qanastek/EMEA-V3 huggingface dataset:
Solution for injection in a cartridge
Soluzzjoni għall- injezzjoni f ’ kunjett Soluzzjoni għall- injezzjoni f ’ skartoċċ Soluzzjoni għall- injezzjoni f ’ skartoċċ Soluzzjoni għall- injezzjoni f ’ skartoċċ Soluzzjoni għall- injezzjoni f ’ skartoċċ
Solution for injection in a cartridge
Użu għal taħt il- ġilda Użu għal taħt il- ġilda Użu għal taħt il- ġilda Użu għal taħt il- ġilda Użu għal taħt il- ġilda Użu għal taħt il- ġilda
Solution for injection in a cartridge
kunjett (ħġieġ) skartoċċ (ħġieġ) skartoċċ (ħġieġ) skartoċċ (ħġieġ) skartoċċ (ħġieġ)
3 ml
10 ml 3 ml 3 ml 3 ml 3 ml
8 cartridges
1 kunjett 1 skartoċċ 3 skartoċċi 6 skartoċċi 8 skartoċċi
Solution for injection in a cartridge
Soluzzjoni għall- injezzjoni f ’ skartoċċ
1 pre-filled pen
1 pinna mimlija għal- lest
6 pre-filled pens
6 pinnen mimlija għal- lest
EU/ 1/ 00/ 134/ 020
1/ 3 Użu għal taħt il- ġilda EU/ 1/ 00/ 134/ 020
8 pre-filled pens
8 pinnen mimlija għal- lest
9 pre-filled pens
9 pinnen mimlija għal- lest
cartridge (glass) for OptiClik
skartoċċ (ħġieġ) għall - OptiClik
1 cartridge
1 skartoċċ
8 cartridges
8 skartoċċi
cartridge (glass) in a pre- filled pen (SoloStar)
skartoċċ (ħġieġ) f’ pinna mimlija għal - lest (SoloStar)
3 pre-filled pens
3 pinnen mimlija għal- lest
10 pre-filled pens
10 pinnen mimlija għal- lest
Lantus 100 Units/ ml solution for injection in a vial
Lantus 100 Unità / ml ta ’ soluzzjoni għall- injezzjoni fi kunjett.
Each ml contains 100 Units insulin glargine (equivalent to 3.64 mg).
Kull ml fih 100 Unità insulin glargine (ekwivalenti għal 3. 64 mg).
Each vial contains 5 ml of solution for injection, equivalent to 500 Units, or 10 ml of solution for injection, equivalent to 1000 Units.
Kull kunjett fih 5 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 500 Unità, jew 10 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 1000 Unità.
Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Insulin glargine huwa magħmul bit- teknoloġija rikombinanti tad- DNA ġo Escherichia coli.
Clear colourless solution.
Soluzzjoni ċara u bla 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 ta ’ diabetes mellitus fl- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin u akbar, meta jkun meħtieġ it - trattament bl- insulina.
The potency of this preparation is stated in units.
Il- qawwa ta ’ dan il- prodott hija stmata f’ unitajiet.
These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues.
Dawn l- unitajiet huma esklussivi għal Lantus u m’ humiex xorta bħal IU jew l- unitajiet użati biex ikunu espressi l- qawwa ta ’ insulini analogi oħra.
See section 5.1 (Pharmacodynamics).
Ara sezzjoni 5. 1 (Tagħrif farmakodinamiku).
Lantus contains insulin glargine an insulin analogue with a prolonged duration of action.
Lantus fih insulin glargine, analogu ta ’ l- insulina li jaħdem fit- tul.
It should be administered once daily at any time but at the same time each day.
Għandu jingħata darba kuljum f’ kwalunkwe ħin tal- ġurnata iżda dejjem fl- istess ħin.
The dosage and timing of dose of Lantus should be individually adjusted.
Id- dożaġġ u l- ħin meta tingħata d- doża ta ’ Lantus għandhom ikunu imfassla skond l- individwu partikolari.
In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products.
F’ pazjenti li għandhom id- diabetes mellitus tip 2, Lantus jista ’ jingħata wkoll flimkien ma ’ prodotti mediċinali attivi mill- ħalq kontra d- dijabete.
In children, efficacy and safety of Lantus have only been demonstrated when given in the evening.
L- effikaċja u s- sigurtà ta ’ Lantus fit- tfal intweriet 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.
