qanastek/EMEA-V3 huggingface dataset:
Always tell people who are caring for you or treating you that you require insulin.
Dejjem għid lin- nies li qegħdin jieħdu ħsiebek jew li qegħdin jikkurawk li għandek bżonn l- insulina.
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Xi mediċini jikkawżaw tibdil fil- livell taz- zokkor fid- demm (tnaqqis, żieda jew it- tnejn li huma, skond iċ- ċirkostanzi).
In each case, it may be necessary to adjust your insulin dosage to avoid blood sugar levels that are either too low or too high.
F’ kull każ, jista ’ jkun meħtieġ li taġġusta d- doża tiegħek ta ’ l- insulina biex tevita livelli taz- zokkor fid- demm li jkunu baxxi wisq jew għoljin wisq.
Be careful when you start or stop taking another medicine.
Oqgħod attent/ a meta tibda jew tieqaf tieħu xi mediċina oħra.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Qabel tieħu xi mediċina staqsi lit- tabib tiegħek jekk tistax teffettwalek il- livell tiegħek taz- zokkor fid- demm, u x’ għandek tagħmel, jekk meħtieġ.
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:
Il- mediċini li jistgħu jbaxxu l- livell taz- zokkor f’ demmek (ipogliċemija) jinkludu:
- all other medicines to treat diabetes,
- il- mediċini l- oħra kollha użati għall- kura tad- dijabete,
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti -
blood pressure),
kundizzjonijiet tal- qalb jew ta ’ pressjoni għolja fid- demm)
- disopyramide (used to treat certain heart conditions),
- disopyramide (użat għall- kura ta ’ ċerti kundizzjonijiet tal- qalb)
- fluoxetine (used to treat depression),
- fluoxetine (użat għall- kura tad- depressjoni)
- fibrates (used to lower high levels of blood lipids),
- fibrates (użati biex ibaxxu l- livelli għoljin tal- lipidi fid- demm)
- monoamine oxidase (MAO) inhibitors (used to treat depression),
- l- inibituri ta ’ monoamine oxidase (MAO) (użati għall- kura tad- depressjoni)
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),
- pentoxifylline, propoxyphene, salicylates (bħall- aspirina, użata biex ittaffi l- uġigħ u tbaxxi d -
- sulfonamide antibiotics.
- l- antibijotiċi sulfonamidi.
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
422 Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
- corticosteroids (such as "cortisone", used to treat inflammation),
- l- kortikosterojdi (bħal "cortisone", użat għall- kura ta ’ l- infjammazzjoni)
- danazol (medicine acting on ovulation),
- danazol (mediċina li taħdem fuq l- ovulazzjoni),
- diazoxide (used to treat high blood pressure),
- diazoxide (użat għall- kura ta ’ pressjoni għolja fid- demm),
- diuretics (used to treat high blood pressure or excessive fluid retention),
- id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew iż- żamma eċċessiva ta ’ fluwidi),
- glucagon (pancreas hormone used to treat severe hypoglycaemia),
- glukagon (ormon tal- frixa użat għall- kura ta ’ ipogliċemija severa),
- isoniazid (used to treat tuberculosis),
- isoniazid (użat għall- kura tat- tuberkulożi),
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),
- l- estroġeni u l- proġesteni (bħal fil- pillola kontraċettiva, użata għall- kontroll tat- twelid),
- phenothiazine derivatives (used to treat psychiatric disorders),
- id- derivattivi ta ’ phenothiazine (użati għall- kura ta ’ disturbi psikjatriċi),
- somatropin (growth hormone),
- somatropin (ormon tat- tkabbir),
- sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to
- il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat
treat asthma),
għall- kura ta ’ l- ażma),
- thyroid hormones (used to treat the thyroid gland disorders),
- ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde),
- protease inhibitors (used to treat HIV),
- l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV),
- atypical antipsychotic medications (such as olanzapine and clozapine).
- l- mediċini hekk imsejjħa atipiċi kontra l- psikożi (bħal olanzapine u clozapine).
Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
- beta-blockers (used to treat high blood pressure),
- imblokkaturi tar- riċetturi beta (użati għall- kura ta ’ pressjoni għolja fid- demm),
- clonidine (used to treat high blood pressure),
- clonidine (użat għall- kura ta ’ pressjoni għolja fid- demm)
- lithium salts (used to treat psychiatric disorders).
- is- sustanzi tal- lithium (użati għall- kura ta ’ disturbi psikjatriċi)
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Pentamidine (użat għall- kura ta ’ xi infezzjonijiet ikkawżati mill- parassiti) jista ’ jikkawża l - ipogliċemija li kultant tkun segwita mill- ipergliċemija.
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
L- imblokkaturi tar- riċetturi beta, bħall- mediċini oħra simpatolitiċi, (bħal clonidine, guanethidine, u reserpine) jistgħu jdgħajjfu jew jaħbu kompletament l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf xi ipogliċemija.
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Jekk m’ intix ċert/ a jekk intix qed tieħu waħda minn dawn il- mediċini staqsi lit- tabib jew lill- ispiżjar tiegħek.
Using Insulin Human Winthrop Rapid with food and drink
Meta tuża Insulin Human Winthrop Rapid ma ’ l- ikel u max- xorb
Your blood sugar levels may either rise or fall if you drink alcohol.
Il- livelli taz- zokkor fid- demm tiegħek jistgħu jogħlew jew jinżlu jekk tixrob l- alkoħol
Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Għarraf lit- tabib tiegħek jekk inti qed tippjana toħroġ tqila, jew diġà tqila b’ tarbija.
Your 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.
Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Il- kontroll bil- ħsieb tad - dijabete tiegħek, u l- prevenzjoni ta ’ l- ipogliċemija, huma importanti għas- saħħa tat- tarbija tiegħek.
However, there is no experience with the use of Insulin Human Winthrop Rapid in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insulin Human Winthrop Rapid waqt it- tqala.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Jekk int qed tredda ’, iddiskutiha mat- tabib tiegħek għax jista ’ jagħti l- każ li teħtieġ tibdiliet fid- dożi ta ’ l- insulina u d- dieta tiegħek.
Your ability to concentrate or react may be reduced if:
L- abbiltà tiegħek biex tikkonċentra u tirreaġixxi tista ’ tonqos jekk:
- 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).
- you have problems with your sight.
- għandek problemi bil- vizta tiegħek
Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or operating machinery).
Żomm din il- problema f’ moħħok f’ kull sitwazzjoni fejn tista ’ tpoġġi lilek innifsek jew lil ħaddieħor f’ riskju (bħal fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
You should contact your doctor for advice on driving if:
Għandek tikkuntatja lit- tabib tiegħek għal parir fuq is- sewqan jekk:
- you have frequent episodes of hypoglycaemia,
- għandek ġrajjiet spissi ta ’ ipogliċemija,
- the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
- l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf l- ipogliċemija huma ridotti jew m’ humiex
Important information about some of the ingredients of Insulin Human Winthrop Rapid
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Rapid
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 ’
HOW TO USE INSULIN HUMAN WINTHROP RAPID
KIF GĦANDEK TUŻA INSULIN HUMAN WINTHROP RAPID
Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will
Skond l- istil ta ’ ħajjtek u r- riżultati tat- testijiet taz- zokkor (glukożju) fid- demm, it- tabib tiegħek sejjer
- determine how much Insulin Human Winthrop Rapid per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insulin Human Winthrop Rapid kuljum,
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- jġħidlek meta teżamina l- livell taz- zokkor f’ demmek, u jekk għandek tagħmel it- testijiet fuq l -
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop Rapid.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop Rapid,
Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Għandek tkun taf liema huma biex tkun tista ’ tirreaġixxi kif suppost meta jkun hemm tibdil fil- livell taz- zokkor f’ demmek u biex ma tħallihx jogħla jew jitbaxxa wisq.
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.
Frequency of administration
Kemm- il darba jingħata
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 15 sa 20 minuta qabel ikla.
Your 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.
With each injection, change the puncture site within the particular area of skin that you are using.
Ma ’ kull injezzjoni biddel il- post tat- titqiba, fiż- żona partikolari tal- ġilda li qiegħed tuża.
