qanastek/EMEA-V3 huggingface dataset:
The physician should be consulted when using other medications in addition to Humalog BASAL.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog Mix50.
4.6 Pregnancy and lactation
50 4. 6 Tqala u Treddigħ
Insulin requirements usually fall during the first trimester and
Il- ħtiġijiet ta 'l- insulina normalment jonqsu waqt l- ewwel tlett xhur u jiżdiedu waqt it- tieni u t- tielet tlett xhur.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
51 Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
48 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
It- teħid sostenut ta 'karboidrati u l- osservazzjoni jistgħu jkunu neċessarji minħabba li zokkor baxx fid - demm jista' jerġa jseħħ wara li l- pazjent ikun jidher li rkupra klinikament.
Intermediate acting human insulin analogue.
Analogu ta ’ insulina umana li ddum taħdem għal ħin intermedju.
Humalog BASAL has a prolonged absorption profile, achieving a maximum insulin concentration approximately 6 hours after dosing.
Humalog BASAL għandu profil ta ’ assorbiment prolongata, u jikseb il- konċentrazzjoni massima ta ’ insulina bejn wieħed u ieħor 6 siegħat wara d- doża.
When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves.
Meta tiġi kkunsidrata r- relevanza klinika ta 'dawn il- kinetiċi, huwa aktar xieraq li jiġu eżaminati l- kurvi dwar l- użu ta ’ glucose (kif diskuss f' 5. 1).
5.3 Preclinical safety data
52 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Protamine sulphate m-cresol [1.76 mg/ ml] Phenol [0.80 mg/ ml] 49 Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0 – 7.8.
Protamine sulphate m- cresol [1. 76 mg/ ml] Phenol [0. 80 mg/ ml] Glycerol Dibasic sodium phosphate. 7H2O Zinc oxide Ilma għall- injezzjonijiet Hydrochloric acid u sodium hydroxide jistgħu jintużaw biex jaġġustaw il- pH għal 7. 0 - 7. 8.
Mixing Humalog BASAL with insulins other than Humalog has not been studied.
It- taħlit ta ’ Humalog BASAL ma ’ insulini oħra għadu ma ġiex studjat.
This medicinal product must not be mixed with other medicinal products than Humalog.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra.
After insertion of the cartridge in a pen, the suspension should be used in 21 days when stored below 30°C.
Wara li ddaħħal l- iskartoċċ fil- pinna, is- suspensjoni għandha tintuża fi żmien 21 ġurnata, meta tinħażen f' temperatura taħt 30°C.
Not all packs may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali
5 x 3 ml Humalog BASAL cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog BASAL cartridges for a 3 ml pen
2 x (5 x 3 ml) skrataċ ta ’ Humalog BASAL għal pinna ta ’ 3 ml.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li ghandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Instructions for use and handling Humalog BASAL cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
53 Istruzzjonijiet għall- użu u mmaniġġar L- iskrataċ ta ’ Humalog BASAL għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
Cartridges containing Humalog BASAL should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
Skrataċ li fihom Humalog BASAL għandhom ikunu mdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet immedjatament qabel ma jintużaw sabiex l- insulina terġa ’ ssir suspensjoni u tidher imċajpra jew qiesa ħalib b’ mod uniformi.
If not, repeat the above procedure until contents are mixed.
Jekk le, irrepeti din il- proċedura sakemm il- kontenut jitħallat.
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 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 tal- kunjett, u jidher qiesu ġelu.
Humalog BASAL cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- iskrataċ ta ’ Humalog BASAL mhumiex iddisinjati biex tkun tista ’ tħallat insulini oħra fl- iskartoċċ.
Cartridges are not designed to be refilled.
L- iskrataċ mhumiex iddisinjati biex jerġgħu jintmlew.
50 The following is a general description.
Din li ġejja hija deskrizzjoni ġenerali.
The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
Għandek timxi skond l- istruzzjonijiet tal- manifattur li hemm ma ’ kull pinna biex timla l- iskartoċċ, twaħħal il- labra u tagħti l- injezzjoni ta ’ l- insulina.
Clean the skin as instructed.
Naddaf il- ġilda kif qalulek.
Using the outer needle cap, unscrew the needle and dispose of it safely.
Bl- użu tal- għatu ta ’ barra tal- labra, ħoll il- labra u armiha b’ mod li ma tkunx ta ’ periklu.
5 x 3 ml Humalog BASAL cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog BASAL cartridges for a 3 ml pen
5 x 3 ml skrataċ Humalog BASAL għal pinna ta ’ 3ml 2 x (5 x 3 ml) skrataċ ta ’ Humalog BASAL għal pinna ta ’ 3ml
Humalog Pen 100 U/ ml, solution for injection
Pinna Humalog 100 U/ ml, soluzzjoni għall- injezzjoni
Humalog Pen is a sterile, clear, colourless, aqueous solution.
Pinna Humalog huwa soluzzjoni akweja sterili, ċara u bla kulur.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Għall- kura ta 'adulti u tfal li għandhom id- dijabete mellitus li għandhom bżonn l- insulina għall - manteniment omeostatiku ta' livelli normali ta ’ glucose.
Humalog Pen is also indicated for the initial stabilisation of diabetes mellitus.
Humalog huwa ukoll indikat għall - istabbilizzazzjoni fil- bidu tad- dijabete mellitus.
