qanastek/EMEA-V3 huggingface dataset:
A clinical response to anakinra generally appeared within 2 weeks of initiation of treatment and was sustained with continued administration of anakinra.
Rispons kliniku għal anakinra deher ġeneralment fi żmien ġimgħatejn mill- bidu tal- kura u nżamm billi tkompla jingħata anakinra.
22% responders as measured by ACR20
22% ta ’ pazjenti li rrispondew, mkejla skond il- kriterju ACR20).
The absolute bioavailability of anakinra after a 70 mg SC bolus injection in healthy subjects (n = 11) is 95%.
Il- biodisponibilità assoluta ta ’ anakinra wara injezzjoni ta ’ 70 mg taħt il- ġilda f ’ daqqa f ’ pazjenti b ’ saħħithom (n=11) hija ta ’ 95%.
18 months.
18- il xahar
For the purpose of ambulatory use, Kineret may be removed from the refrigerator for 12 hours at temperature not above 25°C, without exceeding the expiry date.
Għall- użu ambulatorju, Kineret jista ’ jitneħħa mill- friġġ għal 12- il siegħa f ’ temperatura ta 'mhux aktar minn 25°C, mingħajr ma' tkun għaddiet id- data ta 'meta jiskadi.
0.67 ml of solution for injection in a vial (Type I glass) with rubber stoppers, aluminium seals and plastic flip-off cap in a pack size of 1.
0. 67 ml ta 'soluzzjoni għall- injezzjoni ġo kunjett (Ħġieġ Tip I) b' tappijiet tal- lastiku, b 'siġilli ta' l - aluminjum, u għatu tal- plastik li jinqala 'faċilment b' sebgħa wieħed f 'pakkett ta' 1.
The vial stopper contains dry natural rubber (a derivative of latex).
It- tapp tal- kunjett fih lastiku naturali niexef (mnissel mill- latex).
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema għal immaniġġar ieħor
Allow the vial to reach room temperature before injecting.
Ħalli l- kunjett jilħaq temperatura ambjentali qabel ma tinjetta.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ SIRINGA MIMLIJA GĦAL- LEST
Kineret 100 mg solution for injection in a pre-filled syringe Anakinra
Kineret 100 mg soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest Anakinra
Each 0.67 ml pre-filled syringe contains 100 mg of anakinra.
Kull siringa mimlija għal- lest ta '0. 67 ml fiha 100 mg ta' anakinra.
Excipients: sodium citrate, sodium chloride, disodium edetate, polysorbate 80, sodium hydroxide, water for injections.
Sustanzi mhux attivi: sodium citrate, sodium chloride, disodium edetate, polysorbate 80, sodium hydroxide u ilma għall- injezzjoni.
Solution for injection in a single use pre-filled syringe 1 pre-filled syringe 7 pre-filled syringes 28 pre-filled syringes
Soluzzjoni għall- injezzjoni ġo siringa waħda mimlija għal- lest għall- użu ta ’ darba Siringa waħda mimlija għal- lest 7 siringi mimlija għal- lest 28 siringa mimlija għal- lest
For subcutaneous use Read the package leaflet before use.
Użu għal taħt il- ġilda Aqra l- fuljett ta ’ tagħrif qabel l- użu.
EXP.:
JIS.:
Store in the original container in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF NECESSARY
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 02/ 203/ 001 – 1-pack EU/ 1/ 02/ 203/ 002 – 7-pack EU/ 1/ 02/ 203/ 003 – 28-pack
EU/ 1/ 02/ 203/ 001 – Pakkett ta 'waħda EU/ 1/ 02/ 203/ 002 – Pakkett ta' 7 EU/ 1/ 02/ 203/ 003 – Pakkett ta '28
CARTON OF 7 PRE-FILLED SYRINGE AS AN INTERMEDIATE PACK (WITHOUT BLUE BOX)
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA '7 SIRIGNI MIMLIJA GĦAL- LEST BĦALA PAKKETT INTERMEDJU (MINGĦAJR BLUE BOX)
Solution for injection in a single use pre-filled syringe 7 pre-filled syringes This box containing 7 pre-filled syringes, is part of a 28-multipack.
Soluzzjoni għall- injezzjoni ġo siringa waħda mimlija għal- lest għall- użu ta ’ darba 7 siringi mimlija għal- lest Din il- kaxxa li fiha 7 siringi mimlija għal- lest, hija parti mill- pakkett ta '28.
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA 'SIRINGA MIMLIJA GĦAL- LEST
Kineret 100 mg injection Anakinra
Kineret 100 mg injezzjoni Anakinra
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA 'KUNJETT
Kineret 100 mg solution for injection in a vial Anakinra
Anakinra
Each 0.67 ml vial contains 100 mg of anakinra.
Kull kunjett ta '0. 67 ml fih 100 mg ta' anakinra.
Solution for injection in a single use vial 1 vial
Soluzzjoni għall- injezzjoni ġo kunjett wieħed għall- użu ta ’ darba Kunjett wieħed
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA 'KUNJETT
30 PACKAGE LEAFLET:
30 FULJETT TA ’ TAGĦRIF:
What Kineret is and what it is used for 2.
X’ inhu Kineret u għalxiex jintuża 2.
Before you use Kineret 3.
Qabel ma tuża Kineret 3.
How to use Kineret 4.
Kif għandek tuża Kineret 4.
How to store Kineret 6.
Kif taħżen Kineret 6.
WHAT KINERET IS AND WHAT IT IS USED FOR
X’ INHU KINERET U GĦALXIEX JINTUŻA
Kineret (an immunosuppressive agent) is a type of cytokine that is used to treat rheumatoid arthritis.
Kineret (aġent immunosoppressiv) huwa tip ta ’ ċitokina li jintuża għall- kura ta ’ l- artrite rewmatika.
Cytokines are proteins made by your body that co-ordinate communication between cells and help control cell activity.
