qanastek/EMEA-V3 huggingface dataset:
Insulin Human Winthrop Comb 15 contains 100 IU insulin per ml.
Insulin Human Winthrop Comb 15 fih 100 IU insulina kull millilitru.
Only injection syringes designed for this insulin concentration (100 IU per ml) must be used.
Għandhom jintużaw biss dawk is- siringi għall- injezzjoni li huma magħmulin għall- qawwa ta ’ din l- insulina (100 IU kull ml).
The injection syringes must not contain any other medicines or traces of medicines (such as traces of heparin).
Is - siringi ta ’ l- injezzjoni m’ għandhomx ikollhom ebda mediċini oħrajn jew xi traċċi tagħhom (bħal traċċi ta ’ eparina).
It must not be used if it remains clear or if, for example, clumps, flakes, particles or anything similar are in the suspension or on the sides or bottom of the vial.
M’ għandhiex tintuża jekk is- suspensjoni tibqa ’ ċara jew, per eżempju, jitfaċċaw ċapep, biċċiet li jixbħu t- trofof tas- suf, partikuli jew kwalunkwe ħaġa simili fis- suspensjoni jew mal- ġnub jew il- qiegħ tal- kunjett.
A new vial with a uniform suspension on mixing must then be used.
F’ każijiet bħal dawn, kunjett ġdid li jagħti suspensjoni uniformi meta titħallat għandu jintuża.
Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża kunjett ġdid jekk tinnota li l- kontroll tiegħek taz- zokkor fid- demm qiegħed bla mistenni jmur għall- agħar.
Before injection remove any air bubbles.
Qabel l- injezzjoni neħħi l- bżieżaq ta ’ l- arja li jista ’ jkun hemm.
Do not mix insulin with any other medicines.
Tħallatx l- insulina ma ’ ebda mediċini oħra.
Insulin Human Winthrop Comb 15 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
573 Insulin Human Winthrop Comb 15 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l - insulina.
574 Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- aventis.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insulin Human Winthrop Comb 15.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insulin Human Winthrop Comb 15.
If you use more Insulin Human Winthrop Comb 15 than you should
Jekk tuża Insulin Human Winthrop Comb 15 aktar milli suppost
- If you have injected too much Insulin Human Winthrop Comb 15, your blood sugar level
- Jekk injettajt aktar Insulin Human Winthrop Comb 15 milli meħtieġ, il- livell taz- zokkor
may become too low (hypoglycaemia).
tiegħek fid- demm jista ’ jitbaxxa wisq (ipogliċemija).
If you forget to use Insulin Human Winthrop Comb 15
Jekk tinsa tuża Insulin Human Winthrop Comb 15
- If you have missed a dose of Insulin Human Winthrop Comb 15 or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Comb 15 jew jekk ma injettajtx biżżejjed
enough insulin, your blood sugar level may become too high (hyperglycaemia).
insulina, il- livell tiegħek taz- zokkor fid- demm jista ’ jogħla wisq (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.
If you stop using Insulin Human Winthrop Comb 15 This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Comb 15 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 Comb 15 without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insulin Human Winthrop Comb 15 mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit - tabib jew lill- ispiżjar tiegħek.
Like all medicines, Insulin Human Winthrop Comb 15 can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insulin Human Winthrop Comb 15 jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi
575 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.
The y can also spread around the injection site.
Dawn jistgħu wkoll jinfirxu madwar il- post ta ’ l- injezzjoni.
HOW TO STORE INSULIN HUMAN WINTHROP COMB 15
KIF TAĦŻEN INSULIN HUMAN WINTHROP COMB 15
Do not use Insulin Human Winthrop Comb 15 after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insulin Human Winthrop Comb 15 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta tal- kunjett.
Do not put Insulin Human Winthrop Comb 15 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 15 m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
Keep the vial in the outer carton in order to protect from light
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).
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 - dawl dirett (dawl tax- xemx dirett jew viċin lampa).
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma l- iskart domestiku.
576 6.
