qanastek/EMEA-V3 huggingface dataset:
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
F’ pazjenti li għandhom indeboliment fil- funzjoni renali, il- ħtieġa għall- insulina tista ’ tonqos dovuta għat - tnaqqis tal- metaboliżmu ta ’ l- insulina.
13 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ ta ’ kontroll inadegwat taz- zokkor, jew fejn ikun hemm tendenza biex jiżviluppaw episodji ta ’ ipergliċemija jew ipogliċemija, jridu jkunu ikkunsidrati jekk il- pazjent hux isegwi l- iskema tat- trattament li ngħatatlu, is- siti ta ’ l- injezzjonijiet, il- metodu ta ’ kif qed tingħata l- injezzjoni, u l- fatturi rilevanti l- oħra kollha, qabel l- tibdil fid- doża tkun ikkunsidrata.
Switching a patient to another type or brand of insulin should be done under strict medical supervision and may require change in dose.
Meta pazjent jinqaleb minn għamla jew kwalità oħra ta ’ insulina, dan irid isir taħt superviżjoni stretta tat - tabib u jista ’ jkollu bżonn bidla fid- doża.
In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
F’ każijiet rari, il- preżenza ta ’ antikorpi għall- insulina jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ l- insulina biex tikkoreġi t- tendenza għall - iper - jew l- ipo- gliċemija.
Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Sabiex inaqqsu r- riskju ta ’ l- ipogliċemija huwa essenzjali li l- pazjent iżomm mad- dożaġġ u l- kura permezz tad- dieta, li jieħu l- insulina kif suppost, u li jagħraf is- sintomi ta ’ l- ipogliċemija.
14 Intercurrent illness
Mard li jitfaċċa minn żmien għall- ieħor
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e. g. clozapine and olanzapine) and protease inhibitors.
Sustanzi li jistgħu jnaqqsu l- effett tat- tnaqqis fil- livell tal- glukożju fid- demm jinkludu l- corticosteroids, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestogens, id- derivattivi ta ’ phenothiazine, somatropin, is- sustanzi simpatomimetiċi (e. ż. epinephrine [adrenaline], salbutamol u terbutaline), l- ormoni tat- tirojde, il- prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine) u l - inibituri tal- protease.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Hekk ukoll, is- sinjali adrenerġiċi kontra l- kontroll jistgħu jitnaqqsu jew ikunu assenti taħt l- effetti ta ’ prodotti mediċinali simpatolitiċi bħal l- imblokkaturi tar- reċetturi beta, clonidine, guanethidine u reserpine.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available.
Tqala Għal insulin glargine m’ hemmx tagħrif kliniku minn studji kliniċi ikkontrollati dwar l- użu waqt it- tqala.
A limited number of exposed pregnancies from Post Marketing Surveillance indicate no adverse effects of insulin glargine on pregnancy or on the health of the foetus and newborn child.
Minn informazzjoni miġbura waqt il- perijodu ta ’ Sorveljanza, Wara li l- Prodott Mediċinali Tpoġġa Fuq is - Suq, ma kienx hemm effetti avversi f’ numru żgħir ta ’ nisa li kienu esposti għall- insulina glargine, kemm fuq
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal / foetal development, parturition or postnatal development (see section 5.3).
Studji fuq l- annimali ma jurux effetti ħżiena diretti fuq it- tqala, fuq l- iżvilupp ta ’ embriju / fetu, ħlas jew żvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
15 The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Il- ħila tal- pazjent biex jikkonċentra u jirreaġixxi jistgħu jkunu mnaqqsa minħabba l- ipogliċemija jew l - ipergliċemija jew, per eżempju, bħala riżultat tat- tnaqqis fil- vista.
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Ġeneralment, aktar ma tkun qawwija u mgħaġġla l- waqgħa fil- livell tal- glukusju fid - demm, aktar ikun immarkat dan il- fenomenu u s- sintomi tiegħu.
In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
F’ każijiet rari, il - preżenza ta ’ antikorpi għall- insulina tista ’ tinħtieġ aġġustament fid- doża ta ’ l- insulina biex tikkoreġi t - tendenza għall- iper - jew l- ipo- gliċemija.
Nervous system disorders:
Disturbi fis- sistema nervuża
Rare:
Disturbi fl- għajnejn Rari:
Visual impairment A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Tnaqqis fil- vista Tibdil sostanzjali fil- kontroll taz- zokkor fid- demm jista ’ jikkaġuna tixkil temporanju fil- vista, minħabba tibdil temporanju li jikkonsisti f’ nefħa tal- lenti ta ’ l- għajn u bidla fl- indiċi rifrattiv tagħha.
In patients with proliferative retinopathy,
Madankollu, l- intensifikar tat- terapija bl- insulina biex il- livell taz- zokkor fid- demm ikun ikkontrollat f’ daqqa, jista ’ jġib miegħu aggravament temporanju tar- retinopatija tad- dijabete.
16 particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
F’ pazjenti li għandhom retinopatija proliferattiva, speċjalment meta ma tkunx ittrattata b’ photocoagulation, episodji ta ’ ipogliċemija severa jistgħu jwasslu għal amaurosis temporanja.
