qanastek/EMEA-V3 huggingface dataset:
Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 13).
Imbagħad imbotta l - planġer biex tinjetta s- soluzzjoni kollha b’ rata kostanti u bil- mod, u fissa (ara Dijagramma 13).
Storing the Enbrel solution between doses
Kif taħżen is- soluzzjoni ta ’ Enbrel bejn id- dożi
 If the doctor has told you that you can withdraw two doses from one vial of Enbrel, you must store the solution in a refrigerator (2 C – 8 C) between the first and second doses.
• Jekk it- tabib qallek li tista ’ tiġbed żewġ dożi minn fjala waħda ta ’ Enbrel għandek taħżen is - soluzzjoni fi friġġ (2°C – 8°C) bejn l- ewwel u t- tieni doża.
The vial should be stored upright in the refrigerator between doses.  Each vial of Enbrel 25 mg/ ml should be used for a maximum of 2 doses, administered to the same child.
Il- kunjett għandu jinħażen iħares ’ il fuq fil- friġġ bejn l- għoti tad- dożi. • Kull fjala ta ’ Enbrel 25 mg/ ml għandha tintuża għal massimu ta ’ 2 dożi, mogħtija lill- istess tifel/ tifla.
Withdrawing a second dose of Enbrel from a vial that was previously prepared
Kif tiġbed it- tieni doża minn Enbrel minn fjala li tkun ġiet preparata qabel
 Remove the Enbrel solution from the refrigerator.
• Neħħi s- soluzzjoni ta ’ Enbrel mill- friġġ.
Wait 15 to 30 minutes to allow the Enbrel in the vial to reach room temperature.
Stenna 15 sa 30 minuta biex il- fjala tikseb it - temperatura tal- kamra.
Do not warm Enbrel in any other way (for example, do not warm it in a microwave or in hot water).  Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
Issaħanx Enbrel bl- ebda mod (per eżempju, issaħnux fil- microwave jew fl- ilma sħun). • Uża swab ġdida ta ’ l- alkoħol biex tnaddaf l- għatu l- griż fuq il- fjala ta ’ Enbrel.
After cleaning, do not touch the stopper with your hands or allow it to touch any surface.  To prepare the second dose of Enbrel from the vial, start with the instructions under f. ‘ Withdrawing the Enbrel solution from the vial’ using the other empty syringe, needles and swabs from the tray.  If there is insufficient Enbrel solution in the vial for your next dose, discard the vial and start again with a new tray.  After you have withdrawn the second dose of Enbrel from the vial, discard the vial (even if some liquid remains).
325 • Biex tipprepara t- tieni doża ta ’ Enbrel mill- fjala, ibda bl- istruzzjonijiet minn f. ‘ Kif tiġbed is - soluzzjoni ta 'Enbrel minn ġol- fjala ’ billi tuża s- siringa l- vojta l- oħra, il- labar u l- swabs mit - rej. • Jekk m’ hemmx biżżejjed soluzzjoni ta ’ Enbrel fil- fjala għad- doża li jmissek, armi l- fjala u erġa ’ ibda bi trej ġdid. • Wara li tkun ġbidt it- tieni doża ta ’ Enbrel mill- fjala armi l- fjala (anke jekk jifdal xi likwidu).
340 PACKAGE LEAFLET:
326 FULJETT TA ’ TAGĦRIF:
Enbrel 25 mg solution for injection in pre-filled syringe Etanercept
Enbrel 25 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Etanercept
It may harm them, even if their symptoms are the same as yours or those of the child you are caring for.  If you are concerned about any side effect, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek jew tat - tifel/ tifla li jinsabu taħt il- kura tiegħek. • Jekk inti imħasseb dwar xi effetti sekondarji, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew spiżjar tiegħek.
341 Enbrel is also prescribed for the treatment of the following diseases in children and adolescents:
Enbrel jingħata wkoll b’ riċetta għall- kura tal- mard li ġej fit- tfal u fl- adolexxenti:
 Polyarticular juvenile idiopathic arthritis (a type of juvenile arthritis that affects many joints) in patients from the age of 4 years who have had an inadequate response to (or are unable to take) methotrexate.
• Artrite idjopatika ġuvenili poliartikulari (tip ta ’ artrite ġuvenili li taffettwa ħafna ġogi) f’ pazjenti mill- età ta ’ 4 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) methotrexate.
 Severe psoriasis in patients from the age of 8 years who have had an inadequate response to (or are unable to take), phototherapies or other systemic therapies.
327 • Psorjasi severa f’ pazjenti mill- età ta ’ 8 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
Tell your doctor if you or the child have a history of recurrent infections, or suffer from diabetes or other conditions that increase the risk of infection.  Infections/ monitoring:
Għid lit- tabib tiegħek jekk int jew t- tifel/ tifla għandkom storja ta 'infezzjonijiet rikorrenti, jew tbatu mid- dijabete jew kundizzjonijiet oħra li jżidu r- riskju ta' infezzjoni. • Infezzjonijiet/ monitoraġġ:
Such symptoms may point to the
Fittex għal parir mediku minnufih jekk inti jew it- tifel/ tifla tiegħek għandkom xi sinjali jew sintomi bħal ta 'deni persistenti, uġigħ fil- griżmejn, tbenġil, fsada jew sfurija.
342 existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.  Nervous system and eye disorders:
Sintomi bħal dawn jistgħu jindikaw eżistenza ta 'disturbi tad- demm li jistgħu jkunu ta' periklu għal ħajja, li jistgħu jinħtieġu li jitwaqqaf Enbrel. • Disturbi tas- sistema nervuża u ta 'l- għajnejn:
Your doctor will determine if Enbrel is an appropriate treatment.  Congestive heart failure:
328 • Insuffiċjenza tal- qalb konġestiva:
If possible, children should be up to date with all vaccinations before using Enbrel.
