qanastek/EMEA-V3 huggingface dataset:
Do not use Humalog BASAL KwikPen, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.
Tużax Humalog BASAL KwikPen jekk jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb ta ’ l- iskartoċċ, u jidher qiesu ġelu.
What Humalog BASAL 100 U/ml KwikPen, suspension for injection contains
X’ fiha Humalog BASAL 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
The insulin
Id- Dehra ta ’ Humalog BASAL 100 U/ ml KwikPen suspensjoni għall- injezzjoni u l- kontenuti tal - pakkett:
310 lispro in Humalog BASAL is available in a suspension together with protamine sulphate.
Humalog BASAL 100 U/ ml KwikPen, suspensjoni għall- injezzjoni, hu suspensjoni abjad u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) suspensjoni għal injezzjoni.
Each Humalog BASAL KwikPen contains 300 units (3 millilitres).
Kull Humalog BASAL KwikPen fiha 300 unità (3 millilitri).
The Humalog BASAL Kwik Pen comes in a pack of 5 pre-filled pens or a multipack of 2 x 5 pre-filled pens.
Il- Humalog BASAL KwikPen tiġi f’ pakketti ta ’ 5 pinen mimlijin għal- lest jew f’ pakkett multiplu ta ’ 2 x 5 pinen mimlijin għal- lest.
The Humalog BASAL in your KwikPen is the same as the Humalog BASAL, which comes in separate Humalog BASAL cartridges.
Il- Humalog BASAL fil- KwikPen tiegħek hi l- istess bħall- Humalog BASAL li jiġi fl- iskrataċ separati ta ’ Humalog BASAL.
Marketing Authorisation Holder and Manufacturer Humalog BASAL 100 U/ml KwikPen, suspension for injection is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France • Lilly Pharma Fertigung und Distribution GmbH & Co.
Il- Humalog BASAL 100 U/ ml KwikPen, suspensjoni għall- injezzjoni huwa manifatturat minn: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Lilly Pharma Fertigung und Distribution GmbH & Co.
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, The Netherlands.
319 Il- liċenzja tal- prodott hija ta 'Eli Lilly Nederland B. V., Groostlag 1- 5, 3991 RA Houten, L- Olanda.
България ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Eli Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
Please see manual text later.
MANWAL GĦAL MIN QED JAGĦMEL UŻU MINNU Jekk jogħġbok ara l- kitba tal- manwal aktar ’ il quddiem.
312 USER MANUAL
320 MANWAL GĦAL MIN QED JAGĦMEL UŻU MINNU
KwikPen INSULIN DELIVERY DEVICE
KwikPen APPARAT GĦALL- GĦOTI TA 'L- INSULINA
Lilly Introduction
Daħla
The KwikPen is designed for ease of use.
Il- KwikPen hija magħmula biex tintuża b' faċilità.
It is a disposable insulin delivery device (“insulin Pen”) containing 3 mL (300 units) of U-100 insulin.
Hija apparat għall- għoti ta 'l- insulina li tintrema wara l- użu ("Pinna ta' l- insulina") li fiha 3 mL (300 unità) ta 'U- 100 ta' insulina.
You can inject from 1 to 60 units of insulin in one injection.
Tista 'tinjetta minn 1 sa 60 unità ta' insulina f' injezzjoni waħda.
If you dial too many units, you can correct the dose without wasting any insulin.
Tista ’ tisselezzjona d- doża tiegħek b’ unità waħda kull darba. Jekk tisselezzjona aktar unitajiet milli suppost, tista 'tikkoreġi d- doża mingħajr ħela ta' insulina.
Before using the KwikPen, read the entire manual completely and follow the directions carefully.
Qabel ma tuża l- KwikPen, aqra l- manwal kollu u segwi l- istruzzjonijiet bir- reqqa.
If you do not follow these directions completely, you may get too much or too little insulin.
Jekk ma ssegwix dawn l- istruzzjonijiet kollha, tista 'tirċievi wisq jew ftit wisq ta ’ insulina.
DO NOT USE your Pen if any part appears broken or damaged.
TUŻAX il- Pinna jekk xi partijiet jidhru miksura jew bil- ħsara.
Always carry an extra Pen in case yours is lost or damaged.
Dejjem ġorr Pinna żejda f' każ li tintiliflek jew titħassarlek.
This Pen is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the product.
Din il- Pinna m’ hijiex irrakkomandata għall- użu minn persuni għomja jew b' vista batuta mingħajr l- assistenza ta 'persuna mħarrġa fl- użu tajjeb ta' dan il- prodott.
Preparing the KwikPen Important Notes
Preparazzjoni tal- KwikPen Noti Importanti
• Read and follow the directions provided in the package leaflet for the insulin. • Check the label on your Pen before each injection for the expiration date and to make sure you are using the correct type of insulin. • Your healthcare professional has prescribed the most appropriate type of insulin for you.
• Aqra u segwi l- istruzzjonijiet li ssib fil- fuljett ta 'tagħrif ta ’ l- l- insulina. • Qabel kull injezzjoni, ikkontrolla t- tikketta fuq il- Pinna għad- data ta' skadenza u sabiex tkun żgur li qed tuża t- tip tajjeb ta 'insulina. • It- tip ta' insulina l- aktar adattata għalik ġiet ordnata mill- professjonist/ a tal- kura tas- saħħa tiegħek.
Any changes in insulin therapy should be made only under medical supervision. • The KwikPen is suitable for use with Becton, Dickinson and Company (BD) pen needles. • Be sure the needle is completely attached to the Pen before use. • Do not share your Pen or needles. • Keep these directions for future reference.
Kull tibdil fil- kura bl- insulina għandu jsir biss taħt superviżjoni medika. • Il- KwikPen tista 'tintuża ma' labar tal- pinen Becton, Dickinson and Company (BD). • Qabel l- użu kun ċert li l- labra tkun imwaħħla sew mal- Pinna. • Tagħtix il- Pinna jew labar tiegħek lil xi ħadd ieħor. • Żomm dawn l- istruzzjonijiet biex tirreferi għalihom 'il quddiem.
Frequently Asked Questions about Preparing the Pen
Mistoqsijiet Komuni dwar il- Preparazzjoni tal- Pinna
• What should my insulin look like?
• Kif għandha tkun id- dehra ta 'l- insulina tiegħi?
Some insulins are cloudy while others are clear, be sure to refer to your insulin package leaflet for the appearance of your specific insulin.