Skin and subcutaneous tissue disorders
Disturni fil- ġilda u fit -- tessuti ta ’ taħt il- ġilda
As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din iżżomm lura l- assorbiment lokali ta ’ l- insulina.
Oedema Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Edema Rarament, l- insulina tista ’ twassal li jakkumula s- sodju u tiżviluppa ta ’ l- edema, speċjalment jekk qabel kien hemm kontroll metaboliku fqir li wara tjieb b’ terapija intensifikata bl- insulina.
Paediatric population
Pazjenti pedjatriċi
17 Pharmacotherapeutic group:
Kategorija farmakoterapewtiku:
Insulins and analogues for injection, long-acting.
Insulini u l- analogi għall- injezzjoni, li jaħdmu fit - tul.
Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
Insulin glargine hija insulina analoga umana imfassla b’ mod li ma tinħallx biżżejjed f’ pH newtrali.
In clinical pharmacology studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses.
Fi studji farmakoloġiċi kliniċi, insulin glargine u l- insulina umana, it- tnejn intravenużi, ntwerew li għandhom l- istess qawwa meta ngħataw fl- istess doża.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
F’ persuni b’ saħħithom jew f’ pazjenti dijabetiċi tat- tip 1, fejn il- livell taz- zokkor fid- demm inżamm kostanti (euglycaemic clamp), il- ħin biex jibda jaħdem insulin glargine fit- tessut subkutanju kien aktar bil- mod mill - NPH insulina umana; l- effett kien kontinwu u dejjiemi, mingħajr avariji fil- konċentrazzjoni.
End of observation Time (h) after s. c. injection period *determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
Il- ħin (sigħat) li għadda wara l- injezzjoni subkutanja * ikkalkulat bħala l- ammont ta ’ glukożju injettat biex iżomm il- livelli tal- glukożju kostanti fil- plażma (valuri medji kull siegħa).
18 In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Fi studju kliniku, is- sintomi ta ’ l- ipogliċemija jew ir- rispons ormonali kontro- regolatorju kienu simili wara insulin glargine intravenuż u insulina umana intravenuża, kemm f’ individwi voluntiera b’ saħħithom kif ukoll f’ pazjenti bid- dijabete tip 1.
Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine.
Il- konċentrazzjonijiet, għalhekk, kienu konsisteni mal- profil tal - ħin ta ’ l- attività farmakodinamika ta ’ insulin glargine.
Shelf life after first use of the cartridge The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Żmien kemm idum tajjeb l- iskartoċċ wara l- ewwel użu Il- prodott jista ’ jinħażen għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis - sħana diretta jew mid- dawl dirett.
The pen containing a cartridge must not be stored in the refrigerator.
Il- pinna li fiha l- iskartoċċ m’ għandhiex tinħażen fil- friġġ.
19 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Unopened cartridges Store in a refrigerator (2°C-8°C).
Skartoċċi mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ).
Do not put Lantus next to the freezer compartment or a freezer pack.
Lantus m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
In use cartridges For storage precautions, see section 6.3.
Għal kundizzjonijiet ta ’ ħażna, ara sezzjoni 6. 3.
3 ml solution in a cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber).
3 ml soluzzjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer iswed (lastku bromobutyl) u għatu bi flanġ (aluminju), b’ tapp (lastku bromobutyl jew b’ safef ta ’ lastku polyisoprene u bromobutyl).
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges are available.
Pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi huma disponibbli.
Insulin pen The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Lantus cartridges, and as recommended in the information provided by the device manufacturer.
Pinna ta ’ l- insulina L- iskartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħrajn li jaqblu ma ’ l- iskartoċċi ta ’ Lantus, u skond kif inhu rrakkomandat fit- tagħrif ipprovdut mill- manifattur tal- pinna.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
L- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa meta jiddaħħal l - iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Jekk il- pinna ta ’ l- insulina hija bil- ħsara jew mhix taħdem sew (dovut għal xi difetti mekkaniċi) għandha tintrema, u pinna ġdida ta ’ l- insulina għandha tintuża.
If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 Units/ ml) and injected.
Jekk il- pinna ma taħdimx sew (ara l- istruzzjonijiet dwar l- użu tal- pinna), is- soluzzjoni tista ’ titella ’ mill - iskartoċċ f’ siringa (adatta għal insulina ta ’ 100 Unità/ ml) u tiġi njettata.
Inspect the cartridge before use.
Skartoċċ Qabel ma jiddaħħal fil- pinna, l- iskartoċċ għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn. Ifli l- iskartoċċ sew qabel l- użu.
It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Għandu jintuża biss jekk is- soluzzjoni tkun ċara u bla kulur, mingħajr ebda frak viżibbli, u ta ’ konsistenza tixbah dik ta ’ l- ilma.
Since Lantus is a solution, it does not require resuspension before use.
Peress li Lantus hu soluzzjoni, m’ hemmx bżonn ta ’ ri- sospensjoni qabel l- użu.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Il- bżieżaq ta ’ l- arja jridu jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet kif għandha tintużal - pinna).
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, il- Ġermanja.
