qanastek/EMEA-V3 huggingface dataset:
Ask your doctor to tell you about glucagon.
Staqsi lit- tabib tiegħek biex jgħidlek dwar il- glukagon.
If you forget to use Humalog If you take less Humalog than you need, a high blood sugar may occur.
Jekk tinsa tuża Humalog Jekk tieħu inqas Humalog milli ghandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
Check your blood sugar.
Iċċekkja l- livell taz- zokkor fid demm tiegħek
189 If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “ Possible Side Effects”). • Always keep spare syringes and a spare vial of Humalog. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu).
If you stop using Humalog.
Jekk tieqaf tuża Humalog
If you take less Humalog than you need, a high blood sugar may occur.
Jekk tieħu inqas Humalog milli ghandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
Do not change your insulin unless your doctor tells you to.
Tbiddilx l- insulina tiegħek sakemm ma jgħidlekx it- tabib.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
198 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Humalog can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Humalog jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Local allergy is common (≥ 1/ 100 to < 1/ 10).
Allerġija lokali hija komuni (> 1/ 100 sa < 1/ 10).
Some people get redness, swelling or itching around the area of the insulin injection.
Ftit nies ikollhom ħmura, nefħa jew ħakk madwar it - titqiba ta 'l- insulina.
This usually clears up in anything from a few days to a few weeks.
Dawn issoltu jiċċaraw fi żmien ftit ġranet sa ftit ġimgħat.
If this happens to you, tell your doctor.
Jekk jiġrilek hekk, għid lit- tabib tiegħek.
Systemic allergy is rare (≥ 1/ 10,000 to < 1/ 1,000).
Allerġija sistemika hija rari (> 1/ 10, 000 sa < 1/ 1000):
The symptoms are as follows: • • •
• •
rash over the whole body • difficulty in breathing • wheezing • sweating.
Tinżillek il- pressjoni tad- demm
blood pressure dropping heart beating fast
Diffikultà fin- nifs
If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.
Jekk taħseb li qed ikollok din it- tip t' allerġija għall- insulina bi Humalog għid lit- tabib tiegħek minnufih.
If you notice your skin thickening or pitting at the injection site, tell your doctor.
Lipodistrofija (li teħxien jew titħaffer il- ġilda) m’ hijiex komuni (> 1/ 1, 000 sa < 1/ 100). Jekk tinnota li l- ġilda qed teħxien jew titħaffer fis- sit ta 'l- injezzjoni, għid lit- tabib tiegħek.
Common problems of diabetes
Problemi komuni tad- dijabete
Hypoglycaemia Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood.
Din tista 'tkun ikkawżata jekk:
This can be caused if: • you take too much Humalog or other insulin; • you miss or delay meals or change your diet; • you exercise or work too hard just before or after a meal; • you have an infection or illness (especially diarrhoea or vomiting); • there is a change in your need for insulin; or • you have trouble with your kidneys or liver which gets worse.
• Tagħmel wisq eżerċizzju jew taħdem iż- żejjed eżatt qabel jew wara ikla;
Alcohol and some medicines can affect your blood sugar levels.
L- alkoħol u xi mediċini jistgħu jaffettwaw il- livelli taz- zokkor fid- demm tiegħek.
The first symptoms of low blood sugar usually come on quickly and include the following: •
L- ewwel sintomi ta 'zokkor baxx fid- demm issoltu jiġru malajr u jinkludu dawn li ġejjin:
tiredness • rapid he
• •
• tiredness •
Għeja
rapid heartbeat
Taħbit mgħaġġel tal- qalb
nervousness or shakiness • headache • cold sweat.
Nervożità jew rogħda
feeling sick
Uġigħ ta 'ras
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.
199 Meta ma tkunx konfidenti li taf tagħraf is- sintomi ta 'twissija, evita sitwazzjonijiet, eż. li ssuq karozza, li tista' tpoġġi lillek jew lil oħrajn f' riskju minħabba zokkor baxx fid- demm.
Hyperglycaemia and diabetic ketoacidosis 190 Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.
Zokkor għoli fid- demm u l- ketoaċidożi dijabetika
Hyperglycaemia can lead to diabetic ketoacidosis.
Jista ’ jaqbdek zokkor għoli fid - demm minħabba:
The first symptoms come on slowly over many hours or days.
• Li ma tieħux Humalog tiegħek jew insulina oħra;
The symptoms include the following: •
• Li qed tieħu anqas insulina milli jgħidlek it- tabib tiegħek;
feeling sleepy • no ap
• Li tiekol ħafna aktar milli tippermettilek id- dieta tiegħek; jew
• feeling sleepy •
• Deni, infezzjoni jew stress emozzjonali.
no appetite
Is- sintomi jinkludu li ġejjin:
flushed face • fruity smell on the
Tħossok bi ngħas
• flushed face •
•
fruity smell on the breath
Ħmura fil- wiċċ
thirst • feeling or bein
Rieħa ħelwa fin- nifs
feeling or being sick
Tħossok jew tkun ma tiflaħx
Severe symptoms are heavy breathing and a rapid pulse.
Sintomi qawwija huma nifs qawwi u polz mgħaġġel.
Get medical help immediately.
Ġib għajnuna medika minnufih.
Illness If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.
Jekk int ma tiflaħx, speċjalment jekk qed tħossok imdardar jew jekk inti mdardar, l- ammont ta 'insulina li għandek bżonn tista' tinbidel.
Even when you are not eating normally, you still need insulin.
Anke meta ma tkunx qed tiekol normalment, xorta ikollok bżonn l- insulina.