Iċ- ċitokini huma proteini li jagħmilhom ġismek u li jikkordinaw il- komunikazzjoni bejn iċ- ċelluli u jgħinu fil- kontroll ta ’ l- attività taċ- ċelluli.
In rheumatoid arthritis, your body produces too much of a cytokine called interleukin-1.
Fl- artrite rewmatika, ġismek jipproduċi wisq minn ċitokina partikolari li jisimgħa interleukin- 1.
This results in harmful effects such as swelling and tissue damage.
Din iġġib effetti ħżiena bħal nefħa u ħsara fit- tessuti.
Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
Normalment, ġismek jipproduċi proteina li timblokka l- effetti ta ’ ħsara ta ’ interleukin- 1.
In rheumatoid arthritis your body does not produce enough of this blocking protein.
Fl- artrite rewmatika ġismek ma jipproduċix biżżejjed minn din il- proteina li timblokka.
The active substance of Kineret is anakinra produced by DNA technology using the micro-organism E. coli and works in the same way as your natural blocking protein.
Is- sustanza attiva ta ’ Kineret hija anakinra li hija magħmula b 'teknoloġija ta ’ DNA bl- użu tal- mikro- organiżmu E. coli u taħdem bl- istess mod bħall- proteina li timblokka naturali tiegħek.
Kineret is used to treat the signs and symptoms of rheumatoid arthritis in combination with another medicine called methotrexate.
Kineret jintuża sabiex jikkura s- sinjali u s- sintomi ta ’ l- artirite rewmatika flimkien ma ’ mediċina oħra li jisimgħa methotrexate.
Kineret is for patients whose response to methotrexate on its own is not good enough to control the rheumatoid arthritis.
Kineret għandu jintuża f’ pazjenti li r- rispons tagħhom għall- methotrexate mhuwiex tajjeb biżżejjed biex jikkontrolla l- artrite rewmatika.
BEFORE YOU USE KINERET
QABEL MA TUŻA KINERET
Kineret is for use in adults only (age 18 years and over).
Kineret huwa għall- użu fl- adulti biss (minn 18- il sena ‘ l fuq)
Do not use Kineret:
Tużax Kineret
• if you are allergic (hypersensitive) to Kineret (anakinra) or to any of the other ingredients in Kineret;
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal Kineret (anakinra) jew sustanzi oħra ta ’ Kineret;
• if you are allergic to other products that are produced by DNA technology using the micro- organism E. coli;
• jekk inti allerġiku/ a għal prodotti oħra li huma magħmula b 'teknoloġija ta ’ DNA bl- użu tal - mikro- organiżmu E. coli
• if you have severe renal impairment (kidney damage).
• jekk inti għandek indeboliment renali serju (ħsara fil- kliewi).
31 Contact your doctor immediately:
31 Għarraf lit- tabib tiegħek minnufih:
• if you get a rash all over your body, shortness of breath, wheezing, fast pulse or sweating after your Kineret injection.
• jekk jitlagħlek raxx ma ’ ġismek kollu, ikollok qtugħ ta ’ nifs, tisfir, polz imgħaġġel jew ixoqq l - għaraq għalik wara l- injezzjoni ta ’ Kineret.
These may be signs that you are allergic to Kineret.
Dawn jistgħu jkunu sinjali li int allerġiku għal Kineret.
Take special care with Kineret
Oqgħod attent ħafna b’ Kineret
Discuss with your doctor:
Kellem lit- tabib tiegħek jekk:
• if you have a history of recurring infections, or if you suffer from asthma.
• għandek passat ta ’ infezzjonijiet rikorrenti, jew jekk tbati mill- ażma.
Kineret may worsen these conditions;
Kineret jista ’ jaggrava dawn il- kundizzjonijiet;
• if you have cancer.
• għandek kanċer.
Your doctor will have to decide if you can still be given Kineret;
It- tabib tiegħek ikollu jiddeċiedi jekk tistax xorta tingħata Kineret;
• if you require vaccinations.
• teħtieġ tilqim.
You must not be given live vaccines while being treated with Kineret;
M’ għandekx tingħata tilqim ħaj waqt li qed tiġi kkurat b’ Kineret.
• if you know you are allergic to latex.
• jekk inti allerġiku għall- latex.
The needle cover on the pre-filled syringe contains a derivative of latex.
L- għatu tal- labra tas- siringa mimlija għal- lest fih sustanza mnissla mill- latex.
Kineret has not been tested in pregnant women.
Kineret ma ġiex ittestjat f ’ nisa tqal.
It is important to tell your doctor if you:
Huwa importanti li tavża lit- tabib jekk:
• think you may be pregnant; or
• taħseb li inti tqila; jew
• plan to get pregnant.
• qed taħseb biex issir tqila.
It is not known whether anakinra is excreted in human milk.
Mhuwiex magħruf jekk anakinra jiġi eliminat fil- ħalib tal- bniedem.
You must stop breast-feeding if you use Kineret.
Għandek tieqaf tredda ’ jekk qed tuża Kineret.
Important information about some of the ingredients of Kineret
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Kineret
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, i. e. essentially ‘ sodium-free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta 'sodium (23 mg) f' kull doża ta '100 mg, għalhekk huwa essenzjalment ‘ mingħajr sodium ’
HOW TO USE KINERET
KIF GĦANDEK TUŻA KINERET
Always use Kineret exactly as your doctor has told you.
Dejjem għandek tuża Kineret eżattament kif qallek it- tabib tiegħek.
Kineret must be injected under your skin (subcutaneous) once daily.
Kineret jrid jingħata permezz ta ’ injezzjoni taħt il- ġilda darba kuljum.
You should try to have the injection at the same time each day.
Għandek tipprova tieħu l- injezzjoni fl- istess ħin kuljum.
