qanastek/EMEA-V3 huggingface dataset:
Instructions for use and handling Liprolog Mix50 cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
Istruzzjonijiet għall- użu u mmaniġġar L- istoċċijiet ta ’ Liprolog Mix50 għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
a) Preparing a dose
32 a) Preparazzjoni ta 'doża
Cartridges containing Liprolog Mix50 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.
Stoċċijiet li fihom Liprolog Mix50 għandhom ikunu mdawra 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.
Cartridges contain a small glass bead to assist mixing.
L- istoċċijiet fihom żibġa żgħira tal- ħġieġ biex tassisti fit- taħlit.
Liprolog Mix50 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- istoċċijiet ta ’ Liprolog Mix50 mhumiex iddisinjati biex tkun tista ’ tħallat insulini oħra fl- istoċċ.
5 x 3 ml Liprolog Mix50 cartridges for a 3 ml pen 2 x (5 x 3 ml) Liprolog Mix50 cartridges for a 3 ml pen
2 x (5 x 3ml) stoċċijiet ta ’ Liprolog Mix50 għal pinna ta ’ 3 ml.
Liprolog Basal 100 U/ ml suspension for injection in cartridge
Liprolog Basal 100 U/ ml, suspensjoni għall- injezzjoni fi skartoċċ
Liprolog Basal consists of insulin lispro protamine suspension.
Liprolog Basal tikkonsisti f’ suspensjoni ta ’ insulina lispro protamine.
Liprolog Basal is a white, sterile suspension.
Liprolog Basal huwa suspensjoni bajda u sterili.
Liprolog Basal is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Liprolog Basal huwa indikat għall- kura ta 'pazjenti li għandhom id- dijabete mellitus li għandhom bżonn l- insulina għall- manteniment omeostatiku ta' livelli normali ta ’ glucose.
Liprolog Basal may be used alone, in combination with oral agents, or mixed with insulin lispro solution.
Liprolog Basal jista 'jintuża waħdu, flimkien ma ’ sustanzi li jittieħdu mill- ħalq jew jitħallat ma ’ soluzzjoni ta ’ insulina lispro.
In intensive insulin therapy Liprolog Basal may be used as basal insulin (evening and/ or morning injection) with fast-acting insulin given at meals.
F’ terapija intensiva ta ’ insulina, Liprolog Basal jista ’ jintuża bħala insulina bażika (injezzjoni filgħaxija u/ jew filgħodu) ma ’ insulina li taħdem malajr mogħti ma ’ l- ikel.
Liprolog Basal should only be given by subcutaneous injection.
Liprolog Basal għandu jingħata biss b' injezzjoni taħt il- ġilda.
Under no circumstance should Liprolog Basal be given intravenously.
Liprolog Basal m’ għandux jingħata ġol - vina taħt l- ebda ċirkostanzi.
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen (see section 6.6).
L- għoti taħt il- ġilda għandu jsir fil- parti ta 'fuq tad- driegħ, fil- koxxox, fil - warrani, jew fl- addome (ara sezzjoni 6. 6).
Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
L- użu tas- siti ta 'l- injezzjoni għandhom jinbidlu sabiex l - istess sit ma jintużax aktar minn madwar darba f' xahar.
When administered subcutaneously care should be taken when injecting Liprolog Basal to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Liprolog Basal ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
As with all insulin preparations, the duration of action of Liprolog Basal is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħall- preparazzjonijiet kollha ta ’ l- insulina, kemm idum jaħdem Liprolog Basal jiddependi fuq id- doża, is- sit ta 'l- injezzjoni, il - provvista tad- demm, it- temperatura u fuq l- attività fiżika.
Hypoglycaemia.
35 Ipogliċemija
33 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Under no circumstances should Liprolog Basal be given intravenously.
Liprolog Basal m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
Mixing Liprolog Basal with insulins other than Liprolog has not been studied.
It- taħlit ta ’ Liprolog Basal ma ’ insulini oħra għadu ma ġiex studjat.
