qanastek/EMEA-V3 huggingface dataset:
Refer to them before using your medicine.
Irreferi għalihom qabel ma tuża l- mediċina tiegħek.
It comes in cartridges designed for use in an injection device of the OptiPen series.
Tiġi f’ skartoċċi magħmula għall- użu ġo apparat ta ’ l- injezzjoni tat- tip OptiPen.
Insulin Human Winthrop Rapid may also be used for treating 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) as well as for controlling blood sugar before, during and after surgery.
Insulin Human Winthrop Rapid tista ’ wkoll tintuża biex tikkura l- ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u l - ketoaċidożi (akkumulazzjoni t’ aċidu fid- demm għaliex il- ġisem qiegħed jutilizza x- xaħam minflok iż - żokkor), kif ukoll għall- kontroll taz- zokkor fid- demm qabel, waqt u wara li ssirlek operazzjoni.
Do not use Insulin Human Winthrop Rapid in insulin pumps - special insulin preparations are available for use in such devices.
Tużax Insulin Human Winthrop Rapid fil- pompi għall- insulina – hemm preparazzjonijiet apposta t’ insulina disponibbli għall- użu ma ’ dan l- apparat.
Take special care with Insulin Human Winthrop Rapid
442 Oqgħod attent ħafna b’ Insulin Human Winthrop Rapid:
447 Special patient groups
Gruppi speċjali ta ’ pazjenti
How to handle the cartridges
Kif timmaniġġa l- skartoċċi
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 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.
Keep the cartridge at room temperature for 1 or 2 hours before inserting it into the pen.
Żomm l- iskartoċċ fit- temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn qabel iddaħħlu fil - pinna.
Look at the cartridge before you use it.
Spezzjona l- iskartoċċ qabel tużah.
Only use it if the solution is clear, colourless, with no solid particles visible, and has a water-like consistency.
Uża biss jekk is- soluzzjoni hija ċara, mingħajr kulur mingħajr partikoli solidi viżibli u tixbah id- dehra ta ’ l- ilma.
Before injection remove any air bubbles (see instructions for using the pen).
Qabel l- injezzjoni neħħi l- bżieżaq ta ’ l- arja li jista ’ jkun hemm (ara l- istruzzjonijiet dwar l- użu tal - pinna).
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.
- Do not re-fill and re-use empty cartridges.
- Terġax timla u terġa ’ tuża l- skartoċċi vojta.
- Do not add any other insulin to the cartridge.
- Iżżidx xi insulina oħra fl- iskartoċċ.
- Do not mix insulin with any other medicines.
- Tħallatx Insulin Human Rapid ma ’ mediċini oħrajn
Problems with the pen?
Diffikultajiet bil- pinna
Refer to the manufacturer’ s instructions for using the pen.
Irreferi għall- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna.
If the pen does not function well, you can draw the insulin from the cartridge into an injection syringe.
Jekk il- pinna mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ b’ siringa ta ’ l- injezzjoni.
Therefore, keep injection syringes and needles as well.
Għalhekk, żomm is- siringi ta ’ l- injezzjoni u kif ukoll il- labar.
However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Madankollu, uża biss dawk is- siringi ta ’ l- injezzjoni li huma magħmulin għall- qawwa ta ’ preparat ta ’ insulina ta ’ 100 IU (Unitajiet Internazzjonali) kull ml.
450 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have injected too much Insulin Human Winthrop Rapid, your blood sugar level may
- Jekk injettajt aktar Insulin Human Winthrop Rapid milli meħtieġ, il- livell taz- zokkor fid -
become too low (hypoglycaemia).
demm tiegħek jista ’ jinżel wisq (ipogliċemija). il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq (ipogliċemija).
In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Ġeneralment, biex tevita l - ipogliċemija għandek tiekol aktar u timmoniterja z- zokkor f’ demmek.
For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
Għal informazzjoni fuq il- kura ta ’ l- ipogliċemija, ara l- kaxxa fit- tmiem ta ’ dan il- fuljett.
For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Għal aktar informazzjoni dwar l- effetti sekondarji ta ’ livell baxx ta ’ zokkor fid- demm u ta ’ livell għoli ta ’ zokkor fid- demm, ara l- kaxxa fl- aħħar ta ’ dan il- fuljett
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
446 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 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.