Insulin administration into a vein for example to treat severe hyperglycaemia and ketoacidosis, requires experience and special safety precautions.
L- għoti ta ’ l- insulina fil- vina per eżempju biex titratta l- ipergliċemija severa u l- ketoaċidożi, tirrikjedi esperjenza u prekawzjonijiet speċjali ta ’ sigurtà.
For these reasons, it must be done in a clinic or a similar setting.
Għal dawn ir- raġunijiet, din trid issir fi klinika jew xi post ieħor simili.
How to handle the vials
Kif timmaniġġa l- kunjetti
Insulin Human Winthrop Rapid contains 100 IU insulin per ml.
Insulin Human Winthrop Rapid fih 100 IU t’ insulina kull ml.
Only injection syringes designed for this insulin concentration (100 IU per ml) must be used.
Uża biss is- siringi għall- injezzjoni magħmula għal din il- konċentrazzjoni t’ insulina (100 IU/ ml).
The injection syringes must not contain any other medicines or traces of medicines (such as traces of heparin).
Is- siringi ta ’ l- injezzjoni m’ għandhomx ikollhom kwalunkwe mediċina oħra jew traċċi ta ’ mediċini (bħal traċċi ta ’ eparina).
Before the first withdrawal of insulin you must remove the safety tear-off cap on the vial.
Qabel tiġbed l- ewwel doża ta ’ l- insulina, għandek tneħħi l- għatu tas- sigurtà tal- kunjett.
Insulin Human Winthrop Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and has a water-like consistency.
Insulin Human Winthrop Rapid għandu jintuża biss jekk is- soluzzjoni hija ċara, bla kulur, mingħajr partikoli solidi viżibbli, u għandha l- konsistenza tixbah lil dik ta ’ l- ilma.
Do not shake the vial vigorously as this could cause froth to form.
Iċċekċikx il- kunjett bil- goff għax dan jista ’ jikkaġuna l- formazzjoni tar- ragħwa.
Froth can make it difficult for you to measure the correct dose.
Ir- ragħwa tista ’ tagħmilha diffiċili biex tikkalkula d- doża eżatta.
Special care before injection
424 Attenzjoni speċjali qabel l- injezzjoni
Before injection remove any air bubbles.
Qabel l- injezzjoni, neħħi l- bżieżaq ta ’ l- arja li jista ’ jkun hemm.
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Aċċerta ruħek li la l- alkoħol u anqas disinfettanti oħra jew xi sustanzi oħra jikkontaminaw l- insulina.
Do not mix insulin with any other medicines.
Tħallatx l- insulina ma ’ kwalunkwe mediċina oħra.
Insulin Human Winthrop Rapid may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
Insulin Human Winthrop Rapid jista ’ jitħallat mal- preparazzjonijiet kollha ta ’ l- insulini umani ta ’ Sanofi- Aventis, b’ EĊĊEZZJONI ta ’ dawk magħmulin speċifikament għall- użu mal- pompi ta ’ l - insulina.
Also, it must NOT be mixed with animal source insulins or insulin analogues.
Hekk ukoll, m’ GĦANDEKX tħallatha ma ’ l- insulini derivati mill- annimali jew ma ’ l - insulini analogi.
Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx tħallat l- insulini umani ta ’ Sanofi- Aventis.
If you need to inject a mixture, draw Insulin Human Winthrop Rapid into the injection syringe before the other insulin.
Jekk ghandek bżonn tinjetta taħlita, iġbed Insulin Human Winthrop Rapid fis- siringa ta ’ l- injezzjoni qabel l- insulina l- oħra.
Inject as soon as you have mixed them.
Injetta hekk kif tkun ħallathom.
Do not mix insulins of different strengths (for example 100 IU per ml and 40 IU per ml).
Tħallatx l- insulini ta ’ qawwa differenti (per eżempju 100 IU kull ml ma ’ 40 IU kull ml).
