qanastek/EMEA-V3 huggingface dataset:
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).
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
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 Very rare:
Disturbi fis- sistema nervuża
Eyes disorders
Rari ħafna: disturbi fit- togħma
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- vistaTibdil 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.
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.
6 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.
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.
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.
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.
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.
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.
Insulins and analogues for injection, long-acting.
Insulini u l- analogigħall- 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 bmod li ma tinħallx biżżejjed ftit f’ pH newtrali.
It is completely soluble at the acidic pH of the Optisulin injection solution (pH 4).
Hi tinħall għal kollox fil- pH aċiduża tas- soluzzjoni għall- injezzjoni ta ’ Optisulin (pH 4).
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 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.
The following graph shows the results from a study in patients:
8 Il- graff li jmiss turi r- riżultati minn studju li sar fuq pazjenti:
8 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.
Effects of Optisulin (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 ’ Optisulin (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 Optisulin was compared to NPH insulin.
Meta Optisulin ġie mqabbel mal- insulina NPH, ma dehritx xi differenza sinifikanti fil- progress ta ’ retinopatija tad- dijabete.
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.
When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
9 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 fuq studji konvenzjonali ta ’ sigurta ’ farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is - sistema riproduttiva, ma turi l- ebda xi perikolu speċjali għall- bniedem.
Zinc chloride, m-cresol, glycerol, hydrochloric acid,
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 be noted on the label.
Huwa rrakkomandat li d- data ta ’ l- ewwel użu mill- kunjett tkun mniżżla fuq it- tikketta.
Keep the vial in the outer carton in order to protect from light.
Optisulin 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.
Packs of 1, 2, 5 and 10 vials are available.
Pakketti ta ’ 1, 2, 5 u 10kunjetti huma disponibbli.
10 ml solution in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (type 1, laminate of polyisoprene and bromobutyl rubber) 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.
Pakketti ta ’ kunjett 1 huma disponibbli.
Inspect the vial before use.
Ifli l- kunjett sew qabel l- użu.
Since Optisulin is a solution, it does not require resuspension before use.
Peress li Optisulin huwa soluzzjoni, m’ hemmx bżonn ta ri- sospensjoni qabel l- użu.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L - AWTORIZZAZZJONI
Date of first approval:
Data ta ’ l- ewwelapprovazzjoni:
27 June 2000 Date of latest renewal:
27 ta ’ Ġunju 2000 Data ta ’ l- aħħar tiġdid:
27 June 2005
27 ta ’ Ġunju 2005
Optisulin 100 Units/ ml solution for injection in a cartridge.
Optisulin 100 Unità / ml ta ’ soluzzjoni għall- injezzjoni fi skartoċċ.
Optisulin contains insulin glargine an insulin analogue with a prolonged duration of action. 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.
12 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 Optisulin should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
12 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 ’ Optisulin ta ’ darba kuljum, għandhom inaqqsu d- doża bażi ta ’ kuljum b’ 20% sa 30%, waqt l- ewwel ftit ġimgħat tat- trattament.
4.4 Special warnings and precautions for use
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi 4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
Due to limited experience the efficacy and safety of Optisulin 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 ’ Optisulin 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.
13 F’ pazjenti li għandhom indeboliment fil- funzjoni renali, il- ħtieġa għall- insulina tista ’ tonqos dovuta għat- tnaqqis tal- metaboliżmu ta ’ l- insulina.
13 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.
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 (p. e. clozapine u olanzapine) u l- inibituri tal- protease.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available.
Tqala Għal insulin glargine m’ hemmx tagħrif kliniku minn studji kliniċi ikkontrollati dwar l- użu waqt it - tqala.
The available clinical data is insufficient to exclude a risk.
15 Id- data klinika disponibbli m’ hix biżżejjed biex teskludi xi riskju.
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.
15 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem il- magni
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom. L - effetti l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
Allergic reaction Immediate-type allergic reactions to insulin are rare.
Reazzjoni allerġika Reazzjonijiet allerġiċi immedjati għall- insulina li jseħħu 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 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.
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
16 Eyes disorders
16 glargine.
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 tfixkil temporanju fil- vista, minħabba tibdil temporanju li jikkonsisti f’ nefħa tal- lenti ta ’ l- għajn u bidla fl- indiċi rifrattiv tagħha.
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.
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit -- tessuti ta ’ taħt il- ġilda
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.
