qanastek/EMEA-V3 huggingface dataset:
The manufacturer of Ketek is: sanofi-aventis S. p. A.
27 Il- manifattur ta ’ Ketek huwa: sanofi- aventis S. p. A.
Strada Statale No 17, km 22 I-67019 Scoppito (L’ Aquila), Italy
Strada Statale No 17, km 22 I- 67019 Scoppito (L’ Aquila), L- Italja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja ir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Italia sanofi-aventis S. p. A.
28 Italia sanofi- aventis S. p. A.
What is Kineret?
X' inhu Kineret?
Kineret is a solution for injection in a vial or a pre-filled syringe.
Kineret huwa soluzzjoni għal injezzjoni f' kunjett jew f' siringa mimlija minn qabel.
It contains the active substance anakinra (100 mg).
Fiha s- sustanza attiva anakinra (100 mg).
What is Kineret used for?
Għal xiex jintuża Kineret?
Kineret is used to treat of the signs and symptoms of rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Kineret jintuża biex jittratta sinjali u sintomi ta 'artrite rewmatojde (marda tas- sistema immunitarja li tikkawża infjammazzjoni tal- ġogi).
It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone.
Jintuża f' kombinazzjoni ma 'methotrexate (mediċina użata biex tnaqqas l- infjammazzjoni) f' pazjenti li ma jkunux irrispondew b' mod adegwat għal methotrexate waħdu.
How is Kineret used?
Kif jintuża Kineret?
Kineret treatment should be started and supervised by a doctor who has experience in the treatment of rheumatoid arthritis.
It- trattament b' Kineret għandu jinbeda u jiġi sorveljat minn tabib li għandu esperjenza fit- trattament ta 'artrite rewmatojde.
The recommended dose of Kineret is 100 mg once a day, given by injection under the skin at around the same time each day.
Id- doża rakkomandata ta 'Kineret hija 100 mg darba kuljum, mogħtija b' injezzjoni taħt il- ġilda bejn wieħed u ieħor fl- istess ħin tal- ġurnata kuljum.
The injection site should be varied with each dose to avoid discomfort.
Il- punt fejn tingħata l- injezzjoni għandu jinbidel għal kull doża biex tkun evitata skumdità.
Kineret should be used with caution in patients who have moderate problems with their kidneys, and should not be used in patients with severe kidney problems.
Kineret għandu jintuża b' kawtela f' pazjenti li għandhom problemi moderati bil- kliewi tagħhom u ma għandux jintuża f' pazjenti bi problemi serji fil- kliewi.
How does Kineret work?
Kif jaħdem Kineret?
The active substance in Kineret, anakinra, is an immunosuppressive medicine.
Is- sustanza attiva f' Kineret, anakinra, hija mediċina immunosoppressiva.
It blocks the receptors for a chemical messenger in the body called interleukin-1.
Timblokka r- riċetturi għal messaġġier kimiku fil- ġisem imsejjaħ interleukin- 1.
This messenger is produced in high levels in patients with rheumatoid arthritis, causing inflammation of the joints and joint damage.
Dan il- messaġġier jiġi prodott f' livelli għoljin f' pazjenti b' artrite rewmatojde, u dan jikkawża infjammazzjoni tal- ġogi u ħsara fil- ġogi.
By attaching to the receptors that interleukin-1 would normally attach itself to, anakinra blocks the activity of interleukin-1, helping to relieve the symptoms of the disease.
Billi twaħħal interleukin- 1 mar- riċetturi li normalment jeħel magħhom, anakinra timblokka l- attività ta 'interleukin- 1, u dan jgħin biex jittaffew is- sintomi tal- marda.
The active substance in Kineret, anakinra, is a copy of a natural human protein called ‘ human interleukin-1 receptor antagonist’.
Is- sustanza attiva f' Kineret, anakinra, hija kopja tal- proteina umana naturali imsejħa 'antagonista tar - riċettur interleukin- 1 uman'.
It is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce anakinra.
Hija prodotta b' metodu magħruf bħala 'teknoloġija rikombinanti tad - DNA': hija magħmula minn batterju li jkun irċieva ġene (DNA), li bih ikun jista 'jipproduċi anakinra.
The replacement anakinra acts in same way as the natural protein.
L- anakinra ta 'sostituzzjoni taġixxi bl- istess mod bħal proteina naturali.
How has Kineret been studied?
Kif ġie studjat Kineret?
Kineret has been studied in three main studies involving a total of 1,388 patients with rheumatoid arthritis.
Kineret ġie studjat fi tliet studji prinċipali li b' kollox involvew 1, 388 pazjent b' artrite rewmatojde.
All three studies compared the effectiveness of Kineret with that of placebo (a dummy treatment).
It - tliet studji qabblu l- effikaċja ta 'Kineret ma' dik tal- plaċebo (trattament finta).
The first study included 468 patients, some of whom had taken other medicines for their 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- ewwel studju inkluda 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. disease in the past, and who were given either Kineret on its own or placebo.
468 pazjent, li xi wħud minnhom kienu ħadu mediċini oħrajn għall- marda tagħhom fil- passat, u li ngħataw jew Kineret waħdu jew il- plaċebo.
In the other two studies, the medicines were used as an add-on to existing treatment including methotrexate: one study, which involved 419 patients, used a range of doses of Kineret that depended on the patient’ s weight, and the other study, which involved 501 patients, used Kineret at a fixed dose of 100 mg once a day.
Fiż- żewġ studji l- oħrajn, il- mediċini ntużaw bħala żieda għat- trattament eżistenti inkluż methotrexate: studju wieħed, li kien jinvolvi 419- il pazjent uża firxa ta ’ dożi ta ’ Kineret li kienu jiddependu fuq il- piż tal- pazjent, u l- istudju l- ieħor, li kien jinvolvi 501 pazjent uża Kineret f’ doża fissa ta ’ 100 mg darba kuljum.
In all three studies, the main measure of effectiveness was the number of patients with an improvement in symptoms of at least 20% after six months.
Fit- tliet studji kollha, il- kejl ewlieni tal - effikaċja kien l- għadd ta ’ pazjenti b' titjib ta 'mill- inqas 20% fis- sintomi wara sitt xhur.
Symptoms were measured by the doctor and the patient using the ‘ American College of Rheumatology ’ score, which includes measurements of the number of painful or tender joints, disease activity, pain, disability and levels of C-reactive protein in the blood (a marker of inflammation).