Injecting Kineret yourself
Tinjetta lilek innifsek b' Kineret
Your doctor may decide that it would be more convenient for you to inject Kineret yourself.
It- tabib tiegħek jista ’ jiddeċiedi li jkun aktar konvenjenti għalik jekk tinjetta lilek innifsek b’ Kineret.
Your doctor or nurse will show you how to inject yourself.
It- tabib jew l- infermiera tiegħek juruk kif tagħmel dan.
Do not try to inject yourself if you have not been trained.
Tippruvax tinjetta lilek innifsek jekk ma ġejtx mgħallem kif.
32 For instructions on how to inject yourself with Kineret, please read the section at the end of this leaflet.
32 Għal aktar istruzzjonijiet dwar kif tinjetta lilek innifsek b’ Kineret, jekk jogħġbok aqra s- sezzjoni fi tmiem dan il- fuljett ta 'tagħrif.
If you use more Kineret than you should
Jekk tuża Kineret aktar milli suppost
You should have no serious problems if you accidentally take more Kineret than you need.
M’ għandekx ikollok problemi serji jekk bi żball tieħu aktar Kineret milli għandek bżonn.
However, you should contact your doctor, nurse or pharmacist if this does happen.
Madanakollu, jekk jiġri dan, għandek tgħarraf lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek.
If you feel unwell in any way you should contact your doctor or nurse immediately.
Jekk tħossok b’ xi mod ma tiflaħx trid tgħarraf lill- infermiera jew lit- tabib tiegħek immedjatament.
If you forget to use Kineret
Jekk tinsa tieħu Kineret:
If you have forgotten to take a dose of Kineret, you should contact your doctor to discuss when you should take the next dose.
Jekk insejt tieħu doża ta ’ Kineret, kellem lit- tabib tiegħek biex jara meta jmissek tinjetta d- doża li jmiss.
Like all medicines, Kineret may cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Kineret jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (seen in more than 1 in 10 people who take Kineret) are:
Effetti sekondarji komuni ħafna (osservati f 'aktar minn 1 kull 10 persuni li jużaw Kineret) huma:
• Redness, swelling, bruising or itching at the injection site.
• ħmura, nefħa, tbenġil u ħakk fil- post ta ’ l- injezzjoni.
This is generally mild to moderate and is more common at the start of your treatment.
Dan is- soltu jkun ħafif għal moderat u huwa aktar komuni meta tibda l- kura tiegħek.
• Headaches.
• uġigħ ta ’ ras.
Common side effects (seen in more than 1, but less than 10 in 100 people taking Kineret) are:
Effetti sekondarji komuni (osservati f 'aktar minn 1, iżda f' anqas minn 10 f 'kull 100 persuna li jużaw Kineret) huma:
• Neutropenia (low white blood cell count) determined after a blood test.
• newtropenja (għadd baxx ta ’ ċelluli bojod tad- demm) misjuba wara test tad- demm.
This might increase the risk of you getting an infection.
Dan għandu mnejn iżidlek ir- riskju li taqbdek infezzjoni.
Symptoms of infection might include a fever or a sore throat.
Sintomi ta ’ infezzjoni jistgħu jinkludu deni jew uġigħ fil- ġriżmejn.
• Serious infections such as pneumonia (a chest infection) or infections of the skin.
• infezzjonijiet serji bħal pulmonite (infezzjoni fis- sider) jew infezzjonijiet fil- ġilda.
Symptoms might include a fever, a cough or redness and tenderness of the skin.
Sintomi jistgħu jinkludu deni, sogħla jew ħmura u nefħa tal- ġilda.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek.
HOW TO STORE KINERET
KIF TAĦŻEN KINERET
Do not use Kineret after the expiry date which is stated on the label and carton after EXP.
Tużax Kineret wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna wara JIS.
Store in original carton in order to protect from light.
Żommu fil- pakkett oriġinali biex tilqa ’ mid- dawl.
Do not use Kineret if you think it has been frozen.
Tużax Kineret jekk taħseb li ġie ffriżżat.
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 12 hours or disposed of.
La darba siringa tkun tneħħiet mill- friġġ u tkun laħqet temperatura ambjentali (mhux aktar minn 25°C) għandha tintuża fi żmien 12- il siegħa jew tintrema.
What Kineret contains
X’ fih Kineret:
The active substance is anakinra.
Is- sustanza attiva hi anakinra.
Each pre-filled syringe contains 100 mg of anakinra.
Kull siringa mimlija għal- lest fiha 100 mg ta 'anakinra.
• sodium citrate, sodium chloride, disodium edetate, polysorbate 80 and sodium hydroxide and water for injections.
• sodium citrate, sodium chloride, disodium edetate, polysorbate 80, sodium hydroxide u ilma għall- injezzjoni.
What Kineret looks like and contents of the pack
Id- dehra ta ’ Kineret u l- kontenuti tal- pakkett:
Kineret is a clear, colourless-to-white solution for injection and is supplied ready for use in a pre-filled syringe.
Kineret huwa soluzzjoni għall- injezzjoni ċara, mingħajr kulur għal bajda, u pprovduta ġo siringa mimlija għal- lest lesta għall- użu.
It may contain some translucent-to-white particles of protein.
Jista ’ jkun fiha xi frak ta ’ proteini trasluċidi għal bojod.
Not all pack sizes may be marketed.
Pakketti ta 'siringa waħda mimlija għal- lest, 7 siringi mimlija għal- lest jew 28 siringa mimlija għal - lest Jista' jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali..
This leaflet was last approved in Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/ __________________________________________________________________________________
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
Information on how to give yourself an injection of Kineret
Tagħrif dwar kif tinjetta lilek innifsek b' Kineret.
This section contains information on how to give yourself an injection of Kineret.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tagħti injezzjoni b 'Kineret lilek innifsek.
It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
Importanti li ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejt taħriġ speċjali mit- tabib, mill - infermiera jew mill- ispiżjar tiegħek.
