qanastek/EMEA-V3 huggingface dataset:
It must not be shared with anyone else. • If the injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
M’ għandhiex tintuża minn ħaddieħor. • Jekk l- injezzjoni tiegħek tingħata minn persuna oħra, għandha tittieħed attenzjoni speċjali minn din il- persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u titrasmetti xi l- infezzjoni. • Qatt tuża OptiSet jekk tkun bil- ħsara jew m’ intix ċert li qed taħdem sew. • Dejjem żomm miegħek OptiSet żejda f’ każ li OptiSet tiegħek tintilef jew jiġrilha l- ħsara.
Storage Instructions
Tagħrif kif għandek taħżen
Please check section 6.4 of this leaflet for instructions on how to store OptiSet.
Jekk jogħġbok, iċċekkja sezzjoni 6. 4 ta ’ dan il- fuljett għall- istruzzjonijiet kif għandek taħżen OptiSet.
If OptiSet is in cool storage, it should be taken out 1 to 2 hours before injection to allow it to warm up.
Jekk OptiSet qiegħda maħżuna fil- kesħa, trid toħroġha minn siegħa sa sagħtejn qabel l- injezzjoni biex tilħaq tisħon.
Cold insulin is more painful to inject.
L- insulina kiesħa tweġġa ’ aktar biex tinjettha.
The used OptiSet must be discarded as required by your local authorities.
L- OptiSet użata għandha tintrema kif jitolbu l- liġijiet lokali.
OptiSet has to be protected from dust and dirt.
OptiSet għandha tkun protetta mit- trab u l- ħmieġ.
You can clean the outside of your OptiSet by wiping it with a damp cloth.
Tista ’ tnaddaf minn barra l- OptiSet tiegħek billi timsaħha b’ ċaruta niedja.
Do not soak, wash or lubricate the pen as this may damage it.
Ixxarrabx, taħsilx jew tillubrikax l- pinna għax dan jista ’ jagħmlilha l- ħsara.
OptiSet is designed to work accurately and safely.
OptiSet hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
It should be handled with care.
Trid timmaniġġha b’ attenzjoni.
Avoid situations where OptiSet might be damaged.
Evita sitwazzjonijiet fejn l- OptiSet jista ’ jiġrilha l- ħsara.
If you are concerned that your OptiSet may be damaged, use a new one.
Jekk taħseb li l- OptiSet seta ’ ġralha xi ħsara, uża waħda ġdida.
Step 1.
1
Check the Insulin
Iċċekkja l- insulina
After removing the pen cap, the label on the pen and the insulin reservoir should be checked to make sure it contains the correct insulin.
Wara li tneħħi l- kappa tal- pinna, iċċekkja t- tikketti tal- pinna u r- riżervwar biex tiżgura li għandha t- tip korrett t’ insulina.
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.
Id- dehra ta ’ l- insulina trid tkun iċċekkjata wkoll: is- soluzzjoni ta ’ l- insulina għandha tkun ċara, mingħajr kulur, b’ ebda partikuli solidi u viżibbli u għandu jkollha konsistenza bħal dik ta ’ l - ilma.
Do not use this OptiSet if insulin is cloudy, coloured or has particles.
Tużax din l- OptiSet jekk l- insulina hija mdardra, ikkulurita jew għandha l- partikuli.
37 Step 2.
2
Attach the needle
Waħħal il- labra
The needle should be carefully attached straight onto the pen.
b’ kawtela u dritta fuq il- pinna.
Step 3.
3
Perform a safety test
Agħmel test ta ’ sigurtà
Prior to each injection a safety test has to be performed.
isir test ta ’ sigurtà.
For a new and unused OptiSet, a dose of 8 units is already preset by the manufacturer for the first safety test.
Għal OptiSet ġdid u mhux użat, doża ta ’ 8 Unità hija diġà issettjata mill- manifattur għall- ewwel test ta ’ sigurtà.
In-use OptiSet, select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2.
Għal OptiSet fl- użu, agħżel doża ta ’ 2 unitajiet billi ddawwar ’ il quddiem il- mekkaniżmu li jisselezzjona d- dożaġġ, sakemm il- vleġġa li tindika d- doża tipponta lejn “ 2 ”.
The dosage selector will only turn in one direction.
Dan il- mekkanizmu jdur biss f’ direzzjoni waħda.
Pull out the injection button completely in order to load the dose.
Iġbed għal kollox ’ il barra l- buttun ta ’ l- injezzjoni sabiex ittella ’ d- doża.
Never turn the dosage selector after injection button has been pulled out.
Qatt m’ għandek iddawwar il - mekkaniżmu li jagħżel id- dożaġġ wara li tkun ġbidt il- buttun ta ’ l- injezzjoni ’ il barra.
The outer and inner needle caps should be removed.
Il- kappi ta ’ barra u ta ’ ġewwa tal- labra għandhom jitneħħew.
Keep the outer cap to remove the used needle.
