qanastek/EMEA-V3 huggingface dataset:
ra If your blood sugar is too high (hyperglycaemia) Your blood sugar level may be too high, if for example: – you have not taken enough insulin, or if it has become less effective, e.g. through incorrect stora ge,
x Iz- zokkor f’ demmek jista ’ jkun għoli wisq, jekk per eżempju:
ge – you are doing less physical exercise, you are under stress (emotional distress, excitement), or if you have an injury, operation, feverish illness or certain other diseases, n – you are taking or have taken certain other medicines (see section 2, “Taking other medicines”). lo Symptoms that may tell you that your blood sugar levels are too high: thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low o
du – ma tkunx ħadt biżżejjed insulina, jew jekk din tkun saret inqas effettiva eż. minħabba ħażna inkorretta, ħa – tkun qed tagħmel anqas eżerċizzju fiżiku, tkun taħt stress (stress emozzjonali, eċitament), jew jekk ikollok xi korriment, operazzjoni, mard bid- deni jew ċertu mard ieħor. – tkun qed tieħu jew kont qed tieħu ċerti mediċina oħra (ara sezzjoni 2, “ Meta tieħu mediċini oħra ”) ’ g im
blood pressure, fast heartbeat, and glucose and ketone bodies in urine may be signs of too high blood tn
Sintomi li jistgħu jgħidulek li l- livelli taz- zokkor f’ demmek huma għoljin wisq: għatx, bżonn akbar li tagħmel l- awrina, għeja, ġilda xotta, ħmura fil- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa, taħbit tal- qalb mgħaġġel, u glukosju u korpi tal- ketones fl- awrina jistgħu jkunu sinjali ta ’ il
sugar.
zokkor għoli fid- demm.
Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin. uc
Uġigħ fl- istonku, teħid tan- nifs mgħaġġel u fil- fond, tħossok trid torqod jew anke tintilef minn sensik; dawn kollha jistgħu jkunu sinjali ta ’ kondizzjoni serja (ketoaċidożi) li al
Test your blood sugar level and your urine for ketones as soon as any such symptoms of hyperglycaemia occur as described above.
Ittestja l- livell taz- zokkor f’ demmek u l- awrina tiegħek għal ketones malli tħoss xi sintomi bħal iċ
treated by a doctor, normally in a hospital. pr
ta ’ ipergliċemija hekk kif deskritt hawn fuq.
Carry some information with you to show you are diabetic. al
Ġorr miegħek xi informazzjoni li turi li inti dijabetiku. m
HOW TO STORE EXUBERA in
KIF TAĦŻEN EXUBERA t ot
Keep out of the reach and sight of children. ic
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. od
Store below 30°C.
Aħżen f’ temperatura taħt 30oC.
Store in the original package in order to protect from moisture. ed
Aħżen fil- kontenitur oriġinali sabiex tilqa ’ mill- umdità.
Do not refrigerate or freeze the blisters.
Wara li tiftaħ il- qartas tal- bużżieqa: aħżen f’ temperatura taħt 25oC u uża fi żmien 3 xhur minn meta tiftħu.
Do not use EXUBERA if you notice that a blister is not properly sealed or damaged.
Tużax EXUBERA jekk tinnota li l- bużżieqa mhix issiġillata sew jew fiha l- ħsara.
Do not use EXUBERA after the expiry date (EXP) stated on the pack or unit dose blisters.
Tużax EXUBERA wara d- data ta ’ skadenza (JIS) li tidher fuq il- pakkett jew il- bżieżaq ta ’ doża waħda.
For instructions on how to look after your insulin inhaler see “Instructions for Use” at the end of the package leaflet.
62 Għal aktar tagħrif fuq kif tieħu ħsieb l- inalatur ta ’ l- insulina tiegħek ara “ Tagħrif fuq l- Użu ” fil- parti ta ’ wara tal- Fuljett ta ’ Tagħrif.
What EXUBERA contains
X’ fiha EXUBERA
- The active substance is insulin human.
- Is- sustanza attiva hija insulina umana.
Each unit dose blister contains 1 mg or 3 mg of the
Kull bużżieqa ta ’ doża waħda fiha 1 mg jew 3 mg tas -
active substance insulin human.
sustanza attiva insulina umana.
- The other ingredients are: mannitol, glycine, sodium citrate (as dihydrate) and sodium
- Is- sustanzi l- oħra huma: mannitol, glycine, sodium citrate (bħala dihydrate) u sodium
hydroxide.
hydroxide.
Taking three separate 1 mg blisters delivers more insulin to your lungs than a single 3 mg blister does.
Tliet bżieżaq ta ’ doża waħda ta ’ 1 mg m’ għandhomx jiġu sostitwiti
ed Three 1 mg blisters should not be substituted for one 3 mg blister (see section 2, “Take special care with EXUBERA” and section 3, “How to take EXUBERA”).
to b’ bużżieqa waħda ta ’ 3 mg (ara sezzjoni 2, “ Oqgħod attent ħafna b’ EXUBERA ”, sezzjoni 3, “ Kif tieħu EXUBERA ”).
ris What EXUBERA looks like and contents of the pack
aw Id- Dehra ta ’ EXUBERA u d- daqs tal- pakkett
For the 1 mg product, the spine of the blister card has one raised ridge with the individual blisters embossed
x EXUBERA hija trab għall- inalazzjoni, diġà lest, u tiġi f’ bżieżaq ta ’ doża waħda li jiċċartu immarkati
ut with one raised dot each.
du jew b ’ ‘ 1 mg EXUBERA ’ b’ linka ħadra jew ‘ 3 mg EXUBERA ’ b’ linka blu.
For the 3 mg product, the spine of the blister card has three raised ridges
Fil- bużżieqa ta ’ 1 mg, l - ispina tal- kartuna għandha xifer li tiela ’ ’ l fuq bil- folji individwali mmarkati b’ tikka mtella ’ l’ fuq.
ra with the individual blisters embossed with three raised dots each.
Fil - bużżieqa ta ’ 3 mg, l- ispina tal- kartuna għandha tlett ixfar tiegħlin ’ il fuq bil- folji individwali mmarkati ħa bi tlett tikki mtella ’ l’ fuq.
There are 6 blisters on each card and 5 cards per tray.
Hemm 6 bżieżaq f’ kull kartuna u 5 kartuniet f’ kull trej.
The tray is sealed in a plastic foil pouch with a desiccant, which keeps the medicine dry and should not be eaten.