Kun żgur li tirreferi għall- fuljett ta 'tagħrif ta' l- insulina tiegħek għad- dehra ta 'l- insulina speċifika tiegħek.
• Why should I use a new needle for each injection?
321 • Għaliex għandi nuża labra ġdida għal kull injezzjoni?
If needles are reused, you may get the wrong amount of insulin, a clogged needle, a jammed Pen, or an infection.
Jekk terġa 'tuża l- istess labar, tista ’ tirċievi l- ammont ħażin ta' insulina, ikollok xi labra misduda, tista ’ tiġġammjalek il- Pinna jew tieħu xi infezzjoni.
313 Priming the Kwik Pen
L- Ikkargar tal- KwikPen
Important Notes
Noti Importanti
• Prime every time.
• Ikkarga kull darba.
The Pen must be primed to a stream of insulin before each injection to make sure the Pen is ready to dose. • If you do not prime, you may get too much or too little insulin.
Qabel kull injezzjoni, il- Pinna trid tiġi kkargata sakemm tara nixxiegħa ta 'insulina biex tiżgura li l- Pinna tkun lesta għad- doża • Jekk ma tikkargax, tista' tirċievi wisq jew ftit wisq ta ’ insulina.
Frequently Asked Questions about Priming
Mistoqsijiet Komuni dwar l- Ikkargar
• Why should I prime my Pen before each dose?
• Għaliex għandi nikkarga l- Pinna qabel kull doża?
Ensures that the Pen is ready to dose.
Tiżgura li l- Pinna hija lesta għall- użu.
Confirms that a stream of insulin comes out of the tip of the needle when you push the Dose Knob in.
Tikkonferma li nixxiegħa ta 'insulina toħroġ mill- ponta tal- labra meta tagħfas il- Buttuna ta ’ Dożaġġ.
Removes air that may collect in the needle or insulin cartridge during normal use.
Tneħħi l- arja li tista 'tinġema' fil- labra jew fl- iskartoċċ ta 'l- insulina waqt l- użu normali.
• What should I do if I cannot completely push in the Dose Knob when priming the Pen?
• X' għandi nagħmel jekk ma nkunx nista 'nagħfas il- Buttuna ta ’ Dożaġġ kollha ’ l ġewwa waqt li qed nikkarga l- Pinna?
Attach a new needle.
Waħħal labra ġdida.
Prime the Pen.
Ikkarga l- Pinna.
• What should I do if I see an air bubble in the cartridge?
• X' għandi nagħmel jekk nara bużżieqa ta 'l- arja fl- iskartoċċ?
You need to prime the Pen.
Hemm bżonn li tikkarga l- Pinna.
Remember, do not store the Pen with the needle attached as this may cause air bubbles to collect in the insulin cartridge.
Ftakar, taħżinx il- Pinna bil- labra mwaħħla għaliex jistgħu jinġabru bżieżaq ta 'l- arja fl- iskartoċċ ta' l- insulina.
Injecting Your Dose
L- Injezzjoni tad- Doża
Important Notes • Follow the instructions for sanitary injection technique recommended by your healthcare professional. • Do not attempt to inject your insulin by turning the Dose Knob.
Noti Importanti • Segwi l- istruzzjonijiet ta ’ teknika ta 'injezzjoni iġjenika rrakkomandata mill- professjonist/ a tal - kura tas- saħħa tiegħek. • Tippruvax tinjetta l- insulina billi ddawwar il- Buttuna ta ’ Dożaġġ.
You will NOT receive your insulin by turning the Dose Knob.
MHUX ser tieħu l- insulina billi ddawwar il- Buttuna ta ’ Dożaġġ.
You must PUSH the Dose Knob straight in for the dose to be delivered. • Do not attempt to change the dose while injecting. • The directions regarding needle handling are not intended to replace local, healthcare professional and/or institutional policies. • Remove the needle after completing each injection.
Trid TAGĦFAS il- Buttuna ta ’ Dożaġġ s' isfel nett biex tieħu d- doża. • Tippruvax tbiddel id- doża waqt li tkun qed tagħmel l- injezzjoni. • L- istruzzjonijiet dwar l- immaniġġar tal- labar mhumiex maħsuba li jieħdu post il- linji gwida lokali istituzzjonali u/ jew tal- professjoni tal- kura tas- saħħa. • Wara li ttemm kull injezzjoni, neħħi l- labra.
Frequently Asked Questions about Injecting Your Dose
Mistoqsijiet Komuni dwar l- Injezzjoni tad- Doża
• Why is it difficult to push the Dose Knob when I try to inject?
• Għaliex qed tkun iebsa li nagħfas il- Buttuna ta ’ Dożaġġ meta nipprova nagħmel injezzjoni?
Your needle may be clogged.
Il- labra tista 'tkun misduda.
Try attaching a new needle.
Ipprova waħħal labra ġdida.
Pressing the Dose Knob quickly may make the Dose Knob harder to push.
Tista 'tħoss il- Buttuna ta ’ Dożaġġ iebsa biex tagħfas jekk tagħfasha f' daqqa.
Pressing the Dose Knob more slowly may make it easier.
Tista 'tiffaċilita dan billi tagħfas il- Buttuna ta ’ Dożaġġ bil- mod.
Using a larger diameter needle will make it easier to push the Dose Knob during your injection.
Jekk tuża labra b' dijametru akbar ikun aktar faċli li tagħfas il- Buttuna ta ’ Dożaġġ waqt l - injezzjoni.
See your healthcare professional to determine which needle size is best for you.
Kellem lill- professjonist/ a tal- kura tas- saħħa tiegħek biex tara liema daqs ta 'labra tgħodd għalik.
If the Dose Knob continues to be difficult to push after following the steps above, you may need a new Pen.
Jekk il- Buttuna ta ’ Dożaġġ tibqa 'iebsa biex tagħfasha wara li tkun segwejt dawn l - azzjonijiet, jista' jkollok bżonn Pinna ġdida.
• What should I do if my Pen is jammed?
• X' għandi nagħmel jekk il- pinna tiġġammja?
Your Pen is jammed if it is difficult to inject a dose or dial a dose.
Il- pinna tiegħek tkun iġġammjata jekk tkun diffiċli li tinjetta doża jew li tisselezzjona doża.
To clear the jam:
Biex terġa 'tħaddimha:
Dial your dose and inject.
Isselezzjona d- doża u injettaha.
314 • Why is insulin leaking from the needle after I finished my dose?