451 • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
Do not use Insulin Human Winthrop Rapid after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insulin Human Winthrop Rapid 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 (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 Skartoċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux ‘ il fuq minn 25°Ċ., ’ il bogħod mis- sħana diretta
The cartridge in-use must not be stored in a refrigerator.
L- iskartoċċ ċ fl- użu m’ għandux jinżamm fi friġġ.
Do not use the cartridge after this time period.
Tużahx wara dan il- perijodu ta ’ żmien
100 IU (International Units) of the active substance insulin human.
100 IU (Unita Internazzjonali) tas- sustanza attiva insulina umana.
452 Insulin Human Winthrop Rapid is supplied in cartridges containing 3 ml solution (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.
Huma disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi ta ’ 3 ml.
Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
448 Ελλάδα sanofi- aventis AEBE Τηλ: +30 210 900 16 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
449 IPERGLIĊEMIJA U IPOGLIĊEMIJA
- your insulin pen does not work properly,
- int qiegħed tagħmel anqas eżerċizzju fiżiku mis- soltu, jew int qiegħed taħt stress (inkwiet,
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or
eċitament), jew għandek xi ferita, saritlek xi operazzjoni, għandek xi infezzjoni jew għandek id - deni.
454 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.
455 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:
451 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
456 PACKAGE LEAFLET:
452 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 IU/ 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, OptiSet before you start using this medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet għall- użu ta ’ Insulin Human Winthrop Rapid, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
Insulin Human Winthrop Rapid is a solution for injection under the skin.
Insulin Human Winthrop Rapid huwa soluzzjoni għall- injezzjoni għal taħt il- ġilda.
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.
Insulin Human Winthrop Rapid is an insulin preparation with a rapid onset and short duration of action.
Insulin Human Winthrop Rapid huwa preparat ta ’ l- insulina li jibda jaħdem malajr u jdum jaħdem għal żmien qasir.
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.
Insulin Human Winthrop Rapid is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Rapid huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete 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 fejn ġismek ma jagħmilx biżżejjed insulina biex jikkontrolla l- livell taz- zokkor fid- demm.
Do not use Insulin Human Winthrop Rapid
Tużax Insulin Human Winthrop Rapid
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Rapid.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina Insulin Human Winthropjew għal xi sustanzi oħra ta ’ Insulin Human Winthrop Rapid.
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 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.
457 Travel
453 Safar
3.
455 3.
459 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insulin Human Winthrop Rapid is injected under the skin 15 to 20 minutes before a meal.
Insulin Human Winthrop Rapid huwa injettat taħt il- ġilda minn 15 sa 20 minuta qabel ikla.
OptiSet delivers insulin in increments of 2 units up to a maximum single dose of 40 units.
OptiSet tagħti l- insulina f’ zidiet ta ’ 2 unitajiet, sa massimu ta ’ 40 unità f’ doża waħda.
How to handle OptiSet
Kif timmaniġġa l- OptiSet
Insulin Human Winthrop Rapid comes in cartridges sealed in disposable pen injectors, OptiSet.
Insulin Human Winthrop Rapid huwa fornut f’ skartoċċi ssiġillati f’ injettaturi ta ’ pinen OptiSet, li jintremew wara li jinħlew..
Read carefully the "OptiSet Instructions for Use" included in this package leaflet.
Aqra bir- reqqa “ L- Istruzzjonijiet Dwar l- Użu ta ’ OptiSet ” li jinsabu f’ dan il- fuljett ta ’ tagħrif.
You must use the pen as described in these Instructions for Use.
Ghandek tuża l- pinna kif deskritt fl- Istruzzjonijiet Dwar l- Użu.
A new injection needle must be attached before each use.
Labra ġdida ghandha titwaħħal qabel kull darba li tużha.
Only use needles that have been approved for use with OptiSet.
Uża biss labar li huma kompatibbli għall- użu ma ’ OptiSet).
A safety test must be performed before each injection.
Test ta ’ sigurtà għandu jsir qabel kull injezzjoni.