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Lantus ma ntwerewx fi tfal taħt is- 6 snin.
Transition from other insulins to Lantus
Il- bidla minn tipi oħrajn ta ’ insulina 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 il- bidla minn reġimen ta ’ trattament b’ insulina li għandha effett intermedju jew twil, għal wieħed b’ Lantus, bidla fid- doża bażi ta ’ l- insulina tista ’ tkun meħtieġa, u t- trattament fl- istess waqt kontra d- dijabete għandu mnejn ikollu bżonn ikun aġġustat (id- doża u l- ħin ta ’ insulini regolari u addizzjonali jew l- analogi ta ’ l- insulina li jaħdmu malajr, jew id- doża ta ’ sustanzi orali kontra d- dijabete).
2 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.
- 2 - Biex jitnaqqas ir- riskju ta ’ l- ipogliċemija matul il- lejl u filgħodu kmieni, il- pazjenti li qed jaqilbu s- sistema bażi tal- kura tagħhom b’ NPH insulin minn darbtejn kuljum, għall- sistema ta ’ kura b ’ Lantus ta ’ darba kuljum, għandhom inaqqsu d- doża bażi ta ’ kuljum b’ 20% sa 30%, waqt l- ewwel ftit ġimgħat tat- trattament.
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.
F’ dawn l- ewwel ftit ġimgħat, it- tnaqqis irid ikun, almenu parzjalment, ikkumpensat b’ żieda fid- doża ta ’ l - insulina fil- ħin ta ’ l- ikel, u wara dan il- perijodu, is- sistema ta ’ kura trid tkun imfassla skond l- 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.
Kif jiġri b’ analogi oħra ta ’ insulina, il- pazjenti li qegħdin jieħdu dożi għoljin ta ’ insulina minħabba l - antikorpi kontra l- insulina umana, jista` jkollhom rispons aħjar għall- insulina b ’ Lantus.
Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
Ħarsien bir- reqqa għall- metaboliżmu huwa irrakkomandat waqt il- perijodu ta ’ bidla, u wara, fl- ewwel ftit ġimgħat.
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, aktar tibdil 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).
Tibdil fid- doża jista ’ jkun meħtieġ, per eżempju, meta ssir bidla fil- piż tal- pazjent, jew fl- istil tal- ħajja tiegħu, jew bidla fil- ħin meta d- doża ta ’ insulina tittieħed, jew meta jseħħu xi ċirkostanzi oħra li jżidu s- suxxettibbiltà għall- ipogliċemija jew għall- ipergliċemija (ara sezzjoni 4. 4).
Lantus is administered subcutaneously.
Lantus jingħata b’ mod subkutanju.
Lantus should not be administered intravenously.
Lantus m’ għandhux jingħata fil- vina.
The prolonged duration of action of Lantus is dependent on its injection into subcutaneous tissue.
L- effett fit- tul ta ’ Lantus jiddependi fuq it- teħid b’ injezzjoni fit- tessut subkutanju.
Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
L- użu intravenuż tad- doża subkutanja tas- soltu tista ’ twassal għall- 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 dak tal- glukożju fis- seru tad- demm wara li jingħata Lantus fit- tessut taż- żaqq, il- parti laterali ta ’ fuq tad- driegħ, jew fil- koxxa.
Injection sites must be rotated within a given injection area from one injection to the next.
Is- siti fejn isiru l - injezzjonijiet iridu jinbidlu, b’ sistema ta ’ tidwir, fiż- żona partikolari magħżula għalihom, minn titqiba waħda għall- oħra.
Lantus must not be mixed with any other insulin or diluted.
Lantus m’ għandux jitħallat ma ’ ebda insulina oħra u anqas jiġi dilwit.
Mixing or diluting can change its time/ action profile and mixing can cause precipitation.
Meta jitħallat jew jiġi dilwit jista ’ jinbidel il- profil tal- ħin jew l- effett, u t- taħlit jista ’ jikkawża l- formazzjoni ta ’ trab fin fis- sustanza likwida.
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).
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Lantus ma setgħux ikunu mistħarrġa f’ dawn il - gruppi ta ’ pazjenti: dawk li għandhom indeboliment fil- funzjoni epatika jew dawk il- pazjenti b’ indeboliment ta ’ grad moderat / sever fil- funzjoni renali (ara sezzjoni 4. 4).
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal xi waħda mis- sustanzi mhux attivi.
Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis.