• Għaliex wara li nispiċċa d- doża ikun hemm tnixxiegħa ta ’ l- insulina mil- labra?
You may have removed the needle from your skin too quickly.
Jista 'jkun li tkun neħħejt il- labra mill- ġilda malajr wisq.
Make sure you see a 0 in the Dose Window.
Kun żgur li tara 0 fit- Tieqa tad- Dożaġġ.
For the next dose, push and hold the Dose Knob in and count slowly for 5 seconds before removing the needle.
Għad- doża li jmiss, agħfas u żomm il- Buttuna ta ’ Dożaġġ ’ il ġewwa u għodd bil- mod għal 5 sekondi qabel ma tneħħi l- labra.
• What should I do if my dose is dialed and the Dose Knob is accidentally pushed in without a needle attached?
• X' għandi nagħmel jekk id- doża tkun isselezzjonata u l- Buttuna ta ’ Dożaġġ tingħafas bi żball mingħajr ma jkun hemm labra mwaħħla?
• What should I do if I dial a wrong dose (too high or too low)?
• X' għandi nagħmel jekk nisselezzjona doża ħażina (għolja wisq jew baxxa wisq)?
Turn the Dose Knob backward or forward to correct the dose.
Dawwar il - Buttuna ta ’ Dożaġġ 'il quddiem jew lura biex tikkoreġi d- doża.
• What should I do if I see insulin leaking from the Pen needle while dialing the dose or correcting the dose?
• X' għandi nagħmel jekk nara li qed tnixxi l- insulina mil- labra tal- Pinna waqt li nkun qed nisselezzjona jew nikkoreġi d- doża?
Do not inject the dose because you may not get your complete dose.
Tinjettax id- doża għaliex tista 'ma tieħux id- doża kollha.
Dial the Pen down to zero and prime the Pen again (see “Priming the Pen” steps 2 A-D).
Isselezzjona l- Pinna għal fuq iż- żero u erġa 'kkargaha (ara "L- Ikkargar tal- Pinna" proċeduri 2 A - D).
• What should I do if my full dose cannot be dialed?
• X' għandi nagħmel jekk ma nistax nisselezzjona d- doża kollha?
The Pen will not allow you to dial a dose greater than the number of insulin units remaining in the cartridge.
Il- Pinna ma tħallikx tisselezzjona doża akbar minn- numru ta 'unitajiet ta' l- insulina li fadal fl- iskartoċċ.
For example, if you need 31 units and only 25 units remain in the cartridge you will not be able to dial past 25.
Eżempju, jekk għandek bżonn 31 unità u fl- iskartoċċ fadal 25 unità biss ma tkunx tista 'tisselezzjona aktar lilhemm minn 25.
Do not attempt to dial past this point.
Tippruvax tisselezzjona aktar lilhemm minn dan il- punt.
If a partial dose remains in the Pen you may either:
Jekk fil- Pinna tibqa 'doża parzjali tista' jew:
Give the partial dose and then give the remaining dose using a new Pen. or 2.
Tagħti d- doża parzjali u mbagħad tagħti l- bqija tad- doża b' Pinna ġdida jew 2.
Give the full dose with a new Pen.
Tagħti d- doża kollha b' Pinna ġdida.
• Why can I not dial the dose to use the small amount of insulin that remains in my cartridge?
• Għaliex ma nistax nisselezzjona d- doża biex nuża l- ammont żgħir ta 'insulina li fadal fl - iskartoċċ?
The Pen is designed to deliver at least 300 units of insulin.
Il- Pinna hi magħmula biex tagħti ta 'l- anqas 300 unità ta' insulina.
The Pen design prevents the cartridge from being completely emptied because the small amount of insulin that remains cannot be delivered accurately.
Id- disinn tal- Pinna ma jħallix l- iskartoċċ jiżvojta kompletament għaliex l- ammont żgħir ta 'insulina li jifdal ma jistax jingħata b' mod preċiż.
Storage and Disposal
Ħażna u Rimi
• Before the first use store your Pen in a refrigerator (2°C – 8°C).
• Qabel l- ewwel użu aħżen il- Pinna fi friġġ (2°C – 8°C).
Do not use a Pen if it has been frozen. • Keep your Pen in use at room temperature and away from heat and light. • Do not store the Pen with the needle attached.
Tużax Pinna li kienet ġiet iffriżata. • Żomm il- Pinna li tkun qed tuża f' temperatura tal- kamra u 'l bogħod mis- sħana u d- dawl.
If the needle is left on, insulin may leak from the Pen, insulin may dry inside the needle causing the needle to clog, or air bubbles may form in the cartridge. • Refer to the Information for the package leaflet for complete insulin storage instructions. • After first use the pen should not be used beyond the time specified in the insulin package leaflet. • Dispose of used needles in a puncture-resistant container or as directed by your healthcare professional. • Dispose of used Pens as instructed by your healthcare professional and without the needle attached. • Keep the Pen out of the reach of children.
Jekk tħalli l- labra mwaħħla tista 'tnixxi l- insulina mill- Pinna, l- insulina fil- labra tista' tinxef u b' hekk tinstadd il- labra, jew jistgħu jiffurmaw bżieżaq ta 'l- arja fl - iskartoċċ. • Irreferi għall- informazzjoni fil- fuljett ta' tagħrif għall- istruzzjonijiet kompleti dwar il- ħażna ta 'l - insulina. • Wara l- ewwel użu l- pinna m' għandiex tibqa' tintuża wara ż- żmien speċifikat fil- fuljett ta 'tagħrif ta' l- insulina. • Armi l- labar użati ġo kontenitur adattat għal dan l- iskop jew skond l- istruzzjonijiet tal - professjonist/ a tal- kura tas- saħħa tiegħek. • Armi l- Pinen użati skond l- istruzzjonijiet tal- professjonist/ a tal- kura tas- saħħa tiegħek u mingħajr ma l- labra tkun imwaħħla. • Żomm il- Pinna fejn ma tintlaħaqx mit- tfal.
If you have any questions or problems with your KwikPen, contact your healthcare professional for assistance.
Jekk ikollok xi mistoqsijiet jew problemi bil- KwikPen, kellem lill- professjonist/ a tal- kura tas - saħħa tiegħek għall- għajnuna.