If necessary, Humalog may also be administered intravenously, for example; for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Jekk hemm bżonn, Humalog jista 'ukoll jingħata ġol- vina, per eżempju; għall- kontroll tal- livelli ta ’ glucose fid- demm waqt ketoaċidożi, mard akut jew waqt perijodi ta' waqt operazzjoni jew wara.
When administered subcutaneously care should be taken when injecting Humalog Pen to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Pinna Humalog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
Humalog Pen takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Pinna Humalog jaġixxi malajr u għandu żmien t' attività aktar qasira (2 sa 5 sigħat) meta jingħata taħt il- ġilda meta mqabbel ma 'insulina regolari.
As with all insulin preparations, the duration of action of Humalog Pen is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħal b' kull preparazzjonijiet ta 'l- insulina, iż- żmien ta' kemm iddum l- azzjoni ta 'Pinna Humalog jiddependi fuq id- doża, is- sit ta' l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
Humalog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
56 Humalog jista 'jintuża flimkien ma' insulina umana li ddum taħdem għal ħin itwal jew sustanzi sulphonylurea li jittieħdu mill- ħalq, fuq il- parir ta 'tabib.
52 Use of Humalog in an insulin infusion pump:
Użu ta 'Humalog ġo pompa ta' l- infużjoni ta 'l- insulina
For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/ fasting glucose control.
Fil- każ ta ’ insulini li jaġixxu malajr, kull pazjent li qiegħed ukoll fuq insulina bażilari irid isib l- aħjar doża possibbli għaż - żewġ insulini biex il- livelli tal- glucose jiġu kkontrollati matul il- gurnata kollha, speċjalment il- kontroll ta ’ glucose billejl/ wara s- sawm.
Insulin requirements may be reduced in the presence of renal impairment.
57 Il- ħtiġijiet ta 'l- insulina jistgħu jonqsu meta jkun hemm indeboliment tal- kliewi.
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements
Il- ħtiġijiet ta 'l - insulina jistgħu jitnaqqsu f' pazjenti b’ indeboliment tal- fwied minħabba l- kapaċità mnaqqsa għal glukoneoġeneżi u metaboliżmu mnaqqas ta' l- insulina; madankollu, f' pazjenti b’ indeboliment kroniku tal- fwied, żjieda fir- reżistenza għall- insulina tista 'twassal għall- ħtiġijiet miżjuda ta' l- insulina.
53 Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Tista 'ukoll tkun neċessarja varjazzjoni fid- doża jekk il- pazjenti jagħmlu aktar attività fiżika jew jekk ibiddlu d- dieta tagħhom tas- soltu.
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Il- ħtiġijiet għall- insulina jistgħu jonqsu fil- preżenza ta 'sustanzi b' attività li tbaxxi z- zokkor fid- demm, bħal ma huma l- mediċini orali li jbaxxu z- zokkor fid- demm, salicylates (per eżempju, acetyl salicylic acid), antibijotiċi sulpha, ċerti antidipressanti, (impedituri ta ’ monoamine oxidase), ċerti impedituri t' enżimi li jibdlu l- anġjotensina (captopril, enalapril), sustanzi li jibblokkjaw ir- riċetturi anġjotensin II l- imblokkaturi tat- tip beta, octreotide jew l- alkoħol.
The physician should be consulted when using other medications in addition to Humalog Pen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog.
4.8 Undesirable effects
58 4. 8 Effetti mhux mixtieqa
It may cause a rash over the whole
L- allerġija sistemika, li hi rari (1/ 10, 000 sa < 1/ 1, 000), iżda li tista 'tkun aktar serja, hija allerġija ġeneralizzata għall- insulina.
54 body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.
Tista 'tikkawża raxx mal- ġisem kollu, qtugħ ta' nifs, tħarħir, tnaqqis fil- pressjoni tad - demm, polz mgħaġġel, jew ħafba għaraq.
Fast-acting human insulin analogue, ATC code:
Analogu ta 'l- insulina umana li ddum taħdem.
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.
Fit- tessut tal- muskolu dan jinkludi ż- żieda fil- glycogen, aċidi grassi, il- formazzjoni tal - glycerol u l- proteini u l- ġbir ta 'ammino aċidi, fil- waqt li jkun hemm tnaqqis fit- tkissir tal- glycogen, il -
55 Insulin lispro Humulin R Hypoglycemic Activity
Humulin R Attività ta ’ Hypoglycaemic zokkor baxx fid - Activity demm
Time (Hours) The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv ta ’ glucose maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha ta ’ glucose fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu ta ’ glucose maż- żmien.
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in lower glycosylated haemoglobin levels compared to soluble insulin.
Meta użat bil- pompi ta 'l- infużjoni taħt il- ġilda, il- kura bl- insulina lispro wriet li tirriżulta f' livell ta' l - emoglobina glycosylated inqas imqabbel ma 'l- insulina li tinħall.
The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.
Differenzi glukodinamiċi bejn l- insulina lispro u l- insulina umana li tinħall, kif
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function.
60 imkejla waqt proċedura fejn il- livell ta ’ glucose fid- demm inżamm kostanti, dawn inżammu fuq firxa wiesa ta 'funzjoni tal- kliewi.
When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).
Meta tiġi kkunsidrata r- relevanza klinika ta 'dawn il- kinetiċi, huwa aktar xieraq li jiġu eżaminati l- kurvi dwar l- użu ta ’ glucose (kif diskuss f' 5. 1).