575 6.
What Insulin Human Winthrop Comb 15 contains
X’ fih Insulin Human Winthrop Comb 15
One ml of Insulin Human Winthrop Comb 15 contains
Millilitru wieħed ta ’ Insulin Human Winthrop Comb 15 fih
15% of the insulin is dissolved in water; the other 85% is present as tiny crystals of insulin protamine.
15% ta ’ l- insulina hija maħlula fl- ilma; il- 85% l- oħra hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
What Insulin Human Winthrop Comb 15 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 15 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Comb 15 u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Comb 15 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Insulin Human Winthrop Comb 15 is supplied in vials containing 5 ml suspension (500 IU).
Insulin Human Winthrop Comb 15 huwa fornut f’ kunjetti ta ’ 5 ml ta ’ suspensjoni (500 IU).
577 España sanofi-aventis, S.A.
576 España sanofi- aventis, S. A.
578 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
579
578
580 PACKAGE LEAFLET:
579 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 15 40 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Comb 15 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
Special patient groups
580 Gruppi speċjali ta ’ pazjenti
581 Travel
Safar
Important information about some of the ingredients of Insulin Human Winthrop Comb 15
582 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 15
Insulin Human Winthrop Comb 15 contains 40 IU insulin per ml.
Insulin Human Winthrop Comb 15 fih 40 IU insulina kull millilitru.
Only injection syringes designed for this insulin concentration (40 IU per ml) must be used.
Għandhom jintużaw biss dawk is - siringi għall- injezzjoni li huma magħmulin għall- qawwa ta ’ din l- insulina (40 IU kull ml).
Before the first withdrawal of insulin you must remove the safety tear-off capon the vial.
Qabel ittella ’ l- ewwel doża ta ’ l- insulina għandek tneħħi l- għatu ta ’ sigurtà tal- kunjett billi ċċarrtu.
Special care before injection
583 Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Comb 15 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
Insulin Human Winthrop Comb 15 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l - insulina.
584 Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- Aventis.
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
If you stop using Insulin Human Winthrop Comb 15 This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Comb 15 Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
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.
584 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.
585 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.
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).
585 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 - dawl dirett (dawl tax- xemx dirett jew viċin lampa).
15% of the insulin is dissolved in water; the other 85% is present as tiny crystals of insulin protamine.
15% ta ’ l- insulina hija maħlula fl - ilma; il- 85% l- oħra hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
Insulin Human Winthrop Comb 15 is supplied in vials containing 10 ml suspension (400 IU).
Insulin Human Winthrop Comb 15 huwa fornut f’ kunjetti ta ’ 10 ml ta ’ suspensjoni (400 IU).
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
586 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
587 IPERGLIĊEMIJA U IPOGLIĊEMIJA
588 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
588 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
589 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
590 PACKAGE LEAFLET:
590 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 15 100 IU/ml suspension for injection in a cartridge Insulin human
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
It comes in cartridges designed for use in an injection device of the OptiPen series.
Huwa disponibbli f’ skartoċċi magħmulin għall- użu f’ sistema ta ’ injezzjoni fis- serje ta ’ l- OptiPen.
591 Special patient groups
591 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.
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.
593 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 ’.
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 tal- injezzjoni, u tingħata l- injezzjoni ta ’ l - insulina.
Always use a new cartridge must also be used if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża skartoċċ ġdid jekk tinnota li l- kontroll tiegħek taz- zokkor fid- demm qiegħed bla mistenni jmur għall- agħar.
Special care before injection
594 Attenzjoni speċjali qabel l- injezzjoni
594 Problems with the pen?
Diffikultajiet bil- pinna?
However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
Madankollu, uża biss dawk is- siringi li huma magħmulin għall- qawwa ta ’ preparat ta ’ insulina ta ’ 100 IU (Unitajiet Internazzjonali) kull ml.
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.
595 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.