315 Getting Ready Make sure you have the following items:
324 Qabel ma tibda Kun żgur li għandek dawn l - oġġetti li ġejjien:
New Pen Needle
Labra tal - Pinna Ġdida
Alcohol Swab
Tajjara mxarrba bl- alkoħol
KwikPen, and Needle∗ Assembly ∗sold separately
It- Tagħqid tal- KwikPen u l- Labra∗ ∗mibjugħa separatament Partijiet tal- Pinna
Pen Needle Parts
Partijiet tal- Labra tal- Pinna (Labar m’ humiex inklużi)) Siġill protettiv
(Needles Not Included)
Partijiet tal- KwikPen
Paper Tab
Tikketta
KwikPen Parts
Indikatur
Label
Għatu Għatu
Dose
Labra
Indicator Dose Knob Outer Needle Shield
Kappa tal- pinna Siġill
Inner Needle Shield
Kontenitur ta ’
Needle
Parti
Pen cap Rubber seal
ta ’ Barra ta ’
Cartridge Holder
l- Iskartoċċ
Pen Body
prinċipali
Dose Window
Dożaġġ
Routine Use Follow these instructions for each injection 1.
Użu ta ’ Rutina Segwi dawn l- istruzzjonijiet għal kull injezzjoni 1.
Preparing the KwikPen A.
Preparazzjoni tal - KwikPen A.
For Cloudy Insulin only:
Għall - insulina biss li tidher opaka:
Pull Pen Cap to remove.
325 Iġbed il- Kappa tal - Pinna biex tneħħiha.
Be sure to check
tal- Labra.
Gently roll the Pen ten times
dritt għal fuq il - Pinna.
Remove paper tab from Outer Needle Shield.
• Tip • Data ta ’
Push capped needle straight onto the Pen.
darbiet. u aqleb il -
your insulin for: • Type • Expiration date • Appearance
bl- alkoħol sabiex timsaħ is- siġill tal -
and invert the Pen ten times.
Invita l- labra sakemm tkun
The insulin should look evenly mixed.
gomma fit- tarf tal -
Use an alcohol swab to wipe the rubber seal on the end of the Cartridge Holder.
issikkata sew.
Screw needle on until secure.
taħt fuq
Priming the KwikPen Caution:
L- Ikkargar tal - KwikPen Avviż:
If you do not prime before each injection, you may get too much or too little insulin.
Jekk ma tikkargax qabel kull injezzjoni, tista ’ tieħu wisq jew ftit wisq ta ’ insulina.
D. • With needle pointed up, push Dose Knob in until it stops and 0 is seen in the Dose
D. • Bil- labra tipponta ’ l fuq, agħfas ’ il ġewwa l - Buttuna ta ’ Dożaġġ sakemm tista ’
Pull off Outer Needle Shield.
Neħħi l- Għatu ta ’ Isselezzjona 2 Barra tal- Labra.
Dial 2 Units by
Unitajiet billi Tarmiehx. ddawwar il -
Point Pen up.
Ipponta ’ l Pinna ’ l fuq.
Window. • Hold Dose
u għandu jidher 0 fit - tieqa tad -
Do not throw away.
Buttuna ta ’
Pull off Inner
Taptap il -
Holder to collect air at top.
dożaġġ.
Knob in and count slowly for 5 seconds.
Neħħi l- Għatu ta ’ Dożaġġ.
Needle Shield and throw away.
Kontenitur ta ’ l - Iskartoċċ sabiex l - arja tinġabar ’ il fuq.
• Priming is complete when a stream of insulin appears from the needle tip. • If a stream of insulin does not appear, repeat priming steps 2B thru 2D.
• Żomm il - Buttuna ta ’ Dożaġġ ’ il ġewwa u għodd bil - mod għal 5 sekondi • L- ikkargar ikun lest meta mill- ponta tal- labra tidher nixxiegħa ta ’ insulina. • Jekk in - nixxiegħa ta ’ insulina ma tidhirx, irrepeti l - proċeduri ta ’ kkargar minn 2B sa 2D.
If you do not see a stream of insulin from the needle tip and dialing the Pen is more difficult, change the needle and prime the Pen.
Jekk ma tarax nixxiegħa ta ’ insulina mill - ponta tal- labra u li tisselezzjona l - Pinna huwa iżjed diffiċli, ibdel il - labra u kkarga l - Pinna.
Injecting Your Dose A.
Buttuna ta ‘ Dożaġġ
Turn Dose Knob to the number of units you need to inject.
Dawwar il - Buttuna ta ’ Dożaġġ skond in - numru ta ’ unitajiet li
If you dial too many units, you can correct the dose by dialing
Sabiex tieħu d- doża kollha, żomm il - Buttuna ta ’ Dożaġġ magħfusa’ l ġewwa u għodd bil- mod għal
Insert needle into skin using injection technique recommended by your healthcare professional.
B’ attenzjoni erġa ’ qiegħed l- Għatu ta ’ Barra tal - Labra.
To deliver the full dose, hold Dose Knob in and count slowly for 5 seconds.
mill - professjonist/ a tal- kura tas - saħħa tiegħek.
Remove needle from skin.
Neħħi l - labra minn ġol- ġilda.
Carefully replace the Outer Needle Shield.
tal- kura tas- saħħa tiegħek.
Unscrew the capped needle and throw away as directed by your healthcare professional.
Aċċerta ruħek
backwards.
Neħħi l -
The odd numbers are shown as full lines between the even numbers.
tikkoreġi billi tisselezzjona b’ lura. In- numri
Place your thumb on the Dose Knob and push firmly until the Dose Knob stops moving.
Poġġi subgħajk il- kbir fuq il - Buttuna ta ’
Check to make sure you see 0 in the Dose Window to confirm you received the complete dose.
li tara 0 fit- Tieqa tad - Dożaġġ sabiex tikkonferma li tkun
Remove the needle after each injection to keep air out of the cartridge.
labra wara kull injezzjoni sabiex ma tħallix l- arja
Do not store the Pen with the needle attached.
Taħżinx il- Pinna
Replace Pen Cap.
Kappa tal- Pinna..
10 units shown.
Jidhru 10 unitajiet.
The Pen will not allow you to dial more than the number of units left in the Pen.
Il- Pinna ma tħallikx tisselezzjona iżjed minn numru ta ’ unitajiet li jkun fadal fil- Pinna.
You may use this function to determine the total amount of insulin remaining in the Pen when the cartridge has less than 60 units remaining.
Tista ’ tuża din il- funzjoni sabiex tikkalkula l- ammont totali ta ’ insulina li jkun fadal fil- Pinna meta l - iskartoċċ ikun fadallu inqas minn 60 unità.