Żomm il- kappa ta ’ barra biex tneħħi l - labra.
While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped 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 il- bżieżaq ta ’ l- arja kollha jitilgħu ’ l fuq lejn il- labra.
Then the injection button should be pressed all the way in.
Imbagħad agħfas il- buttun ta ’ l- injezzjoni sa ġewwa.
If insulin has been expelled through the needle tip, then the pen and the needle are working properly.
Jekk l- insulina toħroġ mill- ponta tal- labra, dan ifisser li l- pinna u l- labra qed jaħdmu sew.
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 still no insulin comes out, change the needle, as it might be blocked and try again.
Jekk l- insulina xorta ma toħroġx, biddel il- labra, għax din tista ’ tkun li nstaddet u erġa ’ pprova.
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.
Do not use this OptiSet.
Tużax din l- OptiSet.
Step 4.
4
Select the dose
Tagħżel id- doża
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.
Check if you have enough insulin for the dose.
Iċċekkja jekk għandhekx biżżejjed insulina għad- doża.
The residual insulin scale on the transparent insulin reservoir shows approximately how much insulin remains in the OptiSet.
L- iskala ta ’ l- insulina li fadal fuq ir- riżervwar trasparenti turi bejn wieħed u ieħor kemm fadal insulina fl- OptiSet.
This scale must not be used to set the insulin dose.
M’ għandhiex tintuża din l- iskala biex tkun imkejjla d- doża ta ’ l- insulina.
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 - istrixxa ikkulurita, allura hemm madwar 40 Unità t’ 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 ikkulurita, allura hemm madwar 20 Unità t’ 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 ’ il quddiem sakemm il- vleġġa qed tipponta lejn id- doża meħtieġa.
Step 5.
5
Load the dose
Ttella ’ d- doża
The injection button should be pulled out as far as it will go in order to load the pen.
għandu jinġibed kollu ’ l barra sabiex tgħabbi l- pinna.
Check if the selected dose is fully loaded.
Iċċekkja jekk id- doża magħżula telgħetx kollha.
Note that the injection button only goes out as far as the amount of insulin that is left in the reservoir.
Kun af li l- buttun ta ’ l- injezzjoni joħroġ biss ’ il barra sa l- ammont t’ insulina li fadal fir- riżervwar.
The injection button allows checking the actual loaded dose.
38 Il- buttun ta ’ l- injezzjoni jippermetti li tkun iċċekkjata d- doża attwali mtella ’.
The injection button must be held out under tension during this check.
Il- buttun ta ’ l- injezzjoni għandu jinżamm miġbud ’ il barra waqt dan it- test.
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 t’ insulina li telgħet.
When the injection button is held out only the top part of this thick line can be seen.
Meta l- buttun ta ’ l- injezzjoni jinżamm ’ il barra il- parti ta ’ fuq biss ta ’ din il- linja ħoxna tista ’ tidher.
38 Step 6.
Pass Nru.
Inject the dose
Tinjetta d- doża
The patient should be informed on the injection technique by his health care professional.
Il- pazjent għandu jkun mgħallem fuq it- teknika ta ’ l- injezzjoni mill- professjonist tiegħu fil- qasam tas - saħħa.
The needle should be inserted into the skin.
Il- labra trid tiddaħħal fil- ġilda.
The injection button should be pressed all the way in.
Il- buttun ta ’ l- injezzjoni għandu jingħafas sa ġewwa.
A clicking sound can be heard, which will stop when the injection button has been pressed in completely.
Jinstama ’ ħoss, li jieqaf meta l- buttun ta ’ l - injezzjoni jingħafas kompletament ’ il ġewwa.
Then the injection button should be held down 10 seconds before withdrawing the needle from the skin.
Wara, l- buttun ta ’ l- injezzjoni għandu jinżamm ’ l isfel għal 10 sekondi qabel ma tinġibed il- labra barra mill- 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
Remove and discard the needle
Tneħħi u tarmi l- labra
The needle should be removed after each injection and discarded.
Il- labra trid titneħħa wara kull injezzjoni u tintrema.
This helps prevent contamination and/ or infection as well as entry of air into the insulin reservoir and leakage of 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.
Needles must not be reused.
Il- labar m’ għandhomx jerġgħu jintużaw.
The pen cap should be replaced on the pen.
Il- kappa tal- pinna għandha titpoġġa lura f’ postha fuq il- pinna.
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml fih 100 IU ta ’ insulina umana (ekwivalenti għal 3. 5 mg).
Each cartridge contains 3 ml of solution for injection, equivalent to 300 IU insulin.
Kull skartoċċ fih 3 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 300 IU insulina.
Solution for injection in a cartridge for OptiClik.
Soluzzjoni għall- injezzjoni ġo skartoċċ għal OptiClik.
40 Transfer to Insulin Human Winthrop Rapid
40 Kif taqleb għal Insulin Human Winthrop Rapid
Insulin Human Winthrop Rapid in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Rapid fi skartoċċi għal OptiClik. ġie żviluppat għall- użu f’ OptiClik biss.