17 4.9 Overdose
17 Sintomi
18 The following graph shows the results from a study in patients:
18 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
5 Glucose Utilization Rate* (mg/ kg/ min)
5 glukożju * (mg/ kg/ min) Ir- rata li biha jintuża l -
When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
19 Meta jingħataw fil- vina, il- half- life ta ’ l- eliminazzjoni ta ’ insulin glargine u l- insulina umana huma komparabbli.
19 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 klinikamiġbura minn studji konvenzjonali ta ’ sigurta ’ 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.
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.
Iż- 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.
Do not put Optisulin next to the freezer compartment or a freezer pack.. Keep the cartridge in the outer carton in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
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 (lasktu bromobutyl) u għatu bi flanġ (aluminju), b’ tapp (lastku bromobutyl jew b’ safef ta ’ lasktu polyisoprene u bromobutyl).
Packs of 4, 5 and 10 cartridges are available.
Pakketti ta ’ 4, 5 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 Optisulin 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 ’ iskartoċċi ta ’ Optisulin, u skond kif inhu irrakkomandat fit- tagħrif ipprovdut mill - manifattur tal- pinna.
20 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.
Cartridge Before insertion into the pen, the cartridge must be stored at room temperature for 1 to 2 hours.
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.
Since Optisulin is a solution, it does not require resuspension before use.
Peress li Optisulin 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 tuża tal - pinna).
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma il- Kumissjoni Ewropea dwar il - pjanijiet għat- tqegħid fis- suq għal dan il- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Optisulin 100 Units/ ml Solution for injection in a vial Insulin glargine
Insulin glargine
Excipients: zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injections
Sustanzi mhux attivi: zinc chloride, m- cresol, glycerol, hydrochloric acid, sodium hydroxide, ilma għall- injezzjonijiet
Keep in the outer carton.
Żomm fil- kartuna ta ’ barra.
EU/ 1/ 00/ 133/ 001 1 vial of 5ml EU/ 1/ 00/ 133/ 002 2 vials of 5ml EU/ 1/ 00/ 133/ 003 5 vials of 5ml EU/ 1/ 00/ 133/ 004 10 vials of 5ml
EU/ 1/ 00/ 133/ 001 kunjett 1 ta ’ 5 ml EU/ 1/ 00/ 133/ 002 2 kunjetti ta ’ 5 ml EU/ 1/ 00/ 133/ 003 5 kunjetti ta ’ 5 ml EU/ 1/ 00/ 133/ 004 10 kunjetti ta ’ 5 ml
Optisulin 100 Units/ ml Solution for injection in a vial Insulin glargine
Optisulin 100 Unità / ml Soluzzjoni għall- injezzjoni, f’ kunjett Insulin glargine
Date of first use :……………
Data ta ’ l- ewwel użu.............
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Excipients: zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, polysorbate 20, water for injections
Sustanzi mhux attivi: zinc chloride, m- cresol, glycerol, hydrochloric acid, polysorbate 20, sodium hydroxide, ilma għall- injezzjonijiet
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Optisulin 100 Units/ ml Solution for injection in a cartridge Insulin glargine
Optisulin 100 IU/ ml Soluzzjoni għall- injezzjoni fi skartoċċ Insulin glargine
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Optisulin cartridges.
L- iskartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- iskartoċċi ta ’ Optisulin.
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 qed taħdem sew (minħabba xi difetti mekkaniċi) għandha tintrema, u tintuża pinna ġdida ta ’ l- insulina.
The pen containing the cartridge must not be stored in the refrigerator.
Il - pinna li fiha l- iskartoċċ m’ għandhiex tinżamm fil- friġġ.
EU/ 1/ 00/ 133/ 005 4 cartridges of 3ml EU/ 1/ 00/ 133/ 006 5 cartridges of 3ml EU/ 1/ 00/ 133/ 007 10 cartridges of 3ml
EU/ 1/ 00/ 133/ 005 4 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 133/ 006 5 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 133/ 007 10 skartoċċi ta ’ 3 ml
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Optisulin 100 Units/ ml Solution for injection in a cartridge Insulin glargine
Insulin glargine
This cartridge is to be used with OptiPen.
Dan l- iskartoċċ għandu jintuża ma ’ l’ OptiPen.
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Optisulin 100 Units/ ml solution for injection in a vial Insulin glargine
Optisulin 100 Unità/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina glargine
- If any of the side effects gets serious, or if you notice any side effects not listed on this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Optisulin is and what it is used for 2.
