The amount indicated on the injection button is higher than the dose selected.
L- ammont indikat fuq
Discard insulin, then set your dose and check again.
Armi l- insulina, imbagħad issettja d- doża u erġa ’ iċċekkja.
If the same error occurs again, OptiSet may be damaged, use a new OptiSet.
Jekk jerġa ’ jiġri l- istess żball, l- OptiSet jista ’ jkollha l- ħsara, uża OptiSet ġdida. • Id- differenza hija aktar minn żewġ (2) unitajiet.
• Difference is more than 2 units.
M’ hemmx biżżejjed insulina fir- riżervwar.
OptiSet is damaged, use a new OptiSet.
L- ammont indikat fuq • il- buttun ta ’ l- injezzjoni
The amount indicated on the injection button is lower than the dose selected.
Tista ’ tinjetta l- ammont indikat fuq il- buttun ta ’ l- injezzjoni
There is not enough insulin in the reservoir • you can inject the amount indicated on the injection button from this OptiSet and then inject the remaining dose using a new pen, or • you can inject the entire dose using a new pen.
minn din l- OptiSet u wara tinjetta l- bqija tad- doża minn pinna ġdida, jew Tista ’ tinjetta d- doża sħiħa minn pinna ġdida.
Remove needle and replace with a new needle attaching it on straight.
Neħħi l - L- insulina qed tqattar labra, biddilha m’ oħra ġdida u waħħalha dritta.
Perform the safety test.
Agħmel it- test ta ’ mill- pinna. sigurtà.
Small amounts of air may be present in the needle and insulin reservoir during normal use.
Jista ’ jkun hemm ammont żgħir ta ’ arja fil- labra u fir- riżervwar ta ’ l - Hemm il- bżieżaq ta ’ l - insulina waqt l- użu normali.
You must remove this air by performing the safety test.
Għandek tneħħi din l- arja permezz tat- test arja fir- riżervwar. ta ’ sigurtà.
Do not force it.
Tisforzahiex.
Do not try to repair nor use tools on it.
Tipprovax tirranġha jew tuża l- għodda fuqha.
Use a new OptiSet.
L- OptiSet bil- ħsara jew Uża OptiSet ġdida. mhix qed taħdem sew.
545 PACKAGE LEAFLET:
543 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Basal 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
It comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Dan jiġi fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l - insulina.
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
544 Gruppi speċjali ta ’ pazjenti Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
Important information about some of the ingredients of Insulin Human Winthrop Basal
546 Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insulin Human Winthrop Basal
See the box at the end of this leaflet for further information.
Ara l- informazzjoni f’ kaxxa li ssib fi tmiem ta ’ dan il- fuljett għal aktar dettalji
How to handle the cartridges for OptiClik
Kif timmaniġġa l- iskrataċ għal OptiClik
Insulin Human Winthrop Basal in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Basal fi skartoċċi għal OptiClik kien żviluppat għall- użu f ’ OptiClik biss..
The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
L - istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa biex jitgħabba l - iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża skartoċċ ġdid jekk tinnota li l- kontroll tiegħek taz- zokkor fid- demm qiegħed bla mistenni jmur għall- agħar.
This is because the insulin may have lost some of its effectiveness.
Dan għaliex l- insulina tista ’ tkun tilfet xi ftit 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, hudħa biex tiġi iċċekkjata mit- tabib jew mill- ispiżjar tiegħek.
Special care before injection
547 Attenjoni speċjali qabel l- injezzjoni
- Do not mix insulin with any other medicines.
- Tħallatx l- insulina ma ’ ebda mediċini oħra..
549 Problems with OptiClik?
Diffikultajiet b’ OptiClik?
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.
548 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.
550 Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients) • Severe allergic reaction with low blood pressure (shock) • Injection site urticaria (itchy rash)
Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
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) 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.
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 (.
Keep the cartridge in the outer carton in order to protect from light.
Insulin Human Winthrop 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).
(ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux’ il fuq minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
The cartridge in-use must not be stored in a refrigerator.
L- iskartoċċ fl - użum’ għandux jinżamm fi friġġ.
Insulin Human Winthrop Basal comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insulin Human Winthrop Basal huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
Insulin Human Winthrop Basal is supplied in cartridges for OptiClik containing 3 ml suspension (300 IU).
Insulin Human Winthrop Basal huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ soluzzjoni (300 IU).