Date of first authorisation:
Data ta ’ l- ewwel awtoriżżazzjoni:
Lantus 100 Units/ ml solution for injection in a cartridge.
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni, fi skartoċċ
Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
L- insulina glargine hija magħmula bit- teknoloġija rikombinanti tad- DNA ġo Escherichia coli
Clear colourless solution.
Soluzzjoni ċara u mingħajr kulur.
For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required.
Għat- trattament tad- dijabete mellitus fl- adulti, l- adoloxxenti u t- tfal ta ’ l- età ta ’ 6 snin jew akbar fejn l - insulina hija meħtieġa għall- kura.
Lantus contains insulin glargine an insulin analogue with a prolonged duration of action.
Lantus fih l- insulina glargine bħala insulina analoga li taħdem fuq tul twil ta ’ żmien.
It should be administered once daily at any time but at the same time each day.
Għandu jingħata darba kuljum f’ kwalunkwe ħin iżda fl- istess ħin kuljum.
The dosage and timing of dose of Lantus should be individually adjusted.
Id- dożaġġ u l- ħin meta tingħata għandu jkun individwalment aġġustat.
In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products.
F’ pazjenti bid- dijabete mellitus tip 2, Lantus jista ’ jingħata flimkien ma ’ prodotti mediċinali antidijabetiċi li huma oralment attivi.
In children, efficacy and safety of Lantus have only been demonstrated when given in the evening.
Fit- tfal l- effikaċja u s- sigurtà ta ’ Lantus intwerew biss meta ngħata filgħaxija.
Due to limited experience, the efficacy and safety of Lantus have not been demonstrated in children below the age of 6 years.
Dovut għal esperjenza limitata l- effikaċja u s- sigurtà ta ’ Lantus ma ntwerewx fit- tfal taħt l- età ta’ 6 snin.
Transition from other insulins to Lantus
Il- bidla minn insulini oħra għal Lantus
When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast- acting insulin analogues or the dose of oral antidiabetic agents).
Meta ssir bidla minn sistema ta ’ trattament b’ insulina li taħdem fuq żmien intermedju jew twil għal waħda b’ Lantus, jista ’ jkun meħtieġ bidla fid- doża ta ’ l- insulina bażika u t- trattament antidijabetiku konkomittanti jista ’ jkollu bżonn jiġi aġġustat (id- doża u l- ħin meta jingħataw l- insulini regolari addizzjonali jew l- insulini analogi li jaħdmu malajr, jew id- doża tas- sustanzi mediċinali orali antidijabetiċi).
22 To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Biex jonqos ir- riskju ta ’ l- ipogliċemija billejl jew filgħodu kmieni, il- pazjenti li qed jaqilbu minn sistema ta ’ insulina bażika, minn waħda ibbażata fuq it- teħid ta ’ darbtejn kuljum ta ’ insulina NPH, għal sistema oħra ta ’ darba kuljum b’ Lantus, għandhom inaqqsu d- doża ta ’ kuljum ta ’ l- insulina bażika b’ 20- 30% waqt l- ewwel ftit ġimgħat tal- kura.
During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
Waqt dawn l- ewwel ġimgħat, it- tnaqqis għandu ta ’ l- anqas jiġi ikkumpensat parzjalment b’ żieda fl- insulina waqt il- ħin ta ’ l- ikel; wara dan iż- żmien is- sistema għandha tiġi aġġustata għall- individwu.
As with other insulin analogues, patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus.
Bħal ma jiġri b’ insulini analogi oħra, pazjenti li qed jieħdu dożi kbar ta ’ insulina dovut għall- preżenza ta ’ antikorpi għall- insulina umana, jistgħu jkollhom rispons aħjar bl- insulina Lantus.
Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
L- immoniterjar metaboliku mill- qrib huwa irrakkomandat waqt il- perijodu ta ’ tranżazzjoni u fl- ewwel ftit ġimgħat ta ’ wara.
With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dosage regimen may become necessary.
Meta l- kontroll metaboliku jitjieb u tiżdied is- sensittività għall- insulina, aġġustament ulterjuri fis - sistema tad- dożaġġ jista ’ jkun meħtieġ.
Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo-or hyperglycaemia (see section 4.4).
Aġġustament fid- dożaġġ jista ’ wkoll ikun meħtieġ jekk, per eżempju, l- piż tal- pazjent, kambjamenti fl- istil tal- ħajja, bidla tal- ħin meta d- doża ta ’ l- insulina tittieħed, jew xi ċirkustanzi oħra jinqalgħu, li jżidu s- suxxettibilità għall- ipogliċemija jew l- ipergliċemija (ara sezzjoni 4. 4).
Administration
Kif għandu jingħata
Lantus is administered subcutaneously.
Lantus jingħata fit- tessut ta ’ taħt il- ġilda.
Lantus should not be administered intravenously.
Lantus m’ għandux jingħata ġol- vina.
The prolonged duration of action of Lantus is dependent on its injection into subcutaneous tissue.
Il- ħin twil li jdum jaħdem Lantus jiddependi fuq li l- injezzjoni tingħata fit- tessut ta ’ taħt il- ġilda.
Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
Jekk id- doża subkutaneja tas- soltu tingħata ġol vina dan jista ’ jikkaġuna ipogliċemija severa.
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Lantus.
M’ hemmx differenzi klinikament rilevanti fil- livelli ta ’ l- insulina jew tal- glukosju fis- seru, wara li Lantus jingħata fiż- żaqq, fil- parti tad- deltoid tad- driegħ jew fil- koxxa.
Injection sites must be rotated within a given injection area from one injection to the next.
Is- siti ta ’ l- injezzjoni għandhom jinbidlu f’ żona partikulari minn injezzjoni waħda għall- oħra.
Lantus must not be mixed with any other insulin or diluted.
Lantus m’ għandux jitħallat ma ’ ebda insulina oħra jew jiġi dilwit.
Mixing or diluting can change its time/ action profile and mixing can cause precipitation.
It- taħlit ta ’ l- insulini u l- insulina dilwita jistgħu jbiddlu l- profili tal- ħin u l- effett, fil- waqt li t- taħlit jista ’ jikkaġuna s- separazzjoni ta ’ sustanza solida mill- likwidu li jkun fih.
For further details on handling, see section 6.6.
Għal aktar tagħrif dwar l- immaniġġar, ara sezzjoni 6. 6.
Due to limited experience the efficacy and safety of Lantus could not be assessed in the following groups of patients: patients with impaired liver function or patients with moderate/ severe renal impairment (see section 4.4).
Dovuta għal esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Lantus ma setgħetx tkun analiżżata f’ dawn il - gruppi ta ’ pazjenti: pazjenti b’ indeboliment tal- fwied jew pazjenti b’ indeboliment moderat jew sever tal - kliewi (ara sezzjoni 4. 4).
Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis.
Lantus mhux l- insulina adatta għat- trattament tal- kitoaċidożi dijabetika.
Instead, regular insulin administered intravenously is recommended in such cases.
Minflok, l- insulina regolari mogħtija ġol- vina hija irrakkomandata f’ każijiet bħal dawn.
Safety and efficacy of Lantus have been established in adolescents and children of 6 years and above.
Is- sigurtà u l- effikaċja ta ’ Lantus huma stabbiliti fl- adoloxxenti u t- tfal ta ’ 6 snin fl- età u akbar.
Due to limited experience the efficacy and safety of Lantus could not be assessed in children below 6 years of age, in patients with impaired liver function or in patients with moderate/ severe renal impairment (see section 4.2).
Dovuta għal esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Lantus ma kienux stabbiliti fit- tfal taħt l- età ta ’ 6 snin, f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied jew f- pazjenti li għandhom indeboliment moderat jew sever tal- kliewi (ara sezzjoni 4. 2).
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
F’ pazjenti b’ indeboliment tal- kliewi, il- ħtieġa għall- insulina taf tonqos dovuta għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Fl- anzjani, d- deterjorament progressiv tal- funzjoni tal- kliewi jista ’ jwassal għal tnaqqis sostnut għall- ħtieġa ta ’ l- insulina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti li għandhom indeboliment sever tal- fwied, il- ħtieġa għall- insulina tista ’ tonqos dovuta għat - tnaqqis fl- abbiltà tal- produzzjoni tal- glukosju u tnaqqis fil- metaboliżmu ta ’ l- insulina.
23 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F ’ każ ta ’ nuqqas adegwat fil- kontroll tal- livelli tal- glukosju jew f’ każijiet ta ’ tendenza għall- iżvilupp ta ’ ġrajjiet ta iper - jew ipo- gliċemija, għandhom jiġu ikkunsidrati mill- ġdid jekk il- pazjent hux qiegħed iżomm mal- kura preskritta, is- siti ta ’ l- injezzjonijiet u t- teknika użata għall- injezzjoni, u l- fatturi l- oħra kollha rilevanti, qabel ma jiġi ikkunsidrat l- aggustament fid- doża.
Switching a patient to another type or brand of insulin should be done under strict medical supervision and may require change in dose.
Meta pazjent jinqaleb minn għamla jew kwalità oħra ta ’ insulina, dan irid isir taħt superviżjoni stretta tat - tabib u jista ’ jkun hemm bżonn ta ’ bidla fid- doża.
The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Il- ħin meta tiġri l- ipogliċemija jiddependi fuq il- profil ta ’ azzjoni ta ’ l- insulini użati u, għalhekk, jista ’ jinbidel meta s- sistema ta ’ trattament tinbidel.
Due to more sustained basal insulin supply with Lantus, less nocturnal but more early morning hypoglycaemia can be expected.