It- trej huwa ssiġġilat f’ pawċ laminat tal- fojl flimkien ma ’ dessikant, li jżomm il- mediċina niexfa u dan m’ għandux jittiekel. ’ g
EXUBERA is available i n the following pack sizes:
EXUBERA tiġi f’ pakketti tad- daqsijiet li ġejjin: im
n
• Pakkett fih 30, 60, 90, 180 u 270 x 1 ta ’ 1 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda il al
• A pack containing 30, 60, 90, 180 and 270 x 1 of 1 mg PVC/Aluminium perforated unit dose lo blisters o
• Pakkett fih 30, 60, 90, 180 u 270 x 1 ta ’ 3 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda in
• A pack containing 30, 60, 90, 180 and 270 x 1 of 3 mg PVC/Aluminium perforated unit dose tn
• Pakkett fih 60 x 1 ta ’ 1 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (2 pawċijiet) u iċ
blisters uc
2 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ ed
• A pack containing 60 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU) od
• Pakkett fih 270 x 1 ta ’ 1 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (9 pawċijiet) u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ m
• A pack containing 270 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU) pr
• Pakkett fih 60 x 1 ta ’ 3 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (2 pawċijiet) u t
• A pack containing 60 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU) al in
2 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ ot
• A pack containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches) and 2 spare Insulin Release Units (IRU) ic
• Pakkett fih 90 x 1 ta ’ 3 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (3 pawċijiet) u od
• A pack containing 180 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (6 pouches) ed
2 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ Pr
and 2 spare Insulin Release Units (IRU) M
• Pakkett fih 180 x 1 ta ’ 3 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (6 pawċijiet) u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ
• A pack containing 270 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)
• Pakkett fih 270 x 1 ta ’ 3 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (9 pawċijiet) u 6 Units tar- Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ
• A kit containing 90 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
• Kitt fih 90 x 1 of 1 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (3 pawċijiet), inalatur ta ’ l- insulina, ċejmber fuq ir- riħ u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ
• A kit containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
63 • Kitt fih 90 x 1 of 3 mg bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (3 pawċijiet), inalatur ta ’ l- insulina, ċejmber fuq ir- riħ u 6 Units għar- Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ
62 Additional insulin inhaler, insulin release units and chamber packages are available.
Hemm ukoll inalatur ta ’ l- insulina, units ta ’ rilaxx ta ’ l- insulina u kaxex b’ komportamenti addizzjonali.
Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
The marketing authorisation holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom.
t za Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, Ir- Renju Unit.
The manufacturer is Heinrich Mack Nachf.
riz Il- manifattur huwa Heinrich Mack Nachf.
KG, Heinrich Mack Strasse 35, 89257,
KG, Heinrich Mack Strasse 35, 89257, Illertissen, Il- Ġermanja.
ed Illertissen, Germany.
to Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja liċ- Ċentru lokali tal- Kura tal- Klijent
For any information about this medicine, please contact the local EXUBERA Customer Care Centre.
aw ta ’ EXUBERA.
ho Klanteninformatiedienst voor EXUBERA/ EXUBERA- Service-Center/Service Client local EXUBERA
x Klanteninformatiedienst voor EXUBERA /
8002 5350
Service Client local EXUBERA/ EXUBERA -
ut Tél/Tel:
du EXUBERA- Service- Center/ Service Client local EXUBERA Tél/ Tel:
Tél/Tel: + 32 (0)2 554 62 11
8002 5350 Tél/ Tel: + 32 (0) 2 554 62 11 ħa
o
al
Tel:
800 62451 Tel:
800106108
800106108 in
Tel: + 420 283 004 111
Tel: + 356 21 220717 Tel: + 420 283 004 111 iċ
uc
ed
Klanteninformatiedienst voor EXUBERA Tel:
Klanteninformatiedienst voor EXUBERA EXUBERA kundecenter Tel:
Tlf: + 45 44 20 11 00 pr
80 60 10 40 Tel: + 31 (0) 10 406 43 01 Tlf: + 45 44 20 11 00 m
Tel: + 31 (0)10 406 43 01
Deutschland t
Deutschland EXUBERA-Service-Center Tel:
EXUBERA- Service- Center ot
0800 3982372 al
0800 3982372 od
Norge EXUBERA kundetelefon Tlf:
Tlf:
Tel: + 49 (0)721 6101 9000 in
Tel: + 49 (0) 721 6101 9000
800 206746 Tel: + 351 21 423 5500
za Tel: + 351 21 423 5500
France Service Client local EXUBERA Tél:
riz France Service Client local EXUBERA Tél:
ed Ireland EXUBERA Customer Care Centre
aw Ireland EXUBERA Customer Care Centre Tel:
080 2682 Tel: + 386 1 52 11 400
x Tel: + 386 1 52 11 400 Tel: + 44 (0) 1737 331111
ho Ísland EXUBERA neytendaþjónusta
du Ísland
Slovenská republika EXUBERA Centrum starostlivosti o pacientov
Slovenská republika ħa
Italia Customer Care locale di EXUBERA Tel:
EXUBERA- asiakaspalvelunumero Customer Care locale di EXUBERA Puh/ Tel:
0800 021354 Tel: + 39 06 33 18 21
0800 021354 il
0800 915 133 n Puh/Tel: + 358 (0)9 43 00 40
Puh/ Tel: + 358 (0) 9 43 00 40 Tel: + 39 06 33 18 21 al
lo Sverige
Κύπρος Κέντρο Εξυπηρέτησης και Ενημέρωσης in
tn
iċ
(& 800 92656:
800 92656 Τηλ: +30 210 6785 798 ed
Tel: + 371 670 35 775 pr
EXUBERA pacientu atbalsta centrs Tel: + 371 670 35 775 t ot
Lietuva EXUBERA pacient* prieži+ros centras Tel:
Lietuva EXUBERA pacientų priežiūros centras od
Tel. + 3705 2514000 in
8 800 22000 Tel. + 3705 2514000 Pr
This leaflet was last approved in ic ed M
Dan il- fuljett ġie approvat l- aħħar fi
64 Insulin Inhaler Instructions for Use
65 Struzzjonijiet għall- Użu ta ’ Inalatur ta ’ l- Insulina
Read all of this leaflet carefully before starting to use your insulin inhaler
Aqra dan il- fuljett kollu qabel tibda tuża l- inalatur ta ’ l- insulina tiegħek.
Always make sure you have the correct blisters available before using your insulin inhaler.
