qanastek/EMEA-V3 huggingface dataset:
NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
For intravenous use.
Leukoscan 0. 31 mg, trab ghal soluzzjoni ghall- injezzjoni 0. 31 mg sulesomab liofilizzat, stannous chloride u stabilizzanti Ghall- uzu i. v.
For Intravenouse Use.
Ghall- uzu i. v.
EXP 48 Months
48 xahar
Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
0. 31 mg sulesomab liofilizzat, stannous chloride u stabilizzanti
Rehydrate with sterile, non-pyrogenic 99mTc Na pertechnetate.
Zid Tc99m Na pertechnetate sterili
19 PACKAGE LEAFLET:
16 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
Leukoscan 0. 31 mg, trab ghal soluzzjoni ghall- injezzjoni (sulesomab)
You may need to read it again. • It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
This leaflet only applies to LeukoScan. • If you have any further questions, please ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What LeukoScan is used for 2.
X’ inhu Leukoscan u għalxiex jintuża 2.
Before you use LeukoScan 3.
Qabel ma tuża Leukoscan 3.
How to use LeukoScan 4.
Kif għandek tuża Leukoscan 4.
How to store LeukoScan 6.
Kif taħżen Leukoscan 6.
WHAT LEUKOSCAN IS AND WHAT IT IS USED FOR
X’ INHU X U GĦALXIEX JINTUŻA
An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body.
Antibody hija sustanza naturali maghmula mill- gisem li tintrabat ma sustanzi barranin biex tnehhihom mill- gisem.
You produce many different kinds of antibodies.
Inti tirrpoduci diversi tipi ta ’ antibodies.
LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes.
Leukoscan (sulesomab) huwa tip specjali ta ’ antibody li jorbot ma ’ wicc ic- celluli bojod tad- demm.
It is produced in mice and purified so that it can be used in humans.
Jigi prodott mill- grieden u jigi msaffi ghall- uzu fil- bnedmin.
When it is combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal accumulation of white blood cells and attaches to them.
Meta jigi marbut mas- sustanza radjuattiva technetium u injettata fil- vina, ifittex akkumulazzjoni mhux tas- soltu ta ’ celluli bojod u torbot maghhom.
One to eight hours later after the injection you will be placed on a special table and pictures will be taken with standard nuclear cameras.
Minn siegha sa tmien sieghat wara l- injezzjoni, jittiehdu ir- ritratti b’ magni apposta.
This helps your doctor make a diagnosis and evaluate the extent of your illness.
Dan ighin biex it- tabib ikun jista ’ jaghmel dijanjosi and jara l- entita ’ tal- marda tieghek.
The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located.
Dan jaghmlu billi juza scanner specjali li turi zoni ta ’ radjuattivita ’ biex jara fejn hemm l- infezzjoni.
This medicine is for diagnostic use only.
Din il- medicina hija ghall- uzu dijanjositku biss.
LeukoScan is used to determine the presence of infections in long bones.
Leukoscan tintuza biex jigi iddeterminat il- presenza ta ’ infezzjoni fl- ghadam it- twal.
Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein.
Ftit minuti wara li il- Leukoscan jithallat mas- sustanza radjuattiva technetium, it- tabib itik l- injezzjoni.
One to eight hours later you will be placed on a special table and pictures will be taken with standard nuclear cameras to see where the infections are located.
Minn siegha sa tmien sieghat wara, jittiehdu ritratti b’ magna apposta biex jigu lokalizzati l- infezzjonijiet.
LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium.
Leukoscan huwa framment ta ’ antibody li huwa marbut ma ’ sustanza radjuattiva msejha technetium.
LeukoScan is used in patients with suspected infection of the bone called osteomyelitis.
Leukoscan jintuza f’ pazjenti li jista ’ jkun li ghandhom infezzjonijiet fl- ghadam it- twal.
The antibody is able to bind to the surface of white blood cells which infiltrate the area of infection.
L- antibody jorbot ma wicc ic- celluli bojod tad- demm li jkunu fil- parti infettata.
When the radioactive antibody binds to the white blood cells, your doctor can determine where the infection is located by using a special imaging camera that reveals areas of radioactivity.
Meta dan jigri, it- tabib tieghek jista ’ jara fejn hemm infezzjoni billi juza magni specjali li juru dawn il- partijiet radjuattivi.
The doctor can also determine how much disease there is.
It- tabib jista ’ wkoll ighid l- entita ’ tal- marda.
This will help the doctor determine whether there is infection in the bone and what kind of treatment to use.
Hu jkun jista jghid jekk hemmx infezzjoni fl- ghadam u jiddetermina liema kura ghandha tinghata.
BEFORE YOU USE LEUKOSCAN
QABEL MA TUZA LEUKOSCAN
You should not use LeukoScan 0.31 mg, sulesomab, powder for solution for injection
Tuzax Leukoscan
• If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor.
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal protejina tal- grieden jew sustanzi
You must then not be given LeukoScan.
oħra ta ’ Leukoscan
Take special care with LeukoScan
Oqgħod attent ħafna b’ Leukoscan
• It is possible to have a serious allergic reaction to LeukoScan.
17 Huwa possibli li jkollok rejazzjoni allergika serja bil- Leukoscan.
Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine.
Ghalhekk, it- tabib ghandu jzommok taht il- hars tieghu ghal xi zmien wara li jtik l- injezzjoni.
• If you have ever received LeukoScan or another product made from a mouse antibody, your doctor should take a sample of blood for testing to be sure that you have not developed an allergy to it.
Jekk fil- passat, kont hadt injezzjoni ta ’ Leukoscan jew prodott iehor maghmuil minn antibody ta ’ gurdien, it- tabib tieghek ghandu jiehu kampjun tad- demm tieghek biex jara li m’ intix allergiku ghaliha.
• If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be used.
Jekk il- prodott wara li jigi ppreparat, jidher li fih il- frak jew mhux car, dan ghandu jigi mormi.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta. >
Using Leukoscan with food and drink
Meta tieħu Leukoscan ma ’ l- ikel u max- xorb
No studies effects of food/ drink have been performed.
Ma saru l- ebda studji fuq l- effett ta ’ xorb/ ikel
• You should not be given LeukoScan if you are pregnant.