Dovut għal forniment sod u miżmum ta ’ l- insulina bażika b’ Lantus, huwa anqas probabbli li titfaċċa l- ipogliċemija billejl, iżda huwa aktar probabbli li tiġri filgħodu kmieni
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Il- kawtela speċjali trid tiġi eżerċitata u huwa irrakkomandat li jsir l- immoniterjar intensifikat tal- livell tal - glukosju fid- demm, f’ pazjenti fejn ġrajjiet ipogliċemiċi jkunu ta ’ rilevanza klinika partikolari, bħal dawk il - pazjenti li għandhom djuq sinifikanti ta ’ l- arterji koronarji jew ta ’ dawk l- arterji li jissupplixxu d- demm lill - moħħ (riskju ta ’ kumplikazzjonijiet li jeffettwaw il- qalb u l- moħħ), kif ukoll dawk il- pazjenti li qed ibatu minn retinopatija proliferattiva, speċjalment jekk mhumiex qed jirċievu l- kura bil- fotokoagulazzjoni (riskju ta ’ għama temporanja li titfaċċa wara l- ipogliċemija)
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Il- pazjenti għandhom ikunu konxji taċ- cirkustanzi fejn is- sintomi ta ’ twissija ta ’ l- ipogliċemija huma mnaqqsin.
The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups.
Is- sintomi ta ’ twissija ta ’ l- ipogliċemija jistgħu jinbiddlu, jkunu anqas immarkati jew anki assenti f’ ċerti gruppi li qegħdin f’ riskju.
- in whom glycaemic control is markedly improved,
- fejn il- kontroll tal- glokosju fid- demm tjieb ħafna,
- in whom hypoglycaemia develops gradually,
- fejn l- ipogliċemija tiżviluppa bil- mod,
- after transfer from animal insulin to human insulin,
- li jaqilbu minn insulina derivata mill- annimali għall- insulina umana,
- in whom an autonomic neuropathy is present,
- li għandhom in- newropatija awtonomika,
- with a long history of diabetes,
- li ilhom dijabetiċi għal żmien twil,
- receiving concurrent treatment with certain other medicinal products (see section 4.5).
- li qed jieħdu trattament konkomittanti bi prodotti mediċinali oħra (ara sezzjoni 4. 5).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Sitwazzjonijiet bħal dawn jistgħu jwasslu għal ipogliċemija severa (u possibilment it- telf mis- sensi) qabel ma l- pazjent jinduna li sejjer jiżviluppa l- ipogliċemija.
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
L- effett imtawwal ta ’ l- insulina glargine mogħtija fit- tessut ta ’ taħt il- ġilda jista ’ jwassal għad- dewmien fil - fejqan ta ’ l- ipogliċemija.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Jekk wieħed jinnota livelli normali jew imnaqqsin ta ’ l- emoglobina glycated, il- possibbilità ta ’ ġrajjiet ta ’ ipogliċemija rikurrenti, u mhux magħrufin (speċjalment billejl) trid tkun ikkunsidrata.
Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Biex jitnaqqas ir- riskju ta ’ l- ipogliċemija, huwa essenzjali li l- pazjent iżomm mad- dożaġġ u d- dieta, jieħu l - insulina b’ mod korrett, u jkun konxju tas- sintomi ta ’ l- ipogliċemija.
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Il- fatturi li jżidu is- suxxettibbiltà għall - ipogliċemija jeħtieġu l- immoniterjar mill- qrib u jistgħu jirrikjedu l- aġġustament fid- doża.
- change in the injection area,
- bidla fiż- żona ta ’ fejn tingħata l- injezzjoni,
- improved insulin sensitivity (by, e. g., removal of stress factors),
- sensittività miżjuda għall- insulina (bħal per eżempju t- tneħħija ta ’ fatturi stressanti),
- unaccustomed, increased or prolonged physical activity,
- attività fiżika mhux imdorrija, miżjuda jew fit- tul,
- intercurrent illness (e. g. vomiting, diarrhoea),
- mard kurrenti ieħor (eżempju t- tqalligħ u d- dijarea),
- inadequate food intake,
- tnaqqis fl- ammont ta ’ ikel ikkonsmat,
- alcohol consumption,
- konsum ta ’ alkoħol,
- certain uncompensated endocrine disorders, (e. g. in hypothyroidism and in anterior pituitary or
- ċertu mard endokrinoloġiku mhux kumpensat (per eżempju meta it- tirojde qed taħdem bil- mod jew
adrenocortical insufficiency),
meta hemm isuffiċjenza tal- parti anterjuri tal- pitwitarja jew tal- kortiċi tas- surrenali),
- concomitant treatment with certain other medicinal products.
- trattament konkomittanti bi prodotti mediċinali oħra.
Intercurrent illness
Mard Kurrenti
In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet it- testijiet għall- preżenza tal - kitoni fl- awrina huma meħtieġa, u ħafna drabi huwa neċessarju li tiġi aġġustata d- doża ta ’ l- insulina.
The insulin requirement is often increased.
Il - ħtieġa għall- insulina spiss tiżdied.
A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
Hemm numru ta ’ sustanzi li jeffettwaw il- metaboliżmu tal- glukosju u dan għandu mnejn jeħtieġ aġġustament fid- doża ta ’ l- insulina glargine.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Is- sustanzi mediċinali li jistgħu jbaxxu aktar l- effett tat- tnaqqis fil- livell tal- glukosju fid- demm u b’ hekk iżidu s- suxxettibilità għall- ipogliċemija jinkludu s- sustanzi antidijabetiċi orali, inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE), disopyramide, fibrati, fluoxetine, inibituri ta ’ monamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates u l- antibijotiċi tal- klassi sulfonamide.