Test your urine or blood, follow your ‘sick rules’, and tell your doctor.
Eżamina l- awrina jew id- demm tiegħek, segwi 'r- regoli tiegħek ta' meta tkun ma tiflaħx ', u għid lit- tabib tiegħek.
HOW TO STORE HUMALOG
KIF TAĦŻEN HUMALOG
Before the first use store your Humalog in a refrigerator (2°C – 8°C).
Qabel ma tuzah l- ewwel darba żomm Humalog fi friġġ (2°C- 8°C).
Do not put it near heat or in the sun.
Żomm il - kunjett li ħa tuża f' temperatura ambjentali ta 'ġewwa (taħt 30°C) għal użu sa 28 ġurnata. Tħallihx ħdejn is- sħana jew fix- xemx.
Do not use Humalog after the expiry date which is stated on the label and the carton.
Tużax Humalog wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar >.
Do not use Humalog, if it is coloured or it has solid pieces in it.
Tużax Humalog jekk għandu xi kulur jew jidhru xi frak.
You must use it only if it looks like water.
Ghandek tużah biss jekk jidher qiesu ilma.
Check this each time you inject yourself.
Din il- ħaġa għamila kull darba li se tinjetta lillek innifsek.
What Humalog 100 U/ml solution for injection in vial contains
200
- The active substance is insulin lispro.
- Is- sustanza attiva hi insulin lispro.
Insulin lispro is made in the laboratory by a ‘recombinant
L- insulina lispro hija magħmula fil- laboratorju bi proċess ta '
DNA technology’ process.
teknoloġija rikombinanti mid- DNA.
It is a changed form of human insulin and so is different from other human and animal insulins.
Hija forma mibdula ta 'insulina umana u għalhekk hija differenti minn insulini oħra umani jew insulina mill- annimali.
Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.
L- insulina lispro hija relatata mill- viċin għal insulina umana li huwa ormon naturali magħmul mill- frixa.
- The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and
- Is- sustanzi l- oħra huma m- cresol, glycerol, dibasic sodium phosphate 7 H20, zinc oxide u ilma
water for injection.
għall- injezzjoni.
Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.
Sodium hydroxide jew hydrochloric acid setgħu ġew użati biex tkun aġġustata l- aċidità.
191 What Humalog looks like and contents of the pack Humalog 100 U/ml, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 U/ml) solution for injection.
Humalog 100 U/ ml, soluzzjoni għal injezzjoni, hu soluzzjoni akweju, bla kulur, ċar u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) soluzzjoni għal injezzjoni.
Each vial contains 1000 units (10 millilitres).
Kull kunjett fih 1000 unità (10 millilitri).
Humalog 100 U/ml, solution for injection in vial comes in a pack of 1 vial, 2 vials or a multipack of 5 x 1 vial.
Humalog 100 U/ ml, soluzzjoni għal injezzjoni ġo kunjett jiġi f’ pakkett ta ’ kunjett 1, 2 kunjetti jew pakkett multiplu ta ’ 5 x 1 kunjett.
Marketing Authorisation Holder and Manufacturer Humalog 100 U/ml, solution for injection in vial is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Lilly Pharma Fertigung und Distribution GmbH & Co.
Humalog 100 U/ ml, soluzzjoni għal injezzjoni ġo kunjett huwa manifatturat minn: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Lilly Pharma Fertigung und Distribution GmbH & Co.
KG, Teichweg 3, 35396 Giessen, Germany,
KG, Teichweg 3, 35396 Giessen, Germanja,
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, The Netherlands.
Il- liċenzja tal- prodott hija ta 'Eli Lilly Nederland B. V., Groostlag 1- 5, 3991 RA Houten, L- Olanda.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
201 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Belgique/België/Belgien Eli Lilly Benelux S.A.
Τηλ: +30 210 629 4600 España Lilly S. A.
Luxembourg/Luxemburg Eli Lilly Benelux S.A.
Tél: +33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353 - (0) 1 661 4377 Ísland Icepharma hf.
Tél/ Tel: + 32-(0)2 548 84 84
Sími + 354 540 8000 Italia Eli Lilly Italia S. p. A.
България ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
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 /.
193 PACKAGE LEAFLET:
202 FULJETT TA ’ TAGĦRIF:
Humalog 100 U/ml solution for injection in cartridge (insulin lispro)
Humalog 100 U/ ml, soluzzjoni għall- injezzjoni ġo skartoċċ (insulina lispro)
Humalog is used to tre at diabetes.
Humalog huwa użat biex id- dijabete tiġi trattata.
Take special care with Humalog • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
203 • Jekk il- livelli taz- zokkor fid- demm tiegħek huma kkontrollati sew bit- terapija ta 'l- insulina li qed tuża bħalissa, tista' ma tħossx is- sintomi ta 'twissija meta jinżillek wisq iz- zokkor fid - demm.
194 • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different.
• Ftit nies li kellhom zokkor baxx fid- demm wara li qalbu minn insulina ta 'l- annimali għal isulina umana rrapportaw li l- ewwel sintomi ta' twissija kienu anqas ovji jew differenti.
The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home. • If the 40 U/ml vial is the product normally prescribed, do not take insulin from a 100 U/ml cartridge using a 40 U/ml syringe.
Id- differenza fil- ħin bejn il- pajjiżi tista 'tfisser li jkollok tieħu l- injezzjonijiet u l - ikliet f' ħinijiet differenti milli meta tkun id- dar.
