natgillin/translations-raw huggingface dataset:
Furthermore, the overall incidence of malignancies was not increased during 3 years of patient exposure to Kineret.
Poleg tega se celotna incidenca malignomov v 3 letih izpostavljenosti Kineretu ni povečala.
Immunogenicity
5 Imunogenost
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.
V kliničnih preskušanjih je bilo do 3% odraslih bolnikov vsaj enkrat med študijo seropozitivnih za protitelesa, ki lahko nevtralizirajo biološke učinke anakinre.
The occurrence of antibodies was typically transient and not associated with clinical adverse reactions or diminished efficacy.
Pojav protiteles je bil praviloma prehoden in ni bil povezan s kliničnimi neželenimi reakcijami ali manjšo učinkovitostjo.
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.
Poleg tega je bilo v enem kliničnem preskušanju 6% pediatričnih bolnikov vsaj enkrat med študijo seropozitivnih pri testiranju za protitelesa, zmožna nevtralizirati biološke učinke anakinre.
No dose-limiting toxicities were observed during clinical trials in rheumatoid arthritis patients.
Med kliničnimi preskušanji pri bolnikih z revmatoidnim artritisom niso opazili toksičnosti, ki bi omejevale odmerek.
In studies of sepsis, 1,015 patients received Kineret at doses up to 2 mg/ kg/ hour over a 72 hour treatment period.
V študijah sepse je 1. 015 bolnikov dobivalo Kineret v odmerkih do 2 mg/ kg/ uro skozi 72 urno obdobje zdravljenja.
Immunosuppressants, ATC code:
Farmakoterapevtska skupina: dravila za zaviranje imunske odzivnosti, oznaka 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).
Interlevkin- 1 (IL- 1) je ključni vnetje pospešujoči citokin, ki posreduje številne celične odzive, med drugimi tudi tiste, ki so pomembni pri sinovialnem vnetju.
Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation.
IL- 1 najdemo v plazmi in sinovialni tekočini bolnikov z revmatoidnim artritisom.
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.
Poročali so o korelaciji med koncentracijami IL- 1 v plazmi in aktivnostjo bolezni.
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 zavira odzive, ki jih izzove IL- 1 in vitro, med drugim indukcijo tvorbe dušikovega oksida in prostaglandina E2 in/ ali kolagenaze v sinovialnih celicah, fibroblastih in hondrocitih.
The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in patients with varying degrees of disease severity.
Varnost in učinkovitost anakinre v kombinaciji z metotreksatom so dokazali pri bolnikih z različnimi stopnjami izraženosti bolezni.
6 A clinical response to anakinra generally appeared within 2 weeks of initiation of treatment and was sustained with continued administration of anakinra.
Klinični odziv na anakinro se je običajno pojavil v 2 tednih po uvedbi zdravljenja in se je s stalnim dajanjem anakinre vzdrževal.
22% responders as measured by ACR20 criteria).
Kombinirano zdravljenje z anakinro in metotreksatom je pokazalo statistično in klinično pomembno zmanjšanje resnosti znakov in simptomov revmatoidnega artritisa pri bolnikih, pri katerih je bil odziv na metotreksat sam nezadosten (38% proti 22% bolnikov, ki so se odzvali po kriterijih 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.
Pomembno izboljšanje vidimo pri bolečini, številu občutljivih sklepov, telesnem funkcioniranju (lestvica HAQ), reaktantih akutne faze in globalni oceni tako bolnika kot zdravnika.
These have shown no deleterious effect on joint cartilage.
Le- te niso pokazale škodljivih učinkov na sklepni hrustanec.
The absolute bioavailability of anakinra after a 70 mg SC bolus injection in healthy subjects (n = 11) is 95%.
Absolutna biološka uporabnost anakinre po s. c. bolusni injekciji 70 mg pri zdravih osebah (n = 11) je 95%.
The absorption process is the rate-limiting factor for the disappearance of anakinra from the plasma after SC injection.
Dejavnik, ki omejuje hitrost izginjanja anakinre iz plazme po s. c. injekciji, je proces absorpcije.
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.
Pri osebah z RA so se največje koncentracije anakinre v plazmi pojavile 3 do 7 ur po s. c. aplikaciji anakinre v klinično primernih odmerkih (1 do 2 mg/ kg; n = 18); končni razpolovni čas je bil od 4 do 6 ur.
In RA patients, no unexpected accumulation of anakinra was observed after daily SC doses for up to 24 weeks.
Pri bolnikih z RA niso opazili nikakršnega nepričakovanega kopičenja anakinre po dnevnih s. c. odmerkih do 24 tednov.
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.
Vpliv demografskih sospremenljivk na farmakokinetiko anakinre so proučevali s populacijsko farmakokinetično analizo, ki je zajela 341 bolnikov, ki so prejemali vsakodnevne s. c. injekcije anakinre v odmerkih po 30, 75 in 150 mg do 24 tednov.
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.
Populacijska farmakokinetična analiza je pokazala, da je bila povprečna vrednost plazemskega očistka po s. c. aplikaciji bolusa približno 14% večja pri moških kot pri ženskah in približno 10% večja pri osebah, mlajših od 65 let, kot pri osebah, starih 65 let ali več.
However, after adjusting for creatinine clearance and body weight, sex and age were not significant factors for mean plasma clearance.
Vendar po prilagoditvi na očistek kreatinina in telesno maso spol in starost nista bila pomembna dejavnika za srednji plazemski očistek.
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.
Pri anakinri niso opazili učinkov na plodnost, zgodnji razvoj, razvoj zarodka in plodu ali perinatalni in postnatalni razvoj pri podgani v odmerkih, do 100- krat večjih od človeškega odmerka.
No effects on embryo-foetal development in the rabbit were observed at doses 100 times the human dose.
Pri odmerkih, do 100- krat večjih od človeškega odmerka, niso opazili učinkov na razvoj zarodka in plodu pri kuncu.
Data from mice over expressing IL-1ra and IL-1ra mutant knock-out mice, did not indicate an increased risk of tumour development.
Podatki, pridobljeni na transgenih miših s prekomerno ekspresijo IL- 1ra in tistih z mutiranim IL- 1ra niso pokazali zvečane nevarnosti za razvoj tumorjev.
A formal toxicologic and toxicokinetic interaction study in rats revealed no evidence that Kineret alters the toxicologic or pharmacokinetic profile of methotrexate.
Uradna študija o toksikoloških in toksikokinetičnih interakcijah pri podganah ni razkrila dokazov, da Kineret spreminja toksikološki ali farmakokinetični profil metotreksata.
Sodium citrate Sodium chloride Disodium edetate Polysorbate 80 Sodium hydroxide Water for injections
natrijev citrat natrijev klorid dinatrijev edetat polisorbat 80 natrijev hidroksid voda za injekcije
Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (med 2 ºC in 8 ºC).
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.
7 V primerih ambulantne uporabe se sme Kineret hraniti izven hladilnika 12 ur pri temperaturi do 25°C, če pri tem ni prekoračen datum roka uporabnosti zdravila.
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, 67 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (iz stekla tipa I) z batnim zamaškom (iz bromobutilne gume) v pakiranjih po 1, 7 ali 28 napolnjenih injekcijskih brizg.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex).
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suh naravni kavčuk (derivat lateksa).
Kineret is a sterile unpreserved solution.
Kineret je sterilna raztopina brez dodanih sredstev za konzerviranje.
Before administration, visually inspect the solution for particulate matter and discolouration.
Pred uporabo morate raztopino pregledati, če vsebuje morebitne delce in/ ali je obarvana.
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 – pakiranje po 1 EU/ 1/ 02/ 203/ 002 – pakiranje po 7 EU/ 1/ 02/ 203/ 003 – pakiranje po 28
8 March 2002 Date of latest renewal:
8. marec 2002 Datum podaljšanja dovoljenja za promet:
Kineret 100 mg solution for injection in a vial.
Kineret 100 mg raztopina za injiciranje v viali.
Each vial contains 100 mg of anakinra* per 0.67 ml (150 mg/ ml).
Ena viala vsebuje 100 mg anakinre * na 0, 67 ml (150 mg/ ml).
Solution for injection (injection) in a vial.
Raztopina za injiciranje (injekcijo) v viali.
Clear, colourless-to-white solution for injection that may contain some product-related translucent-to- white amorphous particles.
Bistra, brezbarvna do bela raztopina za injiciranje, ki lahko zaradi zdravila vsebuje nekaj prosojnih do belih amorfnih delcev.
Kineret is supplied ready for use in a vial.
Kineret je na voljo pripravljen za uporabo v viali.
10 Renal impairment
9 Ledvična okvara
Hypersensitivity to the active substance, any of the excipients or to E. coli derived proteins.
Preobčutljivost za zdravilno učinkovino, katerokoli pomožno snov ali za beljakovine, ki izvirajo iz E coli.
The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Pokrovček na viali vsebuje suh naravni kavčuk (derivat lateksa), ki lahko povzroči alergijske reakcije.
Therefore the use of Kineret in patients with pre-existing malignancy is not recommended.
Vpliv zdravljenja s Kineretom na že obstoječe malignome ni raziskan, zato Kinereta ni priporočljivo uporabljati pri bolnikih z obstoječim malignomom.
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
V kliničnem preskušanju (n = 126), kontroliranem s placebom, so sočasno s Kineretom uporabili toksoid tetanusa/ davice.
11 was administered concurrently with Kineret.
Pri tem med skupino, ki je dobivala Kineret, in tisto, ki je dobivala placebo, niso ugotovili razlik v odzivu protiteles proti tetanusu.
No data are available on the effects of vaccination with other inactivated antigens in patients receiving Kineret.
Za bolnike, ki so dobivali Kineret, ni podatkov o učinkih cepljenja z drugimi inaktiviranimi antigeni.
Women of child-bearing potential must use effective contraception during treatment.
Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
12 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
The infections observed consisted primarily of bacterial events such as cellulitis, pneumonia, and bone and joint infections.
Zabeležene okužbe so obsegale predvsem bakterijske, npr. flegmono, pljučnico ter okužbe kosti in sklepov..
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).
V študijah s Kineretom, kontroliranih s placebom, je bilo zdravljenje povezano z majhnim znižanjem srednjih vrednosti vseh belih krvničk in absolutnega števila nevtrofilcev (ANC – » absolute neutrophil count «).
13 Malignancies
Maligne bolezni
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.
V kliničnih študijah je bila sama incidenca malignih bolezni pri bolnikih, ki so dobivali Kineret in placebo, enaka in se ni razlikovala od tiste v splošni populaciji.
Immunogenicity
12 Imunogenost
Immunosuppressants, ATC code:
Zdravila za zaviranje imunske odzivnosti,, oznaka ATC:
L04AC03
L04AC03.
22% responders as measured by ACR20
Kombinirano zdravljenje z anakinro in metotreksatom je pokazalo statistično in klinično pomembno zmanjšanje resnosti znakov in simptomov revmatoidnega artritisa pri bolnikih, pri katerih je bil odziv na metotreksat sam nezadosten (38% proti 22% bolnikov, ki so se odzvali po kriterijih ACR20).
However, after adjusting for creatinine clearance and body weight, sex and age were not significant factors for mean plasma clearance.
Vendar po prilagoditvi na očistek kreatinina in telesno maso, spol in starost nista bila pomembna dejavnika za srednji plazemski očistek.
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.
14 V primerih ambulantne uporabe se sme Kineret hraniti izven hladilnika 12 ur pri temperaturi do 25°C, če pri tem ni prekoračen datum roka uporabnosti zdravila.
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 raztopine za injiciranje v viali (iz stekla tipa I) z gumijastimi zamaški, aluminijastimi zaporkami in plastičnimi pokrovčki v pakiranju po 1.
The vial stopper contains dry natural rubber (a derivative of latex).
Pokrovček na viali vsebuje suh naravni kavčuk (derivat lateksa).
Allow the vial to reach room temperature before injecting.
Viala naj pred injiciranjem doseže sobno temperaturo.
Before administration, visually inspect the solution for particulate matter and discolouration.
Pred uporabo morate raztopino pregledati, če vsebuje kakšne delce in/ ali je obarvana.
Only clear, colourless-to-white solutions that may contain some product-related translucent-to-white amorphous particles should be injected.
Injicirati smete samo bistro, brezbarvno do belo raztopino, ki lahko zaradi zdravila vsebuje nekaj prosojnih do belih amorfnih delcev.
17 ANNEX II
15 PRILOGA II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKO AKTIVNE SUBSTANCE IN IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN ZA SPROŠČANJE SERIJ V PROMET
CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI ZA PRIDOBITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
16 A IZDELOVALEC BIOLOŠKO AKTIVNE SUBSTANCE IN IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN ZA SPROŠČANJE SERIJ V PROMET
5550 Airport Boulevard Boulder, CO 80301 U. S. A.
5550 Airport Boulevard Boulder, CO 80301 ZDA
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serij v promet
CONDITIONS OF THE MARKETING AUTHORISATION
B POGOJI ZA DOVOLJENJE ZA PROMET Z DRAVILOM
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE, KI SE TIČEJO DOBAVE IN UPORABE NALOŽENIH NA IMETNIKA DOVOLJENJA ZA PROMET Z DRAVILOM
Medicinal product subject to restricted medical prescription (See Annex I:
(glejte prilogo I:
19 ANNEX III
17 DODATEK III
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
19 PODATKI NA ZUNANJI OVOJNINI
Kineret 100 mg solution for injection in a pre-filled syringe Anakinra
Kineret 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi anakinra
Each 0.67 ml pre-filled syringe contains 100 mg of anakinra.
Vsaka 0, 67 ml napolnjena injekcijska brizga vsebuje 100 mg anakinre.
Excipients: sodium citrate, sodium chloride, disodium edetate, polysorbate 80, sodium hydroxide, water for injections.
Pomožne snovi: natrijev citrat, natrijev klorid, dinatrijev edetat, polisorbat 80, natrijev hidroksid, voda za injekcije.
Solution for injection in a single use pre-filled syringe 1 pre-filled syringe 7 pre-filled syringes 28 pre-filled syringes
1 napolnjena injekcijska brizga 7 napolnjenih injekcijskih brizg 28 napolnjenih injekcijskih brizg
For subcutaneous use Read the package leaflet before use.
za subkutano uporabo Pred uporabo preberite priloženo navodilo.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF NECESSARY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
CARTON OF 7 PRE-FILLED SYRINGE AS AN INTERMEDIATE PACK (WITHOUT BLUE BOX)
ŠKATLA S 7 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI KOT VMESNO PAKIRANJE (BREZ MODRE ŠKATLE)
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.
7 napolnjenih injekcijskih brizg Ta škatla z 7 napolnjenimi injekcijskimi peresniki je del pakiranja po 28.
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PRE-FILLED SYRINGE LABEL
NALEPKA NAPOLNJENE INJEKCIJSKE BRIZGE
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
24 PODATKI NA ZUNANJI OVOJNINI
VIAL CARTON
ŠKATA Z VIALO
Kineret 100 mg solution for injection in a vial Anakinra
Kineret 100 mg raztopina za injiciranje v viali anakinra
Each 0.67 ml vial contains 100 mg of anakinra.
Vsaka 0, 67 ml viala vsebuje 100 mg anakinre.
Solution for injection in a single use vial 1 vial
1 viala
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Kineret 100 mg solution for injection in a pre-filled syringe Anakinra
Kineret 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Anakinra
What Kineret is and what it is used for 2.
Kaj je zdravilo Kineret in za kaj ga uporabljamo 2.
Before you use Kineret 3.
Kaj morate vedeti, preden boste uporabili zdravilo Kineret 3.
How to use Kineret 4.
Kako uporabljati zdravilo Kineret 4.
How to store Kineret 6.
Shranjevanje zdravila Kineret 6.
WHAT KINERET IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO KINERET IN ZA KAJ GA UPORABLJAMO
Kineret (an immunosuppressive agent) is a type of cytokine that is used to treat rheumatoid arthritis.
Kineret (imunosupresivno sredstvo) je vrsta citokina, ki se uporablja za zdravljenje revmatoidnega artritisa.
Cytokines are proteins made by your body that co-ordinate communication between cells and help control cell activity.
Citokini so beljakovine, ki jih izdeluje vaše telo, ki uravnavajo komuniciranje med celicami in pomagajo kontrolirati celično aktivnost.
In rheumatoid arthritis, your body produces too much of a cytokine called interleukin-1.
Pri revmatoidnem artritisu vaše telo izdeluje preveč citokina, ki se imenuje interlevkin- 1.
Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
Vaše telo normalno izdeluje beljakovino, ki blokira škodljive učinke interlevkina- 1.
In rheumatoid arthritis your body does not produce enough of this blocking protein.
Pri revmatoidnem artritisu vaše telo ne izdeluje dovolj te blokirajoče beljakovine.
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.
Zdravilna učinkovina v zdravilu Kineret je anakinra, izdelana s tehnologijo DNA z uporabo mikroorganizma E. coli, in deluje na enak način kot vaša naravna blokirajoča beljakovina.
Kineret is used to treat the signs and symptoms of rheumatoid arthritis in combination with another medicine called methotrexate.
Kineret se uporablja za zdravljenje znakov in simptomov revmatoidnega artritisa v kombinaciji s še enim zdravilom, ki se imenuje metotreksat.
Kineret is for patients whose response to methotrexate on its own is not good enough to control the rheumatoid arthritis.
Kineret je namenjen bolnikom, katerih odziv na metotreksat sam ni dovolj dober, da bi obvladal revmatoidni artritis.
BEFORE YOU USE KINERET
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO KINERET
Kineret is for use in adults only (age 18 years and over).
Kineret je namenjen samo za odrasle (stare 18 let in več).
Do not use Kineret:
Ne uporabite zdravila Kineret:
• if you are allergic (hypersensitive) to Kineret (anakinra) or to any of the other ingredients in Kineret;
če ste alergični na (preobčutljivi za) Kineret (anakinro) ali katerokoli pomožno snov zdravila • Kineret;
• if you are allergic to other products that are produced by DNA technology using the micro- organism E. coli;
če ste alergični na druge produkte, izdelane s tehnologijo DNA z uporabo mikroorganizma • E. coli;
• if you have severe renal impairment (kidney damage).
če imate težko ledvično okvaro (ledvično poškodbo). •
31 Contact your doctor immediately:
29 Nemudoma se obrnite na svojega zdravnika:
• if you get a rash all over your body, shortness of breath, wheezing, fast pulse or sweating after your Kineret injection.
če se po injekciji zdravila Kineret pojavi izpuščaj po vsem telesu, kratko sapo, sopenje, hiter • srčni utrip ali znojenje.
These may be signs that you are allergic to Kineret.
To utegnejo biti znaki, da ste alergični na Kineret.
Take special care with Kineret
Bodite posebno pozorni pri jemanju zdravila Kineret
Discuss with your doctor:
Pogovorite se z zdravnikom:
• if you have a history of recurring infections, or if you suffer from asthma.
če imate anamnezo ponavljajočih se okužb ali če imate astmo.
Kineret may worsen these conditions;
Kineret lahko poslabša ti dve • stanji;
• if you have cancer.
če imate raka.
Your doctor will have to decide if you can still be given Kineret;
Vaš zdravnik bo moral odločiti, ali lahko kljub temu dobite Kineret; •
• if you require vaccinations.
če se boste morali cepiti.
You must not be given live vaccines while being treated with Kineret;
Med zdravljenjem z zdravilom Kineret se ne smete cepiti z živimi • cepivi;
• if you know you are allergic to latex.
če veste, da ste alergični na lateks.
The needle cover on the pre-filled syringe contains a derivative of latex.
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje • snov, pridobljeno iz lateksa.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tako kot velja za vsa zdravila, morate svojemu zdravniku povedati, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Kineret has not been tested in pregnant women.
Pri nosečnicah zdravila Kineret niso preskusili.
It is important to tell your doctor if you:
Pomembno je, da poveste svojemu zdravniku, če:
• are pregnant;
ste noseči; •
• think you may be pregnant; or
mislite, da utegnete biti noseči; ali •
• plan to get pregnant.
načrtujete zanositev. •
You must stop breast-feeding if you use Kineret.
Če uporabljate Kineret, morate prenehati dojiti.
Important information about some of the ingredients of Kineret
Pomembne informacije o nekaterih sestavinah zdravila Kineret
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, i. e. essentially ‘ sodium-free’.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg, kar v bistvu pomeni "brez natrija".