It- tifel/ tifla, jekk possibbli, għandhom ikunu aġġornati bil- vaċċinazzjonijiet kollha qabel ma jintuża Enbrel.
Tell the doctor or pharmacist if you or the child are taking, or have recently taken any other medicines, even those not prescribed by the doctor.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jew tat- tifel/ tifla tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Important information about latex
Informazzjoni importanti dwar il- latex
Before using Enbrel, contact your doctor if it will be handled by, or given to, someone with an allergy to latex, since the needle cover in the Enbrel pack is made from latex.
Qabel tuża Enbrel, ikkuntattja lit- tabib tiegħek jew dan se jintuża jew jingħata lil persuna li hi magħrufa li għanda sensittività eċċessiva (allerġija) għal latex.
343 Dosing for adult patients (aged 18 years or over)
Doża għal pazjenti adulti (ta '18- il sena jew aktar)
Plaque psoriasis
329 Psorjasi tal- plakka
This is a single-use syringe for patients weighing 62.5 kg or more.
Din hi siringa li tintuża darba biss għal pazjenti li jiżnu 62. 5 mg jew aktar.
25 mg vials are available for paediatric use from which doses less than 25 mg can be administered.
Kunjetti ta ’ 25 mg huma disponibbli għall- użu pedjatriku, li minnhom jista ’ jingħataw dożi ta ’ inqas minn 25 mg, u għandhom jingħataw darbtejn fil- ġimgħa.
Detailed instructions on how to inject Enbrel are provided in section 7, “ INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL”.
Struzzjonijiet dettaljati dwar kif għandek tinjetta Enbrel huma pprovduti f' sezzjoni 7, “ STRUZZJONIJIET GĦALL- PREPARAZZJONI U KIF TAGĦTI INJEZZJONI TA ’ ENBREL ”.
344 If you forget to inject Enbrel
Jekk tinsa tinjetta Enbrel
If you forget a dose, you should inject it as soon as you remember, unless your next scheduled dose is the next day, in which case you should skip the missed dose.
Jekk tinsa tieħu doża, inti għandek tinjettaha hekk kif tiftakar, ħlief meta d- doża skedata tiegħek li jmiss tkun l- għada, f' liema każ inti għandek taqbeż id- doża maqbuża.
Then continue to inject the medicine on the usual day(s).
Imbagħad issokta billi tinjetta l - mediċina fil- jum/ jiem li suppost.
4.
330 4.
345 Other side effects
Effetti sekondarji oħra li jista ’ jkollu
 Uncommon (may occur in less than 1 in 100, but more than 1 in 1,000 patients): serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); localized swelling of the skin (angioedema); low blood platelet count; hives (elevated patches of red or pale skin that often itch); psoriasis; rash; inflammation or scarring of the lungs.
331 • Mhux komuni (jistgħu jseħħu f' inqas minn 1 f' 100, imma aktar minn 1 f' 1, 000 pazjent): infezzjonijiet serji (li jinkludu pnewmonja, infezzjonijiet fil- fond tal- ġilda, infezzjonijiet tal- ġog, infezzjoni tad- demm, u infezzjonijiet f' siti differenti); nefħa lokalizzata tal- ġilda (anġjoedema); għadd baxx ta 'plejtlets fid- demm; ħorriqija (irqajja' elevati ta 'ġilda ħamra jew pallida li ħafna drabi iqabduk il- ħakk); psorjasi; raxx; infjammazzjoni jew ċikatriċi tal- pulmun.
Store in a refrigerator (2 – 8 C).
Aħżen fi friġġ (2° – 8°C).
After taking a syringe from the refrigerator, the Enbrel solution should be allowed to reach room temperature (15-30 minutes).
Wara li toħroġ is- siringa mill- friġġ, is- soluzzjoni ta ’ Enbrel għandha titħalla tilħaq it- temperatura tal- kamra (15- 30 minuta).
Immediate use is then recommended.
Imbagħad, użu immedjat huwa rakkomandat.
Make sure the solution in the pre-filled syringe is clear, colourless or pale yellow, and practically free from visible particles.
Kun ċert li s- soluzzjoni fis- siringa mimlija għal- lest hija ċara, mingħajr kulur jew isfar ċar, u prattikament ħielsa minn frak viżibbli.
Otherwise, do not inject the solution.
Inkella tinjettax is- soluzzjoni.
Use a different Enbrel pre-filled syringe, then contact your pharmacist for assistance.
Uża siringa mimlija għal- lest ta ’ Enbrel u imbagħad ikkuntattja lill- ispiżjar tiegħek għall- għajnuna.
346 Medicines should not be disposed of via waster water or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each pre-filled syringe contains 0.5 ml of solution, providing 25 mg of etanercept.
Kull siringa mimlija għal- lest fiha 0. 5 ml ta ’ soluzzjoni, li tipprovdi 25 mg ta ’ etanercept.
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate and sodium phosphate dibasic dihydrate, and water for injections.
Is- sustanzi l- oħra huma sukrożju, sodium chloride, L- arginine hydrochloride, sodium phosphate monobasic dehydrate u sodium phosphate dibasic dihydrate u ilma għall- injezzjonijiet
What Enbrel looks like and contents of the pack
332 Id- dehra ta 'ENBREL u l- kontenuti tal- pakkett
Enbrel is supplied as a pre-filled syringe containing a clear, colourless or pale yellow solution for injection.
Enbrel hu provdut bħala siringa mimlija għal- lest li fiha soluzzjoni ċara, mingħajr kulur jew safar ċara għall- injezzjoni.
Each pack contains 4, 8 or 24 pre-filled syringes and 8, 16 or 48 alcohol swabs.
Kull pakkett fih 4, 8 jew 24 siringi mimlija għal- lest u 8, 16 jew 48- il swab ta ’ l - alkoħol.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsjijiet kollha jkun għall- skop kummerċjali.
