qanastek/EMEA-V3 huggingface dataset:
This will give each injection site a chance to fully recover before receiving another injection.
Dan ser jagħti ċans lil kull sit ta ’ l- injezzjoni biex jirkupra għal kollox qabel tirċievi injezzjoni oħra.
Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Jekk jogħġbok irreferi għall- iskeda tar- rotazzjoni fl- aħħar ta ’ dan l- Anness biex titgħallem kif tagħżel post ta ’ l- injezzjoni.
An example of a medication record is also included.
Eżempju ta ’ rekord tal- mediċina hu inkluż ukoll.
This should give you an idea of how you can keep track of your injection sites and dates.
Dan hu maħsub li jagħtik idea dwar kif tista ’ żżomm rekord tal- postijiet ta ’ l- injezzjoni u tad- dati.
• Medicine
• Mediċina
You will need the medicine:
Ikollok bżonn il- mediċina:
1 Extavia vial (with powder for solution for injection) 1 pre-filled syringe of solvent for Extavia (sodium chloride solution (0.54% (w/v))
1 kunjett ta ’ Extavia (bi trab għal soluzzjoni għall- injezzjoni) 1 siringa mimlija għal- lest għal Extavia (soluzzjoni ta ’ sodium chloride (0. 54% (w/ v))
To reconstitute and inject your medicine you will need the following components:
Biex tirrikostitwixxi u tinjetta l- mediċina tiegħek inti se jkollok bżonn dawn il- komponenti li ġejjin:
a needle suitable for reconstitution 30-gauge needle (for manual injection) OR a 27-gauge needle (for use with an auto- injector)
labra adattata għar- rikostituzzjoni labra b’ gauge 30 (ghall- injezzjoni manwali) JEW labra b’ gauge 21 (ghal użu ma auto - injector)
alcohol wipes
biċċiet bl- alkoħol
You will also need a disposal unit for used syringes and needles.
Ser ikollok bżonn ukoll ta ’ reċipjent tar- rimi għal siringi u labar użati.
Alternatively, you can use an Extavia Application Kit (supplied separately from your medicine), which contains a vial adapter for reconstituting your medicine, needles for injecting your medicine, alcohol wipes and a disposal unit for used needles, as well as instructions on how to use these components.
B’ mod alternattiv inti tista ’ tuża s- Sett għall- Applikazzjoni ta ’ Extavia (fornut separat mill- mediċina tiegħek), li fih adapter għall- kunjett għar- rikostituzzjoni tal- mediċina tiegħek, labar biex tinjetta l - mediċina tiegħek, biċċiet bl- alkoħol u reċipjent għar- rimi tal- labar użati, kif ukoll istruzzjonijiet dwar kif tuża dawn il- komponenti.
For skin disinfection use an appropriate disinfectant.
Għad- diżinfettar tal- ġilda, uża diżinfettant xieraq.
C) Reconstituting the solution, step by step
C) Rikostituzzjoni tas- soluzzjoni, pass, pass
2 - Open the Extavia vial and put it on the table.
2 - Iftaħ il- kunjett ta ’ Extavia u poġġih fuq il- mejda.
It is best to use your thumb rather than your nail as it could break.
Ikun aħjar li tuża subgħajk il- kbir minflok difrek, għax tista ’ tqaċċtu.
3 - Clean the top of the vial with an alcohol wipe, moving the wipe in one direction only.
3 - Naddaf in- naħa ta ’ fuq tal- kunjett b’ biċċa drapp bl- alkoħol li timsaħ, billi tħarrek il- biċċa li timsaħ f’ direzzjoni waħda biss.
Leave the wipe on top of the vial.
Ħalli l- biċċa fuq il- kunjett.
4 – Take out the pre-filled solvent syringe from its package.
4 - Oħroġ is- siringa mimlija għal- lest bis- solvent mill- pakkett tagħha.
Remove the tip cap from the pre-filled syringe by twisting it off.
Neħħi l- għatu tal- ponta mis - siringa mimlija għal- lest billi ddawwru u taqilgħu.
44 5 - Take the needle suitable for reconstitution out of its wrapping and place it firmly onto the tip (nozzle) of the syringe.
45 5 - Oħroġ il- labra adattata għar- rikostituzzjoni mill- pakkett tagħha u poġġiha soda fuq il- ponta (nozzle) tas- siringa.
Remove the needle guard from the needle.
Neħħi l- ilqugħ tal- labra minn mal- labra.
6 - Holding the Extavia vial on a stable surface, slowly insert the needle of the syringe (containing 1.2 ml of liquid) all the way through the stopper of the vial.
6 - Billi żżomm il- kunjett ta ’ Extavia fuq wiċċ stabbli, daħħal bil- mod il- labra tas- siringa (li fiha 1. 2 ml ta ’ likwidu) sa ġewwa nett mit- tapp tal- kunjett.
7 - Push the plunger down slowly, directing the needle toward the side of the vial to allow the liquid to run down the inside of the vial.
7 - Imbotta l- planġer bil- mod ’ l isfel, billi tidderieġi l- labra lejn il- ġenb tal- kunjett sabiex il- likwidu iċarċar fuq ġewwa tal- kunjett.
Injecting solvent directly onto the powder will cause excess foaming.
Jekk tinjetta s- solvent direttament fuq it- trab, ser tifforma ħafna ragħwa.
Transfer all the solvent to the vial.
Ittrasferixxi s- solvent kollu fil- kunjett.
8 - After the solvent in the syringe has been completely injected into the Extavia vial, hold the vial between your thumb, forefinger and middle finger with the needle and syringe resting against your hand and swirl the vial gently to completely dissolve the powder of Extavia.
8 - Wara li s- solvent fis- siringa jkun ġie injettat kollu fil- kunjett ta ’ Extavia, żomm il- kunjett bejn is- saba ’ l- kbir, is- saba ’ l- werrej u s- saba ’ tan- nofs bil- labra u s- siringa jserrħu ma ’ idejk u dawwar il- kunjett bil- mod biex iddewweb it- trab ta ’ Extavia għal kollox.
9 - Examine the solution carefully.
9 - Eżamina s- soluzzjoni b’ attenzjoni.
If the solution is discoloured or contains particles, discard it and start again with a syringe and vial out of your package.
Jekk is- soluzzjoni tkun bla kulur jew jekk ikun fiha xi frak, armiha u ibda mill- ġdid billi toħroġ siringa u kunjett mill- pakkett tiegħek.
If foam is present –- which can happen if the vial is shaken or swirled too vigorously – let the vial sit undisturbed until the foam settles.
Jekk ikun hemm ir- ragħwa – li jista ’ jiġri jekk il- kunjett jitħarrek jew jiddawwar bis- saħħa – ħalli l - kunjett joqgħod mingħajr ma tħarrku sakemm ir- ragħwa tissetilja.
D) Drawing up the solution for injection
D) Kif tipprepara s- soluzzjoni għall- injezzjoni
10 - In order to redraw the solution back into the syringe, turn the syringe-vial-assembly, needle pointing upwards.