Look at the cartridge before you use the pen.
Eżamina l- iskartoċċ qabel tuża l- pinna.
Do not use Insulin Human Winthrop Rapid if you notice particles in it.
Tużax Insuman Rapid jekk tinnota li fih l- partikuli.
Only use Insulin Human Winthrop Rapid if the solution is clear, colourless and waterlike.
Uża biss Insuman Rapid jekk is- soluzzjoni hija ċara, mingħajr kulur u tixbaħ l- ilma.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża pinna ġdida jekk tinnota li l- kontroll taz- zokkor tiegħek fid- demm qiegħed imur għal agħar, bla mistenni.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Jekk taħseb li ghandek problema b’ OptiSet, ara s- sezzjoni dwar Mistoqsijiet u Tweġibiet fl - istruzzjonijiet dwar l- użu ta ’ OptiSet, jew ħudha għand it- tabib jew lill- ispiżjar tiegħek
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Kun żgur li la l- alkoħol u anqas disinfettanti oħra, jew xi sustanzi oħra, ma jikkontaminaw l- insulina.
Insulin Human Winthrop Rapid, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insulin Human Winthrop Rapid, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
Empty pens must not be re-filled and must be properly discarded.
Pinen vojta m’ għandhomx jerġgħu jimtlew u għandhom jintremew kif jixraq.
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.
456 Tużax l- OptiSet jekk hi bil- ħsara jew mhix qed taħdem sew (dovut għall- difetti mekkaniċi); din għandha tintrema u OptiSet ġdida tintuża minflok.
Mistakes in dosage
Żbalji fid- dożaġġ
460 If you forget to use Insulin Human Winthrop Rapid
Jekk tinsa tuża Insulin Human Winthrop Rapid
For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Għal aktar informazzjoni dwar l- effetti sekondarji ta ’ livell baxx ta ’ zokkor fid- demm u ta ’ livell għoli ta ’ zokkor fid- demm, ara l- kaxxa fl- aħħar ta ’ dan il- fuljett.
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.
457 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.
Changing the injection site with each injection may help to prevent such skin changes.
Bidla fis- sit tal - injezzjoni ma ’ kull injezzjoni jgħin biex dawn il- bidliet fil- ġilda ma jiġrux. • Reazzjonijiet tal- ġilda u dawk allerġiċi.
461 • 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..
Not in-use pens Store in a refrigerator (2°C - 8°C).
Pinen mhux fl- użu Aħżen fi friġġ (2°Ċ- 8°Ċ).
Do not put the pre-filled pen next to the freezer compartment or a freezer pack.
Tagħmilx il- pinna mimlija għal- lest viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
In-use pens Pre-filled pens in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Pinen fl- użu Pinen mimlija għal- lest fl- użu jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
The pen in-use must not be stored in a refrigerator.
Il- pinna fl- użu m’ għandiex tinżamm fi friġġ.
Do not use the pen after this time period.
Tużahiex wara dan il- perijodu ta ’ żmien
6.
458 6.
- The other ingredients are: metacresol, sodium dihydrogen phosphate dihydrate, glycerol,
- Is- sustanzi l- oħra huma: meta- cresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium
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, OptiSet li fihom 3 ml ta ’ soluzzjoni (300 IU). Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen ta ’ 3 ml.
462 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:
France sanofi-aventis France Tél:
459 France sanofi- aventis France Tél:
Warning symptoms of hyperglycaemia
460 Sintomi ta ’ twissija ta ’ ipergliċemija
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.
464 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.
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
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.
465 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
Your doctor or nurse should have discussed this with you previously.
Jekk l- ipogliċemija terga ’ tfeġġ erġa ’ ħu minn 10 sa 20 g ta ’ zokkor.
466 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
OptiSet is a disposable pen for the injection of insulin.
OptiSet hija pinna li tintrema wara li tinħela, għall- injezzjoni ta ’ l- insulina.
Doses from 2 to 40 units can be set in steps of 2 units.
Dożi minn 2 sa 40 Unità jistgħu jkunu ssettjati, f’ qabżiet ta ’ 2 Unità il- waħda.