Marketing Authorisation Holder:
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG United Kingdom
New Lane Havant Hampshire, PO9 2NG Ir- Renju Unit
Tél/ Tel: +32 10 49 47 11 Fax: +32 10 49 48 70
T el, Tel.: +32 10 49 47 11 Fax: +32 10 49 48 70
Tel: + 351 21 412 82 00 Fax: +351 21 412 01 11
T el, Tel.: +351 21 412 82 00 Fax: +351 21 412 01 11
Danmark Wyeth Danmark Tlf: + 45 44 88 88 05 Fax: +45 44 88 88 06
Danmark Wyeth Danmark Tél, Tel.: +45 44 88 88 05 Fax: +45 44 88 88 06
42-1-2-654-128-16 Fax:
42- 1- 2- 654- 128- 16 Tel:
347 Deutschland Wyeth Pharma GmbH Tel: + 49 180 2 29 93 84 Fax: +49 251 204 1128
Deutschland Wyeth Pharma GmbH
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE T: +357 22 817690 Φαζ: + 357 22 751855
Tηλ: +357 22 817690 Tel: + 357 22 751855
Magyarország Wyeth Kft Tel: +36 1 453 33 30 Fax: +36 1 240 4632
Wyeth Kft Tel.: +36 1 453 33 30 Fax: + 36 1 240 4632
Tel: + 34 91 334 65 65 Fax: + 34 91 663 65 53
Tel.: +34 91 334 65 65 Fax: +34 91 663 65 53
Norge Wyeth Tlf: +47 40 00 23 40 Fax: +47 40 00 23 41
Norge Wyeth Tlf.: +47 40 00 23 40 Fax: +47 40 00 23 41
7.
334 7.
This section is divided into the following sub-sections:
Din is- sezzjoni hija maqsuma fis- sub- sezzjonijiet segwenti:
Introduction Step 1:
Introduzzjoni L- 1 Fażi:
Setting up for an injection Step 2:
Kif tlesti għall- injezzjoni It- 2 Fażi:
Choosing an injection site Step 3:
Kif tagħżel is- sit ta 'l- injezzjoni It- 3 Fażi:
Injecting the Enbrel solution Step 4:
Kif tinjetta s- soluzzjoni ta 'Enbrel Ir- 4 Fażi:
You will be instructed by your doctor or his/ her assistant on the techniques
Inti ser tkun mgħallem mit- tabib tiegħek jew l - assistent tiegħu/ tagħha kif għandek tinjetta lilek innifsek jew kif tinjetta lit- tifel/ tifla tiegħek.
Step 1:
L- 1 Fażi:
Select a clean, well-lit, flat working surface.
Agħżel superfiċje ċatta, nadifa u mdawwla fejn tipprepara l- injezzjoni.
Take the Enbrel carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface.
Oħroġ il- kartuna li fiha s- siringi mimlija għal- lest ta ’ Enbrel mill- friġġ u poġġiha fuq wiċċ ċatt biex taħdem.
Remove one pre-filled syringe and one alcohol swab and place them on the work surface.
Oħroġ siringa mimlija għal- lest u swab ta ’ l- alkoħol u poġġihom fuq il- wiċċ fejn se taħdem.
Do not shake the pre-filled syringe of Enbrel.
Tħawwadx is- siringa mimlija għal- lest ta ’ Enbrel.
Place the carton containing any remaining pre- filled syringes back into the refrigerator.
Poġġi l- kartuna li għad fadalla xi siringi mimlija għal- lest lura fil- friġġ.
Please see section 5 for instructions on how to store Enbrel.
Jekk jogħġbok ara s- sezzjoni 5 dwar kif taħżen Enbrel.
If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
Jekk għandek xi mistoqsijiet dwar il- ħażna, agħmel kuntatt mat- tabib, infirmier jew spiżjar tiegħek għal aktar struzzjonijiet.
You should allow 15 to 30 minutes for the Enbrel solution in the syringe to reach room temperature.
Għandek tħalli 15 sa 30 minuta għas- soluzzjoni ta ’ Enbrel biex tilħaq it- temperatura tal - kamra.
DO NOT remove the needle cover while allowing it to reach room temperature.
TNEĦĦIX l- għatu tal- labra sakemm ikun qed jilħaq it- temperatura tal- kamra.
Assemble the additional supplies you will need for your injection.
Iġbor xi oġġetti oħra li se jkollok bżonn għall- injezzjoni tiegħek.
These include an alcohol swab and a cotton ball or gauze.
Dawn jinkludu swab ta ’ l - alkoħol u ballun tat- tajjar jew garża.
Wash your hands with soap and warm water.
Aħsel idejk bis- sapun u bl- ilma sħun.
Make sure the solution in the pre-filled syringe is clear, colourless or pale yellow, and practically free from visible particles.
Kun ċert li s- soluzzjoni fis- siringa mimlija għal- lest hija ċara, mingħajr kulur jew safar ċara, u prattikament ħielsa minn kull farka viżibbli.
Otherwise, do not inject the solution.
B’ mod alternattiv, intwera li tinjettax is- soluzzjoni.
Use a different Enbrel pre-filled syringe, then contact your pharmacist for assistance.
Uża siringa mimlija għal- lest ta ’ Enbrel differenti u imbagħad kkuntattja lill- ispiżjar tiegħek għall- għajnuna.
Step 2:
It- 2 Fażi:
The three recommended injection sites for Enbrel using a pre-filled syringe include:
It- tliet siti rakkomandati għall- injezzjoni bl- użu ta ’ siringa mimlija għal- lest b’ Enbrel jinkludu:
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 1).
(1) il- parti ta ’ quddiem fin- nofs tal- koxxa; (2) l- istonku ħlief għal 5 ċm mad- dawra taż- żokra; u (3) iż- żona ta ’ barra tal- parti ta ’ fuq tad- driegħ (ara Dijagramma 1).