Insulin Human Winthrop Rapid must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing.
41 Insulin Human Winthrop Rapid m’ għandhux jintuża f’ pompi ta ’ l- insulina, kemm dawk esterni kif ukoll dawk imdaħħla fil- ġisem, jew f’ pompi peristaltiċi b’ tubi ta’ silikon.
41 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
42 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
42 Biex jitnaqqas ir- riskju ta ’ l- ipogliċemja huwa essenzjali li l- pazjent iżomm mad- dożaġġ u l- kura bid - dieta, it- teħid korrett ta ’ l- insulina, u li l- pazjent ikun konxju tas- sintomi ta ’ l- ipogliċemja.
Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Il- ħtieġa għall- insulina tonqos fl- ewwel tliet
43 Lactation
43 xhur u normalment tiżdied waqt it- tieni u t- tielet perijodi ta ’ tliet xhur- il wieħed.
Metabolism and nutrition disorders
44 Disturbi fil- metaboliżmu u n- nutrizzjoni
44 Eyes disorders
Disturbi fl- għajnejn
45 Mode of action
Il- mod kif jaħdem
In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
F’ pazjenti b’ saħħithom, il- ħin biex id- doża ta ’ l- insulina tonqos bin- nofs fis- seru tad- demm huwa bejn wieħed u ieħor minn 4 sa 6 minuti.
6.3 Shelf life
46 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
46 Shelf life after first use of the cartridge:
Żmien kemm idum tajjeb l- iskartoċċ wara l- ewwel użu:
The cartridge in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Meta l- iskartoċċ ikun qed jintuża (ġol- pinna ta ’ l- insulina) jew ikun qed jinġarr bħala riżerva, jista ’ jinħażen għal massimu ta ’ 4 ġimgħat, f’ temperatura mhux ’ il fuq minn 25°C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
The pen containing a cartridge must not be stored in the refrigerator.
Il- pinna li fiha skartoċċ m’ għandiex tinħażen fil- friġġ.
The glass cartridge is irreversibly integrated in a transparent container and assembled to a plastic mechanism with a threaded rod at one extremity.
L- iskartoċċ tal- ħġieġ huwa ħaġa waħda ma ’ kontenitur trasparenti mgħammar b’ mekkaniżmu tal - plastik li fiha virga b’ kamin f’ tarf wieħed.
Packs of 3, 4, 5, 6, 9 or 10 cartridges for OptiClik are available.
Pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi għal OptiClik huma disponibbli.
Insulin pen The cartridges for OptiClik are to be used in conjunction OptiClik only and as recommended in the information provided by the device manufacturer.
Pinna ta ’ l- insulina L- skartoċċi għal OptiClik. għandhom jintużaw flimkien ma ’ OptiClik biss u skond kif inhu rrakkomandat fl- informazzjoni pprovduta mill- manifattur tal- pinna.
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik pen has to be used.
Jekk l- OptiClik hija bil- ħsara jew mhix taħdem sew (dovut għal xi difetti mekkaniċi) għandha tintrema, u OptiClik ġdida għandha tintuża.
If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ 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.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
47 Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet dwar l - użu tal- pinna).
47 Mixing of insulins
Taħlit ta ’ l- insulini
Insulin Human Winthrop Rapid cartridges for OptiClik are not designed to allow any other insulin to be mixed in the cartridge for OptiClik.
L- skartoċċi ta ’ Insulin Human Winthrop Rapid għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċċ għal OptiClik.
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a pre-filled pen.
Insulin Hunan Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Insulina umana hija magħmula permezz tat- teknoloġija rikombinanti tad- DNA ġo Escherichia coli.
SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit.
SoloStar tagħti insulina f’ ammonti minn 1 sa 80 unitajiet f’ qabżiet ta ’ Unita ’ waħda (1).
Each pen contains multiple doses.
Kull pinna fiha diversi dożi
49 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
49 Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
Qabel tintuża SoloStar, l- Istruzzjonijiet dwar l- Użu li jinsabu fil- Fuljett ta ’ Taghrif għandhom jinqraw bir- reqqa.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
50 F’ pazjenti li għandhom mard sever tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil- kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
50 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ ta ’ nuqqas adegwat tal- kontroll tal- livell tal- glucose, jew f’ każ ta ’ tendenza biex jokkorru attakki ta ’ l- ipergliċemija jew l- ipogliċemja, għandha ssir rievalwazzjoni ta ’ kemm il- pazjent qiegħed jieħu t- trattament preskritt, is- siti ta ’ l- injezzjoni, it- teknika korretta ta ’ kif qed issir l- injezzjoni u kull fattur ieħor rilevanti, qabel ma tkun ikkunsidrata l- tibdil tad- doża.
Intercurrent illness
51 Mard kurrenti
Intercurrent illness requires intensified metabolic monitoring.
Mard kurrenti jirrikjedi l- moniteraġġ metaboliku aktar intensiv.