Tqala u Treddigħ Itlob il- parir tat- tabib tiegħek qabel tieħu Leukoscan.
• If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you have been given LeukoScan.
Jekk qieghda tredda ’, ieqaf ghal 24 siegha wara li tinghata Leukoscan.
No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma saru l- ebda studji f’ dan ir- rigward
Important information about some ingredients of LeukoScan
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Leukoscan
If you have been told that you have an intolerance to some sugars, inform your doctor before you are given this medicine.
Jekk ma tittolerax iz- zokkor, ghid lit- tabib qaebel ma jtik il- medicina
HOW TO USE LEUKOSCAN
KIF GĦANDEK TUŻA LEUKOSCAN
You will receive a single dose of 0.25 mg of LeukoScan.
Inti tircevi doza wahda ta ’ 0. 25mg ta ’ Leukoscan.
It will contain the radioactive technetium isotope in an amount called 740-1110 MBq.
Dan ikun fih ammont ta ’ radjuattivita ’ bejn 740 - 1110MBq
Method and/ or route(s) of administration
Metodi ta ’ somministrazzjoni
Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.
It- tabib tieghek jipprepara il- Leukoscan u s- sostanza radjuattiva bi 740- 1110MBq ta ’ technetium.
This material will then be injected into your vein.
Dan wara jigi injettat fil- vina.
This dose of radioactivity is safe and will be gone from the body in about 24 hours.
Id- doza ta ’ radjazzjoni ma fihiex periklu u tkun telqet minn gismek wara 24 siegha.
Frequency of administration
Frekwenza ta ’ somminstrazzjoni
LeukoScan is prepared for a single injection.
Leukoscan huwa ippreparat ghal injezzjoni wahda.
If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to LeukoScan.
Jekk it- tabib jiddeciedi li jerga jtik doza ohra wara ftit gimghat jew xhur, l- ewwel jittiehedlek test tad- demm biex wiehed jara jekk intix allergiku.
If you take more LeukoScan than you should
Jekk tiehu iktar Leukoscan milli suppost
The maximum amount of LeukoScan that can be administered has not been determined.
L- ammont massimu li jista ’ jittiehed ma giex iddeterminat.
Patients have been given four times the amount you will receive with no adverse reactions.
Pazjenti inghatalhom 4 darbiet l- ammont li ha tircevi int u ma kien hemm l- ebda effetti mhux mixtieqa.
If you have any further questions on the use of this product, ask your doctor.
Fil- kaz mhux tas- soltu li jkollok doza ta ’ radjazzjoni iktar qawwija bil- Leukoscan, id- doza assorbita tista ’ titnaqqas billi wiehed jixrob jew jiehu likwidi fil- vina.
22 4.
18 4.
Like all medicines, LeukoScan can cause side effects, although not everybody gets them.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.
Bħal kull mediċina oħra, Leukoscan jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE LEUKOSCAN
KIF TAĦŻEN X
Expiry date and storage conditions
Skadenza
Kit - 48 months.
Fjala 48 xahar.
Store in a refrigerator (2°C-8°C).
Zomm fi fridge (2- 8°C).
Reconstituted and radiolabelled material - 4 hours.
Materjal ippreparat 4 sieghat.
Do not refrigerate or freeze.
Izzomx f’ temperatura iktar minn 25°C.
After use, the container should be disposed of as radioactive waste.
Wara l- uzu, armi bhala skart radjuattiv.
What LeukoScan contains
X’ fih Leukoscan:
The kit does not include the radioisotope.
- Is- sustanza( attiva hi sulesomab.....
The active substance is sulesomab Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′ -SH antigranulocyte monoclonal antibody fragments).
- Kull fjala fiha 0. 31mg sulesomab (IMMU- MN3 murine Fab ’ - SH antigranulocyte monoclonal
The other ingredients are:
Is- sustanzi l- ohra huma:
What LeukoScan looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
23 Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Immunomedics GmbH Otto- Rohm- Strabe 69 D- 64293 Darmstadt Germany
24
19
Levemir 100 U/ ml solution for injection in a cartridge.
Levemir 100 U/ ml soluzzjoni għall- injezzjoni fi skartoċċ.
1 ml contains 100 U of insulin detemir (produced by recombinant DNA technology in Saccharomyces cerevisiae).
1 ml fih 100 U insulin detemir (prodotta mit- teknoloġija rikombinanti tad- DNA fis- Saccharomyces cerevisiae).
1 cartridge contains 3 ml equivalent to 300 U.
1 skartoċċ fih 3 ml ekwivalenti għal 300 U.
One unit of insulin detemir contains 0.142 mg salt-free anhydrous insulin detemir.
Unità waħda ta ’ insulin detemir fiha 0. 142 mg ta ’ insulin detemir anidru mingħajr melħ.
One unit (U) of insulin detemir corresponds to one IU of human insulin.
Unità waħda (U) ta ’ insulin detemir tikkorrispondi għal IU wieħed ta ’ l- insulina umana.
Clear, colourless, neutral solution.
Soluzzjoni ċara, bla kulur u newtrali.
Treatment of diabetes mellitus.
Għat- trattament ta ’ diabetes mellitus.
Levemir is a long-acting insulin analogue used as a basal insulin..
Levemir huwa analog ta ’ l- insulina li jaħdem fit- tul, użat bħala insulina bażi..
In combination with oral antidiabetic agents it is recommended to initiate Levemir treatment with once daily administration at a dose of 10 U or 0.1-0.2 U/ kg.
Flimkien ma ’ aġenti antidijabetiċi orali, huwa rrikkmandat li l- kura b’ Levemir tibda permezz ta ’ amministrazzjoni darba kuljum f’ doża ta’ 10 U jew 0. 1- 0. 2 U/ kg.
The dose of Levemir should be titrated based on individual patients’ needs.
Id- doża ta ’ Levemir għandha tiġi ddeterminata skond il- bżonnijiet individwali tal- pazjenti.