If you are self injecting, you should not use the outer area of the upper arms.
Jekk tkun qed tagħti l - injezzjoni lilek innifsek, m’ għandekx tuża n- naħa ta ’ barra tan- naħa ta ’ fuq tad- dirgħajn.
Diagram 1.
335 Dijagramma 1.
A different site should be used for each new injection.
Għal kull injezzjoni għandek tuża sit ġdid.
Avoid
TINJETTAX f’ postijiet fejn il - ġilda hija tenera, mbenġla, ħamra jew iebsa.
349 areas with scars or stretch marks.
Evita żoni fejn għandek xi feriti jew stretch marks.
(It may be helpful to keep notes on the location of the previous injections.) 3.
(Jista ’ jkun utli li żżomm noti dwar il- post fejn ikunu ngħataw l- injezzjonijiet ta ’ qabel.) 3.
If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“ psoriasis skin lesions”).
Jekk int jew it- tifel/ tifla tiegħek għandkom il- psorjażi, ipprova tinjettax direttament ġo partijiet imqabbżin, ħoxnin, ħomor jew bil- qoxra tal- ġilda (“ feriti tal- ġilda psorjatiċi ”).
Step 3:
It- 3 Fażi:
Injecting the Enbrel solution
Kif tipprepara s- sit ta 'l- injezzjoni u tinjetta s- soluzzjoni ta' Enbrel
Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion.
Imsaħ bi swabs bl- alkoħol is- sit fejn ser tagħti l- injezzjoni ta ’ Enbrel, waqt li tuża movimenti ċirkulari.
DO NOT touch this area again before giving the injection.
TERĠAX TMISS din l- erja qabel tagħti l- injezzjoni.
Pick up the pre-filled syringe from the flat work surface.
Aqbad is- siringa mimlija għal- lest mill- wiċċ ċatt fejn qed taħdem.
Remove the needle cover by firmly pulling it straight off the syringe (see Diagram 2).
Neħħi l- għatu tal- labra billi tiġbdu b’ mod sod dritt ’ il fuq mis- siringa (ara Dijagramma 2).
When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
Meta tneħħi l- għatu tal- labra jista ’ jkun hemm taqtira ta ’ likwidu fit- tarf tal- labra; dan hu normali.
Do not touch the needle or allow it to touch any surface.
Tmissx il- labra u tħallihiex tmiss ma ’ xi wiċċ.
Do not touch or bump the plunger.
Tmissx u tinbutax il- planġer.
Doing so could cause the liquid to leak out.
Jekk tagħmel dan, jista ’ joħroġ il- likwidu.
When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Meta tinxef iż- żona tal- ġilda mnaddfa oqrosha u żommha sew b’ id waħda.
With the other hand, hold the syringe like a pencil.
Bl- id l- oħra żomm is - siringa bħal lapes.
With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 3).
B’ moviment mgħaġġel u qasir, imbotta l- labra ’ l isfel kemm tista ’ ġol- ġilda f’ angolu bejn 45° u 90° (ara Dijagramma 3).
Diagram 3
336 Dijagramma 3
When the needle is completely inserted into the skin, release the skin that you are holding.
Meta l- labra tkun iddaħħlet kompletament ġol- ġilda, erħi l- ġilda li tkun qed iżżomm.
Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 4).
Imbagħad imbotta l - planġer biex tinjetta s- soluzzjoni kollha b’ rata kostanti u bil- mod, u fissa (ara Dijagramma 4).
Diagram 4
Dijagramma 4
When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Meta s- siringa tiżvojta, oħroġ il- labra mill- ġilda waqt li toqgħod attent li tibqa ’ żżommha angolata kif kienet meta daħħaltha.
There may be a little bleeding at the injection site.
Jista ’ jkun hemm ftit demm fis- siti ta ’ l- injezzjoni.
You can press a cotton ball or gauze over the injection site for 10 seconds.
Tista ’ tagħfas ballun tat- tajjar jew garża fuq is- sit ta ’ l- injezzjoni għal 10 sekondi.
Do not rub the injection site.
Tħokkx is- sit ta ’ l- injezzjoni.
If needed, you may cover the injection site with a bandage.
Jekk hemm bżonn, tista ’ tagħtti s- sit ta ’ l- injezzjoni b’ faxxa.
Step 4:
Ir- 4 Fażi:
 The pre-filled syringe is for single-use administration only.
• Is- siringa mimlija għal- lest hi biex tintuża għal għoti wieħed biss.
The syringe and needle should NEVER be re-used.
Is- siringa u l- labra qatt m’ għandhom jerġgħu jintużaw.
NEVER re-cap a needle.
QATT terġa ’ tgħatti labra.
If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Enbrel.
Jekk għandek xi mistoqsijiet jekk jogħġbok kellem lit- tabib, infirmier jew spiżjar li huwa familjara ma ’ Enbrel.
351 PACKAGE LEAFLET:
337 FULJETT TA ’ TAGĦRIF:
Enbrel 50 mg solution for injection in pre-filled syringe Etanercept
Enbrel 50 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Etanercept
You may need to read it again.  Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Enbrel.  If you any have further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you.
Jista jkollok bżonn terġa ’ taqrah. • It- tabib tiegħek ser jagħtik ukoll Patient Alert Card, li fiha informazzjoni importanti dwar is - sigurtà li inti jeħtieġ li tkun taf dwarha qabel u matul il- kura b’ Enbrel. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
352 Enbrel is not effective in the treatment of Wegener’ s granulomatosis, a rare inflammatory disease.
Enbrel mhux effettiv għat- trattament tal- granulomatosi ta 'Wegener, marda infjammatorja rari.
2.
338 2.
If you are allergic to etanercept or any of the other ingredients of Enbrel.
Jekk int tkun allerġiku għal etanercept jew xi wieħed mis- sustanzi ta 'Enbrel.
If you have or are at risk of developing a serious blood infection called sepsis.
