qanastek/EMEA-V3 huggingface dataset:
46 If no insulin appears at the needle tip, step 3 should be repeated two more times until insulin appears at the needle tip.
Jekk ebda insulina ma titfaċċa fil- ponta tal- labra, l- pass numru 3 għandu jiġi repetut darbtejn oħra sakemm l- insulina titfaċċa fil- ponta tal- labra.
If no insulin comes out after changing the needle, the OptiSet may be damaged.
Jekk ebda insulina ma toħroġ mill- labra, wara li tkun inbidlet il- labra jista ’ jagħti l- każ li l- OptiSet hija bil- ħsara.
Step 4
Pass Nru.
The dose can be set in steps of 2 units, from a minimum of 2 units to a maximum of 40 units.
Id- doża tista ’ tiġi ssettjata f’ qabżiet ta ’ żewġ unitajiet ’ il waħda, minn minimu ta żewġ (2) unitajiet għall- massimu ta ’ 40 unità.
If a dose greater than 40 units is required, it should be given as two or more injections.
Jekk id- doża meħtieġa hija akbar minn 40 unità, din trid tingħata f’ żewġ injezzjonijiet jew aktar.
If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.
Jekk il- planġer iswed qiegħed fil- bidu ta ’ l- indikatur ikkulurit, allura hemm madwar 40 unità ta ’ insulina disponibbli.
If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- indikatur ikkulurit, allura hemm madwar 20 unità ta ’ insulina disponibbli.
The dosage selector should be turned forward until the dose arrow points to the required dose.
Dawwar il- mekkaniżmu għas- selezzjoni tad- dożaġġ sakemm il- vleġġa tkun qed tipponta lejn id- doża meħtieġa.
Step 5
Pass Nru.
button should be pulled out as far as it will go in order to load the pen.
Il- buttun ta ’ l- injezzjoni għandu jinġibed kollu ’ l barra sabiex tgħabbi l- pinna.
The injection button allows checking the actual loaded dose.
49 Il- buttun ta ’ l- injezzjoni jippermetti li tkun iċċekkjata d- doża attwali mtella ’.
The last thick line visible on the injection button shows the amount of insulin loaded.
L- aħħar linja ħoxna viżibbli fuq il- buttun ta ’ l - injezzjoni turik l- ammont ta ’ insulina li telgħet.
The needle should be inserted into the skin
Il- labra trid tiddaħal fil- ġilda.
This ensures that the full dose of insulin has been delivered..
Dan jiżgura li d- doża sħiħa ta ’ l- insulina ingħatat.
Step 7
7
This helps prevent contamination and/ or infection as well as entry of air into the insulin reservoir and leakage, of the insulin, which can cause inaccurate dosing.
Dan jgħin biex tevita l- kontaminazzjoni u/ jew l - infezzjoni kif ukoll id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u t- tqattir ta ’ l- insulina, li tista ’ twassal għal doża mhux eżatta.
The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables.
Ir- rata ta ’ assorbiment, u konsegwentement it- tul ta ’ ħin biex is- sustanza tibda taħdem u kemm iddum taħdem, jistgħu jiġu effetwati mil- post ta ’ l- injezzjoni, l- ezerċizzju u fatturi oħra li jistgħu jinbiddlu.
Care should be taken to ensure that a blood vessel has not been entered.
51 Wieħed irid joqgħod attent li l- injezzjoni ma ssirx ġo vina jew arterja.
After injection, the site of injection should not be massaged.
Wara li ssir l- injezzjoni, il- post ta ’ l- injezzjoni m’ għandux jiġi immassaġjat.
49 In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
Fin- nuqqas ta ’ studji dwar il- kompatibiltà, l- insulina glulisine m’ għandhiex titħallat ma ’ sustanzi mediċinali oħra, ħlief għall- insulina umana NPH.
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully (see section 6.6).
Qabel ma jintuża OptiSet, l- Istruzzjonijiet Għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif għandhom jinqraw b’ attenzjoni (ara sezzjoni 6. 6).
Renal impairment The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment.
Indeboliment renali Il- karateristiċi farmakokinetiċi ta ’ l- insulina glulisine ġeneralment dehru mantnut f’ pazjenti b’ indeboliment renali.
However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).
Madankollu, l- ħtieġa għall- insulina tista ’ tonqos meta jkun hemm l - indeboliment renali (ara sezzjoni 5. 2).
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
52 L- aġġustament tad- dożaġġ jista ’ jkun meħtieġ ukoll f’ dawk il- pazjenti li jżidu l- attività fiżika jew jibdlu l- ħin tas- soltu meta jieklu.
50 When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
Meta mqabbla ma ’ l- insulina solubbli umana, jekk l- ipogliċemija tiġri wara injezzjoni ta ’ analogi ta ’ l - insulina analoga li jaħdmu malajr, din tista ’ titfaċċa aktar kmieni.
Handling of the pen Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
L- immaniġġar tal- pinna Qabel ma jintuża SoloStar, l- Istruzzjonijiet Għall- Użu li jinsabu fil- Fuljett ta ’ tagħrif għandhom jinqraw b’ attenzjoni.
SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
Solostar għandu jintuża kif irrakkomandat fl- Istruzzjonijiet għall- Użu (ara sezzjoni 6. 6).
Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Pentamidine jista ’ jikkawża l- ipogliċemija, li xi kultant tkun tista ’ segwita mill- ipergliċemija
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
53 Huwa essenzjali li jinżamm kontroll metaboliku tajjeb tul it- tqala kollha fil- pazjenti li żviluppaw id - dijabete qabel jew waqt it- tqala innifisha.
51 It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Mhux magħruf jekk l- insulina glulisine toħroġx fil- ħalib tas- sider fil- bniedem, iżda normalment l - insulina ma tgħaddix fil- ħalib tas- sider u m’ hix assorbita wara li tingħata oralment.
