natgillin/translations-raw huggingface dataset:
G. Hold the pinched skin.
Držite kožu stisnutu.
Important: Always hold the pre-filled syringe by the syringe barrel.
Važno: Napunjenu štrcaljku uvijek držite samo za tijelo štrcaljke.
Elderly (aged 65 years and over) No dose adjustment is recommended in elderly patients (see section 5.2).
Ne preporučuje se prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
The efficacy and safety of Kyntheum was assessed in 4373 adult plaque psoriasis patients across three multinational, randomised, double-blind, phase 3, placebo-controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3).
Djelotvornost i sigurnost lijeka Kyntheum ocjenjivala se u 4373 odrasla bolesnika s plak psorijazom u tri višenacionalna, randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja faze
pharmacist or nurse if you or your caregiver have any questions about the right way to inject Kyntheum.
Nazovite liječnika, ljekarnika ili medicinsku sestru u slučaju da Vi ili Vaš njegovatelj imate bilo kakvih pitanja u vezi s ispravnim injiciranjem lijeka Kyntheum.
In cynomolgus monkeys, no effects on embryo-foetal or postnatal (up to 6 months of age) development were observed when brodalumab was dosed subcutaneously throughout pregnancy at exposure levels up to 27-fold higher than those achieved in human patients receiving Kyntheum 210 mg every 2 weeks based on the area under the concentration curve (AUC).
U makaki majmuna nisu opaženi učinci na embrijsko-fetalni ili postnatalni (do dobi od 6 mjeseci) razvoj pri supkutanom doziranju brodalumaba u cijeloj trudnoći uz razine izloženosti do 27 puta veće od onih u ljudskih bolesnika koji primaju Kyntheum od 210 mg svaka dva tjedna na temelju površine ispod krivulje (AUC).
Following a single subcutaneous administration of brodalumab 210 mg in plaque psoriasis patients, the apparent clearance (CL/F) is 2.95 L/day.
Nakon pojedinačne potkožne primjene 210 mg brodalumaba u bolesnika s plak psorijazom prividni klirens (CL/F) iznosi 2,95 l/dan.
Each pre-filled syringe is for single use only.
Jedna napunjena štrcaljka namijenjena je samo za jednokratnu uporabu.
A caregiver may also give you an injection in your upper, outer arm.
Njegovatelj vam može dati injekciju i u stražnji dio nadlaktice.
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu zahvatiti do 1 osobe na 100 ljudi):
Tell your doctor if you are breast-feeding or plan to breast-feed.
Obavijestite liječnika ako dojite ili planirate dojiti.
Population pharmacokinetic modelling indicated that age did not have an effect on brodalumab pharmacokinetics, which was co-based on 259 (6%) patients being 65-74 years old and on 14 (0.3%)
Populacijsko farmakokinetičko modeliranje pokazalo je da dob nije utjecala na farmakokinetiku brodalumaba, što se temeljilo na 259 (6%) bolesnika u dobi od 65 do 74 godine i na 14 (0,3%) bolesnika u dobi od 75 godina i više, unutar ukupne PK populacije od 4271 bolesnika s plak psorijazom.
Kyntheum is a solution for injection that is a clear to slightly pearly, colourless to slightly yellow liquid, with no particles.
Kyntheum je otopina za injekciju koja je bistra do blago biserna, bezbojna do žućkasta tekućina bez čestica.
Both trials included a 12-week double-blind, placebo- and ustekinumab-controlled induction phase followed by a double-blind maintenance phase up to 52 weeks.
Oba su ispitivanja uključivala 12-tjednu, dvostruko slijepu, placebom, odnosno ustekinumabom kontroliranu fazu indukcije nakon koje je slijedila dvostruko slijepa faza održavanja do 52 tjedna.
Rescue treatment was available at or after Week 16 for patients with an inadequate response single sPGA ≥3 or persistent sPGA of 2 over at least a 4-week period.
≥3 ili trajnim odgovorom sPGA od 2 tijekom razdoblja od najmanje četiri tjedna.
Patients were predominantly men (69%) and white (91%), with a mean age of 45 years (18 to 86 years), of these 6.1% were >65 years of age and 0.3% were >75 years of age.