Is- sintomi tkejlu mit- tabib u l- pazjent li jużaw il- punteġġ tal - 'American College of Rheumatology', li jinkludi kejl tan- numru ta 'ġogi b' uġigħ jew sensittivi, uġigħ, disabilità u livelli ta' proteina reattiva Ċ fid- demm (markatur tal- infjammazzjoni).
What benefit has Kineret shown during the studies?
X' benefiċċju wera Kineret waqt l- istudji?
The first study showed that certain doses of Kineret were more effective than placebo in reducing the symptoms of rheumatoid arthritis.
L- ewwel studju wera li ċerti dożi ta 'Kineret kienu aktar effikaċi mill- plaċebo fit- tnaqqis tas- sintomi ta' artrite rewmatodje.
However, because of the way the study was designed, the results were considered insufficient to support the use of the medicine on its own.
Madankollu, minħabba l- mod li tfassal l- istudju, ir- riżultati tqiesu bħala insuffiċjenti bħala l- uniku sostenn għall- użu tal- mediċina.
The other two studies showed that Kineret was more effective than placebo when used as an add-on to methotrexate.
Iż- żewġ studji l- oħra wrew li Kineret kien aktar effikaċi minn plaċebo meta użata bħala żieda għal methotrexate.
In the study using a fixed dose of Kineret, 38% of the patients adding Kineret had at least a 20% reduction in symptoms after six months, compared with 22% of those adding placebo.
Fl- istudju li uża doża fissa ta ’ Kineret, 38% tal- pazjenti li żiedu Kineret kellhom tnaqqis ta 'mill- inqas 20% fis- sintomi wara sitt xhur, meta mqabbel ma' 22% ta 'dawk li żiedu plaċebo.
What is the risk associated with Kineret?
X' inhu r- riskju assoċjat ma 'Kineret?
The most common side effects with Kineret (seen in more than 1 patient in 10) are headache and injection site reactions (redness, bruising, pain and inflammation).
L- aktar effetti sekondarji komuni b' Kineret (li dehru f' aktar minn pazjent 1 minn kull 10) huma uġigħ ta 'ras u reazzjonijiet fil- punt fejn ingħatat l- injezzjoni (ħmura, tbenġil, uġigħ u infjammazzjoni).
For the full list of all side effects reported with Kineret, see the Package Leaflet.
Għal - lista sħiħa tal- effetti sekondarji kollha rrapportati ma 'Kineret, ara l- Fuljett ta' Tagħrif.
Kineret should not be used in people who may be hypersensitive (allergic) to anakinra, to any of the other ingredients, or to proteins produced by Escherichia coli (a type of bacterium).
Kineret ma għandux jintuża f' nies li jistgħu jkunu ipersensittivi (allerġiċi) għal anakinra, għal kwalunkwe sustanza oħra tiegħu, jew għal proteini prodotti minn Escherichia coli (tip ta 'batterju).
Kineret should not be used in patients who have severe problems with their kidneys.
Kineret ma għandux jintuża f' pazjenti li għandhom problemi serji bil- kliewi tagħhom.
The use of Kineret with tumour necrosis factor (TNF) antagonists (other medicines used in rheumatoid arthritis) is not recommended.
L- użu ta 'Kineret ma' antagonisti tal- fattur ta 'nekrożi tumorali (TNF) (mediċini oħrajn użati f' artrite rewmatojde) mhuwiex rakkomandat.
Why has Kineret been approved?
Għalfejn ġie approvat Kineret?
The Committee for Medicinal Products for Human Use (CHMP) decided that Kineret’ s benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Kineret huma akbar mir- riskji tiegħu għat- trattament tas- sinjali u sintomi ta' artrite rewmatojde f' kombinazzjoni ma 'methotrexate, f' pazjenti b' rispons mhux adegwat għal methotrexate waħdu.
The Committee recommended that Kineret be given marketing authorisation.
Il - Kumitat irrakkomanda li Kineret jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Kineret:
Tagħrif ieħor dwar Kineret:
The European Commission granted a marketing authorisation valid throughout the European Union for Kineret on 8 March 2002.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Kineret valida fl- Unjoni Ewropea kollha lil Amgen Europe B. V. fit- 8 ta 'Marzu 2002.
The marketing authorisation was renewed on 8 March 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 8 ta 'Marzu 2007.
The marketing authorisation holder is Biovitrum AB (publ).
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Biovitrum AB (publ).
The full EPAR for Kineret can be found here.
L- EPAR sħiħ għal Kineret jista ’ jiġi kkonsultat hawn.
Kineret 100 mg solution for injection in a pre-filled syringe.
Kineret 100 mg soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest
Each pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ ml).
Kull siringa mimlija għal- lest fiha 100 mg ta 'anakinra * kull 0. 67 ml (150 mg/ ml).
* Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.
* Antagonist tar- riċettur ta 'interleukin- 1 uman (r- metHuIL- 1ra) magħmul b ’ teknoloġija ta' DNA rikombinanti f’ ċelluli ta 'Escherichia coli.
Solution for injection (injection) in a pre-filled syringe.
Soluzzjoni għall- injezzjoni (injezzjoni) ġo siringa mimlija għal- lest
Clear, colourless-to-white solution for injection that may contain some product-related translucent-to- white amorphous particles.
Soluzzjoni għall- injezzjoni ċara, mingħajr kulur għal bajda li jista ’ jkun fiha xi frak amorfu trasluċidu għal abjad li huwa relatat mal- prodott.
Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Kineret huwa indikat għall- kura tas- sinjali u s- sintomi ta ’ l- artrite rewmatika, u jintuża flimkien ma ’ methotrexate f 'pazjenti li m’ għandhomx rispons adegwat għal methotrexate waħdu.
The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection.
Id- doża rakkomandata ta ’ Kineret hija ta ’ 100 mg mogħtija darba kuljum b ’ injezzjoni taħt il- ġilda.
The dose should be administered at approximately the same time each day.
Id - doża għandha tingħata bejn wieħed u ieħor fl- istess ħin kuljum.
For patient convenience, Kineret is supplied ready for use in a pre-filled syringe.
Għall- konvenjenza tal- pazjent, Kineret jiġi lest għall- użu f’ siringa mimlija għal- lest.
The instructions for use and handling are given in section 6.6.
L- istruzzjonijiet għall- użu u l- immaniġġar huma mogħtija f ’ sezzjoni 6. 6.