430 Mistakes in dosage
Żbalji fid- dożaġġ
If you use more Insulin Human Winthrop Rapid than you should
Jekk tuża aktarInsulin Human Winthrop Rapid milli suppost
- If you have injected too much Insulin Human Winthrop Rapid, your blood sugar level may
- Jekk injettajt Insulin Human Winthrop Rapid aktar milli meħtieġ il- livell taz- zokkor
become too low (hypoglycaemia).
tiegħek fid- demm jista ’ jitbaxxa wisq (ipogliċemija).
Check your blood sugar frequently.
Iċċekkja spiss iz- zokkor f’ demmek.
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.
If you forget to use Insulin Human Winthrop Rapid
Jekk tinsa tuża Insulin Human Winthrop Rapid
- If you have missed a dose of Insulin Human Winthrop Rapid or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Rapid jew ma injettajtx biżżejjed insulina, il -
enough insulin, your blood sugar level may become too high (hyperglycaemia).
livell taz- zokkor f’ demmek jista ’ jogħla ħafna (ipergliċemija).
For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Għal informazzjoni fuq il- kura ta ’ l- ipergliċemija, ara l- kaxxa li tinsab fit- tmiem ta ’ dan il- fuljett.
- Do not take a double dose to make up for a forgotten dose.
- Tieħux doża doppja biex tpatti għal dik li nsejt.
If you stop using Insulin Human Winthrop Rapid This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Rapid Insulin Human WinthropDan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid - demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x - xaħam minflok iz- zokkor).
Do not stop Insulin Human Winthrop Rapid without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insulin Human Winthrop Rapid mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insulin Human Winthrop Rapid can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insulin Human Winthrop Rapid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
As with all insulin therapy, the most frequent side effect is hypoglycaemia (low blood sugar).
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- aktar effett sekondarju frekwenti huwa l- ipogliċemija (livell baxx ta ’ zokkor fid- demm).
Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Ipogliċemija serja tista ’ tkun il- kawża ta ’ attakk ta ’ qalb jew ta ’ ħsara fil- moħħ u tista ’ tkun fatali.
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 ’ din is- sezzjoni.
Severe allergic reactions to insulin may occur which may become life-threatening.
Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
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 reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq.
Side effects reported 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
425 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
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
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 Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
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.
Insulin that you inject in such a site may not work very well.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjeb sew.
Changing the injection site with each injection may help to prevent such skin changes. • 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..
They can also spread around the injection site.
Dawn jistgħu wkoll jinfirxu madwar il- post ta ’ l- injezzjoni.
Most minor reactions to insulins usually resolve in a few days to a few weeks.
Il- biċċa l- kbira tar- reazzjonijiet żgħar għall- insulini s- soltu jirriżolvu fi ftit jiem jew ftit ġimgħat.
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
It- trattament bl- insulina jista ’ jġiegħel il- ġisem jipproduċi l- antikorpi (sustanzi li jaġġixxu kontra l - insulina).
However, only very rarely, this will require a change to your insulin dosage.
Madankollu, huwa biss rari ħafna li dan ikun jeħtieġ bidla fid- dożaġġ tiegħek ta ’ l- insulina.
Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk tinnota kwalunkwe waħda minn dawn l- effetti sekondarji elenkati hawn fuq jew kwalunkwe effetti mhux mixtieqa jew mhux mistennija.
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurs suddenly or gets worse rapidly.
Biex tilqa ’ minn qabel reazzjonijiet serji, kellem lit- tabib immedjatament jekk l- effett sekondarju huwa sever, jiġri f’ daqqa jew jiddeterjora malajr.
HOW TO STORE INSULIN HUMAN WINTHROP RAPID
KIF TAĦŻEN INSULIN HUMAN WINTHROP RAPID
Do not use Insulin Human Winthrop Rapid after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insulin Human Winthrop Rapid wara d- data ta ’ skadenza li tidher fuq ilkaxxa u fuq it- tikketta tal- kunjett.
Unopened vials Store in a refrigerator (2°C – 8°C).
Kunjetti mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ).
Do not put Insulin Human Winthrop Rapid next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Rapid m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
Opened vials Once in-use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Kunjetti miftuħa Ġaladarba fl- użu, il- kunjett jista ’ jinħażen sa massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ fil- kartuna ta ’ barra u ’ l bogħod mis- sħana diretta (eż. viċin apparat li jitfa ’ s- sħana) jew mid -
Do not use the vial after this time period.