Jekk int għandek, jew tinsab f' riskju li tiżviluppa infezzjoni tad - demm serja li tissejjaħ sepsis.
Please consult your doctor before you receive any vaccines.  Chickenpox:
Jekk jogħġbok ikkonsulta mat- tabib qabel ma int jew it- tifel/ tifla tirċievu xi vaċċinazzjonijiet. • Ġidri r- riħ:
Tell you doctor if you are exposed to chickenpox when using Enbrel.
Għid lit- tabib jekk int espost għal ġidri r- riħ meta tieħu Enbrel.
353 Using other medicines
339 Meta tuża mediċini oħra
If you become pregnant, you should consult your doctor.
Jekk tinqabad tqila, inti għandek tikkonsulta t- tabib tiegħek.
Always use Enbrel exactly as your doctor has told you. You should check with your doctor if or pharmacist you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
A 25 mg strength of Enbrel is available for doses of 25 mg.
Qawwa ta ’ 25 mg hija disponibbli għal dożi ta ’ 25 mg (jew anqas).
354 Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Inkella, 50 mg jistgħu jingħataw darbtejn fil- ġimgħa sa 12- il ġimgħa, segwiti minn 25 mg mogħtija darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
Your doctor will decide how long you should take Enbrel and whether retreatment is needed based on your response.
340 It- tabib tiegħek ser jiddeċidi għal kemm żmien għandek tieħu Enbrel u jekk għandux ikun hemm trattament mill- ġdid skond ir- rispons tiegħek.
Detailed instructions on how inject Enbrel are provided in section 7, “ INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL”.
Struzzjonijiet dettaljati dwar kif għandek tinjetta Enbrel huma pprovduti f' sezzjoni 7, “ STRUZZJONIJIET GĦALL- PREPARAZZJONI U KIF TAGĦTI INJEZZJONI TA ’ ENBREL ”.
355 Allergic reactions
Reazzjonijiet allerġiċi
 Trouble swallowing or breathing.  Swelling of the face, throat, hands, or feet.  Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/ or a warm feeling.  Severe rash, itching, or hives (elevated patches of red or pale skin that often itch).
341 • Jekk issib problemi biex tibla jew tieħu n- nifs. • Jekk il- wiċċ, il- ġriżmejn, l- idejn jew is- saqajn jintefħu. • Tħossok nervuż/ a jew anzjuż/ a, sensazzjonijiet ta 'taħbit il- qalb, ħmura f' daqqa fil- ġilda u/ jew sensazzjoni ta ’ sħana. • Raxx, ħakk jew ħurrieqa qawwija (rqajja' elevati ta 'ġilda ħamra jew pallida li xi kultant iġġagħlek tħokk).
356  Rare (may occur in less than 1 in 1,000 patients): serious allergic reactions (including severe localized swelling of the skin and wheezing); combined low platelet, red, and white blood cell count; nervous system disorders (with signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; worsening congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); inflammation of the blood vessels; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; elevated liver blood tests; skin rash which may lead to severe blistering and peeling of the skin.
• Rari (jistgħu jseħħu f' inqas minn 1 f' 1, 000 pazjent): reazzjonijiet allerġiċi serji (li jinkludu tinfih lokalizzat qawwi tal- ġilda u tħarħir); għadd baxx ta ’ plejtlets, taċ- ċelloli ħomor u ċ- ċelloli bojod; disturbi tas- sistema nervuża (b' sinjali u sintomi simili għal dawk ta 'sklerożi multipla jew infjammazzjoni tan- nervi ta' l- għajnejn jew l- korda spinali); tuberkolożi; tiħżin tal- insuffiċjenza konġestiva tal- qalb, aċċessjonijiet, sindromu ta 'lupus jew bħal ta' lupus (sintomi jistgħu jinkludu raxx persistenti, deni, uġigħ fil- ġogi u għejja); infjammazzjoni tal- kanali tad- demm; għadd totali baxx taċ- ċelloli ħomor tad- demm, għadd baxx totali taċ- ċelloli bojod tad- demm, għadd baxx ta '342 newtrofili (tip ta' ċelloli bojod tad- demm); l- enżimi tal- fwied fid- demm ikunu ogħla; raxx tal - ġilda li jista ’ jwassal għal infafet u tqaxxir sever tal- ġilda.
After taking a syringe from the refrigerator, the Enbrel solution should be allowed to reach room temperature (15-30 minutes).
Wara li toħroġ is- siringa mill- friġġ, is- soluzzjoni ta 'Enbrel għandha titħalla tilħaq it- temperatura tal- kamra (15- 30 minutes).
Immediate use is then recommended.
Imbagħad, użu immedjat huwa rrakkomandat.
Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept.
Kull siringa mimlija għal- lest fiha 1. 0 ml ta ’ soluzzjoni, li tipprovdi 50 mg ta 'etanercept.
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate and sodium phosphate dibasic dihydrate, and water for injections.
Is- sustanzi l- oħra huma sukkrożju, sodium chloride, L- arginine hydrochloride, sodium phosphate monobasic dihydrate u sodium phosphate dibasic dehydrate u ilma għall- injezzjonijiet
357 What Enbrel looks like and contents of the pack
Id- dehra ta 'ENBREL u l- kontenuti tal- pakkett
Enbrel is supplied as a pre-filled syringe containing a clear, colourless or pale yellow solution for injection.
Enbrel hu provdut bħala siringa mimlija għal- lest li fiha soluzzjoni ċara, mingħajr kulur jew isfar ċar għall- injezzjoni.
Each pack contains 2, 4 or 12 pre-filled syringes and 4, 8 or 24 alcohol swabs.
Kull pakkett fih 2, 4 jew 12 siringa mimlija għal- lest u 4, 8 jew 24 ġbara ta ’ l- alkoħol.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
343 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
358 Ελλάδα Wyeth Hellas A. E. B. E.