Talk with your healthcare professional about proper injection technique before using OptiSet.
Kellem lill- professjonist tiegħek fil- qasam tas- saħħa dwar it- teknika xierqa ta ’ l- injezzjoni qabel ma tuża OptiSet.
Read these instructions carefully before using your OptiSet.
Aqra sew dawn l- istruzzjonijiet qabel tuża l- OptiSet tiegħek.
If you are not able to follow all the instructions completely on your own, use OptiSet 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 OptiSet biss jekk issib għajnuna minn persuna oħra li tista ’ ssegwi l - istruzzjonijiet.
If you have any questions about OptiSet 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 ’ l- OptiSet jew id- dijabete, saqsi lill- professjonist tiegħek fil- qasam tas- saħħa jew ċempel fuq in- numru lokali ta ’ Sanofi- Aventis, li ssibu fuq il- faċċata ta ’ dan il- fuljett.
Keep this leaflet for future reference each time you use OptiSet.
462 Żomm dan il- fuljett għax jista ’ jkollok bżonn terġa ’ taqrah kull darba li tuża OptiSet.
New information for use: • Name of the insulin is printed on the pen. • Dosage selector can only be turned in one direction.
Tagħrif ġdid dwar l- użu: • L- isem ta ’ l- insulina huwa stampat fuq il- pinna. • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda.
Important information for use of OptiSet:
Tagħrif importanti dwar l- użu ta ’ OptiSet:
• Always attach a new needle before each use.
• Dejjem waħħal labra ġdida qabel kull darba li tintużha.
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 attenzjoni speċjali minn din il- persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u titrasmetti xi l- infezzjoni. • Qatt m’ għandek tuża OptiSet jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm OptiSet żejda f’ każ li l- OptiSet tiegħek tintilef jew jiġrilha l- hsara.
Take off the pen cap.
Neħħi l- kappa tal- pinna.
Check the label on the pen and insulin reservoir to make sure you have the correct insulin.
Iċċekkja t- tikketta tal- pinna u r- riżervwar ta ’ l- insulina biex tiżgura li qed tuża t- tip korrett t’ insulina.
Insulin Human Winthrop Rapid is a clear insulin.
Insulin Human Winthrop Rapid hija insulina ċara.
Do not use this OptiSet if the insulin is cloudy, coloured or has particles.
Tużax din l- OptiSet jekk l- insulina hija mdardra, ikkulurita jew fiha xi partikuli.
467 Step 2.
2
Always use a new sterile needle for each injection.
Dejjem uża labra sterili
This helps prevent contamination, and potential needle blocks.
Dan jgħin biex telimina l- kontaminazzjoni,
Remove the protective seal from a new needle.
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).
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.
463 • 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.
Always perform the safety test before each injection.
Dejjem agħmel test ta ’ sigurtà qabel kull injezzjoni.
This ensures that you get an accurate dose by: • making sure that pen and needle work properly • removing air bubbles If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer, otherwise the pen will not function properly.
Jekk qed tuża OptiSet ġdida t- test inizjali ta ’ sigurtà għandu jsir bi 8 unitajiet kif inhu s- settjat mill - manifattur, jista ’ jkun li l- pinna mhux ser taħdem sew.
Make sure the injection button is pressed in.
Kun żgur li l- buttun ta ’ l- injezzjoni huwa magħfus ’ il ġewwa.
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. • Għal OptiSet fl- użu: agħżel doża ta ’ 2 unitajiet billi ddawwar is- selettur tad- dożaġġ ’ il quddiem sakemm il- vleġġa tipponta lejn in- numru “ 2 ”.
The dosage selector will only turn in one direction.
Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda.
Pull out the injection button completely in order to load the dose.
Iġbed kompletament ’ il barra l- buttun ta ’ l- injezzjoni biex ittella ’ doża.
Never turn the dosage selector after injection button has been pulled out.
Qatt m’ għandek iddawwar is- selettur tad- dożaġġ wara li tkun ġbidt il- buttun ta ’ l- injezzjoni ’ l barra.
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 biha tneħħi l- labra użata wara l- injezzjoni.
Take off the inner needle cap and discard it.
