natgillin/translations-raw huggingface dataset:
EU/2/98/006/001 (1,000 doses, vial) EU/2/98/006/002 (2,500 doses, vial) EU/2/98/006/003 (5,000 doses, vial) EU/2/98/006/004 (10,000 doses, vial) EU/2/98/006/005 (10x 1,000 doses, vials) EU/2/98/006/006 (10x 2,500 doses, vials) EU/2/98/006/007 (10x 5,000 doses, vials) EU/2/98/006/008 (10x 10,000 doses, vials) EU/2/98/006/009 (1x 500 doses, vial)
EU/2/98/006/001 (1.000 odmerkov, viale) EU/2/98/006/002 (2.500 odmerkov, viale) EU/2/98/006/003 (5.000 odmerkov, viale) EU/2/98/006/004 (10.000 odmerkov, viale) EU/2/98/006/005 (10 x 1.000 odmerkov, viale) EU/2/98/006/006 (10 x 2.500 odmerkov, viale) EU/2/98/006/007 (10 x 5.000 odmerkov, viale) EU/2/98/006/008 (10 x 10.000 odmerkov, viale)
1x 500 doses 1x 1,000 doses 1x 2,500 doses 1x 5,000 doses 1x 10,000 doses 10x 500 doses 10x 1,000 doses 10x 2,500 doses 10x 5,000 doses 10x 10,000 doses
1x 500 odmerkov 1x 1.000 odmerkov 1x 2.500 odmerkov 1x 5.000 odmerkov 1x 10.000 odmerkov 10x 500 odmerkov 10x 1.000 odmerkov 10x 2.500 0dmerkov 10x 5.000 odmerkov 10x 10.000 odmerkov
The vaccine should preferably be dissolved in distilled water or alternatively in cool, clean water.
Cepivo je najbolje raztopiti v destilirani vodi, lahko pa tudi v hladni, čisti vodi.
For administration of the vaccine, as a general rule, dissolve 1,000 doses in one litre per age in days up to a maximum volume of 20 litres per 1,000 doses.
Po splošnem navodilu ga pripravimo tako, da raztopimo 1000 odmerkov v enem litru vode na starost v dnevih, do največjega volumna 20 litrov na 1000 odmerkov.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials, derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
The vaccine virus may spread from vaccinated to non-vaccinated chickens and appropriate care should be taken to separate vaccinated from non-vaccinated.
Vakcinalni virus se lahko razširi s cepljenih na necepljene piščance in paziti je treba, da so cepljeni piščanci ločeni od necepljenih.
Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses.
Zapečatena merica iz aluminijevega laminata s polipropilenskim (merica) in polipropilensko polietilenskim (pokrovček) stičnim slojem, ki vsebuje 1.000, 2.500, 5.000 ali 10.000 odmerkov.
Water withholding should be kept as short as possible with a minimum of half an hour.
Čas, ko jim odtegujemo vodo, je zelo odvisen od klimatskih razmer in naj bo čim krajši, vendar najmanj pol ure.
One drop should be applied onto one nostril or one eye.
Dajemo po eno kapljico na nosnico ali v oko.
The vaccine may be delivered as a freeze-dried cake in a glass vial or as freeze-dried spheres in cups.
Cepivo se lahko dobavi kot liofilizirana pogača v stekleni viali ali kot liofilizirane kroglice v mericah.
Ocular/intranasal administration or coarse spray gives the best responses and these should be the methods of choice, especially when vaccinating young chickens.
Po okularnem/intranazalnem dajanju ter razprševanju z večjimi kapljicami je odzivnost najboljša, zato so ti načini izbirni načini dajanja, zlasti pri cepljenju mladih piščancev.
The spray apparatus should be free from sediments, corrosion and traces of disinfectants and ideally should be used for vaccination purposes only.
Priprava za razprševanje ne sme vsebovati usedlin, rje ali ostankov razkužil in jo je najbolje uporabljati samo za cepljenje.
EU/2/98/006/010 (10x 500 doses, vials) EU/2/98/006/011 (10x 1,000 doses, cups) EU/2/98/006/012 (10x 5,000 doses, cups) EU/2/98/006/013 (10x 10,000 doses, cups EU/2/98/006/014 (10x 2,500 doses, cups)
EU/2/98/006/009 (1 x 500 odmerkov, viale) EU/2/98/006/010 (10 x 500 odmerkov, viale) EU/2/98/006/011 (10 x 1.000 odmerkov, merice) EU/2/98/006/012 (10 x 5.000 odmerkov, merice) EU/2/98/006/013 (10 x 10.000 odmerkov, merice) EU/2/98/006/014 (10 x 2.500 odmerkov, merice)
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or intranasal/ocular administration to commercial chicks from one day of age onwards.
