qanastek/EMEA-V3 huggingface dataset:
The cartridges for OptiClik are to be used in conjunction with OptiClik only and as recommended in the information provided by the device manufacturer.
L- iskartoċċi għal OptiClik għandhom jintużaw flimkien ma ’ OptiClik biss u skond kif inhu irrakkomandat fit- tagħrif ipprovdut mill- manifattur tal- pinna.
Before insertion into the pen, the cartridge must be stored at room temperature for 1 to 2 hours.
Qabel ma jiddaħħal fil- pinna, l- iskartoċċ għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn.
Inspect the cartridge before use.
Eżamina l- iskartoċċ qabel l- użu.
It must only be used if the cartridge is intact and the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Għandu jintuża biss jekk l- iskartoċċ huwa ntatt u s- soluzzjoni hija ċara, bla kulur, mingħajr ebda partikuli solidi u viżibbli, u jekk għandha konsistenza tixbah dik ta ’ l - ilma.
Since Lantus is a solution, it does not require resuspension before use.
Peress li Lantus huwa soluzzjoni, m’ għandux bżonn li tirrissospendih qabel l- użu.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet dwar l- użu tal - pinna).
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Ġermanja.
Lantus 100 Units/ ml solution for injection in a pre-filled pen
Lantus 100 Unità / ml, soluzzjoni għall- injezzjoni, f’ pinna mimlija għal- lest
Each pen contains 3 ml of solution for injection, equivalent to 300 Units.
Kull pinna fiha 3 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 300 Unità.
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6. 1
PHARMACEUTICAL FORM
FORMA FARMAĊEWTIKA
Solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal lesta.
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif jingħata
OptiSet delivers insulin in increments of 2 Units up to a maximum single dose of 40 Units.
OptiSet jagħti ammont ta ’ insulina b’ żidiet ta ’ 2 unitajiet, sa massimu ta ’ doża waħda ta ’ 40 Unità.
The dosage and timing of dose of Lantus should be individually adjusted.
Id- dożaġġ u l- ħin meta jingħata għandu jkun individwalment aġġustat.
In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products.
F’ pazjenti bid- dijabete mellitus tip 2, Lantus jista ’ jingħata flimkien ma ’ prodotti mediċinali antidijabetiċi li huma attivi meta jittieħdu mill- ħalq.
32 To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Biex jitnaqqas ir- riskju ta ’ l- ipogliċemija matul il- lejl u filgħodu kmieni, il- pazjenti li qed jaqilbu s- sistema bażi tal- kura tagħhom b’ NPH insulin minn darbtejn kuljum, għall- sistema ta ’ kura b ’ Lantus ta ’ darba kuljum, għandhom inaqqsu d- doża bażi ta ’ kuljum b’ 20% sa 30%, waqt l- ewwel ftit ġimgħat tat- trattament.
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully (see section 6.6)
L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif għandhom jinqraw bir- reqqa qabel tintuża l - OptiSet (ara sezzjoni 6. 6).
Safety and efficacy of Lantus have been established in adolescents and children of 6 years and above.
Is- sigurtà u l- effikaċja ta ’ Lantus intweriet fl- adoloxxenti u t- tfal ta ’ sitt snin u ’ l fuq.
33 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti li għandhom indeboliment sever fil- funzjoni epatika, il- ħtieġa għall- insulina tista ’ tonqos, dovuta għat- tnaqqis fil- ħila li jifforma l- glukożju minn molekuli li mhumiex karboidrati, u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ ta ’ kontroll inadegwat taz- zokkor, jew fejn ikun hemm tendenza biex jiżviluppaw episodji ta ’ ipergliċemija jew ipogliċemija, jridu jkunu ikkunsidrati jekk il- pazjent hux isegwi l- iskema tat- trattament li ngħatatlu, is- siti ta ’ l- injezzjonijiet, il- metodu ta ’ kif qed tingħata l- injezzjoni, u l- fatturi rilevanti l- oħra kollha, qabel l- tibdil fid- doża tkun ikkunsidrata.
Switching a patient to another type or brand of insulin should be done under strict medical supervision and may require change in dose.
Meta pazjent jinqaleb minn għamla jew kwalità oħra ta ’ insulina, dan irid isir taħt superviżżjoni stretta tat - tabib u jista ’ jkun hemm bżonn ta ’ bidla fid- doża.
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Pazjenti li għandhom id- dijabete tat- tip 1 għandhom jibqgħu jikkunsmaw, għal ta ’ l- anqas ammont żgħir ta ’ karboidrati fuq bażi regolari, anke jekk jistgħu jieklu biss ftit jew ma jistgħux jieħdu ebda ikel, jew qegħdin jirrimettu eċċ.