In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet l- analiżi ta ’ l- awrina għall- ketones huma ndikati, u ta ’ spiss ikun neċessarju li d- doża ta ’ l- insulina tiġi aġġustata.
The insulin requirement is often increased.
Il- ħtieġa għall- insulina normalment tiżdied.
51 Handling of the pen
L- immaniġġar tal- pinna
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
Qabel tuża SoloStar, aqra bir- reqqa l- Istruzzjonijiet ghall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif.
SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
SoloStar għandha tintuża skond kif inhu irrakkomandat fl- Istruzzjonijiet ghall- Użu (ara sezzjoni 6. 6).
4.7 Effects on ability to drive and use machines
52 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
52 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Eyes disorders
53 Disturbi fl- għajnejn
53 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Mode of action
54 Il- mod kif jaħdem
54 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Pens in-use must not be stored in the refrigerator.
55 Il- pinen fl- użu m’ għandhomx jinżammu fil- friġġ.
55 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
The cartridges are sealed in a disposable pen injector.
L- iskartoċċ huwa issiġillat f’ pinna għall- injezzjoni li tintrema wara li tinħela.
Injection needles are not included in the pack.
Il- labar m’ humiex inklużi fil- pakkett.
56 Handling of the pen
56 L- immaniġġar tal- pinna
The Instructions for Use included in the Package Leaflet must be read carefully before using SoloStar.
L- Istruzzjonijiet dwar l- Użu li jinsabu fil- Fuljett ta ’ Tagħrif fil- pakkett għandhom jinqraw bir - reqqa qabel tintuża SoloStar
Important information for use of SoloStar:
Tagħrif importanti għall- użu ta ’ SoloStar:
• Before each use, a new needle must always be carefully attached and a safety test must be performed.
• Dejjem waħħal labra ġdida u għandu jsir it- test ta ’ sigurtà qabel kull darba li tużaha.
Only use needles that are compatible for use with SoloStar. • Special caution must be taken to avoid accidental needle injury and transmission of infection. • Never use SoloStar if it is damaged or if you are not sure that it is working properly. • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Uża biss labar li huma kompatibbli ma ’ l- użu ta ’ SoloStar • Trid tittieħed il- kawtela kollha biex tevita li tweġġa ’ aċċidentalment bil- labra u tieħu xi infezzjoni • Qatt tuża SoloStar jekk tkun bil- ħsara jew m’ intix ċert li qed taħdem sew. • Dejjem żomm miegħek SoloStar żejda f’ każ li SoloStar tintilef jew jiġrilha l- ħsara.
Please check section 6.4 for instructions on how to store SoloStar.
Jekk jogħġbok, iċċekkja sezzjoni 6. 4 għall- istruzzjonijiet kif għandek taħżen is- SoloStar.
If SoloStar is in cool storage, it should be taken out 1 to 2 hours before injection to allow it to warm up.
Jekk is- SoloStar qiegħda maħżuna fil- kesħa, trid toħroġha minn siegħa sa sagħtejn qabel l- injezzjoni biex tilħaq tisħon.
The used SoloStar must be discarded as required by your local authorities.
Is- SoloStar użata għandha tintrema kif jitolbu l- liġijiet lokali.
SoloStar has to be protected from dust and dirt.
Is- SoloStar għandha tkun protetta mit- trab u l- ħmieġ.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Tista ’ tnaddaf minn barra s- SoloStar tiegħek billi timsaħha b’ ċaruta niedja.
SoloStar is designed to work accurately and safely.
Is- SoloStar hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
Avoid situations where SoloStar might be damaged.
Evita sitwazzjonijiet fejn is- SoloStar jista ’ jiġrilha l- ħsara.
If you are concerned that your SoloStar may be damaged, use a new one.
Jekk taħseb li s- SoloStar seta ’ ġralha xi ħsara, uża waħda ġdida.
Check the insulin
Iċċekkja l- insulina
The label on the pen should be checked to make sure it contains the correct insulin.
Iċċekkja t- tikketti tal- pinna biex tiżgura li għandha t- tip korrett t’ insulina. L- Insulin Human Winthrop SoloStar hija ta ’ kulur abjad b’ kulur fuq il- buttun ta ’ l- injezzjoni.
Insulin Human Winthrop SoloStar is white with a colour on the injection button.
Il- kulur tal- buttun ta ’ l- injezzjoni jista ’ jvarja skond il- formulazzjoni tal- insulina Insulin Human Winthrop.
The injection button colour will vary based on the formulation of Insulin Human Winthrop insulin used.
Wara li tneħħi l- kappa tal- pinna, iċċekkja wkoll id- dehra ta ’ l- insulina:
After removing the pen cap, the appearance of the insulin should also be checked: • The insulin solution (Insulin Human Winthrop Rapid) must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
57 • Is- soluzzjoni ta ’ l- insulina (Insulin Human Winthrop Rapid) għandha tkun ċara, mingħajr kulur, b’ ebda partikuli solidi u viżibbli u għandha jkollha konsistenza bħal dik ta ’ l- ilma.
