qanastek/EMEA-V3 huggingface dataset:
OUTER CARTONS / 3 ML PRE-FILLED PEN OPTISET
KARTUNA TA ’ BARRA / PINNA MIMLIJA GĦAL- LEST TA ’ 3 ML OPTSET
Insuman Comb 50 100 IU/ ml suspension for injection in a pre-filled pen
Insuman Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
407 IMPORTANT INFORMATION Always first attach a new needle before using OptiSet.
404 INFORMAZZJONI IMPORTANTI L- ewwel dejjem waħħal labra ġdida qabel tuża OptiSet.
EU/ 1/ 97/ 030/ 081 (3 pens of 3 ml) EU/ 1/ 97/ 030/ 082 (4 pens of 3 ml) EU/ 1/ 97/ 030/ 083 (5 pens of 3 ml) EU/ 1/ 97/ 030/ 104 (6 pens of 3 ml) EU/ 1/ 97/ 030/ 109 (9 pens of 3 ml) EU/ 1/ 97/ 030/ 084 (10 pens of 3 ml)
EU/ 1/ 97/ 030/ 081 (3 pinen ta ’ 3 ml) EU/ 1/ 97/ 030/ 082 (4 pinen ta ’ 3 ml) EU/ 1/ 97/ 030/ 083 (5 pinen ta ’ 3 ml) EU/ 1/ 97/ 030/ 104 (6 pinen ta ’ 3 ml) EU/ 1/ 97/ 030/ 109 (9 pinen ta ’ 3 ml) EU/ 1/ 97/ 030/ 084 (10 pinen ta ’ 3 ml)
408 15.
405 15.
409 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
406 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
410 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
407 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
EU/ 1/ 97/ 030/ 134 (3 cartridges of 3 ml) EU/ 1/ 97/ 030/ 135 (4 cartridges of 3 ml) EU/ 1/ 97/ 030/ 136 (5 cartridges of 3 ml) EU/ 1/ 97/ 030/ 137 (6 cartridges of 3 ml) EU/ 1/ 97/ 030/ 138 (9 cartridges of 3 ml) EU/ 1/ 97/ 030/ 139 (10 cartridges of 3 ml)
EU/ 1/ 97/ 030/ 134 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 97/ 030/ 135 (4 skartoċċita ’ 3 ml) EU/ 1/ 97/ 030/ 136 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 97/ 030/ 137 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 97/ 030/ 138 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 97/ 030/ 139 (10 skartoċċi ta ’ 3 ml)
413 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
409 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
414 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
410 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insuman Comb 50 100 IU/ ml suspension for injection in a pre-filled pen
Insuman Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
415 8.
411 8.
416 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
412 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
417 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
413 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insuman Infusat 100 IU/ ml solution for injection in a vial
Insuman Infusat 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
418 10.
414 10.
419 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
415 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Insuman Infusat 100 IU/ ml solution for injection in a vial
Insuman Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett
420 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
416 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN, FUQ IL- PAKKETT EWLIENI
Insuman Infusat 100 IU/ ml solution for injection in a cartridge
Insuman Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ
422 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
418 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
423 B.
419 B.
424 PACKAGE LEAFLET:
420 FULJETT TA ’ TAGĦRIF:
Insuman Rapid 100 IU/ ml solution for injection in a vial Insulin human
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana
It may harm them, even if their
Tista ’ tagħmlilhom
symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Insuman Rapid is and what it is used for 2.
X’ inhu Insuman Rapid u għalxiex jintuża 2.
Before you use Insuman Rapid 3.
Qabel ma tuża Insuman Rapid 3.
How to use Insuman Rapid 4.
Kif għandek tuża Insuman Rapid 4.
How to store Insuman Rapid 6.
Kif taħżen Insuman Rapid 6.
WHAT INSUMAN RAPID IS AND WHAT IT IS USED FOR
X’ INHU INSUMAN RAPID U GĦALXIEX JINTUŻA
Insuman Rapid is a solution for injection under the skin or, in exceptional circumstances, into a vein (blood vessel).