Handling of the pen
M’ għandhom qatt iwaqqfu għal kollox l- insulina.
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully.
L- immaniġġar tal- pinna Qabel tuża OptiSet, aqra bir- reqqa l- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif.
OptiSet has to be used as recommended in these Instructions for Use (see section 6.6).
OptiSet għandha tintuża skond kif inhu rrakkomandat fl- Istruzzjonijiet għall- Użu (ara sezzjoni 6. 6).
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Hekk ukoll, is- sinjali adrenerġiċi kontra l- kontroll jistgħu jitnaqqsu jew ikunu assenti taħt l- effetti ta ’ prodotti mediċinali simpatolitiċi bħall- imblokkaturi tar- reċetturi beta, clonidine, guanethidine u reserpine.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available.
TqalaGħal insulin glargine m’ hemmx tagħrif kliniku minn studji kliniċi kkontrollati dwar l- użu waqt it- tqala.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal / foetal development, parturition or postnatal development (see section 5.3).
Studji fuq l- annimali ma jurux effetti ħżiena diretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju / fetu, ħlas jew l - iżvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
35 Lactation Lactating women may require adjustments in insulin dose and diet.
Treddigħ Nisa li qegħdin ireddgħu għandu mnejn ikollhom bżonn ta ’ tibdil fid- doża ta ’ l- insulina u fid- dieta.
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Il- ħila tal- pazjent biex jikkonċentra u jirreaġixxi jistgħu jkunu mnaqqsa minħabba l- ipogliċemija jew l - ipergliċemija jew, per eżempju, bħala riżultat tat- tnaqqis fil- vista.
Rare:
Disturbi fl’ għajnejn Rari:
Musculoskeletal and connective tissue disorders
Distrubi muskolu- skeletrali u tal- connective tissue
General disorders and administration site conditions
Distrubi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-precipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/ time profile with a prolonged duration of action.
Dan jipprovdi profil ta ’ konċentrazzjoni dejjiemi mingħajr varjazzjoni fil- konċentrazzjoni, u li jaħdem għal perijodu twil.
38 The following graph shows the results from a study in patients:
- 38 -
Activity Profile in Patients with Type 1 Diabetes
Il- Profil ta’ Attività F’ Pazjenti li Għandhom id- Dijabete Tip Ir- rata li biha jintuża l -
6
6 (mg/ kg/ min) glukożju *
4 Insulin glargine
4 Insulin glargine NPH Insulin 3
Time (h) after s. c. injection
Il- punt fejn twaqqaf il - perijodu ta' osservazzjoni
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Fi studju kliniku, is- sintomi ta ’ l- ipogliċemija jew ir- rispons ormonali kontro- regolatorju kienu simili wara insulin glargine intravenuż u insulina umana intravenuża, kemm f’ individwi voluntiera b’ saħħithom kif ukoll f’ pazjenti bid- dijabete tip 1.
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
F’ persuni b’ saħħithom u f’ pazjenti dijabetiċi, il- livelli ta ’ l- insulina fis- serum juru assorbiment aktar bil- mod, imtawwal ħafna aktar, mingħajr avariji fil- koncentrazzjoni, wara injezzjoni subkutanja ta ’ insulin glargine
39 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhiex klinika, miġbura fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku, fuq is- sistema riproduttiva, ma ’ turi l- ebda perikolu speċjali għall- bniedem.
Zinc chloride m-cresol glycerol hydrochloric acid sodium hydroxide water for injections.
Zinc chloride M- cresol Glycerol Hydrochloric acid Sodium hydroxide Ilma għall- injezzjonijiet
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.
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.
Pens in use must not be stored in the refrigerator.
Il- pinen fl- użu m’ għandhomx jinżammu fil- friġġ.
The pen cap must put back on the pen after each injection in order to protect from light.
Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed lura fuq il- pinna sabiex tilqa ’ mid- dawl.
Not in-use pens Store in a refrigerator (2°C-8°C).
Aħżen fi friġġ (2°Ċ- 8°Ċ).
Keep the prefilled 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.
In-use pens For storage precautions, see section 6.3.
Għal kundizzjonijiet ta ’ ħażna, ara sezzjoni 6. 3.
The cartridge is sealed in a disposable pen injector.
L- iskartoċċ huwa ssiġillat f’ pinna għall- injezzjoni li tintrema wara li tintuża.
Needles are not included in the pack.
Il- labar mhumiex inklużi fil- pakkett.
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens are available.
Pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 pinen huma disponibbli.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali...
40 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Before first use, the pen must be stored at room temperature for 1 to 2 hours.