Wyeth Hellas A. E. B. E.
INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL
Struzzjonijiet għall- preparazzjoni u kif tagħti injezzjoni ta ’ Enbrel
Select a clean, well-lit, flat working surface.
Agħżel wiċċ nadif, imdawwal sew u ċatt.
Take the Enbrel carton containing the pre-filled syringes out of the refrigerator and place it on a flat work surface.
Oħroġ il- kartuna li fiha s- siringi mimlija għal- lest ta ’ Enbrel mill- friġġ u poġġiha fuq wiċċ ċatt biex taħdem.
Remove one pre-filled syringe and one alcohol swab and place them on your work surface.
Oħroġ siringa mimlija għal- lest u ġbara ta ’ l- alkoħol u poġġihom fuq il- wiċċ fejn se taħdem.
You should allow 15 to 30 minutes for the Enbrel solution in the syringe to reach room temperature.
Għandek tħalli 15 sa 30 minuta għas- soluzzjoni ta ’ Enbrel fis- siringa biex tilħaq temperatura tal- kamra.
DO NOT remove the needle cover while allowing it to reach room temperature.
TNEĦĦIX l- għatu tal- labra sakemm ikun qed jilħaq it- temperatura tal - kamra.
These include an alcohol swab and a cotton ball or gauze.
Dawn jinkludu ġbara ta ’ l - alkoħol u ballun tat- tajjar jew garża.
Make sure the solution in the pre-filled syringe is clear, colourless or pale yellow, and practically free from visible particles.
Kun ċert li s- soluzzjoni fis- siringa mimlija għal- lest hija ċara, mingħajr kulur jew isfar ċar, u prattikament ħielsa minn kull partiċella viżibbli.
Otherwise, do not inject the solution.
B’ mod alternattiv, intwera li tinjettax is - soluzzjoni.
Three recommended injection sites for Enbrel using a pre-filled syringe include:
Tliet siti rakkomandati għall- injezzjoni bl- użu ta ’ siringa mimlija minn qabel b’ Enbrel jinkludu:
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 1).
(1) il- parti ta ’ quddiem fin- nofs tal- koxxx; (2) l- istonku ħlief għal 5 ċm mad- dawra taż- żokkra; u (3) iż- żona ta ’ barra tal- parti ta ’ fuq tad- driegħ (ara Dijagramma 1).
Diagram 1.
345 Dijagramma 1.
Avoid areas with scars or stretch marks.
(Jista ’ jkun utli li żżomm noti dwar il- post fejn ikunu ngħataw l- injezzjonijiet ta ’ qabel.) Evita żoni fejn għandek xi feriti jew stretch marks.
If you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“ psoriasis skin lesions”).
Jekk int jew it- tifel/ tifla tiegħek għandkom il- psorjażi, ipprova tinjettax direttament ġo partijiet imqabbżin, ħoxnin, ħomor jew bil- qoxra tal- ġilda (“ feriti tal- ġilda psorjatiċi ”).
3.
It- 3 Fażi:
360 When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
Meta tneħħi l- għatu tal- labra jista ’ jkun hemm taqtira ta ’ likwidu fit- tarf tal- labra; dan hu normali.
Do not touch the needle or allow it to touch any surface.
Tmissix il- labra u tħallihiex tmiss ma ’ xi wiċċ.
Do not touch or bump the plunger.
Tmissix u tibbutax il- planġer.
When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Bl- id libera tiegħek, żomm is- siringa qrib il- bażi tagħha biex tistabbilizzaha.
With the other hand, hold the syringe like a pencil.
Dijagramma 4
With your free hand, hold the syringe near its base to stabilise it.
Meta s- siringa tiżvojta, oħroġ il- labra mill- ġilda waqt li toqgħod attent li tibqa ’ żżommha angolata kif kienet meta daħħaltha.
There may be a little bleeding at the injection site.
Jista ’ jkun hemm ftit demm fis- sit ta ’ l- injezzjoni.
Do not rub the injection site.
Togħrokx is- sit fejn tajt l- injezzjoni.
If needed, you may cover the injection site with a bandage.
Jekk hemm bżonn, tista ’ tkopri s- sit ta ’ l- injezzjoni b’ faxxa.
The syringe and needle should NEVER be reused.
Is- siringa u l- labra qatt m’ għandhom jerġgħu jintużaw.
NEVER recap a needle.
QATT terġa ’ tgħatti labra.
362
347
What is Enviage?
X' inhu Enviage?
Enviage is a medicine containing the active substance aliskiren.
Enviage hu mediċina li fiha s- sustanza attiva aliskiren.
It is available as tablets (pink, round:
Jiġi bħala pilloli (roża, tondi:
150 mg; red, oval:
150 mg; ħomor, ovali:
What is Enviage used for?
Għal x' hiex jintuża Enviage?
Enviage is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Enviage jintuża fit- trattament tal- pressjoni għolja essenzjali. ‘ Essenzjali 'tfisser li ma tkunx tista' tinstab kawża speċifika għall- pressjoni għolja.
How is Enviage used?
Kif jintuża Enviage?
The recommended dose of Enviage is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Id- doża rrakkomandatata ta 'Enviage hi 150 mg darba kuljum, jew waħedha jew flimkien ma' mediċini oħra għall- pressjoni għolja.
It should be taken with a light meal preferably at the same time each day.
Għandu jittieħed ma 'ikla ħafifa, preferibbilment fl- istess ħin kuljum.
The dose may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Id - doża tista 'tiżdied għal 300 mg darba kuljum fil- pazjenti li l- pressjoni tagħhom ma tkunx tista' tiġi kkontrollata adegwatament.
Enviage is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Enviage mhux rakkomandat għat- tfal, minħabba nuqqas ta 'tagħrif dwar is- sigurtà u l- effikaċja f' dan il- grupp.
How does Enviage work?
Kif jaħdem Enviage?