10 - Sabiex tiġbed is- soluzzjoni lura fis- siringa, dawwar il- muntaġġ tas- siringa- kunjett, bil- labra tħares ’ l fuq.
Redraw the needle a little bit back within the vial so that the needle tip rests at the lowest point of the vial.
Iġbed il- labra kemmxejn lura fil- kunjett sabiex il- ponta tal- labra tkun fl- aktar punt baxx tal - kunjett.
11 - Any excessive air rises to the top of the solution.
11 - L- arja żejda titla fil- wiċċ tas- soluzzjoni.
Remove the air bubbles by gently tapping the syringe and pushing the plunger to the 1 ml mark, or to the volume prescribed by your doctor.
Neħħi l- bżieżaq ta ’ l- arja billi ttektek bil- mod fuq is - siringa u billi timbotta l- planġer sal- marka ta ’ 1 ml, jew sal- volum preskritt mit- tabib tiegħek.
If too much solution goes into the vial along with the air bubbles, pull the plunger back a little to withdraw the solution back from the vial into the syringe.
Jekk wisq soluzzjoni tmur fil- kunjett mal- bżieżaq ta ’ l- arja, iġbed kemmxejn lura l- planġer biex tiġbed is- soluzzjoni lura mill- kunjett għal ġos- siringa.
12 - Disconnect the syringe and the needle.
12 - Skonnettja s- siringa u l- labra.
13 - Take the 30-gauge needle (if you are manually injecting without use of an auto-injector), take it out of its wrapping and place it firmly onto the tip (nozzle) of the syringe.
13 - Aqbad il- labra b’ gauge ta ’ 30 (ghall- injezzjoni manwali minghajr użu ta ’ auto- injector), oħroġha mill- ippakkjar tagħha u waħħalha sewwa mal- ponta (nozzle) tas- siringa.
OR
JEW
- Take the 27-gauge needle (if you are injecting using an auto-injector), take it out of its wrapping
- Aqbad il- labra b’ gauge ta ’ 27 (ghall- injezzjoni b’ użu ta ’ auto- injector), oħroġha mill- ippakkjar
and place it firmly onto the tip (nozzle) of the syringe.
tagħha u waħħalha sewwa mal- ponta (nozzle) tas- siringa.
45 15 - You are now ready to inject.
15 - Issa inti lest/ a biex tinjetta.
If, for some reason, you are not able to inject Extavia immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Jekk, għal xi raġuni, ma tkunx tista ’ tinjetta Extavia minnufih, tista ’ tpoġġi s- soluzzjoni fis- siringa ġol - friġġ sa 3 sigħat qabel ma tużaha.
Make sure the needle cap is fixed properly while the syringe is stored in the fridge.
Aċċerta ruħek li l- għatu jkun imwaħħal sewwa waqt li s- siringa tkun maħżuna fil- friġġ.
Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Tiffriżax is- soluzzjoni, u tistenniex iktar minn 3 sigħat biex tinjettaha.
If more than 3 hours pass, discard the medicine and prepare a new injection.
Jekk jgħaddu iktar minn 3 sigħat, armi l- mediċina u ipprepara injezzjoni ġdida.
E) Making the injection manually (to make an injection with an auto-injector, refer to the instructions for use provided with the auto-injector)
46 E) Kif tagħmel l- injezzjoni manwalment (biex taghmel l- injezzjoni b’ auto- injector, irreferi ghall- istruzzjonijiet ghal użu ipprovduti ma ’ l- auto- injector)
2 - Use an alcohol swab to clean the skin at the injection site.
2 - Uża biċċa li tnaddaf bl- alkoħol biex tnaddaf il- ġilda fil- post ta ’ l - injezzjoni.
Let the skin air-dry.
Ħalli l- ġilda tinxef bl- arja.
Throw the swab away.
Armi l- biċċa li tnaddaf.
3 - Remove the cap from the needle by pulling and not twisting it.
3 - Neħħi l- għatu mil- labra billi tiġbdu u mhux billi tgħawġu.
4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
4 - Oqros il- ġilda bil- mod madwar is- sit ta ’ l- injezzjoni diżinfettata (biex ittellagħha ftit ’ il fuq).
5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90˚ angle with a quick, firm motion.
5 - Filwaqt li żżomm is- siringa bħal ma żżomm lapes jew dart, waħħal il- labra bi dritt ġol- ġilda f’ angolu ta ’ 90˚, b’ moviment mgħaġġel u sod.
6 - Inject the medicine using a slow, steady push on the plunger.
6 - Injetta l- mediċina billi timbotta bil- mod u b’ mod kostanti fuq il - planġer.
7 - Discard the syringe in the disposal unit.
7 - Armi s- siringa fir- reċipjent tar- rimi.
46 F) Quick review of the process
F) Reviżjoni malajr tal- proċess
Take out the contents needed (1 vial, 1 pre-filled syringe, 2 alcohol wipes, needle suitable for reconstitution, 30-gauge needle (for use for manual injection) OR 27-gauge needle (for use with an auto-injector)).
Oħroġ il- kontenut meħtieġ (1 kunjett, 1 siringa mimlija għal- lest, 2 biċċiet ta ’ l- alkoħol, labra adattata għar- rikostituzzjoni, labra b’ gauge ta ’ 30 (ghall- injezzjoni manwali) JEW labra b’ gauge 27 (ghal użu ma auto- injector)).
Take off the cap from the vial and clean the rubber stopper with an alcohol wipe.
Neħħi l- għatu mill- kunjett u naddaf l- għatu tal- gomma b’ biċċa bl- alkoħol.
Unwrap the needle suitable for reconstitution and fix it to the syringe from which you removed the tip cap before.
Neħħi l- labra adattata għar- rikostituzzjoni mill- ippakkjar u waħħalha mas- siringa minn fejn qabel tkun neħħejt l- għatu tal- ponta.
5.
Ittrasferixxi s- solvent mis- siringa għall- kunjett billi timbotta l- planġer it- tul kollu 5.
Turn the syringe-vial-assembly over, then withdraw plunger to redraw the solution.
Dawwar il- muntaġġ tas- siringa- kunjett ta ’ taħt fuq, imbagħad iġbed il- planġer biex tiġbed is - soluzzjoni.
Unwrap the 30-gauge needle (for use for manual injection) OR 27-gauge needle (for use with an auto-injector) and connect it to the syringe.
Neħħi l- labra b’ gauge ta ’ 30 (ghall- injezzjoni manwali) JEW labra b’ gauge 27 (ghal użu ma auto- injector) mill- ippakkjar u waħħalha mas- siringa.
Remove needle cap just before injection - you are now ready to inject.
Neħħi l- għatu tal- labra eżattament qabel l- injezzjoni – issa lest/ a biex tinjetta.
The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours).
L- injezzjoni għandha tingħata minnufih wara li tħallatha (jekk l- injezzjoni ddum ma tingħata, kessaħ is- soluzzjoni u injettaha fi żmien 3 sigħat).
