natgillin/translations-raw huggingface dataset:
Date of first authorisation: 06/11/2015.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 06/11/2015.
One carton contains one blister of 1, 3 or 6 tablets.
Ena škatla vsebuje 1 pretisni omot s 1, 3 ali 6 tabletami.
Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects.
Z laboratorijskimi študijami na podganah in kuncih teratogeni učinki niso bili dokazani.
Use appropriate combination of available strengths to achieve the recommended dose of 2-4 mg/kg.
Uporabite ustrezno kombinacijo razpoložljivih jakosti tablet, da dosežete priporočeni odmerek 2 do 4 mg/kg telesne teže.
No treatment-related clinical signs were observed.
Pri tem niso opazili nobenih kliničnih znakov, povezanih z zdravljenjem.
Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Zdravljenje je treba nadaljevati, dokler kožni ostružki niso negativni ob najmanj dveh zaporednih odvezmih, v razmaku enega meseca.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Bolhe in klopi se morajo pritrditi na gostitelja in se začeti hraniti, da so izpostavljeni učinkovini.
For the treatment of demodicosis (caused by Demodex canis) the administration of a single dose once monthly for three consecutive months is efficacious and leads to a marked improvement of clinical signs.
Za zdravljenje demodikoze (ki jo povzroča Demodex canis) je učinkovita uporaba enkratnega odmerka enkrat mesečno, tri zaporedne mesece, in vodi do izrazitega izboljšanja kliničnih znakov.
During clinical field trials, no interactions between Simparica chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Med terenskimi kliničnimi testiranji niso opazili nobenih interakcij žvečljivih tablet Simparica za pse z rutinsko uporabljenimi zdravili za uporabo v veterinarski medicini.
Ticks on the animal prior to administration are killed within 24 hours.
Klopi, ki so že na živali pred dajanjem zdravila, poginejo v 24 urah.
For each strength, the chewable tablets are available in the following pack sizes: carton with 1 blister of 1, 3 and 6 tablets.
Za vsako jakost so žvečljive tablete na voljo v naslednjih velikostih: kartonska škatla z 1 pretisnim omotom s po 1, 3 ali 6 tabletami.
ATC vet code: QP53BE03.
Farmakoterapevtska skupina: ektoparazitiki za sistemsko uporabo Oznaka ATCvet: QP53BE03.
Sarolaner is well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 5 times the recommended dose.
Sarolaner so dobro prenašali koliji z nezadostnim MDR 1-/- (multidrug-resistance-protein 1) po enkratnem peroralnem dajanju 5-krat večjega odmerka od priporočenega.
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Zdravilo se lahko uporablja kot del strategije zdravljenja dermatitisa zaradi alergije na bolhe (Flea Allergy dermatitis FAD).
Sarolaner was dose proportional in Beagle dogs when dosed from the intended use dose of 2-4 mg/kg, to 20 mg/kg.
Sarolaner je bil sorazmeren odmerku pri psih pasme beagle pri odmerjanju od predpisanega odmerka 2 do 4 mg/kg do odmerka 20 mg/kg.
The veterinary medicinal product kills newly emerged fleas on the dogs before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.
To zdravilo ubije bolhe, ki pridejo na psa po dajanju zdravila, preden bi lahko izlegle jajčeca in tako prepreči onesnaženje okolja z bolhami na področjih, do katerih ima pes dostop.
The number embossed on one side refers to the strength (mg) of the tablets: “5”, “10”, ”20”, “40”, “80” or “120”.
Številka vtisnjena na eni strani žvečljive tablete se nanaša na jakost (v mg) tablet: »5«, »10«, »20«, »40«, »80« or »120«.
For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis).
Za zdravljenje infestacij z bolhami (Ctenocephalides felis in Ctenocephalides canis).
Aluminium foil/foil blister package.
Aluminijeva folija/ pretisni omot iz folije.
The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors).
Primarni cilj delovanja sarolanerja pri insektih in pršicah je funkcionalna blokada od ligandov odvisnih klorovih kanalčkov (receptorji GABA in receptorji glutamata).
Simparica tablets are chewable and palatable and readily consumed by dogs when offered by the owner.
Tablete Simparica so žvečljive in okusne, zato jih psi radi sprejmejo od lastnika.
Sarolaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and the cumarin derivative warfarin.
Sarolaner se močno veže na plazemske beljakovine in lahko tekmuje z drugimi zdravili, ki se izrazito vežejo na plazemske beljakovine, kot so nesteroidna protivnetna zdravila (NSAID) in kumarinski derivat varfarin.
For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continue throughout the flea and/or tick season based on local epidemiological situations.
Za optimalni nadzor infestacije s klopi in bolhami je treba zdravilo dajati v mesečnih razmikih in nadaljevati z dajanjem skozi celotno sezono bolh in/ali klopov glede na krajevne epidemiološke situacije.
In the overdose groups, transient and self-limiting neurological signs were observed in some animals: mild tremors at 3 times the maximum exposure dose and convulsions at 5 times the maximum exposure dose.
V skupinah psov s prekomernim odmerjanjem so pri nekaterih živalih opazili naslednje prehodne in samoomejujoče nevrološke znake: blago tresenje pri 3-krat večjem odmerku od največjega priporočenega in krče pri 5-krat večjem odmerku od največjega priporočenega.
PACKAGE LEAFLET: Simparica chewable tablets for dogs
NAVODILO ZA UPORABO Simparica žvečljive tablete za pse
In a margin of safety study, the veterinary medicinal product was administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum exposure dose of 4 mg/kg at 28 day intervals for 10 doses.
V študiji varnosti so zdravilo dajali peroralno 8 tednov starim psičkom pasme beagle, v odmerkih, ki so bili 0, 1, 3 in 5 krat večji od največjega priporočenega odmerka 4 mg/kg telesne teže, po 10 odmerkov v 28 dnevnih presledkih.
For the treatment of ear mite infestations (Otodectes cynotis) a single dose should be administered.
Za zdravljenje ušesne garjavosti (ki jo povzroča Otodectes cynotis) je treba dati enkratni odmerek zdravila.
For the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) a single dose should be administered at monthly intervals for two consecutive months.
Za zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis) je treba dajati enkratni odmerek zdravila enkrat mesečno, dva meseca zapored.
Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Sarolaner zavira GABA- in glutamat- odvisne kloridne kanale v centralnem živčnem sistemu insektov in pršic.
Plasma protein binding was determined in vitro and calculated at ≥99.9%.
Razpolovna doba je bila primerljiva pri intravenozni in peroralni poti na 12. in 11. dan. Vezava na plazemske proteine je bila določena in vitro in je bila izračunana pri ≥99,9%.
EU/2/15/191/011 (40 mg, 3 tablets) EU/2/15/191/012 (40 mg, 6 tablets) EU/2/15/191/013 (80 mg, 1 tablet) EU/2/15/191/014 (80 mg, 3 tablets) EU/2/15/191/015 (80 mg, 6 tablets) EU/2/15/191/016 (120 mg, 1 tablet) EU/2/15/191/017 (120 mg, 3 tablets) EU/2/15/191/018 (120 mg, 6 tablets)
EU/2/15/191/015 (80 mg, 6 tablets) EU/2/15/191/016 (120 mg, 1 tablet) EU/2/15/191/017 (120 mg, 3 tablets) EU/2/15/191/018 (120 mg, 6 tablets)
EU/2/15/191/001 (5 mg, 1 tablet) EU/2/15/191/002 (5 mg, 3 tablets) EU/2/15/191/003 (5 mg, 6 tablets) EU/2/15/191/004 (10 mg, 1 tablet) EU/2/15/191/005 (10 mg, 3 tablets) EU/2/15/191/006 (10 mg, 6 tablets) EU/2/15/191/007 (20 mg, 1 tablet) EU/2/15/191/008 (20 mg, 3 tablets) EU/2/15/191/009 (20 mg, 6 tablets) EU/2/15/191/010 (40 mg, 1 tablet)
EU/2/15/191/001 (5 mg, 1 tablet) EU/2/15/191/002 (5 mg, 3 tablets) EU/2/15/191/003 (5 mg, 6 tablets) EU/2/15/191/004 (10 mg, 1 tablet) EU/2/15/191/005 (10 mg, 3 tablets) EU/2/15/191/006 (10 mg, 6 tablets) EU/2/15/191/007 (20 mg, 1 tablet) EU/2/15/191/008 (20 mg, 3 tablets) EU/2/15/191/009 (20 mg, 6 tablets) EU/2/15/191/010 (40 mg, 1 tablet) EU/2/15/191/011 (40 mg, 3 tablets) EU/2/15/191/012 (40 mg, 6 tablets) EU/2/15/191/013 (80 mg, 1 tablet) EU/2/15/191/014 (80 mg, 3 tablets)
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Zaradi pomanjkanja podatkov, se to zdravilo za uporabo v veterinarski medicini sme uporabljati za mladiče do 8 tednov starosti oziroma pri psih, ki tehtajo manj kot 1,3 kg le v skladu z oceno razmerja med koristjo in tveganjem, ki jo opravi odgovorni veterinar.