If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Jekk għandek xi mistoqsijiet dwar kif tinjetta, jekk jogħġbok staqsi lit- tabib, lill- infermiera jew lill- ispiżjar għall- għajnuna.
How do you or the person injecting you, use the Kineret pre-filled syringe?
Kif inti jew il- persuna li se tinjettak, tuża is- siringa mimlija għal- lest b' Kineret?
You will need to give yourself an injection at the same time every day.
Ikollok bżonn tagħti injezzjoni lilek innifsek fl- istess ħin kuljum.
This is called a subcutaneous injection.
Kineret jingħata bħala injezzjoni eżatt taħt il- ġilda.
Equipment:
Apparat li teħtieġ:
To give yourself a subcutaneous injection you will need:
Biex tagħti injezzjoni taħt il- ġilda lilek innifsek teħtieġ:
• a new pre-filled syringe of Kineret; and
34 • siringa mimlija għal- lest b’ Kineret ġdida; u
• alcohol wipes or similar.
• msielaħ ta’ l- alkoħol jew simili;
34 What should you do before you give yourself a subcutaneous injection of Kineret?
X’ għandek tagħmel qabel ma tinjetta lilek nnifsek taħt il- ġilda b’ Kineret?
Take your Kineret pre-filled syringe out of the refrigerator.
Oħroġ s- siringa mimlija għal- lest b’ Kineret mill- friġġ.
Do not shake the pre-filled syringe.
Tħawwadx is- siringa mimlija għal- lest.
Do not use it if the date has passed the last day of the month shown.
Tużax jekk id - data qabżet l- aħħar ġurnata tax- xahar muri.
Check the appearance of Kineret.
Iċċekkja d- dehra ta ’ Kineret.
It must be a clear, colourless-to-white solution.
Din għandha tkun likwidu ċar u mingħajr kulur għal abjad.
There may be some translucent-to-white particles of protein in the solution.
Jista ’ jkun hemm xi frak ta ’ proteini trasluċidi għal bojod fis- soluzzjoni.
The solution should not be used if it is discoloured or cloudy, or if any particles other than translucent-to-white particles are present.
Is- soluzzjoni m ’ għandiex tintuża jekk jkollha tidnis tal- kulur jew jekk tkun mċajpra, jew jekk jkun hemm frak li mhux frak transluċidu għal abjad.
For a more comfortable injection, leave at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Għal injezzjoni aktar komda, ħalliha toqgħod f 'temperatura ambjentali għal bejn wieħed u ieħor 30 minuta jew żomm is- siringa mimlija għal- lest delikatament f’ idejk għal ftit minuti.
Do not warm Kineret in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Kineret bl’ ebda mod ieħor (eżempju: issaħħanx fil- majkrowejv jew f’ ilma jaħraq).
Do not remove the cover from the syringe until you are ready to inject.
Tneħħix l- għatu tas- siringa qabel ma tkun lest biex tinjetta.
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Sib post komdu, mdawwal sew, naddaf il- wiċċ, u poġġi dak kollu li għandek bżonn fejn tista 'tilħaqhom.
How do you prepare your Kineret injection?
Kif tipprepara l- injezzjoni ta ’ Kineret?
Before you inject Kineret you must do the following:
Qabel ma tinjetta Kineret trid tagħmel dan li ġej:
Hold the syringe barrel and gently take the cover from the needle without twisting.
Żomm it- tubu tas- siringa u aqla ’ bil- mod l- għatu minn mal- labra mingħajr ma ddawwar jew tgħawweġ.
You may notice a small air bubble in the pre-filled syringe.
Jista 'jkun li tinnota bużżieqa ta' l- arja żgħira ġewwa s- siringa mimlija għal- lest.
You do not have to remove the air bubble before injecting.
M' hemmx bżonn tneħħi l- bużżieqa ta 'l- arja qabel ma tinjetta.
Injecting the solution with the air bubble is harmless.
Tinjetta l- likwidu bil- bużżieqa ta 'l- arja mhux ta' ħsara.
Where should you give your injection?
Fejn għandek tagħti l- injezzjoni lilek nnifsek?
the top of your thighs; and the abdomen, except for the area around the navel.
in- naħa ta ’ fuq ta ’ kuxxtejk; u l- addome, minbarra l- parti ta 'madwar iż- żokkra.
Change the place that you inject each time so you don’t become sore in one area.
il- post ta 'l- injezzjoni kull darba sabiex ma jkollokx uġigħ fil- post ta' l -
If someone else is injecting for you, they can also use the back of your arms.
Jekk xi ħadd ieħor qed jinjettak, jista ’ wkoll juża in- naħa ta ’ wara tad - driegħ.
How do you give your injection?
35 Kif tagħti l- injezzjoni?
Disinfect your skin by using the alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Iddisinfetta l- ġilda billi tuża msielaħ ta ’ l- akoħol u oqros il- ġilda bejn sebgħek il- kbir u sebgħek il- werrej, mingħajr ma tagħfas.
Put the needle fully into the skin as shown by your nurse or doctor.
Daħħal il- labra għal kollox fil- ġilda kif wrewk l- infermiera jew it- tabib tiegħek.
Only use each syringe for one injection.
Uża kull siringa għal injezzjoni waħda biss.
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Jekk għandek xi problemi, jekk jogħġbok tibżax issaqsi lit- tabib jew lill- infermiera tiegħek għal għajnuna jew parir.
Disposing of used syringes
Rimi ta ’ siringi użati
• Do not put the cover back on used needles.
• Terġax tqiegħed l- għatu fuq labar użati.
• Keep used syringes out of reach and sight of children
• Żommu siringi użati ‘ l bogħod minn fejn jistgħu jilħquhom jew jarawhom it- tfal.
• Never put the pre-filled syringes that you have used into your normal household rubbish bin.