Using other medicines Your insulin needs may change if you are taking the contraceptive pill, steroids, thyroid hormone replacement therapy, oral hypoglycaemics, acetyl salicylic acid, sulpha antibiotics, octreotide, “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline), beta-blockers, or some antidepressants (monoamine oxidase inhibitors), danazol, some angiotensin converting (ACE) inhibitors (for example captopril, enalapril), and angiotensin II receptor blockers.
Meta tuża mediċini oħra Il- bżonnijiet tiegħek ta 'l- insulina jistgħu jinbidlu jekk qed tieħu il- pillola kontraċettiva, sterojdi, terapija biex tpatti għan- nuqqas ta' l- ormoni tat- tirojde, mediċini orali li jbaxxu z- zokkor fid- demm, acetyl salicylic acid, antibijotiċi sulpha, octreotide, "stimulanti tat- tip beta 2" (per eżempju ritodrine, salbutamol jew terbutaline), imblokkaturi tat- tip beta, jew ċerti antidipressanti (impedituri ta ’ monoamine oxidase), danazol, ċerti impedituri t' enżimi li jibdlu l- anġjotensina (per eżempju captopril, enalapril) u sustanzi li jibblokkjaw ir- riċetturi anġjotensin II
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery).
Jekk jogħġbok żomm din il- problema f' moħħok f' kull sitwazzjoni fejn tkun tista 'tpoġġi lilek innifsek jew oħrajn f' riskju (eż. sewqan ta' karozza jew tħaddim ta 'magni).
3.
• Sinjali ta ’ twissija mnaqqsa jew assenti meta jkollok zokkor baxx fid- demm 204 3.
The 3 ml cartridge is only for use in 3ml pens.
L- iskartoċċ tat- 3ml għandu jintuza biss mal- pinen tat- 3ml.
It is not for use in 1.5 ml pens.
M’ għandux jintuza fil- pinen 1. 5ml.
Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy.
Dejjem eżamina il- pakkett u t- tabella ta ’ l- iskartoċċ għall- isem u għat- tip ta 'l- insulina meta ġġibu mill- ispiżerija.
Follow them exactly and visit your diabetes clinic regularly.
Segwihom eżatt u mur il- klinika tad- dijabete tiegħek regolarment.
195 • If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before.
• Jekk tibdel it- tip ta 'l- insulina li tuża (per eżempju minn insulina umana jew minn ta' l - annimali għall- prodott ta 'Humalog), jista' jkun ikollok bżonn tieħu aktar jew anqas minn qabel.
Preparing Humalog • Humalog is already dissolved in water, so you do not need to mix it.
• Humalog huwa diġa maħlul fl- ilma, għalhekk m' għandekx bżonn tħalltu.
Getting the pen ready to use • First wash your hands.
Iddisinfetta r- rita tal- gomma ta ’ l- iskartoċċ.
Disinfect the rubber membrane of the cartridge. • You must only use Humalog cartridges in compatible CE marked pens.
• Għandek tuża biss skrataċ tal- Humalog f’ pinnen kompattibli mmarkati CE.
Please make sure that Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen.
Jekk jogħġbok aċċerta ruħek li jissemmew l- iskrataċ Humalog jew Lilly fil- fuljett ta ’ mal- pinna.
The 3 ml cartridge only fits the 3 ml pen. • Follow the instructions that come with the pen.
L- iskartoċċ ta ’ 3 ml jesa biss il- pinna ta ’ 3 ml.
Put the cartridge into the pen. • You will set the dose to 1 or 2 units.
• Għandek tissettja d- doża sa 1 jew 2 unità.
Then hold the pen with the needle pointing up and tap the side of the pen so that any bubbles float to the top.
Umbagħad żomm il- pinna bil- labra tipponta ’ l fuq u taptap il- ġenb tal- pinna biex xi bżieżaq jitilgħu fil- wiċċ.
With the pen still pointing up, press the injection mechanism.
Bil- pinna għada tipponta ’ l fuq, agħfas il- mekkaniżmu ta ’ l- injezzjoni.
Do this until a drop of Humalog comes out of the needle.
Agħmel hekk sakemm qatra Humalog toħroġ minn ġol- labra.
There may still be some small air bubbles left in the pen.
Jista ’ jkun li jibqgħu xi bżieżaq żgħar ta ’ l- arja ġol- pinna.
These are harmless, but if the air bubble is too big, it may make the dose of your injection less accurate.
Dawn ma jagħmlux ħsara, pero jekk il- bużżieqa ta ’ l- arja tkun kbira wisq, id- doża ta ’ l- injezzjoni tista ’ tkun inqas eżatta.
Injecting Humalog • Before you make an injection, clean your skin as you have been instructed.
• Qabel ma tagħmel l- injezzjoni, naddaf il- ġilda tiegħek kif ġejt mgħallem.
Inject under the skin, as you were taught.
Injetta taħt il- ġilda, kif ġejt mgħallem.
Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught.
Kun żgur li tinjetta għal ta 'l- anqas nofs pulzier (1 cm)' l bogħod mill- aħħar injezzjoni u li tbiddel il- postijiet li tinjetta, kif ġejt mgħallem.
It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human insulin. • You must not administer Humalog by the intravenous route.
Mhux importanti liema sit tuża, jew il- parti ta '205 fuq tad- driegħ, il- koxxa, il- warrani jew fiż- żaqq, l- injezzjoni ta' Humalog xorta taħdem aktar malajr minn insulina umana li tinħall.
Inject Humalog as your physician or nurse has taught you.
• M' għandekx tagħti Humalog ġol- vina.