The active substance in Enviage, aliskiren, is a renin inhibitor.
Is- sustanza attiva f' Enviage, aliskiren, hi inibitur tar- renin.
It blocks the activity of a human enzyme called renin, which is involved in the production of a substance, angiotensin I, in the body.
Timblokka l- attività ta 'enzim uman magħruf bħala renin, li għandu x' jaqsam mal- produzzjoni ta' sustanza, angiotensin I, fil- ġisem.
Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (it narrows blood vessels).
Angiotensin I jinbidel fl- ormon angiotensin II, li hu vasokonstrittur (sustanza li ddejjaq l- arterji u l - vini) qawwi.
By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Bl- imblukkar tal- produzzjoni ta 'l- angiotensin I, il- livelli kemm ta' angiotensin I kif ukoll ta 'angiotensin II jonqsu.
This causes vasodilation (widening of the blood vessels), so that the blood pressure drops and the potential risk of damage caused by high blood pressure may be reduced.
Dan iwassal għal twessigħ ta 'l- arterji u l- vini, u b' hekk titnaqqas il- pressjoni u jista ’ jonqos ukoll ir- riskju potenzjali ta' ħsara kkawżata mill- pressjoni għolja.
How has Enviage been studied?
Kif ġie studjat Enviage?
The effects of Enviage were first tested in experimental models before being studied in humans.
L- effetti ta 'Enviage għall- ewwel ġew ittestjati f' mudeli esperimentali qabel ma ġew studjati fil - bnedmin.
Enviage was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Enviage ġie studjat f' 14- il studju ewlieni li fihom ħadu sehem iktar minn 10, 000 pazjent bi pressjoni għolja essenzjali.
Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
Fi tlettax minn dawn l- istudji ħadu sehem pazjenti bi pressjoni għolja bejn ħafifa u moderata, u fl- istudju l- ieħor ħadu sehem pazjenti bi pressjoni għolja severa.
In five of the studies, the effects of Enviage taken alone were compared with those of placebo (a dummy treatment).
F' ħamsa mill - istudji, l- effetti ta 'Enviage meħud waħdu tqabblu ma' dawk ta 'plaċebo (trattament finta).
Enviage, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Enviage, meħud waħdu jew flimkien ma 'mediċini oħra, tqabbel ma' mediċini oħra għall- pressjoni għolja.
Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L - istudji kombinatorji ħarsu lejn l- effett ta 'Enviage użat flimkien ma' inibitur ta 'enzim li jikkonverti l - angiotensin (ramipril), ma' sustanza li timblokka r- riċettur ta 'l- angiotensin (valsartan), ma' beta - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged diuretic (hydrochlorothiazide).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged blocker (atenolol), u ma 'sustanza li timblokka l- kanali tal- kalċju (amlodipine) u sustanza diuretika (hydrochlorothiazide).
The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (diastolic) or when the chambers of the heart are contracting (systolic).
L- istudji damu bejn sitta u 52 ġimgħa u l- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- tibdil fil- pressjoni matul il- fażi ta' mistrieħ tat- taħbita tal- qalb (il- pressjoni dijastolika) jew waqt li il- fażi ta ’ kontrazzjoni tal- qalb (il- pressjoni sistolika).
What benefit has Enviage shown during the studies?
X' inhu l- benefiċċju ta 'Enviage li ntwera f' dawn l- istudji?
Enviage on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Enviage waħdu kien iktar effettiv mill- plaċebo u kien effettiv daqs it- trattamenti komparattivi fit - tnaqqis tal- pressjoni.
When the results of the five studies comparing Enviage taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Enviage, from an average of 99.4 mmHg at the start of the study.
Meta r- riżultati tal- ħames studji li qabblu Enviage meħud waħdu ma 'plaċebo ġew studjati flimkien, il- pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil- pressjoni dijastolika ta' 9. 0 mmHg wara tmien ġimgħat jieħdu 150 mg Enviage, minn medja ta '99. 4 mmHg fil - bidu tat- trattament.
This was compared with a fall of 5.8 mmHg from 99.3 mmHg in those taking placebo.
Min- naħa l- oħra kien hemm tnaqqis ta '5. 8 mmHg minn 99. 3 mmHg fil- pazjenti li kienu qed jieħdu l- plaċebo.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Enviage.
Fil- pazjenti li kellhom 65 sena jew iktar u f' dawk li kienu qed jieħdu dożi ogħla ta 'Enviage kien hemm tnaqqis ikbar fil- pressjoni.
Enviage also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Enviage ġab ukoll tnaqqis fil- pressjoni fil - pazjenti bid- dijabete, pazjenti b' piż eċċessiv, u f' dawk li kellhom iktar minn 65 sena.
The medicine’ s effects were maintained for up to 52 weeks in two of the studies.
L- effetti tal - mediċina baqgħu jidhru sa massimu ta '52 ġimgħa f’ tnejn mill- istudji.
The studies also showed that Enviage, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Enviage.
L- istudji wrew ukoll li Enviage, meta meħud flimkien ma 'mediċini oħra (speċjalment hydrochlorothiazide), jista' jwassal għal iktar tnaqqis fil- pressjoni meta mqabbel mat- tnaqqis fil - pressjoni kkawżat minn dawn il- mediċini meħuda mingħajr Enviage.
What is the risk associated with Enviage?
X' inhu r- riskju assoċjat ma 'Enviage?
The most common side effect with Enviage (seen in between 1 and 10 patients in 100) is diarrhoea.
L- iktar effett sekondarju komuni ta 'Enviage (li deher f' bejn pazjent wieħed u 10 minn kull 100) hi d - dijarea.
For the full list of all side effects reported with Enviage, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Enviage, ara l- Fuljett ta 'Tagħrif.
Enviage should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Enviage m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal aliskiren jew għal xi sustanza oħra tiegħu.
It must also not be used during the second or third trimesters of pregnancy (from around the fourth month of pregnancy).