Neħħi l- kappa ta ’ ġewwa tal- labra u armiha.
discard
464 armi żomm
Hold the pen with the needle pointing upwards.
Żomm il- pinna bil- labra ippuntata ’ l fuq.
Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Taptap fuq ir- riżervwar ta ’ l- insulina biex jekk hemm xi bżieżaq ta ’ l- arja dawn jitilgħu ’ l fuq lejn il- labra.
Press the injection button all the way in.
Agħfas il- buttun ta ’ l- injezzjoni ’ l ġewwa kollu.
Check if insulin comes out of the needle tip.
Iċċekkja li l- insulina qed toħroġ mill- ponta tal- labra.
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.
Għandu mnejn li jkollok tagħmel it- test ta ’ sigurtà diversi drabi qabel ma tara l- insulina ħierġa. • Jekk ebda insulin ma titfaċċa, iċċekkja jekk hemmx bżieżaq ta ’ l- arja u erġa ’ irrepeti t- test ta ’ sigurtà darbtejn oħra. • Jekk xorta ebda insulina ma toħroġ, il- labra tista ’ tkun miżduda.
Change the needle and try again. • If no insulin comes out after changing the needle, your OptiSet may be damaged.
Ibdel il- labra u erġa ’ ipprova. • Jekk l- anqas toħroġ l- insulina wara li tkun bdilt il- labra, l- OptiSet tiegħek tista ’ tkun bil- ħsara.
Select the dose
Tagħzel id- doża
You can set the dose in steps of 2 units, from a minimum of 2 units to a maximum of 40 units.
Tista ’ tissettja d- doża f’ qabżiet ta ’ 2 unitajiet, minn minimu ta ’ 2 unitajiet sa massimu ta ’ 40 Unità.
If you need a dose greater than 40 units, you should give it as two or more injections.
Jekk għandek bżonn ta ’ doża akbar minn 40 Unità, din trid taqsamha f’ żewġ injezzjonijiet jew aktar.
Check if you have enough insulin for your dose.
Iċċekkja li għandek biżżejjed insulina għad- doża tiegħek.
• The residual insulin scale on the transparent insulin reservoir shows approximately how much insulin remains in the OptiSet.
• L- iskala li turi kemm fadal insulina fuq ir- riżervwar trasparenti ta ’ l- insulina turik bejn wieħed u ieħor kemm fadal insulina fl- OptiSet.
This scale must not be used to set the insulin dose.
Din l- iskala m’ għandhiex tintuża biex tkejjel id- doża ta ’ l - insulina.
• If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.
• Jekk il- planġer iswed qiegħed fil- bidu ta ’ l- istrixxa ikkulurita, allura hemm madwar 40 Unità t’ insulina disponibbli.
• If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
• Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- istixxa ikkulurita, allura hemm madwar 20 Unità t’ insulina disponibbli.
469 B.
465 B.
Select your required dose by turning the dose selector forward.
Agħżel id- doża meħtieġa għalik billi ddawwar is- selettur tad- doża ’ l quddiem.
If you turned past your dose, • and you have not yet pulled the injection button, you can keep turning forward till you reach your dose again, • and you have already pulled the injection button out, you must discard the dose that has been loaded before you turn the dosage selector again.
Jekk qbiżt id- doża tiegħek, • u għadek ma ġbidtx il- buttun ta ’ l- injezzjoni, tista ’ tibqa ’ ddawwar ’ l quddiem sakemm issib d - doża tiegħek mill- ġdid, • u diġà ġbidt il- buttun ta ’ l- injezzjoni ’ l barra, għandek tarmi d- doża li tellajt qabel ma ddawwar is- selettur tad- dożaġġ mill- ġdid.
Load the dose
Ittella ’ d- doża
Pull out the injection button completely in order to load the dose.
Iġbed il- buttun ta ’ l- injezzjoni kompletament ’ il barra biex b’ hekk ittella ’ d- doża.
Check if the selected dose is fully loaded.
Iċċekkja telgħetx id- doża sħiħa meħtieġa.
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.
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.
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.