• Qatt tqiegħed is- siringi mimlija għal- lest li tkun użajt flimkien ma 'l- iskart domestiku tiegħek.
• The used pre-filled syringe should be disposed of in accordance with local requirements.
• Is- siringa mimlija għal- lest użata għandha tintrema kif jitolbu l- liġijiet lokali.
Kineret 100 mg solution for injection in a vial Anakinra
Kineret 100 mg soluzzjoni għall- injezzjoni ġo kunjett Anakinra
The active substance of Kineret is anakinra produced by DNA technology using the micro-organism E coli and works in the same way as your natural blocking protein.
Is- sustanza attiva ta ’ Kineret hija anakinra li hija magħmula b 'teknoloġija ta ’ DNA bl- użu tal- mikro- organiżmu E. coli u taħdem bl- istess mod bħall- proteina li timblokka naturali tiegħek.
• if you are allergic to other products that are produced by DNA technology using the micro- organism E coli;
• jekk inti allerġiku/ a għal prodotti oħra li huma magħmula b 'teknoloġija ta ’ DNA bl- użu tal - mikro- organiżmu E. coli
37 Contact your doctor immediately:
37 Għarraf lit- tabib tiegħek minnufih:
The vial stopper contains a derivative of latex.
It- tapp tal- kunjett fih sustanza mnissla mill- latex.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e. essentially ‘sodium-free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta 'sodium (23 mg) f' kull doża ta '100 mg, għalhekk huwa essenzjalment ‘ mingħajr sodium ’
Your doctor may decide that it would be m ore convenient for you to inject Kineret yourself.
It- tabib tiegħek jista ’ jiddeċiedi li jkun aktar konvenjenti għalik jekk tinjetta lilek innifsek b’ Kineret.
Your doctor or nurse will show you how to inject yourself.
It- tabib jew l- infermiera juruk kif tagħmel dan.
38 For instructions on how to inject yourself with Kineret, please read the section at the end of this leaflet.
38 Għal aktar istruzzjonijiet dwar kif tinjetta lilek innifsek b’ Kineret, jekk jogħġbok aqra s- sezzjoni fi tmiem dan il- fuljett ta 'tagħrif.
• redness, swelling, bruising or itching at the injection site.
• ħmura, nefħa, tbenġil u ħakk fil- post ta ’ l- injezzjoni.
• headaches.
• uġigħ ta ’ ras.
• neutropenia (low white blood cell count) determined after a blood test.
• newtropenja (għadd baxx ta ’ ċelluli bojod tad- demm) misjuba wara test tad- demm.
• serious infections such as pneumonia (a chest infection) or infections of the skin.
• infezzjonijiet serji bħal pulmonite (infezzjoni fis- sider) jew infezzjonijiet fil- ġilda.
Once a vial has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 12 hours or disposed of.
La darba kunjett jkun tneħħa mill- friġġ u jkun laħaq temperatura ambjentali (mhux aktar minn 25°C) għandu jintuża fi żmien 12- il siegħa jew jintrema.
Each vial contains 100 mg of anakinra.
Kull kunjett fih 100 mg ta 'anakinra.
Kineret is a clear, colourless-to-white solution for injection in a vial.
Kineret huwa soluzzjoni għall- injezzjoni ċara, mingħajr kulur għal bajda, ġo kunjett.
It may contain some translucent- to-white particles of protein.
Jista ’ jkun fiha xi frak ta ’ proteini trasluċidi għal bojod.
The presence of these particles does not affect the quality of the product.
Il- preżenza ta ’ dan il- frak ma jeffettwax il- kwalità tal - prodott.
Pack size of 1 vial.
Pakkett ta 'kunjett wieħed.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ __________________________________________________________________________________
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
How do you or the person injecting you, use the Kineret vial?
Kif inti jew il- persuna li se tinjettak, tuża l- kunjett ta 'Kineret?
• a new vial of Kineret;
• kunjett ta ’ Kineret ġdid;
40 • alcohol wipes or similar.
40 • siringa u labar sterili; u
What should you do before you give yourself a subcutaneous injection of Kineret?
X’ għandek tagħmel qabel ma tinjetta lilek nnifsek taħt il- ġilda b’ Kineret?
Take your Kineret vial out of the refrigerator.
Oħroġ il- kunjett ta 'Kineret mill- friġġ.
Check the expiry date on the vial label (EXP).
Iċċekkja d- data ta ’ skadenza fuq it- tikketta tal- kunjett (JIS).
Do not use it if the date has passed the last day of the month shown.
Tużax jekk id- data qabżet l- aħħar ġurnata tax- xahar muri.
For a more comfortable injection, leave at room temperature for approximately 30 minutes.
Għal injezzjoni aktar komda, ħalliha toqgħod f 'temperatura ambjentali għal bejn wieħed u ieħor 30 minuta.
Remove the plastic top from the vial by pushing upwards to expose the rubber stopper.
Neħħi l- għatu tal- plastik minn fuq il- kunjett billi timbottah 'l fuq sabiex tesponi it- tapp tal - lastiku.
Clean the stopper with a fresh alcohol wipe.
Naddaf it- tapp tal- lastiku b 'mselħa ta ’ l- akoħol ġdida.
Remove the syringe and needles from their packaging.
Neħħi s- siringa u l- labar mill- ppakkjar tagħhom.
Attach the longer needle to the syringe and remove the cover.
Waħħal l- itwal labra mas- siringa u neħħi l - għatu.
Pull the syringe plunger out, filling the syringe with air to the amount prescribed by your doctor.
Iġbed il- planġer tas- siringa 'l barra sa l- ammont preskritt mit- tabib tiegħek, b' hekk timla s - siringa bl- arja.
Push the needle through the rubber stopper and introduce the air into the vial by pushing the plunger.
Imbotta l- labra minn ġot- tapp tal- lastiku u daħħal l- arja fil- kunjett billi timbotta l- planġer.