General disorders Uncommon:
54 Disturbi ġenerali Mhux komuni:
52 There are no specific data available concerning overdose with insulin glulisine.
M’ hemmx data speċifika disponibbli dwar dożaġġ eċċessiv bl- insulina glulisine.
Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin.
L- insulina glulisine hija anologu ta ’ l- insulina rikombinanti tal- bniedem li hija ekwipotenti ma ’ l - insulina regolari umana.
In a study with 18 male subjects with diabetes mellitus type 1 aged 21 to 50 years, insulin glulisine displayed dose-proportional glucose lowering effect in the therapeutic relevant dose range 0.075 to 0.15 U/ kg, and less than proportional increase in glucose lowering effect with 0.3 U/ kg or higher, like human insulin.
55 Fi studju fuq 18- il individwu maskil b’ dijabete mellitus tat- tip 1 ta ’ età minn 21 sa 50 sena, l- insulina glulisine uriet proporzjonalità bejn id- doża u l- effett fit- tnaqqis tal- livell tal- glukosju f’ doża terapewtika rilevanti ta ’ firxa minn 0. 075 sa 0. 15 U/ kg, u anqas minn żieda proporzjonali fuq l- effett fit- tnaqqis tal- livell tal- glukosju b’ 0. 3 U/ kg jew ogħla, bħall- insulina umana.
Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus.
Il- medja ta ’ l- effett fuq it- tnaqqis fil- livelli tal- glukosju fuq tul ta ’ ħin ta ’ 6 sigħat f’ 20 pazjent bid- dijabete mellitus tat- tip I.
Insulin glulisine given 2 minutes (GLULISINE pre) before the start of a meal compared to regular human insulin given 30 minutes (REGULAR 30 min) before the start of the meal (figure 1A) and compared to regular human insulin given 2 minutes (REGULAR pre) before a meal (figure 1B).
L- insulina glulisine, mogħtija 2 minuti (GLULISINE pre) qabel il- bidu ta ’ ikla mqabbla ma ’ insulina regolari umana mogħtija 30 minuta (REGULAR 30 min) qabel il - bidu ta ’ l- ikla (figura 1A), u mqabbla ma ’ l- insulina regolari umana mogħtija 2 minuti (REGULAR pre) qabel l- ikla (figura 1B).
Obesity A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has demonstrated that insulin glulisine maintains its rapid-acting properties.
Studju fil- fażi I fuq l- insulina glulisine, lispro u l- insulina regolari umana fi grupp ta ’ pazjenti obeżi wera li l- insulina glulisine iżżomm l- abbiltà li taħdem malajr.
12
56 12
Glucose infusion rates after subcutaneous injection of 0.3 U/ kg of insulin glulisine (GLULISINE) or insulin lispro (LISPRO) or regular human insulin (REGULAR) in an obese population.
Ir- rati ta ’ l- infużjoni tal- glukosju wara injezzjoni il- ġilda ta ’ 0. 3 U/ kg ta ’ l- insulina glulisine (GLULISINE) jew l- insulina lispro (LISPRO) jew l- insulina regolari umana (REGULAR) fi grupp ta ’ pazjenti obeżi.
54 The average total GIR AUC between 0– 1 hour was 102±75 mg/ kg and 158±100 mg/ kg with 0.2 and 0.4 U/ kg insulin glulisine, respectively, and was 83.1±72.8 mg/ kg and 112.3±70.8 mg/ kg with 0.2 and 0.4 U/ kg insulin lispro respectively.
Il- medja totali ta ’ GIR AUC bejn 0 sa siegħa waħda kien 102±75 mg/ kg u 158±100 mg/ kg b’ 0. 2 u 0. 4 U/ kg insulina glulisine, rispettivament, u kien 83. 1±72. 8 mg/ kg u 112. 3±70. 8 mg/ kg b’ 0. 2 u 0. 4 U/ kg insulina lispro, rispettivament.
Type 1 diabetes mellitus-Paediatric A 26-week phase III clinical study compared insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in children (4-5 years: n=9; 6-7 years: n=32 and 8-11 years: n=149) and adolescents (12-17 years: n=382) with type 1 diabetes mellitus using insulin glargine or NPH as basal insulin.
57 Fi studju kliniku, fil- fażi III, ta ’ 26 ġimgħa, ġew imqabbla l- insulina glulisine u l- insulina lispro li ingħataw taħt il- ġilda ftit ħin (0 sa 15- il minuta) qabel ikla, fi tfal (4- 5 snin: n=9; 6- 7 snin: n=32 u 8- 11 snin: n=149) u adoloxxanti (12- 17 – il sena: n=382) bid- dijabete mellitus tat- tip 1, fil- waqt li l- insulina glargine jew NPH intużaw bħala insulina bażika.
Type 2 diabetes mellitus-Adults A 26-week phase III clinical study followed by a 26-week extension safety study was conducted to compare insulin glulisine (0-15 minutes before a meal) with regular human insulin (30-45 minutes before a meal) injected subcutaneously in patients with type 2 diabetes mellitus also using NPH insulin as basal insulin.
Id- dijabete mellitus tat- tip 2 – Adulti Sar studju kliniku, fil- fażi III, fuq tul ta ’ żmien ta ’ 26 ġimgħa, segwit minn studju ieħor ta ’ 26 ġimgħa dwar is- sigurtà, biex jikkompara l- insulina glulisine (0 sa 15- il minuta qabel ikla) ma ’ l- insulina regolari umana (30- 45 minuta qabel ikla), injettata taħt il- ġilda, f’ pazjenti bid- dijabete mellitus tat- tip 2, li kienu ukoll qed jużaw l- insulina NPH bħala l- insulina bażika.