If your dose is greater than the number of
Jekk id- doża tiegħek hija akbar minn numru ta ’ unitajiet li fadal fil- Pinna, tista ’ jew tieħu dak l- ammont li fadal u tuża Pinna ġdida biex tkompli d- doża JEW tieħu d- doża kollha permezz ta ’ Pinna ġdida..
Example:
mwaħħla.
What is Humira?
X’ inhu Humira?
Humira is a medicine containing the active substance adalimumab.
Humira huwa mediċina li fiha s- sustanza attiva adalimumab.
It is available as a solution for injection in a vial, pre-filled syringe or pre-filled pen, all containing 40 mg adalimumab.
Jiġi bħala soluzzjoni għall- injezzjoni f’ kunjett, siringa mimlija għal- lest jew pinna mimlija għal- lest, kollha fihom 40 mg ta ’ adalimumab.
What is Humira used for?
Għal xiex jintuża Humira?
Humira is an anti-inflammatory medicine.
Humira hu prodott mediċinali anti- infjammatorju.
It is used to treat the following groups of patients: • adults with moderate to severe active rheumatoid arthritis (an immune system disease causing inflammation of the joints) who have not responded adequately to other treatments, and adults with severe active rheumatoid arthritis that is progressive (getting worse) who have not taken methotrexate (another medicine that acts on the immune system) before.
Jintuża għat- trattament ta ’ dawn il- gruppi ta ’ pazjenti: • adulti b’ artrite rewmatika moderata għal severa (marda tas- sistema immunitarja li tikkawża infjammazzjoni tal- ġogi) li ma jkunux irrispondew adegwatament għal trattamenti oħrajn, u adulti b’ artrite rewmatika severa attiva li tkun progressiva (qed tiggrava) li ma jkunux ħadu methotrexate (mediċina oħra li taġixxi fuq is- sistema immunitarja) qabel.
Humira is used in combination with methotrexate, or on its own in patients who cannot take methotrexate; • adolescents aged between 13 and 17 years with polyarticular juvenile idiopathic arthritis (an immune system disease affecting children and adolescents that causes inflammation of at least five joints) who have not responded adequately to other treatments.
Humira jintuża flimkien ma ’ methotrexate, jew jittieħed waħdu f’ pazjenti li ma jistgħux jieħdu methotrexate • adoloxxenti b’ età bejn it- 13 u s- 17 - il sena b’ artrite idjopatika ġuvenili poljartikulari (marda tas - sistema immunitarja li taffetwa t- tfal u l- adoloxxenti li tikkawża infjammazzjoni ta ’ minn l- inqas ħames ġogi) li ma jkunux irrispondew adegwatament għal trattamenti oħrajn.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Humira jintuża flimkien ma ’ methotrexate, jew waħdu f’ pazjenti li ma jistgħux jieħdu methotrexate., • adulti b’ artrite psorjatika attiva u progressiva (marda li tikkawża rqajja ’ ħomor, bil- qxur fuq il - ġilda u infjammazzjoni tal- ġogi) f’ pazjenti li ma jkunux wieġbu b’ mod adegwat għal trattamenti oħra, • adulti li jkollhom forma attiva u severa ta ’ spondilite ankilotika (marda li tikkawża infjammazzjoni u uġigħ fil- ġogi tas- sinsla tad- dahar) f’ pazjenti li ma jkunux wieġbu b’ mod adegwat għal trattamenti oħra. • adulti li jkollhom forma attiva u severa tal- marda ta ’ Crohn (marda li tikkawża infjammazzjoni ta ’ l- imsaren) li ma jkunux irrispondew b’ mod adegwat għal trattamenti oħra • adulti bi psorijażi (psoriasis) (marda li tikkawża rqajja ’ ħomor bil- qxur fuq il- ġilda) li ma jkunux irrispondew b’ mod adegwat għal trattamenti oħra Għal iktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss b’ riċetta minn tabib.
How is Humira used?
Kif jintuża Humira?
Treatment with Humira must be initiated and supervised by a doctor who has experience in the treatment of the diseases that Humira is used to treat.
It- trattament b’ Humira għandu jinbeda u jiġi ssorveljat minn tabib li jkollu esperjenza fit- trattament ta ’ mardiet li jiġu ttrattati b’ Humira.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged Id- doża rakkomandata ta ’ Humira hi ta ’ 40 mg mogħtija kull ġimgħatejn bħala injezzjoni waħda taħt il- ġilda, iżda għall- marda ta ’ Crohn u l- psorijażi, tingħata doża ta ’ 80mg, u wara tingħata 40mg kull ġimgħatejn.
(160 mg followed by 80 mg), although this might increase the risk of side effects.
Dawk il- pazjenti li jkollhom bżonn ta ’ rispons iktar rapidu għall- marda ta ’ Crohn jista ’ jkollhom bżonn jibdew b’ żewġ dożi iktar għoljin (160mg segwita bi 80mg), għalkemm dan jista ’ jżid ir- riskju ta ’ effetti sekondarji.
Patients may be given other medicines during treatment with Humira, such as corticosteroids (other anti-inflammatory medicines).
Il- pazjenti jistgħu jingħataw mediċini oħra matul it- trattament b’ Humira, bħal kortikosterojdi (mediċini oħra kontra l- infjammazzjoni).
After training, patients may inject themselves with Humira if their doctor agrees.
Wara li jkunu ngħataw taħriġ, il- pazjenti jistgħu jinjettaw lilhom infushom jekk it- tabib jaqbel.
Patients who take Humira must be given the special alert card that summarises the safety information about the medicine.
Il- pazjenti li jkunu qed jieħdu Humira għandhom jingħataw karta ta ’ twissija speċjali li tagħti tagħrif fil- qosor dwar is- sigurtà tal- mediċina.
How does Humira work?
Kif jaħdem Humira?
The active substance in Humira, adalimumab, is a monoclonal antibody.
Is- sustanza attiva f’ Humira, adalimumab, hi antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in the body.
Antikorp monoklonali hu antikorp (tip ta ’ proteina) li jkun ġie ddisinjat biex jagħraf u jeħel ma ’ struttura speċifika (magħrufa bħala antiġen) li tinstab fil- ġisem.
Adalimumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor (TNF).
Adalimumab ġie ddisinjat biex jeħel ma ’ messaġġier kimiku fil- ġisem magħruf bħala fattur tan- nekrożi minn tumur (TNF).