Alternating the injection site is recommended to avoid discomfort at the site of injection.
Huwa rakkomandat li jinbidel il- post ta ’ l- injezzjoni sabiex tiġi evitata l- iskumdita` fil- post ta’ l - injezzjoni.
Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Il- kura b’ Kineret għandha tinbeda u tiġi sorveljata minn tobba speċjaliżżati li għandhom esperjenza fid- dijanjożi u il- kura ta ’ l- artrite rewmatika.
Elderly patients (≥ 65 years)
Pazjenti anzjani (≥ 65 sena)
No dose adjustment is required.
Mhiex meħtieġa l- ebda tibdil fid- doża.
Posology and administration are the same as for adults 18 to 64 years of age.
Il- pożoloġija u l- mod ta ’ kif jingħata huma l- istess bħall- adulti ta ’ bejn 18 u 64 sena.
Children and adolescents (< 18 years)
Tfal u adolexxenti (≤ 18- il sena)
There are insufficient data to recommend the use of Kineret in children and adolescents under 18 years of age.
M’ hemmx biżżejjed tagħrif sabiex ikun jista ’ jiġi rrakkomandat l- użu ta ’ Kineret fi tfal u adolexxenti taħt it- 18- il sena.
2 Hepatic impairment
2 Indeboliment tal- fwied
No dose adjustment is required.
Mhuwiex meħtieġ tibdil fid- doża.
No dosage adjustment is needed for patients with mild renal impairment (CLcr 50 to 80 ml/ minute).
Mhuwiex meħtieġ tibdil fid- doża għall- pazjenti b 'indeboliment renali ħafif (CLcr 50 sa 80 ml/ minuta).
In the absence of adequate data, Kineret should be used with caution in patients with moderate renal impairment (CLcr 30 to 50 ml/ minute).
Fin- nuqqas ta ’ tagħrif adegwat, Kineret għandu jintuża b’ attenzjoni f ’ pazjenti b ’ indeboliment renali moderat (CLcr 30 sa 50 ml / minuta).
Kineret should not be used in patients with severe renal impairment (CLcr < 30 ml/ minute) (see section 4.3).
Kineret m’ għandux jintuża f’ pazjenti b ’ indeboliment renali gravi (CLcr < 30 ml/ minuta) (ara sezzjoni 4. 3).
Hypersensitivity to the active substance, any of the excipients or to E. coli derived proteins.
Sensittività eċċessiva għas- sustanza attiva, għal xi sustanzi mhux attivi jew għall- proteini mnissla minn E. coli.
Kineret should not be used in patients with severe renal impairment (CLcr < 30 ml/ minute) (see section 4.2).
Kineret m’ għandux jintuża f 'pazjenti b’ indeboliment renali gravi (CLcr < 30 ml/ minuta) (ara sezzjoni 4. 2).
Allergic reactions associated with administration of Kineret during clinical trials were rare.
Kienu rari r- reazzjonijiet allerġiċi assoċjati ma ’ l- għotja ta ’ Kineret waqt l- istudji kliniċi.
The majority of these reactions were maculopapular or urticarial rashes.
Il - maġġoranza ta ’ dawn ir- reazzjonijiet kienu raxx makulari bl- infafet jew raxx ta ’ urtikarja.
If a severe allergic reaction occurs, administration of Kineret should be discontinued and appropriate treatment initiated.
Jekk jkun hemm reazzjoni allerġika qawwija, l- għotja ta ’ Kineret għandha titwaqqaf u tinbeda il- kura xierqa.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
L- għatu tal- labra tas- siringa mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex), li jista 'jikkawża reazzjonijiet allerġiċi.
Kineret has been associated with an increased incidence of serious infections (1.8%) vs. placebo (0.7%).
Kineret kien assoċjat ma ’ inċidenza akbar ta ’ infezzjonijiet serji (1. 8%) meta mqabbla mal- plaċebo (0. 7%).
For a small number of patients with asthma, the incidence of serious infection was higher in Kineret-treated patients (4.5%) vs. placebo-treated patients (0%).
F 'numru żgħir ta' pazjenti bl- ażżma, l- inċidenza ta 'infezzjonijiet serji kienet ogħla f' pazjenti ttrattati b 'Kineret (4. 5%) meta mqabbla ma' pazjenti li rċevew plaċebo (0%).
The safety and efficacy of Kineret in patients with chronic infections have not been evaluated.
Is- sigurta` u l- effikaċja ta ’ Kineret f 'pazjenti b’ infezzjonijiet kroniċi għadhom ma ġewx evalwati.
Physicians should exercise caution when administering Kineret to patients with a history of recurring infections or with underlying conditions which may predispose them to infections.
It- tobba għandhom joqgħodu attenti meta jagħtu Kineret lill- pazjenti b 'passat ta ’ infezzjonijiet rikorrenti jew ta ’ kundizzjonijiet li jistgħu jippredisponuhom għall- infezzjonijiet.
Neutropenia
Newtropenja
Administration of Kineret was associated with neutropenia (ANC < 1.5 x 109/ l) in 2.4% of patients compared with 0.4% of placebo patients.
L- għotja ta ’ Kineret kienet assoċjata ma ’ newtropenja (ANC < 1. 5 x 109/ l) f ’ 2. 4% tal- pazjenti meta mqabbla ma ’ 0. 4% tal- pazjenti li rċevew plaċebo.
None of these patients had serious infections associated with the neutropenia.
Ħadd minn dawn il- pazjenti ma kellu infezzjonijiet serji assoċjati man- newtropenja.
Kineret treatment should not be initiated in patients with neutropenia (ANC < 1.5 x 109/ l).
Il- kura b ’ Kineret m’ għandhiex tinbeda f ’ pazjenti b ’ newtropenja (ANC < 1. 5 x 109/ l).
It is recommended that neutrophil counts be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly during the first 6 months of treatment and quarterly hereafter.
Huwa rrakkomandat li l- għadd ta ’ newtrofili jiġi stmat qabel ma tinbeda kura b ’ Kineret, u waqt li qed jingħata Kineret, kull xahar għall- ewwel 6 xhur ta ’ kura u wara dan kull tliet xhur.
In patients who become neutropenic (ANC < 1.5 x 109/ l) the ANC should be monitored closely and Kineret treatment should be discontinued.
F ’ pazjenti li taqbadhom newtropenja (ANC < 1. 5 x 109/ l), l- ANC għandu jiġi mmonitorjat mill- qrib u l- kura b’ Kineret għandha titwaqqaf.