595 Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients) • Severe allergic reaction with low blood pressure (shock) • Injection site urticaria (itchy rash)
Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision. • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
Jekk qed tbati minn retinopatija proliferattiva (marda ta ’ l- għajnejn relatata mad- dijabete) attakki severi ta ’ l- ipogliċemija jistgħu jirriżultaw f’ telf temporanju tal- vista. • Tibdiliet fil- ġilda fis- sit tal- injezzjoni (lipodistrofija) Jekk tinjetta l- insulina spiss wisq fl- istess sit tal- ġilda, t- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jogħlob jew jeħxien.
Do not use Insulin Human Winthrop Comb 15 after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insulin Human Winthrop Comb 15 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta ta ’ l- iskartoċċ.
Do not put Insulin Human Winthrop Comb 15 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 15 m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża..
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).
Skartoċċifl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux ‘ il fuq minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
What Insulin Human Winthrop Comb 15 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 15 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Comb 15 u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Comb 15 huwa likwidu uniformi jixbaħ il- ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insulin Human Winthrop Comb 15 is supplied in cartridges containing 3 ml suspension (300 IU).
Insulin Human Winthrop Comb 15 huwa fornut f’ skartoċċi li fihom 3 ml ta ’ suspensjoni (300 IU).
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
597 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
598 IPERGLIĊEMIJA U IPOGLIĊEMIJA
598 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
599 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
599 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
Tell your relatives, friends and close colleagues the following:
600 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
600 PACKAGE LEAFLET:
601 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 15 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal - lest Insulina umana
Read all of this leaflet carefully, including the In structions for Use of Insulin Human Winthrop Comb 15, 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 Comb 15, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
BEFORE YOU USE INSULIN HUMAN WINTHROP COMB 15
QABEL MA TUŻA INSULIN HUMAN WINTHROP COMB 15 OPTISET
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
602 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.
601 Travel
Safar
Important information about some of the ingredients of Insulin Human Winthrop Comb 15
604 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 15
Insulin Human Winthrop Comb 15 comes in cartridges sealed in disposable pen injectors, OptiSet.
Insulin Human Winthrop huwa fornut f’ skartoċċi ssiġillati f’ pinen għall- injezzjoni, OptiSet, li jintremew wara li jinħlew.
It must not be used if it remains clear or if, for example, clumps, flakes, particles or anything similar are in the suspension or on the sides or bottom of the cartridge in the pen.
605 kwalunkwe ħaġa simili fis- suspensjoni jew mal- ġnub jew il- qiegħ ta ’ l- iskartoċċ fil- pinna.
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 fid- demm mar għall- agħar mingħajr mistenni.
If you think you may have a problem with OptiSet, refer to the Questions and Answers section of the attached OptiSet Instructions for Use, or have it checked by your doctor or pharmacist.
Jekk taħseb li 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
604 Special care before injection
Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Comb 15, pre-filled pen, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Comb 15, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
Empty pens must not be re -filled and must be properly discarded.
Pinen vojta m’ għandhomx jerġgħu jimtlew u għandhom jintremew kif jixraq.
If you use more Insulin Human Winthrop Comb 15 than you should
Żbalji fid- dożaġġ Jekk tuża Insulin Human Winthrop Comb 15 aktar milli suppost
- If you have injected too much Insulin Human Winthrop Comb 15, your blood sugar level
- Jekk injettajt aktarInsulin Human Winthrop Comb 15 milli meħtieġ, il- livell taz- zokkor
Severe allergic reactions to insulin may occur which may become life-threatening.
606 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
605 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
HOW TO STORE INSULIN HUMAN WINTHROP COMB 15
KIF TAĦŻEN INSULIN HUMAN WINTHROP COMB 15 OPTISET
Keep the pre -filled pen in the outer carton in order to protect from light.
Żomm il- pinna mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
In-use pens Pre-filled pens in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
607 Pinen fl- użu Pinen mimlija għal- lest fl- użu jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
What Insulin Human Winthrop Comb 15 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 15 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insulin Human Winthrop Comb 15 u l- kontenuti tal- pakkett Wara li jitħallat, Insulin Human Winthrop Comb 15 huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni), mingħajr ċapep, partikuli jew trofof viżibbli.