In this study, the majority of patients (79%) mixed their short acting insulin with NPH insulin immediately prior to injection and 58% of subjects used oral hypoglycemic agents at randomization and were instructed to continue to use them at the same dose.
F’ dan l- istudju, il- maġġoranza tal- pazjenti (79%) ħalltu l- insulina tagħhom, li taħdem fuq perijodu qasir, ma ’ l- insulina NPH immedjatament qabel l- injezzjoni, u 58% ta ’ l- individwi mingħajr ma ’ saret l- għazla, użaw is- sustanzi orali ipogliċemiċi; dawn ingħataw struzzjonijiet biex jibqgħu jużawhom fl- istess doża.
Race and Gender In controlled clinical trials in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
Razza u Sess maskil/ femminil Fi provi kliniċi ikkontrollati fl- adulti, l- insulina glulisine ma urietx differenzi fis- sigurtà u l- effikaċja, meta saret l- analiżi f’ sottogrupp, imqassma fuq bażi ta ’ razza u s- sess maskil/ femminil.
55 In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favors more rapid absorption.
Fl- insulina glulisine, is- sostituzzjoni ta ’ l- aċidu amminiku asparagine ta’ l- insulina umana f’ pożizzjoni B3 b’ lysine, u l- lysine f’ pożizzjoni B29 sostitut bl- aċidu glutamiku, jiffavorixxu l- assorbiment aktar mgħaġġel.
Figure 3:
ĦIN -
In a study in patients with type 2 diabetes mellitus after subcutaneous administration of 0.2 U/ kg insulin glulisine, the Cmax was 91 µU/ ml with the interquartile range from 78 to 104 µU/ ml.
Fi studju f’ pazjenti bid- dijabete mellitus tat- tip 2, wara li ngħatat l- insulina glulisine taħt il- ġilda, f’ doża ta ’ 0. 2 U/ kg, iċ- Cmax kien 91 µU/ ml fil- medda interquartile minn 78 sa 104 U/ ml.
56 The time to 10% of total INS exposure was reached earlier by approximately 5– 6 min with insulin glulisine.
Il- ħin ta ’ 10% ta ’ l- espożizzjoni totali ta ’ l- INS intleħaq aktar kmieni b’ madwar 5- 6 minuti bl- insulina glulisine.
After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half-life of 42 minutes compared to 86 minutes.
59 Wara li l- insulina tingħata taħt il- ġilda, l- insulina glulisine titneħħa aktar malajr mill- insulina regolari umana, b’ half- life apparenti ta ’ 42 minuta meta mqabbla ma ’ 86 minuta.
Non-clinical data did not reveal toxicity findings others than those linked to the blood glucose lowering pharmacodynamic activity (hypoglycemia), different from regular human insulin or of clinical relevance for humans.
Data mhux ta ’ natura klinika m’ urietx effetti tossiċi, ħlief għal dawk marbuta ma ’ l- attività farmakodinamika tat- tnaqqis fil- livelli tal- glukosju fid- demm (l- ipogliċemija), li kienu differenti minn dawk ta ’ l- insulina regolari umana jew li għandhom xi relevanza klinika għal bniedem.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except NPH human insulin.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief għall- insulina umana NPH.
2 years.
60 Sentejn
Shelf life after first use of the pen The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Żmien kemm iddum tajba l- pinna 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.
Not in-use pens Store in a refrigerator (2°C-8°C).
Aħżen fi friġġ (2°Ċ - 8°Ċ)..
Keep the pre-filled pen in the outer carton in order to protect from light.
Żomm il- pinna mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
Before first use, the pen must be stored at room temperature for 1 to 2 hours.
Qabel ma tintuża għall- ewwel darba, il- pinna trid tinżamm f‘ temperatura tal- kamra minn siegħa sa sagħtejn.
It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Għandu jintuża biss jekk is- soluzzjoni hija ċara, u bla kulur, mingħajr frak viżibbli u ta ’ konsistenza bħal dik ta ’ l- ilma.
58 Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using SoloStar.
61 L- immaniġġar tal- pinna L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif għandhom jinqraw bir- reqqa qabel tintuża is- SoloStar.
Important information for use of SoloStar:
Informazzjoni importanti għall- użu ta’ SoloStar:
Before each use, a new needle must always be carefully attached and a safety test must be performed.
Qabel kull darba li tintużha, labra ġdida għandha titwaħħal bil- galbu u jsir it- test ta ’ sigurtà.
Only use needles that are compatible for use with SoloStar.
Uża biss labar li huma kompatibbli ma ’ l- użu ta ’ SoloStar.
Special caution must be taken to avoid accidental needle injury and transmission of infection.
Trid tittieħed il- kawtela kollha biex tevita li tweġġa ’ aċċidentalment bil- labra u tieħu xi infezzjoni.
Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Qatt tuża SoloStar jekk tkun bil- ħsara jew m’ intix ċert li qed taħdem sew.
Always have a spare SoloStar in case your SoloStar is lost or damaged.
Dejjem żomm miegħek SoloStar żejjda f’ każ li tintilef jew jiġrilha l- ħsara.
If SoloStar is in cool storage, it should be taken out 1 to 2 hours before you inject to allow it to warm up.
Jekk is- SoloStar tkun maħżuna fil- kesħa, trid tinħareġ biex tisħon, minn siegħa sa sagħtejn qabel l - injezzjoni.
The used SoloStar must be discarded as required by your local authorities.
Is- SoloStar użata għandha tintrema skond il- liġijiet lokali
The outside of SoloStar can be cleaned by wiping it with a damp cloth.
Tista ’ tnaddaf minn barra s- SoloStar billi timsaħha b’ ċaruta niedja.