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e. g. clozapine and olanzapine) and protease inhibitors.
Is- sustanzi mediċinali li jistgħu jaħdmu kontra t- tnaqqis tal- livell tal- glukosju fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, l- estroġeni u l- proġestoġeni, id - derivattivi tal- phenothiazine, somatropin, is- sustanzi simpatomimetiċi (per eżempju epinephrine [l - adrenalina], salbutamol, terbutaline), l- ormoni tat- tirojde, il- prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine) u l- inibituri tal- protease.
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering effect of insulin.
L- imblokkaturi tar- riċetturi beta, clonidine, is sustanzi tal- lithium jew l- alcohol jistgħu jsaħħu jew idgħajjfu l- effett li għandha l- insulina li tbaxxi l- livell tal- glukosju fid- demm.
Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Il- pentamidine jista ’ jikkawża l - ipogliċemija, li xi mdaqqiet tkun segwita mill- ipergliċemija.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Addizjonalment is- sinjali adrenerġiċi ta ’ counter- regulation jistgħu jkunu mnaqqsin jew assenti, taħt l- effetti tas- sustanzi mediċinali simpatolitiċi bħall- imblokkaturi tar- riċetturi beta, clonidine, guanethidine u reserpine.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available.
Tqala Għall- insulina glargine m’ hemmx tagħrif kliniku minn studji kliniċi ikkontrollati dwar l- użu waqt it- tqala.
A limited number of exposed pregnancies from Post Marketing Surveillance indicate no adverse effects of insulin glargine on pregnancy or on the health of the foetus and newborn child.
Minn informazzjoni miġbura waqt il- perijodu ta ’ Sorveljanza, Wara li l- Prodott Mediċinali Tpoġġa Fuq is - Suq, ma kienx hemm effetti avversi f’ numru żgħir ta ’ nisa li kienu esposti għall- insulina glargine waqt it - tqala, kemm fuq it- tqala nfisha kif ukoll fuq is- saħħa tal- fetu u t- tarbija tat- twelid.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal / foetal development, parturition or postnatal development (see section 5.3).
Studji fuq l- annimali ma jurux effetti ħżiena diretti fuq it- tqala, fuq l- iżvilupp ta’ embriju / fetu, ħlas jew żvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Il- ħtieġa għall- insulina tista ’ tonqos waqt l- ewwel trimestru u x’ aktarx tiżdied waqt it- tieni u t- tielet trimestri.
Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Immedjatament wara l- ħlas, il- bżonn għall- insulina jonqos malajr (riskju miżjud ta ’ ipogliċemija).
Careful monitoring of glucose control is essential.
Huwa essenzjali li l- kontroll tal- livell tal- glukosju għandu jkun immoniterjat bir- reqqa.
Lactation Lactating women may require adjustments in insulin dose and diet.
Treddigħ Nisa li qed ireddgħu jistgħu jeħtieġu aġġustamenti fid- doża ta ’ l- insulina u d- dieta.
25 The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
L- abbiltà tal- pazjent biex jikkonċentra u jirreaġixxi jistgħu jonqsu bħala riżultat ta ’ l- ipogliċemija jew l - ipergliċemija jew, per eżempju, bħala riżultat ta ’ indeboliment tal- vista.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom ikunu mwissija biex jieħdu l- prekawzjonijiet ħalli jevitaw l- iżvilupp ta ’ l- ipogliċemija waqt is- sewqan.
This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan huwa speċjalment importanti f’ dawk li għandhom is- sintomi ta ’ twissija ta ’ l - ipogliċemija imnaqqsin jew assenti, jew ibatu minn ġrajjiet spissi ta ’ ipogliċemija.
Hypoglycaemia Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Ipogliċemija Attakki severi ta ’ ipogliċemija, speċjalment jekk rikurrenti, jistgħu jwasslu għal ħsara newroloġika.
Prolonged or severe hypoglycaemic episodes may be life-threatening.
Ġrajjiet fit- tul jew severi ta ’ ipogliċemija jistgħu jkunu fatali.
Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio- oedema, bronchospasm, hypotension and shock, and may be life-threatening.
Reazzjonijiet bħal dawn għall- insulina (inkluża l - insulina glargine) jew għal xi waħda mis- sustanzi mhux attivi jistgħu, per eżempju, ikunu assoċjati ma ’ reazzjonijiet ġeneraliżżati tal- ġilda, anġjo- edema, djuq ostruttiv u akut tal- bronki, pressjoni baxxa tad- demm,
26 Eyes disorders
Disturbi fl’ għajnejn
Visual impairment A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Tnaqqis fil- vista Kambjament sostanzjali fil- kontroll taz- zokkor fid- demm jista ’ jikkawża tnaqqis tamporanju tal- vista, dovut għal bidla temporanja fl- ebbusija u l- indiċi tar- rifrazzjoni tal- lenti ta ’ l- għajn.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Madankollu, l- intensifikar tat- terapija bl- insulina biex il- livell taz- zokkor fid- demm ikun ikkontrollat f’ daqqa, jista ’ jġib miegħu aggravament temporanju tar- retinopatija tad- dijabete.