Do not use this SoloStar if insulin is cloudy, coloured or has particles. • The insulin suspensions (Insulin Human Winthrop Basal or Insulin Human Winthrop mixtures) should be mixed by turning SoloStar up and down at least 10 times to resuspend the insulin.
Tużax din s - SoloStar jekk l- insulina hija mdardra, ikkulurita jew għandha l- partikuli. • Is- suspensjonijiet ta ’ l- insulina (Insulin Human Winthrop Basal jew taħlit ta ’ Insulin Human Winthrop) għandhom jitħalltu billi iddawwar is- SoloStar ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
The pen should be turned gently to avoid foaming in the cartridge.
Il- pinna għandha tiġi mdawwra bilmod biex tevita r- ragħwa fl- iskartoċċ.
After mixing, the insulin suspensions must have an evenly milky-white appearance.
Wara t- taħlit, is- suspensjoni ta ’ l- insulina għandha tkun uniformement bajda qisha ħalib.
57 Step 2.
2
Only needles 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.
Labra sterili ġdida għandha dejjem tintuża għal- kull injezzjoni.
After removing the cap, the needle should be carefully attached straight onto the pen.
Wara li titneħħa l- kappa, l- labra għandha titwaħħal b’ kawtela dritt għal fuq il- pinna.
Prior to each injection, a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
isir test ta ’ sigurtà biex tiżgura li l- pinna u l- labra qed jaħdmu sew u biex
Select a dose of 2 units.
Agħżel doża ta ’ 2 unitajiet.
The outer and inner needle caps should be removed.
Il- kappi ta ’ barra u ġewwa għandhom jitneħħew.
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 ppuntata ’ l fuq, taptap b’ subgħajk ir- riżervwar ta ’ l- insulina sabiex xi bżieżaq ta ’ l- arja jitilgħu ’ l fuq lejn il- labra.
Then the injection button should be pressed in completely.
Mbagħad agħfas il- buttun ta ’ l- injezzjoni sa ġewwa.
If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Jekk ebda insulina ma titfaċċa fil- ponta tal- labra, l- pass numru 3 għandu jiġi repetut sakemm l- insulina titfaċċa fil- ponta tal- labra.
The dose can 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 il- waħda (1), minn minimu ta ’ Unità waħda (1) għall - massimu ta ’ 80 Unità.
If you need a dose greater than 80 units, you should give it as two or more injections.
Jekk id- doża meħtieġa hija akbar minn 80 Unità, din trid tingħata f’ żewġ injezzjonijiet jew aktar.
The dose window must show “ 0 ” following the safety test.
It- tieqa li turi d- dożaġġ trid taqra ‘ 0 ’ wara li jsir it- test ta ’ sigurtà.
The dose can then be selected.
Issa tista ’ tingħażel id- doża.
The injection button should be pressed in completely.
Il- buttun ta ’ l- injezzjoni għandu jingħafas sa ġewwa.
Then the injection button should be held down 10 seconds before withdrawing the needle.
Wara, l- buttun ta ’ l- injezzjoni għandu jinżamm ’ l isfel għal 10 sekondi qabel ma tinġibed il- labra barra mill- ġilda.
This ensures that the full dose of insulin has been injected.
Dan jiżgura li d- doża sħiħa ta ’ l - insulina ngħatat.
Step 6.
6
The needle should always be removed after each injection and discarded.
Il- labra trid titneħħa wara kull injezzjoni u tintrema.
This helps prevent contamination and/ or infection, entry of air into the insulin reservoir and leakage of insulin.
Dan jgħin biex telimina l- kontaminazzjoni u/ jew l- infezzjoni kif ukoll id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u t- tqattir ta ’ l- insulina.
Needles mut not be reused.
Il- labar m’ għandhomx jerġgħu jintużaw.
Special caution must be taken when removing and disposing of the needle.
58 Il- kawtela speċjali trid tiġi eżerċitata meta titneħħa u tintrema l- labra.
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. tikkappja l- labra 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.
The pen cap should be replaced on the pen.
Il- kappa tal- pinna għandha titpoġġa lura f’ postha fil- pinna.
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Basal 100 IU/ ml, suspensjoni għall- injezzjoni, ġo kunjett.
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml 100 IU ta ’ insulina umana (ekwivalenti għal 3. 5mg).
Each vial contains 5 ml of suspension for injection, equivalent to 500 IU insulin.
Kull kunjett fih 5 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għal 500 IU t’ insulina.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
IU (Unita Internazzjonali) waħda hija ekwivalenti għal 0. 035 mg t’ insulina umana anidru.
Insulin Human Winthrop Basal is an isophane insulin suspension.
Insulin Human Winthrop Basal hija suspensjoni ta ’ insulina isophane.
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, are sezzjoni 6. 1.
Suspension for injection in a vial.