Situations where SoloStar might be damaged must be avoided.
Evita sitwazzjonijiet fejn is- SoloStar jista ’ jiġrilha l- ħsara.
The Apidra
Iċċekkja t- tikketti tal- pinna biex tiżgura li għandha t- tip korrett ta ’ insulina.
SoloStar is blue.
L- Apidra SoloStar hija ta ’ kulur ikħal.
It has a dark blue injection button with a raised ring on the top.
Għandha buttun għall- injezzjoni ta’ kulur ikħal skur u li għandu ċirku mqabbeż fil- parti ta ’ fuq.
After removing the pen cap, the appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
Wara li titneħħa l- kappa tal- pinna, id- dehera ta ’ l- insulina trid tkun iċċekkjata ukoll: is- soluzzjoni ta ’ l- insulina għandha tkun ċara, mingħajr kulur, b’ ebda frak viżibbli u għandu jkollha konsistenza bħal dik ta ’ l- ilma.
that are compatible for use with SoloStar should be used.
Labar li huma kompatibbli biss mas- SoloStar għandhom jintużaw.
A new sterile needle will be always used for each injection.
62 Labra sterili ġdida għandha dejjem tintuża għal kull injezzjoni.
Select a dose of 2.
Qabel kull injezzjoni Agħżel doża ta ’ 2.
While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle.
Waqt li żżomm il- pinna bil- labra ippuntata ’ l fuq, taptap b’ subgħajk ir- riżervwar ta ’ l- insulina sabiex xi bżieżaq ta ’ l- arja jitilgħu ’ l fuq lejn il- labra.
be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Id- doża tista ’ tiġi ssettjata f’ qabżiet ta ’ unità l- waħda, minn minimu ta ’ unità waħda (1) għall- massimu ta ’ 80 unità.
If a dose 80 units is required, it should be given as two or more injections.
Jekk id- doża meħtieġa hija akbar minn 80 unità, din trid tingħata f’ żewġ injezzjonijiet jew aktar.
The needle should be inserted into the skin.
Il- labra trid tiddaħal fil- ġilda.
This ensures that the full dose of insulin has been injected.
Dan jiżgura li d- doża sħiħa ta ’ l - insulina ingħatat.
Step 6
Pass Nru.
This helps prevent contamination and/ or infection, entry of air into the insulin reservoir and leakage of insulin.
Dan jgħin biex tevita l- kontaminazzjoni u/ jew l - infezzjoni kif ukoll id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u t- tqattir ta ’ l- insulina.
Follow recommended safety measures for removal and disposal of needles (e. g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri ta ’ sigurtà għat - tneħħija u r- rimi tal- labar (e. ż. permezz ta ’ teknika li tinvolvi l- użu t’ id waħda), biex b’ hekk jonqos ir - riskju li tweġġa ’ aċċidentalment bil- labra u tittrasmetti l- mard infettiv.
Mixing with insulins When mixed with NPH human insulin, Apidra should be drawn into the syringe first.
Meta titħallat ma ’ l- insulina umana NPH, Apidra għandha tittella ’ l- ewwel fis- siringa.
Injection should be given immediately after mixing, as no data are available regarding the mixtures made up a significant time before injection.
L- injezzjoni għandha tingħata immedjatament wara li titħallat għax m’ hemmx data disponibbli rigward it- taħlitiet magħmulin f’ tul ta ’ ħin sinifikanti qabel l- injezzjoni.
61 ANNEX II
64 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance
Isem u indirizz tal- manifattur( i) tas- sustanza bijoloġika( ċi) attiva( i)
Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt Germany
Sanofi- Aventis Deutschland GmbH Industriepark Höchst, D- 65926 Frankfurt Il- Ġermanja
PSURs The Marketing Authorisation Holder will submit PSURs every six months starting June 2008 until the next renewal application.
PSUR’ s Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq se jipprovdi l- PSURs kull sitt xhur li jibdew minn Ġunju 2008 u jibqgħu sa l- applikazzjoni ta ’ tiġdid li jmiss.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1, dated 14-Mar-2008, of the Risk Management Plan (RMP) and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immaniġġjar tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jagħmel l- istudji u l - attivitajiet ta ’ farmakoviġilanza addizzjonali mniżżla fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 1, ta ’ l- 14 ta ’ Marzu 2008, tal- Pjan għall- Immaniġġjar tar- Riskju (RMP) u f’ kull aġġornament sussegwenti ta ’ l- RMP li jkun qabel miegħu s- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Kif dettaljat fil- Linji Gwida tas- CHMP dwar is- Sistemi għall- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, kull RMP aġġornat għandu jiġi sottomess fl- istess żmien mar - Rapport Perjodiku ta ’ Aġġornament Dwar Sigurta ’ (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, RMP aġġornat għandu jiġi sottomess: • Meta tiġi miġbura xi informazzjoni ġdida li tista taffetwa l- Ispeċifikazzjoni attwali dwar is - Sigurtà, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ tnaqqis ta ’ riskji • Fi żmien 60 ġurnata minn meta tkun intlaħqet xi mira (ta ’ farmakoviġilanza jew ta ’ tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA
63 ANNEX III
66 ANNESS III
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Apidra 100 Units/ ml, solution for injection in a vial Insulin glulisine.
Apidra 100 Unità/ ml, soluzzjoni għall- injezzjoni f’ kunjett Insulina glulisine.
Each ml contains 100 Units (equivalent to 3.49 mg) insulin glulisine.
Kull ml fih 100 Unità (ekwivalenti għal 3. 49 mg) insulina glulisine.
Also contains: metacresol, sodium chloride, trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Għandu ukoll: metacresol, sodium chloride, trometamol, polysorbate 20, hydrochloric acid ikkonċentrat, sodium hydroxide, ilma għall- injezzjonijiet.