After injecting • As soon as you have done the injection, take the needle off the pen using the outer needle cap.
• Eżatt kif tkun hadt l- injezzjoni, neħħi l- labra mill- pinna billi tuża il- kappa ta 'barra tal- labra.
This will keep the Humalog sterile and prevent leaking.
Dan iżomm Humalog sterili u jipprevjeni l- ħruġ.
It will also stop air going back into the pen and the needle clogging up.
Huwa jwaqqaf ukoll l- arja milli terġa tidħol lura ġol- pinna u milli tibblokka l- labra.
Do not share your needles.
Tagħtix is- siringi u l- labar tiegħek lil xi ħadd ieħor.
Do not share your pen.
Tagħtix il- pinna tiegħek lil xi ħadd ieħor.
Replace the cap on your pen.
Poġġi il- kappa lura fuq il- pinna.
Further injections • Leave the cartridge in the pen.
• Ħalli l- iskartoċċ ġol- pinna.
Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Humalog comes out of the needle.
Qabel kull injezzjoni, isselezzjona 1 jew 2 unitajiet u agħfas il - mekkaniżmu ta 'l- injezzjoni bil- pinna tipponta' l fuq sakemm toħroġ qattra ta 'Humalog mill - labra.
You can see how much Humalog is left by looking at the gauge on the side of the cartridge.
Tista 'tara hemm baqa' Humalog billi tħares lejn il- gejġ fuq il- ġenb ta 'l- iskartoċċ.
The distance between each mark on the gauge is about 20 units.
Id - distanza bejn kull marka fuq il- gejġ hija ta 'madwar 20 unità.
If there is not enough for your dose, change the cartridge.
Jekk m’ hemmx biżżejjed għad - doża tiegħek, biddel l- iskartoċċ.
Do not mix any other insulin in a Humalog cartridge.
Tħallatx xi insulina oħra fi skartoċċ ta ’ Humalog.
Once the cartridge is empty, do not use it again.
Ladarba l- iskartoċċ jiżvojta, terġax tużah.
A glucagon injection can treat quite severe hypoglycaemia.
Injezzjoni tal- glukagon tista 'tikkura zokkor baxx
Check your blood sugar
Iċċekkja l- livell taz- zokkor fid demm tiegħek
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”). • Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu).
Local allergy is common (≥ 1/100 to < 1/10).
Allerġija lokali hija komuni (> 1/ 100 sa < 1/ 10).
Systemic allergy is rare (≥ 1/10,000 to < 1/1,000).
Allerġija sistemika hija rari (> 1/ 10, 000 sa < 1/ 1000):
The symptoms are as follows: •
Is- sintomi huma dawn li ġejjin:
rash over the whole body • blood pressure d
• •
• rash over the whole body •
Raxx ma 'ġismek kollu
blood pressure dropping
Tinżillek il- pressjoni tad- demm
heart beating fast
Diffikultà fin- nifs
wheezing • s
Il- qalb tħabbat mgħaġġla
sweating
Tħarħir
197 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
• nervousness or shakiness •
Nervożità jew rogħda
headache • cold
Tħossok imdardar
cold sweat.
Uġigħ ta 'ras
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.
Meta ma tkunx konfidenti li taf tagħraf is- sintomi ta 'twissija, evita sitwazzjonijiet, eż. li ssuq karozza, li tista' tpoġġi lillek jew lil oħrajn f' riskju minħabba zokkor baxx fid- demm.
Hyperglycaemia and diabetic ketoacidosis Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.
Zokkor għoli fid- demm u l- ketoaċidożi dijabetika
thirst • feeling or being
Rieħa ħelwa fin- nifs
feeling or being sick.
Tħossok jew tkun ma tiflaħx
198 Do not use Humalog, if it is coloured or it has solid pieces in it.
Tużax Humalog jekk għandu xi kulur jew jidhru xi frak.
What Humalog 100 U/ml solution for injection in cartridge contains
X’ fih Humalog 100 u/ ml soluzzjoni għal injezzjoni ġo skartoċċ:
What Humalog looks like and contents of the pack Humalog 100 U/ml, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 U/ml) solution for injection.
Humalog 100 U/ ml, soluzzjoni għal injezzjoni, hu soluzzjoni akweju, bla kulur, ċar u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) soluzzjoni għal injezzjoni.
Each cartridge contains 300 units (3 millilitres).
Kull skartoċċ fih 300 unità (3 millilitri).
The cartridges come in packs of 5 cartridges or a multipack of 2 x 5 cartridges.
L- iskrataċ jiġi f’ pakketti ta ’ 5 skrataċ jew pakkett multiplu ta ’ 2 x 5 skrataċ.
Marketing Authorisation Holder and Manufacturer Humalog 100 U/ml, solution for injection in cartridge is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Eli Lilly Italia S.p.A., Via A.
Humalog 100 U/ ml, soluzzjoni għal injezzjoni ġo skartoċċ huwa manifatturat minn: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Eli Lilly Italia S. p. A., Via A.
Gramsci 731-733, 50019 Sesto Fiorentino, Florence, Italy.
Gramsci 731- 733, 50019 Sesto Fiorentino, Florence, L- Italja.
199 For any information about this medicinal product, 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:
Belgique/België/Belgien Eli Lilly Benelux S.A.
209 Belgique/ België/ Belgien Eli Lilly Benelux S. A.
Tél/ Tel: + 32-(0)2 548 84 84
Tél/ Tel: + 32 - (0) 2 548 84 84 България ТП “ Ели Лили Недерланд ” Б. В. - България тел. + 359 2 491 41 40 Česká republika ELI LILLY ČR, s. r. o.