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da se to cepivo lahko meša in daje s cepivom Nobilis IB Ma5 za dajanje z razprševanjem ali intranazalno/okularno dajanje komercialnim piščancem od enega dneva starosti dalje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX with 1 vial, 10 vials or 10 cups of lyophilisate
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA z 1 vialo, 10 vialami ali z 10 mericami liofilizata
Water should be withheld before vaccination to make the chickens thirsty.
Pred cepljenjem piščancem ne dajemo vode, da ostanejo žejni.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of turkey rhinotracheitis (TRT) vaccine given within 7 days.
Nobilis IB 4-91, s katerim cepimo enodnevne živali, lahko zmanjša učinkovitost cepiva proti puranjemu rinotraheitisu (TRT), danega v 7 dneh.
≥3.6 log10 EID50 IBV per dose
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) ≥ 3,6 log 10 EID50 IBV v odmerku
Safety and efficacy data are available which demonstrate that Nobilis IB 4-91 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD.
Na voljo so podatki o varnosti in učinkovitosti, ki dokazujejo, da lahko zdravilo Nobilis IB 4-91 dajati na dan stare piščance, ki so cepljene bodisi s subkutano ali in ovo v Innovax-ND-IBD.
In-use shelf life after mixing: 2 hours.
Rok uporabnost po mešanju: 2 uri.
Name and address of the manufacturer of the biological active substance Intervet International B.V.
Ime in naslov proizvajalca biološke učinkovine Intervet International B.V.
Read the product information of Nobilis IB Ma5 before use.
Pred uporabo preberite informacije o cepivu Nobilis IB Ma5.
500 doses 1,000 doses 2,500 doses 5,000 doses 10,000 doses
500 odmerkov 1.000 odmerkov 2.500 odmerkov 5.000 odmerkov 10.000 odmerkov
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
By adding approximately 2 grams of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its activity longer.
Aktivnost virusa podaljšamo, če na liter vode dodamo približno 2 grama posnetega mlečnega prahu ali 20 ml tekočega posnetega mleka.
For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 6 weeks for the claimed protection against the Massachusetts strains and the variant strain 4-91 of IBV.
Za mešana cepiva se začne imunost po 3 tednih in traja 6 tednov za navedeno zaščito proti Massachussets sevom in proti variantnemu sevu kužnega bronhitisa perutnine (IBV) 4-91.
Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.
Aktivna imunizacija piščancev za zmanjšanje respiratornih znakov kužnega bronhitisa, ki ga povzroča variantni sev IB 4-91.
Active immunisation against avian infectious bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
Aktivna imunizacija proti variantnemu sevu kužnega bronhitisa perutnine IB 4-91, ki povzroča kužni bronhitis pri piščancih.
Care should be taken to avoid spread of the vaccine virus from vaccinated chickens to pheasants.
Paziti je treba, da se vakcinalni virus ne bi s cepljenih piščancev prenesel na fazane.
Intranasal/ocular administration
Intranazalno/okularno dajanje
EXP Once reconstituted use within 2 hours.
Rekonstituirano cepivo porabite v 2 urah.
The vaccine can be administered to 7-day and older chickens by drinking water.
Sedemdnevnim in starejšim piščancem lahko dajemo cepivo v vodi za pitje.
Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines.
Nobilis IB 4-91 je namenjen samo za zaščito piščancev proti respiratornim znakom bolezni, ki jo povzroča variantni sev virusa kužnega bronhitisa perutnine 4-91 in ga ne smemo uporabljati kot nadomestilo za druga cepiva, pripravljena iz virusov kužnega bronhitisa.
Future layers and breeders: The vaccine can be administered to future layers and breeders from day old onwards via intranasal/ocular route or coarse spray.
Bodoče nesnice in matične jate: Bodočim nesnicam in matičnim jatam lahko dajemo cepivo od starosti enega dneva dalje intranazalno/okularno ali z razpršilnikom z večjimi kapljicami.
Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥ 3.6 log10 EID50* * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated.
Živi, oslabljeni variantni sev virusa kužnega bronhitisa perutnine (IBV) 4-91: ≥ 3,6 log 10 EID50* * EID50: 50-odstotni infektivni odmerek za zarodke: titer virusa, ki povzroči okužbo pri 50 % inokuliranih zarodkov.
Vials: off-white/cream-coloured pellet.