Lantus mhux l- insulina adatta għat- trattament ta ’ ketoaċidożi tad- dijabete.
Instead, regular insulin administered intravenously is recommended in such cases.
Minflok, l- użu ta ’ insulini regolari fil- vina huwa irrakkomandat 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 intwerew fl- adoloxxenti u t- tfal ta ’ sitt snin u ’ l fuq.
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).
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Lantus ma setgħux ikunu mistħarrġa fit- tfal taħt is- 6 snin, f’ pazjenti li għandhom indeboliment fil- funzjoni epatika, u f’ pazjenti li għandhom indeboliment moderat / sever fil- funzjoni renali (ara sezzjoni 4. 2).
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
- 3 - F’ pazjenti li għandhom indeboliment fil- funzjoni renali, il- ħtieġa għall- insulina tista ’ tonqos dovuta għat - tnaqqis tal- metaboliżmu ta ’ l- insulina.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Fl- anzjani, l- indeboliment progressiv fil- funzjoni renali jista ’ jwassal għal tnaqqis kontinwu u miżmum fil- bżonn 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 fil- funzjoni epatika, il- ħtieġa għall- insulina tista ’ tonqos, dovuta għat- tnaqqis fil- ħila li jifforma l- glukożju minn molekuli li mhumiex karboidrati, u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
3 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 is- superviżjoni stretta tat - tabib u jista ’ jkun hemm bżonn ta` bidla fid- doża.
Insulin administration may cause insulin antibodies to form.
L- għoti ta ’ l- insulina jista ’ jwassal għall- produzzjoni ta ’ l- antikorpi.
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, fil- preżenza ta ’ antikorpi għall- insulina jista` jkun hemm bżonn ta` aġġustament fid- doża ta ’ l- insulina biex tikkorreġi t- tendenza għall- iper - jew l- ipo- gliċemija.
Hypoglycaemia
L- ipogliċemija
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 sseħħ l- ipogliċemija jiddependi fuq il- profil tal- ħidma ta ’ l- insulini wżati u, għalhekk, jista ’ jinbidel meta ssir bidla fis- sistema tat- trattament.
Due to more sustained basal insulin supply with Lantus, less nocturnal but more early morning hypoglycaemia can be expected.
Peress li Lantus jipprovdi livell sostnut tal- bżonn bażiku ta ’ l- insulina, huwa mistenni li jkun hemm anqas possibbiltà ta ’ ipogliċemija matul il- lejl iżda aktar 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).
Kawtela speċjali trid tittieħed, u għandu jkun hemm ħarsien aktar strett tal- livell taz- zokkor fid- demm, f’ dawk il- pazjenti li għandhom dawn l- episodji ta ’ ipogliċemija li jistgħu jkunu ta ’ rilevanza klinika speċjali, bħal dawk il- pazjenti li għandhom djuq sinifikanti ta ’ l- arterji koronarji, jew dawk ta ’ l- arterji li qegħdin iwasslu d- demm għall- moħħ (ir- riskju ta ’ kumplikazzjonijiet kardijaċi jew ċerebrali dovuti għall - ipogliċemija), kif ukoll f’ dawk il- pazjenti li għandhom retinopatija proliferattiva, speċjalment meta mhix qed tkun ittrattata b’ photocoagulation (hemm ir- riskju t’ amaurosis temporanja wara l- ipogliċemija).
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Il- pazjenti jridu jkunu konxji taċ- ċirkostanzi meta s- sintomi ta ’ twissija tal- bidu ta ’ l- ipogliċemija jonqsu.
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 jinbidlu, ikunu anqas evidenti, jew neqsin f’ ċerti gruppi ta ’ pazjenti li qegħdin f’ riskju.
- in whom glycaemic control is markedly improved,
- b’ titjib sostanzjali fil- kontroll taz- zokkor,
- in whom hypoglycaemia develops gradually,
- li tiżviluppalhom l- ipogliċemija bil- mod,
- after transfer from animal insulin to human insulin,
- wara li qalbu minn insulina derivata mill- annimali għal dik ġejja mill- bniedem,
- with a long history of diabetes,
- li ilhom isofru bid- dijabete,
- suffering from a psychiatric illness,
- li jsofru bmard psikjatriku,
- receiving concurrent treatment with certain other medicinal products (see section 4.5).
- li qed jieħdu t- trattament flimkien ma ’ ċerti 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.