Κύπρος Phadisco Ltd Τηλ: +357 22 715000
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
201 PACKAGE LEAFLET:
210 FULJETT TA ’ TAGĦRIF:
Humalog Mix25 100 U/ml suspension for injection in vial (insulin lispro)
Humalog Mix25 100U/ ml, suspensjoni għall- injezzjoni ġo kunjett (insulina lispro)
What Humalog Mix25 is and what it is used for 2.
X’ inhu Humalog Mix25 u għalxiex jintuża 2.
Before you use Humalog Mix25 3.
Qabel ma tuża Humalog Mix25 3.
How to use Humalog Mix 25 4.
Kif għandek tuża Humalog Mix25 4.
How to store Humalog Mix25 6.
Kif taħżen Humalog Mix25 6.
WHAT HUMALOG MIX25 IS AND WHAT IT IS USED FOR
X’ INHU HUMALOG MIX25 U GĦALXIEX JINTUŻA
Humalog Mix25 is a premixed suspension.
Humalog Mix25 hija użata biex id- dijabete tiġi trattata Hija suspensjoni mħallta lesta..
Its active substance is insulin lispro.
Is- sustanza attiva tagħha hija insulina lispro.
25% of the insulin lispro in Humalog Mix25 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly.
25% ta 'l- insulina lispro fi Humalog Mix25 hija maħlula fl- ilma u taħdem aktar malajr minn insulina umana normali għax il- molekula ta' l- insulina ġiet mibdula ftit.
75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate, so that its action is prolonged.
75% ta 'l- insulina lispro fi Humalog Mix25 hija suspensjoni flimkien ma' protamine sulphate, ħalli l - azzjoni tagħha tkun mtawwla.
Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the long term.
Humalog Mix25 huwa sostitwent għall- insulina tiegħek u huwa użat biex jikkontrolla l- glukożju fuq medda twila ta ’ żmien.
Humalog Mix25 works very quickly and longer than soluble insulin.
Humalog Mix25 jaħdem malajr ħafna u għal tul ta ’ żmien itwal mill- insulina li tinħall.
You should normally use Humalog Mix25 within 15 minutes of a meal.
Normalment għandek tuża Humalog Mix25 15- il minuta qabel ikla.
Your doctor may tell you to use Humalog Mix25 as well as a longer-acting insulin.
It- tabib tiegħek jista 'jgħidlek biex tuża Humalog Mix25 kif ukoll insulina li ddum taħdem għal ħin itwal.
BEFORE YOU USE HUMALOG MIX25
QABEL MA TUŻA HUMALOG
Do not use Humalog Mix25
Tużax HUMALOG Mix25
- if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of Humalog
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal insulina lispro jew sustanzi oħra ta ’
Mix25.
Humalog
Take special care with Humalog Mix25 • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
211 • Jekk il- livelli taz- zokkor fid- demm tiegħek huma kkontrollati sew bit- terapija ta 'l- insulina li qed tuża bħalissa, tista' ma tħossx is- sintomi ta 'twissija meta jinżillek wisq iz- zokkor fid - demm.
202 • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different.
• Ftit nies li kellhom zokkor baxx fid- demm wara li qalbu minn insulina ta 'l- annimali għal isulina umana rrapportaw li l- ewwel sintomi ta' twissija kienu anqas ovji jew differenti.
If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor. • If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse
Jekk spiss ikollok zokkor baxx fid- demm jew jekk għandek diffikultà biex tagħrafha, jekk jogħġbok iddiskuti dan mat- tabib tiegħek.
HOW TO USE HUMALOG MIX25
KIF GĦANDEK TUŻA HUMALOG MIX25
Make sure you get the Humalog Mix25 that your doctor has told you to use.
Kun żgur li ġġib Humalog Mix25 li t- tabib tiegħek qallek biex tuża.
Always use Humalog Mix25 exactly as your doctor has told you.
Dejjem għandek tuża Humalog Mix25 skond il- parir tat- tabib.
You should check with your doctor if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib tiegħek jekk ikollok xi dubju.
Dosage • You should normally inject Humalog Mix25 within 15 minutes of a meal.
• Normalment għandek tinjetta Humalog Mix25 fi żmien 15- il minuta qabel ikla.
This might just be for the first injection or it may be a gradual change over several weeks or months. • Inject Humalog Mix25 under the skin.
Dan jista 'jkun biss għal l- ewwel injezzjoni jew tista' tkun bidla gradwali tul ħafna ġimgħat jew xhur.
You should not administer it using a different administration route.
Taħt l - ebda ċirkostanza Humalog Mix25 m' għandha tingħata ġol- vina.
Under no circumstances should Humalog Mix25 be given intravenously.
Preparazzjoni ta 'Humalog Mix25
203 Preparing Humalog Mix25 • Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to resuspend insulin until it appears uniformly cloudy or milky.
• Fjali li għandhom Humalog Mix25 għandhom ikunu mdawra fil- pali ta 'l- idejn qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher kollha mċajpra jew qiesa ħalib.
Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.
Tħawwadiex bis- saħħa għax hekk tista 'toħloq ragħwa li tista' tinterferixxi mal- miżura eżatta tad- doża.
The vials should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial, giving it a frosted appearance.
Il- fjali għandhom ikunu eżaminati ta 'spiss u m' għandhomx jintużaw jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb tal- kunjett, u jidher qiesu ġelu.
Check each time you inject yourself.
Iċċekkja kull darba li tinjetta lilek innifsek.