The physician should be consulted when using other medications in addition to Liprolog Basal.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog Basal.
34 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.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
37 Iz- zokkor baxx fid- demm tista 'tkun assoċjata ma' nuqqas t' attenzjoni, konfużjoni, palpitazzjonijiet, uġigħ ta 'ras, ħafna għaraq u remettar.
35 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 jdum jaħdem għal ħin intermedju.
Liprolog Basal has a prolonged absorption profile, achieving a maximum insulin concentration approximately 6 hours after dosing.
Liprolog Basal għandu profil ta ’ assorbiment prolongata, u jikseb il- konċentrazzjoni massima ta ’ insulina bejn wieħed u ieħor 6 siegħat wara d- doża.
In patients with type 2 diabetes over a wide range of renal function the pharmacokinetic differences between insulin lispro and soluble human insulin were generally maintained and shown to be independent of renal function.
L- insulina lispro
Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
38 żżomm aktar assorbiment rapidu u eliminazzjoni rapida meta mqabbla ma 'l- insulina umana li tinħall f' pazjenti li għandhom indeboliment tal- fwied.
Protamine sulphate m-cresol [1.76 mg/ ml] 36 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 [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 Liprolog.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra.
5 x 3 ml Liprolog Basal cartridges for a 3 ml pen 2 x (5 x 3 ml) Liprolog Basal cartridges for a 3 ml pen
5 x 3 ml skrataċ ta ’ Liprolog Basal għal pinna ta ’ 3 ml.
6.6 Special precautions for disposal and other handling
2 x (5 x 3 ml) skrataċ ta ’ Liprolog Basal għal pinna ta ’ 3 ml.
Any unused product or waste material should be disposed of in accordance with local requirements.
6. 6 Prekawzjonijiet speċjali li ghandhom jittieħdu meta jintrema u għal immaniġġar ieħor 39 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Instructions for use and handling Liprolog Basal cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
Istruzzjonijiet għall- użu u mmaniġġar L- iskrataċ ta ’ Liprolog Basal għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
Cartridges containing Liprolog 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 Liprolog 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.
Liprolog Basal cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- iskrataċ ta ’ Liprolog Basal mhumiex iddisinjati biex tkun tista ’ tħallat insulini oħra fl- iskartoċċ.
37 The following is a general description.
Din li ġejja hija deskrizzjoni ġenerali.
5 x 3 ml Liprolog Basal cartridges for a 3 ml pen 2 x (5 x 3 ml) Liprolog Basal cartridges for a 3 ml pen
5 x 3 ml skrataċ Liprolog Basal għal pinna ta ’ 3ml 2 x (5 x 3 ml) skrataċ ta ’ Liprolog Basal għal pinna ta ’ 3ml
Liprolog Pen 100 U/ ml, solution for injection
Pinna Liprolog 100 U/ ml, soluzzjoni għall- injezzjoni
Liprolog Pen is a sterile, clear, colourless, aqueous solution.
Pinna Liprolog huwa soluzzjoni akweja sterili, ċara u bla kulur.
Liprolog Pen is also indicated for the initial stabilisation of diabetes mellitus.
Liprolog huwa ukoll indikat għall - istabbilizzazzjoni fil- bidu tad- dijabete mellitus.
If necessary, Liprolog 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, Liprolog 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 Liprolog Pen to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Pinna Liprolog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
Liprolog Pen takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Pinna Liprolog jaġixxi malajr u għandu żmien t' attività aktar qasira (2 sa 5 sigħat) meta jingħata taħt il- ġilda meta mqabbel ma 'insulina regolari.
The faster onset of action compared to soluble human insulin is maintained regardless of injection site.
Bħal b' kull
As with all insulin preparations, the duration of action of Liprolog Pen is dependent on dose, site of injection, blood supply, temperature, and physical activity.