Insuman Rapid hija soluzzjoni għall- injezzjoni taħt il- ġilda tiegħek jew, f’ ċirkostanzi rari, tingħata fil - vina (sistema vaskulari).
The insulin contained in Insuman Rapid is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li tinsab f ’ Insuman Rapid, hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina tal- ġisem stess.
Insuman Rapid is an insulin preparation with a rapid onset and short duration of action.
Insuman Rapid hija preparat ta ’ l- insulina li tibda taħdem malajr u ddum taħdem għal żmien qasir.
Insuman Rapid is used to reduce high blood sugar in patents with diabetes mellitus.
Insuman Rapid hija użata biex tbaxxi l- livell għoli taz- zokkor fid- demm tal- pazjenti li qed ibatu min diabetes mellitus.
Insuman Rapid may also be used for treating severe hyperglycaemia (very high blood sugar) and ketoacidosis (build- up of acid in the blood because the body is breaking down fat instead of sugar) as well as for controlling blood sugar before, during and after surgery.
Insuman Rapid tista ’ wkoll tintuża biex tikkura l - ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u l- ketoaċidożi (akkumulazzjoni t’ aċidu fid- demm għaliex il- ġisem qiegħed jutilizza x- xaħam minflok iż- żokkor), kif ukoll għall- kontroll taz - zokkor fid- demm qabel, waqt u wara li ssirlek operazzjoni.
BEFORE YOU USE INSUMAN RAPID
QABEL MA TUŻA INSUMAN RAPID
Do not use Insuman Rapid
Tużax Insuman Rapid:
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Rapid.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insuman Rapid.
Do not use Insuman Rapid in insulin pumps – special insulin preparations are available for use in such devices.
Tużax Insuman Rapid fil- pompi għall- insulina – hemm preparazzjonijiet apposta t’ insulina disponibbli għall- użu ma ’ dan l- apparat.
Also do not use it in peristaltic pumps with silicone tubing.
Hekk ukoll, tużahx għall- pompi peristaltiċi li għandhom tubi tas - silicone.
Take special care with Insuman Rapid
Oqgħod attent ħafna b’ Insuman Rapid:
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
421 Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
425 Travel
Safar
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high
- l- inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE) (użati għall- kura ta ’ ċerti -
isoniazid (used to treat tuberculosis),
- isoniazid (użat għall- kura tat- tuberkulożi),
sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline treat asthma),
- il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline
used to
użatgħall- kura ta ’ l- ażma),
thyroid hormones (used to treat the thyroid gland disorders), protease inhibitors (used to treat HIV),
- ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde),
426
- 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:
Using Insuman Rapid with food and drink
Meta tuża Insuman Rapid ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insuman Rapid in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insuman Rapid waqt it- tqala.
Important information about some of the ingredients of Insuman Rapid
423 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman 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 INSUMAN RAPID
KIF GĦANDEK TUŻA INSUMAN RAPID
- determine how much Insuman Rapid per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insuman Rapid kuljum,
- tell you when you may need to inject a higher or lower dose of Insuman Rapid.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Rapid,
427 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Rapid is injected under the skin 15 to 20 minutes before a meal.
Insuman Rapid huwa injettat taħt il- ġilda 15 sa 20 minuta qabel ikla.
Insuman Rapid contains 100 IU insulin per ml.
Insuman Rapid fih 100 IU t’ insulina kull ml.
Before the first withdrawal of insulin you must remove the safety tear-off lid on the vial.
Qabel tiġbed l- ewwel doża ta ’ l- insulina, għandek tneħħi l- għatu tas- sigurtà tal- kunjett.
Insuman Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and has a water-like consistency.
Insuman 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.
Insuman Rapid may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
Insuman 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.
424 It- tabib tiegħek sejjer jgħidlek jekk għandekx tħallat l- insulini umani ta ’ Sanofi- Aventis.
If you need to inject a mixture, draw Insuman Rapid into the injection syringe before the other insulin.