Qabel tintuża għall- ewwel darba, il- pinna trid tinżamm f’ temperatura ambjentali ta ’ ġewwa 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 tkun ċara u bla kulur, mingħajr frak viżibbli, u ta ’ konsistenza bħal dik ta ’ l- ilma.
Since Lantus is a solution, it does not require resuspension before use.
Peress li Lantus huwa soluzzjoni, ma teħtieġx li tagħmilha f’ soluzzjoni qabel l- użu.
Empty pens must never be reused and must be properly discarded.
Pinen vojta m’ għandhom qatt jintużaw u għandhom jintremew kif jixraq.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Biex tkun evitata kull tip ta ’ kontaminazzjoni, l- użu ta ’ pinna mimlija għal- lest għandha tkun ristretta għall - użu minn pazjent wieħed biss.
Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
L- immaniġġar tal- pinna L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif fil- pakkett għandhom jinqraw bir- reqqa qabel tintuża l- OptiSet.
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If a new OptiSet is used the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (change the dose) after injection button has been pulled out. • This pen is only for the patients use.
Uża biss labar li huma kompatibbli ma ’ l- użu ta ’ OptiSet. • Dejjem agħmel it- test ta ’ sigurtà qabel kull injezzjoni. • Jekk ser tintuża OptiSet ġdida, it- test inizjali ta ’ sigurtà għandu jsir bit- 8 Unità issettjati minn qabel mill- manifattur. • Il- mekkaniżmu għas- selezzjoni tad- dożaġġ jista ’ jdur f’ direzzjoni waħda. • Qatt m’ għandek iddawwar dan il- mekkaniżmu (tibdel id- doża) wara li l- buttun ta ’ l- injezzjoni ikun inġibed ’ il barra. • Din il- pinna hija intiża għall- użu mill- pazjent biss.
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 tingħata minn persuna oħra, din ta ’ l- aħħar għandha togħod attenta ħafna biex tevita li tweġġa ’ aċċidentalment bil- labra u tieħu 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 tintilef jew jiġrilha l- ħsara.
Cold insulin is more painful to inject.
L- insulina kiesħa tweġġa ’ aktar meta tinjettaha.
41 Maintenance
Manutenzjoni
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’ ċarruta niedja.
Do not soak, wash or lubricate the pen as this may damage it.
Ixxarrabx, taħsilx jew tillubrikax il- pinna għax dan jista ’ jagħmlilha l- ħsara.
It should be handled with care.
Trid timmaniġġaha b’ attenzjoni.
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 frak solidi u viżibbli u għandu jkollha konsistenza bħal dik ta ’ l- ilma.
Do not use this OptiSet if the insulin is cloudy, coloured or has particles.
Tużax din l- OptiSet jekk l- insulina hija mdardra, ikkulurita jew għandha l- frak.
The needle should be carefully attached straight onto the pen.
Il- labra għandha titwaħħal b’ kawtela dritt għal fuq il- pinna.
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 jagħżel d - dożaġġ, sakemm il- vleġġa li tindika d- doża tipponta lejn 2.
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 ppuntata ’ l fuq, taptap b’ subgħajk ir- riżervwar ta ’ l- insulina sabiex il - bżieżaq ta ’ l- arja kollha jitilgħu ’ l fuq lejn il- labra.
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
If no insulin comes out after changing the needle, the OptiSet may be damaged.
Jekk ebda insulina ma toħroġ mil- labra, wara li tkun inbidlet il- labra jista ’ jagħti l - każ li l- OptiSet hija bil- ħsara.
42 Step 4.
4
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.
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.
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 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 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 qed tipponta lejn id- doża meħtieġa.
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 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.
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.
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.
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.
The pen cap should be replaced on the pen.
Il- kappa tal- pinna għandha titpoġġa `lura f’ postha fuq il- pinna.
Lantus 100 Units/ ml solution for injection in a pre-filled pen
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni, f’ pinna mimlija għal- lest
Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
L- insulina glargine hija magħmula bit- teknoloġija rikombinanti tad- DNA ġo Escherichia coli.
SoloStar.
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
45 To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Biex jonqos ir- riskju ta ’ l- ipogliċemija billejl jew filgħodu kmieni, il- pazjenti li qed jaqilbu minn sistema ta ’ insulina bażika, minn waħda ibbażata fuq it- teħid ta ’ darbtejn kuljum ta ’ insulina NPH, għal sistema oħra ta ’ darba kuljum b’ Lantus, għandhom inaqqsu d- doża ta ’ kuljum ta ’ l- insulina bażika b’ 20- 30% waqt l- ewwel ftit ġimgħat tal- kura.
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully (see section 6.6).
L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif għandhom jinqraw bir- reqqa qabel jintuża s - SoloStar (ara sezzjoni 6. 6).