42 preparazzjonijiet ta 'l- insulina, iż- żmien ta' kemm iddum l- azzjoni ta 'Pinna Liprolog jiddependi fuq id - doża, is- sit ta' l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
39 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
Liprolog jista 'jintuża flimkien ma' insulina umana li ddum taħdem għal ħin itwal jew sustanzi sulphonylurea li jittieħdu mill- ħalq, fuq il- parir ta 'tabib.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
43 L- użu ta 'dożaġġi li mhumiex adegwati jew it- twaqqif tal- kura, speċjalment f' dijabetiċi li jiddependu fuq l- insulina, jistgħu jwasslu għaz- zokkor għoli fid- demm u l- ketoaċidożi dijabetika; kundizzjonijiet li jistgħu jikkaġunaw il- mewt.
40 Insulin requirements may be increased during illness or emotional disturbances.
Il- ħtiġijiet ta 'l- insulina jistgħu jiżdiedu waqt mard jew disturbi emozzjonali.
The physician should be consulted when using other medications in addition to Liprolog Pen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Il- pazjenti għandhom jiġu avżati biex jieħdu l- prekawzjonijiet biex jevitaw iz- zokkor baxx fid- demm waqt is- sewqan, dan huwa speċjalment importanti f' dawk li għandhom is- sinjali ta 'twissija ta' l -
41 Local allergy in patients is common (1/ 100 to < 1/ 10).
L- allerġija lokali f' pazjenti hija komuni (1/ 100 sa < 1/ 10).
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.
45 Barra minn hekk, l- insulini għandhom ħafna effetti anaboliċi u anti- kataboliċi fuq diversi tessuti differenti.
42 As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.
Bħal bil- preparazzjonijiet kollha ta 'l- insulina, il- ħin ta' l- azzjoni ta 'l- insulina lispro jista' jvarja f' individwi differenti jew f' ħinijiet differenti fl- istess individwu u jiddependi fuq id- doża, is- sit ta 'l - injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
Insulin lispro Humulin R Hypoglycemic Activity
Humulin R Hypoglycaemic Attività ta ’ Activity baxx fid - zokkor demm
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin.
F' xi studji, it -
In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.
46 tnaqqis ta 'zokkor baxx fid- demm ta' matul il- lejl kien assoċjat ma 'żieda fl- episodji ta' zokkor baxx fid- demm matul il- ġurnata.
When considering the clinical
Il- farmakokinetiċi ta 'l- insulina lispro jirriflettu sustanza li hija assorbita rapidament, u jikseb l- ogħla livelli fid- demm minn 30 sa 70 minuta wara l- injezzjoni taħt il- ġilda.
43 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).
After first use of the pen, the solution should be used within 28 days, when stored below 30°C.
47 Wara l- ewwel użu tal- pinna, is- soluzzjoni għandha tintuża fi żmien 28 ġurnata, meta tinħażen f' temperatura taħt 30°C.
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 stoċċijiet 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- istoċċ, u/ jew l- istoċċ tal- ħġieġ.
The 3 ml cartridges are sealed in a disposable pen injector.
L- istoċċijiet 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.
44 5 x 3 ml Pens 2 x (5 x 3 ml) Pens
5 x 3ml Pinen 2 x (5 x 3 ml) Pinen
Inspect the Liprolog Pen solution.
Eżamina s- soluzzjoni ta 'Pinna Liprolog.
Do not use Liprolog Pen if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Tużax Pinna Liprolog jekk jidher imċajpar, magħqud, jew ftit ikkulurit jew jekk jidhru partiċelli solidi.
(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- istoċċ 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.
A dose greater than the number of units remaining in the cartridge cannot be dialed.
Doża akbar minn- numru t' unitajiet li tibqa 'fl- istoċċ ma tistax tkun ikkalibbrata.
EU/ 1/ 01/ 195/ 005 EU/ 1/ 01/ 195/ 013
49 EU/ 1/ 01/ 195/ 005 EU/ 1/ 01/ 195/ 013
5 x 3 ml Pens 2 x (5 x 3 ml) Pens
5 x 3 Pinen 2 x (5 x 3 ml) Pinen
Liprolog Mix25 100 U/ ml Pen, suspension for injection
Pinna Liprolog Mix25 100 U/ ml, suspensjoni għall- injezzjoni
Liprolog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Liprolog Mix25 tikkonsisti fi 25% insulina lispro u 75% suspensjoni ta ’ insulina lispro protamine.