Dejjem kun żgur li għandek il- bżieżaq it- tajbin disponibbli qabel tuża l- inalatur ta ’ l- insulina tiegħek.
Also, read the Patient Information Leaflet for, EXUBERA 1 mg and 3 mg powder for inhalation pre- dispens ed.
Barra minn hekk, aqra l- Fuljett ta ’ Tagħrif għall- Pazjent għal, EXUBERA 1 mg u 3 mg trab għal inalazzjoni magħmul għal- lest.
ed REPLACING YOUR INHALER AND THE INSULIN RELEASE (IRU)
t za TIBDIL TA ’ L- INALATUR U TAR- RILAXX TA ’ L- INSULINA (IRU) TIEGĦEK
You should change your insulin inhaler once a year from the date you first use the inhaler.
Għandek tibdel l- inalatur ta ’ l- insulina tiegħek darba fis- sena mid- data li fiha tuża għall- ewwel darba
ris You should change the IRU in your insulin inhaler every 2 weeks.
Għandek tibdel l- IRU fl- inalatur ta ’ l- insulina tiegħek kull ġimagħtejn.
The IRU must be changed after accidental exposure to extremely moist conditions, e.g. steamy bathroom.
L- IRU irid jinbidel wara
ho HOW TO STORE YOUR INSULIN INHALER
aw KIF TAĦŻEN L- INALATUR TA ’ L- INSULINA TIEGĦEK
ut Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
ra Store the insulin inhaler in a dry place at room temperature.
x Aħżen l- inalatur ta ’ l- insulina f’ post xott f’ temperatura tal- kamra.
Do not store the insulin inhaler in the refrigerator or freezer.
du Taħżinx l- inalatur ta ’ l- insulina fil- friġġ jew friża. ’ g im il al in iċ ed m t ot od Pr
uc od pr al in ic ed M
66 Biċċa tal- ħalq
65 Mouthpiece
Tikketta ta ’ Exubera
Exubera Label
t za Ċejmber
Chamber
riz to KUN AF X’ INHUMA L -
ed ris ho KNOW THE PARTS OF YOUR INSULIN INHALER
aw PARTIJIET TA ’ L- INALATUR TA ’ L- INSULINA TIEGĦEK
ut Insulin Release Unit
Unit ta ’ Rilaxx ta ’ l- Insulina
Chamber Release Button
Buttuna ta ’ Rilaxx ta ’ l- Insulina Buttuna blu
(not visible)
x (ma tidhirx) (ma tidhirx)
ge Grey Button Chamber Release
du Buttuna Griża Ċejmber ta ’ Rilaxx Bużżieqa ta ’ l- Insulina ħa ta ’ l- Insulina Button ’ g Qiegħ Pum Blu im il
Black Ring od
Ħolqa Sewda al in iċ
1.
KIF GĦANDEK TIEĦU D- DOŻA TIEGĦEK 1.
Set up your insulin inhaler Hold your insulin inhaler in your hand.
Żomm l- inalatur ta ’ l- insulina f’ idek.
Be sure that the word “EXUBERA” at the top faces you. al in ic ed M
Kun żgur li l- kelma “ EXUBERA ” fil- parti ta ’ fuq ta ’ l - m
66 Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.
67 Żomm il- ħolqa sewda li tinsab fil- qiegħ tal- bażi u użaha biex tiġbed il- bażi ‘ l barra miċ- ċejmber.
ed You will hear a click when the inhaler is fully
t za Meta l- inalatur jinfetaħ kollu u jingħalaq f’ postu
ris extended and locked into place.
riz għandek tisma ’ ħoss ta ’ klikk.
The bottom of the chamber MUST be above the grey button.
Il- qiegħ taċ - ċejmber GĦANDU jkun ’ il fuq mill- buttuna
ho ut ra n ge lo
aw x du ħa ’ g im
Load your insulin blister o
Il- bużżieqa ta ’ 1mg doża li jiċċartu immarkati al
Hold the insulin blister by the tab with printed tn
jew b ’ ‘ 1 mg EXUBERA ’ b’ linka ħadra jew ‘ 3 mg EXUBERA ’ b’ linka blu. in
side up with the notch pointed towards the insulin inhaler, insert the blister. uc
Il- bużżieqa li tiċċarrat ta’ 1 mg, hija mmarkata iċ
The 1 mg blister is printed with green ink and has one raised dot on the protruding end of each od
b’ linka ħadra u kull folja mmarkata b’ tikka mtella ’ l’ fuq. ed
The 3 mg blister is printed with blue ink and has pr
Il- bużżieqa li tiċċarrat ta’ 3 mg, hija mmarkata b’ linka blu u kull folja mmarkata bi tlett tikek m
three raised dots on the protruding end of each blister. al
mtella ’ l’ fuq.
The ra ised dots can be felt even when the blister in
Dawn it- tikek mtella ’ l’ fuq jistgħu jinħassu ukoll t ot
is already inserted for reassurance that the correct dose is used. ic ed
meta l- bużżieqa tkun iddaħħlet, sabiex tkun ċert li id- doża tajba qed tintuża. od
Slide the insulin blister straight into the blister slot as far as it will go.
Daħħal il- bużżieqa ta ’ l- insulina dritt fl- islott tal - bużżieqa ’ l ġewwa kemm jista ’ jkun.
Getting ready to take your dose Make sure that the mouthpiece is clos ed.
Ipprepara biex tieħu d- doża tiegħek Kun żgur li l- biċċa tal- ħalq hija magħluqa.
ed ris ho ut ra Pull out the blue ha ndle as far as it will go.
t za riz to aw Iġbed il- pum blu ’ l barra kemm jista ’ jkun.
n ge lo Squeeze the handle until it snaps shut. o tn uc od
x du ħa Agħfas il- pum sakemm jingħalaq b’ tifqigħa. ’ g im il al in
Stand or sit up straight. pr
Oqgħod bilwieqfa jew bilqiegħda dritt. iċ
Breathe out normally. al in ic ed M
Ħu n- nifs ’ il barra b’ mod normali. ed m t ot od Pr
Inhale your insulin dose Perform the following steps in immediate sequence.
Iġbed id- doża ta ’ l- insulina man- nifs
Hold the insulin inhaler upright with the blue button facing towards you.
Żomm l- inalatur ta ’ l- insulina f’ pożizzjoni vertikali bil- buttuna blu tħares lejk.
Push the blue button until it clicks and watch for the insulin cloud to appear in the chamber.