X’ inhu Optisulin u għalxiex jintuża 2.
Before you use Optisulin 3.
Qabel ma tuża Optisulin 3.
How to use Optisulin 4.
Kif għandek tuża Optisulin 4.
How to store Optisulin 6.
Kif taħżen Optisulin 6.
WHAT OPTISULIN IS AND WHAT IT IS USED FOR
X’ INHU OPTISULIN U GĦALXIEX JINTUŻA
Optisulin is a clear, colourless solution for injection containing insulin glargine.
Optisulin huwa soluzzjoni, ċara u bla kulur, għal injezzjoni, li għandha Insulin glargine.
Insulin glargine has a long and steady blood-sugar-lowering action.
Huwa magħmul permezz ta ’ proċess bijoteknoloġiku Insulin glargine għandu effett kostanti u fit- tul, li jbaxxi l- livell taz- zokkor fid- demm.
Optisulin is used to reduce high blood sugar in adults, adolescents and children of 6 years or above with diabetes mellitus.
Optisulin huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fl- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin u akbar li jbatu minn diabetes mellitus.
BEFORE YOU USE OPTISULIN
QABEL MA TUŻA OPTISULIN
Do not use Optisulin
Tużax Optisulin:
If you are allergic (hypersensitive) to insulin glargine or any of the other ingredients of Optisulin.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina glargine jew għal xi waħda mis - sustanzi l- oħra ta ’ Optisulin.
Take special care with Optisulin
Oqgħod attent/ a ħafna b’ Optisulin
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Segwi sew l- istruzzjonijiet għad- dożaġġ, monitoraġġ (tad- demm u l- urina permezz tat- testijiet), id - dieta u l- attività fiżika (xogħol fiżiku u eżerċizzju) kif diskuss mat- tabib tiegħek.
There is limited experience with the use of Optisulin in children less than 6 years old and in patients whose liver or kidneys do not function well.
Gruppi speċjali ta ’ pazjenti Hemm esperjenza limitata bl- użu ta ’ Optisulin fit- tfal taħt is- 6 snin u f’ pazjenti li għandhom il- fwied jew il- kliewi mhux jiffunzjonaw sew.
37
37 Safar Qabel tivvjaġġa kellem lit- tabib tiegħek.
- the possible effects of changing to different time zones,
- il- ħin ta ’ l- ikel u t- teħid ta ’ l- insulina waqt l- ivvjaġġar
- possible new health risks in the countries to be visited
- l- effetti possibbli fit- tibdil minn żona ta ’ ħin għal oħra differenti,
- If you are not eating enough your blood sugar level may become too low
- Jekk m’ intix qed tiekol biżżejjed, il- livell taz- zokkor fid- demm tiegħek jista ’ jinżel iżżejjed
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Xi mediċini jikkawżaw tibdil fil- livell taz- zokkor fid- demm (tnaqqis, żieda jew it- tnejn li huma skond iċ- ċirkostanzi).
- angiotensin converting enzyme (ACE) inhibitors used to treat certain heart conditions
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti -
or high blood pressure),
kundizzjonijiet tal- qalb jew ta ’ pressjoni għolja fid- demm),
- disopyramide (used to treat certain heart conditions),
- disopyramide (użat għall- kura ta ’ ċerti kundizzjonijiet tal- qalb),
- fluoxetine (used to treat depression),
- fluoxetine (użat għall- kura tad- depressjoni),
- fibrates (used to lower high levels of blood lipids),
- fibrates (użati biex ibaxxu l- livelli għoljin tal- lipidi fid- demm),
monoamine oxidase (MAO) inhibitors (used to treat depression),
- l- inibituri ta ’ monoamine oxidase (MAO) (użati għall- kura tad- depressjoni),
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and
- pentoxifylline, propoxyphene, salicylates (bħal aspirina, użata biex ittaffi l- uġigħ u tbaxxi d -
lower fever),
deni),
- diuretics (used to treat high blood pressure or excessive fluid retention),
- id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew iż- żamma eċċessiva ta ’
- somatropin (growth hormone),
fluwidi),
- sympathomimetic medicines (such as epinephrine [adrenaline], or salbutamol,
- glukagon (ormon tal- frixa użat għall- kura ta ’ ipogliċemija severa),
- thyroid hormones (used to treat thyroid gland disorders),
- isoniazid (użat għall- kura tat- tuberkulożi),
- atypical antipsychotic medications (such as clozapine, olanzapine),
- l- estroġeni u l- proġesteni (bħal fil- pillola kontraċettiva, użata għall- kontroll tat- twelid),
- beta-blockers (used to treat high blood pressure),
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
- clonidine (used to treat high blood pressure),
- imblokkaturi tar- riċetturi beta (użati għall- kura ta ’ pressjoni għolja fid- demm),
-
- clonidine (użat għall- kura ta ’ pressjoni għolja fid- demm)
lithium salts (used to treat psychiatric disorders).