46 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti li għandhom indeboliment sever tal- fwied, il- ħtieġa għall- insulina tista ’ tonqos dovuta għat - tnaqqis fl- abbiltà tal- produzzjoni tal- glukosju u tnaqqis fil- metaboliżmu ta ’ l- insulina.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F ’ każ ta ’ nuqqas adegwat fil- kontroll tal- livelli tal- glukosju jew f’ każijiet ta ’ tendenza għall- iżvilupp ta ’ ġrajjiet ta iper - jew ipo- gliċemija, għandhom jiġu ikkunsidrati mill- ġdid jekk il- pazjent hux qiegħed iżomm mal- kura preskritta, is- siti ta ’ l- injezzjonijiet u t- teknika użata għall- injezzjoni, u l- fatturi l- oħra kollha rilevanti, qabel ma jiġi ikkunsidrat l- aggustament fid- doża.
Handling of the pen
L- immaniġġar tal- pinna
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Is- sustanzi mediċinali li jistgħu jbaxxu aktar l- effett tat- tnaqqis fil- livell tal- glukosju fid- demm u b’ hekk iżidu s- suxxettibilità għall- ipogliċemija jinkludu s- sustanzi antidijabetiċi orali, inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE), disopyramide, fibrati, fluoxetine, inibituri ta ’ monamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates u l- antibijotiċi tal- klassi sulfonamide.
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering effect of insulin.
L- imblokkaturi tar- reċetturi beta, clonidine, is sustanzi tal- lithium jew l- alcohol jistgħu jsaħħu jew idgħajjfu l- effett li għandha l- insulina li tbaxxi l- livell tal- glukosju fid- demm.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Addizjonalment is- sinjali adrenerġiċi ta ’ counter- regulation jistgħu jkunu mnaqqsin jew assenti, taħt l- effetti tas- sustanzi mediċinali simpatolitiċi bħall- imblokkaturi tar- reċetturi beta, clonidine, guanethidine u reserpine.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available.
Tqala Għall- insulina glargine m’ hemmx tagħrif kliniku minn studji kliniċi kkontrollati dwar l- użu waqt it- tqala.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal / foetal development, parturition or postnatal development (see section 5.3).
Studji fuq l- annimali ma jurux effetti ħżiena diretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju / fetu, ħlas jew żvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
48 Lactation Lactating women may require adjustments in insulin dose and diet.
Treddigħ Nisa li qed ireddgħu jistgħu jeħtieġu aġġustamenti fid- doża ta ’ l- insulina u d- dieta.
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
L- abbiltà tal- pazjent biex jikkonċentra u jirreaġixxi jistgħu jonqsu bħala riżultat ta ’ l- ipogliċemija jew l - ipergliċemija jew, per eżempju, bħala riżultat ta ’ indeboliment tal- vista.
Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemija, ġeneralment, hija l- aktar effett spiss li mhux mixtieq, tat- terapija bl- insulina; din tista ’ tiġri jekk id- doża ta ’ l- insulina hija għolja wisq relatata mal- bżonnijiet tal- persuna għal insulina.
49 Eyes disorders
Distrubi fl’ għajnejn
Skin and subcutaneous tissue disorders
Distrubi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Oedema Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Edema Rarament, l- insulina tista ’ twassal li jakkumula s- sodju u tiżviluppa l- edema, speċjalment jekk qabel kien hemm kontroll metaboliku fqir li wara tjieb b’ terapija intensifikata bl- insulina
No clinical study safety data are available in patients below 6 years of age.
M’ hemmx data klinika disponibbli dwar is- sigurtà f’ pazjenti 6 snin.
50 Management
Trattament
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose.
Ġrajjiet aktar severi b’ koma, aċċessjoni jew indeboliment newroloġiku jistgħu jkunu ittrattati b’ injezzjoni ta ’ glucagon fil- muskolu/ fit- tessut ta ’ taħt il- ġilda, jew b’ injezzjoni ġol vina ta ’ soluzzjoni ikkonċentrata tal - glukosju.
After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-precipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/ time profile with a prolonged duration of action.
Wara li tkun injettata fit- tessut ta ’ taħt il- ġilda, s- soluzzjoni aċiduża twassal għall- formazzjoni ta ’ sustanza solida mikroskopika, li tissepara mil- likwidu li tkun miżmuma fih, u li minnha ammonti żgħar ta ’ insulina glargine joħorġu kontinwament; dan jipprovdi profil ta ’ konċentrazzjoni dejjiema mingħajr varjazzjoni, u li jaħdem għal perjodu twil.
Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
L - insulina u l- analogi tagħha jbaxxu l- livelli tal- glukosju fid- demm billi jistimulaw il- ġbir tal- glukosju mit - tessuti periferali, specjalment il- muskoli skeletrali u x- xaħam, kif ukoll jinibixxu l- produzzjoni tal- glukosju mill- fwied.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
Fi studji fuq suġġetti b’ saħħithom jew f’ pazjenti bid dijabete tat- tip 1, fejn il- livell taz- zokkor fid- demm inżamm stabbli u normali, l- ħin biex tibda taħdem doża ta ’ insulina glargine mogħtija fit- tessut ta ’ taht il - ġilda, kien itwal minn insulina umana NPH, il- profil kellu effett kostanti u dejjiemi mingħajr avariji u ċaqlieq.
51 The following graph shows the results from a study in patients:
Il- graff li tmiss turi r- riżultati minn studju fuq pazjenti:
5
5 L- Użu tal- Glukosju Rata * (mg/ kg/ min) Rate * (mg/ kg/ min) Glucose Utilization
Time (h) after s. c. injection
Time (h) after s. c. injection
End of observation period
Ħin (sigħat) wara injezzjoni taħt il- ġilda
*determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
t' ossevazzjoni
The longer duration of action of insulin glargine is directly related to its slower rate of absorption and supports once daily administration.
* ikkalkulata bħala l- ammont ta ’ glukosju mogħti bħala infuzzjoni biex iżomm il- livelli tal- glukosju kostanti fil- plażma (stima medja f’ siegħa) Ir- raġuni għaliex l- insulina glargine taħdem fuq medda itwal ta ’ ħin hija direttament relatata għar- rata baxxa ta ’ assorbiment u din tikkonferma li għandha tingħata darba biss kuljum.
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
F’ suġġetti b’ saħħithom u f’ pazjenti dijabetiċi, il- konċentrazzjoni ta ’ l- insulina fis- seru indikat assorbiment aktar bil- mod u ferm aktar fit- tul, u nuqqas ta ’ punt ta ’ intensità, wara injezzjoni fit- tessut ta ’ taħt il- ġilda ta ’
In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Fi studji kliniċi, l- analiżi ta ’ sottogruppi ibbażati fuq l- età u s- sess maskil/ femminil m’ urew ebda differenza fis- sigurtà u l- effikaċja, fil- pazjenti ittrattati bl- insulina glargine meta mqabblin mal- grupp kollu li fuqu sar l - istudju.
52 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma ’ turi l- ebda periklu speċjali għall- bnedmin
Zinc chloride m-cresol glycerol hydrochloric acid sodium hydroxide water for injections.
Zinc chloride m- cresol glycerol hydrochloric acid sodium hydroxide ilma għall- injezzjonijiet.
The pen cap must be put back on the pen after each injection in order to protect from light.
Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed lura fuq il- pinna sabiex tilqa ’ mid- dawl.
Do not put Lantus next to the freezer compartment or a freezer pack.
Tagħmilhomx fil- friża. Lantus m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal - friża.
In use pens For storage precautions, see section 6.3.
Għal kundizzjonijiet ta ’ ħażna, ara sezzjoni 6. 3.
3 ml solution in a cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber). The cartridge is sealed in a disposable pen injector.
L- iskartoċċ huwa issiġillat f’ pinna għall- injezzjoni li tintrema wara li tinħela.
Needles are not included in the pack.
Il- labar m’ humiex inklużi fil- pakkett.
53 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Before first use, the pen must be stored at room temperature for 1 to 2 hours.
Qabel tintuża għall- ewwel darba, l- pinna trid tinżamm f’ temperatura ambjentali ta ’ ġewwa 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, bla kulur, mingħajr frak viżibbli, u ta ’ konsistenza bħal dik ta ’ l- ilma.
Empty pens must never be reused and must be properly discarded.
Biex tkun evitata kull tip ta ’ kontaminazzjoni, l- użu ta ’ pinna mimlija għal- lest għandha tkun ristretta għall - użu minn pazjent wieħed biss.
To prevent the possible transmission of disease, each pen must be used by one patient only.
L- immaniġġar tal- pinna L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif fil- pakkett għandhom jinqraw bir- reqqa qabel tintuża s- SoloStar.
Handling of the pen
Siġill Protettiv
The Instructions for Use included in the Package Leaflet must be read carefully before using SoloStar.
Riżervwar ta ’ l- Insulina
Important information for use of SoloStar:
Informazzjoni importanti għall- użu ta ’ SoloStar:
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.
• Qabel kull darba li tintużha, labra ġdida għandha titwaħħal bil- galbu u jsir it- test ta ’ sigurtà. • 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 tintilef jew jiġrilha l- ħsara.