The impact of treatment with Kineret on pre-existing malignancy has not been studied.
L- impatt ta 'kura b' Kineret fuq tumuri malinni diġà eżistenti għad ma ġiex studajt.
Therefore the use of Kineret in patients with pre-existing malignancy is not recommended.
Għalhekk mhux rakkomandat l- użu ta 'Kineret f' pazjenti li diġà għandhom tumur malinn.
3 Vaccinations
3 Tilqim
In a placebo-controlled clinical trial (n = 126), no difference was detected in anti-tetanus antibody response between the Kineret and placebo treatment groups when a tetanus/ diphtheria toxoid vaccine was administered concurrently with Kineret.
Fi studju kliniku kkontrollat bil- plaċebo (n=126), ma ġietx nnotata l- ebda differenza fir- rispons ta 'l - anti- korpi kontra t- tetnu bejn il- grupp ikkurat b' Kineret u l- grupp li ngħata l- plaċebo meta ngħatat tilqima tat- toxoid tat- tetnu u difterite flimkien ma 'Kineret.
No data are available on the effects of vaccination with other inactivated antigens in patients receiving Kineret.
M’ hemm l- ebda tagħrif dwar l- effetti ta ’ tilqim b 'antiġeni inattivi oħra f’ pazjenti li qed jingħataw Kineret.
No data are available on either the effects of live vaccination or on the secondary transmission of infection by live vaccines in patients receiving Kineret.
M’ hemm l- ebda tagħrif dwar l- effetti ta ’ tilqim ħaj jew dwar it- tixrid sekondarju ta ’ l- infezzjoni minn tilqim ħaj f’ pazjenti li qed jingħataw Kineret.
Therefore, live vaccines should not be given concurrently with Kineret.
Għalhekk, tilqim ħaj m' għandux jingħata flimkien ma 'Kineret.
A total of 635 patients ≥ 65 years of age, including 131 patients ≥ 75 years of age, were studied in clinical trials.
Total ta ’ 635 pazjent ≥ 65 sena, fosthom 131 pazjent ≥ 75 sena, ġew studjati waqt studji kliniċi.
No overall differences in safety or effectiveness were observed between these patients and younger patients.
Ma ġew osservati l- ebda differenzi fis- sigurta` jew l- effikaċja bejn dawn il- pazjenti u pazjenti iżgħar.
Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Minħabba li hemm inċidenza ogħla ta ’ infezzjonijiet fil- popolazzjoni anzjana b’ mod ġenerali, il- kura ta’ dawn il- pazjenti anzjani trid issir b’ attenzjoni.
Concurrent Kineret and TNF antagonist treatment
Kura b ’ Kineret u antagonista ta ’ TNF flimkien
Concurrent administration of Kineret and etanercept has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
L- għotja ta ’ Kineret u etanercept flimkien ġiet assoċjata ma ’ riskju ogħla ta ’ infezzjonijiet serji u newtropenja meta mqabbla ma ’ għotja ta 'etanercept waħdu.
This treatment combination has not demonstrated increased clinical benefit.
Din it- taħlita ta ’ kuri ma wrietx żjieda fil- benefiċju kliniku.
The concurrent administration of Kineret and etanercept or other TNF antagonists is not recommended (see section 4.5).
L- għotja ta ’ Kineret u etanercept flimkien jew flimkien ma ’ antagonisti oħrajn ta ’ TNF, mhix rakkomandata (ara sezzjoni 4. 5)
Interactions between Kineret and other medicinal products have not been investigated in formal studies.
L- interazzjonijiet bejn Kineret u prodotti mediċinali oħra ma ġewx investigati fi studji formali.
In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory drugs, corticosteroids, and DMARDs) have not been observed.
Fi studji kliniċi, ma ġewx osservati interazzjonijiet bejn Kineret u prodotti mediċinali oħra (inkluż mediċini għall- kura ta ’ l- infjammazzjoni li mhumiex sterojdi, kortikosterojdi, u DMARDs).
Concurrent Kineret and TNF antagonist treatment
Kura b ’ Kineret u antagonista TNF flimkien
In a clinical trial with patients receiving background methotrexate, patients treated with Kineret and etanercept were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept alone and higher than observed in previous trials where Kineret was used alone.
Fi studju kliniku f ’ pazjenti li kienu ġa qed jieħdu methotrexate, ġie osservat li pazjenti li ngħataw Kineret u etanercept kellhom rata ogħla ta ’ infezzjonijiet serji (7%) u newtropenja minn dawk il - pazjenti li ngħataw etanercept waħdu, u rata ogħla milli ġie osservat fi studji oħra ta ’ qabel fejn intuża Kineret waħdu.
Concurrent Kineret and etanercept treatment has not demonstrated increased clinical benefit.
Il- kura b ’ Kineret u etanercept flimkien ma wrietx żjieda fil- benefiċju kliniku.
The concurrent use of Kineret with etanercept or any other TNF antagonist is not recommended (see section 4.4).
L- għotja ta ’ Kineret u etanercept flimkien jew flimkien ma ’ antagonisti oħrajn ta ’ TNF, mhix rakkomandata (ara sezzjoni 4. 4)
For information on vaccinations see section 4.4.
Għal tagħrif dwar tilqim ara sezzjoni 4. 4.
There are no adequate data from the use of Kineret in pregnant women.
M ’ hemm l- ebda tagħrif kliniku xieraq dwar l- użu ta ’ Kineret f’ nisa tqal.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fl- annimali ma indikawx effetti ta ’ ħsarat diretti jew indiretti f’ dak li għandu x ’ jaqsam mat - tqala, l- iżvilupp ta ’ l- embriju u tal- fetu, il- ħlas jew l- iżvilupp wara t- twelid (ara sezzjoni 5. 3).
The use of Kineret in pregnant women is not recommended.
L- użu ta ’ Kineret f’ nisa tqal mhuwiex rakkomandat.
4 Women of child-bearing potential must use effective contraception during treatment.
4 Mhuwiex magħruf jekk anakinra jiġi eliminat fil- ħalib uman.
The use of Kineret in women who are breast-feeding is not recommended.
L- użu ta ’ Kineret waqt it- treddigħ mhuwiex rakkomandat.
No studies on the effects of Kineret on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti ta 'Kineret fuq il- ħila biex issuq jew tħaddem magni.