- is- sustanzi tal- lithium (użati għall- kura ta ’ disturbi psikjatriċi)
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Jekk m’ intix ċert/ a jekk intixqed tieħu waħda minn dawn il- mediċini staqsi lit- tabib jew lill- ispiżjar tiegħek.
Using Optisulin with food and drink
Meta tuża Optisulin ma ’ l- ikel u max- xorb
Your insulin dosage may need to be changed during pregnancy and after giving birth.
Id- dożaġġ tiegħek ta ’ l - insulina għandu mnejn jeħtieġ li jinbidel waqt it- tqala u wara li twelled.
Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Il- kontroll għaqli tad- dijabete tiegħek, u l- prevenzjoni ta ’ l- ipogliċemija, huma importanti għas- saħħa tat- tarbija tiegħek.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Jekk int qed tredda ’ iddiskutiha mat- tabib tiegħek, għax jista ’ jagħti l- każ li teħtieġ tibdiliet fid- dożi ta ’ l- insulina u d- dieta tiegħek.
Your ability to concentrate or react may be reduced if: − you have hypoglycaemia (low blood sugar levels), − you have hyperglycaemia (high blood sugar levels), − you have problems with your sight.
- għandek l- ipergliċemija (livell għoli ta ’ zokkor fid- demm)
You should contact your doctor for advice on driving if:
Għandek tikkuntattja lit- tabib tiegħek għal parir fuq is- sewqan jekk:
Important information about some of the ingredients of Optisulin
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Optisulin
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i. e. it is essentially ‘ sodium-free’.
Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e, tista ’ tgħid li “ ‘ nieqes minnsodium ”.
HOW TO USE OPTISULIN
KIF GĦANDEK TUŻA OPTISULIN
Dosage Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will:
Skond l- istil ta ’ ħajtek u r- riżultati tat- testijiet taz- zokkor (glukożju) fid- demm u l- użu preċedenti tiegħek ta ’ l- insulina, it- tabib tiegħek sejjer:
- determine how much Optisulin per day you will need and at what time,
- jikkalkula kemm għandek bżonn Optisulin kuljum u f’ liema ħin trid tieħdu,
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- jgħidlek meta teżamina l- livell taz- zokkor f’ demmek, u jekk għandekx tagħmel it- testijiet fuq l -
- tell you when you may need to inject a higher or lower dose of Optisulin..
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Optisulin.
Optisulin is a long-acting insulin.
Optisulin huwa tip ta ’ insulina li taħdem fit- tul.
You need one injection of Optisulin every day, at the same time of the day.
Għandek bżonn ta ’ injezzjoni waħda ta ’ Optisulin kuljum, fl- istess ħin tal- ġurnata.
Optisulin is injected under the skin.
Optisulin huwa injettat taħt il- ġilda.
Do NOT inject Optisulin in a vein, since this will change its action and may cause hypoglycaemia.
TINJETTAX Optisulin fil- vina għax dan jibdillu l- effett u jista ’ jikkaġuna ipogliċemija.
Your doctor will show you in which area of the skin you should inject Optisulin.
It- tabib tiegħek sejjer jurik f’ liema post fil- ġilda għandek tinjetta Optisulin.
With each injection, change the puncture site within the particular area of skin that you are using.
B’ kull injezzjoni, biddel is- sit tat- titqiba, fiż- żona partikolari tal- ġilda li qed tuża.
Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it.
Użaha biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah l- ilma, u ma jkunx jidher xi frak fiha.
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
M’ għandekx tħawdu jew tħalltu qabel ma tużah Kun żgur li la l- alkoħol u anqas disinfettanti oħra, jew xi sustanzi oħra, ma jikkontaminaw l- insulina.
Do not mix Optisulin with any other insulins or medicines.
Tħallatx Optisulin ma ’ insulini oħra jew ma ’ xi mediċini.