Turn the vial upside down, pull on the plunger and fill the syringe with the correct amount of liquid.
Dawwar il- kunjett rasu 'l isfel, iġbed il- planġer u imla s- siringa bl- ammont tajjeb ta' likwidu.
It is important that the needle is always in the liquid in order to prevent air bubbles forming in the syringe.
Huwa importanti li l- labra tkun dejjem fil- likwidu sabiex tevita li jiffurmaw bżieżaq ta 'l- arja ġewwa s- siringa.
Remove the needle from the vial.
Neħħi l- labra minn ġewwa l- kunjett.
Remove the needle from the syringe.
Neħħi l- labra minn mas- siringa.
Put the short needle on the syringe and remove the cover.
Waħħal il- labra l- qasira mas- siringa u neħħi l- għatu.
Hold the syringe with the needle pointing up to see if it has any air bubbles inside.
Żomm is- siringa bil- labra tipponta 'l fuq u ara jekk hemm xi bżieżaq ġewwa.
If there are, gently press the plunger until all the air (but none of the liquid) has been removed.
Jekk hemm, imbotta l- planġer bil- mod sa kemm l- arja kollha tkun nħarġet (iżda ma jridx joħroġ l- ebda likwidu)
The syringe is ready for you to use.
Is- siringa hija lesta biex tużaha.
Where should you give your injection?
41 Fejn għandek tagħti l- injezzjoni lilek nnifsek?
the top of your thighs; and
in- naħa ta ’ fuq ta ’ kuxxtejk; u l- addome, minbarra l- parti ta 'madwar iż- żokkra.
41 • the abdomen, except for the area around the navel.
il- post ta 'l- injezzjoni kull darba sabiex ma jkollokx uġigħ fil- post ta' l -
Change the place that you inject each time so you don’t become sore in one area.
injezzjoni.
How do you give your injection?
Kif tagħti l- injezzjoni?
Only use each syringe for one injection.
Wara li tinjetta l- likwidu, neħħi l- labra u itlaq il- ġilda.
You must not use any Kineret that is left in the vial.
M' għandekx tuża Kineret li jkun fadal fil- kunjett.
Disposing of used needles, syringes and vials
Rimi ta ’ labar, siringi u kunjetti użati
• Keep used needles and syringes out of reach and sight of children
• Żommu labar u siringi użati ‘ l bogħod minn fejn jistgħu jilħquhom jew jarawhom it- tfal.
• Never put the syringes and vials that you have used into your normal household rubbish bin.
• Qatt tqiegħed siringi u kunjetti li tkun użajt flimkien ma 'l- iskart domestiku tiegħek.
• The used syringes and vials should be disposed of in accordance with local requirements.
• Is- siringi u kunjetti użati għandhom jintremew kif jitolbu l- liġijiet lokali.
What is Kinzalkomb?
X' inhu Kinzalkomb?
Kinzalkomb is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Kinzalkomb huwa mediċina li fiha żewġ sustanzi attivi, telmisartan u hydrochlorothiazide.
It is available as oval tablets (red and white:
Huwa disponibbli f' pilloli ovali (ħomor u bojod:
40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; yellow and white:
40 mg jew 80 mg telmisartan u 12. 5 mg hydrochlorothiazide; sofor u bojod:
80 mg telmisartan and 25 mg hydrochlorothiazide).
80 mg telmisartan u 25 mg hydrochlorothiazide).
What is Kinzalkomb used for?
Għal xiex jintuża Kinzalkomb?
Kinzalkomb is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
'Essenzjali' tfisser li l- pressjoni tad- demm għolja mhijiex ikkawżata minn xi kundizzjoni oħra.
The safety and effectiveness of Kinzalkomb have not been established in patients below 18 years of age.
Is- sigurtà u l- effikaċja ta 'Kinzalkomb ma ntwerewx f' pazjenti taħt l- età ta' 18- il sena.
The medicine can only be obtained with a prescription.
Din il- mediċina tista 'tinkiseb biss b' riċetta tat- tabib.
How is Kinzalkomb used?
Kif jintuża Kinzalkomb?
Kinzalkomb is taken by mouth once a day with liquid, with or without food.
Kinzalkomb jittieħed oralment darba kuljum ma 'xarba likwida, mal- ikel jew mingħajru.
The dose of Kinzalkomb to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/ 12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/ 12.5 mg tablets.
Id- doża ta 'Kinzalkomb li għandha tintuża tiddependi mid- doża ta' telmisartan li l- pazjent kien qiegħed jieħu qabel: il- pazjenti li qegħdin jieħdu 40 mg telmisartan għandhom jieħdu pilloli tal- 40/ 12. 5 mg filwaqt li l- pazjenti li kienu qegħdin jieħdu 80 mg telmisartan għandhom jieħdu pilloli tat- 80/ 12. 5 mg.
The 80/ 25 mg tablets are used in patients whose blood pressure is not controlled using the 80/ 12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Kinzalkomb.
Il- pilloli tat- 80/ 25 mg jintużaw minn pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata permezz ta 'pilloli tat- 80/ 12. 5 mg jew li l- qagħda tagħhom ġiet stabbli permezz ta' żewġ sustanzi attivi meħuda separatament qabel ma qalbu għal Kinzalkomb.
How does Kinzalkomb work?
Kif jaħdem Kinzalkomb?
Kinzalkomb contains two active substances, telmisartan and hydrochlorothiazide.
Kinzalkomb fih żewġ sustanzi attivi, telmisartan u hydrochlorothiazide.
Telmisartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Telmisartan hu tip ta '' antagonist tar- riċetturi tal- anġjotensina II 'li tfisser li jimblokka l- azzjoni tal - ormon fil- ġisem imsejjaħ l- anġjotensina II.
How has Kinzalkomb been studied?
Kif ġie studjat Kinzalkomb?
Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Kinzalkomb ġiet studjat f' ħames studji ewlenin li involvew total ta '2, 985 pazjent li jbatu minn ipertensjoni minn ħafifa għal moderata.
In four of these studies (2,272 patients), Kinzalkomb was compared with placebo (a dummy treatment) and with telmisartan taken alone.
F' erbgħa fost dawn l- istudji (jiġifieri 2, 272 pazjent), Kinzalkomb tqabbel mal- plaċebo (trattament finta) u ma 'telmisartan meħud waħdu.
The fifth study compared the effects of remaining on the 80/ 12.5 mg tablet with switching to the 80/ 25 mg tablet in 713 patients who had not responded to the 80/ 12.5 mg tablet.
Il- ħames studju qabbel l- effetti li ġew reġistrati meta l- pazjent baqa 'fuq pilloli tat- 80/ 12. 5 mg ma' dawk li jiġu reġistrati meta jaqleb għal pilloli tat- 80/ 25 mg.
In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Fl- istudji kollha, il- kejl ewlieni tal- effikaċja kien it- tnaqqis tal- pressjoni tad- demm dijastolika (pressjoni tad- demm mkejla bejn żewġ taħbitiet tal- qalb).
What benefit has Kinzalkomb shown during the studies?
X' inhuma l- benefiċċji ta 'Kinzalkomb li ntwerew f' dawn l- istudji?
Kinzalkomb was more effective than placebo and than telmisartan taken alone in reducing diastolic blood pressure.
Kinzalkomb kellu aktar effett mill- plaċebo u minn telmisartan waħdu fit- tnaqqis tal- pressjoni tad - demm dijastolika.
In patients who were not controlled on the 80/ 12.5 mg tablet, switching to the 80/ 25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.
Fil- pazjenti li ma kinux ikkontrollati bil- pilloli tat- 80/ 12. 5 mg, il- fatt li qalbu għall - pilloli tat- 80/ 25 mg kellu aktar effett fit- tnaqqis tal- pressjoni tad- demm dijastolika milli jekk baqgġu fuq doża inferjuri.
What is the risk associated with Kinzalkomb?
X' inhu r- riskju assoċjat ma 'Kinzalkomb?
The most common side effects with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness.
L- aktar effett sekondarju komuni b' Kinzalkomb huwa l- isturdament.
For the full list of all side effects reported with Kinzalkomb, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtata b' Kinzalkomb, ara l- Fuljett ta 'Tagħrif.
Kinzalkomb should not be used in people who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients (including sorbitol).
Kinzalkomb ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal telmisartan, hydrochlorothiazide, sulfonamide jew kwalunkwe fost l- ingredjenti l- oħra (inkluż sorbitol).
It must not be used in women who are more than three months pregnant or who are breast-feeding.
Din il - mediċina ma għandhiex tintuża minn nisa li ilhom aktar minn tliet xhur tqal jew li jreddgħu.
Its use during the first three months of pregnancy is not recommended.
L- użu tiegħu waqt l- ewwel tliet xhur tat- tqala mhuwiex rakkomandat.
Kinzalkomb must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Kinzalkomb ma għandux jintuża wkoll minn persuni li jbatu minn problemi gravi fil- fwied, kliewi jew problemi biljari, persuni li jkollhom livelli wisq baxxi ta 'potassju fid- demm, jew livelli wisq għoljin ta' kalċju fid- demm.
Care must be taken when using Kinzalkomb with other medicines that have an effect on blood potassium levels.
Kinzalkomb għandu jintuża b' kawtela meta użat ma 'mediċini oħra li jkollhom effett fuq il- livelli ta' potassju fid- demm.
The full list of these medicines is given in the Package Leaflet.
Il- lista sħiħa ta 'dawn il- mediċini tinsab fil- Fuljett ta' Tagħrif.
Why has Kinzalkomb been approved?
Għaliex ġie approvat Kinzalkomb?
The Committee for Medicinal Products for Human Use (CHMP) decided that Kinzalkomb’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li Kinzalkomb għandu iktar benefiċċji milli riskji fit- trattament tal- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad - demm tagħhom mhijiex adegwatament ikkontrollata b' telmisartan waħdu.
The Committee recommended that Kinzalkomb be given marketing authorisation.
Il- Kumitat irrakkomanda li Kinzalkomb jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Kinzalkomb:
Tagħrif ieħor dwar Kinzalkomb:
The marketing authorisation holder is Bayer Healthcare AG.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Kinzalkomb lil Bayer AG fid- 19 ta 'April 2002.
The marketing authorisation was renewed on 19 April 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 19 ta 'April 2007.
The full EPAR for Kinzalkomb is available here.
L- EPAR sħiħ dwar Kinzalkomb jista 'jiġi kkonsultat hawn.
This summary was last updated in 01-2009.
Dan is- sommarju kien aġġornat l- aħħar fi:
40 mg/ 12,5 mg 40 mg/ 12,5 mg 40 mg/ 12,5 mg 40 mg/ 12,5 mg 40 mg/ 12,5 mg 80 mg/ 12,5 mg 80 mg/ 12,5 mg 80 mg/ 12,5 mg 80 mg/ 12,5 mg 80 mg/ 12,5 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg
40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC)
folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC)
14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola 56 pillola 98 pillola 14- il pillola 28 pillola 28 x 1 pillola 56 pillola 98 pillola 14- il pillola 28 pillola 28 x 1 pillola 56 pillola 98 pillola
Kinzalkomb 40 mg/ 12.5 mg tablets
Kinzalkomb 40 mg/ 12. 5 mg pilloli
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Kull pillola fiha 40 mg ta ’ telmisartan u 12. 5 mg ta ’ hydrochlorothiazide.
Each tablet contains 112 mg of lactose monohydrate and 169 mg sorbitol (E420).