(18 do 86 godina), od čega ih je 6,1% bilo starije od 65 godina, a 0,3% starije od 75 godina.
• the medicine is cloudy or discoloured or contains flakes or particles
• lijek je zamućen, promijenio je boju ili sadrži komadiće ili čestice
Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
Jedna napunjena štrcaljka sadrži 210 mg brodalumaba u otopini od 1,5 ml.
Keep this medicine out of the sight and reach of children.
Kako čuvati Kyntheum Lijek čuvajte izvan pogleda i dohvata djece.
• Do not inject into an area of the skin that is tender, bruised, red, hard or in an area of skin that is affected by psoriasis.
• Nemojte injicirati lijek u područje kože koje je osjetljivo na dodir, prekriveno modricama, crveno, tvrdo, debelo ili u područje kože zahvaćeno psorijazom.
During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.8% of patients treated with Kyntheum compared with 0.5% of patients treated with placebo.
Tijekom 12-tjednog razdoblja placebom kontroliranih kliničkih ispitivanja prijavljena je neutropenija u 0,8% bolesnika koji su primali Kyntheum u usporedbi s 0,5% bolesnika koji su primali placebo.
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation.
Povišene razine određenih citokina (npr. IL-1, IL-6, IL-10, TNFα, IFN) tijekom kronične upale mogu promijeniti stvaranje enzima CYP450.
Live vaccines should not be given concurrently with Kyntheum (see section 4.5).
Živa se cjepiva ne smiju davati istodobno s lijekom Kyntheum (vidjeti dio 4.5).
Live vaccines should not be given concurrently with Kyntheum (see section 4.4).
Živa se cjepiva ne smiju davati istodobno s lijekom Kyntheum (vidjeti dio 4.4).
The most commonly reported adverse reactions in all Kyntheum-treated patients were arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal pain (2.1%).
glavobolja (4,3%), umor (2,6%), proljev (2,2%) i orofaringealna bol (2,1%).
• Avoid injecting into areas with scars or stretch marks.
• Nemojte injicirati lijek u područja prekrivena ožiljcima ili strijama.
Elevated levels of expression of IL-12B and IL-23A, the genes for the two subunits of IL-23, an upstream activator of IL-17A and IL-17F expression, are also found in psoriatic plaques.
U psorijatičnim plakovima pronađene su i povišene razine ekspresije za IL-12B i IL-23A, gena za dvije podjedinice IL-23, uzvodnog aktivatora ekspresije za IL-17A i IL-17F.
Based on population pharmacokinetic modelling the estimated half-life of brodalumab was 10.9 days at steady-state after every other week subcutaneous dose of 210 mg.
Poluvrijeme brodalumaba procijenjeno na temelju populacijskog farmakokinetičkog modeliranja iznosilo je 10,9 dana u stanju dinamičke ravnoteže nakon supkutane doze od 210 mg svakog drugog tjedna.
Kyntheum 210 mg injection brodalumab
Kyntheum 210 mg injekcija brodalumab s.c.
• feeling sick
• osjećaj mučnine
It is recommended that patients be brought up-to-date with all immunisations in accordance with local immunisation guidelines prior to initiation of treatment with Kyntheum.
Prije početka liječenja lijekom Kyntheum preporučuje se izvršiti sva potrebna cijepljenja u skladu s lokalnim smjernicama za imunizaciju.
PASI 75 response at 2 weeks ranged between 20% and 25% in the Phase 3 trials compared to placebo (0% to 0.6%) and ustekinumab (3% to 3.5%).
*p-vrijednost u odnosu na odgovarajući placebo, prilagođena za faktore stratifikacije <0,001 Odgovor PASI 75 nakon dva tjedna bio je u rasponu od 20% do 25% u ispitivanjima 3. faze u usporedbi s placebom (0% do 0,6%) i ustekinumabom (3% do 3,5%).
Tel: +420 225 992 272
Pharma s.r.o. Tel: +420 225 992 272
Throw away Kyntheum that has been stored at room temperature for longer than 14
Bacite Kyntheum ako je bio na sobnoj temperaturi dulje od 14 dana.