Jekk ghandek bżonn tinjetta taħlita, iġbed Insuman Rapid fis- siringa ta ’ l- injezzjoni qabel l- insulina l- oħra.
If you use more Insuman Rapid than you should
Jekk tuża aktarInsuman Rapid milli suppost
- If you have injected too much Insuman Rapid, your blood sugar level may become too low
- Jekk injettajt Insuman Rapid aktar milli meħtieġ il- livell taz- zokkor tiegħek fid- demm jista ’
(hypoglycaemia).
jitbaxxa wisq (ipogliċemija).
If you forget to use Insuman Rapid
Jekk tinsa tuża Insuman Rapid
- If you have missed a dose of Insuman Rapid or if you have not injected enough insulin, your blood
- Jekk qbiżt doża ta ’ Insuman Rapid jew ma injettajtx biżżejjed insulina, il- livell taz- zokkor
sugar level may become too high (hyperglycaemia).
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.
428 If you stop using Insuman 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 Insuman 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).
Do not stop Insuman Rapid without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insuman Rapid mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insuman Rapid can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insuman Rapid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Dawn ir - reazzjonijiet għall- insulina jew għas- sustanzi mhux attivi jistgħu jwasslu 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
• 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. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturbyour vision temporarily.
425 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.
HOW TO STORE INSUMAN RAPID
KIF TAĦŻEN INSUMAN RAPID
Do not use Insuman Rapid after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insuman Rapid wara d- data ta ’ skadenza li tidher fuq ilkaxxa u fuq it- tikketta tal- kunjett.
Do not put Insuman Rapid next to the freezer compartment or a freezer pack.
Insuman Rapid m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
What Insuman Rapid contains
X’ fih Insuman Rapid
One ml of Insuman Rapid contains 100 IU (International
Millilitru wieħed ta ’ Insuman Rapid fih 100 IU (Unita
Units) of the active substance insulin human.
Internazzjonali) tas- sustanza attiva insulina umana.
- The other ingredients are: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium
- Is- sustanzi l- oħra huma: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium
hydroxide, hydrochloric acid (for pH adjustment) and water for injections.
hydroxide, hydrochloric acid (għall- aġġustament tal- pH), u ilma għall- injezzjonijiet.
What Insuman Rapid looks like and contents of the pack Insuman Rapid is a clear, colourless solution for injection, with no solid particles visible, and of a water- like consistency.
Id- Dehra ta ’ Insuman Rapid u l- kontenuti tal- pakkett Insuman Rapid huwa soluzzjoni għall- injezzjoni ċara, minghajr kulur, bla ebda partikuli solidi u viżibbli, u tixbaħ l- ilma.
Insuman Rapid is supplied in vials containing 5 ml solution (500 IU).
Insuman Rapid huwa fornut f’ kunjetti ta ’ 5 ml ta ’ soluzzjoni (500 IU).
Ireland sanofi-aventis Ireland Ltd.
427 Ireland sanofi- aventis Ireland Ltd.
431 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 /
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you
- int qiegħed tagħmel anqas eżerċizzju fiżiku mis- soltu, jew int qiegħed taħt stress (inkwiet,
have an injury, operation, infection or fever,
eċitament), jew għandek xi ferita, saritlek xi operazzjoni, għandek xi infezzjoni jew għandek id - deni.
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.
428 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.