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. o jekk int għażilt 12- il Unità tista ’ tinjetta d- doża tiegħek. o Jekk int għażilt aktar minn 12- il Unità allura 12- il Unità biss mid- doża sħiħa tiegħek ta ’ l - insulina tista ’ tkun injettata b’ din il- pinna.
In this case what should you do: • either you can inject what is remaining in the pen and complete your dose with a new OptiSet. • or use a new OptiSet for your full dose.
F’ każ bħal dan x’ għandek tagħmel: • jew tinjetta dak li fadal fil- pinna u tkompli tieħu li fadallek għad- doża sħiħa minn OptiSet ġdida. • jew tuża OptiSet ġdida għad- doża sħiħa.
Use the injection method as instructed by your health care professional.
Uża t- teknika ta ’ l- injezzjoni kif uriek il- professjonist fil- qasam tas- saħħa.
Insert the needle into the skin.
Daħħal il- labra fil- ġilda.
Deliver the dose by pressing the injection button in all the way.
Ħu d- doża billi tagħfas il- buttun ta ’ l- injezzjoni sa ġewwa.
A clicking sound can be heard, which will stop when the injection button has been pressed in completely.
Tista ’ tisma ’ ċekċieka, li tieqaf meta l- buttun ta ’ l- injezzjoni jingħafas kollu ’ l ġewwa.
Keep the injection button pressed in and slowly count to 10 before you withdraw the needle from the skin.
Żomm il- buttun ta ’ l- injezzjoni magħfus ’ il ġewwa u bil- mod għodd sa 10 qabel ma tiġbed il - labra ’ l barra mill- ġilda.
This ensures that the full dose will be delivered.
Dan jiżgura li d- doża sħiħa tkun ingħatat.
Always remove the needle after each injection and store OptiSet without a needle attached.
Dan jgħin biex
This helps prevent: • Contamination and/ or infection • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
• Il- kontaminazzjoni • Id- dħul ta ’ l- arja
Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
Poġġi l- kappa ta ’ barra lura fuq il- labra, u użaha biex tħoll il- labra mill- pinna.
To reduce the risk of accidental needle injury, never replace the inner needle cap.
Biex jonqos ir - riskju li wieħed iweġġa ’ aċċidentalment bil- labra, qatt m’ għandek tpoġġi lura l- kappa ta ’ ġewwa tal- labra.
• If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle.
• Jekk l- injezzjoni tiegħek ser tingħata minn persuna oħra, għandha tittieħed il- kawtela speċjali minn din il- persuna waqt li tneħħi u tarmi l- labra.
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.
Dispose of the needle safely, as instructed by your healthcare professional.
Armi l- labra mingħajr periklu, kif spjegalek il- professjonist fil- qasam tas- saħħa.
Put the pen cap back on, 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 tieħu.
Storage Instructions
Struzzjonijiet dwar il- ħażna
Please check section 5 – How to store Insulin Human Winthrop Rapid - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insulin Human Winthrop Rapid - fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
If your OptiSet is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature.
Jekk l- OptiSet tiegħek hija maħzuna fil- kesħa, oħroġha minn siegħa sa sagħtejn qabel tinjetta biex tħalliha tisħon u tilħaq it- temperatura ambjentali ta ’ ġewwa.
Discard your used OptiSet as required by your local regulations.
Armi l- OptiSet użata tiegħek kif jitolbu l- liġijiet lokali.
471 Maintenance
Manutenzjoni
Protect your OptiSet from dust and dirt.
Żomm l- Optiset tiegħek ’ il bogħod mit- trab u l- ħmieġ.
You can clean the outside of your OptiSet by wiping it with a damp cloth.
Tista ’ tnaddaf l- OptiSet tiegħek minn barra billi timsaħħa 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 l- ħsara.
Your OptiSet is designed to work accurately and safely.
L- OptiSet 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 OptiSet may be damaged, discard it and use a new one.
Jekk int qed tinkwieta li l- OptiSet tiegħek seta ’ ġralha xi ħsara, armiha u uża waħda ġdida.
Questions and Answers
467 Mistoqsijiet u Tweġibiet
Wrong dose selected.
• Doża ħażina magħżula.
Follow the instructions in Step 4 to select the correct dose.
4 biex tagħżel id- doża korretta.