Based on study results, the following titration guideline is recommended:
Bħala linja gwida għad- determinazzjoni tad- doza hija rakkomandata din li ġejja, li hija bbażata fuq riżultati ta ’ studju:
Average pre-breakfast SMPG > 10.0 mmol/ L (180 mg/ dL) 9.1-10.0 mmol/ L (163-180 mg/ dL) 8.1-9.0 mmol/ L (145-162 mg/ dL) 7.1-8.0 mmol/ L (127-144 mg/ dL) 6.1-7.0 mmol/ L (109-126 mg/ dL) If one SMPG measurement
> 10. 0 mmol/ L (180 mg/ dL) 9. 1- 10. 0 mmol/ L (163- 180 mg/ dL) 8. 1- 9. 0 mmol/ L (145- 162 mg/ dL) 7. 1- 8. 0 mmol/ L (127- 144 mg/ dL) 6. 1- 7. 0 mmol/ L (109- 126 mg/ dL) Jekk hemm miżura waħda ta ’ l- SMPG
3.1-4.0 mmol/ L (56-72 mg/ dL) < 3.1 mmol/ L (< 56 mg/ dL)
3. 1- 4. 0 mmol/ L (56- 72 mg/ dL) < 3. 1 mmol/ L (< 56 mg/ dL)
When Levemir is used as part of a basal-bolus insulin regimen Levemir should be administered once or twice daily depending on patients’ needs.
Meta Levemir jiġi użat bħala parti minn kors ta ’ insulina ta ’ basal- bolus, Levemir għandu jiġi mgħoti darba jew darbtejn kuljum skond il- bżonnijiet tal- pazjenti.
Dosage of Levemir should be adjusted individually.
Id- dożaġġ ta ’ Levemir jeħtieġ li jkun aġġustat individwalment.
2 For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
2 Għal pazjenti li jeħtieġu dożaġġ darbtejn kuljum biex jikkontrollaw aħjar il- glukosju fid- demm, id - doża ta ’ filgħaxija tista ’ tingħata filgħaxija jew f’ ħin l- irqad.
Transfer from other insulins:
It- trasferiment minn insulini oħrajn:
Transfer to Levemir from intermediate or long-acting insulins may require adjustment of dose and timing of administration (see section 4.4).
It- trasferiment għal Levemir minn insulini li jaħdmu b’ mod intermedju jew fit- tul jista ’ jeħtieġ aġġustament fid- doża u fil- ħin ta ’ l- għoti (ara sezzjoni 4. 4).
As with all insulins, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
Bħall- insulini l- oħrajn kollha, huwa rrikkmandat li jsir monitoraġġ mill- qrib tal- glukosju waqt it - trasferiment u fil- ġimgħat wara li jsir it- trasferiment.
Concomitant antidiabetic treatment may need to be adjusted (dose and/ or timing of oral antidiabetic agents or concurrent short/ rapid-acting insulins).
It- trattament tad- dijabete li jingħata fl- istess ħin jista ’ jkun jeħtieġ aġġustament (id- doża u/ jew l- ħin ta ’ l- għoti ta ’ agenti antidijabetiċi orali jew ta ’ insulini li jintuzaw fl- istess ħin li jaħdmu f’ ħin qasir/ ta ’ malajr).
As with all insulins, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and insulin detemir dosage adjusted on an individual basis.
Bħall- insulini l- oħrajn kollha, f’ pazjenti anzjani u f’ pazjenti b’ mard tal- kliewi u tal- fwied, il - monitoraġġ tal- glukosju għandu jiġi intensifikat u d- dożaġġ ta ’ insulin detemir għandu jiġi aġġustat fuq bażi individwali.
The efficacy and safety of Levemir were demonstrated in children and adolescents aged 6 to 17 years in studies up to 6 months (see section 5.1).
L- effikaċja u s- sigurtà ta ’ Levemir intwerew fi tfal u f’ adolexxenti t’ età ta ’ bejn 6 u 17- il sena fi studji li damu sa 6 xhur (ara sezzjoni 5. 1).
The efficacy and safety of Levemir have not been studied in children below the age of 6 years.
L- effikaċja u s- sigurtà ta ’ Levemir ma ġewx studjati fuq tfal taħt is- 6 snin.
Adjustment of dosage may also be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Aġġustament fid- dożaġġ jista ’ jkun neċessarju wkoll jekk il- pazjenti jżidu l- attività fiżika tagħhom, jibdlu d- dieta normali tagħhom jew waqt xi mard li jseħħ fl- istess żmien.
Administration:
Kif Jingħata:
Subcutaneous use.
Għal użu taħt il- ġilda.
Levemir is administered subcutaneously by injection in the thigh, abdominal wall, or the upper arm.
Levemir jingħata taħt il- ġilda b’ injezzjoni fil- koxxa, fiż- żaqq, jew fin- naħa ta ’ fuq tad- driegħ.
As with human insulins, the rate and extent of absorption of insulin detemir may be higher when administered s. c. in the abdomen or deltoid than in the thigh.
Bħal fil - każ ta ’ l- insulini umani, ir- rata u l- firxa ta ’ l- assorbiment ta ’ insulin detemir jistgħu jkunu ogħla meta jingħata taħt il- ġilda fiż- żaqq jew fid- deltoid milli fil- koxxa.
Injection sites should therefore be alternated within the same region.
Għalhekk, l- injezzjoni għandha tingħata darba f’ post u darba f’ ieħor, fl- istess żona tal- ġisem.
Levemir Penfill is accompanied by a package leaflet with detailed instruction for use to be followed.
Levemir Penfill huwa akkompanjat b’ fuljett ta ’ tagħrif li fih struzzjonijiet dettaljati għall- użu li għandhom jiġu segwiti.
Levemir Penfill is designed to be used with Novo Nordisk delivery systems and NovoFine needles.
Levemir Penfill hu maħsub biex jintuża ma ’ sistemi ta ’ Novo Nordisk li jerħu l- mediċini u labar tat- tip NovoFine.
Detailed instruction accompanying the delivery system must be followed.
L- istruzzjonijiet dettaljati li jakkompanjaw is- sistema li terħi l- mediċina għandhom jiġu segwiti.
Hypersensitivity to insulin detemir or to any of the excipients.
Sensittività eċċessiva għal insulin detemir jew għal xi sustanzi mhux attivi.
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Dożaġġ mhux adegwat jew twaqqif tal- kura, speċjalment f’ dijabete ta ’ tip 1, jista ’ jwassal għal ipergliċemija u ketoaċidożi dijabetika.