In all placebo-controlled studies, the most frequently reported adverse event with Kineret was injection site reaction (ISRs), which was mild to moderate in the majority of patients.
Fl- istudji kollha kkontrollati bil- plaċebo, l- aktar effett avvers irrappurtat ta 'spiss b’ Kineret kien reazzjoni fil- post ta ’ l- injezzjoni (ISRs) li kien ħafif għal moderat fil- biċċa l- kbira tal- pazjenti.
The most common reason for withdrawal from study in Kineret-treated patients is injection site reaction.
L - aktar raġuni komuni għal waqfien mill- istudju ta ’ pazjenti kkurati b ’ Kineret kienet minħabba reazzjoni fil- post ta ’ l- injezzjoni.
The subject incidence of serious adverse events at the recommended dose of Kineret (100 mg/ day) is comparable with placebo (7.1% compared with 6.5% in the placebo group).
L- inċidenza ta ’ effetti avversi serji fil- pazjenti bid- doża rakkomandata ta ’ Kineret (100 mg/ kuljum) tista ’ titqabbel ma ’ dawk bil- plaċebo (7. 1% mqabbel ma ’ 6. 5% tal- grupp tal- plaċebo).
The incidence of serious infection was higher in Kineret-treated patients compared with patients receiving placebo (1.8% vs.
L- inċidenza ta ’ infezzjonijiet serji kienet ogħla f’ pazjenti kkurati b ’ Kineret meta mqabbla ma ’ pazjenti li ngħataw il- plaċebo (1. 8% vs.
0.7%).
0. 7%).
Neutrophil decreases occurred more frequently in patients receiving Kineret compared with placebo.
Tnaqqis fin- newtrofili seħħ aktar spiss f ’ pazjenti li ngħataw Kineret milli f’ dawk bil- plaċebo.
MedDRA Organ System Blood and lymphatic system disorders
Sistema tal- organi Medra Disturbi tad- demm u tas - sistema limfatika
Frequency Common (≥ 1/ 100 to < 1/ 10)
Frekwenza Komuni (≥ 1/ 100 to < 1/ 10)
Undesirable Effect Neutropenia
Effett mhux mixtieq Newtropenja
Nervous system disorders Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Very common (≥ 1/ 10) Very common (≥ 1/ 10)
Komuni ħafna (≥ 1/ 10)
Headache Injection site reaction
Reazzjoni fil- post ta ’ l - injezzjoni
Common (≥ 1/ 100 to < 1/ 10)
Komuni (≥ 1/ 100 to < 1/ 10)
Serious infections requiring hospitalisation
Infezzjonijiet serji li jeħtieġu kura fl- isptar
Injection site reactions
Reazzjonijiet fil- post ta ’ l- injezzjoni
The most common and consistently reported treatment-related adverse events associated with Kineret were ISRs.
L- aktar effetti avversi komuni li kellhom x ’ jaqsmu ma ’ kura b’ Kinerei, li ġew rrappurtati konsistentement, kienu reazzjonijiet fil- post ta 'l- injezzjoni.
The majority (95%) of ISRs were reported as mild to moderate.
Il- biċċa l- kbira (95%) ta ’ dawn ir - reazzjonijiet fil- post ta 'l- injezzjoni kienu minn ħfief għal moderati.
These were typically characterised by 1 or more of the following: erythaema, ecchymosis, inflammation, and pain.
Dawn kienu tipikament kkaratterizzati minn waħda jew aktar minn dawn: ħmura fil- ġilda, eċċimosi, infjammazzjoni u uġigħ.
At a dose of 100 mg/ day, 71% of patients developed an ISR compared to 28% of the placebo treated patients, which was typically reported within the first 4 weeks of therapy.
B’ doża ta ’ 100 mg/ kuljum, 71% tal- pazjenti żviluppaw reazzjoni fil- post ta 'l- injezzjoni meta mqabbla ma ’ 28% tal- pazjenti li ngħataw il- plaċebo, din ir- reazzjoni kienet ġeneralment irrappurtata fl- ewwel 4 ġimgħat tal- kura.
The median duration of the above mentioned typical symptoms was 14 to 28 days.
It- tul ta ’ żmien medjan ta ’ dawn is- sintomi tipiċi msemmija hawn fuq kien ta ’ bejn 14 u 28 jum.
The development of ISRs in patients who had not previously experienced ISRs was uncommon after the first month of therapy.
L- iżvilupp ta ’ reazzjonijiet fil- post ta 'l- injezzjoni f’ pazjenti li qatt qabel ma kellhom reazzjoni fil- post ta' l- injezzjoni ma kienx komuni wara l- ewwel xahar ta ’ kura.
The incidence of serious infections in the studies conducted at the recommended dose (100 mg/ day) was 1.8% in Kineret treated patients and 0.7% in placebo-treated patients.
L- inċidenza ta ’ infezzjonijiet serji fl- istudji li saru bid- doża rakkomandata (100 mg/ kuljum) kienet ta ’ 1. 8% f’ pazjenti kkurati b ’ Kineret u 0. 7% f’ pazjenti li ngħataw il- plaċebo.
In observations up to 3 years, the serious infection rate remained stable over time.
F 'osservazzjonijiet tul 3 snin, ir- rata ta' infezzjonijiet serji baqgħet stabbli tul iz- żmien.
The infections observed consisted primarily of bacterial events such as cellulitis, pneumonia, and bone and joint infections.
L- infezzjonijiet osservati kienu kkawżati primarjament minn batterji bħal ċellulite, pulmonite, u infezzjonijiet fl- għadam u fil- ġogi.
Most patients continued on study drug after the infection resolved.
Il- biċċa l- kbira mill- pazjenti komplew bil- mediċina ta ’ l- istudju wara li għaddiet l- infezzjoni.
There were no on-study deaths due to serious infectious episodes.
Ma kien hemm l- ebda mewt waqt l- istudji minħabba episodji ta ’ infezzjonijiet serji.
In clinical studies and post-marketing experience, rare cases of opportunistic infections have been observed and included fungal, mycobacterial, bacterial, and viral pathogens.
Fi studji kliniċi u fl- esperjenza ta 'wara t- tqegħid fuq is- suq, ġew osservati każijiet rari ta' infezzjonijiet opportunistiċi u dawn kienu jinkludu moffa, mikobatterji, batterji u patoġeni ta 'virus.
Infections have been noted in all organ systems and have been reported in patients receiving Kineret alone or in combination with immunosuppressive agents.