Please check section 6.4 of this leaflet 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 tinħareġ biex tisħon, minn siegħa sa sagħtejn qabel l - injezzjoni.
Cold insulin is more painful to inject.
L- insulina kiesħa tweġġa ’ aktar meta tinjettha.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Tista ’ tnaddaf minn barra s- SoloStar billi timsaħħa b’ ċaruta niedja.
54 Step 1.
1
Check the Insulin
Iċċekkja t- tikketti
The label on the pen should be checked to make sure it contains the correct insulin.
tal- pinna biex tiżgura li għandha t- tip korrett t’ insulina.
The Lantus SoloStar is grey with a purple injection button.
Il- Lantus SoloStar hija ta ’ kulur
After removing the pen cap, the appearance of insulin should also be checked: the insulin solution must be clear, colorless, with no solid particles visible, and must have a water-like consistency.
Wara li titneħħa l- kappa tal- pinna, id- dehra ta ’ l- insulina trid tkun iċċekkjata ukoll: 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.
Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Qabel kull injezzjoni jrid isir test ta ’ sigurtà biex tiżgura li l- pinna u l- labra qed jaħdmu sew u biex jitneħħew il- bżieżaq ta ’ l- arja.
Select a dose of 2.
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 ppuntata ’ l fuq, taptap b’ subgħajk ir- riżervwar ta ’ l- insulina sabiex xi bżieżaq ta ’ l- arja jitilgħu ’ l fuq lejn il- 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 l- waħda, minn minimu ta ’ Unità waħda (1) għall- massimu ta ’ 80 Unità.
If a dose greater than 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.
This ensures that the full dose of insulin has been injected.
Dan jiżgura li d- doża sħiħa ta ’ l- insulina ngħatat.
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.
Special caution must be taken when removing and disposing the needle.
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. g. 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.
55 Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, il- Ġermanja.
56 ANNEX II
- 56 -
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
57 A.
- 57 -
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Alternative site 10 ml vials:
Sît alternattiv għal- kunjetti ta ’ 10ml
A PSUR covering the period 22 October 2004 – 21 October 2006 will be submitted in December 2006.
PSUR li jkopri l- perijodu bejn it- 22 ta ’ Ottubru 2004 ul- 21 ta ’ Ottubru 2006 jintbagħat f’ Diċembru 2006.
Subsequent PSURs will be submitted in accordance with the European legislation unless otherwise requested by the CHMP.
PSURs sussegwenti ser jintbagħatu skond ma tirrikjedi l- legislazzjoni Ewropea sakemm mhux mitluba xort’ oħra mis- CHMP.
58 ANNEX III
- 58 -
59 A.
- 59 -
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
- 60 -
OUTER CARTON
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Lantus 100 Units/ ml Solution for injection in a vial Insulin glargine
Insulin glargine
1 ml contains 100 Units (3.64 mg) insulin glargine
1 ml fih 100 Unità (3. 64 mg) insulin glargine
Excipients: zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injections
Sustanzi mhux attivi: zinc chloride, m- cresol, glycerol, hydrochloric acid, sodium hydroxide, ilma għall - injezzjonijiet
Solution for injection, 1 vial of 5 ml.
Soluzzjoni għall- injezzjoni, kunjett 1 ta ’ 5 ml.
Solution for injection, 2 vials of 5 ml.
Soluzzjoni għall- injezzjoni, 2 kunjetti ta ’ 5 ml.
Solution for injection, 5 vials of 5 ml.
Soluzzjoni għall- injezzjoni, 5 kunjetti ta ’ 5 ml.
Solution for injection, 10 vials of 5 ml.
Soluzzjoni għall- injezzjoni, 10 kunjetti ta ’ 5 ml.
Subcutaneous use.
Użu għall taħt il- ġilda.
EXP (month/ year):
EXP {XX/ SSSS}:
61 Unopened vials:
Kunjetti mhux miftuħin:
Store in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Once in use, vials may be stored for a maximum of 4 weeks not above 25°C.
Ġaladarba fl- użu, il- kunjetti jistgħu jinżamm għal massimu ta ’ 4 ġimgħat mhux ’ il fuq minn 25°Ċ.
Keep in the outer carton.
Żomm fil - kartuna ta ’ barra.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, il- Ġermanja.
EU/ 1/ 00/ 134/ 001 1 vial of 5 ml EU/ 1/ 00/ 134/ 002 2 vials of 5 ml EU/ 1/ 00/ 134/ 003 5 vials of 5 ml EU/ 1/ 00/ 134/ 004 10 vials of 5 ml
EU/ 1/ 00/ 134/ 001 kunjett 1 ta ’ 5 ml EU/ 1/ 00/ 134/ 002 2 kunjetti ta ’ 5 ml EU/ 1/ 00/ 134/ 003 5 kunjetti ta ’ 5 ml EU/ 1/ 00/ 134/ 004 10 kunjetti ta ’ 5 ml
62 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
- 62 -
Lantus 100 Units/ ml Solution for injection in a vial Insulin glargine
Lantus 100 Unità / ml Soluzzjoni għall- injezzjoni, f’ kunjett Insulin glargine
Date of first use :……………
Data ta ’ l- ewwel użu:..............