- you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances
- int ma tiekolx biżżejjed, jew qed tiekol ikel li fih anqas karboidrati minn normal, (zokkor u
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),
432 Hypoglycaemia is also more likely to occur if:
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
- you change the area of skin where you inject insulin (for example from the thigh to the upper arm),
- int bdilt iż- żona tal- ġilda fejn tinjetta l- insulina (per eżempju mill- koxxa għall- parti ta ’ fuq tad -
- you have recently changed from an animal insulin to a human insulin such as Insuman,
- dan l- aħħar biddilt it- tip ta ’ insulina minn dik li ġejja mill- annimali għal dik tat- tip umana bħall -
433 PACKAGE LEAFLET:
430 FULJETT TA ’ TAGĦRIF:
Insuman Rapid 40 IU/ ml solution for injection in a vial Insulin human
Insuman Rapid 40 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana
The insulin contained in Insuman Rapid is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li tinsab f ’ Insuman Rapid, hija magħmula bi proċess bijoteknoloġiku. u hija identika għall- insulina tal- ġisem stess.
Insuman Rapid is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Rapid hija użata biex tbaxxi l- livell għoli taz- zokkor fid- demm tal- pazjenti li qed ibatu min diabetes mellitus.
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
431 Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
434 Travel
Safar
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti -
pressure),
kundizzjonijiet tal- qalb jew ta ’ pressjoni għolja fid- demm)
Important information about some of the ingredients of Insuman Rapid
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Rapid
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i. e. it is essentially ‘ sodium- free’.
433 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 ’.
436 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Rapid contains 40 IU insulin per ml.
Insuman 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).
Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
434 It- tabib tiegħek sejjer jgħidlek jekk għandekx tħallat l- insulini umani ta ’ Sanofi- Aventis.
If you use more Insuman Rapid than you should
Jekk tuża Insuman Rapid aktar milli suppost
- If you have injected too much Insuman Rapid, your blood sugar level may become too
- Jekk injettajt aktar Insuman Rapid milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm
low(hypoglycaemia).
jista ’ jitbaxxa wisq (ipogliċemija).
- If you have missed a dose of Insuman Rapid or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Rapid jew ma injettajtx biżżejjed insulina, il- livell taz- zokkor
blood sugar level may become too high (hyperglycaemia).
f’ demmek jista ’ jogħla ħafna (ipergliċemija).
437 If you stop using Insuman 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 Insuman 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 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)
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.
435 Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
Do not use Insuman Rapid after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insuman Rapid wara d- data ta ’ skadenza li tidher fuq ilkaxxa jew fuq it- tikketta tal- kunjett.
Keep the vial in the outer carton in order to protect from light.
Insuman 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.
One ml of Insuman Rapid contains 40 IU of the active
Millilitru wieħed ta ’ Insuman Rapid fih 40 IU (Unita
substance insulin human.
Internazzjonali) tas- sustanza attiva insulina umana.
Insuman Rapid is supplied in vials containing 10 ml solution (400 IU).
Insuman Rapid huwa fornut f’ kunjetti ta ’ 10 ml ta ’ soluzzjoni (400 IU).
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:
België/ Belgique/ Belgien sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00
Belgique/ België/ Belgien sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00
Ireland sanofi-aventis Ireland Ltd.
437 Ireland sanofi- aventis Ltd.
440 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 /
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.
438 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.
441 Hypoglycaemia is also more likely to occur if:
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
442 PACKAGE LEAFLET:
440 FULJETT TA ’ TAGĦRIF:
Insuman Rapid 100 IU/ ml solution for injection in a cartridge Insulin human
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ Insulina umana
Do not use Insuman Rapid in insulin pumps - special insulin preparations are available for use in such devices.
Tużax Insuman Rapid fil- pompi għall- insulina – hemm preparazzjonijiet apposta t’ insulina disponibbli għall- użu ma ’ dan l- apparat.
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
441 Segwi sew l- istruzzjonijiet fuq id- dożaġġ, il- moniteraġġ (permezz ta ’ analiżi tad- demm u ta ’ l - awrina), id- dieta, u l- eżerċizju fiżiku (xogħol fiżiku u eżerċizju), kif diskuss mat- tabib tiegħek.
443 Special patient groups
Gruppi speċjali ta ’ pazjenti
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions orhigh blood
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti -
Important information about some of the ingredients of Insuman Rapid
443 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman 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 ’.