Insulin Human Winthrop Comb 15 is supplied in pre-filled pens, OptiSet, containing 3 ml suspension, (300 IU).
Insulin Human Winthrop Comb 15 huwa fornut f’ pinen mimlija għal- lest, OptiSet, li fiha 3 ml ta ’ suspensjoni, (300 IU).
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
608 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
609 IPERGLIĊEMIJA U IPOGLIĊEMIJA
608 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
Hypoglycaemia is also more likely to occur if:
610 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
609 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
Tell your relatives, friends and close colleagues the following:
611 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
610 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
611 Step 2.
2
This helps prevent contamination, and potential needle blocks.
Dan jgħin biex telimina l- kontaminazzjoni, tnaqqas ir- riskju li tistadt il- labra A Neħħi s- siġill protettiv mil- labra l- ġdida.
Check if insulin comes out of the needle tip.
Iċċekkja li l- insulina qed toħroġ mill- ponta tal - labra
Change the needle and try again. • If no insulin comes out after changing the needle, your OptiSet may be damaged.
614 • Jekk ebda l- insulina ma toħroġ wara li tibdel il- labra, l- OptiSet tiegħek tista ’ tkun bil- ħsara.
Do not use this OptiSet.
Tużax din l- OptiSet..
Select y our required d ose by turning the dose selector forward.
Agħżel id- doża meħtieġa għalik billi ddawwar is- selettur tad- doża ’ l quddiem.
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.
615 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.
B.
616 B.
Please check section 5 – How to store Insulin Human Comb 15 - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insulin Human Winthrop Comb 15 - fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
If you r 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.
615 Maintenance
Manutenzjoni
Dose has been selected and the injection button has been pulled out and pressed in again without a needle attached.
Id- doża hija magħżula u l- buttun ta ’ l - injezzjoni miġbud ’ il
• Difference is more than 2 units.
617 M’ hemmx biżżejjed insulina fir- riżervwar.
There is not enough insulin in the reservoir • you can inject the amount indicated on the injection button from this OptSet and then inject the remaining dose using a new pen, or • you can inject the entire dose using a new pen.
minn din l- OptiSet u wara tinjetta l- bqija tad- doża minn pinna ġdida, jew Tista ’ tinjetta d- doża sħiħa minn pinna ġdida.
617 PACKAGE LEAFLET:
618 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 15 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
Insulin Human Winthrop Comb 15 is an insulin preparation with a gradual onset and long duration of action.
Insulin Human Winthrop Comb 15 huwa preparat ta ’ l- insulina li jibda jaħdem b’ mod gradwali u jdum jaħdem għal żmien twil..
Do not use it in insulin pumps or other infusion pumps - special insulin preparations are available for use in such devices.
Tużahx f’ pompi ta ’ l - insulina jew pompi oħra għall- infuzzjoni - hemm preparazzjonijiet apposta ta ’ l- insulina disponibbli għall- użu ma ’ dan l- apparat.
618 If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
619 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.
- 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 kundizzjonijiet
blood pressure),
tal- qalb jew ta ’ pressjoni għolja fid- demm)
Important information about some of the ingredients of Insulin Human Winthrop Comb 15
621 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 15
Do sage
Dożaġġ
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- jgħidlek meta teżamina l- livell tiegħek taz- zokkor fid- demm, u jekk ghandekx bżonn tagħmel
The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the 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.
Special care before injection
622 Attenzjoni speċjali qabel l- injezzjoni
621 Problems with OptiClik?
Diffikultajiet b’ OptiClik?
If OptiClik does not function well, you can draw the insulin from the cartridge into an injection syringe.
Jekk OptiClik ma taħdimx sew, tista ’ ttella ’ l- insulina mill- iskartoċċ f’ siringa għall- injezzjoni.
- Do not take a double dose to make up for a forgotten dose.
- - Tieħux doża doppja biex tpatti għal dik li nsejt..