Agħfas il - buttuna blu sakemm tfaqqa ’ u stenna sakemm tara l- għabra ta ’ l- insulina fiċ- ċejmber.
ed ris ho ut After the cloud appears, immediately turn the
t za riz to aw Wara li tidher l- għabra, dawwar il- biċċa tal- ħalq fil- pront.
The mouthpiece should now be facing towards you.
Il- biċċa tal- ħalq għandha tkun wiċċha lejk.
n ge lo o tn
x du ħa ’ g im
Quickly form a seal with your lips around the uc
Agħlaq l- arja malajr b’ xufftejk madwar il- biċċa tal- ħalq biex b’ hekk l- insulina ma toħroġx. il
mouthpiece so the insulin will not leak out. od
Timblukkax il- fetħa tal- biċċa tal- ħalq b’ ilsienek al
Do not block the opening of the mouthpiece with your tongue or teeth.
Tonfoħx fil- biċċa tal- ħalq. in
Slowly and deeply breathe in the insulin cloud al
Iġbed ’ il ġewwa bil- mod u fil- fond l- għabra ta ’ l - iċ
through your mouth in one breath. in
insulina minn ħalqek f’ nifs wieħed. ed m
Do not blow into the mouthpiece. ic
Tonfoħx fil- biċċa tal- ħalq.
Take the mouthpiece out of your mouth. ed
Neħħi l- biċċa tal- ħalq minn ħalqek. t ot
Close your mouth and hold your breath for 5 M
Agħlaq ħalqek u żomm in- nifs għal 5 sekondi. od
After your dose Turn the mouthpiece back to its clos ed position.
70 Dawwar il- biċċa tal- ħalq lura fil- pożizzjoni magħluqa tagħha.
ed ris Press the grey button and pull out the insulin blister.
t za Agħfas il- buttuna l- griża u iġbed ’ il barra l -
ho If you need another blister(s) as part of your
riz bużżieqa ta ’ l- insulina.
ut dose, repeat steps 2, 3 and 4.
to Jekk ikollok bżonn aktar bżieżaq bħala parti mid - doża tiegħek, irrepeti l- passi 2, 3 u 4.
ra 6.
aw x du 6.
After your dosing is completed Squeeze the two chamber release buttons at the same time on the side of the base.
Wara t- teħid tad- doża Agħfas iż- żewġ buttuni ta ’ rilaxx taċ- ċejmber f’ daqqa fuq il- ġenb tal- bażi.
Push the base n ge lo back into the chamber to store. o tn uc
Qabel ma terfa ’ l - ħa inalatur f’ postu, imbotta l- qiegħ lura fiċ- ċejmber. ’ g im il
HOW TO TAKE CARE OF YOUR INSULIN od
KIF GĦANDEK TIEĦU ĦSIEB L - al
INHALER It is important to follow these steps so that your pr
INALATUR TA ’ L- INSULINA TIEGĦEK Huwa importanti li ssegwi dawn il- passi sabiex l - in
insulin inhaler stays clean and works properly.
inalatur ta ’ l- insulina jibqa ’ nadif u jaħdem iċ
Take your insulin inhaler apart Hold the insulin inhaler in your hand.
Żomm l- inalatur ta ’ l- insulina f’ idek.
Be sure al
Kun żgur li l- kelma “ EXUBERA ” fil- parti ta ’ fuq ta ’ l - m
that the word “EXUBERA” at the top faces you. in ic ed M
istrument tkun qegħda tħares lejk. t ot od Pr
70 Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.
71 Żomm il- ħolqa sewda li tinsab fil- qiegħ u użaha biex tiġbed il- qiegħ ’ l barra miċ- ċejmber.
ed With one hand, squeeze the two chamber release
t za B’ id waħda, agħfas f’ daqqa ż- żewġ buttuni ta ’
ris Buttons at the same time on the side of the base while pulling the base all the way out of the chamber with the other hand.
riz rilaxx taċ- ċejmber li jinsabu fuq il- ġenb tal - qiegħ, waqt li bl- id l- oħra tiġbed il- qiegħ
ho ut ra n ge lo
to sakemm taqalgħu ’ l barra miċ- ċejmber.
Cleaning o
aw x du ħa ’ g im
Chamber and mouthpiece – once a week tn uc od pr al in
It- tindif Iċ- ċejmber u l- biċċa tal- ħalq – darba fil - ġimgħa il al in iċ ed m t
How ic
Kif ot
Take your insulin inhaler apart. ed
Iżżarma l- inalatur ta ’ l- insulina.
Turn the mouthpiece to the open position.
miftuħa.
See above.
Ara fuq.
71 Dampen a clean soft cloth and use mild liquid soap to wipe the outside and inside of the chamber and mouthpiece.
Uża ċarruta nadifa u ratba niedja u sapun likwidu ħafif biex timsaħ barra u ġewwa taċ- ċejmber u tal- biċċa tal- ħalq.
Do NOT put the chamber in the dishwasher.
TPOĠĠIX iċ- ċejmber f’ magna għall- ħasil tal- platti (dishwasher).
Thoroughly rinse the soap out of the chamber and mouthpiece with warm water.
72 Bl- akbar reqqa laħlaħ is- sapun miċ- ċejmber u l - biċċa tal- ħalq bl- ilma sħun.
Allow to air dry.
Ħallih jinxef bl- arja.
Ensure that no water droplets remain, and then close the mouthpiece.
Kun żgur li ma jibqa ’ l- ebda qtar ta ’ l- ilma, u mbagħad agħlaq il- biċċa tal - ħalq.
Reattach the chamber to the base.
Erġa ’ waħħal iċ- ċejmber mal- qiegħ.
ed For instructions on how to attach the chamber to the base refer to the section “Put your insulin inhaler together”.
Għal struzzjonijiet dwar kif għandek twaħħal iċ - ċejmber mal- qiegħ irreferi għas- sezzjoni “ Kif tarma l- inalatur ta ’ l- insulina ”.
ris If the washed chamber is not dry prior to taking your next dose, use your spare chamber.
t ma tieħu d- doża li jmiss, uża ċ- ċejmber sostitut.
ho Base - once a week
za Il- qiegħ - darba f’ ġimgħa
Do not put the base in water. tn
riz to aw x du Kif Tpoġġix il- qiegħ fl- ilma. ħa Ixxarrabx l- IRU minn ġewwa. ’ g
Do not get the inside of the IRU wet. uc
Tużax sapun jew sustanza oħra li tnaddaf. im
Do not use soap or any other cleanser. od
Uża ċarruta ratba u nadifa niedja bl- ilma. il
Dampen a clean soft cloth with water. pr
Toħroġx l - al
Do not take the IRU out at this time.