Usually the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Normalment l- ewwel sintomi ta ’ ipergliċemija jiżviluppaw gradwalment matul perijodu ta ’ sigħat jew ġranet.
They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Dawn jinkludu għatx, frekwenza miżjuda ta ’ għamil ta ’ l- awrina, dardir, rimettar, nagħas, ġilda xotta u ħamra, ħalq xott, nuqqas ta ’ aptit, kif ukoll riħa ta ’ aċetun fin- nifs.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
F’ dijabete ta ’ tip 1, avvenimenti ipergliċemiċi li ma jkunux ittrattati, eventwalment iwasslu għal ketoaċidożi dijabetika, li tista ’ tkun fatali.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.8 and 4.9).
3 Ipogliċemija tista ’ sseħħ jekk id- doża ta ’ l- insulina tkun għolja wisq meta mqabbla mal- ħtieġa ta ’ l - insulina (ara sezzjoni 4. 8 u 4. 9).
Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia.
Li taqbeż ikla jew li tagħmel eżerċizzju fiżiku qawwi mhux ippjanat jista ’ jwassal għal ipogliċemija.
3 Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Pazjenti, li l- kontroll tal- glukosju fid- demm tagħhom jitjieb bil- kbir, eż. permezz ta ’ terapija bl - insulina intensifikata, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tagħhom ta ’ ipogliċemija, u għandhom jingħataw parir kif xieraq.
Usual warning symptoms may disappear in patients with longstanding diabetes.
Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom bid- dijabete għal żmien twil.
Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Mard li jseħħ fl- istess żmien, speċjalment infezzjonijiet u kondizzjonijiet ta ’ deni, normalment iżidu l - ħtieġa ta ’ l- insulina tal- pazjent.
Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analogue) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.
Tibdil fil- qawwa, marka (manifattur), tip, oriġini (mill- annimali, mill- bniedem, minn analog ta ’ l- insulina umana) u/ jew fil- metodu ta ’ manifattura (DNA rikombinanti kontra insulina li ġejja mill- annimali) jista ’ jirriżulta fil- ħtieġa ta ’ bidla fid- doża.
Patients taking Levemir may require a change in dosage from that used with their usual insulin.
Pazjenti li qed jieħdu Levemir jistgħu jeħtieġu bidla fid- doża minn dik li jieħdu ma ’ l- insulina tas- soltu tagħhom.
If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Jekk ikun meħtieġ xi aġġustament, dan jista ’ jseħħ ma ’ l- ewwel doża jew matul l- ewwel ftit ġimgħat jew xhur.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Bħalma ma jiġri fi kwalunkwe terapija bl- insulina, jistgħu jseħħu reazzjonijiet fis- sit ta ’ l- injezzjoni u dawn jinkludu wġigħ, ħakk, urtikarja, nefħa u infjammazzjoni.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Rotazzjoni kontinwa tas- sit ta ’ l - injezzjoni f’ żona partikulari tista ’ tgħin biex tnaqqas jew tevita dawn ir- reazzjonijiet.
Reactions usually resolve in a few days to a few weeks.
Ir- reazzjonijiet normalment ifiequ fi żmien ftit jiem sa ftit ġimgħat.
On rare occasions, injection site reactions may require discontinuation of Levemir.
F’ okkażjonijiet rari, reazzjonijiet fis- sit ta ’ l - injezzjoni jista ’ jkollhom bżonn li t- trattament b’ Levemir titwaqqaf.
Levemir should not be administered intravenously as it may result in severe hypoglycaemia.
Levemir m’ għandux jingħata ġol- vina għax dan jista ’ jirriżulta f’ ipogliċemija serja.
Intramuscular administration should be avoided.
L- għoti ġol- muskoli għandu jkun evitat.
If Levemir is mixed with other insulin preparations the profile of action of one or both individual components will change.
Jekk Levemir jitħallat ma ’ preparazzjonijiet oħrajn ta ’ l- insulina, il- profil ta ’ l- azzjoni ta ’ komponent wieħed jew taż- żewġ komponenti individwali jinbidel.
Mixing Levemir with a rapid acting insulin analogue like insulin aspart, results in an action profile with a lower and delayed maximum effect compared to separate injections.
Li tħallat Levemir ma ’ analog ta ’ l- insulina li jaħdem bil- għaġġla, bħal aspart ta ’ l- insulina, jirriżulta fi profil t’ azzjoni b’ effett massimu iktar baxx u li jdum iżjed biex iseħħ, meta mqabbel ma ’ injezzjonijiet separati.
Therefore, mixing of rapid acting insulin with Levemir should be avoided.
Għalhekk, it- taħlit ta ’ l- insulina li taħdem bil- għaġġla ma ’ Levemir għandu jkun evitat.
There are limited data in patients with severe hypoalbuminaemia.
Hemm informazzjoni limitata dwar pazjenti b’ ipoalbuminemija serja.
Careful monitoring is recommended in these patients.
Fil- każ ta ’ dawn il- pazjenti, huwa rrikkmandat monitoraġġ attent.
Levemir is not to be used in insulin infusion pumps.
Levemir m’ għandux jintuża f’ pompi ta ’ infużjoni ta ’ l- insulina.
Levemir contains metacresol, which may cause allergic reactions.
Levemir fih metacresol, li jista ’ jikkawża reazzjonijiet allerġiċi.
A number of medicinal products are known to interact with the glucose metabolism.
Numru ta ’ prodotti mediċinali huma magħrufa li jkollhom azzjoni reċiproka mal- metaboliżmu tal - glukosju.
The following substances may reduce the insulin requirements:
Dawn is- sustanzi li ġejjin jistgħu jnaqqsu l- ħtiġijiet ta ’ l- insulina:
Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates and alcohol.
Prodotti mediċinali kontra d- dijabete li jittieħdu mill- ħalq, inibituri ta ’ monoamine oxidase (MAOI), sustanzi mhux selettivi tat- tip beta- blocking, inibituri ta ’ l- enżima li tibdel angiotensin (ACE), salicylates u alkoħol.