Liprolog Mix25 is a white, sterile suspension
Liprolog Mix25 huwa suspensjoni bajda u sterili.
The duration of action of the insulin lispro protamine suspension (Basal) component of Liprolog Mix25 is similar to that of a basal insulin (NPH).
Iż- żmien kemm idum jaħdem il- komponent protamine tas- suspensjoni ta ’ insulina lispro (Basal) ta ’ Liprolog Mix25 huwa simili għall- insulina bażi (NPH).
Hypersensitivity to insulin lispro or to any of the excipients.
51 Sensittività eċċessiva għall- insulina lispro jew għal xi sustanzi mhux attivi.
47 Hypoglycaemia.
Ipogliċemija
The physician should be consulted when using other medications in addition to Liprolog Mix25.
52 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog Mix25..
48 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.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
53 Iz- zokkor baxx fid- demm tista 'tkun assoċjata ma' nuqqas t' attenzjoni, konfużjoni, palpitazzjonijiet, uġigħ ta 'ras, ħafna għaraq u remettar.
49 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.
Liprolog Mix25 is a premixed suspension consisting of insulin lispro (fast-acting human insulin analogue) and insulin lispro protamine suspension (intermediate acting human insulin analogue).
Liprolog Mix25 huwa suspensjoni mħallta lesta li tikkonsisti f’ insulina lispro (analogu ta ’ l- insulina umana li jaġixxi malajr) u suspensjoni ta ’ insulina lispro protamine (analogu ta ’ insulina umana li jdum jaħdem għal ħin intermedju).
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with Liprolog 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’ Liprolog Mix25 mqabbla ma' taħlita 30/ 70 ta ’ insulina umana.
Hypoglycaemic activity Liprolog Mix25 Liprolog Basal
54 Liprolog Mix25 Liprolog Basall
50 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.
The pharmacokinetics of Liprolog Mix25 are representative of the individual pharmacokinetic properties of the two components.
Il- farmakokinetiċi ta ’ Liprolog Mix25 jirreflettu l- propjetajiet farmakokinetiċi taż - żewġ komponenti.
51 Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.
L- insulina lispro ma kkaġunatx tnaqqis fil- fertilità, u anqas uriet embrijutossiċità jew teratoġeniċità fi studji fuq l- annimali.
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
Do not expose to excessive heat or direct sunlight.
Tagħmlux fil- friża Tesponix għall- sħana eċċessiva jew f' dawl dirett tax - xemx.
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 stoċċijiet 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- istoċċ, u/ jew l- istoċċ tal- ħġieġ.
The 3 ml cartridges are sealed in a disposable pen injector, called the “ Pen”.
L - istoċċijiet 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) Liprolog Mix25 100 U/ ml Pens.
5 x 3ml Pinen Liprolog Mix25 100 U/ ml 2 x (5 x 3 ml) Pinen Liprolog Mix25 100 U/ ml
Inspect the Liprolog Mix25 100 U/ ml Pen.
Eżamina s- soluzzjoni ta 'Pinna Liprolog Mix25 100 U/ ml.
Do not
L- istoċċijiet fihom żibġa żgħira tal- ħġieġ biex tassisti fit- taħlit.
52 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 tfixkel il- miżura eżatta tad- doża.
Wipe the rubber seal with alcohol.
57 Imsaħ is- siġill bl- alkoħol.
A dose greater than the number of units remaining in the cartridge cannot be dialled.
Doża akbar minn- numru t' unitajiet li tibqa 'fl- istoċċ ma tistax tkun ikkalibbrata.
The pre-filled pen can be used until it is empty.