Ċirkostanzi bħal dawn jistgħu jirriżultaw f ’ ipogliċemija severa (u possibbilment telf mis- sensi) qabel ma ’ l - pazjent jinduna bl- ipogliċemija
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
L- effett fit- tul ta ’ Insulin glargine subkutanju jista ’ jittardja l- 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 ikunu innotati livelli normali jew imnaqqsin ta ’ glycated haemoglobin, il- possibbiltà ta ’ episodji ta ’ ipogliċemija mingħajr ma wieħed jintebaħ (speċjalment matul il- lejl) 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.
- 4 - 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.
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Il- fatturi li jżidu s - suxxettibbilità għall- ipogliċemija jeħtieġu monitoraġġ speċjali mill- qrib u għandu mnejn ikun meħtieġ tibdil fid- doża.
- improved insulin sensitivity (by, e. g., removal of stress factors),
- sensittività akbar għall- insulina (e. ż. permezz tat- tneħħija ta ’ fatturi stressanti),
- unaccustomed, increased or prolonged physical activity,
- attività fiżika mhux tas- soltu, żieda fl- attività fiżika, jew dik fit- tul,
- inadequate food intake,
- ammont inadegwat ta ’ ikel,
- certain uncompensated endocrine disorders, (e. g. in hypothyroidism and in anterior pituitary or
- disturbi fil- glandoli endokrini mhux ikkumpensati (e. ż. l- ipotirojdiżmu, l- insuffiċjenza tal- parti
adrenocortical insufficiency),
anterjuri tal- pitwitarja u insuffiċjenza adrenokortikali),
- concomitant treatment with certain other medicinal products.
- trattament fl- istess waqt ma ’ xi prodotti oħra mediċinali.
Intercurrent illness
Mard li jitfaċċa minn żmien għall- ieħor
Intercurrent illness requires intensified metabolic monitoring.
Mard li jitfaċċa minn żmien għall- ieħor jeħtieġ monitoraġġ intensiv tal- metaboliżmu.
In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet, testijiet ta ’ l- urina għall- preżenza tal- ketones huwa indikat, u ta ’ spiss huwa meħtieġ tibdil fid- doża ta ’ l - insulina.
The insulin requirement is often increased.
Il- bżonn għal aktar insulina ta ’ spiss jiżdied.
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
M’ għandhom qatt iwaqqfu għal kollox l- insulina.
A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
Hemm numru ta ’ sustanzi li jeffettwaw il- metaboliżmu tal- glukożju u għandu mnejn ikun meħtieġ tibdil fid - doża ta ’ Insulin 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.
Sustanzi li jistgħu jżidu l- effett tat- tnaqqis fil- livell tal- glukożju fid- demm, u jżidu r- riskju għall- iżvilupp ta ’ l- ipogliċemija, jinkludu sustanzi orali kontra d- dijabete, inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE), disopyramide, fibrati, fluoxetine, inibituri ta ’ monamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates, u l- antibijotiċi sulphonamide.
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.
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering effect of insulin.
L- imblokkaturi tar- reċetturi beta, clonidine, is- sustanzi b’ lithium, jew l- alkoħol jistgħu iqawwu jew idgħajfu l- effett ta ’ l- insulina fuq it- tnaqqis fil- livell ta ’ glukożju.
Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Pentamidine jista ’ jġib l- ipogliċemija li xi minn daqqiet tista ’ tkun segwita b’ 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.
Hekk ukoll, is- sinjali adrenerġiċi kontra l- kontroll jistgħu jitnaqqsu jew ikunu assenti taħt l- effetti ta ’ prodotti 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 Għal insulin glargine m’ hemmx tagħrif kliniku minn studji kliniċi kkontrollati 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
To date, no other relevant epidemiological data are available.
Sa illum, m’ hemmx data oħra epidemjoloġika u rilevanti disponibbli.
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 ’ l - embriju / fetu, ħlas jew żvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
The available clinical data is insufficient to exclude a risk.
Id- data klinika disponibbli m’ hix biżżejjed biex teskludi xi riskju.
The use of Lantus may be considered in pregnancy, if necessary.
L- użu ta ’ Lantus waqt it- tqala jista ’ jkun ikkunsidrat, f’ każ ta ’ bżonn.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Huwa essenzjali li pazjenti li kellhom id- dijabete minn qabel, jew għandhom id- dijabete ta ’ waqt it- tqala, li jżommu kontroll metaboliku tajjeb tul it- tqala.