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
- 63 -
Excipients: zinc chloride, m-cresol, glycerol, hydrochloric acid, polysorbate 20, sodium hydroxide, water for injections
Sustanzi mhux attivi: zinc chloride, m- cresol, glycerol, hydrochloric acid, polysorbate 20, sodium hydroxide, ilma għall- injezzjonijiet
Solution for injection, 1 vial of 10 ml.
Soluzzjoni għall- injezzjoni, kunjett 1 ta ’ 10 ml.
Use only clear and colourless solutions.
Uża biss taħlitiet likwidi li huma ċari u bla kulur.
EXP (month/ year):
EXP{ XX/ SSSS}:
64 Unopened vials:
Kunjetti mhux miftuħin:
Store in the outer carton in order to protect from light.
Żomm fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Once in use, vials may be stored for a maximum of 4 weeks not above 25°C.
Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu għal massimu ta ’ 4 ġimgħat mhux ’ il fuq minn 25°Ċ.
Keep in the outer carton.
Żommu fil- kartuna ta ’ barra.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany.
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, il- Ġermanja.
65 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
- 65 -
Lantus 100 Units/ ml Solution for injection in a vial Insulin glargine
Lantus 100 Unita ’ / ml Soluzzjoni għall- injezzjoni, f’ kunjett.
Date of first use :……………
EXP Data ta ’ l- ewwel użu:..............
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
- 66 -
Lantus 100 Units/ ml Solution for injection in a cartridge Insulin glargine
Lantus 100 Unita ’ / ml Soluzzjoni għall- injezzjoni fi skartoċċ Insulin glargine
Solution for injection, 1 cartridge of 3 ml.
Soluzzjoni għall- injezzjoni, skartoċċ 1 ta ’ 3 ml.
Solution for injection, 3 cartridges of 3 ml.
Soluzzjoni għall- injezzjoni, 3 skartoċċi ta ’ 3 ml.
Solution for injection, 4 cartridges of 3 ml.
Soluzzjoni għall- injezzjoni, 4 skartoċċi ta ’ 3 ml.
Solution for injection, 5 cartridges of 3 ml.
Soluzzjoni għall- injezzjoni, 5 skartoċċi ta ’ 3 ml.
Solution for injection, 6 cartridges of 3 ml.
Soluzzjoni għall- injezzjoni, 6 skartoċċi ta ’ 3 ml.
Solution for injection, 8 cartridges of 3 ml.
Soluzzjoni għall- injezzjoni, 8 skartoċċi ta ’ 3 ml.
Solution for injection, 9 cartridges of 3 ml.
Soluzzjoni għall- injezzjoni, 9 skartoċċi ta ’ 3 ml.
Solution for injection, 10 cartridges of 3 ml.
Soluzzjoni għall- injezzjoni, 10 skartoċċi ta ’ 3 ml.
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Lantus cartridges Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used
Jekk il- pinna ta ’ l- insulina hija bil- ħsara jew mhix qed taħdem sew (minħabba xi difetti mekkaniċi) għandha tintrema, u tintuża pinna ġdida ta ’ l- insulina.
Unopened cartridges Store in a refrigerator.
Aħżen fi friġġ.
Store in the outer carton in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Once in use the cartridge may be stored for a maximum of 4 weeks not above 25°C.
Ġaladarba fl- użu, l- iskartoċċ jista ’ jinżamm għal massimu ta ’ 4 ġimgħat mhux ’ il fuq minn 25°Ċ.
The pen containing the cartridge must not be stored in the refrigerator.
Il- pinna li fiha l- iskartoċċ m’ għandhiex tinżamm fil- friġġ.
EU/ 1/ 00/ 134/ 013 1 cartridge of 3 ml EU/ 1/ 00/ 134/ 014 3 cartridges of 3 ml EU/ 1/ 00/ 134/ 005 4 cartridges of 3 ml EU/ 1/ 00/ 134/ 006 5 cartridges of 3 ml EU/ 1/ 00/ 134/ 015 6 cartridges of 3 ml EU/ 1/ 00/ 134/ 016 8 cartridges of 3 ml EU/ 1/ 00/ 134/ 017 9 cartridges of 3 ml EU/ 1/ 00/ 134/ 007 10 cartridges of 3 ml
EU/ 1/ 00/ 134/ 013 skartoċċ 1 ta ’ 3 ml EU/ 1/ 00/ 134/ 014 3 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 005 4 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 006 5 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 015 6 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 016 8 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 017 9 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 007 10 skartoċċi ta ’ 3 ml
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
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CARTRIDGE
SKARTOĊĊ
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U KIF GĦANDU JINGĦATA
Lantus 100 Units/ ml Solution for injection in a cartridge Insulin glargine
Insulin glargine
To be used with OptiPen.