58 Il- pinna mimlija lesta tista 'tintuża sakemm tiżvojta.
5 x 3 ml Liprolog Mix25 100 U/ ml Pens 2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml Pens
5 x 3ml Pinen Liprolog Mix25 100 U/ ml 2 x (5 x 3 ml) Pinen Liprolog Mix25 100 U/ ml
Liprolog Mix50 100 U/ ml Pen, suspension for injection
Pinna Liprolog Mix50 100 U/ ml, suspensjoni għall- injezzjoni
The duration of action of the insulin lispro protamine suspension (Basal) component of Liprolog 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 ’ Liprolog Mix50 huwa simili għall- insulina bażi (NPH).
55 Hypersensitivity to insulin lispro or to any of the excipients.
60 Sensittività eċċessiva għall- insulina lispro jew għal xi sustanzi mhux attivi.
The physician should be consulted when using other medications in addition to Liprolog Mix50.
61 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog Mix50.
56 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.
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.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
62 Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
57 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.
ATC Code:
Liprolog Mix50 huwa suspensjoni mħallta lesta li tikkonsisti f’ insulina lispro (analogu ta ’ l- insulina umana li jaġixxi malajr) u suspensjoni ta ’ insulina lispro protamine (analogu ta ’ insulina umana li jdum jaħdem għal ħin intermedju). Kodiċi ATC:
A10A D04.
A10A D04
In the figure below the pharmacodynamics of Liprolog Mix50 and Liprolog Basal are illustrated.
Fid - dijagramma ta ’ hawn taħt hemm murija l- farmakodinamiċi ta ’ Liprolog Mix50 u Liprolog Basal.
Liprolog Liprolog Basal
63 Liprolog Mix50 Liprolog Basall
58 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.
The pharmacokinetics of Liprolog Mix50 are representative of the individual pharmacokinetic properties of the two components.
Il- farmakokinetiċi ta ’ Liprolog Mix50 jirreflettu l- propjetajiet farmakokinetiċi taż - żewġ komponenti.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin.
64 lispro mar- riċetturi ta 'l- insulina, hija ekwivalenti ma' l- insulina umana.
59 Two years.
Sentejn.
5 x 3 ml Liprolog Mix50 100 U/ ml Pens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml Pens.
5 x 3ml Pinen Liprolog Mix50 100 U/ ml 2 x (5 x 3 ml) Pinen Liprolog Mix50 100 U/ ml
Instructions for use and handling a) Preparing a dose
65 Istruzzjonijiet għall- użu u mmaniġġar a) Preparazzjoni ta 'doża
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 Liprolog 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.
Depress the injection button fully until you feel or hear a 60 click.
Għafas kompletament il- buttuna ta 'l- injezzjoni sakemm tħoss jew tisma klikk.
61 EU/ 1/ 01/ 195/ 007 EU/ 1/ 01/ 195/ 015
EU/ 1/ 01/ 195/ 007 / EU/ 1/ 01/ 195/ 015
5 x 3 ml Liprolog Mix50 100 U/ ml Pens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml Pens
5 x 3ml Pinen Liprolog Mix50 100 U/ ml 2 x (5 x 3 ml) Pinen Liprolog Mix50 100 U/ ml
Liprolog Basal 100 U/ ml Pen, suspension for injection
Pinna Liprolog Basal 100 U/ ml, suspensjoni għall- injezzjoni
Liprolog Basal may be used alone or in combination with oral agents.
Liprolog Basal jista 'jintuża waħdu jew flimkien ma ’ sustanzi li jittieħdu mill- ħalq.
Under no circumstances should Liprolog Basal be given intravenously.
Liprolog Basal m’ għandux jingħata ġol - vina taħt l- ebda ċirkostanzi.
When administered subcutaneously care should be taken when injecting Liprolog Basal to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Liprologikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
63 4.4 Special warnings and precautions for use
68 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Mixing Liprolog Basal with insulins other than Liprolog has not been studied.
It- taħlit ta ’ Liprolog Basal ma ’ insulini oħra ħlief Liprolog għadu ma ġiex studjat.