Solution for injection 2 pre-filled syringes
Otopina za injekciju 2 napunjene štrcaljke
This medicine should not be used if the solution is cloudy or discoloured or contains lumps, flakes, or particles.
Ovaj lijek se ne smije upotrijebiti ako primijetite da je otopina zamućena, ako je promijenila boju ili sadrži grudice, komadiće ili čestice.
Kyntheum can be kept at room temperature up to 25°C in the outer carton for 14 days.
Kyntheum se može čuvati 14 dana u vanjskom pakiranju na sobnoj temperaturi do 25°C.
The trial included a 12-week double-blind, placebocontrolled induction phase followed by a double-blind withdrawal and retreatment phase up to 52 weeks.
placebom kontroliranu fazu indukcije, nakon koje je slijedila dvostruko slijepa faza ukidanja liječenja i ponovnog liječenja do 52 tjedna.
• Do not shake the syringe.
• Nemojte tresti štrcaljku.
Patients randomised to Kyntheum received 210 mg or 140 mg at Week 0 (day 1), Week 1, and Week 2 followed by same dose every 2 weeks.
Bolesnici randomizirani za liječenje lijekom Kyntheum primali su 210 mg ili 140 mg u 0. tjednu (1. dan), 1. tjednu i 2. tjednu, nakon čega je slijedila ista doza svaka 2 tjedna.
Patients originally randomised to placebo and those who did not meet the criteria for re-randomisation received Kyntheum 210 mg every two weeks beginning at Week 12.
Bolesnici koji su izvorno randomizirani za primanje placeba ili oni koji nisu ispunili kriterije za ponovnu randomizaciju primali su 210 mg lijeka
Oropharyngeal pain
Tijelo štrcaljke
After use
Nakon primjene
NA
SAD
B. Check the Kyntheum pre-filled syringe
Provjerite napunjenu štrcaljku lijeka Kyntheum
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
Tel: +421 2 5939 6236
Pharma s.r.o. Tel: +421 2 5939 6236
How is Kyntheum given
Kako se Kyntheum daje
N = number of patients, which are presented at baseline, Week 12, and Week 52 Q2W = every 2 weeks *Patients were administered ustekinumab in the induction phase and continued on ustekinumab in the maintenance phase **Patients were administered Kyntheum 210 mg every 2 weeks in the induction phase and re-randomised to Kyntheum 210 mg every 2 weeks in the maintenance phase NRI= Non-responder imputation
**Bolesnici su primali Kyntheum 210 mg svaka dva tjedna u indukcijskoj fazi i bili su ponovno randomizirani za liječenje lijekom Kyntheum od 210 mg svaka dva tjedna u fazi održavanja NRI (Non-responder imputation) = dodavanje bolesnika bez odgovora
• Do not shake.
• Nemojte tresti.
Always hold the syringe by the syringe barrel.
Štrcaljku uvijek držite samo za tijelo štrcaljke.
Across treatment groups, the baseline Psoriasis Area Severity Index (PASI) score ranged from 9.4 to 72 (median: 17.4)
Psoriasis Area Severity Index, PASI) od 9,4 do 72 (medijan: 17,4), a početna vrijednost zahvaćene površine kože (engl. body surface area, BSA) bila je u rasponu od 10 do 97 (medijan: 21).
If any of these side effects becomes severe, tell your doctor, nurse, or pharmacist.
Ako bilo koja od nuspojava postane teška, obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
Along with primary efficacy endpoints, clinically important improvements were observed in Psoriasis Scalp Severity Index (PSSI) at Week 12 (AMAGINE-1) and in Nail Psoriasis Severity Index (NAPSI) at Week 12 and 52 (AMAGINE-1,-2, and -3).
Nail Psoriasis Severity Index, NAPSI) u 12. i 52. tjednu (AMAGINE-1, -2 i -3).
What you need to know before you use Kyntheum Do not use Kyntheum:
Što morate znati prije nego počnete primjenjivati Kyntheum
• Do not grasp the grey needle cap.
• Nemojte primati sivi zatvarač igle.
• fever, flu-like symptoms, night sweats • feeling tired or short of breath, cough which will not go away
• vrućicu, simptome nalik gripi, noćno znojenje
Tel: +386 4 2366 700
PHARMAGAN d.o.o. Tel: +386 4 2366 700
• Do not hold the plunger.