This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Humira is used to treat.
Dan il- messaġġier għandu x’ jaqsam mal- ħolqien ta ’ infjammazzjoni u jinstab f’ livelli għoljin f’ pazjenti li jkollhom mardiet li jiġu ttrattati b’ Humira.
By blocking TNF, adalimumab reduces the inflammation and other symptoms of the diseases.
Bl- imblukkar ta ’ TNF, adalimumab inaqqas l- infjammazzjoni u s- sintomi l- oħra tal- mardiet.
How has Humira been studied?
Kif ġie studjat Humira?
Humira has been studied in five studies of patients with moderate to severe rheumatoid arthritis.
Humira ġie studjat f’ ħames studji ta ’ pazjenti b’ artrite rewmatika moderata jew severa.
In four of these studies, the effectiveness of Humira, alone or as an as add-on to other anti-inflammatory medicines including methotrexate, was compared with that of placebo (a dummy treatment) in over 2,000 patients.
F’ erbgħa minn dawn l- istudji, l- effikaċja ta ’ Humira, waħdu jew flimkien ma ’ mediċini anti- inflammatorji oħra, inkluż methotrexate, tqabblet ma ’ dik ta ’ plaċebo (trattament finta) f’ iktar minn 2000 pazjent.
The fifth study compared the combination of Humira and methotrexate to methotrexate or to Humira alone in 799 patients who had not taken methotrexate before.
Dan l- istudju sar fuq 799 pazjent li ma kienux ħadu methotrexate qabel.
For polyarticular juvenile idiopathic arthritis, Humira was compared with placebo, alone or as an add- on to methotrexate, in one main study involving 171 patients aged between four and 17 years.
Għall- artrite idjopatika ġuvenili poljoartikulari, Humira ġiet imqabbla ma ’ plaċebo, waħdu jew miżjud ma ’ methotrexate, fi studju wieħed prinċipali li kien jinvolvi 171 - il pazjent f’ età ta ’ bejn l- erba ’ u s - 17 - il sena.
For psoriatic arthritis, Humira was compared with placebo over 12 weeks in two studies including 413 patients.
Il- pazjenti kollha rċevew Humira għal 16 - il ġimgħa qabel ma ġew assenjati Humira jew plaċebo għal 32 ġimgħa oħra, Għall- artrite psorjatika, Humira tqabbel ma ’ plaċebo għal żmien ta ’ 12 - il ġimgħa f’ żewġ studji li fihom ħadu sehem 413- il pazjent.
The medicines were taken alone or in combination with another anti-inflammatory medicine.
Il- mediċini ttieħdu weħidhom jew flimkien ma ’ mediċini anti - infjammatorji oħra.
For ankylosing spondylitis, Humira and placebo as an add-on to existing treatment were compared over 12 weeks in two studies involving 397 patients.
Għall- ispondilite ankilotika, Humira u plaċebo miżjuda ma ’ trattament eżistenti ġew studjati għal perjodu ta ’ 12- il ġimgħa bis- sehem ta ’ 397 pazjent.
For Crohn’ s disease, the effectiveness of the first two doses of Humira (induction) was compared with that of placebo in two studies involving 624 patients over four weeks.
Għall- marda ta ’ Crohn, l- effikaċja ta ’ l- ewwel żewġ dożi ta ’ Humira (induzzjoni) ġiet imqabbla ma ’ dik ta ’ plaċebo f’ żewġ studji li kienu jinkludu 624 pazjent fuq żmien ta ’ erba ’ ġimgħat.
Another study looked at the long-term effects (maintenance) of Humira in 854 patients over up to 56 weeks.
Studju ieħor ħares lejn l- effetti fuq żmien twil (żamma) ta ’ Humira fi 854 pazjent sa 56 ġimgħa.
A second study compared Humira with methotrexate and with placebo in 271 patients over 16 weeks.
Studju ieħor qabbel Humira ma ’ methotrexate u mal- plaċebo f’ 271 pazjent fuq 16 - il ġimgħa.
In all of the studies, the main measure of effectiveness was the change in symptoms.
Fl- istudji kollha, il- kejl ewlieni ta ’ l- effikaċja kien it- tibdil fis- sintomi.
What benefit has Humira shown during the studies?
X’ inhuma l- benefiċċji ta ’ Humira li ntwerew f’ dawn l- istudji?
Humira was more effective than placebo in all diseases studied.
Humira kien iktar effikaċi mill- plaċebo fil- mard kollu studjat.
In rheumatoid arthritis, the greatest reductions in symptoms were seen in the studies examining Humira as an add-on to methotrexate: around two thirds of the patients adding Humira had at least a 20% reduction in symptoms after six months, compared with a quarter of those adding placebo.
Fl- artrite rewmatika, l- ikbar tnaqqis fis- sintomi deher fl- istudji li eżaminaw Humira meta miżjud ma ’ methotrexate: madwar żewġ terzi tal- pazjenti li żdidulhom Humira kellhom tnaqqis fis- sintomi ta ’ mill- inqas 20% wara sitt xhur, meta mqabbla ma ’ kwart minn dawk li żdidilhom il- plaċebo.
Patients adding Humira also had less joint damage and experienced less reduction in physical function after a year.
Il- pazjenti li żdidilhom Humira kellhom inqas ħsara fil- ġogi u għaddew minn inqas tnaqqis fil- funzjoni fiżika minn dawk li żdidilhom il- plaċebo wara sena mit- trattament.
In patients who had not taken methotrexate in the past, the combination of Humira and methotrexate was also more effective than methotrexate alone.
Fil- pazjenti li ma kinux ħadu methotrexate qabel, il- kombinazzjoni ta ’ Humira u methotrexate kienet ukoll iktar effettiva minn methotrexate meħud waħdu.
For polyarticular juvenile idiopathic arthritis, around 40% of the patients receiving Humira, either alone or in combination with methotrexate, had a flare-up of arthritis, compared with around 69% of those receiving placebo.
Għall- artrite idjopatika ġuvenili poljartikulari, madwar 40% tal- pazjenti li rċevew Humira, waħdu jew flimkien ma ’ methotrexate, kellhom żieda fl- artrite meta mqabbla ma ’ madwar 69% ta ’ dawk li rċevew il- plaċebo.
However, fewer patients receiving Humira with methotrexate developed antibodies, so the results favoured the use of Humira with methotrexate over Humira used alone.