In general, the safety profile for patients ≤ 18 years of age is similar to the safety profile for patients > 18 years.
Ġeneralment, il- profil ta ’ sigurtà f’ pazjenti fl- età ta ’ ≤18- il sena huwa l- istess bħall- profil ta ’ sigurtà f’ pazjenti ta ’ > 18- il sena.
The adverse event reports received from Post Marketing Surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in patients ≤ 18 years of age than in patients > 18 years.
Ir- rapporti dwar effetti avversi li oriġinaw mis- Sorveljanza ta ’ Wara t- Tqegħid fis- Suq jinkludu reazzjonijiet fis- siti ta ’ l- injezzjonijiet relattivament aktar spissi (uġigħ fis- sit ta ’ l- injezzjoni, reazzjoni fis- sit ta ’ l - injezzjoni) u reazzjonijiet tal- ġilda (raxx, urtikarja) f’ pazjenti ta ’ età ta ’ ≤18- il sena, meta mqabblin ma ’ pazjenti ta ’ > 18- il sena.
27 More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose.
Ġrajjiet aktar severi b’ koma, aċċessjoni jew indeboliment newroloġiku jistgħu jkunu ittrattati b’ injezzjoni ta ’ glucagon fil- muskolu/ fit- tessut ta ’ taħt il- ġilda, jew b’ injezzjoni ġol vina ta ’ soluzzjoni ikkonċentrata tal - glukosju.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Il- konsum tal- karboidrati għandu mnejn jeħtieġ li jkun sostnut u l- osservazzjoni tista ’ tkun neċessarja għax l- ipogliċemija tista ’ terġa ’ titfaċċa wara il- fejqan kliniku apparenti.
Insulins and analogues for injection, long-acting.
Insulini u analogi għall- injezzjoni, li jaħdmu fit- tul.
Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
L- insulina glargine hija insulina analoga umana, magħmula biex ma tinħallx biżżejjed f’ pH newtrali.
It is completely soluble at the acidic pH of the Lantus injection solution (pH 4).
Hija tinħall kompletament fil- pH aċiduża tas- soluzzjoni għall- injezzjoni ta ’ Lantus (pH 4).
After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-precipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/ time profile with a prolonged duration of action.
Wara li tkun injettata fit- tessut ta ’ taħt il- ġilda, s- soluzzjoni aċiduża twassal għall- formazzjoni ta ’ sustanza solida mikroskopika, li tissepara mil- likwidu li tkun miżmuma fih, u li minnha ammonti żgħar ta ’ insulina glargine joħorġu bla waqfien; dan jipprovdi profil ta ’ konċentrazzjoni dejjiema mingħajr varjazzjoni fil- konċentrazzjoni, u li jaħdem għal perijodu twil.
Insulin receptor binding:
L- irbit mar- riċettur ta ’ l- insulina:
Insulin glargine is very similar to human insulin with respect to insulin receptor binding kinetics.
L- insulina glargine huwa simili ħafna għall- insulina umana fil - komportament kinetiku, fejn tidħol ir- rabta mar- riċettur ta ’ l- insulina.
It can, therefore, be considered to mediate the same type of effect via the insulin receptor as insulin.
Huwa, għalhekk, li hija meqjusa li jkollha l- istess effett bħall- insulina billi taqbad mar- riċettur ta ’ l- insulina.
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
L- attività primarja ta ’ l- insulina, inkluża l- insulina glargine, hija li tirregola l- metaboliżmu tal- glukosju.
Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
L - insulina u l- analogi tagħha jbaxxu l- livelli tal- glukosju fid- demm billi jistimulaw il- dħul tal- glukosju mit - tessuti periferali, specjalment il- muskoli skeletrali u x- xaħam, kif ukoll jinibixxu l- produzzjoni tal- glukosju mill- fwied.
Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
L- insulina tinibixxi l- lipolisi fl- adipoċiti, tinibixxi l- proteolisi u tistimula s- sintesi tal- proteini.
In clinical pharmacology studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses.
Fi studji kliniċi farmakoloġiċi, l- insulina glargine u l- insulina umana, mogħtija ġol vina, intwerew li huma ekwipotenti, meta ngħataw fl- istess dożi.
As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
Bħal ma jiġri bl- insulini kollha, l- hin kemm iddum taħdem l - insulina glargine tista ’ tkun affettwata minn attività fiżika u fatturi varjabbli oħra.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
Fi studji fuq suġġetti b’ saħħithom jew f’ pazjenti bid- dijabete tat- tip 1, fejn il- livell taz- zokkor fid- demm inżamm stabbli u normali, l- ħin biex tibda taħdem doża ta ’ insulina glargine mogħtija fit- tessut ta ’ taht il - ġilda, kien itwal minn insulina umana NPH, il- profil kellu effett kostanti u dejjiemi, mingħajr avariji u ċaqlieq.