The following substances may increase the insulin requirements:
Dawn is- sustanzi li ġejjin jistgħu jżidu l- ħtiġijiet ta ’ l- insulina:
Thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Thiazides, glucocorticoids, ormoni tat- tirojde u beta- sympathomimetics, ormon tat- tkabbir u danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
4 Aġenti tat- tip beta- blocking jistgħu jaħbu s- sintomi ta ’ ipogliċemija u jittardjaw il- fejqan mill - ipogliċemija.
Octreotide/ lanreotide may both increase and decrease insulin requirement.
Octreotide/ lanreotide jistgħu t- tnejn iżidu jew inaqqsu l- ħtieġa ta ’ l- insulina.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
L- alkoħol jista ’ jħarrax u jtawwal l- effetti ipogliċemiċi ta ’ l- insulina.
4 Pregnancy:
It- tqala:
There is no clinical experience with insulin detemir during pregnancy.
Għal insulin detemir m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal reproduction studies have not revealed any differences between insulin detemir and human insulin regarding embryotoxicity and teratogenicity.
Studji dwar ir- riproduzzjoni fl- annimali ma żvelaw l- ebda differenza bejn insulin detemir u l- insulina umana fir- rigward ta ’ l- embrijotossiċità u t- teratoġeniċità.
Caution should be exercised when prescribing to pregnant women.
Għandha tingħata attenzjoni meta din il - mediċina tkun preskritta lil nisa tqal.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
B’ mod ġenerali, kontroll intensifikat tal- glukosju fid- demm u l- monitoraġġ ta ’ nisa tqal bid- dijabete huma rrikkmandati matul it- tqala u meta dawn in- nisa jkunu qegħdin jippjanaw li jinqabdu tqal.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester.
Il - ħtiġijiet ta ’ l- insulina normalment jonqsu fl- ewwel tliet xhur u jiżdiedu sussegwentement matul it- tieni u t- tielet tliet xhur.
After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Wara l- ħlas, il- ħtiġijiet ta ’ l- insulina normalment jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
Lactation:
It- treddigħ:
There is no clinical experience with insulin detemir during lactation.
Għal insulin detemir m’ hemmx tagħrif kliniku dwar l- użu waqt it- treddigħ.
Caution should be exercised when prescribing to lactating women.
Għandha tingħata attenzjoni meta din il- mediċina tkun preskritta lil nisa li qed ireddgħu.
Lactating women may require adjustments in insulin dose and diet.
Nisa li qed ireddgħu jistgħu jeħtieġu aġġustament fid- doża ta ’ l- insulina u fid- dieta.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il- ħila tal- pazjent li jikkonċentra u jirreaġixxi tista ’ titnaqqas minħabba ipogliċemija.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dan jista ’ joħloq riskju f’ sitwazzjonijiet meta dawn il- ħiliet huma ta ’ importanza speċjali (eż. waqt sewqan ta ’ karozza jew tħaddim ta ’ makkinarju).
Patients should be advised to take precautions to avoid hypoglycaemia while driving.
Il- pazjenti għandhom jingħataw parir biex jieħdu prewkawzjonijiet biex jevitaw ipogliċemija waqt is - sewqan.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan huwa partikolarment importanti f’ dawk li għandhom għarfien imnaqqas jew ma għandhomx għarfien tas- sinjali ta ’ twissija ta ’ ipogliċemija jew li għandhom episodji spissi ta ’ ipogliċemija.
The advisability of driving should be considered in these circumstances.
F’ ċirkostanzi bħal dawn, huwa rrikkmandat li s- sewqan isir bi prudenza.
Adverse drug reactions observed in patients using Levemir are mainly dose-dependent and due to the pharmacologic effect of insulin.
Reazzjonijiet avversi għall- mediċina osservati f’ pazjenti li kienu qed jużaw Levemir huma prinċipalment tat- tip li jiddependu mid- doża u minħabba l- effett farmakoloġiku ta ’ l- insulina.
Hypoglycaemia is a common undesirable effect.
Ipogliċemija hija effett mhux mixtieq komuni.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Din tista ’ sseħħ jekk id- doża ta ’ l- insulina tkun għolja wisq meta mqabbla mal- ħtieġa ta ’ l- insulina.
From clinical investigations it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir.
Minn investigazzjonijiet kliniċi huwa magħruf li ipogliċemija maġġuri, definita bħala l- ħtieġa ta ’ intervent minn terza persuna, isseħħ f’ madwar 6% tal - pazjenti ttrattati b’ Levemir.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Ipogliċemija serja tista ’ twassal għal telfien mis- sensi u/ jew għal konvulżjonijiet u tista ’ tirriżulta fi ħsara temporanja jew permanenti tal- funzjoni tal- moħħ jew anke f’ mewt.
Injection site reactions are seen more frequently during treatment with Levemir than with human insulin.
Reazzjonijiet fis- sit ta ’ l- injezzjoni jidhru iktar ta ’ sikwit matul it- trattament b’ Levemir milli bl - insulina umana.
These reactions include redness, inflammation, bruising, swelling and itching at the injection site.
Dawn ir- reazzjonijiet jinkludu ħmura, infjammazzjoni, tbenġil, tinfiħ u ħakk tal- ġilda fil- parti injettata.
Most of the injection site reactions are minor and of a transitory nature, i. e. they normally disappear during continued treatment in a few days to a few weeks.
Il- biċċa l- kbira tar- reazzjonijiet fis- sit ta ’ l- injezzjoni huma ħfief u ta ’ natura temporanja, jiġifieri normalment jisparixxu matul it- tkomplija tat- trattament fi żmien ftit jiem sa ftit ġimgħat.
The overall percentage of treated patients expected to experience adverse drug reactions is estimated to be 12%.
5 Il- perċentwal totali ta ’ pazjenti ttrattati li kien mistenni li jkollhom reazzjonijiet avversi għall- mediċina huwa stmat li hu 12%.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to Levemir are listed below.
Il- frekwenzi tar- reazzjonijiet avversi għall- mediċina minn provi kliniċi, li b’ ġudizzju totali huma kkunsidrati li huma relatati ma ’ Levemir, huma elenkati hawn taħt.