Lanqas ma għandu jintuża mir- raba ’ xahar tat- tqala ‘ l fuq.
Its use during the first trimester of pregnancy and in women planning to become pregnant is not recommended.
Mhux rakkomandat li jintuża matul l- ewwel tliet xhur tat- tqala u min- nisa li jkunu qed jippjanaw li joħorġu tqal.
Why has Enviage been approved?
Għaliex ġie approvat Enviage?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Enviage are greater than its risks for the treatment of essential hypertension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Enviage fit- trattament tal- pressjoni għolja essenzjali huma ikbar mir- riskji tiegħu.
The Committee recommended that Enviage be given marketing authorisation.
Il- Kumitat irrakkomanda li Enviage jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Enviage:
Tagħrif ieħor dwar Enviage:
The European Commission granted a marketing authorisation valid throughout the European Union for Enviage to Novartis Europharm Limited on 22 August 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Enviage lil Novartis Europharm Limited fl- 22 ta 'Awwissu ta' l- 2007.
The full EPAR for Enviage can be found here.
L- EPAR sħiħ għal Enviage jinsab hawn.
This summary was last updated in 07-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' Lulju ta 'l- 2007.
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Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali Pillola miksija b’ rita Użu orali
Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC)
Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC) Folja (PA/ Alu/ PVC)
7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 (3x28) tablets 90 tablets 98 (2x49) tablets 280 (20x14) tablets 7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 (3x28) tablets 90 (3x30) tablets 98 (2x49) tablets 280 (20x14) tablets
7 pilloli 14 pilloli 28 pilloli 30 pilloli 50 pilloli 56 pilloli 84 (3x28) pilloli 90 pilloli 98 (2x49) pilloli 280 (20x14) pilloli 7 pilloli 14 pilloli 28 pilloli 30 pilloli 50 pilloli 56 pilloli 84 (3x28) pilloli 90 (3x30) pilloli 98 (2x49) pilloli 280 (20x14) pilloli
Enviage 150 mg film-coated tablets
Enviage 150 mg pilloli miksijin b’ rita
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Kull pillola miksija b’ rita fiha 150 mg aliskiren (bħala hemifumarate).
Light-pink, biconvex, round tablet, imprinted “ IL ” on one side and “ NVR” on the other side.
Pillola roża ċar, konvessa miż- żewġ naħat, tonda, ittimbrata ‘ IL ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
Treatment of essential hypertension.
Kura ta ’ pressjoni għolja naturali.
The recommended dose of Enviage is 150 mg once daily.
Id- doża irrikkmandata ta ’ Enviage hija 150 mg darba kuljum.
In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily.
F’ pazjenti li l- pressjoni ma tkunx kontrollota kif jixraq, id- doża tista ’ tkun miżjuda għal 300 mg kuljum.
The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
L- effett li titbaxxa l- pressjoni jseħħ fi żmien ġimgħatejn (85- 90%) wara li tibda t- terapija b’ 150 mg kuljum.
Enviage may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
Enviage jista ’ jintuża waħdu jew ma ’ aġenti oħra li jbaxxu l- pressjoni (ara sezzjonijiet 4. 4 u 5. 1).
Enviage should be taken with a light meal once a day, preferably at the same time each day.
Enviage għandu jittieħed ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin tal- ġurnata kuljum.
Grapefruit juice should not be taken together with Enviage.
Il - meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Enviage.
Renal impairment No adjustment of the initial dose is required for patients with mild to severe renal impairment (see sections 4.4 and 5.2).
Indeboliment renali M’ hemmx bżonn li jkun hemm aġġustamenti tad- doża tal- bidu għall- pazjenti li jkollhom indeboliment renali ħafif għal sever (ara sezzjonijiet 4. 4 u 5. 2).
Hepatic impairment No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
Indeboliment epatiku M’ hemmx bżonn li jkun hemm aġġustamenti tad- doża tal- bidu għall- pazjenti li jkollhom indeboliment epatiku ħafif għal sever (ara sezzjoni 5. 2).
Elderly patients (over 65 years) No adjustment of the initial dose is required for elderly patients.
Pazjenti anzjani (minn 65 sena ’ l fuq) M’ hemmx bżonn ta ’ tibdil fid- doża tal- bidu għal pazjenti anzjani.
Paediatric patients (below 18 years) Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Pazjenti tfal (taħt it- 18- il sena) Enviage mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
2 Second and third trimesters of pregnancy (see section 4.6).
2 It- tieni u t- tielet trimestri tat- tqala (ara sezzjoni 4. 6).
The concomitant use of aliskiren with ciclosporin, a highly potent P-gp inhibitor, and other potent P- gp inhibitors (quinidine, verapamil), is contraindicated (see section 4.5).
L- użu konkomittanti ta ’ aliskiren ma ’ ciclosporin, inibitur ta ’ P- gp qawwi ħafna, u inibituri ta ’ P- gp qawwija oħrajn (quinidine, verapamil), huwa kontra- indikat (ara sezzjoni 4. 5).
Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/ or those with reduced kidney function and/ or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy.
Pazjenti li jkunu qed jirċievu prodotti mediċinali oħrajn li jinibixxu s- sistema renin- angiotensin (RAS), u/ jew dawk b’ funzjoni tal- kliewi mnaqqsa u/ jew dijabete mellitus għandhom riskju akbar li jkollhom iperkalimja waqt it- terapija b’ aliskiren.
Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Aliskiren għandu jintuża bil- kawtela f’ pazjenti b’ insuffiċjenza tal- qalb konġestiva serja (Klassi Funzjonali III- IV ta ’ l- Assoċjazzjoni Tal- Qalb ta ’ New York [NYHA]).
In the event of severe and persistent diarrhoea, Enviage therapy should be stopped.
F’ każ ta ’ dijarea severa u persistenti, it- terapija b’ Enviage għandha titwaqqaf.