The physician should be consulted when using other medications in addition to Liprolog Basal 100 U/ ml Pen.
69 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Pinna Liprolog 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.
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.
64 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.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
70 Iz- zokkor baxx fid- demm tista 'tkun assoċjata ma' nuqqas t' attenzjoni, konfużjoni, palpitazzjonijiet, uġigħ ta 'ras, ħafna għaraq u remettar.
65 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.
Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
71 żżomm aktar assorbiment rapidu u eliminazzjoni rapida meta mqabbla ma 'l- insulina umana li tinħall f' pazjenti li għandhom indeboliment tal- fwied.
Protamine sulphate m-cresol [1.76 mg/ ml] 66 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 [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 Liprolog.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra ħlief Liprolog.
6.6 Special precautions for disposal and other handling
5 x 3ml Pinen Liprolog Basal 100 U/ ml 2 x (5 x 3 ml) Pinen Liprolog Basal 100 U/ ml 72 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Inspect the Liprolog Basal 100 U/ ml Pen.
Eżamina l- Pinna Liprolog Basal 100 U/ ml.
67 Wipe the rubber seal with alcohol.
Imsaħ is- siġill bl- alkoħol.
(b) Injecting a dose
73 b) Injezzjoni ta 'doża
5 x 3 ml Liprolog Basal Pen for a 3 ml pen 2 x (5 x 3 ml) Liprolog Basal Pen for a 3 ml pen
5 x 3ml Pinna Liprolog Basal għal pinna ta ’ 3ml 2 x (5 x 3 ml) Pinna Liprolog Basal għal pinna ta ’ 3ml
DATE OF REVISION OF THE TEXT
DATA TA 'META ĠIET RIVEDUTA L- KITBA 74 1.
Liprolog KwikPen 100 U/ ml, solution for injection
Liprolog 100 U/ ml KwikPen, soluzzjoni għall- injezzjoni
Liprolog KwikPen is a sterile, clear, colourless, aqueous solution.
Liprolog KwikPen huwa soluzzjoni akweja sterili, ċara u bla kulur.
Liprolog KwikPen is also indicated for the initial stabilisation of diabetes mellitus.
Liprolog KwikPen huwa ukoll indikat għall - istabbilizzazzjoni fil- bidu tad- dijabete mellitus.
When administered subcutaneously care should be taken when injecting Liprolog KwikPen to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Liprolog KwikPen ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
Liprolog KwikPen takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Liprolog 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 Liprolog KwikPen is dependent on dose, site of injection, blood supply, temperature, and physical activity.
75 preparazzjonijiet ta 'l- insulina, iż- żmien ta' kemm iddum l- azzjoni ta 'Liprolog KwikPen jiddependi fuq id- doża, is- sit ta' l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
70 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
Liprolog jista 'jintuża flimkien ma' insulina umana li ddum taħdem għal ħin itwal jew sustanzi sulphonylurea li jittieħdu mill- ħalq, fuq il- parir ta 'tabib.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
76 L- użu ta 'dożaġġi li mhumiex adegwati jew it- twaqqif tal- kura, speċjalment f' dijabetiċi li jiddependu fuq l- insulina, jistgħu jwasslu għaz- zokkor għoli fid- demm u l- ketoaċidożi dijabetika; kundizzjonijiet li jistgħu jikkaġunaw il- mewt.
71 Insulin requirements may be increased during illness or emotional disturbances.
Il- ħtiġijiet ta 'l- insulina jistgħu jiżdiedu waqt mard jew disturbi emozzjonali.
The physician should be consulted when using other medications in addition to Liprolog KwikPen.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog KwikPen.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
77 Il- pazjenti għandhom jiġu avżati biex jieħdu l- prekawzjonijiet biex jevitaw iz- zokkor baxx fid- demm waqt is- sewqan, dan huwa speċjalment importanti f' dawk li għandhom is- sinjali ta 'twissija ta' l - ipoglikimja mnaqqsa jew assenti jew jekk għandhom episodji ta 'zokkor baxx fid- demm frekwenti.