Viale: belkasta/krem obarvana peleta.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Desetkratni največji odmerek je bil pri vseh priporočenih načinih in metodah dajanja varen za živali,
To be supplied only on veterinary prescription.
Izdaja zdravila za uporabo v veterinarski medicini je na veterinarski recept.
The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area.
Cepivo smemo uporabiti le, ko je epidemiološko dokazana prisotnost variantnega seva virusa kužnega bronhitisa 4-91 na območju, kjer ga bomo uporabili.
Lyophilisate for oculonasal suspension/use in drinking water
Liofilizat za okulonazalno suspenzijo / uporabo v vodi za pitje
Cups: off-white, predominantly sphere shaped.
Merice: belkaste, večinoma okrogle oblike.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
Broiler: The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by intranasal/ocular administration.
Brojlerji: Cepivo lahko pri enodnevnih in starejših piščancih dajemo z razpršilnikom z večjimi kapljicami ali ga dajemo intranazalno/okularno.
Special warnings for each target species:
POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako ciljno vrsto Cepite samo zdrave živali.
Ten times the maximum dose was shown to be safe for the target species by all the recommended routes and methods of administration.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Desetkratni največji odmerek je bil pri vseh priporočenih načinih in metodah dajanja varen za živali, ki jim je izdelek namenjen.
Live attenuated infectious bronchitis virus strain 4-91 ≥ 3.6 log10 EID50* per dose *EID50: 50% embryo infective dose
NAVEDBA ZDRAVILNE(IH) UČINKOVINE Živi, oslabljeni sev virusa kužnega bronhitisa perutnine 4-91: ≥ 3,6 log 10 EID50* na odmerek * EID50: 50-odstotni infektivni odmerek za zarodke
The vials should be opened under water or the content of the cup(s) should be poured into the water.
Viale je treba odpreti pod vodo ali pa vsebino meric(e) stresti v vodo.
Name and address of the manufacturer responsible for batch release Intervet International B.V.
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij Intervet International B.V.
BATCH NUMBER.
ŠTEVILKA SERIJE
Lay: Nobilis IB4-91 has been shown to be safe in layers and breeders during lay.
Pokazalo se je, da je uporaba Nobilisa IB4-91 varna pri nesnicah in matični jati v obdobju nesnosti.
Zero days.
KARENCA(E) Nič dni.
Live IBV, 4-91
KOLIČINA UČINKOVIN(E) Živi virus IB 4-91
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL - Lyophilisate VIALS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Gelatine
Liofilizat
Lyophilisate
Nesnost
Cardboard box with 10 cups of 2,500 doses.
Kartonska škatla z 10 mericami po 2.500 odmerkov.
Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
IMETNIK DOVOLJENJA ZA PROMET Intervet International B.V.
Coarse spray, oculonasal or in drinking water use.
Razprševanje, okulonazalmo dajanje ali v vodi za pitje.
Pancreatic digest of casein Disodium phosphate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi sorbitol želatina pankreasni presnovek kazeina dinatrijev fosfat voda za injekcije
Spray method
NAVODILO ZA UPORABO
Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water
Nobilis IB 4-91 liofilizat za okulonazalno suspenzijo / uporabo v vodi za pitje
Vials: off-white/cream-coloured pellet Cups: off-white, predominantly sphere shaped
Viale: belkasta/krem obarvana peleta
Cardboard box with 1 or 10 vials of 2,500 doses.
Kartonska škatla z 1 ali 10 vialami po 2.500 odmerkov.
The appropriate number of vials should be opened under water or the content of the cup(s) should be poured into the water.
Ustrezno število vial odpremo pod vodo ali vsebino meric(e) stresti v vodo.
Cardboard box with 10 cups of 1,000 doses.
Kartonska škatla z 10 mericami po 1.000 odmerkov.
Guideline
Navodilo
Glass vial (type I hydrolytic glass) of 10 ml containing 500; 1,000; 2,500; 5,000 or 10,000 doses closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.
Steklena viala (steklo I. hidrolitične skupine) po 10 ml, ki vsebuje 500, 1.000, 2.500, 5.000 ali 10.000
Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water for chickens
Nobilis IB 4-91 liofilizat za okulonazalno suspenzijo / uporabo v vodi za pitje za piščance
For oculonasal use, spray or drinking water administration.
Za okulonazalno uporabo, razprševanje ali dajanje v vodi za pitje.
Cardboard box with 10 cups of 5,000 doses.
Kartonska škatla z 10 mericami po 5.000 odmerkov.
Cardboard box with 1 or 10 vials of 1,000 doses.
Kartonska škatla z 1 ali 10 vialami po 1.000 odmerkov.