Injecting Humalog Mix25 • First wash your hands. • Before you make an injection, clean your skin as you have been instructed.
Naddaf it- tapp tal - gomma fuq il- kunjett, imma tneħħix it- tapp.
Clean the rubber stopper on the vial, but do not remove the stopper. • Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of Humalog Mix25 you want.
• Uża siringa u labra nadifa u sterili biex ittaqqab it- tapp tal- gomma u iġbed l- ammont ta 'Humalog Mix25 li trid.
If you take more Humalog Mix25 than you need If you take more Humalog Mix25 than you need, a low blood sugar may occur.
Jekk tuża Humalog Mix25 aktar milli suppost Jekk tuża Humalog Mix25 aktar milli suppost, jista ’ jkollok livell baxx ta ’ zokkor fid- demm.
Check your blood sugar.
Iċċekkja l- livell taz- zokkor fid- demm tiegħek.
If your blood sugar is low, eat glucose tablets, sugar or drink a sugary drink.
Jekk iz- zokkor fid- demm tiegħek huwa baxx, kul il- pilloli tal- glukożju, zokkor jew ixrob xarba ħelwa.
This will often get you over mild hypoglycaemia or a minor insulin overdose.
B' hekk ħafna mid- drabi jirnexxilek tirkupra minn effetti ta ’ ftit zokkor baxx fid- demm jew minn doża eċċessiva ħafifa ta ’ insulina.
If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once.
Jekk tmur għal agħar u qed tieħu nifs baxx u l- ġilda tiegħek tibjad, għid lit- tabib tiegħek minnufih.
Eat glucose or sugar after the glucagon injection.
Kul il- glukożju 213 jew zokkor wara l- injezzjoni tal- glukagon.
If you do not respond to glucagon, you will have to go to hospital.
Jekk ma jgħaddilekx bil- glukagon, ikollok tmur l- isptar.
If you forget to use Humalog Mix25 If you take less Humalog Mix25 than you need, a high blood sugar may occur.
Jekk tinsa tuża Humalog Mix25 Jekk tieħu inqas Humalog milli għandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”). • Always keep spare syringes and a spare vial of Humalog Mix25. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu).
If you stop using Humalog Mix25.
Jekk tieqaf tuża Humalog Mix25
If you take less Humalog Mix25 than you need, a high blood sugar may occur.
Jekk tieħu inqas Humalog Mix25 milli għandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
Like all medicines, Humalog Mix25 can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Humalog Mix25 jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
204 Systemic allergy is rare (≥ 1/10,000 to < 1/1,000).
Allerġija sistemika hija rari (> 1/ 10, 000 sa < 1/ 1000):
If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once.
Jekk taħseb li qed ikollok din it- tip t' allerġija għall- insulina bi Humalog għid lit- tabib tiegħek minnufih.
This can be caused if: • you take too much Humalog Mix25 or other insulin; • you miss or delay meals or change your diet; • you exercise or work too hard just before or after a meal; • you have an infection or illness (especially diarrhoea or vomiting); • there is a change in your need for insulin; or • you have trouble with your kidneys or liver which gets worse.
214 • Ma tiekolx jew tiekol tard jew jekk tbiddel id- dieta tiegħek; • Tagħmel wisq eżerċizzju jew taħdem iż- żejjed eżatt qabel jew wara ikla; • Għandek infezzjoni jew mard (speċjalment dijarrea jew remettar); • Hemm bidla fil- bżonn tiegħek ta 'l- insulina; jew • Għandek problemi bil- kliewi jew bil- fwied li qed isiru agħar
nervousness or shakiness • headache •
Nervożità jew rogħda
feeling sick cold sweat
Uġigħ ta 'ras
205 C.
Mard
HOW TO STORE HUMALOG MIX25
KIF TAĦŻEN HUMALOG MIX25
Before the first use store your Humalog Mix25 in a refrigerator (2°C – 8°C).
Qabel ma tuzah l- ewwel darba żomm Humalog Mix25 fi friġġ (2°C- 8°C).
Do not put it near heat or in the sun.
Żomm il- kunjett li ħa tuża f' temperatura ambjentali ta 'ġewwa (taħt 30°C) għal użu sa 28 ġurnata. Tħallihx ħdejn is- sħana jew fix- xemx.
Keep out of the reach and sight of children.
215 Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use Humalog Mix25 after the expiry date which is stated on the label and the carton.
Tużax Humalog Mix25 wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
Do not use Humalog Mix25, if clumps of material are present or if solid white particles stick to the bottom or wall of the vial, giving it a frosted appearance.
Tużax Humalog Mix25, jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb tal- kunjett, u jidher qiesu ġelu.
Check each time you inject yourself.
Din il- ħaġa għamila kull darba li se tinjetta lillek innifsek.
What Humalog Mix25 100 U/ml suspension for injection in vial contains
X’ fih Humalog Mix25 100 u/ ml suspensjoni għal injezzjoni ġo kunjett:
- The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium
- Is- sustanzi l- oħra huma protamine sulphate, m- cresol, glycerol, dibasic sodium phosphate 7
phosphate 7H2O, zinc oxide and water for injection.
H20, zinc oxide u ilma għall- injezzjoni.
What Humalog Mix25 100 U/ml suspension for injection in vial looks like and contents of the pack Humalog Mix25 100 U/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 U/ml) suspension for injection.
Humalog Mix25 100 U/ ml, suspensjoni għal injezzjoni, hu suspensjoni abjad u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) suspensjoni għal injezzjoni.
75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate.