Madankollu, inqas pazjenti li kienu qed jieħdu Humira ma ’ methotrexate żviluppaw antikorpi, għalhekk ir- riżultati iffavorixxew l- użu ta ’ Humira ma ’ methotrexate fuq l- użu ta ’ Humira waħdu.
The fixed 40-mg dose, which is the only dose of Humira currently available, was considered to be suitable only for patients aged 13 years or above.
Id- doża fissa ta ’ 40mg,, li hija l- unika doża li tinsab attwalment disponibbli, ġiet ikkunsidrata bħala adatta għall- pazjenti b’ età ta ’ 13- il sena jew iktar.
Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, induction and maintenance phases of treatment for Crohn’ s disease, and psoriasis.
Himira ġab ukoll iktar titjib fis- sintomi mill- plaċebo fi studji ta ’ artrite psorjatika, spondilite ankilotika, fil- fażijiet ta ’ induzzjoni u ta ’ żamma fil- marda ta ’ Crohn u fil- psorjażi.
Due to an increased risk of infection, patients taking Humira must be monitored closely for infections including tuberculosis during and for 2/ 3 up to five months after treatment.
Fl- istudji dwar Humira, l- iktar effetti sekondarji komuni (li dehru f’ iktar minn pazjent wieħed minn kull 10) kienu reazzjonijiet fil- post fejn tingħata l- injezzjoni (inkluż uġigħ, nefħa, ħmura jew ħakk Minħabba ż- żieda fir- riskju ta ’ infezzjoni, il- pazjenti li jkunu qed jieħdu Humira iridu jiġu sorveljati mill- qrib għal infezzjonijiet fosthom it- tuberkulożi, matul u sa 5 xhur wara t- trattament b’ Humira.
For the full list of all side effects reported with Humira, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha li ġew irrappurtati bi Humira, ara l- Fuljett ta ’ Tagħrif.
Humira should not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other ingredients.
Humira m’ għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal adalimumab jew għal kwalunkwe wieħed mis- sustanzi l- oħra.
Humira must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Humira m’ għandux jingħata lil pazjenti li jkollhom it - tuberkulożi, infezzjonijiet severi oħra jew ħsara tal- qalb moderata jew severa (il- qalb ma tkunx tista ’ tippompja biżżejjed demm madwar il- ġisem).
Why has Humira been approved?
Għaliex ġie approvat Humira?
The Committee for Medicinal Products for Human Use (CHMP) decided that Humira’ s benefits are greater than its risks for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Humira fit- trattament ta ’ l- artrite rewmatika, artrite idjopatika ġuvenili poljartikulari, artrite psorjatika, spondilite ankilotika, marda ta ’ Crohn u psorijażi.
The Committee recommended that Humira be given marketing authorisation.
Il- Kumitat irrikomanda li Humira jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Humira?
Liema miżuri qegħdin jittieħdu sabiex jiġi assigurat użu ta ’ Humira mingħajr periklu?
The company that makes Humira will provide educational packs for doctors who will prescribe Humira.
Il- kumpanija li tagħmel Humira se tipprovdi pakketti ta ’ informazzjoni għat- tobba li jippreskrivu Humira.
These packs will include information on the safety of the medicine.
Dawn il- pakketti se jinkludu informazzjoni dwar is- sigurtà tal- mediċina.
Other information about Humira:
Informazzjoni oħra dwar Humira:
The European Commission granted a marketing authorisation valid throughout the European Union for Humira to Abbott Laboratories Ltd. on 8 September 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Humira lil Abbott Laboratories Ltd. nhar it- 8 ta ’ Settembru 2003.
The marketing authorisation was renewed on 8 September 2008.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 8 ta ’ Settembru 2008.
The full EPAR for Humira can be found here.
L- EPAR sħiħ dwar Humira jista ’ jinstab hawn.
Route of Administration
Qawwa
Packaging
farmaċewtika
Package size
Kontenut Daqs tal- pakkett
vial (glass)
Kunjett (Ħġieġ)
1 vial + 1 syringe + 2 alcohol pads
Kunjett 1 + Siringa 1 + 2 Kuxxinetti bl- alkoħol
pre-filled syringe (glass)
Siringa mimlija għal- lest (Ħġieġ)
1 pre-filled syringe + 1 alcohol pad
Siringa waħda mimlija għal- lest + Kuxxinett wieħed bl- alkoħol
2 pre-filled syringes + 2 alcohol pads
2 Siringi mimlija għal- lest + 2 Kuxxinetti bl- alkoħol
4 pre-filled syringes + 4 alcohol pads
4 Siringi mimlija għal- lest + 4 Kuxxinetti bl- alkoħol
6 pre-filled syringes + 6 alcohol pads
6 Siringi mimlija għal- lest + 6 Kuxxinetti bl- alkoħol
1 pre-filled syringe with needleguard + 1 alcohol pad
Siringa waħda ta ’ mimlija għal- lest bil- labra mgħottija + Kuxxinett wieħed bl- alkoħol
Humira 40 mg solution for injection.
Humira 40 mg soluzzjoni għall- injezzjoni
Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Kull kunjett b’ doża waħda ta ’ 0. 8 ml fih 40 mg adalimumab.
Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Adalimumab huwa anti- korp uman monoklonali rikombinanti, espress fiċ- ċelluli ta ’ l- ovarji tal - ħamster ċiniż.
Clear solution for injection.
Soluzzjoni ċara għall- injezzjoni
Rheumatoid arthritis
Artrite rewmatika
Humira in combination with methotrexate, is indicated for:
Humira, flimkien ma ’ methotrexate, huwa indikat għall -:
 the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.  the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
kura ta ’ artrite rewmatika attiva minn moderata sa severa f’ pazjenti adulti, meta r- rispons • tagħhom għal mediċini anti- rewmatiċi li jaffetwaw il- proċess tal- mard, inkluż methotrexate, ma kienx adegwat.
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Humira jista ’ jingħata waħdu f’ każ ta ’ intolleranza għal methotrexate, jew f’ każ li t- tkomplija tal- kura b’ methotrexate ma tkunx tajba.
Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Ġie ppruvat li, meta jingħata flimkien ma ’ methotrexate, Humira jnaqqas ir- rata li biha tipprogressa l - ħsara fil- ġogi kif imkejjel permezz ta ’ X- ray, u li jtejjeb il- funzjoni fiżika.