Metabolism and nutrition disorders
Mard marbut mal- metaboliżmu u nutrizzjoni
Common (> 1/ 100, < 1/ 10)
Komuni (> 1/ 100, < 1/ 10) Mard ġenerali u kundizzjonijiet ta ’ mnejn jittieħed
Hypoglycaemia:
Ipogliċemija:
Symptoms of hypoglycaemia usually occur suddenly.
Sintomi ta ’ ipogliċemija normalment iseħħu għall- għarrieda.
confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Dawn jistgħu jinkludu għaraq kiesaħ, ġilda friska u ċara, għeja kbira, nervożiżmu jew rogħda, ansjetà, għeja jew dgħjufija mhux tas- soltu, konfużjoni, diffikultà biex tikkonċentra, ngħas, ġuħ eċċessiv, tibdil fil - vista, uġigħ ta ’ ras, dardir u palpitazzjoni.
General disorders and administration site conditions
Ipogliċemija serja tista ’ twassal għal telfien mis - sensi u/ jew għal konvulżjonijiet u tista ’ tirriżulta fi ħsara temporanja jew permanenti tal- funzjoni tal- moħħ jew anke f’ mewt.
Injection site reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Reazzjonijiet fis- sit ta ’ l- injezzjoni (ħmura, tinfiħ u ħakk tal- ġilda fil- parti injettata) jistgħu jseħħu waqt it- trattament bl- insulina.
These reactions are usually transitory and normally they disappear during continued treatment.
Dawn ir - reazzjonijiet huma temporanji u normalment jisparixxu matul it- tkomplija tat- trattament.
Uncommon (> 1/ 1,000, < 1/ 100)
Mhux Komuni (> 1/ 1000, < 1/ 100)
Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Il- lipodistrofija tista ’ sseħħ fis- sit ta ’ l- injezzjoni bħala konsegwenza tan- nuqqas li wieħed jalterna s- sit ta ’ l- injezzjoni f’ parti tal- ġisem.
Oedema may occur upon initiation of insulin therapy.
Edema tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
These symptoms are usually of transitory nature.
Dawn is- sintomi huma normalment ta ’ natura temporanja.
Immune system disorders
Mard tas- sistema immunitarja
Common (> 1/ 100, < 1/ 10)
Komuni (> 1/ 100 < 1/ 10)
In three clinical studies with subjects treated in combination with oral antidiabetic agents a higher frequency (2.2%) of allergic reactions and potentially allergic reactions have been observed.
Fi tliet studji kliniċi fejn il- pazjenti ġew ikkurati bl- użu fl- istess ħin ta ’ agenti antidijabetiċi orali ġew osservati frekwenza ogħla (2. 2%) ta ’ reazzjonijiet allerġiċi u ta ’ reazzjonijiet potenzjalment allerġiċi.
Uncommon (> 1/ 1,000, < 1/ 100) Eye disorders
Mhux Komuni (> 1/ 1, 000, < 1/ 100) Mard ta ’ l- għajnejn
Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions:
Reazzjonijiet allerġiċi, reazzjonijiet potenzjalment allerġiċi urtikarja, raxx u nfafet:
Such symptoms may be due to generalised hypersensitivity.
Sintomi bħal dawn jistgħu jseħħu minħabba sensittività eċċessiva ġeneralizzata.
Other signs of generalised hypersensitivity may be itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Sinjali oħra ta ’ sensittività eċċessiva ġeneralizzata jistgħu jkunu ħakk tal- ġilda, għaraq, taqlib gastrointestinali, edema anġjonewrotika, diffikultajiet fit- teħid tan- nifs, palpitazzjoni u tnaqqis fil- pressjoni tad- demm.
Generalised hypersensitivity reactions are potentially life threatening (anaphylactic reactions).
Reazzjonijiet ta ’ sensittività eċċessiva ġeneralizzata jistgħu jkunu ta ’ periklu għall- ħajja (reazzjonijiet anafilattiċi).
Rare (>
Mard tar- rifrazzjoni:
1/ 10,000, < 1/ 1,000)
Rari (> 1/ 10, 000, < 1/ 1, 000)
Peripheral neuropathy:
Newropatija periferali:
Fast improvement in blood glucose control may be associated with the condition “ acute painful neuropathy”, which is usually reversible.
Titjib malajr fil- kontroll tal- glukosju fid- demm jista ’ jkun assoċjat mal- kondizzjoni “ newropatija akuta bl- uġigħ ”, li normalment hija riversibbli.
4.9
4. 9 Doża eċċessiva
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
Doża eċċessiva speċifika għall- insulina ma tistax tiġi definita, madankollu, ipogliċemija tista ’ tiżviluppa fuq medda ta ’ stadji sekwenzjali jekk jingħataw dożi qawwija wisq meta mqabbla mal - ħtieġa tal- pazjent.
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• Episodji ipoglikemiċi ħfief jistgħu jiġu ttrattati bl- għoti mill- ħalq ta ’ prodotti tal- glukosju jew prodotti li fihom iz- zokkor.
It is therefore recommended that the diabetic patient always carries sugar containing products.
Għalhekk huwa rrikkmandat li l- pazjent dijabetiku dejjem iżomm fuqu prodotti li jkun fihom iz- zokkor.
• Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or by glucose given intravenously by a medical professional.
• Episodji ipoglikemiċi serji, meta l- pazjent ikun intilef minn sensih, jistgħu jiġu ttrattati bi glucagon (0. 5 sa 1 mg) mogħti ġol- muskoli jew taħt il- ġilda minn persuna mħarrġa, jew bil - glukosju li jingħata ġol- vina minn professjonist mediku.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Il- glukosju għandu wkoll jingħata ġol - vina, jekk il- pazjent ma jirrispondix għal glucagon fi żmien 10 sa 15- il minuta.
Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Meta jerġa ’ jiġi f’ sensih, l- għoti mill- ħalq ta ’ karboidrati huwa rrikkmandat għall- pazjent sabiex tkun evitata rikaduta.
Drugs used in diabetes.
Mediċini li jintużaw fid- dijabete.
Insulin detemir is a soluble, long-acting basal insulin analogue with a prolonged duration of effect.
Insulin detemir huwa analog ta ’ l- insulina bażi li jinħall u li jaħdem fit- tul, b’ effett fit- tul u li jdum.