• Nemojte primati klip.
Kyntheum is available as a single-use pre-filled syringe.
Kyntheum je dostupan u obliku napunjene štrcaljke za jednokratnu uporabu.
Comprehensive instructions for administration are given in the package leaflet.
Opsežne upute za primjenu navedene su u uputi o lijeku.
Only your caregiver can use:
Samo njegovatelj smije injicirati lijek u:
Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab
Kyntheum 210 mg otopina za injekciju u napunjenoj štrcaljki brodalumab
Label and expiration date
Naljepnica i rok valjanosti
Vaccination of infants
Imunizacija dojenčadi
You may be treated with another medicine for TB before you begin treatment with Kyntheum
Prije početka liječenja lijekom Kyntheum možda ćete se morati liječiti drugim lijekom
• Avoid injecting directly into raised, thick, red or scaly skin patches or lesions.
• Nemojte injicirati lijek u izravno izdignuta, debela, crvena ili ljuskasta mjesta na koži ili lezije.
Carcinogenicity studies with brodalumab have not been conducted.
Nisu provedena ispitivanja za ocjenjivanje kancerogenog potencijala.
During the 12-week placebo-controlled clinical trial period in patients with psoriasis, a decrease in absolute neutrophil count (ANC) was observed in 5.6% of patients receiving Kyntheum, which was generally transient and reversible.
5,6% bolesnika koji su primali Kyntheum opaženo je općenito prolazno i reverzibilno smanjenje apsolutnog broja neutrofila (ANC).
Proline
OBLIK
Higher rates of fungal infections, primarily non-serious skin and mucosal candida infections, were observed in Kyntheum patients compared to placebo patients, 1.8% vs 0.9%, respectively.
opaženi su u bolesnika koji su primali Kyntheum u usporedbi s bolesnicima koji su primali placebo, 1,8% u odnosu na 0,9%.
Kyntheum 210 mg solution for injection in pre-filled syringe
Kyntheum 210 mg otopina za injekciju u napunjenoj štrcaljki.
Kyntheum is a clear to slightly opalescent, colourless to slightly yellow solution, free from particles.
Kyntheum je bistra do blago opalescentna, bezbojna do žućkasta otopina koja ne sadrži čestice.
The grey needle cap on the pre-filled syringe should not be removed while allowing to reach room temperature.
Dok čekate da napunjena štrcaljka dosegne sobnu temperaturu, ne smije se uklanjati sivi zatvarač s igle.
Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
prekrivena modricama, crvena, tvrda, debela, ljuskasta ili zahvaćena psorijazom.
Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal ideation, anxiety, or other mood changes, and they should contact their healthcare provider if such events occur.
suicidalnih misli, anksioznosti ili drugih promjena raspoloženja te da obavijeste svog liječnika u slučaju pojave takvih događaja.
For a 3-fold increase in SC brodalumab dose from 70 to 210 mg, the steady-state serum brodalumab Cmax and AUC0-t increased approximately 18- and 25-fold, respectively.
Pri trostrukom povećanju doze SC brodalumaba sa 70 na 210 mg,
• candida (fungal) infection in the mouth, throat or genitals • discharge from the eye with itching, redness and swelling (conjunctivitis).
• iscjedak iz oka sa svrbežom, crvenilom i oticanjem (konjunktivitis)
Elevated levels of IL-17A, IL-17C and IL-17F gene expression are found in psoriatic plaques.
U psorijatičnim plakovima pronađene su povišene razine ekspresije gena IL-17A, IL-17C i IL-17F.
Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet.
Bolesnike je potrebno uputiti da injiciraju cijelu količinu lijeka
However, brodalumab concentrations below LLOQ (Lower Limit of Quantification) were associated with IL-17 receptor occupancy up to 81%.
No koncentracije brodalumaba ispod donjeg limita kvantifikacije (engl.
Make sure the medicine in the syringe is clear to slightly pearly and colourless to slightly yellow.
Provjerite je li lijek u štrcaljki bistar do blago biseran te bezbojan do žućkast.
Using your Kyntheum pre-filled syringe
Primjena napunjene štrcaljke lijeka Kyntheum
LEO Pharma Sp. z o.o.