Infezzjonijiet ġew osservati fis- sistemi ta 'l- organi kollha u ġew rrappurtati f' pazjenti li ngħataw Kineret waħdu jew flimkien ma 'aġenti immunosoppressivi.
5 Neutropenia
5 Newtropenja
In placebo-controlled studies with Kineret, treatment was associated with small reductions in the mean values for total white blood count and absolute neutrophil count (ANC).
Fi studji kkontrollati bil- plaċebo, trattament b 'Kineret kien assoċjat ma' tnaqqis zgħir fil- valuri medji ta 'l- għadd totali tac- ċelluli bojod u ta' l- għadd assolut tan- newtrofili (ANC).
Neutropenia (ANC < 1.5 x 109/ l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
Newtropenja (ANC < 1. 5 x 109/ l) kienet irrappurtata f '2. 4% tal- pazjenti li ngħataw Kineret meta mqabbla ma' 0. 4% tal- pazjenti li ngħataw plaċebo.
Rheumatoid arthritis (RA) patients may be at a higher risk (on average 2-3 fold) for the development of lymphoma.
Pazjenti b 'artrite rewmatika (RA) jista' jkollhom riskju ogħla (medja ta 'darbtejn sa 3 darbiet aktar) li jiżviluppaw limfoma.
In clinical trials, whilst patients treated with Kineret had a higher incidence of lymphoma than the expected rate in the general population, this rate is consistent with rates reported in general for RA patients.
Din ir- rata ta 'inċidenza hija konsistenti mar - rati rrappurtati f' pazjenti b 'artrite rewmatika.
In clinical trials, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population.
Fi studji kliniċi, ir- rata ta 'l- inċidenza ta ’ tumuri malinni kienet l- istess għall- pazjenti kkurati b’ Kineret u għall- pazjenti li ngħataw il- plaċebo u ma kienitx differenti minn dik fil- popolazzjoni ġenerali.
Furthermore, the overall incidence of malignancies was not increased during 3 years of patient exposure to Kineret.
Barra dan, l- inċidenza ta ’ tumuri malinni ma kienitx qed tiżdied tul it- tlett snin ta 'espożizzjoni ta' pazjenti għal Kineret.
Immunogenicity
Immunogeniċità
In clinical trials, up to 3% of adult patients tested seropositive at least once during the study for antibodies capable of neutralising the biologic effects of anakinra.
Fi studji kliniċi, sa 3% tal- pazjenti adulti rriżultaw seroposittivi mill- anqas darba waqt l- istudju għall - antikorpi li kapaċi jinnewtraliżżaw l- effett bijoloġiku ta 'anakinra.
The occurrence of antibodies was typically transient and not associated with clinical adverse reactions or diminished efficacy.
Il- preżenza ta 'antikorpi kienet ġeneralment temporanja u ma kienitx assoċjata ma' reazzjonijiet avversi kliniċi jew fi tnaqqis ta 'l - effikaċja.
In addition, in a clinical trial 6% of paediatric patients tested seropositive at least once during the study for antibodies capable of neutralising the biologic effects of anakinra.
Barra minn hekk, fi studju kliniku, 6% tal- pazjenti pedjatriċi rriżultaw seroposittivi għal minn ta ’ l- inqas darba waqt l- istudju għall- antikorpi li kapaċi jinnewtraliżżaw l- effett bioloġiku ta 'anakinra.
No dose-limiting toxicities were observed during clinical trials in rheumatoid arthritis patients.
Waqt l- istudji kliniċi fuq pazjenti b’ artitrite rewmatika, ma ġewx osservati tossiċitajiet li jillimitaw id - doża.
In studies of sepsis, 1,015 patients received Kineret at doses up to 2 mg/ kg/ hour over a 72 hour treatment period.
Fi studji dwar is- sepsi, 1, 015- il pazjent ngħataw Kineret f’ dożi sa 2 mg/ kg/ siegħa fuq perjodu ta ’ kura ta ’ 72 siegħa.
The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies.
Il- profil ta 'l- effetti avversi minn dawn l- istudji ma juri l- ebda differenza minn dak osservat fi studji dwar l- artrite rewmatika.
Immunosuppressants, ATC code:
Immunosoppressant,, Kodiċi ATC:
Anakinra neutralises the biologic activity of interleukin-1 α (IL-1α) and interleukin-1 β (IL-1 β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Anakinra jinnewtralizza l- attivita` bijoloġika ta ’ interleukin- 1α (IL- 1α) u interleukin- 1β (IL- 1β) permezz ta ’ inibizzjoni kompetittiva ta ’ l- irbit tagħhom ma ’ riċettur tat- tip 1 ta ’ interleukin- 1 (IL – 1RI).
Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation.
Interleukin- 1 (IL- 1) hija ċitokina pro- infjammatorja ta ’ importanza kbira u hija medjatur f ’ bosta risponsi ċellulari, fosthom dawk importanti fl- infjammazzjoni sinovjali.
IL-1 is found in the plasma and synovial fluid of patients with rheumatoid arthritis, and a correlation has been reported between IL-1 concentrations in the plasma and the activity of the disease.
IL- 1 jinstab fil- plażma u fil- likwidu sinovjali ta ’ pazjenti b’ artrite rewmatika, u nstabet korrelazzjoni bejn il- konċentrazzjonijiet ta ’ IL- 1 fil- plażma u l- attitvita` tal- marda.
Anakinra inhibits responses elicited by IL-1 in vitro, including the induction of nitric oxide and prostaglandin E2 and/ or collagenase production by synovial cells, fibroblasts, and chondrocytes.
Anakinra jinibixxi r- rispons mibdi minn IL- 1 in vitro, inkluż l- induzzjoni ta ’ nitric oxide u prostaglandina E2 u/ jew il- produzzjoni ta ’ collagenase miċ- ċelluli sinovjali, fibroblasti u kondroċiti.
Clinical data
6 Tagħrif kliniku
The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in patients with varying degrees of disease severity.
Is- sigurta` u l- effikaċja ta ’ anakinra flimkien ma ’ methotrexate intwerew f’ pazjenti bi gradi ta ’ gravita`differenti tal- marda.
6 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.
Maximal clinical response was generally seen within 12 weeks after starting treatment.
Rispons kliniku massimu ġeneralment deher fi żmien 12- il ġimgħa wara li nbdiet il- kura.
Combined anakinra and methotrexate treatment demonstrates a statistically and clinically significant reduction in the severity of the signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate alone (38% vs.