Do not freeze.
Tpoġġihiex fi friża.
47 PART II:
47 PARTI II:
ROTATING INJECTION SITES
KIF TAGĦMEL ROTAZZJONI TAL- PARTIJIET FEJN TAGĦTI L - INJEZZJONI
You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
L- ewwel agħżel sit ġdid ta ’ injezzjoni kull darba għax it- tibdil fis- sit jagħti żmien biżżejjed biex il - ġilda tirkupra u jgħin biex jevita xi infezzjoni.
Advice on which areas to choose is given in the first part of this Annex.
Fl- ewwel parti ta ’ dan l- Anness hemm parir fuq liema siti għandek tagħżel.
It is a good idea to know where you plan to inject before you prepare your syringe.
Hija ħaġa tajba li tkun taf fejn għandek il- ħsieb li tinjetta qabel ma tipprepara s - siringa tiegħek.
The schedule shown in the diagram below will help you to vary the sites appropriately.
L- iskeda murija hawn taħt fit- tpinġija għandha tgħinek sabiex tvarja s- siti b’ mod xieraq.
For example, give the first injection into the right side of the abdomen, choose the left side for the second injection, then move to the right thigh for the third, and so on through the diagram until all suitable areas of the body have been used.
Pereżempju, agħti l- ewwel injezzjoni fuq in- naħa tal- lemin taż- żaqq, uża n- naħa tax- xellug għat- tieni injezzjoni, imbagħad mur fuq il- koxxa tal- lemin għat- tielet, u ibqa ’ sejjer hekk mat- tpinġija sakemm jintużaw is- siti xierqa kollha possibbli tal- ġisem.
One way to do that is to note the injection site on the enclosed medication record card.
Mezz biex tagħmel dan huwa li tinnota s- sit ta ’ l- injezzjoni fil- kartuna tal- informazzjoni medika li tinsab fil- pakkett.
By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
Billi ssegwi din l- iskeda, għandek tiġi lura fl- ewwel lok (eż. in- naħa tal- lemin taż- żaqq) wara 8 injezzjonijiet (16- il jum).
This is called a Rotation Cycle.
Dan jissejjaħ Ċiklu tar- Rotazzjoni.
On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites altogether), left, right, upper, middle and lower part of each area.
Fuq l- iskeda bl- eżempju tagħna, kull żona hi maqsuma mill- ġdid f’ 6 postijiet ta ’ l- injezzjoni (għal total ta ’ 48 post ta ’ l- injezzjoni), il- parti tax- xellug u tal- lemin, ta ’ fuq, tan- nofs u t’ isfel ta ’ kull żona.
If you come back to an area after one Rotation Cycle choose the most distant injection site within this area.
Jekk terġa ’ tirritorna lejn żona minnhom wara Ċiklu ta ’ Rotazzjoni wieħed, agħżel l- iktar post ta ’ l- injezzjoni li hu ’ l bogħod f’ din iż- żona.
If an area becomes sore, talk to your doctor or nurse about choosing other injection sites.
Jekk tħoss l- uġigħ f’ xi parti, kellem lit- tabib jew lin- ners tiegħek dwar kif tagħżel postijiet oħrajn għall - injezzjoni.
Rotation Schedule To help you rotate the injection sites appropriately we recommend that you keep a record of the date and location of your injection.
Skeda tar- Rotazzjoni Biex ngħinuk tagħmel rotazzjoni tal- postijiet fejn tagħti l- injezzjonijiet b’ mod adegwat, nirrakkomandaw li żżomm rekord tad- data u tal- post fuq ġismek fejn tajt l- injezzjoni.
You can use the following rotation schedule.
Tista ’ tuża l - iskeda tar- rotazzjoni li ġejja.
Work through each rotation cycle in turn.
Segwi kull ċiklu ta ’ rotazzjoni mogħti hawn taħt, wieħed wara l- ieħor.
By following this sequence, you will give each area a chance to recover before receiving another injection.
Jekk issegwi din is- sekwenza, inti tagħti ċans lil kull żona tirkupra qabel tirċievi injezzjoni oħra.
Rotation Cycle 1:
Ċiklu tar- Rotazzjoni 1:
Rotation Cycle 2:
Ċiklu tar- Rotazzjoni 2:
Rotation Cycle 3:
Ċiklu tar- Rotazzjoni 3:
Rotation Cycle 4 Rotation Cycle 5:
Ċiklu tar- Rotazzjoni 5:
Rotation Cycle 6:
Ċiklu tar- Rotazzjoni 6:
Upper left section of each area Lower right section of each area Middle left section of each area Upper right section of each area Lower left section of each area Middle right section of each area
Is- sezzjoni ta ’ fuq tal- lemin ta ’ kull żona.
48 PART III:
48 PARTI III:
EXTAVIA Medication record
EXTAVIA Rekord tal- mediċina
Instructions for keeping track of your injection sites and dates
Struzzjonijiet biex iżżomm rekord tal- postijiet fejn tagħti l- injezzjoni u tad- dati.
− Start with your first injection (or your last injection if you are not a new Extavia user).
− Ibda bl- ewwel injezzjoni (jew bl- aħħar injezzjoni, jekk diġà qed tuża Extavia).
− Select an injection site.
− Agħżel post għall- injezzjoni.
If you have already been using Extavia start with the area that has not been used during the last rotation cycle, i.e. the past 16 days).
Jekk diġà kont qed tuża Extavia, ibda b’ żona li ma ntużatx fl - aħħar ċiklu tar- rotazzjoni, i. e. l- aħħar 16- il jum).
− After your injection, fill in the used injection site and date in the table in your injection record (See the example:
− Wara l- injezzjoni, imla s- sezzjoni li turi l- parti ta ’ l- injezzjoni li ntużat u d- data fit- tabella fir - rekord ta ’ injezzjoni tiegħek (ara l- eżempju:
Keeping track of your injection sites and dates).
Kif iżżomm rekord tal- postijiet fejn tagħti l - injezzjoni u tad- dati).
49 ROTATION SCHEDULE:
49 SKEDA TAR- ROTAZZJONI:
AREA 1
10- 15 ċm mill- ispalla
AREA 2
ŻONA 2 ŻONA 1 Driegħ tax- xellug 10- 15 ċm mill - Driegħ tal- lemin (iż- żona ta ’ fuq tan - għarqub (iż- żona ta ’ fuq tan- naħa naħa ta ’ wara) ta ’ wara)
AREA 4
ŻONA 4
AREA 8
ŻONA 8
AREA 7
ŻONA 7
50 EXAMPLE OF A MEDICATION RECORD:
50 EŻEMPJU TA ’ REKORD TAL- MEDIĊINA:
ed ris ho ut ra ANNEX I
t za riz to aw x du ANNESS I ħa SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT ’ g im il al in iċ ed m t ot od Pr
SUMMARY OF PRODUCT CHARACTERISTICS lo o tn uc od pr al in ic ed M
ISEM TAL- PRODOTT MEDIĊINALI
NAME OF THE MEDICINAL PRODUCT
EXUBERA 1 mg trab għall- inalazzjoni magħmul għal- lest.