Do not dilute it.
Tiddilwihiex.
Mixing or diluting may change the action of Optisulin.
Jekk tħalltu jew tiddilwiha jista ’ jinbidel l- effett ta ’ Optisulin.
Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża kunjett ġdid jekk tinduna li f’ daqqa waħda l- kontroll taz- zokkor fid- demm tiegħek imur għall- agħar.
If you think you may have a problem with Optisulin, have it checked by your doctor or pharmacist.
Jekk taħseb li għandek xi problema b’ Optisulin, ħudu għand it- tabib jew l- ispiżjar tiegħek biex jeżaminah
If you use more Optisulin than you should
Jekk tuża aktar Optisulin milli suppost
- If you have injected too much Optisulin, your blood sugar level may become too low
Jekk injettajt aktar Optisulin milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq (ipogliċemija).
In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Ġeneralment, biex tevita l- ipogliċemija għandek tiekol aktar u timmonitorja z- zokkor f’ demmek.
For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
Għal aktar informazzjoni fuq il- kura ta ’ l - ipogliċemija, ara l- kaxxa fit- tmiem ta ’ dan il- fuljett.
If you forget to use Optisulin:
40 Jekk tinsa tuża Optisulin:
If you have missed a dose of Optisulin or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia).
Jekk tlift doża ta ’ Optisulin jew jekk ma injettajtx biżżejjed insulina, il- livell tiegħek taz- zokkor fid- demm jista ’ jogħla wisq (ipergliċemija).
For information on the treatment of hyperglycaemia, see box at the end of this leaflet. - Do not take a double dose to make up for a forgotten dose.
Għal informazzjoni fuq il- kura ta ’ l- ipergliċemija, ara l- kaxxa li tinsab fit- tmiem ta ’ dan il- fuljett.
40 If you stop using Optisulin This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Do not stop Optisulin without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Optisulin mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Optisulin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Optisulin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Ara l- kaxxa fit- tmiem ta ’ dan il- fuljett, għal aktar informazzjoni dwar l- effeti sekondarji ta ’ livell baxx ta ’ zokkor fid- demm jew ta ’ livell għoli ta ’ zokkor fid- demm.
Changing the injection site with each injection may help to prevent such skin changes. • Skin and allergic reactions 3 to 4% of patients may experience reactions at the injection site (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation).
3 sa 4% tal- pazjenti jista` jkollhom reazzjonijiet fis- sit ta ’ l- injezzjoni (bħal ħmura, uġigħ qawwi mhux tas- soltu meta ssir l- injezzjoni, ħakk, urtikarja, nefħa jew infjammazzjoni).
Most minor reactions to insulins usually resolve in a few days to a few weeks.
Il- biċċa l- kbira tar- reazzjonijiet zgħar għall- insulini normalment jgħaddu fi żmien ftit jiem sa ftit ġimgħat.
Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 patients) • Severe allergic reactions to insulins Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Każijiet severi ta ’ reazzjonijiet ġeneraliżżati, inkluża r - reazzjoni anafilattika, tista ’ tkun fatali.
These could be symptoms of severe allergic reactions to insulins and may become life-threatening. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
• Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Jekk qed tbati minn retinopatija proliferattiva (marda ta ’ l- għajnejn relatata mad- dijabete) attakki severi ta ’ l- ipogliċemija jistgħu jirriżultaw f’ telf temporanju tal- vista
41 Other side effects include:
Effetti sekondarji oħrajn jinkludu:
HOW TO STORE OPTISULIN
KIF TAĦŻEN OPTISULIN
Do not use Optisulin after the expiry date which is stated on the carton and on the label of the vial.
Tużax Optisulin wara d- data ta ’ skadenza li tidher fuq il - kaxxa u fuq it- tikketta tal- kunjett.
Do not put Optisulin next to the freezer compartment or a freezer pack.
Optisulin m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
Opened vials Once in use, the vial may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light in the outer carton.
Kunjetti miftuħaĠaladarba fl- użu, l- kunjett jista jinħażen sa massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ fil- kartuna ta ’ barra u ’ l bogħod mis- sħana diretta jew mid- dawl dirett..
Do not use Optisulin if you notice particles in it.
Tużax Optisulin jekk tinnota xi frak fih.
Only use Optisulin if the solution is clear, colourless and waterlike.
Uża Optisulin biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah lill- ilma.