The time action profile of insulin detemir is statistically significantly less variable and therefore more predictable than for NPH insulin as seen from the within-subject Coefficients of Variation (CV) for the total and maximum pharmacodynamic effect in Table 1.
Il- profil ta ’ l- azzjoni mal- ħin ta ’ insulin detemir huwa statistikament ferm inqas varjabbli u għalhekk jista ’ jitbassar iktar milli għall- insulina NPH kif jidher mill- Ko- effiċjenti tal- Varjazzjoni (CV) fl- istess suġġett għall- effett farmakodinamiku totali u massimu f’ Tabella 1.
Within-Subject Variability of the time action profile of insulin detemir and NPH insulin
Varjabilità fis- suġġetti tal- profil ta ’ l- azzjoni mal- ħin ta ’ insulin detemir u ta ’ l - insulina NPH.
Pharmacodynamic
Ir- Riżultat
Insulin
Insulin detemir
AUCGIR,0-24h* GIRmax**
Farmakodinamiku Aħħari CV (%)
CV
AUCGIR, 0- 24siegħa * GIRmas **
*Area under the curve insulin detemir
7
** Glucose Infusion Rate p-value < 0.001 for all comparisons with
* Erja taħt il- kurva ** Rata ta ’ Infużjoni tal- Glukosju valur p < 0. 001 għall- paraguni kollha b’ insulin detemir
The prolonged action of insulin detemir is mediated by the strong self-association of insulin detemir molecules at the injection site and albumin binding via the fatty acid side-chain.
L- azzjoni fit- tul ta ’ insulin detemir hija mtaffija bl- assoċjazzjoni qawwija tal- molekuli ta ’ insulin detemir infushom fis- sit ta ’ l- injezzjoni u mit- tgħaqqid ta ’ l- albumina permezz tas- side- chain ta ’ l - aċidi grassi.
Insulin detemir is distributed more slowly to peripheral target tissues compared to NPH insulin.
Insulin detemir jinxtered iktar bil- mod lit- tessuti periferali fil- mira meta mqabbel ma ’ insulina NPH.
These combined mechanisms of protraction provide a more reproducible absorption and action profile of insulin detemir compared to NPH insulin.
Dawn il- mekkaniżmi ta ’ titwil flimkien jipprovdu assorbiment u profil ta’ azzjoni ta ’ insulin detemir iktar riproduċibbli, meta mqabbla ma ’ insulina NPH.
The blood glucose lowering effect of insulin detemir is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
L- effett ta ’ insulin detemir, jiġifieri li jbaxxi l- livell ta ’ glukosju fid- demm, iseħħ minħabba t- teħid faċilitat tal- glukosju wara t- tgħaqqid ta ’ l- insulina mar- riċetturi taċ- ċelluli tal- muskoli u tax- xaħam u minħabba l- inibizzjoni tal- produzzjoni tal- glukosju mill- fwied li ssir fl- istess ħin.
7 Pharmacodynamic Parameters for Levemir and NPH Glucose infusion rate (mg/ kg/ min)
Parametri Farmakodinamici għal Levemir u NPH
Duration of action (hr) GIRmax (mg/ kg/ min) † estimated values
Rata ta ’ infuzjoni tal- glucose
U/ kg U/ kg U/ kg
0. 3 U/ kg †
IU/ kg
0. 3 IU/ kg
Time Since Insulin Injection (hours)
1. 4
0.3 U/ kg... .0.4 U/ kg
0. 3 U/ kg... 0. 4 U/ kg
Activity profiles of Levemir in patients with type 1 diabetes.
Profili ta ’ attività ta ’ Levemir f’ pazjenti b’ dijabete ta ’ tip 1.
The duration of action is up to 24 hours depending on dose providing an opportunity for once or twice daily administration.
L- azzjoni tieħu sa 24 siegħa u dan jiddependi mid- doża, li tista ’ tingħata darba jew darbtejn kuljum.
If administered twice daily, steady state will occur after 2-3 dose administrations.
Jekk tingħata darbtejn kuljum, l- istat stabbli jseħħ wara l- għoti ta ’ 2- 3 dożi.
For doses in the interval of 0.2 - 0.4 U/ kg, Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
Għal dożi fl- intervall ta ’ 0. 2 - 0. 4 U/ kg, Levemir jeżerċita iktar minn 50% ta ’ l- effett massimu tiegħu minn 3- 4 sigħat u sa madwar 14- il siegħa wara l- għoti tad- doża.
Dose proportionality in pharmacodynamic response (maximum effect, duration of action, total effect) is observed after subcutaneous administration.
Il- proporzjonalità tad- doża fir- rispons farmakodinamiku (l- effett massimu, it- tul ta ’ l- azzjoni, l- effett totali) huwa osservat wara l- għoti taħt il- ġilda.
Lower day-to-day variability in FPG was demonstrated during treatment with Levemir compared to NPH in long-term clinical trials.
F’ studji kliniċi fit- tul ġie muri li waqt kura b’ Levemir kien hemm inqas varjabilità ġurnata b’ ġurnata fl- FPG meta mqabbel mal- NPH.
Studies in patients with type 2 diabetes treated with basal insulin in combination with oral antidiabetic drugs demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin glargine and associated with less weight gain, please see Table 2 below.
Studji f’ pazjenti bid- dijabete ta ’ tip 2 ikkurati b’ insulina bażi flimkien ma ’ mediċini antidijabetiċi orali urew li l- kontroll gliċemiku (HbA1c) b’ Levemir huwa simili għal dak b’ insulina NPH u b’ insulina glargine u assoċjat ma ’ żieda inqas fil- piż, jekk jogħġbok ara Tabella 2 hawn taħt.
In the study versus insulin glargine, insulin detemir was allowed to be administered once or twice daily whereas insulin glargine was to be administered once a day, 55% of the insulin detemir-treated subjects completed the 52 weeks of treatment on the twice daily regimen.
Fuq il- kors ta ’ darbtejn kuljum, 55% tal- pazjenti kkurati b’ insulina detemir spiċċaw il- 52 ġimgħa ta ’ kura.