Insulin lispro maintains more rapid 56 absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
L- insulina lispro żżomm aktar assorbiment rapidu u eliminazzjoni rapida meta mqabbla ma 'l- insulina umana li tinħall f' pazjenti li għandhom indeboliment tal- fwied.
After first use of the pen, the solution should be used within 28 days, when stored below 30°C.
Wara l- ewwel użu tal- pinna, is- soluzzjoni għandha tintuża fi żmien 28 ġurnata, meta tinħażen f' temperatura taħt 30°C.
6.4 Special precautions for storage
61 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not expose to excessive heat or direct sunlight.
Tagħmlux fil- friża. Tesponix għall- sħana eċċessiva jew f' dawl dirett tax - xemx.
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and are secured with aluminium seals.
Is- soluzzjoni tiġi fi skrataċ tal- ħġieġ taż- żnied tat- tip I, siġillati b' diski tas- siġill u rjus tal- planġer ta ’ butyl jew halobutyl u miżmuma f' posthom permezz ta 'siġill ta' l- aluminju.
Dimeticone or silicone emulsion may be used to treat the cartridge plunger, and/ or the glass cartridge.
Tista ’ tintuża emulsjoni ta ’ dimethicone jew silicone biex jiġu trattati l- planġer ta ’ l- iskartoċċ, u/ jew l- iskartoċċ tal- ħġieġ.
The 3 ml cartridges are sealed in a disposable pen injector.
L - iskrataċ ta ’ 3ml huma siġillati f’ pinna mimlija lesta u li tintrema wara l- użu, u li tintuża biex tinjetta biha.
Needles are not included.
Il- labar mhumiex mogħtija.
5 x 3 ml Pens 2 x (5 x 3 ml) Pens
5 x 3ml Pinen 2 x (5 x 3 ml) Pinen
Instructions for use and handling
Istruzzjonijiet għall- użu u mmaniġġar a) Preparazzjoni ta 'doża
Inspect the Humalog Pen solution.
Eżamina s- soluzzjoni ta 'Pinna Humalog.
Do not use Humalog Pen if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Tużax Pinna Humalog jekk jidher imċajpar, magħqud, jew ftit ikkulurit jew jekk jidhru partiċelli solidi.
Put on the needle.
Qiegħed il- labra.
Wipe the rubber seal with alcohol.
Imsaħ is- siġill bl- alkoħol.
Remove the paper tab from the capped needle.
Neħħi il- karta minn fuq il- labra b’ kappa.
Screw the capped needle clockwise onto the pen until it is tight.
Dawwar il- labra b’ kappa fuq il - pinna lejn ix- xellug sakemm tkun issikkata.
Hold the pen with needle pointing up and remove the outer needle cap and inner needle cover.
Żomm il- pinna bil- labra tipponta 'l fuq u neħħi l- kappa ta' barra tal- labra u l- kappa ta 'ġewwa tal- labra.
Priming the Pen (check Insulin Flow).
Tħejjija għall- użu tal- pinna (eżamina l- ħruġ ta 'l- insulina)
(a) The arrow should be visible in the dose window.
(a) Il- vleġġa għandha tidher fit- tieqa li turi d- doża.
If the arrow is not present, turn the dose knob clockwise until the arrow appears and notch is felt or visually aligned.
Jekk m’ hemmx il- vleġġa, dawwar il- buttuna tad- doża lejn ix- xellug sakemm tidher il- vleġġa u jinħass skoss jew tidher dritta.
(b) Pull dose knob out (in direction of the arrow) until a “ 0” appears in the dose window.
(b) Iġbed il- buttuna tad- doża 'l barra (fid- direzzjoni tal- vleġġa) sakemm jidher "0" fit- tieqa tad - doża.
A dose cannot be dialled until the dose knob is pulled out.
Doża ma tistax tkun ikkalibbrata sakemm il- buttuna tad- doża tinġibed 'l barra.
(c) Turn dose knob clockwise until a “ 2” appears in the dose window.
(ċ) Dawwar il- buttuna tad- doża lejn ix- xellug sakemm jidher "2" fit- tieqa tad- doża.
(d) Hold the pen with needle pointing up and tap the clear cartridge holder gently with your finger so any air bubbles collect near the top.
(d) Żomm il- pinna bil- labra tipponta 'l fuq u taptap bil- mod fuq il- kontenitur trasparenti ta' l - iskartoċċ b' subgħajk ħalli jinġabru xi bżieżaq ta 'l- arja fil- wiċċ.
Depress the injection button fully until you feel or hear a click.
Għafas kompletament il- buttuna ta 'l - injezzjoni sakemm tħoss jew tisma klikk.
You should see a drop of insulin at the tip of the needle.
Għandek tara qattra ta 'l- insulina fuq il- ponta tal- labra.
If insulin does not appear, repeat the procedure until insulin appears.
Jekk l- insulina ma tidhirx, irrepeti l- proċedura sakemm tidher l- insulina.
(e) Always prime the pen (check the insulin flow) before each injection.
(e) Dejjem ipprajmja il- pinna (eżamina l- ħruġ ta 'l- insulina) qabel kull injezzjoni.
Failure to prime the pen may result in an inaccurate dose.
Jekk ma tipprajmjax il- pinna tista 'tirriżulta f' doża mhux eżatta.
Setting the Dose.
L- issettjar tad- doża
(a) Turn the dose knob clockwise until the arrow appears in the dose window and a notch is felt or visually aligned.