LEO Pharma A/S
• your outer area of upper arm.
• stražnji dio nadlaktice.
• Do not inject into areas where the skin is tender, bruised red, or hard.
• Nemojte injicirati lijek u područja na kojima je koža osjetljiva na dodir, prekrivena modricama,
Water for injections
Otopina za injekciju (injekcija).
Package leaflet: Information for the patient Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Kyntheum 210 mg otopina za injekciju u napunjenoj štrcaljki brodalumab
• Do not twist or bend the grey needle cap. • Do not put the grey needle cap back onto the syringe.
• Nemojte ponovno stavljati sivi zatvarač igle na štrcaljku.
However, there were no proliferative changes in cynomolgus monkeys administered weekly subcutaneous doses of brodalumab at 90 mg/kg for 6 months (AUC exposure 47-fold higher than in human patients receiving Kyntheum 210 mg every 2 weeks).
No primjena brodalumaba u supkutanim dozama od 90 mg/kg jednom tjedno tijekom 6 mjeseci u makaki majmuna nije izazvala promjene u proliferaciji (AUC izloženost 47 puta veća nego u ljudskih bolesnika koji primaju
• any part appears cracked or broken.
• postoje napukline ili oštećenja.
Immunogenicity
Imunizacije
For subcutaneous use
Za potkožnu primjenu
Kyntheum pre-filled syringe can only be used once.
Jedna napunjena štrcaljka lijeka Kyntheum namijenjena je isključivo za jednokratnu uporabu.
Patients randomised to Kyntheum in the induction phase received 210 mg or 140 mg at Week 0 (day 1), Week 1, and Week 2 followed by same dose every 2 weeks.
Kyntheum primali su u indukcijskoj fazi 210 mg ili 140 mg u 0. tjednu (1. dan), 1. tjednu i 2. tjednu,
• tiredness
• proljev
During the 12-week placebo-controlled trial period in plaque psoriasis, infections were reported in 25.4% of patients treated with Kyntheum compared with 23.4% of patients treated with placebo.
prijavljene su infekcije u 25,4% bolesnika koji su primali Kyntheum u usporedbi sa 23,4% bolesnika koji su primali placebo.
Teл.
Ltd.
• diarrhoea
• umor
Tel.: +48 22 244 18 40
LEO Pharma Sp. z o.o. Tel.: +48 22 244 18 40
Do not place your finger on the plunger while inserting the needle.
Nemojte držati prst na klipu pri umetanju igle.
At Week 12, patients in the ustekinumab group continued to receive ustekinumab and then were switched to Kyntheum 210 mg every 2 weeks at Week 52.
a zatim su u 52. tjednu počeli primati Kyntheum 210 mg svaka 2 tjedna.
Posology
Učestalost
This is in case the syringe is broken.
Štrcaljka se možda oštetila.
Brodalumab is a monoclonal antibody, a specialised type of protein that recognises and attaches to certain proteins in the body.
posebna vrsta bjelančevine koja prepoznaje određene bjelančevine u tijelu i veže se za njih.
Frequency Adverse Reaction
Manje često konjunktivitis
Used needle
Upotrijebljena igla
Plunger
Imunogenost
Used syringe barrel
Upotrijebljeno tijelo štrcaljke
E.J.
RMP-a.
Step 1: Preparing A. Remove the Kyntheum pre-filled syringe from the box
PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
Renal or hepatic impairment
Oštećenje funkcije bubrega ili jetre
days.