Għall- użu b’ OptiPen.
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
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Consult your insulin pen instruction booklet for further details.
Ara l- fuljett ta ’ tagħrif fuq il- pinna tiegħek ta ’ l- insulina għal aktar dettalji.
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
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OUTER CARTON (cartridge for OptiClik)
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Lantus 100 Units/ ml Solution for injection in a cartridge Insulin glargine
Lantus 100 Unità / ml Soluzzjoni għall- injezzjoni fi skartoċċ Insulin glargine
The cartridges for OptiClik are to be used in conjunction with OptiClik only.
L- iskartoċċi ta ’ 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 OptiClik hija bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi) għandha tintrema, u OptiClik ġdida trid tintuża minflok.
72 8.
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Unopened cartridges:
Skartoċċi mhux miftuħin:
EU/ 1/ 00/ 134/ 022 1 cartridge of 3 ml EU/ 1/ 00/ 134/ 023 3 cartridges of 3 ml EU/ 1/ 00/ 134/ 024 4 cartridges of 3 ml EU/ 1/ 00/ 134/ 025 5 cartridges of 3 ml EU/ 1/ 00/ 134/ 026 6 cartridges of 3 ml EU/ 1/ 00/ 134/ 027 8 cartridges of 3 ml EU/ 1/ 00/ 134/ 028 9 cartridges of 3 ml EU/ 1/ 00/ 134/ 029 10 cartridges of 3 ml
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 00/ 134/ 022 skartoċċ 1 ta ’ 3 ml EU/ 1/ 00/ 134/ 023 3 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 024 4 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 025 5 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 026 6 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 027 8 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 028 9 skartoċċi ta ’ 3 ml EU/ 1/ 00/ 134/ 029 10 skartoċċi ta ’ 3 ml
INFORMATION ON USE
STRUZZJONIJIET DWAR L- UŻU
73 74 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE FOR OPTICLIK
SKARTOĊĊ GĦAL OPTICLIK
Lantus 100 Units/ ml Solution for injection in a cartridge Insulin glargine
Lantus 100 Unità/ ml Soluzzjoni għall- injezzjoni f’ skartoċċ Insulina glargine.
To be used with OptiClik.
Jintuża ma ’ OptiClik.
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
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OUTER CARTON (PRE-FILLED PEN.
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OptiSet)
KARTUNA TA ’ BARRA (PINNA MIMLIJA GĦAL- LEST, OptiSet)
Lantus 100 Units/ ml Solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Insulin glargine
Insulina glargine.
1 ml contains 100 Units (3.64 mg) insulin glargine
1 ml fih 100 Unità (ekwivalenti għal 3. 64 mg) insulina glargine.
Excipients: zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injections
Sustanzi mhux attivi: zinc chloride, m- cresol, glycerol, hydrochloric acid, sodium hydroxide, ilma għall - injezzjonijiet.
6 pens of 3 ml.
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, OptiSet.
10 pens of 3 ml.
Pinna 1 ta ’ 3 ml 3 pinen ta ’ 3 ml 4 pinen ta ’ 3 ml 5 pinen ta ’ 3 ml 6 pinen ta ’ 3 ml 8 pinen ta ’ 3 ml 9 pinen ta ’ 3 ml 10 pinen ta ’ 3 ml
Only use needles that have been approved for use with OptiSet.
Uża biss il- labar li huma approvati għall- użu ma ’ OptiSet.
76 Always first attach a new needle before using OptiSet.
TAGĦRIF IMPORTANTI Dejjem qabbad l- ewwel labra ġdida qabel ma tuża OptiSet.
Read the package leaflet fully before using OptiSet for the first time
Aqra il- fuljett ta ’ tagħrif kollu qabel tuża OptiSet għall- ewwel darba.
New information for use: • Name of the insulin is printed on the pen • Dosage selector can only be turned in one direction
Tagħrif ġdid għall- użu: • L- isem ta ’ l- insulina huwa stampat fuq il- pinna. • Il- mekkanizmu għas- selezzjoni tad- dożaġġ jista ’ jdur f’ direzzjoni waħda biss.
EXP (month/ year):
EXP (XX/ SSSS):