Dose has been selected and the injection button has been pulled out and pressed in again without a needle attached.
Id- doża hija magħżula
Press the injection button completely in and discard the insulin.
Agħfas il- buttun ta ’ l- injezzjoni ’ l ġewwa kompletament u armi
Perform the safety test.
Agħmel it- test ta ’ sigurtà.
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 Jekk it- test ta sigurtà ma rnexxiex, il- pinna tista ’ tkun bil- ħsara.
If test is not successful, the pen might be damaged.
Uża twaħħlet labra.
Use a new OptiSet.
OptiSet ġdida.
If in any doubt whether the pen is working correctly use a new OptiSet.
Jekk int fid- dubju jekk il- pinna hiex taħdem sew uża OptiSet ġdida.
The dosage selector does not turn.
• Is- selettur tad- dożaġġ ma jdurx.
• You are turning in the wrong direction.
Qed iddawwar fid- direzzjoni ħażina.
The dosage selector can only be turned forward.
Is- selettur tad- dożaġġ jista ’ jdur ’ il quddiem biss.
You are turning forward while the injection button is pulled out.
Qiegħed iddawwar ’ il quddiem waqt li l- buttun ta ’ l- injezzjoni huwa miġbud ’ il barra.
Press the injection button in completely to discard the dose and select again.
Agħfas il- buttun ta ’ l- injezzjoni kompletament ’ il ġewwa biex tarmi d- doża u erġa ’ agħżel mill - ġdid.
The amount indicated on the injection button is higher than the dose selected.
• L- ammont indikat fuq
• Difference is 2 units.
Id- differenza hi ta ’ żewġ (2) unitajiet.
Discard insulin, then set your dose and check again.
il- buttun ta ’ l- injezzjoni huwa ogħla mid- doża magħżula.
• Difference is more than 2 units.
Jekk jerġa ’ jiġri l- istess żball, l- OptiSet jista ’ jkollha l- ħsara, uża OptiSet ġdida. • Id- differenza hija aktar minn żewġ (2) unitajiet.
OptiSet is damaged, use a new OptiSet.
L- OptiSet bil- ħsara, uża OptiSet ġdida.
The amount indicated on the injection button is lower than the dose selected.
L- ammont indikat fuq
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.
Tista ’ tinjetta l- ammont indikat fuq il- buttun ta ’ l- injezzjoni minn din l- OptiSet u wara tinjetta l- bqija tad- doża minn pinna ġdida, jew • Tista ’ tinjetta d- doża sħiħa minn pinna ġdida.
The injection button cannot be pressed in.
Il- buttun ta ’ l - injezzjoni ma jistax
Make sure you pulled out the injection button completely.
Kun ċert li ġbidt il- buttun ta ’ l- injezzjoni ’ il barra kompletament.
Press the injection button completely in to discard the insulin.
Agħfas il- buttun ta ’ l- injezzjoni ’ l ġewwa kompletament biex tarmi l- insulina.
use a new OptiSet.
L- OptiSet hija bil- ħsara, uża waħda ġdida.
Insulin is leaking from the pen.
Ma tismax iċ- ċekċik waqt li qed tinjetta.
Needle may have been attached imprecisely (e.g. at a slant).
Jista ’ jagħti l- każ li l- labra twaħħlet ħażin (e. g. immejjla).
Remove needle and replace with a new needle attaching it on straight.
labra, biddilha m’ oħra ġdida u waħħalha dritta.
Air bubbles are present in the reservoir.
Hemm il- bżieżaq ta ’ l - arja fir- riżervwar.
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 - insulina waqt l- użu normali.
You must remove this air by performing the safety test.
Għandek tneħħi din l- arja permezz tat- test ta ’ sigurtà.
The tiny air bubbles in the insulin reservoir that do not move with tapping will not interfere with the injection and dosage.
Il- bżieżaq żgħar ta ’ l- arja, fir- riżervwar ta ’ l- insulina, li ma jiċċaqalqux bit- taptip mhux ser ifixklu fl- injezzjoni u d- dożaġġ.
OptiSet is damaged or is not working properly.
L- OptiSet bil- ħsara jew mhix qed taħdem sew.