Each unit dose blister contains 1 mg insulin human.
Kull bużżieqa ta ’ doża waħda fiha 1 mg ta ’ insulina umana.
The exposure of human insulin following administration of three 1 mg blisters is significantly greater
L- espożizzjoni ta ’ l - insulina umana wara l- għoti ta ’ tliet bżieżaq ta ’ 1 mg hija ferm akbar milli dik ta ’
ed than that following a single 3 mg blister.
t za wara bużżieqa waħda ta ’ 3 mg.
Therefore, the 3 mg blister is not interchangeable with three 1 mg blisters (see sections 4.2, 4.4 and 5.2).
Għaldaqstant, il- bużżieqa ta ’ 3 mg ma tistax tinbidel ma ’ tliet bżieżaq ta ’ 1 mg (ara sezzjonijiet 4. 2, 4. 4 u 5. 2).
ris Produced by recombinant DNA technology in Escherichia coli.
riz Magħmula permezz ta ’ teknoloġija rekombinanti tad- DNA f’ Escherichia coli.
ho For a full list of excipients, see section 6.1.
to Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
ut 3.
aw 3.
ra Inhalation powder, pre-dispensed.
x Trab għall- inalazzjoni, magħmul għal- lest.
lo
’ g
ge
ħa
Therapeutic indications
4. 1 Indikazzjonijiet terapewtiċi
tn
im
EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy. uc
EXUBERA hija indikata għat- trattament ta ’ pazjenti adulti bid- dijabete mellitus tip 2 li mhijiex ikkontrollata b’ mod adegwat b’ mediċini orali kontra d- dijabete u li jeħtieġu terapija bl- insulina. il al
EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of od
EXUBERA hija ukoll indikata għat- trattament ta ’ pazjenti adulti bid- dijabete mellitus tip 1, flimkien ma ’ insulina li taħdem fit- tul jew għal żmien intermedju li tingħata taħt il- ġilda, għal liema s- siwi in
adding inhaled insulin outweigh the potential safety concerns (see section 4.4). pr
potenzjali taż- żieda ta ’ insulina inalata jisboq it- tħassib potenzjali dwar is- sigurtà (ara sezzjoni 4. 4). iċ
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata ed
EXUBERA (inhaled human insulin) is a fast-acting human insulin for use in type 1 or type 2 diabetes. al
L- insulina umana inalata tista ’ tittieħed waħida jew f’ kumbinazzjoni ma ’ mediċini m
Inhaled human insulin may be used alone or in combination with oral antidiabetic agents and/ or long or intermediate acting subcutaneously administered insulins to optimise glycaemic control. in ic
antidijabetiċi orali u/ jew insulini li jaħdmu fit- tul jew għal żmien intermedju li jingħataw taħt il- ġilda biex jottimizzaw il- kontroll gliċemiku. t ot
EXUBERA is available in 1 mg and 3 mg unit dose blisters which are for administration via the lungs by oral inhalation only with the insulin inhaler. ed
EXUBERA tiġi f’ bżieżaq ta ’ doża waħda ta ’ 1 mg u 3 mg li jingħataw minn ġol- pulmun b ’ inalazzjoni orali permezz ta ’ inalatur ta ’ l- insulina biss. od
Consecutive inhalation of three 1 mg unit dose blisters causes a significantly higher insulin exposure M
Inalazzjoni konsekuttiva ta ’ tliet bżieżaq ta ’ doża waħda ta ’ 1 mg ikkaġunat espożizzjoni għall - Pr
than inhalation of one 3 mg unit dose blister.
insulina ferm ogħla milli inalazzjoni ta ’ bużżieqa ta ’ doża waħda ta ’ 3 mg.
Therefore three 1 mg unit dose blisters should not be substituted for one 3 mg unit dose blister (see sections 2, 4.4 and 5.2).
Għaldaqstant, tliet bżieżaq ta ’ doża waħda ta ’ 1 mg m’ għandhomx jiġu ssostitwiti b’ bużżieqa ta ’ doża waħda ta ’ 3 mg (ara sezzjonijiet 2, 4. 4 u 5. 2).
Inhaled human insulin has a faster onset of activity than subcutaneously administered fast-acting human insulin.
L- insulina umana inalata tibda l- attività tagħha aktar malajr milli insulina umana li taħdem malajr li tingħata taħt il- ġilda.
Due to the rapid onset of activity, inhaled human insulin should be given within 10 minutes before the start of a meal.
Minħabba l- bidu rapidu ta ’ l- attività tagħha, l- insulina umana inalata għandha tingħata fi żmien 10 minuti qabel il- bidu ta ’ ikla.
2 The starting and subsequent dosage (dose and timings) should be determined individually by the physician and adjusted according to the patient’ s individual response and requirements (e. g. diet, physical activity and life-style).
2 Id- dożaġġ tal- bidu u dak sussegwenti (doża u ħinijiet) għandhom jiġu stabbiliti mit- tabib u għandhom jiġu aġġustati skond ir- reazzjoni u l- ħtiġijiet individwali tal- pazjent (eż. dieta, attività fiżika u stil ta ’ ħajja).
Daily doses and timing of administration
Dożi ta ’ kuljum u ħinijiet ta ’ meta tingħata
There are no fixed rules for insulin dosage.
Ma hemm l- ebda regoli fissi għad- dożaġġ ta ’ l- insulina.
However, a recommended starting daily dose is based on the following formula:
Madankollu, id- doża tal- bidu rakkomandata għal kuljum hija bbażata fuq il- formula li ġejja:
Body weight (kg) X 0.15 mg/ kg = Total Daily Dose (mg).
Piż tal- ġisem (kg) X 0. 15 mg/ kg = Doża Totali ta ’ Kuljum (mg).
The total daily dose should be divided into
Id- doża totali ta ’ kuljum għandha tiġi
ed three pre-meal doses.
t za mqassma fi tlett dożi ta ’ qabel l- ikel.
Approximate guidelines for initial, pre-meal EXUBERA doses, based on patient body weight, are
Linji ta ’ gwida approssimattivi għal dożi inizjali ta ’ qabel l- ikel ta ’ EXUBERA, ibbażati fuq il- piż tal -
ris indicated in Table 1:
riz ġisem tal- pazjent, huma indikati f’ Tabella 1.