IRU ‘ il barra f’ dan il- ħin.
Keep the blue handle al
Żomm il- manku blu in
closed in
magħluq iċ
Wipe only the TOP and OUTSIDE surfaces of ic
Imsaħ biss l- uċuh tal- PARTI TA ’ FUQ u N - NAĦA TA ’ BARRA tal- Bażi.
Do not wipe the blister slot ed M
tal- bużżieqa Kif tarma l- inalatur ta ’ l- insulina m
72 Put your insulin inhaler together Line the top of the base with the open end of the chamber.
Ġib il- parti ta ’ fuq tal- bażi bi dritt mat- tarf miftuħ taċ- ċejmber.
The blue dot on the bottom of the chamber must be on the same side as the blue button.
It- tikka blu fil- qiegħ taċ - t
Squeeze the two chamber release buttons at the same time on the side of the base.
ċejmber għandha tkun fuq l- istess naħa bħall - ot
Push the base back into the chamber to store.
Qabel ma Pr
ed ris ho Store your insulin inhaler in a dry place at room
terfa ’ l- inalatur, Imbotta l- bażi lura fiċ- ċejmber.
REPLACING YOUR INSULIN RELEASE
Erfa ’ l- inalatur ta ’ l- insulina f’ post mhux umdu f’ temperatura normali ta ’ kamra.
ra UNIT (IRU) Change the IRU
73 KIF TIBDEL IL- UNIT TA ’ RILAXX TA ’ L - INSULINA (Insulin Release Unit) (IRU) Ibdel il- Unit ta ’ Rilaxx ta ’ l- Insulina
Every 2 weeks You should avoid taking EXUBERA in moist c onditions e.g. a bathroom following a steamy n ge lo shower as this will usually give you a lower insulin dose than you need (see package leaflet o
Kull ġimagħtejn Għandek tevita li tieħu EXUBERA f’ kondizzjonijiet umdi, eż. f’ kamra tal- banju wara doċċa bil- fwar minħabba li din ġeneralment ttik doża ta ’ insulina inqas milli jkollok bżonn (ara l- fuljett ta ’ tagħrif dwar il- bżieżaq għal
on the blisters for advice). tn
t za struzzjonijiet).
If you accidentally expose your inhaler to moist conditions during use, this will usually decrease the dose of insulin you take.
F’ dan il- każ trid tibdel l- IRU qabel ma terġa ’
In this case you uc
Kif
must change the IRU prior to you next inhalation. od
aw Oħroġ l- IRU użata Waqt li ċ- ċejmber jitneħħa mill- qiegħ (ara “ Żarma l- inalatur ta ’ l- insulina ”), żomm il- bażi
How Take out the used IRU While the chamber is removed from the base pr
Dawwar l -
(see “Take your insulin inhaler apart”), hold the base in your hand with the grey button facing al
du IRU użata madwar kwart lejn ix- xellug lejn is - simbolu tal- ftuħ.
you.
’ g
Turn the used IRU about a one-quarter turn counter clockwise towards the unlock symbol. in ic ed M
Iġbed l- IRU użata ‘ il fuq u ‘ l barra mill- bażi u warrabha fil- ġenb. al
73 Pull the used IRU up and out of the base and discard.
Armi l- IRU użata b’ mod sigur skond ir- rekwiżiti in
Dispose of the us ed IRU safely according to local requirements or check with your healthcare professional.
lokali jew inkella iċċekkja mal- professjonist tal - kura tas- saħħa tiegħek. iċ ed m t
ed Put in a new IRU
Poġġi IRU ġdid ot
ris Remove the IRU from its packaging.
Neħħi l- IRU mill- imballaġġ tagħha. od
ho Hold the new IRU so the top is facing you.
Żomm l- IRU ġdida b’ mod li l- parti ta ’ fuq tkun Pr
You will see a blue line on it.
Fuqha għandek tara linja blu.
While holding the IRU
Waqt li żżomm l- IRU f’ id waħda, dawwar il- parti ta ’ fuq lejn ix- xellug safejn tippermettilek.
ut with one hand, turn the top counter-clockwise as far as it will go.
74 Ġib il- linja blu fil- parti ta ’ fuq ta ’ l- IRU f’ linja mas- simbolu tal- ftuħ fuq il- parti ta ’ fuq tal- bażi.
ra Line up the blue line on the top of the IRU with the unlock symbol on the top of the base. n ge lo Push the IRU gently into the base.
Tużax forza, din għandha taqa ’ f’ postha mingħajr tbatija.
(If the new IRU o
(Jekk l- IRU l- ġdida ma tinżilx f’ postha jew togħod issikkata, għandek tneħħiha u terġa ’ tipprova).
does not drop into place or fits tightly, remove tn
t za Dawwar il- parti ta ’ fuq ta ’ l- IRU lejn il- lemin sakemm il- linja blu tiġi tipponta lejn is- simbolu
and try again). uc
riz tal- ftuħ fuq il- parti ta ’ fuq tal- bażi.
Turn the top of the IRU clockwise until the blue od
L- IRU l - ġdida issa hija magħluqa fuq il- parti ta ’ fuq tal - bażi.
The new IRU is now locked in place. pr al in ic ed M
to aw x du ħa ’ g im il al in iċ ed m t ot od Pr
London, 25 September 2008 Doc.
Londra, 25 ta ’ Settembru 2008 Dok.
EMEA/ 477488/ 2008
EMEA/ 548383/ 2008
Questions and answers on the withdrawal of the marketing application for EXULETT
Mistoqsija u Tweġiba dwar l- irtirar ta 'l- applikazzjoni għat- tqegħid fis- suq għal EXULETT
International non-proprietary name (INN): dalbavacin
Denominazzjoni Komuni Internazzjonali (DKI): dalbavacin
On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Fid- 9 ta ’ Settembru 2008, Pfizer Limited innotifikat uffiċjalment lil Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li tixtieq tirita l- applikazzjoni tagħha għal awtorizzazzjoni ta ’ tqegħid fis- suq ta ’ EXULETT, għat- trattament ta ’ infezzjonijiet kkumplikati tal- ġilda u tat- tessuti rotob f’ adulti meta jkun magħruf jew suspettat li ġew ikkawżati mill- batterji suxxettibbli Gram - pożittivi.
What is EXULETT?
X' inhu EXULETT?
EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
EXULETT huwa trab li jsir soluzzjoni għall- infużjoni (dripp fil- vina).
It contains the active substance dalbavancin.
Is- sustanza attiva fih hija dalbavancin.
What was EXULETT expected to be used for?
Għal xiex kien mistenni li jintuża EXULETT?
EXULETT was to be used to treat adults with complicated infections of the skin and the ‘ soft tissues’ below the skin. ‘ Complicated’ means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
EXULETT kellu jintuża fit- trattament ta ’ adulti b’ infezzjonijiet ikkumplikati tal- ġilda u tat - ‘ tessuti rotob ’ taħt il- ġilda. ‘ Ikkumplikati ’ tfisser li l- infezzjoni hija diffiċli li tiġi ttrattata minħabba li nfirxet fit- tessut fond taħt il- ġilda, trattament b’ intervent kirurġiku jista ’ jkun meħtieġ, jew il- pazjent jkollu kundizzjonijiet oħrajn li jistgħu jaffettwaw ir- rispons għat- trattament.
EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘ Gram-positive’ and that would be killed by the medicine.
EXULETT kellu jintuża biss meta l- infezzjoni kienet magħrufa jew maħsuba li ġiet ikkawżata minn tipi ta ’ batterji li huma kklassifikati bħala ‘ Gram- pożittivi ’ u li jistgħu jinqatlu mill- mediċina.
These bacteria include Staphylococcus aureus (including ‘ methicillin-resistant’ forms known as ‘ MRSA’) and Streptococcus pyogenes.
Dawn il - batterji jinkludu Staphylococcus aureus (inklużi forom ‘ methicillin- reżistenti ’ magħrufa bħala ‘ MRSA ’) u Streptococcus pyogenes.
How is EXULETT expected to work?
Kif kien mistenni li jaħdem EXULETT?
The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘ glycopeptides’.
Is- sustanza attiva f’ EXULET, dalbavancin, huwa antibijotiku li jappartjeni għall- grupp tal - ‘ glikopeptidi ’.
It is expected to work by stopping the bacteria making their cell walls.
Huwa mistenni li jaħdem billi jwaqqaf il- batterji milli jibnu l- ħitan taċ- ċelloli.
This kills the bacteria causing the infection.
Dan joqtol il- batterji li jikkawżaw l- infezzjoni.
The effects of EXULETT were first tested in experimental models before being studied in humans.
L- effetti ta ’ EXULETT ġew l- ewwel ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bnedmin.
The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Il- kumpanija ppreżentat ir- riżultati ta ’ l- istudju prinċipali li qabbel l- effetti ta ’ EXULETT ma ’ dawk ta ’ linezolid (antibijotiku ieħor) f’ 873 adult.
The patients included in this study were required to have complicated skin and soft tissue infections (such as abscesses or wound infections) that were due to Gram-positive bacteria.
Il- pazjenti inklużi f’ dan l- istudju kellhom infezzjonijiet ikkumplikati tal- ġilda u tat- tessuti rotob (bħal axxessi jew infezzjonijiet ta ’ ġrieħi) li kienu kkawżati mill- batterji Gram- pożittivi.
The main measure of effectiveness was the number of patients whose infection was treated successfully and who did not need further treatment with any other antibiotics.
Il- kejl prinċipali ta ’ l- effikaċja kien in- numru ta ’ pazjenti li l- infezzjoni tagħhom kienet ittrattata b’ suċċess u li ma kellhomx bżonn trattament ulterjuri b’ antibijotiċi oħrajn.
How far into the evaluation was the application when it was withdrawn?
Sa fejn kienet waslet l- evalwazzjoni ta 'l- applikazzjoni qabel ma din ġiet irtirata?
The application was at day 180 when the company withdrew.
L- applikazzjoni kienet waslet f' jum 180 meta l- kumpanija rtiratha.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Wara li s- CHMP kien ivvaluta t - tweġibiet mill- kumpanija għal lista ta 'mistoqsijiet, kien għad fadal xi kwistjonijiet pendenti li baqgħu ma ġewx solvuti.
The CHMP normally takes up to 210 days to evaluate a new application.
Is- CHMP normalment jieħu sa 210 ijiem biex jevalwa applikazzjoni ġdida.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Fuq il- bażi tar- reviżjoni tad- dokumentazzjoni inizjali, is- CHMP iħejji lista ta 'mistoqsijiet fil- 120 jum, li mbagħad tintbagħat lill- kumpanija.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a licence.
Ladarba l- kumpanija tkun ippreżentat it- tweġibiet tagħha għall- mistoqsijiet imressqa, is- CHMP jirrevedihom u jista ’, qabel ma jagħti opinjoni, jressaq xi mistoqsijiet oħra fil- 180 jum.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Wara 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. l- opinjoni tas- CHMP, il- Kummissjoni Ewropea normalment iddum madwar xahrejn sakemm toħroġ l - awtorizzazzjoni.
Based on the review of the data and the company’ s response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Skond l- analiżi tad- dejta u t- tweġiba tal- kumpanija għal- lista ta ’ mistoqsijiet tas- CHMP, fi żmien l - irtirar, is- CHMP kellu xi tħassib u kellu opinjoni proviżorja li EXULETT ma setax jiġi appruvat għat - trattament ta ’ infezzjonijiet ikkumplikati tal- ġilda u tessut artab f’ adulti meta jkun magħruf jew suspettat li ġew ikkawwżati mill- batterja suxxettibbli Gram- positive.
The CHMP was concerned that the results of the single main study were too limited to support the approval of the medicine because of the way the study had been carried out, and was of the opinion that another study would be needed to confirm the results.
Is- CHMP kien imħasseb li r- riżultati ta ’ l- istudju prinċipali kienu limitati wisq biex jagħti l- appoġġ tiegħu għall- approvazzjoni tal- mediċina minħabba l- mod ta ’ kif twettaq l- istudju u kien ta ’ l- opinjoni li jinħtieġ studju ieħor sabiex jikkonferma r- riżultati.
In addition, the CHMP was concerned over the relevance of the results of the main study, since not all of the patients included in the study seemed to have an infection that was severe enough to need antibiotic treatment given by infusion into a vein.
Barra minn dan, is- CHMP kien imħasseb dwar ir- rilevanza tar- riżultati ta ’ l- istudju prinċipali minħabba li mhux il- pazjenti kollha inklużi fl- istudju jidher li kellhom infezzjoni li kienet gravi biżżejjed li teħtieġ trattament antibijotiku mogħti b’ infużjoni fil- vina.