Use a new OptiSet.
Uża OptiSet ġdida.
OptiSet has been dropped or subjected to impact.
L- OptiSet twaqqgħet jew ġiet soġġetta għal impatt.
473 PACKAGE LEAFLET:
469 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Rapid 100 IU/ml solution for injection in a cartridge for OptiClik Insulin human
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
The instructions for using OptiClik, the insulin pen, are provided with your OptiClik.
L- istruzzjonijiet dwar l- użu ta ’ OptiClik, il- pinna ta ’ l- insulina, huma ipprovduti ma ’ l- OptiClik tiegħek.
Refer to them before using your medicine.
Irreferi għalihom qabel ma tuża il- mediċina tiegħek.
Insulin Human Winthrop Rapid is a solution for injection under the skin or, in exceptional circumst ances, into a vein (blood vessel).
Insulin Human Winthrop Rapid huwa soluzzjoni għall- injezzjoni għal taħt il- ġilda jew, f’ cirkustanzi speċjali, ġewwa vina (sistema vaskulari).
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 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.
This cartridge is for use with OptiClik only.
Dan l- iskartoċċ huwa għall- użu ma ’ OptiClik biss.
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 fejn ġismek ma jagħmilx biżżejjed insulina biex jikkontrolla l- livell taz- zokkor fid- demm.
Insulin Human Winthrop Rapid may also be used for treating 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) as well as for controlling blood sugar before, during and after surgery.
Insulin Human Winthrop Rapid jista ’ jintuża wkoll għat - trattament ta ’ l- ipergliċemija serja u severa (iz- zokkor fid- demm huwa għoli wisq) u l- ketoaċidożi (l - aċidu fid- demm jiżdied għax il- ġisem qiegħed jakkwista l- enerġija mix- xaħam, minflok miz- zokkor), kif ukoll biex jikkontrolla l- livell taz- zokkor fid- demm qabel, waqt u wara operazzjoni kirurġika.
2 BEFORE YOU USE INSULIN HUMAN WINTHROP RAPID
QABEL MA TUŻA INSULIN HUMAN WINTHROP RAPID
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Rapid.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insulin Human Winthrop Rapid.
Take special care with Insulin Human Winthrop Rapid
470 Oqgħod attent ħafna b’ Insulin Human Winthrop Rapid:
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
471 Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
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 ’.
476 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
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop Rapid.
- jgħidlek għandek jkollok bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop
How to handle the cartridges for OptiClik
Kif timmaniġġa l- iskartoċċ għal OptiClik
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.
Insulin Human Winthrop Rapid fi skartoċċi għal OptiClik kien żviluppat għall- użu f’ OptiClik biss. 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.
- Do not re-fill and re-use empty cartridges.
- Terġax timla u terġa ’ tuża l- skartoċċi vojta
- Do not mix insulin with any other medicines.
- Tħallatx l- insulina ma ’ mediċini oħrajn..
Problems with OptiClik?
Diffikultajiet b’ OptiClik?
Refer to the manufacturer’s instructions for using the pen.
Irreferi għall- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna.
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
Jekk OptiClik bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi), għandha tintrema, u OptiClik ġdida għandha tintuża minflok.
If OptiClik does not function well, you can draw the insulin from the cartridge into an injection syringe for injection.
Jekk OptiClik ma taħdimx sew, tista ’ ttella ’ l- insulina mill- iskartoċċ f’ siringa għall- injezzjoni.
Therefore, keep injection syringes and needles as well.
Għalhekk, żomm is- siringi u l- labar ukoll.
However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Madankollu, uża biss is- siringi li huma magħmulin għal konċentrazzjoni ta ’ insulina ta ’ 100 Unità għal kull millilitru.
For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
Għal informazzjoni fuq il- kura ta ’ l- ipogliċemija, ara l- kaxxa fit- tmiem ta ’ dan il - fuljett
For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Għal aktar informazzjoni dwar l- effetti sekondarji ta ’ livell baxx ta ’ zokkor fid- demm u ta ’ livell għoli ta ’ zokkor fid- demm, ara l- kaxxa fl- aħħar ta’ dan il- fuljett.
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
Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent)
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.