Kura b’ anakinra u methotrexate flimkien turi tnaqqis statistikament u klinikament sinnifikanti fil - qawwa tas- sinjali u s- sintomi ta ’ l- artirite rewmatika f’ pazjenti li kellhom rispons mhux adegwat għal methotrexate waħdu (38% vs.
22% responders as measured by ACR20 criteria).
22% ta ’ pazjenti li rrispondew, mkejla skond il- kriterju ACR20).
Significant improvements are seen in the pain, tender joint count, physical function (HAQ score), acute phase reactants and in the patient’ s and physician’ s global assessment.
Jkun hemm titjib sinifikattiv fl- uġigħ, fl- għadd ta ’ ġogi muġugħa, fil- kapaċita` fiżika (punteġġ HAQ), fir - reattanti tal- fażi akuta u fil- valutazzjoni globali mill- pazjent u mit- tabib.
X-ray examinations have been undertaken in one clinical study with anakinra.
F’ wieħed mill- istudji b’ anakinra ittieħdu xbiehat b’ raġġi- X.
These have shown no deleterious effect on joint cartilage.
Dawn ma wrew l- ebda ħsara fil- qarquċa tal- ġogi.
The absolute bioavailability of anakinra after a 70 mg SC bolus injection in healthy subjects (n = 11) is 95%.
Il- biodisponibiltà assoluta ta ’ anakinra wara injezzjoni ta ’ 70 mg taħt il- ġilda f ’ daqqa f ’ pazjenti b ’ saħħithom (n=11) hija ta ’ 95%.
The absorption process is the rate-limiting factor for the disappearance of anakinra from the plasma after SC injection.
Il- proċess ta ’ assorbiment huwa l- fattur li jillimita r- rata ta ’ tneħħijja ta ’ anakinra mill- plażma wara injezzjoni taħt il- ġilda.
In subjects with RA, maximum plasma concentrations of anakinra occurred at 3 to 7 hours after SC administration of anakinra at clinically relevant doses (1 to 2 mg/ kg; n = 18); the terminal half-life ranged from 4 to 6 hours.
F ’ pazjenti b ’ artrite rewmatika, l- ogħla konċentrazzjonijiet fil- plażma seħħew minn 3 sa 7 sigħat wara l- għoti ta ’ anakinra taħt il- ġilda f’ dożi klinikament rilevanti (1 sa 2 mg/ kg; n= 18); il- half- life terminali kienet minn 4 sa 6 sigħat.
In RA patients, no unexpected accumulation of anakinra was observed after daily SC doses for up to 24 weeks.
F ’ pazjenti b’ artrite rewmatika, l- ebda akkumulazzjoni mhux mistennija ta ’ anakinra ma ġiet osservata wara dożi ta ’ kuljum mogħtija taħt il- ġilda sa perijodu ta '24 ġimgħa.
The influence of demographic covariates on the pharmacokinetics of anakinra was studied using population pharmacokinetic analysis encompassing 341 patients receiving daily SC injection of anakinra at doses of 30, 75, and 150 mg for up to 24 weeks.
L- influwenza ta ’ kovarjanti demografiċi fuq il- farmakokinetika ta ’ anakinra ġiet studjata b’ analiżi farmakokinetika ta ’ popolazzjoni ta ’ 341 pazjent li kienu qed jingħataw injezzjoni taħt il- ġilda kuljum ta ’ anakinra f’ dożi ta ’ 30, 75, u 150 mg sa 24 ġimgħa.
The estimated anakinra clearance increased with increasing creatinine clearance and body weight.
It- tneħħija stmata ta ’ anakinra żdiedet hekk kif żdiedu t- tneħħija ta ’ krejatinina u l- piż tal- ġisem.
Population pharmacokinetic analysis demonstrated that the mean plasma clearance value after SC bolus administration was approximately 14% higher in men than in women and approximately 10% higher in subjects < 65 years than in subjects ≥ 65 years.
Analiżi farmakokinetika ta ’ popolazzjoni wriet li l - valur medju ta 'tneħħija mill- plażma wara injezzjoni taħt il- ġilda f’ daqqa kienet bejn wieħed u ieħor 14% ogħla fl- irġiel milli fin- nisa u bejn wieħed u ieħor 10% ogħla f’ pazjenti < 65 sena milli f’ pazjenti ≥ 65 sena.
However, after adjusting for creatinine clearance and body weight, sex and age were not significant factors for mean plasma clearance.
Madanakollu, wara aġġustament għat- tneħħija ta ’ krejatinina u għall- piż tal - ġisem, is- sess u l- eta ’ ma kienux fatturi sinnifikanti għat- tneħħija medja mill- plażma.
Anakinra had no observed effect on the fertility, early development, embryo-foetal development, or peri- and postnatal development in the rat at doses up to 100 times the human dose.
Anakinra ma wera l- ebda effett fuq il- fertilita`, l- iżvilupp bikri, l- iżvilupp embrijofetali, jew l- iżvilupp qabel jew wara t- twelid fil- far b’ dożi sa 100 darba d- doża umana.
No effects on embryo-foetal development in the rabbit were observed at doses 100 times the human dose.
Ma ġew osservati l- ebda effetti fuq l- iżvilupp embrijofetali fil- fenek b’ dożi sa 100 darba d- doża umana.
In a standard battery of tests designed to identify hazards with respect to DNA, anakinra did not induce bacterial or mammalian cell gene mutations.
F’ sensiela standard ta ’ testijiet magħmula biex jiġu identifikati riskji assoċjati ma 'DNA, anakinra ma wassalx għal mutazzjonijiet fil- ġeni taċ- ċelluli tal- batterji jew tal- mammiferi.
Neither did anakinra increase the incidence of chromosomal abnormalities or micronuclei in bone marrow cells in mice.
Anakinra ma żiedx l - inċidenza ta ’ annormalitajiet fil- kromożomi jew fil- mikronukleji fiċ- ċelluli tal- mudullun tal- ġrieden.
Long-term studies have not been performed to evaluate the carcinogenic potential of anakinra.
Ma sarux studji fit- tul sabiex jiġi evalwat il- potenzjal karċinoġeniku ta ’ anakinra.
Data from mice over expressing IL-1ra and IL-1ra mutant knock-out mice, did not indicate an increased risk of tumour development.
Tagħrif minn ġrieden li jipproduċu aktar IL- 1ra minn normal u fuq ġrieden IL- 1ra mutanti knock- out, ma wrew l - ebda żjieda fir- riskju ta ’ żvilupp ta ’ tumuri.
A formal toxicologic and toxicokinetic interaction study in rats revealed no evidence that Kineret alters the toxicologic or pharmacokinetic profile of methotrexate.
Studju formali dwar interazzjonijiet tossikoloġiċi u tossikokinetiċi fil- firien ma wera l- ebda evidenza li Kineret jbiddel il- profil tossikoloġiku jew farmakokinetiku ta ’ methotrexate.
Sodium citrate Sodium chloride Disodium edetate Polysorbate 80 Sodium hydroxide Water for injections
Sodium citrate Sodium chloride Disodium edetate Polysorbate 80 Sodium hydroxide Ilma għall- injezzjoni
Store in the original container in order to protect from light.
Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
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.
At the end of this period, the product must not be put back in the refrigerator and must be disposed of.
Fl- aħħar ta 'dan il- perijodu, il - prodott m' għandux jerġa' jitqiegħed fil- friġġ u jrid jintrema.
0.67 ml of solution for injection in a pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) in pack sizes of 1, 7 or 28.
0. 67ml ta 'soluzzjoni għall- injezzjoni ġo siringa (Ħġieġ Tip I) mimlija għal- lest b' tapp planġer (lastiku bromobutyl), f 'pakketti b' 1, 7 jew 28 siringa mimlija għal- lest
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex).
L- għatu tal- labra tas- siringa mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex).
Kineret is a sterile unpreserved solution.
Kineret huwa soluzzjoni sterili iżda mhux ppreservat.
For single use only.
Għall- użu ta ’ darba.
Do not shake.
Tħawwadx it- taħlita.
Allow the pre-filled syringe to reach room temperature before injecting.
Ħalli s- siringa mimlija għal- lest tilħaq temperatura ambjentali qabel ma tinjetta.
Before administration, visually inspect the solution for particulate matter and discolouration.
Qabel l- għotja, ispezzjona s- soluzzjoni għal materja f ’ sura ta ’ partikuli separati u għal tidnis tal - kulur.
Only clear, colourless-to-white solutions that may contain some product-related translucent-to-white amorphous particles should be injected.
Għandhom jsiru injezzjonijiet biss ta ’ soluzzjoni ċara, mingħajr kulur għal bajda li jista ’ jkun fiha xi frak amorfu trasluċidu għal abjad li huwa relatat mal- prodott.
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.
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 '1 EU/ 1/ 02/ 203/ 002 – Pakkett ta' 7 EU/ 1/ 02/ 203/ 003 – Pakkett ta '28
8 March 2002 Date of latest renewal:
8 Marzu 2002 Data ta 'l- aħħar tiġdid:
20 March 2007
20 Marzu 2007
Kineret 100 mg solution for injection in a vial.
Kineret 100 mg soluzzjoni għall- injezzjoni ġo kunjett
Each vial contains 100 mg of anakinra* per 0.67 ml (150 mg/ ml).
Kull kunjett fih 100 mg ta 'anakinra * kull 0. 67 ml (150mg/ ml).
* Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.
* Antagonist tar- riċettur ta 'interleukin- 1 uman (r- metHuIL- 1ra) magħmul b’ teknoloġija ta' DNA rikombinanti f’ ċelluli ta 'Escherichia coli.
Solution for injection (injection) in a vial.
Soluzzjoni għall- injezzjoni (injezzjoni) ġo kunjett.
Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Kineret huwa indikat għall- kura tas- sinjali u s- sintomi ta ’ l- artrite rewmatika, u jintuża flimkien ma ’ methotrexate f’ pazjenti li m’ għandhomx rispons adegwat għal methotrexate waħdu.
Kineret is supplied ready for use in a vial.
Kineret jiġi lest għall- użu ġo kunjett.
10 Renal impairment
10 Indeboliment tal- fwied
The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
It- tapp tal- kunjett fih lastiku naturali niexef (mnissel mill- latex), li jista 'jikkawża reazzjonijiet allerġiċi.
11 was administered concurrently with Kineret.
11 Tilqim
Women of child-bearing potential must use effective contraception during treatment.
Nisa li jistgħu jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva waqt il- kura.
It is not known whether anakinra is excreted in human milk.
12 Mhuwiex magħruf jekk anakinra jiġi eliminat fil- ħalib uman.
12 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
In all placebo-controlled studies, the most frequently reported adverse event with Kineret was injection site reaction (ISRs), which was mild to moderate in the majority of patients.
Fl- istudji kollha kkontrollati bil- plaċebo, l- aktar effett avvers irrappurtat ta 'spiss b’ Kineret kien reazzjoni fil- post ta ’ l- injezzjoni (ISRs), li kien ħafif għal moderat fil- biċċa l- kbira tal- pazjenti.
The majority (95%) of ISRs were reported as mild to moderate.
Il- biċċa l- kbira (95%) ta ’ dawn r - reazzjonijiet fil- post ta 'l- injezzjoni kienu minn ħfief għal moderati.
The incidence of serious infections in the studies conducted at the recommended dose (100 mg/ day) was 1.8% in Kineret treated patients and 0.7% in placebo-treated patients.
L- inċidenza ta ’ infezzjonijiet serji fl- istudji li saru bid- doża rakkomandata (100 mg/ kuljum) kienet ta ’ 1. 8% f ’ pazjenti kkurati b ’ Kineret u 0. 7% f’ pazjenti li ngħataw il- plaċebo.
In placebo-controlled studies with Kineret, treatment was associated with small reductions in the mean values for total white blood count and absolute neutrophil count (ANC).
Infezzjonijiet ġew osservati fis- sistemi ta 'l- organi kollha u ġew rrappurtati f' pazjenti li ngħataw Kineret waħdu jew flimkien ma 'aġenti immunosoppressivi.
13 Malignancies
13 Newtropenja
Anakinra neutralises the biologic activity of interleukin-1 α (IL-1α) and interleukin-1 β (IL-1 β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Anakinra jinnewtralizza l- attivita` bijoloġika ta ’ interleukin- 1α (IL- 1α) u interleukin- 1β (IL- 1β) permezz ta ’ inibizzjoni kompetittiva ta ’ l- irbit tagħhom ma ’ riċettur tat- tip 1 ta ’ interleukin- 1 (IL- 1RI).
Clinical data
14 Tagħrif kliniku