62 (a) Dawwar il- buttuna tad- doża lejn ix- xellug sakemm tidher vleġġa fit- tieqa tad- doża u jinħass skoss jew tidher dritta.
(b) Pull the dose knob out (in the direction of the arrow) until a “ 0” appears in the dose window.
(b) Iġbed il- buttuna tad- doża 'l barra (fid- direzzjoni tal- vleġġa) sakemm jidher "0" fit- tieqa tad - doża.
A dose cannot be dialled until the dose knob is pulled out.
Id- doża ma tistax tkun ikkalibbrata sakemm il- buttuna tad- doża jinġibed 'l barra.
(c) Turn the dose knob clockwise until the dose appears in the dose window.
(ċ) Dawwar il- buttuna tad- doża lejn ix- xellug sakemm id- doża tidher fit- tieqa tad- doża.
If too high a dose is dialled, turn the dose knob backward (anti-clockwise) until the correct dose appears in the window.
Jekk tkun ikkalibbrata doża wisq għolja, dawwar il- buttuna tad- doża lura (lejn il- lemin) sakemm tidher id- doża t - tajba fit- tieqa.
A dose greater than the number of units remaining in the cartridge cannot be dialed.
Doża akbar minn- numru t' unitajiet li tibqa 'fl- iskartoċċ ma tistax tkun ikkalibbrata.
(b) Injecting a dose
b) Injezzjoni ta 'doża
Press the injection button down with the thumb (until you hear or feel a click); wait 5 seconds.
Agħfas il- buttuna b’ subgħajk il- kbir (sakemm tisma jew tħoss klikk); stenna għal ħames sekondi.
Immediately after an injection, use the outer needle cap to unscrew the needle.
Immedjatament wara l- injezzjoni, uża l- kappa ta 'barra tal- labra biex tħoll il- labra.
Remove the needle from the pen.
Neħħi l- labra mill- pinna.
This will ensure sterility, and prevent leakage, reentry of air, and potential needle clogs.
Dan jassigura sterilità u jipprevjeni taqtir, li terġa tidħol l- arja, u l- potenzjal li tinstadd il- labra.
Do not reuse the needle.
Terġax tuża l- labra.
Dispose of the needle in a responsible manner.
Armi l- labra b' mod risponsabbli.
Needles and pens must not be shared.
Il- labar u l- pinen m' għandhomx jintużaw minn nies oħra.
The prefilled pen can be used until it is empty.
Il- pinna mimlija lesta tista 'tintuża sakemm tiżvojta.
Please properly discard or recycle.
Jekk jogħġbok armi kif suppost jew irriċiklaha.
Replace the cap on the pen.
Poġġi l- kappa lura fuq il- pinna.
The injection button should be fully depressed before using the pen again.
Il- buttuna ta ’ l- injezzjoni għandha tkun imniżżla totalment qabel ma terġa tuża l- pinna.
(c) Mixing insulins
c) Taħlit ta 'insulini
EU/ 1/ 96/ 007/ 015 EU/ 1/ 96/ 007/ 026
EU/ 1/ 96/ 007/ 015 5 x 3 Pinen EU/ 1/ 96/ 007/ 026 2 x (5 x 3 ml) Pinen
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L- AWTORIZZAZZJONI
Humalog Mix25 100 U/ ml Pen, suspension for injection
Pinna Humalog Mix25 100 U/ ml, suspensjoni għall- injezzjoni
Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Humalog Mix25 tikkonsisti fi 25% insulina lispro u 75% suspensjoni ta ’ insulina lispro protamine.
Humalog Mix25 is a white, sterile suspension
Humalog Mix25 huwa suspensjoni bajda u sterili.
60 Hypoglycaemia.
65 Ipogliċemija
4.6 Pregnancy and lactation
66 4. 6 Tqala u Treddigħ
61 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Huwa essenzjali li jinżamm kontroll tajjeb tal- pazjenti kkurati bl- insulina (dawk li jiddependu fuq l - insulina jew id- dijabete ta 'waqt it- tqala) matul it- tqala.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
67 Il- korrezzjoni ta 'zokkor baxx fid- demm moderatament severa tista' tinkiseb b' għoti tal- glucagon intramuskolari jew taħt il- ġilda, segwita minn karboidrat orali meta l- pazjent jirkupra biżżejjed.
However, glucose solution must be given intravenously if glucagon is not available or if the patient
Madankollu, it- taħlita liwida tal- glukożju għandha tingħata ġol- vina jekk il- glukagon mhux disponibbli jew jekk il- pazjent ma jirrispondix għall- glucagon.
Humalog Mix25 is a premixed suspension consisting of insulin lispro (fast-acting human insulin analogue) and insulin lispro protamine suspension (intermediate acting human insulin analogue).
Humalog Mix25 huwa suspensjoni mħallta lesta li tikkonsisti f’ insulina lispro (analogu ta ’ l- insulina umana li jaġixxi malajr).
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with Humalog Mix25 compared to human insulin mixture 30/ 70.
Provi kliniċi f' pazjenti bid- dijabete tat- tip 1 u tat- tip 2 urew tnaqqis fiz- zokkor baxx fid- demm ta 'wara l- ikel b’ Humalog Mix25 mqabbla ma' taħlita 30/ 70 ta ’ insulina umana.
Hypoglycaemic activity Humalog Mix25 Humalog Basal
68 Attività ipogliċemika
63 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv ta ’ glucose maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha ta ’ glucose fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu ta ’ glucose maż- żmien.