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
550 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
553 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
551 IPERGLIĊEMIJA U IPOGLIĊEMIJA
If you r blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Jekk iz- zokkor f’ demmek huwa għoli wisq (ipergliċemija), għandu mnejn ma injettajtx biżżejjed insulina
554 Hypoglycaemia is also more likely to occur if:
552 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
553 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
555 PACKAGE LEAFLET:
554 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Basal 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insulin Human Winthrop Basal 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 Insulin Human Winthrop Basal, 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 Basal, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
Insulin Human Winthrop Basal is a fluid (suspension) for injection under the skin.
Insulin Human Winthrop Basal huwa suspensjoni għall- injezzjoni għal 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 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 b’ mod gradwali u jdum jaħdem għal żmien twil.
It comes in cartridges sealed in disposable pen injectors, SoloStar.
L- insulina hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine Dan jiġi fornut f’ skartoċċi issiġillat, li hija l- parti li tintrema, ta ’ SoloStar, pinna ta ’ l- insulina.
Take special care with Insulin Human Winthrop Basal
Oqgħod attent ħafna b’ Insulin Human Winthrop Basal:
Travel
555 Safar
556 Before travelling, consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tiegħek.
557 Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
Important information about some of the ingredients of Insulin Human Winthrop Basal
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insulin Human Winthrop Basal
3.
557 3.
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop Basal.
- jgħidlek għandek jkollok bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop
558 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Do NOT inject Insulin Human Winthrop Basal into a vein.
TINJETTAX l- Insulina Basal fil- vina.
If you think you have a problem with SoloStar, consult your Healthcare Professional.
Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
To prevent the possible transmission of disease, each pen must be used by one patient only.
558 Dejjem uża pinna ġdida jekk tinnota li l- kontroll taz- zokkor tiegħek fid- demm qiegħed imur għal agħar, bla mistenni.
Insulin Human Winthrop Basal pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insulin Human Winthrop Basal, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
559 Mistakes in dosage
Żbalji fid- dożaġġ
Like all medicines, Insulin Human Winthrop Basal can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insulin Human Winthrop Basal 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
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
559 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)
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
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.
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
560 • 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.
Do not use Insulin Human Winthrop Basal after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insulin Human Winthrop Basal 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).
560 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).
- The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium
- Is- sustanzi l- oħra huma: protamine sulphate, metacresol, phenol, zinc chloride, sodium
Insulin Human Winthrop Basal is supplied in pre-filled pens, SoloStar, containing 3 ml suspension (300 IU).
Insulin Human Winthrop Basal huwa fornut f’ pinen mimlija għal- lest, SoloStar, li fiha 3 ml ta ’ suspensjoni (300 IU).
561 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
561 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
562 IPERGLIĊEMIJA U IPOGLIĊEMIJA
563 HYPOGLYCAEMIA (low blood sugar levels)
IPOGLIĊEMIJA (livell baxx ta ’ zokkor fid- demm)
Hypoglycaemia is also more likely to occur if:
563 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
564 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:
564 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
SoloStar.
Insulin Human Winthrop Basal, suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
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.
Biex tassigura li qed taqra id- doża kif suppost, żomm il- pinna orizzontali, bil- labra fuq ix- xellug u s- selettur tad- dożagg fuq il- lemin kif jidher fl- immaġni hawn taħt.
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.
Taqsamhiex ma ’ ħaddieħor.
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.
565 • 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.
566 C.
Ċ.
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.
Iċċekkja d- dehera ta ’ l- insulina tiegħek. • Jekk qed tuża insulina ċara, (Insulin Human Winthrop) tużax din il- pinna jekk l- 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 mhux anqas minn 10 darbiet.
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.
You may have to perform the safety test several times before insulin is seen.
Għandu mnejn ikollok tagħmel it- test ta ’ sigurtà diversi drabi qabel ma titfaċċa l- insulina.
• 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.
• 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.
568 • 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.
Step 5.
Pass Nru. 5
This helps prevent: • Contamination and/or infection • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
568 • Id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u li l- insulina tqattar mill- pinna, li jistgħu jikkawżaw dożaġġ ineżatt.
Dispose of the needle safely.
Armi l- labra mingħajr periklu, kif spjegalek il- professjonist fil- qasam tas- saħħa.
569 Storage Instructions
Struzzjonijiet dwar il- ħażna
If you r 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.
Armi s- SoloStar użata tiegħek kif jitolbu l- awtoritajiet lokali.
570 PACKAGE LEAFLET:
569 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 15 100 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
What Insulin Human Winthrop Comb 15 is and what it is used for 2.
X’ inhu Insulin Human Winthrop Comb 15 u għalxiex jintuża 2.