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insuman cartridges and as recommended in the information provided by the device manufacturer.
L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- skartoċċi ta ’ Insuman u kif inhu irrakkomandat mill- manifattur tal- pinna.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
L- istruzzjonijiet tal - manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa biex jitgħabba l- iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
- Do not mix Insuman Rapid with any other medicines.
- Tħallatx Insuman Rapid ma ’ mediċini oħrajn
Problems with the pen?
444 Diffikultajiet bil- pinna?
446 If you use more Insuman Rapid than you should
Jekk tuża Insuman Rapid aktar milli suppost
- If you have injected too much Insuman Rapid, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Rapid milli meħtieġ, il- livell taz- zokkor fid- demm tiegħek jista ’
(hypoglycaemia).
jinżel wisq (ipogliċemija). il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq (ipogliċemija).
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 stop using Insuman 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 Insuman 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).
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
445 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. • 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.
447 If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not use Insuman Rapid after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insuman Rapid wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l- iskartoċċ.
In-use cartridges Cartridges in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Skartoċċi fl- użu Skartoċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux ‘ il fuq minn 25°Ċ., ’ il bogħod mis- sħana diretta (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 li qed intuża m’ għandux jinżamm fi friġġ.
Medicines should not be disposed of via wastewater or household waste.
446 Il- mediċini m’ ghandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma l- iskart domestiku.
Insuman Rapid is supplied in cartridges containing 3 ml solution (300 IU).
Insuman Rapid huwa fornut f’ skartoċċi li fihom 3 ml ta ’ soluzzjoni (300 IU).
448 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
447 Ελλάδα sanofi- aventis AEBE Τηλ: +30 210 900 16 00
Examples include:
448 Eżempji jinkludu:
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you
eċitament), jew għandek xi ferita, saritlek xi operazzjoni, għandek xi infezzjoni jew għandek id - deni.
450 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
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 -
452 PACKAGE LEAFLET:
450 FULJETT TA ’ TAGĦRIF:
Insuman Rapid 100 IU/ ml, solution for injection in a pre-filled pen Insulin human
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully including the Instructions for use of Insuman Rapid, pre-filled pen, OptiSet, before you start using this medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet dwar l- użu ta ’ Insuman Rapid, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
Insuman Rapid is a solution for injection under the skin.
Insuman Rapid huwa soluzzjoni għall- injezzjoni għal taħt il- ġilda.
The insulin contained in Insuman Rapid is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Rapid hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insuman Rapid is an insulin preparation with a rapid onset and short duration of action.
Insuman Rapid huwa preparat ta ’ l- insulina li jibda jaħdem malajr u jdum jaħdem għal żmien qasir.
Insuman Rapid is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Rapid huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete mellitus.
Do not use Insuman Rapid
Tużax Insuman Rapid
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Rapid.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insuman Rapid.
453 Travel
Safar
3.
453 3.
455 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Rapid is injected under the skin 15 to 20 minutes before a meal.
Insuman Rapid huwa injettat taħt il- ġilda minn 15 sa 20 minuta qabel ikla.
OptiSet delivers insulin in increments of 2 units up to a maximum single dose of 40 units.
Mod ta ’ kif jingħata OptiSet tagħti l- insulina f’ zidiet ta ’ 2 unitajiet, sa massimu ta ’ 40 unità f’ doża waħda.
Insuman Rapid comes in cartridges sealed in disposable pen injectors, OptiSet.
Insuman Rapid huwa fornut f’ skartoċċi ssiġillati f’ injettaturi ta ’ pinen OptiSet, li jintremew wara li jinħlew..
Do not use Insuman Rapid if you notice particles in it.
Tużax Insuman Rapid jekk tinnota li fih l- partikuli.
Only use Insuman Rapid if the solution is clear, colourless and waterlike.
Uża biss Insuman Rapid jekk is- soluzzjoni hija ċara, mingħajr kulur u tixbaħ l- ilma.