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Il- ħtieġa għall- insulina tista ’ tonqos fl- ewwel tliet xhur u normalment tiżdied waqt it- tieni u t- tielet perijodi ta ’ tliet xhur- il wieħed.
Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Immedjatament wara t- twelid, il - ħtieġa għall- insulina tonqos malajr (b’ riskju akbar ta ’ ipogliċemija).
Careful monitoring of glucose control is essential.
Monitoraġġ bir- reqqa tal- livell taz - zokkor huwa essenzjali.
Lactation Lactating women may require adjustments in insulin dose and diet.
Treddigħ Nisa li qegħdin ireddgħu għandu mnejn ikollhom bżonn ta ’ tibdil fid- doża ta ’ l- insulina u fid- dieta.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem il- magni
5 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.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dawn jikkostitwixxu riskju f’ sitwazzjonijiet fejn dawn il- ħiliet huma ta ’ importanza speċjali (e. ż. sewqan ta ’ karozza jew tħaddim ta ’ makkinarju).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom ikunu mwissija biex jieħdu l- prekawzjonijiet kollha biex 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 partikolarment importanti f’ dawk li għandhom sintomi ta ’ ipogliċemija mnaqqsa, jew ma jistgħux jgħarfu s- sintomi ta ’ twissija tal- bidu, jew għandhom episodji spissi ta ’ ipogliċemija.
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
Għandhu jkun ikkunsidrat jekk ikunx għaqli s- sewqan jew it- tħaddim ta ’ makkinarju f’ ċirkostanzi bħal dawn.
Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemija, li ġeneralment hija l- aktar effett komuni u mhux mixtieq tat- terapija bl- insulina, tista ’ sseħħ meta d- doża ta ’ l- insulina tkun għolja aktar milli meħtieġ.
The following related adverse reactions from clinical investigations were listed below by system organ class and in order of decreasing incidence (very common: ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to < 1/ 100; rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare: < 1/ 10,000).
L- effetti avversi relatati u imniżżlin hawn taħt, miġbura minn studji kliniċi, huma elenkati skond is- sistema tal- klassifika ta ’ l- organi u f’ ordni fejn l- inċidenza dejjem tonqos (komuni ħafna: ≥1/ 10; komuni: ≥ 1/ 100 sa < 1/ 10; mhux komuni: ≥ 1/ 1, 000 sa < 1/ 100; rari: ≥ 1/ 10, 000 sa < 1/ 1, 000; rari ħafna: < 1/ 10, 000).
Hypoglycaemia Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Ipogliċemija Attakki severi ta ’ ipogliċemija, speċjalment meta jirrepetu ruħhom, jistgħu jwasslu għal ħsara newroloġika.
Prolonged or severe hypoglycaemic episodes may be life-threatening.
Episodji twal u severi ta ’ ipogliċemija jistgħu jkunu fatali.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation.
F’ ħafna pazjenti, is- sinjali u s- sintomi ta ’ neurogylcopenia iseħħu wara sinjali ta ’ kontro- regolazzjoni adreneġika.
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Ġeneralment dan il- fenomenu, u s- sintomi tiegħu, huma aktar żviluppati meta t- tnaqqis fil- livell taz- zokkor fid- demm ikun akbar u aktar mgħaġġel.
Immune system disorders
- 6 - Disturbi fis- sistema immuni
Allergic reaction Immediate-type allergic reactions to insulin are rare.
Reazzjoni allerġika Reazzjonijiet allerġiċi immedjati għall- insulina huma rari.
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, u xokk ikkarateriżżat bi tnaqqis sostanzjali ta ’ demm dieħel fit- tessuti periferali u disfunzjoni taċ- ċelluli tal - ġisem, li jistgħu jkunu fatali.
In clinical studies, antibodies that cross- react with human insulin and insulin glargine were observed with the same frequency in both NPH- insulin and insulin glargine treatment groups.
Fi studji kliniċi, antikorpi li jirreaġixxu kemm ma ’ l- insulina umana kif ukoll ma ’ l- insulina glargine kienu rrapportati bl- istess frekwenza fiż- żewġ gruppi ta ’ trattament, kemm f’ dak bl- insulina NPH, kif ukoll f’ dak bl- insulina glargine.
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 tikkorreġi t - tendenza għall- iper - jew l- ipo- gliċemija.