28 The following graph shows the results from a study in patients:
- 28 -
Activity Profile in Patients with Type 1 Diabetes
Il- Profil t' Attivita` f' Pazjenti bid- Dijabete Tip 1
5 Glucose Utilization Rate* (mg/ kg/ min)
5 L- Użu tal- Glukosju Rata * (mg/ kg/ min) Rate * (mg/ kg/ min) Glucose Utilization
End of observation Time (h) after s. c. injection period *determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
* ikkalkulata bħala l- ammont ta ’ glukosju mogħti bħala infuzzjoni biex iżomm il- livelli tal- glukosju kostanti fil- plażma (stima medja f’ siegħa)
The longer duration of action of insulin glargine is directly related to its slower rate of absorption and supports once daily administration.
Ir- raġuni għaliex l- insulina glargine taħdem fuq medda itwal ta ’ ħin hija direttament relatata għar- rata baxxa ta ’ assorbiment u din tikkonferma li għandha tingħata darba biss kuljum.
The time course of action of insulin and insulin analogues such as insulin glargine may vary considerably in different individuals or within the same individual.
Il- ħin kemm idumu jaħdmu l - insulina u l- analogi tagħha, bħall- insulina glargine, jista ’ jvarja ħafna minn persuna għal oħra u anke fl- istess persuna.
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Fi studju kliniku, s- sintomi ta ’ l- ipogliċemija jew ir- rispons ta ’ l- ormoni kontra- regolatorji kienu xorta wara li l- insulina glargine u l- insulina umana ngħataw ġol- vina, kemm f’ voluntiera b’ saħħithom kif ukoll f’ pazjenti bid- dijabete tip 1.
No significant difference was seen in the progression of diabetic retinopathy when Lantus was compared to NPH insulin.
Meta Lantus ġie mqabbel mal- insulina NPH, ma dehritx xi differenza sinifikanti fil- progress ta ’ retinopatija tad- dijabete..
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
F’ suġġetti b’ saħħithom u f’ pazjenti dijabetiċi, il- konċentrazzjoni ta ’ l- insulina fis- seru indikat assorbiment aktar bil- mod u ferm aktar fit- tul, u nuqqas ta ’ punt ta ’ intensità, wara injezzjoni fit- tessut ta ’ taħt il- ġilda ta ’ l- insulina glargine, meta din kienet imqabbla ma ’ l- insulina umana NPH.
Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine.
Il- konċentrazzjonijiet, għalhekk, kienu konsistenti mal- profil tal- ħin ta ’ l- attività farmakodinamika ta ’ l- insulina glargine.
The graph above shows the activity profiles over time of insulin glargine and NPH insulin.
Il- graff hawn fuq turi l- profili ta ’ attività kontra l- ħin ta ’ l- insulina glargine u l- insulina NPH.
Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
L- insulina glargine injettata darba kuljum tilħaq livelli ta ’ stat miżmum minn 2 sa 4 ijiem mill- ewwel doża.
When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Meta l- insulina glargine u l- insulina umana ngħataw ġol- vina l- half- life tat- tnehhija kienu komparabbli.
In man, insulin glargine is partly degraded in the subcutaneous tissue at the carboxyl terminus of the Beta chain with formation of the active metabolites 21A-Gly-insulin and 21A -Gly-des-30B-Thr-insulin.
Fil- bniedem l- insulina glargine hija parzjalment inattivata fit- tessut ta ’ taħt il- ġilda fil- carboxyl terminus tal - Beta chain, bil- produzzjoni ta ’ molekuli metaboliċi attivi 21A- Gly- insulin u 21A- Gly- des- 30B- Thr- insulin.
Unchanged insulin glargine and degradation products are also present in the plasma.
L - insulina glargine u l- prodotti metaboliċi tagħha huma wkoll preżenti fil- plażma.
29 In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Fi studji kliniċi, l- analiżi ta ’ sottogruppi ibbażati fuq l- età u s- sess maskil/ femminil m’ urew ebda differenza fis- sigurtà u l- effikaċja, fil- pazjenti ittrattati bl- insulina glargine meta mqabblin mal- grupp kollu li fuqu sar l - istudju.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhiex klinika, miġbura minn studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
Zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injections.
Zinc chloride, m- cresol, glycerol, hydrochloric acid, sodium hydroxide, ilma għall- injezzjonijiet.
It is important to ensure that syringes do not contain traces of any other material.
Huwa meħtieġ li wieħed jaċċerta ruħu li s- siringi m’ għandhomx xi traċċi ta ’ kwalunkwe materjal ieħor.
Shelf life after first use of the cartridge The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Żmien kemm idum tajjeb wara l- ewwel użu ta ’ l- iskartoċċ Il- prodott jista ’ jinħażen għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis - sħana diretta jew mid- dawl dirett.
Do not freeze.
Skartoċċi mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ).. Tagħmilhomx fil- friża.
Do not put Lantus next the freezer compartment or a freezer pack.
Lantus m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
The glass cartridge is irreversibly integrated in a transparent container and assembled to a plastic mechanism with a threaded rod at one extremity.
L- iskartoċċ tal - ħġieġ huwa ħaġa waħda ma ’ kontenitur trasparenti mgħammar b’ mekkaniżmu tal- plastik li fih virga b’ kamin f’ tarf wieħed.
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges for OptiClik are available.
Pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi għal OptiClik huma disponibbli.
30 6.6 Special precautions for disposal and other handling
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