Number of 1 mg
Doża
Number of 3 mg
Numru ta ’ Bżieżaq Numru ta ’ Bżieżaq
Patient Weight
Doża Inizjali Approssimattiva ta ’ 1 mg kull doża ta ’ 3 mg kull doża
Meal IU Dose
aw
Blisters per Dose
Piż tal- Pazjent
Blisters per Dose
għal kull Ikla
ut
IU
30 to 39.9 kg 40 to 59.9 kg
30 sa 39. 9 kg 40 sa 59. 9 kg
1 mg per meal 2 mg per meal
1 mg kull ikla 2 mg kull ikla
3 IU 1 6 IU 2
3 IU 1 6 IU 2
ra
x
60 to 79.9 kg
60 sa 79. 9 kg 3 mg kull ikla
80 to 99.9 kg
du
4 mg per meal
80 sa 99. 9 kg 4 mg kull ikla
ge
2 ħa
5 mg per meal 6 mg per meal
120 sa 139. 9 kg 6 mg kull ikla
n
’ g
Approximate Guidelines for Initial, Pre-Meal EXUBERA Dose (based on patient lo
Linji ta ’ Gwida Approssimattivi għal Dożi Inizjali ta ’ Qabel l- Ikel ta ’ EXUBERA (fuq il- bażi tal- piż tal- ġisem tal- pazjent). im
body weight). o
Bużżieqa ta ’ 1 mg ta ’ insulina inalata hija ekwivalenti għal madwar 3 IU insulina li taħdem malajr li tingħata taħt il- ġilda.
A 1 mg blister of inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected fast- tn
Bużżieqa ta ’ 3 mg ta ’ insulina inalata hija ekwivalenti għal madwar 8 IU insulina il
acting human insulin.
li taħdem malajr li tingħata taħt il- ġilda.
Table 1 above presents the approximate IU dose of fast-acting human insulin for initial, pre-meal EXUBERA doses in mg. uc
Tabella 1 hawn fuq tippreżenta d- doża IU approssimattiva ta ’ insulina li taħdem malajr għal dożi inizjali ta ’ qabel l- ikel ta ’ EXUBERA f’ mg. al in
The use of od
L- użu ta ’ EXUBERA f’ pazjenti li jeħtieġu titrazzjonijiet tad- doża ta ’ inqas minn 1 mg m’ huwiex irrikmandat iċ
EXUBERA in patients requiring dose titrations of less than 1 mg is not recommended (see section 4.4). pr
(ara sezzjoni 4. 4). ed
Dose adjustment may be required based on the meal size and nutrient composition, time of day (higher insulin requirements in the morning), pre-meal blood glucose concentration, recent or al
Jista ’ jkun hemm bżonn ta ’ aġġustament tad- doża u dan ikun jiddependi fuq id- daqs ta ’ l- ikla u l - kompożizzjoni nutrittiva, il- ħin tal- ġurnata (ħtiġijiet akbar ta ’ insulina filgħodu), il- konċentrazzjoni m
anticipated exercise. in
tal- glukosju fid- demm ta ’ qabel l- ikel, l- eżerċizzju reċenti jew mistenni.
During intercurrent respiratory illness (e. g. bronchitis, upper respiratory tract infections) close monitoring of blood glucose concentrations and dose adjustment may be required on an individual ic
Waqt mard respiratorju interkurrenti (eż. bronkite, infezzjonijiet fil- passaġġi tal- parti ta ’ fuq tas - t ot
basis (see section 4.4). ed
sistema respiratorja), tista ’ tkun meħtieġa sorveljanza mill- qrib tal- konċentrazzjonijiet tal- glukosju fid - demm kif ukoll aġġustament tad- doża fuq bażi individwali (ara sezzjoni 4. 4). od
For further details on how to use the insulin inhaler refer to the instructions for use (IFU).
Għal aktar dettalji fuq kif tuża l- inalatur ta ’ l- insulina rreferi għall- istruzzjonijiet fuq l- użu (IFU).
Hepatic and renal impairment
Indeboliment tal- fwied u tal- kliewi
In patients with hepatic or renal impairment insulin requirements may be diminished.
F’ pazjenti b’ indeboliment tal- fwied jew tal- kliewi, jista ’ jkun hemm inqas ħtieġa għall- insulina.
Long-term safety of inhaled human insulin has not been established in paediatric patients with diabetes and its use is therefore not recommended in patients under 18 years of age (see section 5.2).
Is- sigurtà fuq tul ta ’ żmien ta ’ insulina umana ma ġietx stabbilita f’ pazjenti pedjatriċi bid- djabete u l - użu tagħha għaldaqstant mhuwiex irrikmandat f’ pazjenti taħt it- 18- il sena (ara sezzjoni 5. 2).
3 Elderly
3 Anzjani
75 years of age is limited.
Esperjenza b’ insulina inalata f’ pazjenti b’ età ≥ 75 sena hija limitata.
Congestive heart failure
Falliment konġestiv tal- qalb
Experience with inhaled insulin in patients with congestive heart failure is very limited and its use is therefore not recommended in such patients where lung function is significantly compromised.
L- esperjenza b’ insulina umana inalata f’ pazjenti b’ falliment konġestiv tal- qalb hija limitata ħafna u l - użu tagħha għaldaqstant mhuwiex irrikmandat f’ pazjenti ta ’ din ix- xorta fejn il- funzjoni tal- pulmun hija kompromessa ħafna.
4.3 Contraindications
t za 4. 3 Kontra- indikazzjonijiet
ed Hypersensitivity to the active substance or to any of the excipients.
riz Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
ris Hypoglycaemia.
Ipogliċemija.
ho Patients must not smoke during therapy with EXUBERA and must have stopped smoking at least 6 months prior to starting EXUBERA therapy.
to Il- pazjenti m’ għandhomx ipejpu waqt terapija b’ EXUBERA u għandhom ikunu waqfu t- tipjip
ut utilised (see section 5.2).
aw għallinqas 6 xhur qabel ma jibdew terapija b’ EXUBERA.
ra Poorly controlled, unstable, or severe asthma.
x du Ażżma mhux ikkontrollata sewwa, instabbli jew qawwija.
4.4 Special warnings and precautions for use
Mard pulmonari kroniku u ostruttiv (COPD), qawwi (Stadji III jew IV GOLD). ħa 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu ’ g
Severe (GOLD stage III or IV) Chronic obstructive pulmonary disease (COPD). lo Patients started on EXUBERA must receive comprehensive instructions in the use of the inhaler (see IFU).
Pazjenti mibdija fuq EXUBERA għandhom jirċievu struzzjonijiet komprensivi fuq l- użu ta ’ l- inalatur im
inhalation.
tagħhom (ara IFU).
Patients should then hold their breath for 5 seconds and exhale normally.
Imbagħad, il- pazjenti għandhom iżommu nifishom għal 5 sekondi u jerħu n- nifs ’ l barra normali.
A consistent and tn
Għandha tintuża teknika ta ’ ġbid tan- nifs konsistenti u standard il
standard inhalation technique should be employed to ensure both optimal and consistent drug delivery. uc
biex ikun assigurat li l- mediċina tkun ingħatat bl- aħjar mod u konsistenti. al
Patients should avoid exposing the product to high moisture or relative humidity conditions e. g. a steamy bathroom, when taking their dose. od
Meta jieħdu d- doża tagħhom, il- pazjenti għandhom jevitaw li jesponu l- prodott għal kondizzjonijiet ta ’ in
If the insulin inhaler is inadvertently exposed to extremely moist conditions during use this usually pr
Jekk l- inalatur ta ’ l- insulina jkun involontarjament espost għal kondizzjonijiet estremament umidi ed
leads to a subsequent decreased insulin dose delivered from the inhaler.
waqt l- użu dan issoltu jirriżulta fi tnaqqis tad- doża ta ’ l- insulina mogħtija.