Insuman Rapid pre-filled pen, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Rapid, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
Do not use the OptiSet if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new OptiSet has to be used.
454 Tużax l- OptiSet jekk hi bil- ħsara jew mhix qed taħdem sew (dovut għall- difetti mekkaniċi); din għandha tintrema u OptiSet ġdida tintuża minflok.
- If you have injected too much Insuman Rapid, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Rapid milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’
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.
456 If you forget to use Insuman Rapid
Jekk tinsa tuża Insuman Rapid
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.
455 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.
457 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).
What Insuman Rapid contains
456 X’ fih Insuman Rapid
- The other ingredients are: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium
- Is- sustanzi l- oħra huma: meta- cresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium
Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available.
Insuman Rapid huwa fornut f’ pinen mimlija għal- lest, OptiSet li fihom 3 ml ta ’ soluzzjoni (300 IU). Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen ta ’ 3 ml.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din ilmediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Österreich sanofi- aventis GmbH Tel: +43 1 80 185 - 0
France sanofi-aventis France Tél:
457 France sanofi- aventis France Tél:
459 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
Warning symptoms of hyperglycaemia
458 Sintomi ta ’ twissija ta ’ ipergliċemija
460 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
461 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
462 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
Keep this leaflet for future reference each time you use OptiSet.
460 Żomm dan il- fuljett għax jista ’ jkollok bżonn terġa ’ taqrah kull darba li tuża OptiSet.
Ne w information for use: • Name of the insulin is printed on the pen. • Dosage selector can only be turned in one direction.
Tagħrif ġdid dwar l- użu: • L- isem ta ’ l- insulina huwa stampat fuq il- pinna. • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda.
Insuman Rapid is a clear insulin.
Insuman Rapid hija insulina ċara.
463 Step 2.
Pass Nru.
• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or the needle can be bent.
461 • Jekk il- labra ma tinżammx dritta waqt li qed tqabbadha, din tista ’ tagħmel ħsara l- woxer tal - lastku, u bħala riżultat ta ’ dan, il- pinna tibda tqattar, jew il- labra titgħawweġ.
464 C.
Ċ.
discard
462 armi żomm
Select the dose
4 Tagħzel id- doża
465 • If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
• Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- istixxa ikkulurita, allura hemm madwar 20 Unità t’ insulina disponibbli.
B.
463 B.
Load the dose
5 Ittella ’ d- doża
C.
464 Ċ.
This helps prevent: • Contamination and/ or infection • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Dan jgħin biex telimina: • Il- kontaminazzjoni u/ jew l- infezzjoni • Id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u li l- insulina tqattar mill- pinna, li jistgħu jikkawżaw dożaġġ ineżatt.
Please check section 5 – How to store Insuman Rapid - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insuman Rapid - fuq il- faċċata ta ’ wara (ta ’ l - insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
467 Maintenance
Manutenzjoni
Questions and Answers
465 Mistoqsijiet u Tweġibiet
•
Segwi l- istruzzjonijiet tal- Pass Nru.
468 The injection button cannot be pressed in.
Il- buttun ta ’ l - injezzjoni ma jistax
You don’t hear clicking while injecting.
L- OptiSet hija bil- ħsara, uża waħda ġdida.
OptiSet is damaged, use a new OptiSet.
Ma tismax iċ- ċekċik waqt li qed tinjetta.
Insulin is leaking from the pen.
Jista ’ jagħti l- każ li l- labra twaħħlet ħażin (e. g. immejjla).
469 PACKAGE LEAFLET:
467 FULJETT TA ’ TAGĦRIF:
Insuman Rapid 100 IU/ml solution for injection in a cartridge for OptiClik Insulin human
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
Insuman Rapid is a solution for injection under the skin or, in exceptional circumst ances, into a vein (blood vessel).
Insuman Rapid huwa soluzzjoni għall- injezzjoni għal taħt il- ġilda jew, f’ cirkustanzi speċjali, ġewwa vina (sistema vaskulari).