Simparica chewable tablets sarolaner (mg)
Simparica žvečljive tablete sarolaner (mg)
For ticks (I. ricinus), the onset of efficacy is within 12 hours of attachment during the 28 day period after product administration.
Pri klopih (I. ricinus) začne zdravilo delovati 12 ur po pritrditvi v obdobju 28 dni po dajanju zdravila.
Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus and the mites Demodex canis, Otodectes cynotis and Sarcoptes scabiei.
(Ctenocephalides felis and Ctenocephalides canis) kot tudi na številne vrste klopov (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus in garjavce: Demodex canis, Otodectes cynotis inSarcoptes scabiei.
For fleas, the onset of efficacy is within 8 hours of attachment during the 28 day period after product administration.
Pri začne zdravilo delovati v 8 urah po pritrditvi, v obdobju 28 dni po dajanju zdravila.
For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus).
Za zdravljenje infestacij s klopi (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Ena tableta vsebuje:
Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg
Simparica 5 mg žvečljive tablete za pse 1,3-2,5 kg Simparica 10 mg žvečljive tablete za pse >2,5-5 kg Simparica 20 mg žvečljive tablete za pse >5-10 kg Simparica 40 mg žvečljive tablete za pse >10-20 kg Simparica 80 mg žvečljive tablete za pse >20-40 kg Simparica 120 mg žvečljive tablete za pse >40-60 kg
Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg sarolaner
Simparica 5 mg žvečljive tablete za pse 1,3-2,5 kg Simparica 10 mg žvečljive tablete za pse >2,5-5 kg Simparica 20 mg žvečljive tablete za pse >5-10 kg Simparica 40 mg žvečljive tablete za pse >10-20 kg Simparica 80 mg žvečljive tablete za pse >20-40 kg Simparica 120 mg žvečljive tablete za pse >40-60 kg sarolaner
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij Zoetis Belgium SA
Glucose, liquid (81.5% solids) Spray dried pork liver powder Hydrolysed vegetable protein Gelatin type A
6.1 Seznam pomožnih snovi hipromeloza acetat sukcinat, srednje stopnje laktoza monohidrat natrijev karboksimetilškrob silicijev dioksid, koloidni, brezvodni magnezijev stearat koruzni škrob saharoza glukoza, tekoča (81,5 % trdne snovi) aroma svinjskih jeter, posušena z razprševanjem hidrolizirani rastlinski protein želatina, tip A pšenični kalčki kalcijev hidrogenfosfat, brezvodni
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B POGOJI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
To be supplied only on veterinary prescription.
PRETISNI OMOT IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
250 tablets 30 tablets
250 tablet 30 tablet
80 mg, 25 mg 40 mg, 12.5 mg
80 mg, 25 mg 40 mg, 12.5 mg tablete tablete peroralna uporaba peroralna uporaba steklenička (HDPE) pretisni omot (Alu/Alu)
• Need to ensure appropriate hydration of the patient
• potrebo po zagotovitvi primerne hidriranosti bolnika
• Contraindication in patients with creatinine clearance < 35 ml/min
• kontraindikacije pri bolnikih z očistkom kreatinina < 35 ml/min
The educational programme contains the following:
Izobraževalno gradivo vsebuje naslednje:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Države članice morajo zagotoviti, da se izvajajo vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila kot so opisani v nadaljevanju:
• Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
• ključne znake in simptome resnih neželenih dogodkov • navodila o tem, kdaj je treba poiskati zdravniško pomoč
The Marketing Authorisation Holder (MAH) shall provide an educational programme targeting all physicians who are expected to prescribe/use Zoledronic acid Teva Pharma for the treatment of osteoporosis prior to the launch in Member States.