In this case, the Insulin Release Unit (IRU) must be changed prior to the next inhalation (see section 6.6). al
F’ dan il- każ, il- Unit ta ’ Rilaxx ta ’ l- Insulina (IRU) irid jinbidel qabel l- inalazzjoni li jkun imiss (ara sezzjoni 6. 6). m
Dosing in
Dożaġġ t
Transferring a patient to another type or brand of insulin should be done under strict medical ic
Trasferiment ta ’ pazjent minn fuq tip jew ditta ta ’ insulina għal oħra għandu jsir taħt sorveljanza ot
supervision as this may result in a change in dosage. ed
medika stretta għaliex dan jista ’ jirriżulta f’ bidla fid- dożaġġ. od
Consecutive inhalation of three 1 mg unit dose blisters causes a significantly higher insulin exposure than inhalation of one 3 mg unit dose blister.
Inalazzjoni konsekuttiva ta ’ tliet bżieżaq ta ’ doża waħda ta ’ 1 mg jikkaġunaw espożizzjoni ogħla minn inalazzjoni waħda ta ’ doża waħda ta ’ 3 mg.
Therefore three 1 mg unit dose blisters should not be M
Għaldaqstant, tliet bżieżaq ta ’ doża waħda ta ’ 1 mg Pr
substituted for one 3 mg unit dose blister (see sections 2, 4.2 and 5.2).
m’ għandhomx jiġu sostitwiti minn bużżieqa ta ’ doża waħda ta ’ 3 mg (ara sezzjonijiet 2, 4. 2 u 5. 2).
If the 3 mg blister is temporarily unavailable, two 1 mg blisters should be substituted and blood glucose monitored closely.
Jekk il- bużżieqa ta ’ 3 mg tkun temporanjament mhux disponibbli, żewġ bżieżaq ta ’ 1 mg għandhom jissostitwixxuha u l- glukosju fid- demm għandu jiġi sorveljat mill- qrib.
A 1 mg blister of inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected fast- acting human insulin.
Bużżieqa ta ’ 1 mg ta ’ insulina inalata hija ekwivalenti għal madwar 3 IU ta ’ insulina umana li taħdem malajr injettata taħt il- ġilda.
Therefore, EXUBERA should be used with caution in patients of low body weight.
Għaldaqstant, EXUBERA għandha tintuża b’ kawtela f’ pazjenti b’ piż tal - ġisem ħafif.
The use of EXUBERA in patients requiring dose titrations of less than 1 mg is not recommended (see section 4.2).
L- użu ta ’ EXUBERA f’ pazjenti li jeħtieġu titrazzjonijiet tad- doża ta ’ anqas minn 1 mg mhuwiex irrikmandat (ara sezzjoni 4. 2)
4 Hypoglycaemia
4 Ipogliċemija
Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy including EXUBERA and many oral antidiabetic agents, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemija, b’ mod ġenerali hi l- aktar effett frekwenti mhux mixtieq ta ’ terapija bl- insulina nkluż EXUBERA u ħafna mediċini ta ’ kontra d- dijabete oħra, li tista ’ sseħħ jekk id- doża ta ’ l- insulina tkun għolja wisq meta mqabbla mal- ħtieġa għall- insulina.
Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki ipogliċemiċi qawwija, b’ mod speċjali jekk rikorrenti, jistgħu jwasslu għal ħsara newroloġika.
Prolonged or severe hypoglycaemic episodes may be life threatening.
Episodji ipogliċemiċi fit- tul jew serji jistgħu jkunu ta ’ theddida għall- ħajja.
Symptoms of hypoglycaemia usually occur suddenly.
Sintomi ta ’ ipogliċemija ġeneralment iseħħu f’ daqqa.
They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Dawn jistgħu jinkludu għaraq kiesaħ, ġilda
ed Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
t za pallida u kiesħa, għeja kbira, nervożiżmu jew rogħda, ansjetà, għeja jew dgħjufija mhux tas- soltu, konfużjoni, diffikultà fil- konċentrazzjoni, ħedla, ġuħ eċċessiv, tibdil fil- viżta, uġigħ ta ’ ras, dardir u
ris Hypoglycaemia can generally be corrected by immediate carbohydrate intake.
riz palpitazzjoni.
In order to be able to take action immediately, patients should carry glucose with them at all times.
L- ipogliċemija serja tista ’ twassal għal telf mis- sensi u/ jew aċċessjonijiet u tista ’ tirriżulta f’ indeboliment temporanju jew permanenti tal- funzjoni tal- moħħ jew anke mewt.
ho Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
to L- ipogliċemija ġeneralment tista ’ tiġi kkoreġuta b’ teħid immedjat ta ’ karboidrati.
Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may
Il- pazjenti għandhom iġorru l- glukosju magħhom il- ħin kollu, sabiex ikunu jistgħu jieħdu azzjoni immedjata.
ut experience a change in their usual warning symptoms of hypoglycaemia and should be advised
aw Jekk tinqabeż ikla jew jekk isir eżerċizzju fiżiku qawwi mhux ippjanat, dan jista ’ jwassal għal ipogliċemija.
ra accordingly.
x Pazjenti li l- kontroll tal- glukosju f’ demmhom huwa mtejjeb bil- bosta eż. b’ terapija bl- insulina
Usual warning symptoms may disappear in patients with longstanding diabetes.
du intensifikata, jistgħu jesperjenzaw bidla fis- sintomi ta ’ twissija tagħhom tas- soltu u għandhom għalhekk jiġu avżati.
A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin to human insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin. lo
Is- sintomi ta ’ twissija tas- soltu jistgħu jisparixxu f’ pazjenti li ilhom ibatu bid- dijabete. ’ g Ftit mill- pazjenti li esperjenzaw reazzjonijiet ipogliċemiċi wara trasferiment minn insulina li ġejja mill- annimali għal insulina umana rrapportaw li s- sintomi ta ’ twissija bikrija ta ’ l- ipogliċemija kienu im
Before travelling between different time zones, the patient should be advised to consult the doctor, o
Qabel jivvjaġġaw bejn żoni ta ’ ħinijiet differenti, il- pazjenti għandhom jiġu avżati biex jikkonsultaw lit- tabib, minħabba li dan jista ’ jfisser li l- pazjent ikollu jieħu l- insulina u l- ikliet f’ ħinijiet differenti. al
since this may mean that the patient has to take insulin and meals at different times. tn
Dożaġġ mhux adegwat jew twaqqif ta ’ trattament speċjalment f’ persuni li għandhom id- dijabete in
Inadequate dosage or discontinuation of treatment especially in insulin-dependant diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal. uc
dipendenti fuq l- insulina, jista ’ jwassal għal ipergliċemija u ketoaċidożi dijabetika; kondizzjonijiet li iċ
When used with other antidiabetic agents, the dose of each agent should be carefully adjusted to od
jistgħu jkunu letali. ed
determine the optimal dose required to achieve the desired pharmacological effect. pr
Meta wżata ma ’ mediċini ta ’ kontra d- dijabete, id- doża ta ’ kull mediċina għandha tiġi aġġustata bir - reqqa biex tiġi stabbilita l- aqwa doża biex jinkseb l- effett farmakoloġiku mixtieq. m
Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances, or stress. al
Il- ħtiġijiet għall- insulina jistgħu jinbidlu waqt kondizzjonijiet interkurrenti bħal mard, disturbi emozjonali jew stress. t ot
Pulmonary Safety in
Sigurtà Pulmonari od
Underlying respiratory disorders ic
Disturbi respiratorji diġà eżistenti Pr
EXUBERA should not be used in patients with lung disease such as asthma and COPD, as there are ed
EXUBERA m’ għandhiex tintuża f’ pazjenti b’ mard pulmonari bħalma huma l- ażżma u s- COPD, minħabba li m’ hemmx biżżejjed tagħrif biex isostni użu mingħajr periklu f’ dawn il- pazjenti.