The insulin contained in Insuman Rapid is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Rapid hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu
Insuman Rapid may also be used for treating severe hyperglycaemia (very high blood sugar) and ketoacidosis (build- up of acid in the blood because the body is breaking down fat instead of sugar) as well as for controlling blood sugar before, during and after surgery.
Insuman Rapid jista ’ jintuża wkoll għat- trattament ta ’ l- ipergliċemija serja u severa (iz- zokkor fid- demm huwa għoli wisq) u l- ketoaċidożi (l- aċidu fid- demm jiżdied għax il- ġisem qiegħed jakkwista l- enerġija mix- xaħam, minflok miz- zokkor), kif ukoll biex jikkontrolla l - livell taz- zokkor fid- demm qabel, waqt u wara operazzjoni kirurġika.
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
468 Segwi sew l- istruzzjonijiet fuq id- dożaġġ, il- moniteraġġ (permezz ta ’ analiżi tad- demm u ta ’ l - awrina), id- dieta, u l- eżerċizju fiżiku (xogħol fiżiku u eżerċizju), kif diskuss mat- tabib tiegħek.
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
469 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)
Important information about some of the ingredients of Insuman Rapid
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insuman 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 ’.
- tell you when you may need to inject a higher or lower dose of Insuman Rapid.
- jgħidlek għandek jkollok bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Rapid,
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.
Insuman Rapid fi skartoċċi għal OptiClik kien żviluppat għall- użu f’ OptiClik biss. L- istruzzjonijiet tal - manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa biex jitgħabba l- iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
- Do not mix insulin with any other medicines.
- Tħallatx l- insulina ma ’ mediċini oħrajn. skartoċċi.
473 Mistakes in dosage
Żbalji fid- dożaġġ
- If you have injected too much Insuman Rapid, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Rapid milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm
(hypoglycaemia).
jista ’ jitbaxxa wisq (ipogliċemija).
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
472 Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi • Reazzjonijiet fis- sit ta ’ l- injezzjoni
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
In-use cartridges Cartridges in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
Skartoċċi fl- użu Skaroċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż.
One ml of Insuman Rapid contains 100 IU (International
Millilitru wieħed ta ’ Insuman Rapid fih 100 IU (Unit
475 What Insuman Rapid looks like and contents of the pack Insuman Rapid is a clear, colourless solution for injection, with no solid particles visible, and of a water- like consistency.
Insuman Rapid huwa soluzzjoni għall- injezzjoni ċara, minghajr kulur, bla ebda partikuli solidi u viżibbli, u tixbaħ l- ilma.
Insuman Rapid comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insuman Rapid huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
Packs of 3, 4, 5, 6, 9 and 10 cartridges of 3 ml are available.
Insuman Rapid huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ soluzzjoni (300 IU). Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi ta ’ 3 ml.
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
474 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
475 IPERGLIĊEMIJA U IPOGLIĊEMIJA
477 Warning symptoms of hyperglycaemia
Sintomi ta ’ twissija ta ’ ipergliċemija
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:
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).
477 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).
479 PACKAGE LEAFLET:
478 FULJETT TA ’ TAGĦRIF:
Insuman Rapid 100 IU/ml, solution for injection in a pre -filled pen Insulin human
Insuman Rapid 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully including the Instructions for Use of Insuman Rapid, pre-filled pen, SoloStar, before you start using this medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Insuman Rapid, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. - Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
480 Travel
479 Safar
3.
481 3.
482 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
SoloStar is a pre-filled disposable pen containing insulin human.
SoloStar hija pinna mimlija għal- lest, li tintrema wara li tinħela, u fiha l- insulina umana.
If you think you may have a problem with SoloStar, consult your Healthcare Professional.
Jekk taħseb li għandek xi problema b’ SoloStar, kellem lill Professjonist fil Qasam tas- Saħħa.
Insuman Rapid pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Rapid, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.