25% ta ’ insulin lispro f’ Humalog Mix 25 huwa maħlul fl- ilma. 75% ta ’ l- insulin lispro f’ Humalog Mix25 huwa f’ suspensjoni flimkien ma ’ protamine sulphate.
Each vial contains 1000 units (10 millilitres).
Kull kunjett fih 1000 unità (10 millilitri) Humalog Mix25 100 u/ ml suspensjoni għal injezzjoni f’ kunjett jiġi f’ pakkett ta ’ kunjett 1.
Humalog Mix25 100 U/ml suspension for injection in vial comes in a pack of 1 vial.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Marketing Authorisation Holder and Manufacturer Humalog Mix25 100 U/ml suspension for injection in vial is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Lilly Pharma Fertigung und Distribution GmbH & Co.
Humalog Mix25 100 U/ ml, suspensjoni għal injezzjoni ġo kunjett huwa manifatturat minn:: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Lilly Pharma Fertigung und Distribution GmbH & Co.
Belgique/België/Belgien
216 Belgique/ België/ Belgien Eli Lilly Benelux S. A.
Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
208 PACKAGE LEAFLET:
217 FULJETT TA ’ TAGĦRIF:
Humalog Mix25 100 U/ml suspension for injection in cartridge (insulin lispro)
Humalog Mix25 100U/ ml, suspensjoni għall- injezzjoni ġo skartoċċ (insulina lispro)
How to use Humalog Mix25 4.
Kif għandek tuża Humalog Mix25 4.
Take special care with Humalog Mix25 • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
218 Oqgħod attent ħafna b’ Humalog Mix25 • Jekk il- livelli taz- zokkor fid- demm tiegħek huma kkontrollati sew bit- terapija ta 'l- insulina li qed tuża bħalissa, tista' ma tħossx is- sintomi ta 'twissija meta jinżillek wisq iz- zokkor fid - demm.
209 • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different.
• Ftit nies li kellhom zokkor baxx fid- demm wara li qalbu minn insulina ta 'l- annimali għal isulina umana rrapportaw li l- ewwel sintomi ta' twissija kienu anqas ovji jew differenti.
3.
• Sinjali ta ’ twissija mnaqqsa jew assenti meta jkollok zokkor baxx fid- demm 219 3.
The 3 ml cartridge is only for use in 3ml pens.
L- iskartoċċ ta ’ 3ml għandu jiġi uzat biss mal- pinna ta ’ 3ml.
It is not for use in 1.5 ml pens.
M’ għandux jiġi użat mal- pinen ta ’ 1. 5ml.
210 • If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before.
• Jekk tibdel it- tip ta 'l- insulina li tuża (per eżempju minn insulina umana jew minn ta' l - annimali għall- prodott ta 'Humalog), jista' jkun ikollok bżonn tieħu aktar jew anqas minn qabel.
Preparing Humalog Mix25 • Cartridges containing Humalog Mix25 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky.
• Skrataċ li għandhom Humalog Mix25 għandhom ikunu mdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet eżatt qabel l- użu biex tirrisospendi l- insulina sakemm tidher kollha mċajpra jew qiesa ħalib.
If not, repeat the above procedure until contents are mixed.
Jekk le, irrepeti din il- proċedura sakemm jitħalltu l- kontenuti.
Cartridges contain a small glass bead to assist mixing.
L - iskrataċ fihom żibġa tal- ħġieġ biex tgħin fit- tħallit.
The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.
L- iskrataċ għandhom ikunu eżaminati ta 'spiss u m' għandhomx jintużaw jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb ta ’ l- iskartoċċ, u jidher qiesu ġelu.
Disinfect the rubber membrane of the cartridge. • You must only use Humalog Mix25 cartridges in compatible CE marked pens.
• Għandek tuża biss skrataċ tal- Humalog Mix25 f’ pinnen kompattibli mmarkati CE.
Do this until a drop of Humalog Mix25 comes out of the needle.
Agħmel hekk sakemm qatra Humalog Mix25 toħroġ minn ġol - labra.
Injecting Humalog Mix25 • Before you make an injection, clean your skin as you have been instructed.
• Qabel ma tagħmel l- injezzjoni, naddaf il- ġilda tiegħek kif ġejt mgħallem.
This will keep the Humalog Mix25 sterile and prevent leaking.
Dan iżomm Humalog Mix25 sterili u jipprevjeni l- ħruġ.
Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Humalog Mix25 comes out of the needle.
Qabel kull injezzjoni, isselezzjona 1 jew 2 unitajiet u agħfas il - mekkaniżmu ta 'l- injezzjoni bil- pinna tipponta' l fuq sakemm toħroġ qattra ta 'Humalog Mix25 mill- labra.
You can see how much Humalog is left by looking at the gauge on the side of the cartridge.
Tista 'tara hemm baqa' Humalog Mix25 billi tħares lejn il- gejġ fuq il- ġenb ta 'l - iskartoċċ.
The distance between each mark on the gauge is about 20 units.
Id- distanza bejn kull marka fuq il- gejġ hija ta 'madwar 20 unità.
If there is not enough for your dose, change the cartridge.
Jekk m’ hemmx biżżejjed għad- doża tiegħek, biddel l- iskartoċċ.
Do not mix any other insulin in a Humalog Mix25 cartridge.
Tħallatx xi insulina oħra fi skartoċċ ta ’ Humalog Mix25.
This will often get you over mild
Imbagħad kul il- frott, gallettini, jew sandwiċċ, kif qallek it- tabib tiegħek u strieħ ftit.
211 hypoglycaemia or a minor insulin overdose.