1 vial of 10ml.
Soluzzjoni għall- injezzjoni f’ kunjett.
5 vials of 10ml.
Kunjett 1 ta ’ 10 ml 2 kunjetti ta ’ 10 ml 4 kunjetti ta ’ 10 ml 5 kunjetti ta ’ 10 ml
Unopened vials Store in a refrigerator.
Kunjetti mhux miftuħin Aħżen fi friġġ.
After first use: the product may be stored for a maximum of 4 weeks not above 25°C.
Wara l- ewwel użu: il- prodott jista ’ jinżamm għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, Il- Ġermanja.
EU/ 1/ 04/ 285/ 003 4 vials of 10ml EU/ 1/ 04/ 285/ 004 5 vials of 10ml.
EU/ 1/ 04/ 285/ 001 kunjett 1 ta ’ 10 ml EU/ 1/ 04/ 285/ 002 2 kunjetti ta ’ 10 ml EU/ 1/ 04/ 285/ 003 4 kunjetti ta ’ 10 ml EU/ 1/ 04/ 285/ 004 5 kunjetti ta ’ 10 ml
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Apidra 100Units/ ml Solution for injection in a vial Insulin glulisine.
Apidra 100 Unità/ ml Soluzzjoni għall- injezzjoni f’ kunjett Insulina glulisine.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif fil- pakkett qabel l- użu.
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Apidra 100Units/ ml, solution for injection in a cartridge.
Apidra 100 Unità/ ml, soluzzjoni għall- injezzjoni fi skartoċċ.
Insulin glulisine.
Insulina glulisine.
4 cartridges of 3ml.
Soluzzjoni għall- injezzjoni fi skartoċċ.
10 cartridges of 3ml.
Skartoċċ 1 ta ’ 3 ml 3 skartoċċi ta ’ 3 ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 8 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
This cartridge is for use in conjunction with an insulin pen such as OptiPen and other pens suitable for Apidra cartridges.
Dan l- iskartoċċ għandu jintuża flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra li jaqblu ma ’ skartoċċi ta ’ Apidra.
69 7.
72 7.
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.
TWISSIJA/ JIET SPEĊJALI OĦRA, JEKK MEĦTIEĠA Jekk il- pinna ta ’ l- insulina għandha l- ħsara jew m’ hijiex taħdem tajjeb (minħabba xi difetti mekkaniċi) għandha tintrema u għandha tintuża pinna ta ’ l- insulina ġdida.
Keep the cartridge inserted in the pen protected from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 04/ 285/ 012 10 cartridges of 3ml.
EU/ 1/ 04/ 285/ 005 skartoċċ 1 ta ’ 3 ml EU/ 1/ 04/ 285/ 006 3 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 007 4 skartoċċi ta ’ 3 m EU/ 1/ 04/ 285/ 008 5 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 009 6 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 010 8 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 011 9 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 012 10 skartoċċi ta ’ 3 ml
70 14.
73 14.
71 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
74 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Apidra 100Units/ ml Solution for injection in a cartridge.
Apidra 100 Unità/ ml Soluzzjoni għall- injezzjoni fi skartoċċ.
Insulin glulisine
Insulina glulisine.
This cartridge is for use in conjunction with an insulin pen such as OptiPen.
Dan l- iskartoċċ jintuża flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen.
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
ALUMINIUM FOIL WHICH IS USED FOR SEALING TRANSPARENT PLASTIC TRAY CONTAINING THE CARTRIDGE
FOJL TA ’ L- ALUMINJU LI HIJA UŻATA GĦAS- SIĠILL TA ’ TILAR TAL- PLASTIK TRASPARENTI LI FIH L- ISKARTOĊĊ
Consult your insulin pen instruction booklet for further details.
Ara l- ktejjeb ta ’ struzzjonijiet dwar il- pinna ta ’ l- insulina tiegħek għal aktar dettalji.
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
76 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON (cartridge for OptiClik)
KARTUNA TA ’ BARRA (skartoċċ għal OptiClik)
Solution for injection in a cartridge for OptiClik.
Soluzzjoni għall- injezzjoni fi skartoċċ għal OptiClick.
1 cartridge of 3ml 3 cartridges of 3ml 4 cartridges of 3ml 5 cartridges of 3ml 6 cartridges of 3ml 8 cartridges of 3ml 9 cartridges of 3ml 10 cartridges of 3ml
Skartoċċ 1 ta ’ 3 ml 3 skartoċċi ta ’ 3 ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 8 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
The cartridges for OptiClik are to be used in conjunction with OptiClik only.
L- iskartoċċi ta ’ l- OptiClik għandhom jintużaw flimkien ma ’ OptiClik biss.
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used
Jekk l- OptiClik hija bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi) għandha tintrema, u għandha tintuża OptiClik oħra ġdida.
74 8.
77 8.
EXP (MM/ YYYY)
EXP (XX/ SSSS)
After first use: the product may be stored for a maximum of 4 weeks not above 25°C. Do not refrigerate.
Wara l- ewwel użu: il- prodott jista ’ jinżamm għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ.
Keep the cartridge inserted in the pen protected from light.
Tagħmlux fil- friġġ Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 04/ 285/ 021 1 cartridge of 3ml EU/ 1/ 04/ 285/ 022 3 cartridges of 3ml EU/ 1/ 04/ 285/ 023 4 cartridges of 3ml EU/ 1/ 04/ 285/ 024 5 cartridges of 3ml EU/ 1/ 04/ 285/ 025 6 cartridges of 3ml EU/ 1/ 04/ 285/ 026 8 cartridges of 3ml EU/ 1/ 04/ 285/ 027 9 cartridges of 3ml EU/ 1/ 04/ 285/ 028 10 cartridges of 3ml
EU/ 1/ 04/ 285/ 021 skartoċċ 1 ta ’ 3 ml EU/ 1/ 04/ 285/ 022 3 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 023 4 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 024 5 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 025 6 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 026 8 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 027 9 skartoċċi ta ’ 3 ml EU/ 1/ 04/ 285/ 028 10 skartoċċi ta ’ 3 ml
15.