Dysgeusia
Rari ħafna: disturbi fit- togħma
Eyes disorders
Disturbi fl- għajnejn Rari:
Rare:
Tnaqqis fil- vista.
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.
Tibdil sostanzjali fil- kontroll taz- zokkor fid- demm jista ’ jikkaġuna tfixkil temporanju fil- vista, minħabba tibdil temporanju li jikkonsisti f’ nefħa tal- lenti ta ’ l- għajn u bidla fl- indiċi rifrattiv tagħha.
Retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Retinopatija Il- kontroll tajjeb tal- livell taz- zokkor fid- demm, fuq medda ta ’ żmien, inaqqas ir- riskju tal- progress tar - retinopatija tad- dijabete.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be
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 patients with proliferative retinopathy, 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.
As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħalma jiġri b’ kull tip ta ’ terapija bl- insulina, il- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din iżżomm lura l- assorbiment lokali ta ’ l- insulina.
Lipohypertrophy
Ipertrofija tat- tessut xaħmi
Lipoatrophy
Atrofija tat- tessut xaħmi
Injection site reactions Such reactions include redness, pain, itching, hives, swelling, or inflammation.
Reazzjonijiet fis- siti ta ’ l- injezzjonijiet Reazzjonijiet bħal dawn jinkludu ħmura, uġigħ, ħakk, urtikarja, nefħa, jew infjammazzjoni.
Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.
Il- biċċa l- kbira tar- reazzjonijiet ħfief għall- insulini fis- sit ta ’ l- injezzjoni ġeneralment jgħaddu fi ftit jiem sa ftit ġimgħat.
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 l- edema, speċjalment jekk qabel kien hemm kontroll metaboliku fqir li wara tjieb b’ terapija intensifikata bl- insulina.
Paediatric population
- 7 - Pazjenti pedjatriċi
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.
No clinical study safety data are available in patients below 6 years of age.
M’ hemmx data klinika disponibbli dwar is- sigurtà f’ pazjenti taħt 6 snin.
Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Doża eċċessiva ta ’ insulina tista ’ twassal għal ipogliċemija severa, u xi kull tant fit- tul, u tista ’ tpoġġi l - individwu f’ periklu tal- mewt.
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Episodji ħfief ta ’ ipogliċemija jistgħu normalment ikunu trattati bil- karboidrati mill- ħalq.
Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed.
Tibdil fid- dożaġġ tal- prodott mediċinali, fl- ikliet u fl- attività fiżika jistgħu jkunu meħtieġa.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose.
Episodji aktar severi b’ koma, aċċessjoni, jew disturb newroloġiku jistgħu jiġu ittrattati bil- glucagon intramuskolari jew subkutanju, jew bl- għoti tal- glukożju ikkonċentrat fil- vina.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Jista ’ jkun meħtieġ li t- teħid tal- karboidrati jibqa ’ jseħħ, u monitoraġġ jista ’ jkun neċessarju, għaliex l- ipogliċemija li jkun hemm terġa ’ titfaċċa wara li jkun hemm rispons klinikament pożittiv apparenti.
PHARMACOLOGICAL PROPERTIES
5. 1 Tagħrif farmakodinamiku
5.1 Pharmacodynamic properties 7 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.
It is completely soluble at the acidic pH of the Lantus injection solution (pH 4).
Hi tinħall għal kollox 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.
Dan jipprovdi profil ta ’ konċentrazzjoni dejjiema mingħajr varjazzjoni fil- konċentrazzjoni, u li jaħdem għal perijodu twil.
Insulin receptor binding:
Rabta mar- riċettur ta ’ l- insulina:
Insulin glargine is very similar to human insulin with respect to insulin receptor binding kinetics.
Insulin glargine huwa simili ħafna għall- insulina umana b’ referenza għall - komportament kinetiku ta ’ l- irbit mar- riċettur ta ’ l- insulina.
It can, therefore, be considered to mediate the same type of effect via the insulin receptor as insulin.
Għalhekk, jista ’ jitqies li għandu l- istess effett permezz tar- riċettur ta ’ l- insulina bħal dik ta ’ l- insulina nnifisha.
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
L- attività primarja ta ’ l- insulina, inkluża dik ta ’ insulin glargine, hija li tirregola l- metaboliżmu tal- glukożju.
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- livell tal- glukożju fid- demm, billi jistimulaw id- dħul tal- glukożju mill- periferija għal ġot- tessuti, speċjalment ġol- muskoli ta ’ l- iskeletru u x- xaħam, u billi jinibixxu l - produzzjoni tal- glukożju mill- fwied.
Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
L- insulina tinibixxi l- lipoliżi fit- tessut xaħmi u l- protejoliżi u tinkuraġġixxi s- sinteżi 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 farmakoloġiċi kliniċi, insulin glargine u l- insulina umana, it- tnejn intravenużi, intwerew li għandhom l- istess qawwa meta ngħataw fl- istess doża.
As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
Bħall- insulini kollha, iż- żmien kemm idum jaħdem insulin glargine jista ’ jkun affettwat mill- attività fiżika u fatturi 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.
- 8 - 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.
The following graph shows the results from a study in patients:
Il- graff li jmiss turi r- riżultati minn studju li sar fuq pazjenti:
Activity Profile in Patients with Type 1 Diabetes
Il- Profil ta’ Attività F’ Pazjenti li Għandhom id- Dijabete Tip 1
6
6 Ir- rata li biha jintuża l- glukożju *
NPH insulin
Insulin glargine NPH Insulin 3
Time (h) after s. c. injection
Il- punt fejn twaqqaf il - perijodu ta 'osservazzjoni
End of observation period
Il- ħin (sigħat) li għadda wara l- injezzjoni subkutanja
*determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
* ikkalkulat bħala l- ammont ta ’ glukożju injettat biex iżomm il- livelli tal- glukożju kostanti fil- plażma (valuri medji kull siegħa).
The longer duration of action of insulin glargine is directly related to its slower rate of absorption and supports once daily administration.
Iż- żmien itwal li jdum jaħdem insulin glargine huwa relatat direttament mar- rata aktar bil- mod ta’ assorbiment u jikkonferma l- effikaċja tat- teħid darba 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 ta ’ l- insulina, bħal insulin glargine, jista ’ jvarja ħafna f’ individwi differenti jew fl- istess persuna.
8 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.
Effects of Lantus (once daily) on diabetic retinopathy were evaluated in an open-label 5-year NPH- controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
L- effetti ta ’ Lantus (darba kuljum) fuq retinopatija tad- dijabete ġew evalwati f’ 1024 pażjent fi studju ta ’ ħames snin, fejn kemm l- investigatur kif ukoll il- pazjenti kienu jafu x’ mediċini kienu qed jintużaw, b’ NPH bħala kontrol (NPH jingħata darbtejn kuljum) u fejn il- progress tar- retinopatija bi tlett gradi jew aktar fuq Studju Dwar Trattament Kmieni ta ’ Retinopatija tad- Dijabete (ETDRS) kien investigat b’ ritratt tal- fundus.
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.
5.2 Pharmacokinetic properties
Tagħrif farmakokinetiku
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’ persuni b’ saħħithom u f’ pazjenti dijabetiċi, il- livelli ta ’ l- insulina fis- serum juru assorbiment aktar bil- mod, imtawwal ħafna aktar, mingħajr avariji fil- koncentrazzjoni, wara injezzjoni subkutanja ta ’ insulin glargine meta mqabbla ma ’ l- NPH insulina umana.
Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine.
- 9 - ħin ta ’ l- attività farmakodinamika ta ’ insulin glargine.
The graph above shows the activity profiles over time of insulin glargine and NPH insulin.
Il- graff hawn fuq turi il- profili ta’ attività kontra l- ħin ta ’ Insulin glargine u l- NPH insulin.
Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
Insulin glargine injettata darba kuljum tilħaq livelli fissi u stabbli fi żmien 2 - 4 ijiem wara l- ewwel doża.
When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Meta jingħataw fil- vina, il- half- life ta ’ l- eliminazzjoni ta ’ insulin glargine u l- insulina umana huma 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, insulin glargine huwa parzjalment degradat fit- tessut subkutanju fil- carboxyl terminus tal - katina Beta, bil- formazzjoni ta ’ prodotti metaboliċi attivi 21A- Gly- insulin u 21A- Gly- des- 30B- Thr- insulin.
Unchanged insulin glargine and degradation products are also present in the plasma.
Jinstabu wkoll insulin glargine mhux mibdul u sustanzi oħra ġejjin mid- degradazzjoni tal- prodott fil- plażma.