The concomitant use of bronchodilators such as salbutamol may increase the absorption of EXUBERA and may therefore increase the risk of hypoglycaemia when used to relieve acute respiratory symptoms (see section 4.5).
L- użu fl- istess ħin ta ’ dilaturi tal- bronki bħalma huwa salbutamol jistgħu jżidu l- assorbiment ta ’ EXUBERA u jistgħu jżidu r- riskju ta ’ ipogliċemija meta wżati biex itaffu sintomi respiratorji akuti (ara sezzjoni 4. 5).
Respiratory
Respiratorji
Bronchospasm may rarely occur.
5 F’ każijiet rari jista ’ jseħħ bronkospażmu.
Any patients experiencing such a reaction should discontinue EXUBERA and seek medical evaluation immediately.
Pazjenti li jesperjenzaw reazzjoni bħal din għandhom iwaqqfu EXUBERA u jfittxu attenzjoni medika minnufih.
Re-administration of EXUBERA requires a careful risk evaluation, and may only be done under close medical monitoring with appropriate clinical facilities.
L- għoti mill- ġdid ta ’ EXUBERA jeħtieg evalwazzjoni tar- riskju bir- reqqa, u jista ’ jsir biss taħt sorveljanza medika mill- qrib b’ faċilitajiet kliniċi adattati.
5 Decline in pulmonary function
Tnaqqis fil- funzjoni pulmonari
In clinical trials small but consistent treatment group differences in decline of pulmonary function (particularly Forced Expiratory Volume in one second (FEV1)) favouring comparator treated subjects have been observed.
Fi provi kliniċi ġew osservati differenzi żgħar imma konsistenti fit- tnaqqis tal- funzjoni pulmonari fil - grupp tat- trattament (b’ mod partikolari Volum Espiratorju Sfurzat f’ sekonda (FEV1) li jiffavorixxu suġġetti ttrattati b’ komparatur.
In clinical studies of up to two years duration, there was no accelerated decline beyond 3-6 months.
Fi studji kliniċi li jdumu għaddejjin mhux aktar minn sentejn, ma kien
These small treatment group differences resolved within 6 weeks upon discontinuation after 2 years of treatment (see sections 4.8 and 5.1).
Dawn id- differenzi żgħar fil- grupp ta ’ trattament sparixxew fi żmien 6 ġimgħat mit- twaqqif wara sentejn trattament (ara sezzjonijiet 4. 8 u 5. 1).
All patients initiated on EXUBERA should have a baseline lung function examination (e. g. spirometry to measure FEV1).
riz Il- pazjenti kollha mibdija fuq EXUBERA għandha ssirilhom eżaminazzjoni tal- funzjoni tal- pulmun fil- linja ta ’ referenza bażi (eż. spirometrija biex jitkejjel FEV1).
The efficacy and safety of inhaled human insulin in patients with
L- effikaċja u s- sigurta ta ’ l- insulina
A follow-up lung function measurement is recommended after the first 6 months of therapy.
to umana inalata f’ pazjenti bil- linja bażi mistennija FEV1 < 70% ma ġietx stabbilita, u l- użu ta ’ l- insulina umana inalata f’ din il- popolazzjoni mhux rakkomandata.
If at 6 months a decline of < 15% FEV1 is observed, spirometry should be
Kejl tal- funzjoni pulmonari ta ’ follow- up
ris repeated at one year and then annually.
aw huwa rakomandat wara l- ewwel 6 xhur ta ’ terapija.
If at 6 months a decline of 15-20% or > 500ml from baseline lung function is observed, spirometry should be repeated after 3 months.
Jekk fis- 6 xahar jiġi osservat tnaqqis ta ’ < 15% FEV1, l- ispirometrija għandha tiġi rrepetuta wara sena u mbagħad ta ’ kull sena.
ho In patients with a confirmed (i. e. at least two consecutive tests, 3 to 4 weeks apart) FEV1 decline of > 20% from baseline, EXUBERA therapy should be discontinued and the patient monitored as
Jekk fis- 6 xahar, jiġi osservat tnaqqis ta ’ 15- 20% jew > 500ml mill- funzjoni tal- pulmun fil- linja bażi, l- ispirometrija
ut clinically indicated.
x għandha tiġi rrepetuta wara 3 xhur.
There is no experience with the reinstitution of EXUBERA therapy in patients
Ma hemm l- ebda esperjenza b’ istituzzjoni mill - ġdid ta ’ terapija b’ EXUBERA f’ pazjenti li l- funzjoni pulmonari tagħhom tirkupra. ’ g
Patients developing dyspnoea while treated with EXUBERA should be examined for pulmonary or
Pazjenti li jiżviluppaw qtugħ ta ’ nifs waqt trattament b’ EXUBERA għandhom jiġu eżaminati għal im
ge cardiac causes.
kaġunijiet pulmonari jew kardijaċi.
Where pulmonary oedema is present, or there is a clinically relevant reduction in pulmonary function, EXUBERA should be discontinued and the patient switched to injectable insulin. n Intercurrent Respiratory Illness lo
Meta jkun hemm edema pulmonari, jew ikun hemm tnaqqis fil - funzjoni pulmonari klinikament relevanti, EXUBERA għandha titwaqqaf u l- pazjent għandu jinqeleb għal insulina li tiġi injettata. il
EXUBERA has been administered to patients with intercurrent respiratory illness (e. g. bronchitis, o
Mard Respiratorju Interkurrenti al in
upper respiratory tract infections) during clinical trials.
Waqt provi kliniċi, EXUBERA ngħatat lil pazjenti b’ mard respiratorju interkurrenti (eż. bronkite, infezzjonijiet fil- passaġġi tal- parti ta ’ fuq tas- sistema respiratorja).