DJECE
30 sachets + 1 mixing bottle + 30 single-use oral syringes + 1 screw cap with syringe-port capability
30 vrećica + 1 bočica za miješanje + 30 štrcaljki za usta za jednokratnu uporabu + 1 zatvarač s navojem u koji se može umetnuti štrcaljka
Powder for oral suspension
Prašak za oralnu suspenziju
Oral use sachet (PET/OPA/alu/LDPE)
Vrećica (PET/OPA/alu/LDP E)
MA (EU) number (Invented) name Strength
Broj (EU) odobrenja (Zaštićeno) ime
≥ 2.0 IU***
≥ 2,0 IJ***/ml
103.1 - 105.1 TCID50*
103,1 -105,1 TCID50/ml
Invente d name
Izmišljeno ime
Pharmaceutic al form
Jačina Farmaceutski oblik
Rabies virus, strain SAD Vnukovo-32
Virus bjesnoće, soj SAD Vnukovo-32
--1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
--1 Liofilizat (živi atenuirani) Pseći parainfluenca virus tip 2, soj CPiV-2-Bio 15
EU (MA) number
EU broj odobrenja
Content Package size
Put primjene Pakovanje Sastav Veličina pakovanja
Target specie s
Ciljne vrste životinja
Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091
Leptospira kirschneri serogrupa Grippotyphosa serovar Grippotyphosa, soj MSLB 1091
Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088
Leptospira interrogans serogrupa Australis serovar Bratislava, soj MSLB 1088
** Antibody micro agglutination-lytic reaction.
* 50% infektivne doze kulture tkiva ** mikro aglutinacijska-litička reakcija antitijela *** internacionalnih jedinica
Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089
Suspenzija(inaktivirana) Leptospira interrogans serogrupa Icterohaemorrhagiae serovar Icterohaemorrhagiae, soj MSLB 1089
Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 1090
Leptospira interrogans serogrupa Canicola serovar Canicola, soj MSLB 1090
Packagin g
Liofilzat:
l Suspension (inactivated)
Liofilizat i suspenzija, za suspenziju za injekciju
Strengt h
Liofilizat:
powder: 3 ml solvent: 5 ml
prašak: 3 ml otopina: 5 ml
1 vial + 1 vial
1 bočica + 1 bočica
Intralesional use powder: vial (glass) solvent: vial (glass)
U ozljedu prašak: bočica (staklo) otopina: bočica (staklo)
Xiapex
Doza
Package size
Veličina pakovanja
0.9 mg Powder and solvent for solution for injection
Prašak i otapalo za otopinu za injekciju
The company wanted the authorisation to be recognised in other EU Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom).
Tvrtka je zatražila priznavanje odobrenja u drugim državama članicama EU-a ("državama članicama u postupku", u ovom slučaju Austriji, Belgiji, Bugarskoj, Hrvatskoj, Cipru, Češkoj Republici, Estoniji, Finskoj, Njemačkoj, Grčkoj, Islandu, Irskoj, Italiji, Latviji, Litvi, Nizozemskoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji, Švedskoj i Ujedinjenoj Kraljevini).
Outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended
Ishod postupka u skladu s člankom 33. stavkom 4. Direktive 2001/82/EZ, kako je izmijenjena
Veterinary Medicines Division
Odjel za veterinarsko-medicinske proizvode
The European Commission issued a decision on 28 August 2015.
Europska komisija donijela je odluku dana 28. kolovoza 2015.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 August 2015
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28. kolovoza 2015.
What are the conclusions of the CVMP?
Koje je zaključke donio CVMP?
However, the Member States were not able to reach an agreement and the National Food Chain Safety Office of Hungary referred the matter to the CVMP for arbitration on 24 October 2014.
Međutim, države članice nisu bile u stanju postići dogovor, te je Nacionalna agencija za sigurnost prehrambenog lanca Mađarske 24. listopada 2014. uputila predmet CVMP-u na arbitražu.
Duration of immunity was established for both serotypes (1 and 2) up to 16 weeks after vaccination according to the results of relevant challenge studies.
Trajanje imunosti utvrđeno je za oba serotipa (1 i 2) do 16 tjedana nakon cijepljenja u skladu s rezultatima relevantnima za ispitivanja izazova.
On 3 June 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Coglapix suspension for injection for pigs.
Dana 3. lipnja 2015., Europska agencija za lijekove završila je arbitražni postupak nastavno na neslaganje država članica Europske unije (EU) u vezi s odobrenjem VMP-a Coglapix za injekciju za svinje.
The vaccine is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, in order to reduce the clinical signs and lung lesions associated with the disease.
Cjepivo je predviđeno za aktivnu imunizaciju svinja protiv pleuropnemonije uzrokovane bakterijom A. pleuropneumoniae serotipova 1 i 2, kako bio se smanjili klinički znakovi i lezije pluća povezane s bolesti.