Suspensjoni għall- injezzjoni ġo kunjett.
After re-suspension, milky white suspension.
Wara li s- suspensjoni titħawwad mill- ġdid, tifforma suspensjoni bajda ħalib
Diabetes mellitus where treatment with insulin is required.
Id- dijabete mellitus meta l- kura bl- insulina hija meħtieġa.
Insulin Human Winthrop Basal is injected subcutaneously 45 to 60 minutes before a meal.
Insulin Human Winthrop Basal hija injettata fit - tessut ta ’ taħt il- ġilda minn 45 sa 60 minuta qabel ikla.
Transfer to Insulin Human Winthrop Basal
Kif taqleb għal Insulin Human Winthrop Basal
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another.
L- tibdil tad- dożaġġ jista ’ jkun meħtieġ meta jinbidel il- preparat ta ’ tip t’ insulina għal ieħor fil- pazjenti.
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
Il- ħtieġa ta ’ l- tibdil (e. z. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
60 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
60 Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
- previously required high insulin doses due to the presence of insulin antibodies.
- preċedentmenet kienu jeħtieġu dożi għoljin t’ insulina dovuti għall- preżenza t’ antikorpi kontra l -
- the patient's life-style changes,
- jsiru tibdiliet fl- istil ta ’ ħajja tal- pazjent,
Administration
Kif tingħata
Insulin Human Winthrop Basal contains 100 IU of insulin per ml suspension.
Insulin Human Winthrop Basal fih 100 IU ta ’ insulina f’ kull millilitru ta ’ soluzzjoni.
Only injection syringes designed for this strength of insulin (100 IU per ml) are to be used.
Is- siringi ta ’ l - injezzjoni magħmulin għal din is- saħħa ta ’ preparat ta ’ l- insulina (100 IU kull ml) għandhom jintużaw.
The injection syringes must not contain any other medicinal product or residue (e. g. traces of heparin).
Is- siringi ta ’ l- injezzjoni m’ għandhomx ikollhom fihom ebda prodott mediċinali ieħor, jew xi residwu tagħhom (per eżempju, traċċi tal- ħeparina).
Insulin Human Winthrop Basal is administered subcutaneously.
Insulin Human Winthrop Basal tingħata fit- tessut taħt il- ġilda.
Insulin Human Winthrop Basal must never be injected intravenously.
Insulin Human Winthrop Basal qatt m’ għandha tingħata fil- vina.
For further details on handling, see section 6.6.
Għal aktar dettalji fuq l- immaniġġar, ara sezzjoni 6. 6.
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita ’ eċċesiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Insulin Human Winthrop Basal must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insulin Human Winthrop Basal m’ għandha qatt tingħata intravenuża u m’ għandhiex tintuża f’ pompi għall- infużjoni, jew pompi ta ’ l- insulina, kemm dawk esterni kif ukoll dawk imdaħħla fil- ġisem.
Patients hypersensitive to Insulin Human Winthrop Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
Pazjenti b’ sensittivita ’ eċċesiva għal Insulin Human Winthrop Basal, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u, fejn hemm bżonn, flimkien ma ’ trattament kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Basal, since they may experience immunological cross-reactions.
F’ pazjenti li huma allerġiċi għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir analiżi għar- reazzjonijiet allerġiċi b’ injezzoni żgħira fil- ġilda, qabel ma ssir il- bidla għal Insulin Human Winthrop Basal, għax dawn jistgħu jiżviluppaw kontro- reazzjonijiet immunoloġiċi kontriha.
61 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
61 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
Hypoglycaemia
L- ipogliċemja
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Il- kawtela trid tkun eżerċitata, u l- immoniterjar intensiv tal- livelli tal- glucose fid- demm huwa irrakkomandat f’ dawk il- pazjenti li jiżviluppaw attakki t’ ipogliċemija, u li jkunu t’ importanza klinika patikolarment rilevanti, bħal ngħidu aħna, pazjenti bi djuq sinifikanti ta ’ l- arterji koronarji jew ta ’ l - arterji li jissupplixxu d- demm lill- moħħ (riskju ta ’ kumplikazzjonijiet kardijaċi u ċerebrali dovuti għall- ipogliċemja), kif ukoll dawk il- pazjenti li għandhom retinopatija proliferattiva, speċjalment jekk mhumiex ittrattati b’ photocoagulation (u b’ hekk għandhom ir- riskju li jiżviluppaw amawrosi li tgħaddi wara l- ipogliċemja).
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Il- fatturi li jżidu s- suxxettibbiltà għas- sintomu tal- ipogliċemja jeħtieġu speċjalment l- moniteraġġ mill- qrib u għandhom mnejn jirrikjedu tibdil tad- doża.
62 Intercurrent illness
62
Intercurrent illness requires intensified metabolic monitoring.