78 15.
76 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE LABEL for OptiClik
TIKKETTA TA ’ L- ISKARTOĊĊ għal OptiClik
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Apidra, 100 Units/ ml.
Apidra, 100 Unità/ ml.
Use only clear and colourless solution.
Uża biss soluzzjonijiet ċari u mingħajr kulur.
IMPORTANT INFORMATION Always first attach a new needle before using OptiSet.
TAGĦRIF IMPORTANTI Dejjem l- ewwel qabbad labra ġdida qabel ma tuża OptiSet.
Always perform a Safety Test before using OptiSet.
Dejjem agħmel Test ta ’ Sigurtà qabel ma tuża OptiSet.
Keep the pre-filled pen in the outer carton in order to protect from light.
Żomm il- pinna fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 04/ 285/ 020 10 pens of 3 ml.
EU/ 1/ 04/ 285/ 013 pinna 1 ta ’ 3 ml EU/ 1/ 04/ 285/ 014 3 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 015 4 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 016 5 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 017 6 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 018 8 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 019 9 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 020 10 pinen ta ’ 3 ml
79 13.
82 13.
80 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Solution for injection in a pre-filled pen.
Apidra, 100 Unità/ ml Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Apidra, 100Units/ ml.
Apidra, 100 Unità/ ml.
6 pens of 3 ml.
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
Only use needles that are compatible for use with SoloStar.
Uża biss il- labar li huma approvati għall- użu ma ’ SoloStar.
Unopened Store in a refrigerator (2°C-8°C).
Aħżen fi friġġ (2°Ċ- 8°Ċ).
After its first use, the product may be stored for a maximum of 4 weeks not above 25°C.
Wara l- ewwel użu: il- prodott jista ’ jinżamm għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ.
Do not refrigerate.
Tagħmilhiex fil- friġġ.
Keep the pen protected from light.
Żomm il- pinna fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 04/ 285/ 036 10 pens of 3 ml.
EU/ 1/ 04/ 285/ 029 pinna 1 ta ’ 3 ml EU/ 1/ 04/ 285/ 0303 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 031 4 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 032 5 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 033 6 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 034 8 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 035 9 pinen ta ’ 3 ml EU/ 1/ 04/ 285/ 036 10 pinen ta ’ 3 ml
83 14.
86 14.
84 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
87 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Apidra 100 Units/ ml solution for injection in a vial Insulin glulisine
Apidra 100 Unità/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina glulisine
What Apidra is and what it is used for 2.
X’ inhu Apidra u għalxiex jintuża 2.
Before you use Apidra 3.
Qabel ma tuża Apidra 3.
How to use Apidra 4.
Kif għandek tuża Apidra 4.
How to store Apidra 6.
Kif taħżen Apidra 6.
WHAT APIDRA IS AND WHAT IT IS USED FOR
X’ INHU APIDRA U GĦALXIEX JINTUŻA
Apidra is a clear, colourless, aqueous solution for injection containing insulin glulisine.
Apidra huwa soluzzjoni għall- injezzjoni akweja, ċara u mingħajr kulur, li fiha l- insulina glulisine.
Insulin glulisine is produced by biotechnology.
L - insulina glulisine hija magħmula permezz tal- bijoteknoloġija.
Insulin glulisine has a rapid onset of action and a short duration of action.
L- insulina glulisine tibda taħdem malajr u ddum taħdem għal perijodu qasir.
Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older.
Apidra huwa sustanza mediċinali kontra d- dijabete, użata biex tnaqqas il- livell taz- zokkor għoli fid - demm f’ pazjenti li jbatu bid- dijabete mellitus: dan jista ’ jingħata lill- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin jew akbar.
BEFORE YOU USE APIDRA
QABEL MA TUŻA APIDRA
Do not use Apidra • If you are allergic (hypersensitive) to insulin glulisine or any of the other ingredients of Apidra. • If your blood sugar is too low (hypoglycaemia).
Tużax Apidra • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina glulisine jew għal xi waħda mis- sustanzi l- oħra ta ’ Apidra. • Jekk il- livell taz- zokkor f’ demmek huwa baxx wisq (ipogliċemija).
Follow the guidance for hypoglycaemia.
Segwi l- gwida għall - ipogliċemija.
Take special care with Apidra
Oqgħod attent ħafna b’ Apidra
Follow closely the instructions for dosage, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Segwi sew l- istruzzjonijiet dwar id- dożaġġ, l- immoniterjar (testijiet tad- demm), id- dieta u l- attività fiżika (xogħol fiżiku u eżerċizzju), kif spjegalek it- tabib tiegħek.
If you have liver or kidney problems, speak to your doctor as you may need a lower dose.
Jekk għandek problemi fil- fwied jew fil- kliewi, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
M’ hemmx biżżejjed informazzjoni klinika adegwata dwar l- użu ta ’ Apidra fit- tfal taħt 6 snin.
Travel
90 Safar
- the availability of your insulin in the country you are visiting,
-
87
–
- correct storage of your insulin while travelling,
id- disponibbiltà ta ’ l- insulina tiegħek fil- pajjiż li qiegħed iżżur,
- timing of meals and insulin administration while travelling,
– il- forniment ta ’ l- insulina, siringi eċċ – il- ħażna korretta ta ’ l- insulina tiegħek waqt l- ivvjaġġar – il- ħin ta ’ l- ikel u t- teħid ta ’ l- insulina waqt l- ivvjaġġar, – l- effetti possibbli fit- tibdil minn żona ta ’ ħin għal oħra differenti – il- possibiltà ta ’ riskji ġodda għal saħħtek fil- pajjiż li tkun qiegħed żżur, – x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad.