426 dawl dirett (dawl tax- xemx dirett jew viċin lampa).
Keep the vial.
Tużax il- kunjett wara dan il- perijodu ta ’ żmien.
It is recommended that the date of the first use be noted on the label.
Huwa rrakkomandat li d- data ta ’ l- ewwel użu titniżżel fuq it- tikketta.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ ghandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma l- iskart domestiku.
What Insulin Human Winthrop Rapid contains
X’ fih Insulin Human Winthrop Rapid
- The active substance is insulin human.
- Is- sustanza attiva hi insulina umana.
One ml of Insulin Human Winthrop Rapid contains
Millilitru wieħed ta ’ Insulin Human Winthrop Rapid fih
100 IU (International Units) of the active substance insulin human.
100 UI (Unita Internazzjonali) tas- sustanza attiva insulina umana.
- The other ingredients are: metacresol, sodium dihydrogen phosphate dihydrate, glycerol,
- Is- sustanzi l- oħra huma: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium
sodium hydroxide, hydrochloric acid (for pH adjustment) and water for injections.
hydroxide, hydrochloric acid (għall- aġġustament tal- pH), u ilma għall- injezzjonijiet.
What Insulin Human Winthrop Rapid looks like and contents of the pack Insulin Human Winthrop Rapid is a clear, colourless solution for injection, with no solid particles visible, and of a water-like consistency.
Id- Dehra ta ’ Insulin Human Winthrop Rapid u l- kontenuti tal- pakkett Insulin Human Winthrop Rapid huwa soluzzjoni għall- injezzjoni ċara, minghajr kulur, bla ebda partikuli solidi u viżibbli, u tixbaħ l- ilma.
432 Insulin Human Winthrop Rapid is supplied in vials containing 5 ml solution (500 IU).
Insulin Human Winthrop Rapid huwa fornut f’ kunjetti ta ’ 5 ml ta ’ soluzzjoni (500 IU).
Packs of 1 and 5 vials of 5 ml are available.
Huwa disponibbli f’ pakketti ta ’ kunjett wieħed jew ta ’ 5 kunjetti ta ’ 5 ml.
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.
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:
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
427 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
428 IPERGLIĊEMIJA U IPOGLIĊEMIJA
Carry some information with you to show you are diabetic.
Dejjem ġorr miegħek xi zokkor (għallinqas 20 gramm) Ġorr miegħek xi informazzjoni biex turi li inti dijabetiku/ a.
HYPERGLYCAEMIA (high blood sugar levels)
IPERGLIĊEMIJA (livell għoli ta ’ zokkor fid- demm)
If your 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
Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Examples include:
Eżempji jinkludu:
- you have not injected your insulin or not injected enough, or if it has become less effective, for
- int ma injettajtx l- insulina tiegħek jew ma injettajtx biżżejjed, jew jekk saret anqas effettiva, per
example through incorrect storage,
eżempju minħabba ħażna ħażina,
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or
- int qiegħed tagħmel anqas eżerċizzju fiżiku mis- soltu, jew int qiegħed taħt stress (inkwiet,
you have an injury, operation, infection or fever,
eċitament), jew għandek xi ferita, saritlek xi operazzjoni, għandek xi infezzjoni jew għandek id - deni.
- you are taking or have taken certain other medicines (see section 2, "Using other medicines").
- int qiegħed tieħu jew ħadt ċerti mediċini oħrajn (ara sezzjoni 2, “ Meta tuża mediċini oħra ”).
Warning symptoms of hyperglycaemia
Sintomi ta ’ twissija ta ’ ipergliċemija
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine.
Għatx, il- bżonn miżjud biex tgħaddi l- awrina, għeja, ġilda xotta, ħmura tal- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mgħaġġla u glukosju u ketoni fl- awrina.
Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Uġigħ fl- istonku, in- nifs mgħaġġel u fil- fond, ngħas u anki telf mis- sensi jistgħu jkunu sinjali ta ’ kundizzjoni serja (kitoaċidożi) li tkun ikkaġunata minn nuqqas ta ’ insulina.