Severe allergic reactions to insulin may occur which may become life-threatening.
623 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
622 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
Keep the cartridge in the outer carton in order to protect from light.
Insulin Human Winthrop Rapid m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża. Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
In-use cartridges Cartridges in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
624 Skartoċċi fl- użu Skartoċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux ‘ il fuq minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
The cartridge in -use must not be stored in a refrigerator.
L- iskartoċċ fl- użu m’ għandux jinżamm fi friġġ.
Insulin Human Winthrop Comb 15 comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insulin Human Winthrop Comb 15 huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l - parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
Insulin Human Winthrop Comb 15 is supplied in cartridges for OptiClik containing 3 ml suspension (300 IU).
Insulin Human Winthrop Comb 15 huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ suspensjoni (300 IU).
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
625 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
625 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
626 IPERGLIĊEMIJA U IPOGLIĊEMIJA
626 Hypoglycaemia is also more likely to occur if:
627 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
- you r blood sugar levels are almost normal or are unstable,
- int għandhek il- livelli taz- zokkor fid- demm tiegħek kważi normali jew mhux stabbli,
-In your brain 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.
If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may o therwise 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.
Tell your relatives, friends and close colleagues the following:
628 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
627 PACKAGE LEAFLET:
629 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 15 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insulin Human Winthrop Comb 15 100 Unità/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully, including the Instructions for Use of Insulin Human Winthrop Comb 15, pre-filled pen, SoloStar, before you start using this medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Insulin Human Winthrop Comb 15, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
It comes in cartridges sealed in disposable pen injectors, SoloStar.
Dan jiġi fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, tas- SoloStar, pinna ta ’ l- insulina.
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Comb 15.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insulin Human Winthrop Comb 15.
Take special care with Insulin Human Winthrop Comb 15
Oqgħod attent ħafna b’ Insulin Human Winthrop Comb 15:
628 Travel
630 Safar
Important information about some of the ingredients of Insulin Human Winthrop Comb 15
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insulin Human Winthrop Comb 15
630 3.
632 3.
- determine how much Insulin Human Winthrop Comb 15 per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insulin Human Winthrop Comb 15 kuljum,
- tell you when you may need to inject a higher or lower dose of Insulin Human Winthrop
- jgħidlek għandek jkollok bżonn tinjetta doża akbar jew iżgħar ta ’ Insulin Human Winthrop
Insulin Human Winthrop Comb 15 is injected under the skin 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 15 huwa injettat taħt il- ġilda 30 sa 45 minuta qabel ikla.
Do NOT inject Insulin Human Winthrop Comb 15 into a vein.
TINJETTAX l- Insulina Comb 15 fil- vina.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
633 Dejjem uża pinna ġdida jekk tinnota li l- kontroll taz- zokkor tiegħek fid- demm qiegħed imur għal agħar, bla mistenni.
631 Special care before injection
Attenzjoni speċjali qabel l- injezzjoni
Insulin Human Winthrop Comb 15, pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insulin Human Winthrop Comb 15, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
- If you have missed a dose of Insulin Human Winthrop Comb 15 or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Comb 15 jew ma injettajtx biżżejjed insulina,
enough insulin, your blood sugar level may become too high (hyperglycaemia).
il- livell taz- zokkor f’ demmek jista ’ jogħla ħafna (ipergliċemija).
Severe allergic reactions to insulin may occur which may become life-threatening.
634 Jistgħu jseħħu reazzjonijiet allerġiċi severi għall- insulina, li jistgħu jirriżultaw fatali.
632 Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients) • Severe allergic reaction with low blood pressure (shock) • Injection site urticaria (itchy rash)
Effetti sekondarji rapportati mhux komunement (Jidhru f’ anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1000 pazjent) • Reazzjoni allerġika severa bi pressjoni baxxa tad- demm (xokk) • Urtikarja (raxx bil- ħakk) fis- sit ta ’ l- injezzjonijiet
Do not use Insulin Human Winthrop Comb 15 after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insulin Human Winthrop Comb 15 wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it - tikketta tal- pinna.