B' hekk ħafna mid- drabi jirnexxilek tirkupra minn effetti ta ’ ftit zokkor baxx fid- demm jew minn doża eċċessiva ħafifa ta ’ insulina.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”). • Always keep spare syringes and a spare vial of Humalog Mix25, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
221 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
This can be caused if: • you take too much Humalog Mix25 or other insulin; • you miss or delay meals or change your diet; • you exercise or work too hard just before or after a meal; • you have an infection or illness (especially diarrhoea or vomiting); • there is a change in your need for insulin; or • you have trouble with your kidneys or liver which gets worse.
• Tieħu wisq Humalog Mix25 jew insulina oħra; • Ma tiekolx jew tiekol tard jew jekk tbiddel id- dieta tiegħek; • Tagħmel wisq eżerċizzju jew taħdem iż- żejjed eżatt qabel jew wara ikla; • Għandek infezzjoni jew mard (speċjalment dijarrea jew remettar); • Hemm bidla fil- bżonn tiegħek ta 'l- insulina; jew • Għandek problemi bil- kliewi jew bil- fwied li qed isiru agħar
212 The first symptoms of low blood sugar usually come on quickly and include the following: •
L- ewwel sintomi ta 'zokkor baxx fid- demm issoltu jiġru malajr u jinkludu dawn li ġejjin:
cold sweat
Uġigħ ta 'ras
Keep the product in use at room temperature (below 30°C) for up to 28 days.
Żomm il- prodott li ħa tuża f' temperatura ambjentali ta 'ġewwa (taħt 30°C) għal użu sa 28 ġurnata.
Do not keep your pen or the cartridges you are using in the fridge.
Iżżomx il - pinna jew l- iskrataċ tiegħek li qed tuża fil- friġġ.
Do not put it near heat or in the sun.
Tħallihx ħdejn is- sħana jew fix- xemx.
Do not use Humalog Mix25, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.
Tużax Humalog 50 jekk jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb ta ’ l- iskartoċċ, u jidher qiesu ġelu.
What Humalog Mix25 100 U/ml suspension for injection in cartridge contains
X’ fih Humalog Mix25 100 u/ ml suspensjoni għal injezzjoni ġo skartoċċ:
It is a changed form of human insulin and so is different from other human and animal insulins.
Hija forma mibdula ta 'insulina umana u għalhekk hija 223 differenti minn insulini oħra umani jew insulina mill- annimali.
What Humalog Mix25 100 U/ml suspension for injection in cartridge looks like and contents of the pack Humalog Mix25 100 U/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 U/ml) suspension for injection.
Humalog Mix25 100 U/ ml, suspensjoni għal injezzjoni, hu suspensjoni abjad u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) suspensjoni għal injezzjoni.
The cartridges come in packs of 5 cartridges or a multipack of 2 x 5 cartridges.
L- iskrataċ jiġu f’ pakketti ta ’ 5 skrataċ jew f’ pakkett multiplu ta ’ 2 x 5 skrataċ.
Marketing Authorisation Holder and Manufacturer Humalog Mix25 100 U/ml suspension for injection in cartridge is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Eli Lilly Italia S.p.A., Via A.
Humalog Mix25 100 U/ ml, suspensjoni għal injezzjoni ġo skartoċċ huwa manifatturat minn:: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Eli Lilly Italia S. p. A., Via A.
214 For any information about this medicinal product, 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:
Belgique/België/Belgien Eli Lilly Benelux S.A.
224 Belgique/ België/ Belgien Eli Lilly Benelux S. A.
Tel: + 36 1 328 5100
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
216 PACKAGE LEAFLET:
225 FULJETT TA ’ TAGĦRIF:
Humalog Mix50 100 U/ml suspension for injection in vial (insulin lispro)
Humalog Mix50 100U/ ml, suspensjoni għall- injezzjoni ġo kunjett (insulina lispro)
What Humalog Mix50 is and what it is used for 2.
X’ inhu Humalog Mix50 u għalxiex jintuża 2.
Before you use Humalog Mix50 3.
Qabel ma tuża Humalog Mix50 3.
How to use Humalog Mix50 4.
Kif għandek tuża Humalog Mix50 4.
How to store Humalog Mix50 6.
Kif taħżen Humalog Mix50 6.
WHAT HUMALOG MIX50 IS AND WHAT IT IS USED FOR
X’ INHU HUMALOG MIX50 U GĦALXIEX JINTUŻA
Humalog Mix50 is a premixed suspension.
Humalog Mix50 hija użata biex id- dijabete tiġi trattata Hija suspensjoni mħallta lesta..
50% of the insulin lispro in Humalog Mix50 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly.
50% ta 'l- insulina lispro fi Humalog Mix50 hija maħlula fl- ilma u taħdem aktar malajr minn insulina umana normali għax il- molekula ta' l- insulina ġiet mibdula ftit.
50% of the insulin lispro in Humalog Mix50 is available in a suspension together with protamine sulphate, so that its action is prolonged.
50% ta 'l- insulina lispro fi Humalog Mix50 hija suspensjoni flimkien ma' protamine sulphate, ħalli l - azzjoni tagħha tkun mtawwla.
Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the long term.
Humalog Mix50 huwa sostitwent għall- insulina tiegħek u huwa użat biex jikkontrolla l- glukożju fuq medda twila ta ’ żmien.
Humalog Mix50 works very quickly and longer than soluble insulin.
Humalog Mix50 jaħdem malajr ħafna u għal tul ta ’ żmien itwal mill- insulina li tinħall.