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- analażi ta ’ sottogruppi ibbażati fuq l- età u s- sess, ma indikaw l- ebda differenza fis- sigurtà u l- effikaċja f’ pazjenti ittrattati b’ insulin glargine, mqabblin mal- popolazzjoni sħiħa suġġetta għal dan 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 perikolu speċjali għall- bniedem.
5 ml vial:
Kunjett ta ’ 5 ml:
Zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injections.
Zinc chloride M- cresol Glycerol Hydrochloric acid Sodium hydroxide Ilma għall- injezzjonijiet
10 ml vial:
Kunjett ta ’ 10 ml:
Zinc chloride, m-cresol, glycerol, hydrochloric acid, Polysorbate 20, sodium hydroxide, water for injections
Zinc chloride m- cresol glycerol hydrochloric acid Polysorbate 20 sodium hydroxide ilma għall- injezzjonijiet
It is important to ensure that syringes do not contain traces of any other material.
Huwa importanti li tiżgura li s - siringi ma jkollhomx xi traċċi ta ’ ebda materjal ieħor.
Shelf-life after first use of the vial The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
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.
It is recommended that the date of the first use from the vial be noted on the label.
Huwa rrakkomandat li d- data ta ’ l- ewwel użu mill- kunjett tkun mniżżla fuq it- tikketta.
Unopened vials Store in a refrigerator (2°C-8°C).
Kunjetti mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ).
Keep the vial in the outer carton in order to protect from light.
Lantus m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Opened vials For storage precautions, see section 6.3.
Kunjetti miftuħa Għall- kundizzjonijiet ta ’ ħażna, ara sezzjoni 6. 3.
5 ml solution in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
5 ml soluzzjoni f’ kunjett (ħġieġ tip 1 mingħajr kulur) b’ għatu bi flanġ (aluminju), tapp (lastku tal - chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).
Packs of 1, 2, 5 and 10 vials are available.
Pakketti ta ’ 1, 2, 5 u 10 kunjetti huma disponibbli.
10 ml solution in a vial (type 1 colourless glass) with a flanged cap (aluminium), (type 1, laminate of polyisoprene and bromobutyl rubber) a stopper and a tear-off cap (polypropylene).
10 ml soluzzjoni f’ kunjett (ħġieġ tip 1 mingħajr kulur) b’ għatu bi flanġ (aluminju), tapp (tip 1, b’ safef ta ’ lastku polyisoprene u bromobutyl) u għatu li jiċċarrat (polypropylene).
Packs of 1 vial are available.
Pakkett ta ’ kunjett wieħed huwa disponibbli.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor Ifli l- kunjett 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.
Għandha tintuża biss jekk is- soluzzjoni hija ċara u bla kulur, mingħajr 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 huwa soluzzjoni, m’ hemmx bżonn ta ri - sospensjoni qabel l- użu.
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, il- Ġermanja.
10 Date of first authorisation:
Data ta ’ l- ewwel awtoriżżazzjoni:
9 June 2000 Date of latest renewal:
9 ta ’ Ġunju 2000 Data ta ’ l- aħħar tiġdid:
9 June 2005
9 ta ’ Ġunju 2005
11 1.
1.
Lantus 100 Units/ ml solution for injection in a cartridge.
Lantus 100 Unità / ml ta ’ soluzzjoni għall- injezzjoni fi skartoċċ.
Each ml contains 100 Units insulin glargine (equivalent to 3.64 mg).
Kull ml fih 100 Unità insulina glargine (ekwivalenti għal 3. 64 mg).
Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Kull skartoċċ fih 3 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 300 Unità.
Solution for injection in a cartridge.
Soluzzjoni għall- injezzjoni fi skartoċċ.
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 jitnaqqas ir- riskju ta ’ l- ipogliċemija matul il- lejl u filgħodu kmieni, il- pazjenti li qed jaqilbu s- sistema bażi tal- kura tagħhom b’ NPH insulin minn darbtejn kuljum, għall- sistema ta ’ kura b ’ Lantus ta ’ darba kuljum, għandhom inaqqsu d- doża bażi ta ’ kuljum b’ 20% sa 30%, waqt l- ewwel ftit ġimgħat tat- trattament.
12 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.
F’ dawn l- ewwel ftit ġimgħat, it- tnaqqis irid ikun, almenu parzjalment, ikkumpensat b’ żieda fid- doża ta ’ l - insulina fil- ħin ta ’ l- ikel, u wara dan il- perijodu, is- sistema ta ’ kura trid tkun imfassla skond l- individwu.