Not in-use pens Store in a refrigerator (2°C - 8°C).
635 Pinen mhux fl- użu Aħżen fi friġġ (2°Ċ- 8°Ċ).
The pen in -use must not be stored in a refrigerator.
Il- pinna fl- użu m’ għandiex tinżamm fi friġġ.
Insulin Human Winthrop Comb 15 is supplied in pre-filled pens, SoloStar, containing 3 ml suspension, (300 IU).
Insulin Human Winthrop Comb 15 huwa fornut f’ pinen mimlija għal- lest, SoloStar, li fiha 3 ml ta ’ suspensjoni (300 IU).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- prodott mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
636 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0
sanofi- aventis GmbH Tel: +43 1 80 185 - 0
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
637 IPERGLIĊEMIJA U IPOGLIĊEMIJA
635 Why does hyperglycaemia occur?
Għaliex isseħħ l- ipergliċemija?
636 Warning symptoms of hypoglycaemia
Sintomi ta ’ twissija ta ’ ipogliċemija
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
639 Huwa irrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l - glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
SoloStar.
Insulin Human Winthrop Comb 15, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
Do not share it with anyone else. • If you r injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use SoloStar if it is damaged or if you are not sure that it is working properly. • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Taqsamhiex ma ’ ħaddieħor. • Jekk l- injezzjoni tiegħek tingħata minn persuna oħra, għandha tittieħed attenzjoni speċjali minn din il- persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u titrasmetti xi infezzjoni. • Qatt m’ għandek tuża SoloStar jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm SoloStar żejda f’ każ li s- SoloStar tiegħek tintilef jew jiġrilha l- ħsara.
638 C.
Ċ.
If you are using a suspension insulin (Insulin Human Winthrop Basal or Insulin Human Winthrop mixtures), turn the pen up and down at least 10 times to resuspend the insulin.
insulina hija mdardra, ikkulurita jew għandha xi partikuli. • Jekk qed tuża suspensjoni ta ’ l- insulina (Insulin Human Winthrop Basal jew taħlit ta ’ Insulin Human Winthrop) l- insulina għandha titħallat billi ddawwar il- pinna ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
640 • Do not push the injection button while turning, as insulin will come out.
642 • Timbuttax il- buttun ta ’ l- injezzjoni waqt li qed iddawwar, għax inkella l- insulina toħroġ.
Follow recommended safety measures for removal and disposal of needles (e.g. contact your healthcare professional) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri irrakkomandati ta’ sigurtà għat- tneħħija u r- rimi tal- labar (e. ż. kellem lill- professjonist tiegħek fil- qasam tas- saħħa) biex
641 Storage Instructions
Struzzjonijiet dwar il- ħażna
642 PACKAGE LEAFLET:
644 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a vial Insulin human
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
What Insulin Human Winthrop Comb 25 is and what it is used for 2.
X’ inhu Insulin Human Winthrop Comb 25 u għalxiex jintuża 2.
Before you use Insulin Human Winthrop Comb 25 3.
Qabel ma tuża Insulin Human Winthrop Comb 25 3.
How to use Insulin Human Winthrop Comb 25 4.
Kif għandek tuża Insulin Human Winthrop Comb 25 4.
How to store Insulin Human Winthrop Comb 25 6.
Kif taħżen Insulin Human Winthrop Comb 25 6.
WHAT INSULIN HUMAN WINTHROP COMB 25 IS AND WHAT IT IS USED FOR
X’ INHU INSULIN HUMAN WINTHROP COMB 25 U GĦALXIEX JINTUŻA
Insulin Human Winthrop Comb 25 is a fluid (suspension) for injection under the skin.
Insulin Human Winthrop Comb 25 huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il - ġilda.
The insulin contained in Insulin Human Winthrop Comb 25 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insulin Human Winthrop Comb 25 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu (“ insulina umana ”).