Polyarticular juvenile idiopathic arthritis
Artrite idjopatika poliartikulari taż- żagħżagħ
Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Humira meta jingħata flimkien ma ’ methotrexate huwa ndikat għall- kura ta ’ artrite attiva idjopatika poliartikulari taż- żagħżagħ, f’ adoloxxenti li għandhom bejn 13 u 17 il- sena, li ma kellhomx rispons kif mistenni għal kura b’ mediċini anti- rewmatiċi li jaffetwaw il- proċess tal- mard (DMARDs).
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (see section 5.1).
Humira jista ’ jingħata waħdu f’ każ ta ’ intolleranza għal methotrexate, jew f’ każ li t- tkomplija tal- kura b’ methotrexate ma tkunx tajba (ara sezzjoni 5. 1).
Psoriatic arthritis
Artrite Psorjatika
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Humira huwa ndikat għall- kura ta ’ artrite psorjatika attiva u progressiva f’ adulti meta r- rispons tagħhom għal mediċini anti- rewmatiċi li jaffetwaw il- proċess tal- mard, inkluż methotrexate, ma jkunx adegwat.
Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Ġie ppruvat li, f’ pazjenti li jbatu minn forom poliartikulari simetriċi ta ’ din il- marda (ara Sezzjoni 5. 1), Humira jnaqqas ir- rata li biha tipprogressa l- ħsara fil- ġogi periferali kif imkejjel permezz ta ’ X- ray, u jtejjeb il- funzjoni fiżika.
2 Ankylosing spondylitis
2 Infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Humira huwa indikat għall- kura ta ’ adulti li jbatu minn infjammazzjoni tal- vertebri li jirriżulta fil - vertebri jitwaħħlu flimkien (ankylosing spondylitis), li ma kellhomx rispons adegwat meta ngħataw kura konvenzjonali.
Crohn’ s disease
Il- marda Crohn (Crohn’ s disease)
Humira is indicated for treatment of severe, active Crohn’ s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/ or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Humira huwa indikat għall- marda Crohn severa u attiva f’ pazjenti li, minkejja terapija sħiħa u adegwata li jkunu ingħataw b’ xi corticosteroid u/ jew b’ xi immunosoppressiv, xorta ma kellhomx rispons; jew f’ pazjenti li m’ għandhomx tolleranza għal, jew li jkollhom kontra- indikazzjonijiet mediċi għal dawn it- terapiji.
For induction treatment, Humira should be given in combination with corticosteroids.
Għall- kura tal- bidu, Humira għandu jingħata flimkien ma ’ corticosteroids.
Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
F’ każ ta ’ intolleranza għall- corticosteroids jew f’ każ fejn it- tkomplija tal- kura bil- corticosteroids m’ hijiex adattata, Humira jista ’ jingħata waħdu (ara sezzjoni 4. 2).
Psoriasis
Psorajiżi
Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.
Humira huwa ndikat għall- kura ta ’ psorajiżi tat- tip li tikkawża qoxra mhux normali fuq il- ġilda, li hi minn moderata sa severa, f’ pazjenti adulti li ma kellhomx rispons għal, jew li għandhom kontra - indikazzjoni għal, jew li ma jittollerawx terapija sistemika oħra, li tinkludi cyclosporine, methotrexate jew PUVA.
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease or psoriasis.
Il- kura b’ Humira għandha tinbeda u tiġi ssorveljata minn tobba speċjalisti li għandhom esperjenza fid - dijanjosi u fil- kura ta ’ l- artrite rewmatika, ta ’ l- artrite idjopatika poliartikulari taż- żagħżagħ, ta ’ l - artrite psorjatika, ta ’ l- infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis), tal- marda Crohn (Crohn’ s disease) jew tal- psorajiżi.
Patients treated with Humira should be given the special alert card.
Pazjenti kkurati b’ Humira għandhom jingħataw il- kartuna ta ’ twissija speċjali.
After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary.
Wara li jingħataw taħriġ xieraq fuq it- teknika ta ’ l- injezzjoni, il- pazjenti jistgħu jinjettaw lilhom infushom b’ Humira jekk it- tabib tagħhom jiddeċiedi li dan hu tajjeb għalihom, u jekk ikun hemm sorveljanza medika ta ’ wara l- kura skond il- bżonn.
During treatment with Humira, other concomitant therapies (e. g., corticosteroids and/ or immunomodulatory agents) should be optimised.
Matul il- kura b’ Humira, terapiji oħra (eż., corticosteroids u/ jew aġenti immunomodulatorji) għandhom jiġu aġġustati għall- aħjar effett.
Dose Interruption
Twaqqif tad- doża
Available data suggest that re-introduction of Humira after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Minn tgħarif li għandna jidher li jekk terġa ’ tingħata Humira wara li tkun twaqqfet għal- 70 gurnata jew aktar, dan iwassal għall- istess rispons kliniku u profil ta ’ sigurta ’ li jixbaħ lil dak ta ’ qabel ma twaqqfet id- doża.
Rheumatoid arthritis
Artrire rewmatika
The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Id- doża ta ’ Humira rrakkomandata għal pazjenti adulti li jbatu minn artrite rewmatika hija ta ’ 40 mg adalimumab li tittieħed bħala doża waħda ġimgħa iva u ġimgħa le, permezz ta ’ injezzjoni taħt il- ġilda.
Methotrexate should be continued during treatment with Humira.
Methotrexate għandu jitkompla waqt il- kura b’ Humira.
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira.
Mediċini glukokortikojdi, saliċilati u mediċini anti- infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il- kura b’ Humira.
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Rigward it- teħid flimkien ta ’ Humira ma ’ mediċini anti- rewmatiċi li jaffetwaw il- proċess tal- mard, minbarra methotrexate, ara sezzjoni 4. 4 u 5. 1.
In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
3 Meta Humira jingħata bħala kura waħdu, xi pazjenti li jesperjenzaw tnaqqis fir- rispons tagħhom jistgħu jibbenefikaw minn żieda fl- intesità tad- doża għal 40 mg kull ġimgħa.
3 Psoriatic arthritis and ankylosing spondylitis
Artrite Psorjatika u infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
The recommended dose of Humira for patients with psoriatic arthritis or ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Id- doża ta ’ Humira rrakkomandata għal pazjenti li jbatu minn artrite psorjatika jew infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis), hija ta ’ 40 mg adalimumab li tittieħed bħala doża waħda ġimgħa iva u ġimgħa le, permezz ta ’ injezzjoni taħt il- ġilda.