72 Local allergy in patients is common (1/ 100 to < 1/ 10).
L- allerġija lokali f' pazjenti hija komuni (1/ 100 sa < 1/ 10).
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.
78 Barra minn hekk, l- insulini għandhom ħafna effetti anaboliċi u anti- kataboliċi fuq diversi tessuti differenti.
73 As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.
Bħal bil- preparazzjonijiet kollha ta 'l- insulina, il- ħin ta' l- azzjoni ta 'l- insulina lispro jista' jvarja f' individwi differenti jew f' ħinijiet differenti fl- istess individwu u jiddependi fuq id- doża, is- sit ta 'l - injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.
79 tnaqqis ta 'zokkor baxx fid- demm ta' matul il- lejl kien assoċjat ma 'żieda fl- episodji ta' zokkor baxx fid- demm matul il- ġurnata.
74 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).
After first use of the pen, the solution should be used within 28 days, when stored below 30°C.
80 Wara l- ewwel użu tal- pinna, is- soluzzjoni għandha tintuża fi żmien 28 ġurnata, meta tinħażen f' temperatura taħt 30°C.
The 3 ml cartridges are sealed in a disposable pen injector.
L- istoċċijiet ta ’ 3ml huma siġillati f’ pinna mimlija lesta li tintrema wara l- użu u li tintuża biex tinjetta biha u li tissejjaħ “ KwikPen ”.
75 5 x 3 ml Liprolog 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog 100 U/ ml KwikPen
5 x 3ml Liprolog 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog 100 U/ ml KwikPen
Inspect the Liprolog KwikPen solution.
Eżamina s- soluzzjoni ta 'Liprolog.
Do not use Liprolog KwikPen if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Tużax Liprolog jekk jidher imċajpar, magħqud, jew ftit ikkulurit jew jekk jidhru partiċelli solidi.
b) Mixing insulins Do not mix insulin in vials with insulin in cartridges.
Tħallatx l- insulina fil- kunjetti ma 'l- insulina fl- iskrataċ.
5 x 3 ml Liprolog 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog 100 U/ ml KwikPen
5 x 3 ml Liprolog 100 U/ ml KwikPen 2 X (5 x 3 ml) Liprolog 100 U/ ml KwikPen
Date of first authorisation:
81 Data ta ’ l- ewwel awtorizzazzjoni:
76 1.
82 1.
Liprolog Mix25 100 U/ ml KwikPen, suspension for injection
Liprolog Mix25 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
Hypersensitivity to insulin lispro or to any of the excipients.
83 Sensittività eċċessiva għall- insulina lispro jew għal xi sustanzi mhux attivi.
77 Hypoglycaemia.
Ipogliċemija
The physician should be consulted when using other medications in addition to Liprolog Mix25.
84 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog Mix25 KwikPen..
78 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.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
85 Iz- zokkor baxx fid- demm tista 'tkun assoċjata ma' nuqqas t' attenzjoni, konfużjoni, palpitazzjonijiet, uġigħ ta 'ras, ħafna għaraq u remettar.
79 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 Liprolog Mix25 Liprolog Basal
86 Liprolog Mix25 Liprolog Basall
80 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.
Do not expose to excessive heat or direct sunlight.
Tagħmlux fil- friża Tesponix għal sħana eċċessiva jew f' dawl dirett tax - xemx.
The 3 ml cartridges are sealed in a disposable pen injector, called the “ Pen”.
L - istoċċijiet ta ’ 3ml huma siġillati f’ pinna mimlija lesta u li tintrema wara l- użu, u li tintuża biex tinjetta biha, u li tissejjaħ “ KwikPen ”.
2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml KwikPens.
5 x 3ml Liprolog Mix25 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml KwikPens
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.
82 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 Liprolog Mix25 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml KwikPens
5 x 3ml Liprolog Mix25 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml KwikPens
83 1.
90 1.