What should you do if you experience hyperglycaemia
X’ għandek tagħmel f’ każ ta ’ ipergliċemija?
434 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.
Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
L- ipergliċemija severa jew il- kitoaċidożi għandhom dejjem ikunu ikkurati minn tabib, normalment fi sptar.
HYPOGLYCAEMIA (low blood sugar levels)
IPOGLIĊEMIJA (livell baxx ta ’ zokkor fid- demm)
Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Jekk il- livell taz- zokkor fid- demm tiegħek jinżel wisq tista ’ tintilef minn sensik. Ipogliċemija serja tista ’ tkun il- kawża ta ’ attakk ta ’ qalb jew ta ’ ħsara fil- moħħ u tista ’ tkun fatali.
You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Normalment għandek tinduna li l- livell taz- zokkor fid- demm tiegħek huwa baxx wisq sabiex tkun tista ’ tieħu dawk ir- rimedji li jkun hemm bżonn.
Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
- you inject too much insulin,
- int tinjetta wisq insulina,
- you miss meals or delay them,
- int taqbeż l- ikliet jew teħodhom aktar tard mis- soltu,
- you do not eat enough, or eat food containing less carbohydrate than normal (sugar and
- int ma tiekolx biżżejjed, jew qed tiekol ikel li fih anqas karboidrati minn normal, (zokkor u
substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
sustanzi simili għaz- zokkor li jissejjħu karboidrati; madankollu, l- ħlewwiet artifiċjali M’ HUMIEX karboidrati),
- you lose carbohydrates due to vomiting or diarrhoea,
- int qed titlef il- karboidrati dovut għar- remettar jew id- dijarea,
- you drink alcohol, particularly if you are not eating much,
- int qed tixrob l- alkoħol, speċjalment jekk m’ intix tiekol wisq,
- you are doing more exercise than usual or a different type of physical activity,
- int qiegħed tagħmel aktar eżerċizzju fiżiku mis- soltu jew xi eżerċizzju fiżiku differenti,
- you are recovering from an injury or operation or other stress,
- int qed tirkupra minn xi inċident fejn weġġajt jew xi operazzjoni jew xi stress ieħor,
- you are recovering from an illness or from fever,
- int qed tirkupra minn marda jew mid- deni
- you are taking or have stopped taking certain other medicines (see section 2, "Using other
- int qed tieħu jew waqaft tieħu ċerti mediċini oħra (ara sezzjoni 2, “ Meta tuża mediċini oħra ”).
Hypoglycaemia is also more likely to occur if:
429 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
- you have just begun insulin treatment or changed to another insulin preparation,
- int għadek tibda t- trattament bl- insulina jew qlibt għal preparat ieħor ta ’ insulina,
- your blood sugar levels are almost normal or are unstable,
- int għandhek il- livelli taz- zokkor fid- demm tiegħek kważi normali jew mhux stabbli,
- you change the area of skin where you inject insulin (for example from the thigh to the upper
- int bdilt iż- żona tal- ġilda fejn tinjetta l- insulina (per eżempju mill- koxxa għall- parti ta ’ fuq tad -
arm),
driegħ),
- you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
- int issofri minn mard sever tal- kliewi jew mard tal- fwied, jew xi marda oħra bħat- tnaqqis fil -
Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
- In your body
- Fil- ġisem tiegħek.
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Eżempji ta ’ sintomi li juruk li l- livell taz- zokkor fid- demm tiegħek qed jaqa ’ wisq, jew qiegħed jinżel wisq malajr: għaraq żejjed, ġilda twaħħal, l- ansjetà, il- qalb tħabbat mgħaġġla, pressjoni għolja tad - demm, palpitazzjonijiet u l- qalb tħabbat b’ mod irregolari.
These symptoms often develop before the symptoms of a low sugar level in the brain.
Dawn is- sintomi ta ’ spiss jiżviluppaw qabel is- sintomi dovuti għal livell baxx taz- zokkor fil- moħħ.
- In your brain
- F’ moħħok.