Before you use Insulin Human Winthrop Comb 15 3.
Qabel ma tuża Insulin Human Winthrop Comb 15 3.
How to use Insulin Human Winthrop Comb 15 4.
Kif għandek tuża Insulin Human Winthrop Comb 15 4.
How to store Insulin Human Winthrop Comb 15 6.
Kif taħżen Insulin Human Winthrop Comb 15 6.
WHAT INSULIN HUMAN WINTHROP COMB 15 IS AND WHAT IT IS USED FOR
X’ INHU INSULIN HUMAN WINTHROP COMB 15 U GĦALXIEX JINTUŻA
Insulin Human Winthrop Comb 15 is a fluid (suspension) for injection under the skin.
Insulin Human Winthrop Comb 15 huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il - ġilda.
The insulin contained in Insulin Human Winthrop Comb 15 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Comb 15 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insulin Human Winthrop Comb 15 is an insulin preparation with a gradual onset and long duration of action.
Insulin Human Winthrop Comb 15 huwa preparat ta ’ l- insulina li jibda jaħdem b’ mod gradwali u jdum jaħdem għal żmien twil.
Insulin Human Winthrop Comb 15 is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Comb 15 huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil - pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSULIN HUMAN WINTHROP COMB 15
QABEL MA TUŻA INSULIN HUMAN WINTHROP COMB 15
Do not use Insulin Human Winthrop Comb 15
Tużax Insulin Human Winthrop Comb 15
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Comb 15.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insulin Human Winthrop Comb 15.
Do not inject Insulin Human Winthrop Comb 15 into a vein (blood vessel).
Tinjettax Insulin Human Winthrop Comb 15 ġewwa vina (sistema vaskulari).
Do not use it in insulin pumps or other infusion pumps - special insulin preparations are available for use in such devices.
Tużaħx f’ pompi ta ’ l - insulina jew pompi oħra għall- infuzzjoni - hemm preparazzjonijiet apposta ta ’ insulina disponibbli għall- użu ma ’ dan l- apparat.
Take special care with Insulin Human Winthrop Comb 15
Oqgħod attent ħafna b’ Insulin Human Winthrop Comb 15
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Segwi bil- preċiż l- istruzzjonijiet għad- dożaġġ, l- immoniterjar (testijiet tad- demm u ta ’ l- awrina), id - dieta u l- attività fiżika (xogħol fiżiku u eżerċizzju), kif spjegalek it- tabib tiegħek.
571 Special patient groups
Gruppi speċjali ta ’ pazjenti
Travel
570 Safar
Using Insulin Human Winthrop Comb 15 with food and drink
Meta tuża Insulin Human Winthrop Comb 15 ma ’ l- ikel u max- xorb
Pregnancy and breast -feeding
Tqala u Treddigħ
You r insulin dosage may need to be changed during pregnancy and after giving birth.
Id- dożaġġ tiegħek ta ’ l- insulina għandu mnejn jeħtieġ li jinbidel waqt it- tqala u wara li twelled.
However, there is no experience with the use of Insulin Human Winthrop Comb 15 in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insulin Human Winthrop Comb 15 waqt it- tqala.
- you have hypoglycaemia (low blood sugar levels),
- għandek l- ipogliċemija (livell baxx ta ’ zokkor fid- demm)
- you have hyperglycaemia (high blood sugar levels),
- għandek l- ipergliċemija (livell għoli ta ’ zokkor fid- demm)
Important information about some of the ingredients of Insulin Human Winthrop Comb 15
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 15
573 3.
572 3.
HOW TO USE INSULIN HUMAN WINTHROP COMB 15
KIF GĦANDEK TUŻA INSULIN HUMAN WINTHROP COMB 15
Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will
Skond l- istil tal- ħajja tiegħek u r- riżultati tat- testijiet taz- zokkor (glucose) fid- demm, t- tabib tiegħek sejjer:
- determine how much Insulin Human Winthrop Comb 15 per day you will need,
- jikkalkula kemm għandek bżonn Insulin Human Winthrop Comb 15 kuljum,
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- jgħidlek meta teżamina l- livell tiegħek taz- zokkor fid- demm, u jekk ghandekx tagħmel testijiet
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop
Comb 15.
Comb 15,
Insulin Human Winthrop Comb 15 is injected under the skin 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 15 huwa injettat taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Do NOT inject Insulin Human Winthrop Comb 15 into a vein.
TINJETTAX Insulin Human Winthrop Comb 15 ġewwa vina.