Mard kurrenti
In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet, l- analiżi ta ’ l - awrina għall- ketones huma ndikati, u ta ’ spiss ikun neċessarju li d- doża ta ’ l- insulina tiġi aġġustata.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma’ jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Is- sustanzi li jistgħu jżidu l- effett fuq it- tnaqqis tal- livell tal- glucose fid- demm, u jżidu s- suxxettibbiltà għall- ipogliċemja, jinkludu oral antidijabetiċi orali, inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monoamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates u l- antibijotiċi sulphonamide.
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Fil- kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l- prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
Insulin Human Winthrop Basal can be used during breastfeeding.
Insulin Human Winthrop Rapid jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
4.7 Effects on ability to drive and use machines
63 4. 7 Effetti fuq il- ħila biex issuq u tħaddem maġni
63 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom jingħataw parir biex jieħdu l- prekawzjonijiet biex jevitaw l- ipogliċemja waqt is - sewqan.
Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemja, li ġeneralment hija l- aktar effett komuni u mhux mixtieq tat- terapija bl- insulina, tista ’ tigri meta d- doża ta ’ l- insulina tkun għolja wisq relatata mal- bżonn tagħha.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation.
F’ ħafna pazjenti, is- sinjali u s- sintomi ta ’ newroglukopenja huma preċeduti minn sinjali adrenerġiċi ta ’ tnaqqis fil- kontroll.
Eyes disorders
64 Disturbi fl- għajnejn
64 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common: injection site reactions Uncommon: injection site urticaria Not known: injection site inflammation, injection site swelling, injection site pain, injection site pruritus, injection site erythema.
Komuni: reazzjonijiet fis- sit ta ’ l- injezzjonijiet Mhux komuni: urtikarja fis- sit ta ’ l- injezzjoni Mhux magħrufin: infjammazzjoni fis- sit ta ’ l- injezzjoni, nefħa fis- sit ta ’ l- injezzjoni, uġigħ fis- sit ta ’ l - injezzjoni, ħakk fil - ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
Insulins and analogues, intermediate-acting, ATC Code:
Kodiċi ATC:
Mode of action
65 Il- mod kif jaħdem
Insulin
L- insulina:
- lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects,
- tnaqqas il- livell tal- glucose fid- demm u tinkoraġixxi l- effetti anaboliċi, kif ukoll tnaqqas l- effetti
- increases the transport of glucose into cells as well as the formation of glycogen in the muscles
- iżżid it- trasport tal- glucose ġewwa ċ- ċelluli, kif ukoll il- produzzjoni ta’ glycogen fil- muskoli u l -
and the liver, and improves pyruvate utilisation.
fwied u timmiljora l- użu ta’ pyruvate.
- enhances the uptake of potassium into cells.
- iżżid id- dħul ta’ potassium gewwa ċ- ċelluli.
Insulin Human Winthrop Basal (an isophane insulin suspension) is an insulin with gradual onset and long duration of action.
Insulin Human Winthrop Basal (insulin isophane, likwidu b’ ħafna partiċelli żgħar) hija insulina li ddum biex taħdem u li l- effett tagħha hu wieħed fit- tul.
Following subcutaneous injection, onset of action is within 60 minutes, the phase of maximum action is between 3 and 4 hours after injection and the duration of action is 11 to 20 hours.
Wara l- injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem fi żmien 60 minuta, tilħaq ħidma massima ta ’ bejn 3 u 4 sigħat mill- injezzjoni, u ddum taħdem minn 11 sa 20 siegħa.
65 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Studji fuq l- effetti farmakodinamiċi wara l- għoti fit- tessut ta ’ taħt il- ġilda fil - fniek u l- klieb urew reazzjonijiet ipogliċemiċi kif mistennija.
Protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Protamine sulphate, metacresol, phenol zinc chloride sodium dihydrogen phosphate dihydrate glycerol sodium hydroxide hydrochloric acid (għall- agġustament tal- pH), ilma għall- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief għal dawk imsemmija f’ sezzjoni 6. 6.
Concerning mixing or incompatibility with other insulins see section 6.6.
Dwar it- taħlit u l- inkompattibbiltà ma ’ insulini oħra ara sezzjoni 6. 6.
Care must be taken to ensure that no alcohol or other disinfectants enter the insulin suspension.
Wieħed irid joqgħod attent biex jiżgura li la l- alkoħol u anqas disinfettanti oħra ma jidħlu fl- insulina, li hi taħt għamla ta ’ suspensjoni.
Shelf life after first use of the vial:
66 Żmien kemm idum tajjeb il- kunjett wara l- ewwel użu:
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 °C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Do not put Insulin Human Winthrop Basal next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Basal m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
66 6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
Packs of 1 and 5 vials are available.
5 ml soluzzjoni f’ kunjett (ħġieġ tip 1 mingħajr kulur) b’ għatu bi flanġ (aluminju), tapp (lastku tal - chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).. Pakketti ta ’ 1 u 5 kunjetti huma disponibbli.
Before withdrawing insulin from the vial for the first time, remove the plastic protective cap.