(mean at baseline = 8.7%)
(medja fil- linja bażi = 8. 7%) (medja fil- linja bażi = 8. 5%) Tnaqqis fil- medja ta ’ glucose fid- demm sagħtejn wara l- ikla ta ’ filgħodu / 1 filgħaxija flimkien
(mean at baseline = 8.5%)
3. 46
3.46 mM
mM
0.55 mM
mM
The pharmacokinetics of Humalog Mix25 are representative of the individual pharmacokinetic properties of the two components.
Il- farmakokinetiċi ta ’ Humalog Mix25 jirreflettu l- propjetajiet farmakokinetiċi taż - żewġ komponenti.
Protamine sulphate m-cresol [1.76 mg/ ml] Phenol [0.80 mg/ ml] Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0 – 7.8.
Protamine sulphate m- cresol [1. 76 mg/ ml] Phenol [. 080 mg/ ml] Glycerol Dibasic sodium phosphate. 7H2O Zinc oxide Ilma għall- injezzjonijiet Hydrochloric acid u sodium hydroxide jistgħu jintużaw biex jaġġustaw il- pH għal 7. 0 - 7. 8.
After first use of the pen, the suspension should be used within 28 days, when stored below 30°C.
Wara l- ewwel użu tal- pinna, is- suspensjoni għandha tintuża fi żmien 28 ġurnata, meta tinħażen f' temperatura taħt 30°C.
Do not expose to excessive heat or direct sunlight.
Ġaladarba jkunu fl- użu, l- iskrataċ jistgħu jintużaw sa 21 ġurnata.
6.5 Nature and contents of container
70 6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
The suspension is contained in type I flint glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals.
Is- suspensjoni tiġi fi skrataċ tal- ħġieġ taż- żnied tat- tip I, siġillati b' diski tas- siġill u rjus tal- planġer ta ’ butyl jew halobutyl u miżmuma f' posthom permezz ta 'siġill ta' l- aluminju.
Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/ or the glass cartridge.
Tista ’ tintuża emulsjoni ta ’ dimethicone jew silicone biex jiġu trattati l- planġer ta ’ l- iskartoċċ, u/ jew l- iskartoċċ tal- ħġieġ.
The 3 ml cartridges are sealed in a disposable pen injector, called the “ Pen”.
L - iskrataċ ta ’ 3ml huma siġillati f’ pinna mimlija lesta u li tintrema wara l- użu, u li tintuża biex tinjetta biha, u li tissejjaħ “ Pinna ”.
2 x (5 x 3 ml) Humalog Mix25 100 U/ ml Pens.
5 x 3ml Pinen Humalog Mix25 100 U/ ml 2 x (5 x 3 ml) Pinen Humalog Mix25 100 U/ ml
Instructions for use and handling a) Preparing a dose
Istruzzjonijiet għall- użu u mmaniġġar a) Preparazzjoni ta 'doża
Inspect the Humalog Mix25 100 U/ ml Pen.
Eżamina s- soluzzjoni ta 'Pinna Humalog Mix25 100 U/ ml.
The Pen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
Il- Pinna għandha tkun imdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet immedjatamnet qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
65 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 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 il- ġenb tal- kunjett, u jidher qiesu ġelu.
Priming Pen (check insulin flow).
L- ipprajmar tal- pinna (eżamina l- ħruġ ta 'l- insulina)
(a) Turn the dose knob clockwise until the arrow appears in the dose window and a notch is felt or visually aligned.
71 (a) Dawwar il- buttuna tad- doża lejn ix- xellug sakemm tidher vleġġa fit- tieqa tad- doża u jinħass skoss jew tidher dritta.
A dose greater than the number of units remaining in the cartridge cannot be dialled.
Doża akbar minn- numru t' unitajiet li tibqa 'fl- iskartoċċ ma tistax tkun ikkalibbrata.
This will ensure sterility, and prevent leakage, re-entry of air, and potential needle clogs.
Dan jassigura sterilità u jipprevjeni taqtir, li terġa tidħol l- arja, u l- potenzjal li tinstadd il- labra.
The pre-filled pen can be used until it is empty.
Il- pinna mimlija lesta tista 'tintuża sakemm tiżvojta.
EU/ 1/ 96/ 007/ 016 EU/ 1/ 96/ 007/ 027
EU/ 1/ 96/ 007/ 016 5 x 3ml Pinen Humalog Mix25 100 U/ ml EU/ 1/ 96/ 007/ 027 2 x (5 x 3 ml) Pinen Humalog Mix25 100 U/ ml
Humalog Mix50 100 U/ ml Pen, suspension for injection
Pinna Humalog Mix50 100 U/ ml, suspensjoni għall- injezzjoni
The duration of action of the insulin lispro protamine suspension (BASAL) component of Humalog Mix50 is similar to that of a basal insulin NPH.
Iż - żmien kemm idum jaħdem il- komponent protamine tas- suspensjoni ta ’ insulina lispro (BASAL) ta ’ Humalog Mix50 huwa simili għall- insulina bażi (NPH).
68 Hypoglycaemia.
74 Ipogliċemija.
4.6 Pregnancy and lactation
75 4. 6 Tqala u Treddigħ
69 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Huwa essenzjali li jinżamm kontroll tajjeb tal- pazjenti kkurati bl- insulina (dawk li jiddependu fuq l - insulina jew id- dijabete ta 'waqt it- tqala) matul it- tqala.
Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.
Is - sorveljanza bir- reqqa tal- kontroll ta ’ glucose, kif ukoll tas- saħħa ġenerali, huwa essenzjali f' pazjenti tqal li għandhom id- dijabete.
Hypoglycaemia may occur as a result of an excess of insulin acitivity relative to food intake and energy expenditure.
Iz- zokkor baxx fid- demm jista 'jiġri bħala riżultat t' attività eċċessiva ta' l- insulina relatata mat- teħid ta 'l- ikel u l- ħela ta' enerġija.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
76 Il- korrezzjoni ta 'zokkor baxx fid- demm moderatament severa tista' tinkiseb b' għoti tal- glucagon intramuskolari jew taħt il- ġilda, segwita minn karboidrat orali meta l- pazjent jirkupra biżżejjed.
Time, hours
77 Ħin, sigħat
The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv ta ’ glucose maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha ta ’ glucose fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu ta ’ glucose maż- żmien.
71 The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.
Ir- rispons glukodinamiku għall- insulina lispro m' huwiex affettwat b’ indeboliment fil- funzjoni tal - kliewi jew tal- fwied.
The pharmacokinetics of Humalog Mix50 are representative of the individual pharmacokinetic properties of the two components.
Il- farmakokinetiċi ta ’ Humalog Mix50 jirreflettu l- propjetajiet farmakokinetiċi taż - żewġ komponenti.
6.2 Incompatibilities
78 6. 2 Inkompatibilitajiet
72 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
5 x 3 ml Humalog Mix50 100 U/ ml Pens 2 x (5 x 3 ml) Humalog Mix50 100 U/ ml Pens.
5 x 3ml Pinen Humalog Mix50 100 U/ ml 2 x (5 x 3 ml) Pinen Humalog Mix50 100 U/ ml
The Pen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
Eżamina l- Pinna Humalog Mix50 Il- Pinna għandha tkun imdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet immedjatamnet qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
Priming Pen (check insulin flow)
L- ipprajmar tal- pinna (eżamina l- ħruġ ta 'l- insulina)
(a) The arrow should be visible in the dose window.
79 (a) Il- vleġġa għandha tidher fit- tieqa li turi d- doża.
73 (e) Always prime the pen (check the insulin flow) before each injection.
(e) Dejjem ipprajmja il- pinna (eżamina l- ħruġ ta 'l- insulina) qabel kull injezzjoni.
(a) Turn the dose knob clockwise until the arrow appears in the dose window and a notch is felt or visually aligned.
(a) Dawwar il- buttuna tad- doża lejn ix- xellug sakemm tidher vleġġa fit- tieqa tad- doża u jinħass skoss jew tidher dritta.
EU/ 1/ 96/ 007/ 017 EU/ 1/ 96/ 007/ 028
EU/ 1/ 96/ 007/ 017 5 x 3ml Pinen Humalog Mix50 100 U/ ml EU/ 1/ 96/ 007/ 028 2 x (5 x 3 ml) Pinen Humalog Mix50 100 U/ ml
75 1.
81 1.
Humalog BASAL 100 U/ ml Pen, suspension for injection
Pinna Humalog BASAL 100 U/ ml, suspensjoni għall- injezzjoni
Humalog BASAL can be given in conjunction with Humalog.
Humalog BASAL jista 'jingħata flimkien ma ’ Humalog.
Hypoglycaemia.
Ipoglicemija.
4.4 Special warnings and precautions for use 76 Under no circumstances should Humalog BASAL be given intravenously.
Humalog BASAL m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
Mixing Humalog BASAL with insulins other than Humalog has not been studied.
It- taħlit ta ’ Humalog BASAL ma ’ insulini oħra ħlief Humalog għadu ma ġiex studjat.
The physician should be consulted when using other medications in addition to Humalog BASAL 100 U/ ml Pen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Pinna Humalog BASAL 100 U/ ml.
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
83 4. 6 Tqala u Treddigħ Data fuq numru kbir ta 'każijiet tat- tqala esposti ma tindikax xi effetti avversi ta' l- insulina lispro fuq it- tqala jew fuq is- saħħa tal- fetu/ it- tarbija tat- twelid.
77 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Huwa essenzjali li jinżamm kontroll tajjeb tal- pazjenti kkurati bl- insulina (dawk li jiddependu fuq l - insulina jew id- dijabete ta 'waqt it- tqala) matul it- tqala.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
84 Il- korrezzjoni ta 'zokkor baxx fid- demm moderatament severa tista' tinkiseb b' għoti tal- glucagon intramuskolari jew taħt il- ġilda, segwita minn karboidrat orali meta l- pazjent jirkupra biżżejjed.
78 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
It- teħid sostenut ta 'karboidrati u l- osservazzjoni jistgħu jkunu neċessarji minħabba li zokkor baxx fid - demm jista' jerġa jseħħ wara li l- pazjent ikun jidher li rkupra klinikament.
When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves properties.
Meta tiġi kkunsidrata r- relevanza klinika ta 'dawn il- kinetiċi, huwa aktar xieraq li jiġu eżaminati l- kurvi dwar l- użu ta ’ glucose (kif diskuss f' 5. 1).
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin.
85 lispro mar- riċetturi ta 'l- insulina, hija ekwivalenti ma' l- insulina umana.
Protamine sulphate m-cresol [1.76 mg/ ml] Phenol [0.80 mg/ ml] 79 Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0 – 7.8.