Ensure that the nasal drop is inhaled before freeing the bird.
Preden piščanca spustimo, preverimo, ali je kapljico z nosu vdihnil.
Cardboard box with 1 or 10 vials of 500 doses.
Kartonska škatla z 1 ali 10 vialami po 500 odmerkov.
Use cool, clean water to dissolve the vaccine.
Cepivo raztopimo v hladni, čisti vodi.
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN IN POTI UPORABE
ROUTE(S) OF ADMINISTRATION
INDIKACIJA(E)st
Cardboard box with 1 or 10 vials of 5,000 doses.
Kartonska škatla z 1 ali 10 vialami po 5.000 odmerkov.
Oculonasal use, spray or drinking water
POT(I) UPORABE ZDRAVILA Okulonazalno uporabo, razprševanje ali v vodi za pitje
The length of time of water deprivation is strongly dependent on the climatological circumstances.
Čas, ko jim odtegujemo vodo, je močno odvisen od klimatskih razmer in naj bo čim krajši, vendar najmanj pol ure.
Cardboard box with 10 cups of 10,000 doses.
Kartonska škatla z 10 mericami po 10.000 odmerkov.
Packaging
Razprševanje
Cardboard box with 1 or 10 vials of 10,000 doses.
Kartonska škatla z 1 ali 10 vialami po 10.000 odmerkov.
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
Live attenuated infectious bronchitis virus variant strain 4-91: ≥ 3.6 log10 EID50* per dose * EID50: 50% embryo infective dose - the titre required to infect 50% of the embryos inoculated with the virus.
* EID50 - 50-odstotni infektivni odmerek za zarodke: titer virusa, ki povzroči okužbo pri 50 % inokuliranih zarodkov.
Turn on mains water when all the vaccine water has been consumed.
Ko piščanci popijejo vso vodo s cepivom, odprite sistem za napajanje.
The company provided the results of one study involving over 10,000 patients who had had a heart attack.
Družba je predložila rezultate ene študije, v katero je bilo vključenih več kot 10 000 bolnikov, ki so doživeli srčni napad.
This is expected to help prevent further heart problems.
To naj bi preprečilo nadaljnje težave s srcem.
The beneficial effects seen were considered modest, particularly in patients who also took statins, and were not considered to outweigh the increased risks of serious infections in patients treated with the medicine.
Koristni učinki so bili ocenjeni kot skromni, še zlasti pri bolnikih, ki so jemali tudi statine, in se niso šteli za zadostne, da bi odtehtali povečano tveganje za resne okužbe pri bolnikih, ki so se zdravili s tem zdravilom.
IL-1 beta is part of the immune system (the body's natural defences) and is involved in the inflammatory processes associated with heart and blood vessels problems.
IL-1β je del imunskega sistema (naravne obrambe telesa) in je udeleženo v vnetnih postopkih, povezanih s težavami s srcem in krvnimi žilami.
It was to be available as a solution for injection under the skin in pre-filled pens and pre-filled syringes.
Na voljo naj bi bilo v obliki raztopine za injiciranje pod kožo v napolnjenih peresnikih in napolnjenih injekcijskih brizgah.
The main measure of effectiveness was the decrease in the number of serious events such as heart attack, stroke or death.
Glavno merilo učinkovitosti je bilo zmanjšanje števila resnih dogodkov, kot so miokardni infarkt, srčna kap ali smrt.
Patients also took other medicines
Prejemali so tudi druga
commonly used to prevent heart problems, such as statins.
zdravila, ki se običajno uporabljajo za preprečevanje težav s srcem, na primer statine.
Patients were given canakinumab Novartis at different doses (50, 150 or 300 mg) or placebo (a dummy treatment) once every three months for up to six years.
Bolniki so vsake tri mesece do največ šest let prejemali canakinumab Novartis v različnih odmerkih (50, 150 ali 300 mg) ali placebo (zdravilo brez učinkovine).
The CHMP also questioned the appropriateness of the measure chosen by the company to select patients and to monitor the effectiveness of canakinumab Novartis.
Odbor CHMP je izrazil tudi dvom o učinkovitosti ukrepa, ki ga je družba izbrala za izbiro bolnikov in spremljanje učinkovitosti zdravila canakinumab Novartis.
The company informed the CHMP that, while an extension to the above-mentioned study will stop, other studies investigating canakinumab for the treatment of other conditions will continue as planned.
Družba je odbor CHMP obvestila, da bo sicer ustavila podaljšanje omenjene študije, druge študije, v katerih proučujejo kanakinumab za zdravljenje drugih stanj, pa se bodo nadaljevale po načrtih.