Change in body weight after insulin treatment Study duration Insulin detemir Insulin detemir NPH insulin once daily twice daily 20 week +0.7 kg +1.6 kg
Insulina detemir Insulina detemir darba kuljum darbtejn kuljum
26 weeks 52 weeks +2.3 kg
20 ġimgħa 26 ġimgħa
+1.2 kg +3.7 kg
+1. 6 kg +2. 8 kg
+2.8 kg
+3. 7 kg
+4.0 kg
+4. 0 kg
In trials with the use of OAD-insulin combination therapy Levemir treatment resulted lower risk of minor nocturnal hypoglycaemia compared to NPH insulin.
8 Fi studji fejn intuzat it- terapija kombinata ta ’ mediċini antidijabetiċi orali u insulina, bil- kura ta ’ Levemir kien hemm 61- 65% ta ’ riskju inqas ta ’ ipogliċemija ta ’ matul il- lejl minuri meta mqabbla ma ’ insulina NPH.
In long-term treatment trials in patients with type 1 diabetes, fasting plasma glucose was improved with Levemir compared with NPH insulin when given as basal/ bolus therapy including in children and adolescents aged 6 to 17 years.
Fi provi ta ’ trattament fit- tul f’ pazjenti bid- dijabete ta ’ tip 1, il- glukosju fil- plażma fl- istat sajjem kien imtejjeb b’ Levemir meta mqabbel ma ’ insulina NPH meta mogħti bħala reġimen tat- tip basal/ bolus inkluż lil tfal u adolexxenti ta ’ bejn 6 u 17- il sena.
Glycaemic control (HbA1c) with Levemir is comparable to NPH insulin, with a lower risk of nocturnal hypoglycaemia and no associated weight gain.
Kontroll gliċemiku (HbA1c) b’ Levemir hu komparabbli ma ’ insulina NPH, b’ riskju inqas ta ’ ipogliċemija ta ’ matul il- lejl u l- ebda żjieda assoċjata fil- piż.
In clinical trials using basal bolus insulin therapy, the overall rates of hypoglycaemia with Levemir and NPH insulin were similar.
Fi provi kliniċi bl- użu tat- terapija ta ’ l- insulina basal bolus, ir- rati totali ta ’ ipogliċemija ma ’ Levemir u l- insulina NPH kienu simili.
Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed by capillary blood glucose less than 2.8 mmol/ L or 3.1 mmol/ L if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
Analiżi ta ’ ipogliċemija ta ’ matul il- lejl f’ pazjenti b’ dijabete ta ’ tip 1 uriet riskju ferm iktar baxx ta ’ ipogliċemija ta ’ matul il- lejl minuri (u kapaċi li jikkura lilu nnifsu u kkonfermat mill- glukosju fid- demm kapillari ta ’ inqas minn 2. 8 mmol/ L jew 3. 1 mmol/ L jekk espress bħala glukosju fil- plażma) milli bl- insulina NPH, filwaqt li l- ebda differenza ma ġiet innotata f’ dijabete ta ’ tip 2.
Furthermore, the overall risk of 8 nocturnal hypoglycaemia in children and adolescents aged 6 to 17 years with type 1 diabetes was significantly lower with Levemir compared to NPH insulin.
Barra minn hekk, ir- riskju totali ta ’ ipogliċemija matul il- lejl fit- tfal u fl - adolexxenti ta ’ bejn 6 u 17- il sena b’ dijabete tat- tip 1 kien ferm iktar baxx b’ Levemir meta mqabbel ma ’ insulina NPH.
Antibody development has been observed with the use of Levemir.
Ġie osservat l- iżvilupp ta ’ antikorpi, bl- użu ta ’ Levemir.
However, this does not appear to have any impact on glycaemic control.
Madankollu dan ma jidhirx li għandu xi effett fuq il- kontroll gliċemiku.
Maximum serum concentration is reached between 6 and 8 hours after administration.
Il- konċentrazzjoni massima tas- serum tintlaħaq bejn 6 sa 8 sigħat wara l- għoti.
When administered twice daily, steady state serum concentrations are reached after 2-3 dose administrations.
Meta jingħata darbtejn kuljum, l- istati stabbli tal- konċentrazzjonijiet tas- serum jintlaħqu wara 2- 3 dożi.
Within-patient variation in absorption is lower for Levemir than for other basal insulin preparations.
Il- varjazzjoni fl- assorbiment fil- pazjenti stess hija iktar baxxa għal Levemir milli għal preparazzjonijiet oħrajn ta ’ insulina bażi.
There are no clinically relevant differences between genders in pharmacokinetic properties of insulin detemir.
M’ hemm l- ebda differenza klinikament rilevanti bejn is- sessi fil - karatteristiċi farmakokinetiċi ta ’ insulin detemir.
The absolute bioavailability of insulin detemir when administered subcutaneous is approximately 60%.
Il- bijo- disponibilità assoluta ta ’ insulin detemir meta mogħti taħt il- ġilda hija ta ’ madwar 60%.
An apparent volume of distribution for insulin detemir (approximately 0.1 l/ kg) indicates that a high fraction of insulin detemir is circulating in the blood.
Distribuzzjoni Volum apparenti ta ’ distribuzzjoni ta ’ insulin detemir (madwar 0. 1 l/ kg) jindika li porzjon għoli ta ’ insulin detemir qed jiċċirkola fid- demm.
Degradation of insulin detemir is similar to that of human insulin; all metabolites formed are inactive.
Id- degradazzjoni ta ’ insulin detemir hija simili għal dik ta ’ l- insulina umana; il- metaboliti kollha li jiffurmaw huma inattivi.
The results of the in vitro and in vivo protein binding studies suggest that there is no clinically relevant interaction between insulin detemir and fatty acids or other protein bound medicinal products.
Ir- riżultati ta ’ studji dwar it- tgħaqqid tal- proteina in vitro u in vivo jissuġġerixxu li m’ hemm l- ebda azzjoni reċiproka li hija klinikament rilevanti bejn insulin detemir u l- aċidi grassi jew prodotti mediċinali oħrajn li huma magħquda mal- proteina.
The terminal half-life after subcutaneous administration is determined by the rate of absorption from the subcutaneous tissue.
Il- half- life terminali wara l- għoti taħt il- ġilda huwa stabbilit mir- rata ta ’ l- assorbiment mit- tessut ta ’ taħt il- ġilda.