Protamine sulphate m- cresol [1. 76 mg/ ml] Phenol [0. 80 mg/ ml] Glycerol Dibasic sodium phosphate. 7H2O Zinc oxide Ilma għall- injezzjonijiet Hydrochloric acid u sodium hydroxide jistgħu jintużaw biex jaġġustaw il- pH għal 7. 0 - 7. 8.
This medicinal product must not be mixed with other medicinal products than Humalog.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra ħlief Humalog.
After first use of the pen, the suspension should be used within 21 days, when stored below 30°C.
Wara l- ewwel użu tal- pinna, is- suspensjoni għandha tintuża fi żmien 21 ġurnata, meta tinħażen f' temperatura taħt 30°C.
5 x 3 ml Humalog BASAL 100 U/ ml Pens 2 x (5 x 3 ml) Humalog BASAL 100 U/ ml Pens
5 x 3ml Pinen Humalog BASAL 100 U/ ml 2 x (5 x 3 ml) Pinen Humalog BASAL 100 U/ ml
Inspect the Humalog BASAL 100 U/ ml Pen.
Eżamina l- Pinna Humalog BASAL 100 U/ ml.
The Pen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
86 Il- Pinna għandha tkun imdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet immedjatamnet qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
Torokx is- sit.
5 x 3 ml Humalog BASAL Pen for a 3 ml pen 2 x (5 x 3 ml) Humalog BASAL Pen for a 3 ml pen
5 x 3ml Pinna Humalog BASAL għal pinna 3ml 2 x (5 x 3 ml) Pinna Humalog BASAL għal pinna 3ml
Humalog 100 U/ ml KwikPen, solution for injection
Humalog 100 U/ ml KwikPen, soluzzjoni għall- injezzjoni
Humalog KwikPen is a sterile, clear, colourless, aqueous solution.
Humalog KwikPen huwa soluzzjoni akweja, sterili, ċara u bla kulur.
Humalog KwikPen is also indicated for the initial stabilisation of diabetes mellitus.
Humalog KwikPen huwa wkoll indikat għall - istabbilizzazzjoni fil- bidu tad- dijabete mellitus.
When administered subcutaneously care should be taken when injecting Humalog KwikPen to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Humalog KwikPen ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
Patients must be educated to use the proper injection techniques.
Il- pazjenti għandhom ikunu mgħallma biex jużaw il- metodi xierqa ta 'l- injezzjoni.
Humalog KwikPen takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Humalog KwikPen jaġixxi malajr u għandu żmien t' attività aktar qasira (2 sa 5 sigħat) meta jingħata taħt il- ġilda meta mqabbel ma 'insulina regolari.
As with all insulin preparations, the duration of action of Humalog KwikPen is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħal b' kull preparazzjonijiet ta 'l- insulina, iż- żmien ta' kemm iddum l- azzjoni ta 'Humalog KwikPen jiddependi fuq id- doża, is- sit ta' l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
Humalog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
89 Humalog jista 'jintuża flimkien ma' insulina umana li ddum taħdem għal ħin itwal jew sustanzi sulphonylurea li jittieħdu mill- ħalq, fuq il- parir ta 'tabib.
83 Use of Humalog in an insulin infusion pump:
Użu ta 'Humalog ġo pompa ta' l- infużjoni ta 'l- insulina
Insulin requirements may be reduced in the presence of renal impairment.
90 Il- ħtiġijiet ta 'l- insulina jistgħu jonqsu meta jkun hemm indeboliment tal- kliewi.
84 Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Tista 'ukoll tkun neċessarja varjazzjoni fid- doża jekk il- pazjenti jagħmlu aktar attività fiżika jew jekk ibiddlu d- dieta tagħhom tas- soltu.
The physician should be consulted when using other medications in addition to Humalog KwikPen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog KwikPen.
4.8 Undesirable effects
91 4. 8 Effetti mhux mixtieqa
85 body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.
Tista 'tikkawża raxx mal- ġisem kollu, qtugħ ta' nifs, tħarħir, tnaqqis fil- pressjoni tad - demm, polz mgħaġġel, jew ħafba għaraq.
86 Insulin lispro Humulin R Hypoglycemic Activity
Humulin R Attività ta ’ Hypoglycaemic zokkor baxx fid - Activity demm
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function.
93 imkejla waqt proċedura fejn il- livell ta ’ glucose fid- demm inżamm kostanti, dawn inżammu fuq firxa wiesa ta 'funzjoni tal- kliewi.
Insulin lispro maintains more rapid 87 absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
L- insulina lispro żżomm aktar assorbiment rapidu u eliminazzjoni rapida meta mqabbla ma 'l- insulina umana li tinħall f' pazjenti li għandhom indeboliment tal- fwied.
6.4 Special precautions for storage
94 6. 4 Prekawzjonijiet speċjali għall- ħażna
The 3 ml cartridges are sealed in a disposable pen injector, called the “ KwikPen”.
L - iskrataċ ta ’ 3 ml huma siġillati f’ pinna li tintuża biex tinjetta biha u li tintrema wara l- użu u li tissejjaħ il - “ KwikPen ”.
Needles are not included.
Il- labar m’ humiex mogħtija.
5 x 3 ml Humalog 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog 100 U/ ml KwikPens
5 x 3ml Humalog 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog 100 U/ ml KwikPens
Instructions for use and handling
Istruzzjonijiet għall- użu u mmaniġġar
88 Inspect the Humalog solution.
Eżamina s- soluzzjoni ta 'Humalog.
a) Handling of the pre-filled pen Before using the KwikPen the user manual included in the package leaflet must be read carefully.