- the possible effects of changing to different time zones,
Mard u feriti
- possible new health risks in the countries to be visited,
F’ dawn is- sitwazzjonijiet li ġejjin, l- immaniġġar tad- dijabete tiegħek, jista ’ jkollha bżonn ta ’ ħafna attenzjoni:
- what you should do in emergency situations when you feel unwell or become ill.
- Jekk ma tiflaħx jew għandek xi ferita serja, il- livell taz- zokkor fid- demm tiegħek jista ’ jogħla
Illnesses and injuries
(ipergliċemija)
- If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
- Jekk m’ intix qed tiekol biżżejjed, il- livell taz- zokkor fid- demm tiegħek jista ’ jinżel iżżejjed
- If you are not eating enough your blood sugar level may become too low (hypoglycaemia).
(ipogliċemija).
Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Qabel tieħu xi mediċina staqsi lit- tabib tiegħek jekk tistax teffettwalek il- livell tiegħek taz- zokkor fid- demm, u x’ għandek tagħmel, jekk meħtieġ.
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),
- pentoxifylline, propoxyphene, salicylates (bħall- aspirina, użata biex ittaffi l- uġigħ u tbaxxi
- diuretics (used to treat high blood pressure or excessive fluid retention),
- id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew l- akkumulazzjoni eċċessiva
- glucagon (pancreas hormone used to treat severe hypoglycaemia),
ta ’ fluwidi),
- isoniazid (used to treat tuberculosis),
- glukagon (ormon tal- frixa użat għall- kura ta ’ ipogliċemija severa),
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),
- isoniazid (użat għall- kura tat- tuberkulożi),
- phenothiazine derivatives (used to treat psychiatric disorders),
91
- somatropin (growth hormone),
- - - -
- sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to
l- estroġeni u l- proġesteni (bħal fil- pillola kontraċettiva, użata għall- kontroll tat- twelid), id- derivattivi ta ’ phenothiazine (użati għall- kura ta ’ disturbi psikjatriċi), somatropin (ormon tat- tkabbir), il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat għall- kura ta ’ l- ażma),
treat asthma),
- - -
- atypical antipsychotic medications (such as olanzapine and clozapine).
ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde), l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV) l- mediċini hekk imsejjħa atipiċi kontra l- psikożi (bħal olanzapine u clozapine).
88 Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
L- imblokkaturi tar- riċetturi beta, bħall- mediċini oħra simpatolitiċi, (bħal clonidine, guanethidine, u reserpine) jistgħu jdgħajjfu jew jaħbu kompletament l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf xi ipogliċemija.
Using Apidra with food and drink
Meta tuża Apidra ma ’ l- ikel u max- xorb
Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Il- kontroll bil- ħsieb tad - dijabete tiegħek, u l- prevenzjoni ta ’ l- ipogliċemija, huma importanti għas- saħħa tat- tarbija tiegħek.
There are no adequate data on the use of Apidra in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Apidra waqt it- tqala.
- you have hypoglycaemia(low blood sugar levels)
- għandek l- ipogliċemija( livelli baxxi ta ’ zokkor fid- demm)
- you have hyperglycaemia (high blood sugar levels).
- għandek l- ipergliċemija (livelli għoljin ta ’ zokkor fid- demm)
Important information about some of the ingredients of Apidra
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Apidra
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i. e. it is essentially ‘ sodium-free’.
92 Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e tista ’ tgħid li huwa ‘ ħieles minn sodium ’.
HOW TO USE APIDRA
KIF GĦANDEK TUŻA APIDRA
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will determine how much Apidra you will need.
Skond l- istil tal- ħajja tiegħek u r- riżultati tat- testijiet taz- zokkor (glukosju) fid- demm u l- użu preċedenti ta ’ l- insulina, it- tabib tiegħek ser jikkalkula kemm ser ikollok bżonn Apidra
Apidra is a short-acting insulin.
Apidra huwa insulina li taħdem fuq perijodu qasir.
Your doctor may tell you to use it in combination with an intermediate, long -acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
It- tabib tiegħek jista ’ jagħtik parir biex tieħdu flimkien ma ’ insulina li taħdem fuq perijodu intermedju twil, ma ’ insulina bażika, jew ma ’ pilloli użati għall- kura ta ’ livelli għoljin ta ’ zokkor fid- demm.
If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Jekk taqleb minn insulina oħra għall- insulina glulisine, id- dożaġġ tiegħek jista ’ jkollu jiġi aġġustat mit- tabib tiegħek.
Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Apidra għandu jittieħed ftit (0- 15- il minuta) qabel jew wara l- ikel.
Apidra is injected under the skin (subcutaneously).
Apidra huwa injettat taħt il- ġilda (b’ mod subkutaneju).
Your doctor will show you in which area of the skin you should inject Apidra.
It- tabib tiegħek ser jurik f’ liema parti tal- ġilda għandek tinjetta Apidra.
Apidra can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall.
Apidra tista ’ tkun injettata fiż - żaqq, il- koxxa, l- parti ta ’ fuq tad driegħ, jew permezz ta ’ infużjoni kontinwa fiż- żaqq.
The effect will be slightly quicker if the insulin is injected into your abdomen.
L- effett ikun ftit aktar malajr jekk tinjetta fiż- żaqq.