Insulin Human Winthrop Comb 25 is an insulin preparation with a gradual onset and long duration of action.
Insulin Human Winthrop Comb 25 huwa preparat ta ’ l- insulina li jibda jaħdem b’ mod gradwali u jdum jaħdem għal żmien twil.
Insulin Human Winthrop Comb 25 is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Comb 25 huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil - pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSULIN HUMAN WINTHROP COMB 25
QABEL MA TUŻA INSULIN HUMAN WINTHROP COMB 25
Do not use Insulin Human Winthrop Comb 25
Tużax Insulin Human Winthrop Comb 25
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Comb 25.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insulin Human Winthrop Comb 25.
Do not inject Insulin Human Winthrop Comb 25 into a vein (blood vessel).
Tinjettax Insulin Human Winthrop Comb 25 ġewwa vina (sistema vaskulari).
Take special care with Insulin Human Winthrop Comb 25
Oqgħod attent ħafna b’ Insulin Human Winthrop Comb 25
643 Travel
645 Safar
Beta - blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
L- imblokkaturi tar- riċetturi beta, bħall- mediċini oħra simpatolitiċi, (bħal clonidine, guanethidine, u reserpine) jistgħu jdgħajjfu jew jaħbu kompletament l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf xi ipogliċemija.
Using Insulin Human Winthrop Comb 25 with food and drink
Meta tuża Insulin Human Winthrop Comb 25 ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insulin Human Winthrop Comb 25 in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insulin Human Winthrop Comb 25 waqt it- tqala.
Important information about some of the ingredients of Insulin Human Winthrop Comb 25
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insulin Human Winthrop Comb 25
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.
Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e tista ’ tgħid li huwa ‘ nieqes minn sodium ’..
645 3.
647 3.
HOW TO USE INSULIN HUMAN WINTHROP COMB 25
KIF GĦANDEK TUŻA INSULIN HUMAN WINTHROP COMB 25
- determine how much Insulin Human Winthrop Comb 25 per day you will need,
- jikkalkula kemm għandek bżonn Insulin Human Winthrop Comb 25 kuljum,
Comb 25.
Comb 25,
Insulin Human Winthrop Comb 25 is injected under the skin 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 25 huwa injettat taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Do NOT inject Insulin Human Winthrop Comb 25 into a vein.
TINJETTAX Insulin Human Winthrop Comb 25 ġewwa vina.
Insulin Human Winthrop Comb 25 contains 100 IU insulin per ml.
Insulin Human Winthrop Comb 25 fih 100 IU insulina kull millilitru.
Always use a new vial must also be used if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża kunjett ġdid jekk tinnota li l- kontroll tiegħek taz- zokkor fid- demm qiegħed bla mistenni jmur għall- agħar.
Insulin Human Winthrop Comb 25 may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
648 Insulin Human Winthrop Comb 25 jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l - insulina.
646 Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- aventis.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insulin Human Winthrop Comb 25.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insulin Human Winthrop Comb 25.
If you usemore Insulin Human Winthrop Comb 25 than you should
Jekk tuża Insulin Human Winthrop Comb 25 aktar milli suppost
- If you have injected too much Insulin Human Winthrop Comb 25, your blood sugar level
- Jekk injettajt aktar Insulin Human Winthrop Comb 25 milli meħtieġ, il- livell taz- zokkor
If you forget to use Insulin Human Winthrop Comb 25
Jekk tinsa tuża Insulin Human Winthrop Comb 25
- If you have missed a dose of Insulin Human Winthrop Comb 25 or if you have not injected
- Jekk qbiżt doża ta ’ Insulin Human Winthrop Comb 25 jew jekk ma injettajtx biżżejjed
If you stop using Insulin Human Winthrop Comb 25 This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insulin Human Winthrop Comb 25 Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Do not stop Insulin Human Winthrop Comb 25 without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insulin Human Winthrop Comb 25 mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insulin Human Winthrop Comb 25 can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insulin Human Winthrop Comb 25 jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.