Qabel ittella ’ l- insulina mill- kunjett għall- ewwel darba, neħħi l- għatu protettiv tal- plastik.
Immediately before withdrawal from the vial into the injection syringe, the insulin must be re- suspended.
Immedjatament qabel titella ’ is- sustanza mediċinali mill- kunjett fis- siringa għall- injezzjoni, l- insulina għandha tkun sospiża mill- ġdid.
This is best done by rolling the vial at an oblique angle between the palms of the hands.
Dan l- aħjar li jsir billi iddawwar il- kunjett f’ angolu oblikwu bejn il - pali ta ’ l- idejn.
Do not shake the vial vigorously as this may lead to changes in the suspension (giving the vial a frosted appearance; see below) and cause frothing.
Iċċekkikx il- kunjett bil- qawwa għax dan jista ’ jwassal għal kambjamenti fis - suspensjoni (li jagħtu dehra lill- kunjett qisu miksi bil- ġlata; ara hawn isfel) u jikkaġuna r- ragħwa.
Froth may interfere with the correct measurement of the dose.
Ir - ragħwa tista ’ tfixkel fil- miżura korretta tad- doża.
After resuspension, the fluid must have a uniformly milky appearance.
Wara is- suspensjoni mill- ġdid, il- likwidu għandu jkollu dehra uniformi qisha ħalib.
Insulin Human Winthrop Basal must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the vial.
Insulin Human Winthrop Basal m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina, jew jekk dawn jeħlu mal- ġenb jew il- qiegħ tal- kunjett.
These changes sometimes give the vial a frosted appearance.
Dawn il- kambjamenti x’ imdaqqiet jagħtu dehra lill - kunjett li qisu miksi bil- ġlata.
In such cases, a new vial yielding a uniform suspension must be used.
F’ każijiet bħal dawn, kunjett ġdid li jagħti suspensjoni uniformi għandu jintuża.
It is also necessary to change to a new vial if the insulin requirement changes substantially.
Huwa wkoll meħtieġ li jinbidel il- kunjett jekk il- bżonn għall- insulina jinbidel sostanzjalment.
As with all insulin preparations, Insulin Human Winthrop Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insulin Human Winthrop Basal m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
It must also be remembered that insulin protamine crystals dissolve in an acid pH range.
Wieħed għandu wkoll jiftakar li l- kristalli ta ’ l- insulina protamine jiddisolvu f’ firxa ta ’ pH aciduża.
Mixing of insulins
Taħlit ta ’ l- insulini
Insulin Human Winthrop Basal may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insulin Human Winthrop Basal jista ’ jitħallat ma ’ l- insulini umani kollha ta ’ Sanofi- Aventis, iżda MHUX ma ’ dawk magħmulin speċifikament għall- użu fil- pompi ta ’ l- insulini.
Insulin Human Winthrop Basal must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insulin Human Winthrop Basal ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation.
Jekk żewġ insulini differenti sejrin jittellgħu f’ siringa waħda għall- injezzjoni, huwa rrakkomandat li l - ewwel titella ’ l- insulina li taħdem fuq perijodu iqsar sabiex tevita l- kontaminazzjoni tal- kunjett tal - preparat li jaħdem fuq tul ta ’ ħin itwal. Ta ’ min jirrikkmanda li l- injezzjoni ssir immedjatament wara li
It is advisable to inject immediately after mixing.
67 titħallat.
Insulins of different concentration (e. g.
Insulini ta ’ konċentrazzjoni differenti (e. g.
100 IU per ml and 40 IU per ml) must not be mixed.
100 UI kull ml u 40 UI kull ml) m’ għandhomx jitħalltu.
Insulin Human Winthrop Basal 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Basal 40 IU/ ml, suspensjoni għall- injezzjoni, ġo kunjett.
Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
Kull ml fih 40 IU t’ insulina umana (ekwivalenti għal 1. 4 mg).
Each vial contains 10 ml of suspension for injection, equivalent to 400 IU insulin.
Kull kunjett fih 10 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għal 400 IU t’ insulina.
69 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
69 Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insulin Human Winthrop Basal contains 40 IU of insulin per ml suspension.
Insulin Human Winthrop Basal fih 40 IU ta ’ insulina f’ kull millilitru ta ’ soluzzjoni.
Only injection syringes designed for this strength of insulin (40 IU per ml) are to be used.
Is- siringi ta ’ l - injezzjoni magħmulin għal din is- saħħa ta ’ preparat ta ’ l- insulina (40 IU kull ml) għandhom jintużaw.
Fur further details on handling, see section 6.6.
Għal aktar dettalji fuq l- immaniġġar, ara sezzjoni 6. 6.
70 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
70 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
71 Intercurrent illness
71
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l - prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
4.7 Effects on ability to drive and use machines
72 4. 7 Effetti fuq il- ħila biex issuq u tħaddem maġni
72 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl - aktar serji jitniżżlu l- ewwel..
Eyes disorders
73 Disturbi fl- għajnejn