Medicines should not be disposed of via wastewater or household waste.
42 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma l- iskart domestiku.
What Optisulin contains
X’ fih Optisulin:
One millilitre of the solution contains 100 Units of the
Millilitru wieħed ta ’ soluzzjoni fih 100 Unità tas- sustanza
active substance insulin glargine.
attiva insulina glargine.
- The other ingredients of Optisulin are: zinc chloride, m-cresol, glycerol, sodium hydroxide,
- Is- sustanzi l- oħra ta ’ Optisulin huma: zinc chloride, m- cresol, glycerol, sodium hydroxide,
hydrochloric acid, polysorbate 20 (10 ml vial only) and water for injections.
hydrochloric acid, polysorbate 20 (kunjett ta ’ 10 ml biss) u ilma għall- injezzjonijiet.
42 What Optisulin looks like and contents of the pack
Id- dehra ta ’ Optisulin u l- kontenuti tal- pakkett:
Optisulin 100 Units/ ml solution for injection in a vial is a clear, colourless and waterlike solution.
Optisulin 100 Unità/ ml soluzzjoni għall- injezzjoni f’ kunjett huwa soluzzjoni ċara, mingħajr kulur u tixbah l- ilma.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
43 Deutschland Sanofi- Aventis Deutschland GmbH Tel: +49 (0) 180 2 222010
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Dan il- fuljett kien approvat l- aħħar f ’
44 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
44 IPERGLIĊEMIJA U IPOGLIĊEMIJA
you have an injury, operation, infection or fever,
eċċitament), jew għandek xi ferita, saritlek xi operazzjoni, għandek xi infezzjoni jew għandek id- deni.
Warning symptoms of hyperglycaemia Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat and, glucose and ketone bodies in urine.
Sintomi ta ’ twissija ta ’ ipergliċemija Għatx, tħoss il- bżonn miżjud biextgħaddi l- awrina aktar spiss miss- soltu, għeja, ġilda xotta, ħmura tal - wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mgħġaġġel, u glukosju u ketoni fl - awrina.
Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Uġigħ fl- istonku, in- nifs mgħaġġel u fil- fond, ngħas u anki telf mis- sensi, jistgħu jkunu sinjali ta ’ kundizzjoni serja (kitoaċidożi) li tkun ikkaġunata minn nuqqas ta ’ insulina.
Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Jekk il- livell taz- zokkor fid- demm tiegħekjinżel wisq tista ’ tintilef minn sensik. Ipogliċemija serja tista ’ tkun il- kawża ta ’ attakk ta ’ qalb jew ta ’ ħsara fil- moħħ u tista ’ tkun fatali.
Hypoglycaemia is also more likely to occur if
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
- you have just begun insulin treatment or changed to another insulin preparation (when changing
- int għadek tibda t- trattament bl- insulina jew qlibt għal preparat ieħor ta ’ insulina, (meta tbiddel
from your previous basal insulin to Optisulin hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night),
mill- insulina bażika li kellek għal- Optisulin, l- ipogliċemija, jekk isseħħ, hija aktar probabbli li isseħħ filgħodu milli billejl.)
- you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
- int issofri minn mard sever tal- kliewi jew mard tal- fwied, jew xi marda oħra bħal tnaqqis fil -
-In your body Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Eżempji ta ’ sintomi li juruk li l- livell taz- zokkor fid- demm tiegħek qed jaqa ’ wisq, jew qiegħed jinżel wisq malajr: għaraq żejjed, ġilda twaħħal, l- ansjetà, il- qalb tħabbat mgħaġġla, pressjoni għolja tad - demm, palpitazzjonijiet u l- qalb tħabbat b’ mod irregolari.
-In your brain Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Ezempji ta ’ sintomi li jindikaw livell baxx taz- zokkor fil- moħħ: uġigħ ta ’ ras, ġuħ kbir, dardir, remettar, għeja, ngħas, disturbi fl- irqad,, komportament aggressiv, nuqqas ta ’ attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid- diskors, (xi drabi it- telf komplet tad- diskors), indeboliment tal- vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir - reġjun tal- ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t- telf mis- sensi..
- you have recently changed from an animal insulin to a human insulin such as Optisulin,
- dan l- aħħar biddilt minn tip ta ’ insulina ġejja mill- annimali għal dik tat- tip umana bħal
What should you do if you experience hypoglycaemia?
X’ għandek tagħmel f’ każ ta ’ ipogliċemija?