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Ezempji ta ’ sintomi li jindikaw livell baxx taz- zokkor fil- moħħ:: uġigħ ta ’ ras, ġuħ kbir, dardir, remettar, għeja, ngħas, disturbi fl- irqad, nuqqas ta ’ kwiet, komportament aggressiv, nuqqas ta ’ attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid- diskors, (xi drabi it- telf komplet tad- diskors), indeboliment tal- vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir- reġjun tal- ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t- telf mis- sensi.
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
L- ewwel sintomi li jagħtuk indikazzjoni li ser tiżviluppa l- ipogliċemija (“ sintomi ta ’ twissija ”) jistgħu jinbidlu, jiddgħajfu jew ikunu nieqsin għal kollox, jekk:
- you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of
- int anzjan, int kellek id- dijabete għal żmien twil, inti tbati minn ċertu tip ta ’ mard tas- sistema
nervous disease (diabetic autonomic neuropathy),
nervuża (newropatija awtonomika dijabetika),
- you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,
- int batejt dan l- aħħar mill- ipogliċemija (per eżempju il- jum ta ’ qabel) jew jekk tiżviluppa bil -
- you have almost normal or, at least, greatly improved blood sugar levels,
- int għandek livelli ta ’ zokkor fid- demm li huma kważi normali jew, ta ’ l- inqas, marru għall -
- you have recently changed from an animal insulin to a human insulin such as Insulin Human
- dan l- aħħar biddilt it- tip ta ’ insulina minn dik li ġejja mill- annimali għal dik tat- tip umana bħall -
- you are taking or have taken certain other medicines (see section 2, "Using other medicines").
- int qed tieħu jew ħadt ċerti mediċini oħrajn (ara sezzjoni 2, “ Meta tuża mediċini oħra ”).
435 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.
Be familiar with your warning symptoms.
Kun familjari mas- sintomi ta ’ twissija tiegħek.
If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked.
Jekk hemm bżonn, it- testijiet aktar spissi għaz- zokkor fid- demm jistgħu jgħinuk biex tintebaħ bi ġrajjiet ta ’ l- ipogliċemija ħafifa li altrimenti jista ’ jkun ma kontx tinduna bihom.
If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Jekk m’ intix kunfidenti li tagħraf is- sintomi ta ’ twissija, evita sitwazzjonijiet (bħal issuq karozza) fejn l- ipogliċemija tpoġġi f’ riskju lilek jew lill- oħrajn.
What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
Do not inject insulin.
Tinjettax l- insulina.
Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Immedjatament ħu madwar 10 sa 20 g zokkor, bħal glukosju, dadi taz - zokkor, jew xi xarba ħelwa li fiha z- zokkor.
Caution:
Attent:
Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Ħlewwiet artifiċjali u ikel bi ħlewwiet artifiċjali (bħal xarbiet tad- dieta) m’ għandhom ebda valur fil- kura ta ’ l- ipogliċemija.
Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).
Wara kul xi ħaġa li għandha effett fit- tul li tgħolli z- zokkor fid- demm (bħall- ħobż jew l- għaġin).
Your doctor or nurse should have discussed this with you previously.
Suppost it- tabib jew l- infermier tiegħek kienu iddiskutu din il- ħaġa miegħek qabel.
If the hypoglycaemia comes back again take another 10 to 20 g sugar.
Jekk l- ipogliċemija terga ’ tfeġġ erġa ’ ħu minn 10 sa 20 g ta ’ zokkor.
Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Kellem tabib immedjatament jekk m’ intix kapaċi tikkontrolla l- ipogliċemija jew din terġa ’ titfaċċa.
Tell your relatives, friends and close colleagues the following:
430 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Jekk int ma tistax tibla ’ jew jekk int mitluf minn sensik, int teħtieġ injezzjoni tal- glukosju jew tal - glukagon (mediċina li tgħolli l- livell taz- zokkor fid- demm).
These injections are justified even if it is not certain that you have hypoglycaemia.