There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Kien hemm tħassib ukoll dwar jekk EXULETT jistax jiġi manifatturat bi kwalità konsistenti u tajba.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of EXULETT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċju ta 'EXULETT ma kienx intwera biżżejjed u li kwalunkwe benefiċċju li seta' kellu ma kienx ogħla mir- riskji identifikati.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra mill- kumpanija li tgħarraf lill- EMEA dwar l- irtirar ta 'l- applikazzjoni hija disponibbli hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
X' inhuma l- konsegwenzi ta 'l- irtirar għall- pazjenti li kienu qed jieħdu sehem fi provi kliniċi b’ EXULETT?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Il- kumpanija għarrfet lis- CHMP li ma kienx hemm konsegwenzi għall- pazjenti li kienu qed jieħdu sehem fi provi kliniċi b' EXULETT.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qed tieħu sehem fi prova klinika u teħtieġ iżjed tagħrif dwar it- trattament tiegħek, ikkuntattja lit- tabib li jkun qed jagħtik dan it- trattament.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM IKUNU IMPLEMENTATI FL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM IKUNU IMPLEMENTATI FL- ISTATI MEMBRI
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- iStat Membru għandu jassigura The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all healthcare professionals who are expected to prescribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with access to risk minimisation educational programme.
Id- Detentur ta ’ L- Awtorizazzjoni għat- tqegħid fis- suq għandu jassigura li qabel ma l- prodott jitqiegħed fuq is- suq, kull professjonist tas- saħħa li mistenni jippreskrivi Fablyn jew li jistaqsi għal - ultrasound ġinekoloġiku f’ pazjenti kkurati bil- Fablyn, ikollu aċċess għal programm edukattiv fuq it - tnaqqis tar- riskju.
The programme shall have both electronic and printed form, which are identical in terms of content.
Il- kontenut ta dan il- programm għandu jkun l- istess kemm f’ forma elettronika kif ukoll fuq karta pprintjata.
The programme materials shall be provided via the following means: • Web-based • On CD • Printed on paper
Il- materjal ta ’ dan il- programm għandu jiġi pprovdut f’ dawn il- forom: • Fuq sit elettroniku • Fuq CD • Pprintjat fuq karta
The programme shall convey the following key messages: • FABLYN increases risk of venous thromboembolism (VTE). • The approaches recommended for mitigation of risk of venous thromboembolism based on the SmPC, including contraindication of FABLYN in patients with active or past history of VTE. • FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Il- programm għandu jwassal dawn il- messaġġi primarji: • Fablyn iżid ir- riskju ta ’ trombo- emboliżmu fil- vini (VTE) • Il proċess irrakomandat sabiex jitnaqqas ir- riskju ta ’ trombo- emboliżmu fil- vini, bbażat fuq l - SmPC li jinkludi kontra- indikazzjoni ta ’ Fablyn f’ pazjenti li jbatu jew ġieli batew fil- passat b’ każijiet ta ’ VTE. • Fablyn jikkawża tibdil morfoloġiku, partikolarment atrofija taċ- ċesti tal- endometriju.
It results in increased mean endometrial thickness. • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs. • References to authoritative international guidelines relevant for uterine surveillance. • The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.
Dan jirriżulta żieda fil- ħxuna medja tal- endometriju. • Meta tqis studji klinici, dan it- tibdil morfoloġiku ikkaġunat b’ FABLYN huwa beninn u m’ għandux bżonn aktar investigazzjonijiet sakemm ma jkunx hemm ħruġ ta ’ demm mill - vaġina Għandu jkun hemm referenza għal- linji gwida ta ’ awtorita ’ internazzjonali ta ’ rilevanza għal- sorveljanza tal- utru. • Il- bżonn li titwaqqaf il- kura b’ Fablyn u jkun hemm investigazzjoni meta jkun hemm ħruġ ta ’ demm mill- vaġina li mhux normali.
The programme shall include the full text of the SmPC.
Il- programm għandu jinkludi l- kitba kollha tal- SmPC
The MAH shall also provide access to educational programme for pathologists.
L- MAH għandu wkoll jipprovdi aċċess għal programm edukattiv għal patoloġisti.
This programme should focus on interpretation of endometrial biopsy of women treated with FABLYN.
Dan il- programm għandu jiffoka fuq l- interpretazzjoni ta ’ bijopsija tal- endometriju ta ’ nisa kkurati b’ Fablyn.
It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals.
Għandu jkun ukoll aġġornat ma linji gwida ta ’ awtorita ’ internazzjonali u sostenut b’ evidenza ppublikata f’ ġurnali mediċi rivisti mill- pari.
What is Fablyn?
X’ inhu Fablyn?
Fablyn is a medicine that contains the active substance lasofoxifene.
Fablyn huwa mediċina li fih s- sustanza attiva lasofoxifene.
It is available as triangular, peach-coloured tablets (500 micrograms).
Huwa disponibbli f’ pilloli trijangulari ta ’ lewn il- ħawħ (500 mikrogramma).
What is Fablyn used for?
Għalxiex jintuża Fablyn?
Fablyn is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women (women who have been through the menopause).
Fablyn jintuża għat- trattament u l- prevenzjoni tal- osteoporożi (marda li tagħmel l- għadam fraġli) f' nisa li għaddew mill- menopawża (meta n- nisa kienu fil- menopawża).
It is used in women who are at risk of fracture (broken bones).
Kienet attiva f’ nisa li huma f’ riskju ta ’ ksur (għadam miksur).
Fablyn has been shown to reduce fractures in the spine and elsewhere in the body, but not in the hip.
Fablyn ġie muri li jnaqqas ksur fix- xewka tad- dahar u f’ partijiet oħra tal - ġisem, iżda mhux tal- ġenbejn.
When deciding whether to prescribe Fablyn or other treatments, doctors should consider whether the patient has any symptoms of the menopause, and the possible effects of treatment on the womb, the breast, and the heart and blood vessels.
Meta jiddeċiedu dwar jekk jippreskrivux Fablyn jew trattamenti oħrajn, it- tobba għandhom jikkunsidraw jekk il- pazjenta għandhiex sintomi tal- menopawża, u l- effetti possibbli tat- trattament fuq il- ġuf, is- sider u l- qalb u l- vini u l- arterji.
How is Fablyn used?
Kif jintuża Fablyn?
The recommended dose of Fablyn is one tablet once a day.
Id- doża rakkomandata ta ’ Fablyn hija ta ’ pillola darba kuljum.