Increased risk of hypoglycaemia or poor tn
F’ dawn il- provi, ma ġie osservat iċ
glycaemic control has not been observed in these trials.
ebda riskju akbar ta ’ ipogliċemija jew kontroll gliċemiku bagħtut.
During intercurrent respiratory illness close monitoring of blood glucose concentrations and dose adjustment may be required on an individual basis (see section 4.2).
demm u ta ’ aġġustament tad- doża fuq bażi individwali (ara sezzjoni 4. 2).
There is no experience with EXUBERA in patients with pneumonia. uc
Ma hemm l- ebda esperjenza b’ EXUBERA f’ pazjenti bi pnewmonja. m
Former Smokers od
Pazjenti li kienu jpejpu qabel t ot
In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies pr
Kien hemm ukoll od
among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients.
rapport wieħed wara t- tqegħid tal- prodott fis- suq ta ’ tumur primarju tal- pulmun f’ pazjent trattat b’ Exubera.
In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 al
Fi studji kliniċi kontrollati ta ’ Exubera, l- inċidenza ta ’ tumuri primarji tal- pulmun fi studju ta ’ 100- sena ta ’ pazjenti b’ esposizzjoni għall- mediċina ta ’ 0. 130 (5 każijiet fuq medda ta ’ 3800 – snin Pr
There were too few in
ta ’ pazjenti) għal pazjenti trattati b’ Exubera, u 0. 03 (1 każ fuq medda ta ’ 3900 snin ta ’ pazjenti) għal pazjenti trattati komparattivament.
All patients who were ic
Kien hemm ftit wisq każijiet biex ikun determinat jekk dawn l - episodji kienux relatati ma ’ Exubera / Il- pazjenti kollha li kienu djanjostikati b’ tumur tal- pulmun kienu jpejpu qabel.
4.5 Interaction with other medicinal products and other forms of interaction M
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
A number of substances affect glucose metabolism and may require dose adjustment of insulin.
6 Għadd ta ’ sustanzi jaffettwaw il- metaboliżmu tal- glukosju u jistgħu jeħtieġu aġġustament tad- doża ta ’ l- insulina.
Substances that may enhance the blood-glucose lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, monoamino oxidase (MAO) inhibitors, non-selective beta-blocking agents, salicylates and sulphonamide antibiotics.
Sustanzi li jistgħu jżidu l- effett tat- tnaqqis tal- glukosju fid- demm u jżidu s- suxxettibilità għal ipogliċemija jinkludu mediċini orali ta ’ kontra d- dijabete, impedituri ta ’ l- enzima li tibdel l - anġjotensin (ACE), impedituri ta ’ monoamino oxidase (MAO), mediċini magħrufin bħala beta - blockers mhux selettivi, salicylates u antibijotiċi ta ’ sulphonamide.
Administration of salbutamol prior to EXUBERA may result in increased insulin absorption (see section 5.2).
L- għoti ta ’ salbutamol qabel EXUBERA jista ’ jirriżulta f’ assorbiment akbar ta ’ l- insulina (ara sezzjoni 5. 2).
6 Administration of fluticasone prior to EXUBERA does not appear to affect insulin absorption (see section 5.2).
t za L- għoti ta ’ fluticasone qabel EXUBERA ma jidhirx li jaffettwa l- assorbiment ta ’ l- insulina (ara sezzjoni 5. 2).
Active smoking greatly enhances whereas passive exposure to tobacco smoke in non-smokers decreases the rate and extent of absorption of EXUBERA (see sections 4.3 and 5.2).
to għad- duħħan tat- tabakk f’ dawk li ma jpejpux tnaqqas din ir- rata (ara sezzjonijiet 4. 3 u 5. 2).
Substances that may reduce the blood-glucose lowering effect include corticosteroids, danazol, oral contraceptives, thyroid hormones, growth hormone, sympathomimetic agents and thiazides.
aw Sustanzi li jistgħu jnaqqsu l- effett ta ’ tnaqqis ta ’ l- ammont ta ’ glukosju fid- demm jinkludu kortikosterojdi, danazol, kontraċettivi orali, ormoni tat- tirojde, l- ormon ta ’ l- iżvilupp, mediċini simpatomimetiċi u thiazides.
Octreotide/ lanreotide may both decrease or increase insulin requirements.
Octreotide/ lanreotide t- tnejn jistgħu jżidu jew inaqqsu l- ħtiġijiet għall -
ed Beta-blocking agents may mask the symptoms of hypoglycaemia.
du Mediċini beta- blockers jistgħu jgħattu s- sintomi ta ’ l- ipogliċemija.
ris Administration of EXUBERA 10 minutes prior to administration of salbutamol did not affect the bronchodilatory response to salbutamol in non-diabetic subjects with mild-moderate asthma.
L- alkoħol jista ’ jintensifika u jtawwal l- effett ipogliċemiku ta ’ l- insulina. ħa L- għoti ta ’ EXUBERA 10 minuti qabel l- għoti ta ’ salbutamol m’ affettwax ir- reazzjoni bronkodilatorja ’ g ta ’ salbutamol f’ suġġetti mhux dijabetiċi b’ ażżma ħafifa- moderata. im
ho Other drugs that may alter pulmonary absorption or lung permeability have not been studied.
Mediċini oħra li jistgħu jbiddlu l- assorbiment pulmonari jew il- permeabilità pulmonari ma ġewx studjati.
Close monitoring of blood glucose concentrations and dose titration as appropriate are recommended when
Għandha tintuża l- kawtela meta il
ut inhaled human insulin is used in these patients.
EXUBERA jingħata fl- istess ħin ma ’ mediċini bħal dawn. al
ra EXUBERA and such drugs.
4. 6 Tqala u Treddigħ in
4.6 Pregnancy and lactation
L- insulina inalata ta ’ spiss tinduċi iċ
There is no clinical experience with EXUBERA use in pregnancy.
antikorpi kontra l- insulina.
Inhaled insulin frequently induces insulin antibodies, the risk of which to the foetus is not known.
Għaldaqstant, EXUBERA ed
Therefore, EXUBERA should not be used during pregnancy.
m’ għandhiex tittieħed waqt it- tqala.
When an EXUBERA treated patient becomes pregnant appropriate lo subcutaneous insulin should be substituted for inhaled insulin. o
Meta pazjenta ttrattata b’ EXUBERA toħroġ tqila insulina li tingħata taħt il- ġilda adattata għandha tingħata minflok l- insulina inalata. m
Breast-feeding women may require adjustments in insulin dose and diet. tn
Nisa li jkun qed ireddgħu jistgħu jeħtieġu aġġustamenti fid- dożi ta ’ l- insulina u dieta. t
4.7 Effects on ability to drive and use machines uc
Effetti fuq il- ħila biex issuq u tħaddem magni 4. 7 ot od
As with other insulins, the patient 'ability to concentrate and react may be impaired as a result of s hypoglycaemia.
Bħal b’ insulini oħra, il- kapaċità tal- pazjent li jikkonċentra u li jirreaġġixxi tista ’ tixxekkel b’ konsegwenza ta ’ l- ipogliċemija.