Dawn l- injezzjonijiet huma ġustifikati anki jekk mhux ċert li għandek l- ipogliċemija.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Huwa irrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l - glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
436 PACKAGE LEAFLET:
431 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Rapid 40 IU/ ml solution for injection in a vial Insulin human
Insulin Human Winthrop Rapid 40 UI/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana
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 tinsab f ’ Insulin Human Winthrop Rapid, hija magħmula bi proċess bijoteknoloġiku. u hija identika għall- insulina tal- ġisem stess.
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
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.
Travel
432 Safar
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
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 ’.
439 3.
434 3.
- 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 l -
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop Rapid.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop
Insulin Human Winthrop Rapid contains 40 IU insulin per ml.
Insulin Human Winthrop Rapid fih 40 IU t’ insulina kull ml.
Only injection syringes designed for this insulin concentration (40 IU per ml) must be used.
Uża biss is- siringi għall- injezzjoni magħmula għal din il- konċentrazzjoni t’ insulina (40 IU/ ml).
Special care before injection
Attenzjoni speċjali qabel l- injezzjoni
If you need to inject a mixture, draw Insulin Human Winthrop Rapid into the injection syringe before the other insulin.
Jekk ghandek bżonn tinjetta taħlita, iġbed Insulin Human Winthrop Rapid fis- siringa ta ’ l- injezzjoni qabel
Do not mix insulins of different strengths (for example 100 IU per ml and 40 IU per ml).
Tħallatx l- insulini ta ’ qawwa differenti (per ezempju 100 IU kull ml ma ’ 40 IU kull ml).
440 Mistakes in dosage
Żbalji fid- dożaġġ
If you use more Insulin Human Winthrop Rapid than you should
Jekk tuża Insulin Human Winthrop Rapid aktar milli suppost
- 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
If you forget to use Insulin Humaninthrop Rapid
Jekk tinsa tuża Insulin Human Winthrop Rapid
- Do not take a double dose to make up for a forgotten dose.
- Tieħux doża doppja biex tpatti għal dik li nsejt..
If you stop using Insulin Human Winthrop Rapid This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Rapid Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body); severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Dawn ir - reazzjonijiet għall- insulina jew għas- sustanzi mhux attivi jistgħu jwasslu għal reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq.
Side effects reported 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) • 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.
436 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.
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.
Insulin that you inject in such a site may not work very well.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not use Insulin Human Winthrop Rapid after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insulin Human Winthrop Rapid wara d- data ta ’ skadenza li tidher fuq ilkaxxa jew fuq it - tikketta tal- kunjett.
Unopened vials Store in a refrigerator (2°C - 8°C).
Kunjetti mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ).
Keep the vial 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 il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Opened vials Once in-use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp) Do not use the vial after this time period.
Tużax il- kunjett wara dan il- perijodu ta ’ żmien.
40 IU of the active substance insulin human.
40 UI (Unita Internazzjonali) tas- sustanza attiva insulina umana.
442 Insulin Human Winthrop Rapid is supplied in vials containing 10 ml solution (400 IU).
Insulin Human Winthrop Rapid huwa fornut f’ kunjetti ta ’ 10 ml ta ’ soluzzjoni (500 IU).
Packs of 1 and 5 vials of 10 ml are available.
Huwa disponibbli f’ pakketti ta ’ kunjett wieħed jew ta ’ 5 kunjetti ta ’ 10 ml.
Ireland sanofi-aventis Ireland Ltd.
438 Ireland sanofi- aventis Ireland Ltd.
This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}}
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine.
Uġigħ fl- istonku,
Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
439 in- nifs mgħaġġel u fil- fond, ngħas u anki telf mis- sensi jistgħu jkunu sinjali ta ’ kundizzjoni serja (kitoaċidożi) li tkun ikkaġunata minn nuqqas ta ’ insulina.
444 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:
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
445 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:
Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
446 PACKAGE LEAFLET:
441 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a cartridge Insulin human
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ Insulina umana
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel ma tibda tuża din il- mediċina.
The instructions for using the insulin pen are provided with your insulin pen.
L- istruzzjonijiet dwar l- użu tal- pinna ta ’ l- insulina huma pprovduti mal- pinna ta ’ l- insulina tiegħek.