Imetnik dovoljenja za promet mora pred začetkom trženja v državah članicah zagotoviti, da bo izobraževalno gradivo razširil na vse zdravnike, ki bodo predvidoma predpisovali/uporabljali zdravilo Zoledronska kislina Teva Pharma za zdravljenje osteoporoze.
• Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity
• kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti
• Need to measure serum creatinine before treatment with Zoledronic acid Teva Pharma
• potrebnost meritve kreatinina v serumu pred zdravljenjem z zdravilom Zoledronska kislina
• Contraindication in pregnancy and in breast-feeding women • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
• kontraindikacije med nosečnostjo in dojenjem • potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in
The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authorities in Member States prior to distribution of the educational programme.
Imetnik dovoljenja za promet se mora pred distribucijo izobraževalnega gradiva glede vsebine in oblike gradiva ter načrta za komunikacijo dogovoriti s pristojnim nacionalnim organom.
The patient educational material should contain the following key messages:
Izobraževalno gradivo za bolnika mora vsebovati naslednje ključne sestavine:
The physician educational material should contain the following key messages:
Izobraževalno gradivo za zdravnika mora vsebovati naslednje ključne sestavine:
o Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non-smoking and healthy diet o Key signs and symptoms of serious adverse events o When to seek attention from the health care provider
• That all patients should be provided with the educational material and be counselled about: o potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja o ključne znake in simptome resnih neželenih dogodkov o navodila o tem, kdaj je treba poiskati zdravniško pomoč
• One-yearly dosing regime
• shemo odmerjanja enkrat letno
Further information on Orencia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/orencia.
Nadaljnje informacije o zdravilu Orencia so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/orencia.
Around three-quarters of the patients were also taking methotrexate.
Približno tri četrtine bolnikov je jemalo tudi metotreksat.
What measures are being taken to ensure the safe and effective use of Orencia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Orencia?
Orencia received a marketing authorisation valid throughout the EU on 21 May 2007.
Za zdravilo Orencia je bilo 21. maja 2007 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
As for all medicines, data on the use of Orencia is continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Orencia stalno spremljajo.
The main measure of effectiveness was a reduction in symptoms of at least 20% after 24 weeks of treatment.
Glavno merilo učinkovitosti je bilo zmanjšanje simptomov za vsaj 20 % po 24 tednih zdravljenja.
The Agency decided that Orencia's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zaključila, da so koristi zdravila Orencia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
If Orencia has not worked within 6 months, the doctor should consider if treatment should continue.
Če zdravilo Orencia v šestih mesecih ni bilo učinkovito, mora zdravnik pretehtati, ali naj se zdravljenje nadaljuje.
The main measure of effectiveness was how long it was before the patient's disease flared up again.
Glavno merilo učinkovitosti je bil čas do ponovnega izbruha bolezni.
Other information about Orencia
Druge informacije o zdravilu Orencia
What benefits has Orencia have been shown in studies?
Kakšne koristi je zdravilo Orencia izkazalo v študijah?
The dose depends on the patient's weight.
Odmerek je odvisen od bolnikove telesne mase.
Why is Orencia authorised in the EU?
Zakaj je zdravilo Orencia odobreno v EU?
What is Orencia and what is it used for?
Kaj je zdravilo Orencia in za kaj se uporablja?
T cells are activated when signal molecules attach to receptors on the cells.
Aktivirajo se, ko se signalne molekule vežejo na receptorje na celicah.
An overview of Orencia and why it is authorised in the EU
Pregled zdravila Orencia in zakaj je odobreno v EU
Side effects reported with Orencia are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Orencia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Orencia?
Kakšna tveganja so povezana z zdravilom Orencia?
In this case it should be followed by an injection under the skin the next day.
V tem primeru mora naslednji dan slediti injekcija v podkožje.