It can be taken at any time of day, with or without food or drink.
Tista ’ tiġi meħuda f’ kull ħin tal- ġurnata, kemm mal- ikel jew max- xorb kif ukoll mingħajrhom.
Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet.
Il- pazjenti jistgħu jirċievu wkoll supplimenti ta 'kalċju u ta' vitamina D jekk ma jkunux qegħdin jieħdu biżżejjed mid- dieta tagħhom.
Fablyn is intended for long-term use.
Fablybn hu maħsub għal użu fit- tul.
Fablyn should be used with caution in women with severe liver or kidney problems.
Fablyn għandu jintuża b’ attenzjoni speċjali fin- nisa bi problemi severi tal- fwied jew tal- kliewi.
How does Fablyn work?
Kif jaħdem Fablyn?
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Gradwalment l- għadam jinsilet u jsir aktar fraġli, u għalhekk ikun aktar faċli li jinkiser.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
L- osteoporożi hija aktar komuni fin- nisa li għaddew mill- menopawża minħabba t- tnaqqis tal- livelli tal- estroġeni: l- estroġenu jnaqqas it- tkissir tal- għadam u jagħmel l- għadam inqas suxxettibbli għall- ksur.
The active substance in Fablyn, lasofoxifene, is a selective oestrogen receptor modulator (SERM).
Is- sustanza attiva f' Fablyn, lasofoxifene, hija modulatur selettiv tar- riċettur tal- estroġenu (SERM).
Lasofoxifene acts as an ‘ agonist ’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Lasofoxifene jaġixxi bħala 'agonista' tar- riċettur tal- estroġenu (sustanza li tistimula r- riċettur għal estroġenu) f' xi tessuti fil- ġisem.
Lasofoxifene has the same effect as oestrogen in the bone.
Lasofoxifene għandu l- istess effett bħall- estroġenu fl- għadam.
Two doses of Fablyn (250 and 500 micrograms once a day) have been compared with placebo (a dummy treatment) in one main study involving almost 9,000 postmenopausal women with osteoporosis aged 60 to 80 years.
Żewġ dożi ta ’ Fablyn (250 u 500 mikrogrammi darba kuljum) ġew imqabbla ma ’ plaċebo (trattament finta) fi studju prinċipali li jinvolvi madwar 9, 000 mara wara l- menopawża bl- ostjoporożi ta ’ etajiet 60 sa 80 sena.
The main measure of effectiveness was the number of women who had a new fracture in the spine as seen on X-rays.
Il- kejl ewlieni tal- effikaċja kien in- numru ta ’ nisa li kellhom frattura ġdida fix- xewka tad - dahar kif muri permezz tar- raġġi X.
The study also looked at existing spine fractures that got worse, new fractures in other parts of the body and the density of bones throughout the body.
L- istudju ħares ukoll lejn fratturi tax- xewka tad- dahar eżistenti li marru għall- agħar, fratturi ġodda f’ partijiet oħrajn tal- ġisem u d- densità tal- għadam mal- ġisem kollu.
What benefit has Fablyn shown during the studies?
Liema benefiċċju wera Fablyn waqt l- istudji li ġew mwettqa?
Fablyn was more effective than placebo at reducing the number of new fractures.
Fablyn kien aktar effettiv minn plaċebo fit- tnaqqis tan- numru ta ’ fratturi ġodda.
Over five years, 6% of the women taking Fablyn 500 micrograms had a new spine fracture (155 out of 2,748), compared with 9% of those taking placebo (255 out of 2,744).
Fuq 5 snin, 6% tan - nisa li kienu fuq Fablyn 500 mikrogramma kellhom frattura tax- xewka tad- dahar ġdida (155 minn 2, 748), imqabbla ma ’ 9% ta ’ dawk li jieħdu l- plaċebo (255 minn 2, 744).
Also, results with the 250-microgram dose were pointing to 500 micrograms being more effective.
Riżultati tad- doża tal- 250 mikrogramma urew ukoll illi dik tal- 500 mikrogramma kienet aktar effettiva.
Fewer women taking the higher dose had a fracture outside the spine and there were greater increases in bone density.
Inqas nisa li kienu fuq id- doża l- għolja kellhom frattura mhux tax- xewka tad- dahar u nstab li kien hemm densità tal- għadam akbar.
Fablyn did not reduce the number of hip fractures to a level that would be relevant for patients.
Fablyn ma naqqsitx in- numru ta ’ fratturi tal- ġenbejn għal livell li jista ’ jkun rilevanti għal pazjenti.
What is the risk associated with Fablyn?
X’ inhu r- riskju assoċjat ma ’ Fablyn?
The most common side effect with Fablyn (seen in more than 1 patient in 10) is muscle cramps.
L- iktar effett sekondarju komuni b’ Fablyn (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu l- krampi muskolari.
For the full list of all side effects reported with Fablyn, see the Package Leaflet.
Għal lista sħiħa tal- effetti sekondarji rappuratati tal- Fablyn, ara l- Fuljett ta ’ Tagħrif.
Fablyn should not be used in people who may be hypersensitive (allergic) to lasofoxifene or any of the other ingredients.
Fablyn m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għat- trijossidu arseniku jew għal xi ingredjenti oħrajn.
It must not be used in patients who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Ma għandhux jintuża f’ pazjenti li kellhom problemi b’ tromboemboliżmu tal- vini inkluż trombożi tal- vini l- fondi (DVT), emboliżmu pulmonary (embolu fil- pulmun) u trombożi tal- vini tar- retina (embolu fuq in- naħa ta ’ wara tal- għajn).
It must not be used in women with unexplained bleeding from the womb.
Ma għandux jintuża f’ nisa li jnixxu d- demm mill- ġuf bla ma dan ikun spjegat.
Fablyn is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant, or women who are pregnant or breast-feeding.
Fablyn huwa għal użu biss f’ nisa li għaddew mill- menopawża, allura ma għandux jintuża f’ nisa li jistgħu jinqabdu tqal jew f’ nisa li huma tqal jew li qed ireddgħu.
Why has Fablyn been approved?
Għaliex ġie approvat Fablyn?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fablyn’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Fablyn għandu aktar benefiċċji milli riskji għat- trattament ta 'l- osteoporożi f' nisa wara l- menopawża f' riskju miżjud ta' ksur.
The Committee recommended that Fablyn be given marketing authorisation.
Il- Kumitat irrakkomanda li Xeloda tingħata awtorizzazzjoni għat- tqegħid fis- suq.