As for all insulins, injection sites and infusion sites within an-injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Bħal ma jsir fl- insulini kollha, s- siti ta ’ l- injezzjonijiet u l - infużjonijiet, f’ żona partikolari (żaqq, koxxa u l- parti ta ’ fuq tad- driegħ), għandhom jinbidlu minn injezzjoni għall- ohra.
Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system.
Il- kunjetti ta ’ Apidra huma għall- użu ma ’ siringi ta ’ l- insulina bi skala ta ’ unità korrispondenti u għall - użu ma ’ sistema ta ’ pompa ta ’ l- insulina..
Only use it if the solution is clear, colourless and has no visible particles in it.
Użah biss jekk is- soluzzjoni hija ċara, mingħajr kulur u m’ għandhiex frak vizibbli fiha.
Do not shake or mix it before use Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse.
M’ għandekx tħawdu jew tħalltu qabel ma tużah.
This is because the insulin may have lost some of its effectiveness.
Dejjem uża kunjett ġdid jekk tinduna li f’ daqqa waħda l- kontroll taz- zokkor fid- demm tiegħek imur għall- agħar. Dan jista ’ jkun minħabba li l- insulina tkun tilfet xi ftit mill- qawwa tagħha.
If you think you may have a problem with Apidra, have it checked by your doctor or pharmacist.
Jekk taħseb li għandek xi problema b’ Apidra, ħudu għand it- tabib jew l- ispiżjar tiegħek biex jeżaminah
If you have to mix two types of insulin
Jekk għandek zewġ tipi ta ’ insulina biex tħallat
Apidra must not be mixed with any preparation other than NPH human insulin.
Apidra m’ għandux jitħallat ma ’ ebda preparat ieħor ħlief għall- insulina NPH umana.
If Apidra is mixed with NPH human insulin, Apidra should be drawn into the syringe first.
Jekk Apidra jitħallat ma ’ l- insulina NPH umana, Apidra għandu jitella ’ l- ewwel fis- siringa.
Injection should be given immediately after mixing.
L - injezzjoni għandha tingħata immedjatament wara li titħallat.
How to handle an infusion pump system
Kif timmaniġġa sistema ta ’ infużjoni bil- pompa
Apidra must never be mixed with diluents or any other insulin when used in a pump.
93 Apidra qatt m’ għandu jitħallat b’ dilwenti jew xi tip ta ’ insulina oħra meta jintuża f’ pompa.
In addition, information about any action to be taken in case of illness, too high or too low blood sugar or failure of the pump system.
Qabel Apidra jintuża fis- sistema tal- pompa inti trid tkun ircevejt struzzjonijiet dettaljati dwar dan l - użu, kif ukoll informazzjoni dwar x’ għandek tagħmel f’ każ ta ’ mard, jekk iz- zokkor ikun għoli jew baxx wisq fid- demm jew jekk is- sistema tal- pompa tieqaf.
90 Use the type of pump system recommended by your doctor.
Uża s- sistema ta ’ pompa li irrakkomandalek it- tabib.
Read and follow the instructions that accompany your insulin infusion pump.
Aqra u segwi l- istruzzjonijiet li jiġu mal- pompa tiegħek għall- infużjoni ta ’ l- insulina.
Follow your doctor’ s instructions about the basal infusion rate and the mealtime insulin boluses to be taken.
Segwi l- istruzzjonijiet tat- tabib dwar ir- rata bażika ta ’ l- infużjoni u d- doża bolus ta ’ insulina li trid tittieħed fil- ħin ta ’ l- ikel.
To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, you should measure your blood sugar level regularly.
Biex tieħu l- benefiċċju ta ’ infużjoni ta ’ l - insulina, u biex ikun possibbli li tagħraf li l- pompa ta ’ l- insulina hija bil- ħsara, trid tiċċekja l- livell taz - zokkor fid- demm regolarment.
The infusion set and reservoir should be changed every 48 hours using aseptic technique.
Is- sett ta ’ l- infużjoni u r- riżervwar għandhom jinbidlu kull 48 siegħa permezz ta ’ teknika asettika.
What to do in case of pump system failure?
X’ għandu jsir fil- każ li l- pompa tieqaf?
You should always have alternative insulin available for injection under the skin in case of pump system failure.
Għandu dejjem ikollok insulina alternattiva disponibbli għall- injezzjoni taħt il- ġilda fil- każ li s- sistema tal- pompa tieqaf.
If you use more Apidra than you should
Jekk tuża Apidra aktar milli suppost
- If you have injected too much Apidra, your blood sugar level may become too low
- Jekk injettajt aktar Apidra milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq
If you forget to use Apidra
Jekk tinsa tuża Apidra
- If you have missed a dose of Apidra or if you have not injected enough insulin, your blood sugar
- Jekk tlift doża ta ’ Apidra jew jekk ma injettajtx biżżejjed insulina, il- livell tiegħek taz- zokkor fid -
level may become too high (hyperglycaemia).
demm jista ’ jogħla wisq (ipergliċemija).
If you stop using Apidra
Jekk tieqaf tuża Apidra
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 ’ aċidu fid- demm minħabba li l- ġisem qiegħed ikisser x- xaħam minflok iz- zokkor).
Do not stop Apidra without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Apidra mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Apidra can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Apidra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If your blood sugar level falls too much you may become unconscious.
Jekk il- livell taz- zokkor fid- demm tiegħek jinżel wisq tista ’ tintilef minn sensik.
Serious hypoglycaemia may cause brain damage and may be life- threatening.
Ipogliċemija serja tista ’ tikkawża ħsara fil - moħħ u jista ’ jkun hemm ir- riskju li titlef ħajtek.
If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
Jekk għandek sintomi li juru li l- livell ta ’ zokkor fid - demm huwa baxx, ħu dawk l- azzjonijiet li jżidu b’ mod immedjat il- livell taz- zokkor fid- demm.