Orencia is a medicine that is often used in combination with methotrexate (a medicine that acts on the immune system) to treat the following diseases:
Orencia je zdravilo, ki se pogosto uporablja v kombinaciji z metotreksatom (zdravilom, ki učinkuje na imunski sistem) za zdravljenje naslednjih bolezni:
The main measures of effectiveness were the reduction in symptoms of arthritis after treatment, as well as physical function (the ability to carry out everyday tasks) and the amount of damage to the joints (assessed using X-rays).
Glavna merila učinkovitosti so bila zmanjšanje simptomov artritisa po zdravljenju, funkcijska zmogljivost (sposobnost izvajanja vsakodnevnih nalog) in obseg poškodb sklepov (ocenjen z rentgenskim pregledom).
Orencia was also shown to reduce symptoms of psoriatic arthritis.
Dokazano je bilo tudi, da zdravilo Orencia zmanjšuje simptome psoriatičnega artritisa.
By attaching to signal molecules called CD80 and CD86, abatacept stops them activating the T cells, helping to reduce the inflammation and other symptoms of the diseases.
Abatacept z vezavo na signalne molekule, imenovane CD80 in CD86, onemogoči aktivacijo celic T ter pripomore k zmanjšanju vnetja in drugih simptomov bolezni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orencia have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Orencia upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In around 60% of these patients the TNF alpha blocker had not worked well enough.
Pri približno 60 % bolnikov zaviralec TNF-alfa ni bil dovolj učinkovit.
When given by infusion into a vein, Orencia is given every 2 weeks for the first 3 doses, and then every 4 weeks.
Kadar se zdravilo Orencia daje z infundiranjem v veno, se prvi trije odmerki dajejo vsaka dva tedna, nato pa vsake štiri tedne.
For more information about using Orencia, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Orencia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Subsequently, it is injected under the skin once a week.
V nadaljevanju se zdravilo injicira pod kožo enkrat tedensko.
Patients taking Orencia also had a greater improvement in physical function after six months.
Pri bolnikih, ki so prejemali zdravilo Orencia, je bilo po šestih mesecih opaženo tudi večje izboljšanje funkcijske zmogljivosti.
All patients received Orencia for 4 months, after which the 122 whose condition had improved on Orencia were either switched to placebo or continued receiving Orencia.
Vsi bolniki so zdravilo Orencia prejemali štiri mesece, nato pa je 122 bolnikov, pri katerih se je stanje z zdravilom Orencia izboljšalo, prešlo na placebo ali pa so še naprej prejemali zdravilo Orencia.
Patients who receive Orencia are given a special alert card explaining that it must not be used in patients with certain infections and instructing patients to contact their doctor immediately if they develop an infection during treatment with Orencia.
Bolniki, ki prejemajo zdravilo Orencia, dobijo posebno opozorilno kartico, ki pojasnjuje, da se zdravilo ne sme uporabljati pri bolnikih z določenimi okužbami, ter bolnike opominja, naj nemudoma poiščejo zdravniško pomoč, če se pri njih med zdravljenjem pojavi okužba.
Children between 2 and 6 years should only use Orencia pre-filled syringes.
Pri otrocih, starih od dve do šest let, se lahko uporabijo samo napolnjene injekcijske brizge zdravila Orencia.
It is used in combination with methotrexate, or on its own in patients who cannot take methotrexate.
Uporablja se v kombinaciji z metotreksatom ali samostojno pri bolnikih, ki metotreksata ne morejo jemati;
The most common side effects with Orencia (seen in more than 1 patient in 10) are upper respiratory tract infections (nose and throat infection).
Najpogostejši neželeni učinki zdravila Orencia pri odraslih (ki so se pojavili pri več kot 1 bolniku od 10) so okužbe zgornjih dihal (okužbe nosu in grla).
The study included 259 patients who had previously been treated with a TNF alpha blocker.
Študija je vključevala 259 bolnikov, ki so se predhodno zdravili z zaviralcem TNF-alfa.
The first two studies included 991 patients in whom methotrexate had not worked well enough.
Prvi dve študiji sta vključevali 991 bolnikov, pri katerih metotreksat ni bil dovolj učinkovit.
• highly active and progressive rheumatoid arthritis, used in combination with methotrexate in adults who have not previously been treated with methotrexate;
• močno aktivnega in napredujočega revmatoidnega artritisa v kombinaciji z metotreksatom pri odraslih, ki se z njim predhodno niso zdravili;