Kull pillola fiha 112 mg ta ’ lactose monohydrate u 169 mg ta ’ sorbitol (E420).
Red and white oval shaped two layer tablet engraved with the code number'H4 '.
Pillola ħamra u bajda b’ żewġ saffi, b’ forma ovali, b’ żewġ saffi, imnaqqxa bin- numru tal- kodiċi 'H4'.
Treatment of essential hypertension.
Kura ta ’ pressjoni tad- demm għolja essenzjali.
Kinzalkomb fixed dose combination (40 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
It- taħlita fissa tad- doża ta ’ Kinzalkomb (40 mg telmisartan/ 12. 5 mg ta ’ hydrochlorothiazide) hi indikata għal pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
4.2 Posology and method of administration
4. 2 Pożologija u metodu ta ’ kif għandu jingħata
Adults Kinzalkomb should be taken once daily with liquid, with or without food in patients whose blood pressure is not adequately controlled by telmisartan alone.
Adulti Kinzalkomb għandu jittieħed darba kuljum mal- likwidu, ma ’ l- ikel jew mingħajr ikel f’ pazjenti li l - pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
It- titrazzjoni individwali tad- doża b’ kull wieħed miż- żewġ komponenti hi rakkomandata qabel ma wieħed jaqleb għat- taħlita fissa tad- doża.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Meta jkun klinikament xieraq, bidla diretta minn monoterapija għat- taħlita tista; tkun ikkunsidrata.
• Kinzalkomb 40 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Kinzalmono 40 mg • Kinzalkomb 80 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Kinzalmono 80 mg
• Kinzalkomb 40 mg/ 12. 5 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew bi Pritor 40 mg • Kinzalkomb 80 mg/ 12. 5 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew bi Pritor 80 mg
Periodic monitoring of renal function is advised (see section 4.4).
Il- monitoraġġ perjodiku tal- funzjoni renali hu rakkomandat (ara sezzjoni 4. 4).
In patients with mild to moderate hepatic impairment the posology should not exceed Kinzalkomb 40 mg/ 12.5 mg once daily.
F’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat, il- pożoloġija m’ għandhiex taqbeż Kinzalkomb 40 mg/ 12. 5 mg darba kuljum.
Kinzalkomb is not indicated in patients with severe hepatic impairment.
Kinzalkomb mhuwiex indikat f’ pazjenti b’ indeboliment epatiku sever.
Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).
It- thiazides għandhom jintużaw b’ attenzjoni f’ pazjenti b’ funzjoni epatika indebolita (ara sezzjoni 4. 4).
No dosage adjustment is necessary.
L- ebda aġġustament fid- dożaġġ mhu meħtieġ.
Kinzalkomb is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Kinzalkomb mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is- sigurtà u l- effikaċja.
4.3 Contraindications
2 4. 3 Kontra indikazzjonijiet
2 • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). • Second and third trimester of pregnancy and lactation (see sections 4.4 and 4.6). • Cholestasis and biliary obstructive disorders. • Severe hepatic impairment. • Severe renal impairment (creatinine clearance < 30 ml/ min). • Refractory hypokalaemia, hypercalcaemia.
• Sensittività eċċessiva għas- sustanzi attivi jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1). • Sensittività eċċessiva għal sustanzi oħrajn derivati minn sulphonamides (għax hydrochlorothiazide hu prodott mediċinali derivat minn sulphonamide). • It- tieni u t- tielet trimestru tat- tqala u t- treddigħ (ara sezzjonijiet 4. 4 u 4. 6).  • Kolestasi u mard ostruttiv tal- marrara. • Indeboliment epatiku sever. • Indeboliment renali sever (rata ta ’ tneħħija ta ’ krejatinina ta ’ < 30 ml/ min). • Ipokalemija refrattarja, iperkalċemija.
Pregnancy Angiotensin II receptor antagonists should not be initiated during pregnancy.
Tqala Antagonisti tar- riċetturi ta ’ angiotensin II m’ għandhomx jinbdew waqt it- tqala.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Ħlief jekk it- tkomplija tat- terapija bl- antagonisti tar- riċetturi ta ’ angiotensin II tkun ikkunsidrata li hi essenzjali, il- pazjenti li jkunu qed jippjanaw li joħorġu tqal għandha tinbidlilhom il- kura għal waħda b’ kura alternattiva b’ mediċini kontra l- pressjoni għolja li għandhom profil tas- sigurtà stabbilit għall- użu fit- tqala.
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Meta t - tqala tkun iddijanjostikata, il- kura b’ antagonisti tar- riċetturi ta ’ angiotensin II għandha titwaqqaf immedjatament, u, jekk ikun xieraq, għandha tinbeda kura alternattiva (ara sezzjonijiet 4. 3 u 4. 6).
Kinzalkomb should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
Kinzalkomb m’ għandux jingħata lil pazjenti b’ kolestasi, b’ disturbi ostruttivi tal - marrara jew li għandhom insuffiċjenza epatika severa (ara sezzjoni 4. 3), għax telmisartan hu eliminat fil- biċċa l- kbira tiegħu mal- bili.
These patients can be expected to have reduced hepatic clearance for telmisartan.
Jista ’ jkun mistenni li dawn il- pazjenti jkollhom rata mnaqqsa ta ’ tneħħija epatika għal telmisartan.
In addition, Kinzalkomb should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Flimkien ma ’ dan, Kinzalkomb għandu jintuża bl- attenzjoni f’ pazjenti b’ indeboliment tal- funzjoni epatika jew mard progressiv tal- fwied, għax tibdil żgħir fil- fluwidu u fil- bilanċ ta ’ l- elettroliti jista ’ jikkawża koma epatika.
There is no clinical experience with Kinzalkomb in patients with hepatic impairment.
M’ hemm l- ebda esperjenza klinika b’ Kinzalkomb f’ pazjenti b’ indeboliment epatiku.