Qabel ma jintuża il- KwikPen, wieħed għandu jaqra sew il- manwal għall- użu li hemm fil- fuljett ta ’ tagħrif.
The KwikPen has to be used as recommended in the user manual.
Il- KwikPen għandu jiġi użat skond kif rakkomandat fil- manwal għall- użu.
b) Mixing insulins Do not mix insulin in vials with insulin in cartridges.
b) Taħlit ta 'insulini
5 x 3 ml Humalog 100 U/ ml KwikPen 2 x (5 x 3 ml) Humalog 100 U/ ml KwikPen
5 x 3 Humalog 100 U/ ml KwikPen 2 x (5 X 3 ml) Humalog 100 U/ ml KwikPen
89 1.
95 1.
Humalog Mix25 100 U/ ml KwikPen, suspension for injection
Humalog Mix25 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
90 Hypoglycaemia.
96 Ipogliċemija
The physician should be consulted when using other medications in addition to Humalog Mix25 KwikPen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog Mix25 KwikPen.
4.6 Pregnancy and lactation
97 4. 6 Tqala u Treddigħ
91 Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
Data fuq numru kbir ta 'każijiet tat- tqala esposti ma tindikax xi effetti avversi ta' l- insulina lispro fuq it- tqala jew fuq is- saħħa tal- fetu/ it- tarbija tat- twelid.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
98 Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
92 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Jekk il- pazjent huwa f' koma, il- glucagon għandu jkun mogħti fil- muskolu jew taħt il- ġilda.
Hypoglycaemic activity Humalog Mix25 Humalog Basal
99 Attività ipogliċemika
93 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv ta ’ glucose maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha ta ’ glucose fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu ta ’ glucose maż- żmien.
5.2 Pharmacokinetic properties
100 5. 2 Tagħrif farmakokinetiku
6.5 Nature and contents of container
101 6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
2 x (5 x 3 ml) Humalog Mix25 100 U/ ml KwikPens.
5 x 3ml Humalog Mix25 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix25 100 U/ ml KwikPens
Instructions for use and handling The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
Il- KwikPen għandu jkun imdawwar fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet immedjatamnet qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
95 Handling of the pre-filled pen Before using the KwikPen the user manual included in the package leaflet must be read carefully.
Qabel ma jintuża il- KwikPen, wieħed għandu jaqra sew il- manwal għall- użu li hemm fil- fuljett ta ’ tagħrif.
5 x 3 ml Humalog Mix25 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix25 100 U/ ml KwikPens
5 x 3ml Humalog Mix25 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix25 100 U/ ml KwikPens
Humalog Mix50 100 U/ ml KwikPen, suspension for injection
Humalog Mix50 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
97 Hypoglycaemia.
103 Ipogliċemija.
The physician should be consulted when using other medications in addition to Humalog Mix50 KwikPen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog Mix50 KwikPen.
4.6 Pregnancy and lactation
104 4. 6 Tqala u Treddigħ
98 Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
Data fuq numru kbir ta 'każijiet tat- tqala esposti ma tindikax xi effetti avversi ta' l- insulina lispro fuq it- tqala jew fuq is- saħħa tal- fetu/ it- tarbija tat- twelid.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
105 Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
99 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Jekk il- pazjent huwa f' koma, il- glucagon għandu jkun mogħti fil- muskolu jew taħt il- ġilda.
Humalog Mix50 Humalog Basal
106 Humalog Mix50 Humalog Basal
100 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv ta ’ glucose maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha ta ’ glucose fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu ta ’ glucose maż- żmien.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin.
107 lispro mar- riċetturi ta 'l- insulina, hija ekwivalenti ma' l- insulina umana.
101 Two years.
Sentejn.
The 3 ml cartridges are sealed in a disposable pen injector, called the “ KwikPen”.
L - iskrataċ ta ’ 3ml huma siġillati f’ pinna li tintuża biex tinjetta biha u li tintrema wara l- użu u li tissejjaħ “ KwikPen ”.
5 x 3 ml Humalog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix50 100 U/ ml KwikPens.
5 x 3ml Humalog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix50 100 U/ ml KwikPens
Instructions for use and handling The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
108 Il- KwikPen għandha tkun imdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet immedjatament qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
Handling of the pre-filled pen Before using the KwikPen the user manual included in the package leaflet must be read carefully.
Qabel ma jintuża il- KwikPen, wieħed għandu jaqra sew il- manwal għall- użu li hemm fil- fuljett ta ’ tagħrif.
5 x 3 ml Humalog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix50 100 U/ ml KwikPens
5 x 3ml Humalog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Pinen Humalog Mix50 100 U/ ml KwikPens
DATE OF REVISION OF THE TEXT 102 1.
DATA TA 'META ĠIET RIVEDUTA L- KITBA
Humalog BASAL 100 U/ ml KwikPen, suspension for injection
Humalog BASAL 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
4.4 Special warnings and precautions for use 103 Under no circumstances should Humalog BASAL be given intravenously.
Humalog BASAL m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
The physician should be consulted when using other medications in addition to Humalog BASAL 100 U/ ml KwikPen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog BASAL 100 U/ ml KwikPen.
4.6 Pregnancy and lactation
111 4. 6 Tqala u Treddigħ