Liprolog Mix50 100 U/ ml KwikPen, suspension for injection
Liprolog Mix50 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
Hypersensitivity to insulin lispro or to any of the excipients.
91 Sensittività eċċessiva għall- insulina lispro jew għal xi sustanzi mhux attivi.
84 Hypoglycaemia.
Ipogliċemija.
The physician should be consulted when using other medications in addition to Liprolog Mix50.
92 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog Mix50 KwikPen.
85 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.
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.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
93 Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
86 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.
Liprolog Liprolog Basal
94 Liprolog Mix50 Liprolog Basall
87 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.
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.
95 L- insulina lispro ma kkaġunatx tnaqqis fil- fertilità, u anqas uriet embrijutossiċità jew teratoġeniċità fi studji fuq l- annimali.
88 Two years.
Sentejn.
5 x 3 ml Liprolog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml KwikPens.
5 x 3ml Liprolog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml KwikPens
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
5 x 3 ml Liprolog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml KwikPens
5 x 3ml Liprolog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml KwikPens
Liprolog Basal 100 U/ ml KwikPen, suspension for injection
Liprolog Basal 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
When administered subcutaneously care should be taken when injecting Liprolog Basal to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Liprolog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
Hypoglycaemia.
98 Ipoglicemija.
91 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
The physician should be consulted when using other medications in addition to Liprolog Basal 100 U/ ml KwikPen.
99 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog Basal 100 U/ ml KwikPen.
92 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.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
100 Iz- zokkor baxx fid- demm tista 'tkun assoċjata ma' nuqqas t' attenzjoni, konfużjoni, palpitazzjonijiet, uġigħ ta 'ras, ħafna għaraq u remettar.
Patients who fail to respond to glucagon must be given glucose solution intravenously.
Pazjenti li ma jirrispondux għall- glucagon għandhom jingħataw suspensjoni tal- glukożju ġol- vina.
93 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.
Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
L- insulina lispro 101 żżomm aktar assorbiment rapidu u eliminazzjoni rapida meta mqabbla ma 'l- insulina umana li tinħall f' pazjenti li għandhom indeboliment tal- fwied.
Protamine sulphate m-cresol [1.76 mg/ ml] 94 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 [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.
5 x 3 ml Liprolog Basal 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Basal 100 U/ ml KwikPens
5 x 3ml Liprolog Basal 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Basal 100 U/ ml KwikPens 102 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
6.6 Special precautions for disposal and other handling
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Any unused product or waste material should be disposed of in accordance with local requirements.
Istruzzjonijiet għall- użu u mmaniġġar
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 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.
5 x 3 ml Liprolog Basal 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog Basal 100 U/ ml KwikPen
5 x 3ml Liprolog Basal 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog Basal 100 U/ ml KwikPen
96 ANNEX II
103 ANNESS II
97 A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Cartridges and disposable pens called the „ Pen“ besides Liprolog Basal presentations Eli Lilly Italia S. p. A., Via A.
Skrataċ u pinen li jintremew wara l- użu li jissejħu “ Pinna ” ħlief għal preparazzjonijiet ta ’ Liprolog Basal Eli Lilly Italia S. p. A., Via A.
Disposable pens called the „ KwikPen“
Pinen li jintremew wara li jintużaw li jissejħu “ KwikPen ”
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable
105 • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
98 • OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA
Pharmacovigilance System The MAH must ensure that the system of Pharmacovigilance, as described in version 2.1 presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jassigura li s- sistema ta ’ Farmakoviġilanza, kif deskritta fil- verżjoni 2. 1 ippreżentata fil- Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq hija attiva u funzjonanti qabel ma jiġi mqiegħed fis- suq il - prodott u sakemm dan il- prodott jibqa ’ fis- suq.
99 ANNEX III
106 ANNESS III
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
108 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog 100 U/ ml solution for injection in vial Insulin lispro (rDNA origin)
Liprolog 100 U/ ml soluzzjoni għall- injezzjoni ġo kunjett Insulina lispro (oriġini rDNA)
103 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
110 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT