natgillin/translations-raw huggingface dataset:
176 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Raziskava 1 je bila raziskava 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10% površine telesa.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
169 ODZIVI BOLNIKOV S PSORIAZO V RAZISKAVAH 2, 3 IN 4
177 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Raziskava 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50%.
Paediatric Plaque Psoriasis Outcomes at 12 Weeks Enbrel 0.8 mg/ kg Once
170 Rezultati po 12 tednih pri otrocih s psoriazo v plakih Enbrel 0, 8 mg/ kg enkrat na
178 Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
171 serumskih koncentracij v odvisnosti od odmerka niso formalno preverjali, vendar po v razponu terapevtskih odmerkov ni bilo opaziti nasičenja očistka zdravila.
179 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
5.3 Preclinical safety data
172 5. 3 Predklinični podatki o varnosti
Sucrose Sodium chloride L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Water for injections
saharoza natrijev klorid L- argininijev klorid natrijev dihidrogen fosfat monohidrat natrijev hidrogen fosfat dihidrat voda za injekcije.
Cartons contain 4, 8 or 24 pre-filled syringes of Enbrel and 8, 16, or 48 alcohol swabs.
Škatle vsebujejo 4, 8 ali 24 napolnjenih injekcijskih brizg zdravila Enbrel in 8, 16 ali 48 alkoholnih tamponov.
Not all pack sizes may be marketed.
Pokrovček igle vsebuje posušen naravni kavčuk (lateks) (glejte poglavje 4. 4).
Before injection, Enbrel single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes).
Pred injiciranjem je treba napolnjeno injekcijsko brizgo zdravila Enbrel za enkratno uporabo segreti na sobno temperature (počakati približno 15 do 30 minut).
The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature.
Pri čakanju, da se napolnjena injekcijska brizga segreje na sobno temperaturo pokrovčka igle ne smete odstraniti.
The solution should be clear and colourless or pale yellow and practically free from visible particles.
Raztopina mora biti bistra in brezbarvna ali bledo rumena in ne sme vsebovati vidnih delcev.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
173 Izčrpna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7, "Navodila za pripravo in dajanje injekcij zdravila Enbrel".
182 1.
174 1.
183 function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Izkazalo se je, da Enbrel izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in da upočasni hitrost napredovanja okvar perifernih sklepov, izmerjeno z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
Ankylosing spondylitis
175 Ankilozirajoči spondilitis
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Izčrpna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7, "Navodila za pripravo in dajanje injekcij Enbrel".
184 If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
V primeru ponovnega zdravljenja z zdravilom Enbrel je potrebno upoštevati zgornja navodila glede trajanja zdravljenja.
Paediatric plaque psoriasis (age 8 years and above)
176 Otroška psoriaza v plakih (starost 8 let ali več)
Treatment should be discontinued in patients who show no response after 12 weeks.
Pri bolnikih, ki po 12 tednih ne pokažejo odziva, je treba zdravljenje prekiniti
185 Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely.
Bolnike, pri katerih se med zdravljenjem z zdravilom Enbrel pojavi nova okužba, je treba strogo nadzorovati.
Appropriate screening tests, i. e. tuberculin skin test and chest x-ray, should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba opraviti ustrezne presejalne teste, t. j. tuberkulinski kožni test in rentgensko slikanje pljuč in srca (morda obstajajo lokalna priporočila
186 Concurrent Enbrel and abatacept treatment
Sočasno zdravljenje z zdravilom Enbrel in abataceptom
Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.
178 Pri dveh bolnikih z juvenilnim idiopatskim artritisom so se razvili okužba z noricami in znaki in simptomi aseptičnega meningitisa, ki so izzveneli brez posledic.
In a double blind, placebo controlled, randomised clinical study in adult patients with psoriatic arthritis 184 patients also received a
V dvojno slepi, s placebom kontrolirani, randomizirani klinični raziskavi pri odraslih bolnikih s psoriatičnim artritisom je 184 bolnikov v 4. tednu dobilo tudi multivalentno polisaharidno cepivo proti pnevmokokom.
187 multivalent pneumococcal polysaccharide vaccine at week 4.
Večina bolnikov s psoriatičnim artritisom, ki so dobivali zdravilo Enbrel, je v tej raziskavi zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
Combination therapy
179 Kombinirano zdravljenje
Two large clinical trials evaluating the use of Enbrel in the treatment of
Obstajajo postmarketinška poročila o poslabšanju KSP pri bolnikih, ki jemljejo zdravilo Enbrel, v prisotnosti dejavnikov, ki bi lahko sprožili takšno poslabšanje in brez takšnih dejavnikov.
188 CHF were terminated early due to lack of efficacy.
Dve veliki klinični raziskavi za ovrednotenje uporabe zdravila Enbrel pri zdravljenju KSP sta bili predčasno prekinjeni zaradi slabe učinkovitosti zdravila.
Concurrent Enbrel and abatacept treatment
180 Sočasno zdravljenje z zdravilom Enbrel in abataceptom
Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general
Ni predkliničnih podatkov o peri - in postnatalni toksičnosti etanercepta in o učinkih etanercepta na plodnost in splošne reprodukcijske sposobnosti.
189 reproductive performance are not available.
Uporabe zdravila Enbrel med nosečnostjo ne priporočamo.
The proportion of patients who discontinued treatment due to adverse events was the same in both the Enbrel and placebo treatment groups; in the first active-controlled trial, the dropout rate was significantly higher for methotrexate (10%) than for Enbrel (5%).
V prvem z zdravilno učinkovino kontroliranem preskušanju je bilo število bolnikov, ki so izpadli iz
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (> 1/ 10);
Znotraj organskih sistemov so neželeni učinki navedeni po pogostnosti (število bolnikov, pri katerih se pričakuje pojav učinka), z uporabo naslednjih kategorij: zelo pogosti (> 1/ 10); pogosti (> 1/ 100, < 1/ 10); občasni (> 1/ 1. 000, < 1/ 100); redki (> 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000); neznana (ni mogoče natančno oceniti s pomočjo kliničnih študij).
Nervous system
182 Bolezni živčevja:
disorders:
Redki:
191 General disorders and administration site conditions:
Splošne težave in spremembe na mestu aplikacije:
Among rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis patients in placebo-controlled, active-controlled, and open-label trials of Enbrel, serious adverse events reported included malignancies (see below), asthma, infections (see below), heart failure, myocardial infarction, myocardial ischaemia, chest pain, syncope, cerebral ischaemia, hypertension, hypotension, cholecystitis, pancreatitis, gastrointestinal haemorrhage, bursitis, confusion, depression, dyspnoea, abnormal healing, renal insufficiency, kidney calculus, deep vein thrombosis, pulmonary embolism, membranous glomerulonephropathy, polymyositis, thrombophlebitis, liver damage, leucopenia, paresis, paresthesia, vertigo, allergic alveolitis, angioedema, scleritis, bone fracture, lymphadenopathy, ulcerative colitis, intestinal obstruction, eosinophilia, haematuria, and sarcoidosis.
Pri bolnikih z revmatoidnim artritisom, s psoriatičnim artritisom, z ankilozirajočim artritisom in s psoriazo v plakih so v s placebom kontroliranih preskušanjih, z aktivno učinkovino kontroliranih raziskavah in odprtih raziskavah poročali o resnih neželenih učinkih, vključno z malignimi obolenji (glejte spodaj), astmo, okužbami (glejte spodaj), srčnim popuščanjem, miokardnim infarktom, miokardno ishemijo, bolečinami v prsnem košu, sinkopo, cerebralno ishemijo, hipertenzijo, hipotenzijo, holecistitisom, pankreatitisom, gastrointestinalnimi krvavitvami, burzitisom, zmedenostjo, depresijo, dispnejo, nenormalnim celjenjem ran, ledvično insuficienco, ledvičnimi kamni, globoko vensko trombozo, pljučno embolijo, membransko glomerulonefropatijo, polimiozitisom, tromboflebitisom, okvaro jeter, levkopenijo, parezo, parestezijo, vrtoglavico, alergijskim alveolitisom, angioedemom, skleritisom, zlomi kosti, limfoadenopatijo, ulceroznim kolitisom, intestinalnimi obstrukcijami, eozinofilijo, hematurijo in sarkoidozo.
Malignancies
183 Maligna obolenja
No treatment was given for the majority of injection site reactions in the Enbrel treatment groups, and the majority of patients who were given treatment received topical preparations such as corticosteroids, or oral antihistamines.
V skupini bolnikov, ki so bili zdravljeni z zdravilom Enbrel, večine reakcij na mestu injiciranja ni bilo potrebno zdraviti.
Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of
Večina bolnikov, pri katerih je bilo zdravljenje le potrebno, pa je prejela lokalna zdravila, npr. kortikosteroide ali peroralne antihistaminike.
192 injection along with the simultaneous appearance of injection site reactions at previous injection sites.
Nekateri bolniki so dobili tako imenovano spominsko lokalno reakcijo na mestu injiciranja; ob naslednjem injiciranju se je poleg reakcije na tedanjem mestu injiciranja sočasno pojavila reakcija tudi na prejšnjih mestih injiciranja.
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of
Tudi odstotek bolnikov, ki so razvili nova pozitivna anti- dvojno- vijačna DNK protitelesa, je bil višji, merjeno z radioimunskimi testi (15% pri zdravilu Enbrel in 4% pri placebu) in s testom na Crithidia luciliae (3% pri zdravilu Enbrel in 0% pri placebu).
Undesirable effects in paediatric patients with plaque psoriasis
185 Neželeni učinki pri pediatričnih bolnikih s psoriazo v plakih
Clinical trials
186 Klinična preskušanja
Among patients receiving Enbrel, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always
Pri bolnikih na zdravilu Enbrel se je klinični odziv običajno pojavil že v prvem ali drugem tednu zdravljenja, skoraj vedno pa je nastopil do 3. meseca.
195 occurred by 3 months.
Odziv je bil odvisen od odmerka.
In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score (JSN).
V tej raziskavi je bila strukturna poškodba sklepov ocenjena na rentgenskih slikah in izražena kot sprememba skupne Sharpove ocene (Total Sharp Score, TSS) in njenih komponent, ocene erozije
197 CLINICAL EFFICACY RESULTS AT 12 MONTHS:
188 KLINIČNA UČINKOVITOST PO 12 MESECIH:
198 RADIOGRAPHIC PROGRESSION:
189 RENTGENSKO NAPREDOVANJE:
(1) distal 199 interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
190 (1) distalna interfalangealna prizadetost (DIP); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali (5) spondilitisu podobna ankiloza.
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
191 POVPREČNA (SE) SPREMEMBA SKUPNE SHARPOVE OCENE OD IZHODIŠČA NA LETO
201 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
192 ODZIVI BOLNIKOV Z ANKILOZIRAJOČIM SPONDILITISOM V S PLACEBOM KONTROLIRANEM PRESKUŠANJU Odstotek bolnikov
202 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Raziskava 1 je bila raziskava 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10% površine telesa.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
193 Raziskava 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot raziskava 1, le da so imeli bolniki ob presejanju indeks PASI vsaj 10.
203 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Raziskava 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50%.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
194 V raziskavi 3 je večina bolnikov (77%), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek zdravila Enbrel po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
204 Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
205 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
Elderly patients
196 Starostniki
206 6.2 Incompatibilities
6. 2 Inkompatibilnosti
6.5 Nature and contents of container
197 6. 5 Vrsta ovojnine in vsebina
Cartons contain 2, 4 or 12 pre-filled syringes of Enbrel with 4, 8 or 24 alcohol swabs.
Škatle vsebujejo 2, 4 ali 12 napolnjenih injekcijskih brizg zdravila Enbrel in 4, 8 ali 24 alkoholnih tamponov.
The needle cover contains dry natural rubber (latex) (see section 4.4).
Pokrovček igle vsebuje posušen naravni kavčuk (lateks) (glejte poglavje 4. 4).
208 ANNEX II
198 DODATEK II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
209 A.
199 A.
Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65 D-88397 Biberach an der Riss Germany
Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65 D- 88397 Biberach an der Riss Nemčija
Amgen Rhode Island (ARI) 40 Technology Way West Greenwich, Rhode Island 02817 USA
Amgen Rhode Island (ARI) 40 Technology Way West Greenwich, Rhode Island 02817 ZDA
Wyeth Medica Ireland Wyeth BioPharma Campus at Grange Castle Grange Castle Business Park Clondalkin Dublin 22 Ireland
Wyeth Medica Ireland Wyeth BioPharma Campus at Grange Castle Grange Castle Business Park Clondalkin Dublin 22 Irska
Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG United Kingdom
Wyeth Pharmaceuticals New Lane Havant, Hampshire PO9 2NG Velika Britanija
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Medicinal product subject to restricted medical prescription (See Annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (glej Dodatek I:
 OTHER CONDITIONS
• DRUGI POGOJI
The Marketing Authorisation Holder will submit PSURs annually in April.
Imetnik dovoljenja za promet z zdravilom bo PSUR predložil aprila vsako leto.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 (02-October-2008) of the Risk Management Plan (RMP), presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvajal študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 1. 1 (02- oktober- 2008) načrta za obvladovanje tveganja (RMP – Risk Management Plan), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
210 As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami CHP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted:  When new information is received that may impact the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities  Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached  At the request of the EMEA
200 Poleg tega je treba posodobljen RMP predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja; • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja); • na zahtevo Evropske agencije za zdravila (EMEA).
211 ANNEX III
201 DODATEK III
212 A.
202 A.
213 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
203 PODATKI NA ZUNANJI OVOJNINI
CARTON TEXT – EU/ 1/ 99/ 126/ 001
BESEDILO NA ŠKATLI – EU/ 1/ 99/ 126/ 001
Each vial of Enbrel contains 25 mg etanercept.
Vsaka viala zdravila Enbrel vsebuje 25 mg etanercepta.
Water for injections
Pomožne snovi so: prašek: manitol, saharoza in trometamol vehikel: voda za injekcije.
4 vials of powder 4 pre-filled syringes of 1 ml solvent 8 alcohol swabs
4 napolnjene injekcijske brizge z 1 ml vehikla.
XX/ YYYY
MM/ LLLL
Store in a refrigerator Do not freeze.
Ne zamrzujte.
After preparing the Enbrel solution, immediate use is recommended.
Po pripravi naj se zdravilo po možnosti uporabi takoj.
However, the solution may be use for up to 6 hours when stored in the refrigerator (2 – 8 C)
Lahko se ga uporabi tudi v 6 urah po pripravi, če je shranjeno v hladilniku (2 °C – 8 °C).
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom.
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, Velika Britanija
215 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
205 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 001
BESEDILO NA NALEPKI VIALE – EU/ 1/ 99/ 126/ 001
Enbrel 25 mg powder for injection etanercept Subcutaneous use
Enbrel 25 mg prašek za raztopino za injiciranje etanercept Subkutana uporaba
216 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
206 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
TEXT FOR SYRINGE LABEL – EU/ 1/ 99/ 126/ 001
BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE – EU/ 1/ 99/ 126/ 001
Solvent for Enbrel 1ml water for injections
Vehikel za Enbrel 1 ml vode za injekcije
217 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
207 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 001
BESEDILO NA PODSTAVKU - EU/ 1/ 99/ 126/ 001
218 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
208 PODATKI NA ZUNANJI OVOJNINI
CARTON TEXT – EU/ 1/ 99/ 126/ 002
BESEDILO NA ŠKATLI – EU/ 1/ 99/ 126/ 002
Mannitol, sucrose and trometamol.
Pomožne snovi so: prašek: manitol, saharoza in trometamol.
8 alcohol swabs
prašek za raztopino za injiciranje 4 viale s praškom 8 alkoholnih tamponov
219 9.
209 9.
After preparing the Enbrel solutione use is recommended.
Po pripravi naj se zdravilo po možnosti uporabi takoj.
However, the solution may be used for up to 6 hours when stored in the refrigerator (2 C – 8 C).
Lahko se ga uporabi tudi v 6 urah po pripravi, če je shranjeno v hladilniku (2 °C – 8 °C).
You will also need 1 ml of water for injections and a syringe to administer Enbrel
Potrebovali boste tudi 1 ml vode za injekcije in injekcijsko brizgo za injiciranje zdravila Enbrel.
220 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
210 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 002
BESEDILO NA NALEPKI VIALE – EU/ 1/ 99/ 126/ 002
221 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
211 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 002
BESEDILO NA PODSTAVKU - EU/ 1/ 99/ 126/ 002
222 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
212 PODATKI NA ZUNANJI OVOJNINI
CARTON TEXT – EU/ 1/ 99/ 126/ 003-005
BESEDILO NA ŠKATLI – EU/ 1/ 99/ 126/ 003- 005
Water for injections
Pomožne snovi so: prašek: manitol, saharoza in trometamol. vehikel: voda za injekcije.
4 vials of powder 4 pre-filled syringes of 1 ml solvent 4 stainless steel injection needles 4 vial adaptors 8 alcohol swabs
4 viale s praškom 4 napolnjene injekcijske brizge z 1 ml vehikla 4 igle iz nerjavečega jekla 4 adapterji za viale 8 alkoholnih tamponov
8 vials of powder 8 pre-filled syringes of 1 ml sovent 8 stainless steel injection needles 8 vial adaptors 16 alcohol swabs
8 vial s praškom 8 napolnjenih injekcijskih brizg z 1 ml vehikla 8 igel iz nerjavečega jekla 8 adapterjev za viale 16 alkoholnih tamponov
24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors 48 alcohol swabs
24 vial s praškom 24 napolnjenih injekcijskih brizg z 1 ml vehikla 24 igel iz nerjavečega jekla 24 adapterjev za viale 48 alkoholnih tamponov
However, the solution may be used for up to 6 hours when stored in a refrigerator (2 C – 8 C).
Lahko se ga uporabi tudi v 6 urah po pripravi, če je shranjeno v hladilniku (2 °C – 8 °C).
EU/ 1/ 99/ 126/ 003 4 vials EU/ 1/ 99/ 126/ 004 8 vials EU/ 1/ 99/ 126/ 005 24 vials
EU/ 1/ 99/ 126/ 003 4 viale EU/ 1/ 99/ 126/ 004 8 vial EU/ 1/ 99/ 126/ 005 24 vial
15.
214 15.