Canakinumab Novartis was expected to be used to prevent serious events such as stroke, heart attack or death in patients who have already had a heart attack.
Zdravilo canakinumab Novartis naj bi se uporabljalo za preprečevanje resnih dogodkov, kot so možganska kap, srčni napad ali smrt, pri bolnikih, ki so že doživeli srčni napad.
In particular, the CHMP was of the opinion that the data provided by the company was not robust enough to clearly demonstrate that canakinumab Novartis is effective in all patients who have had a heart attack.
Odbor je zlasti menil, da podatki, ki jih je predložila družba, niso dovolj trdni, da bi jasno pokazali, da je zdravilo canakinumab Novartis učinkovito pri vseh bolnikih, ki so doživeli srčni napad.
On 4 December 2018, Novartis Europharm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for canakinumab Novartis, for the prevention of serious events such as stroke, heart attack or death in patients who have had a heart attack.
Družba Novartis Europharm Ltd. je 4. decembra 2018 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom canakinumab Novartis, ki naj bi se uporabljalo za preprečevanje resnih dogodkov, kot so možganska kap, srčni napad ali smrt, pri bolnikih, ki so doživeli srčni napad.
The active substance in canakinumab Novartis, canakinumab, is a monoclonal antibody (a type of protein) which has been designed to recognise and attach to interleukin 1 (IL-1) beta.
Učinkovina v zdravilu canakinumab Novartis, kanakinumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino interlevkin-1β (IL-1β) in se veže nanjo.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be possible for them to reply to the Agency's concerns within the agreed timeframe.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da v zahtevanem časovnem okviru ne bi mogla zagotoviti potrebnih podatkov o proizvodnji zdravila.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of canakinumab Novartis did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila canakinumab Novartis ne odtehtajo z njim povezanih tveganj.
Canakinumab Novartis is a medicine that contains the active substance canakinumab.
Canakinumab Novartis je zdravilo, ki vsebuje učinkovino kanakinumab.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had remaining concerns and was of the provisional opinion that canakinumab Novartis could not have been approved for the prevention of serious heart problems in patients who have already had a heart attack.
Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila canakinumab Novartis ni mogoče odobriti za preprečevanje resnih težav s srcem pri bolnikih, ki so že doživeli srčni napad.
By attaching to IL-1 beta, canakinumab blocks its activity and reduces inflammation.
Kanakinumab z vezavo na IL-1β zavira njegovo delovanje in zmanjša vnetje.
What is canakinumab Novartis?
Kaj je zdravilo canakinumab Novartis?
What was canakinumab Novartis expected to be used for?
Za kaj naj bi se zdravilo canakinumab Novartis uporabljalo?
How does canakinumab Novartis work?
Kako zdravilo canakinumab Novartis deluje?
EMA/215997/2006 EMEA/V/C/000098
EMA/215997/2006 EMEA/V/A/000098
cefovecin
Convenia cefovecina
Other information about Convenia:
Druge informacije o zdravilu Convenia:
The European Commission granted a marketing authorisation valid throughout the European Union, for Convenia on 19 June 2006.
Evropska komisija je dovoljenje za promet z zdravilom Convenia, veljavno po vsej Evropski uniji, odobrila dne 19. junija 2006.
Depending on the infection concerned, the injection can be repeated if necessary (up to three times).
V odvisnosti od dane okužbe je injiciranje mogoče po potrebi ponoviti (do trikrat).
Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.
Otekanje obraza, ustnic ali oči ali težave z dihanjem so resnejši simptomi, ki zahtevajo nujno medicinsko pomoč.
One injection lasts for up to 14 days.
Ena injekcija učinkuje do 14 dni.
Treated animals should not be used for breeding for 12 weeks after the last injection of Convenia.
Zdravljene živali se za razplod ne smejo uporabljati 12 tednov od zadnjega injiciranja zdravila Convenia.
Convenia should be handled with care and all the recommended precautions be taken to avoid exposure to the product.
Z zdravilom Convenia je treba ravnati previdno in izvesti vse priporočene previdnostne ukrepe, da bi tako preprečili izpostavljenost izdelku.
Like other antibiotics, cefovecin is not effective against all types of bacteria.
Podobno kot drugi antibiotiki tudi cefovecin ni učinkovit proti vsem vrstam bakterij.
Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious.
Cefalosporinski ali penicilinski antibiotiki lahko pri ljudeh povzročijo alergije in včasih so te alergije lahko zelo resne.
What benefit has Convenia shown during the studies?
Kakšne koristi je zdravilo Convenia izkazalo med raziskavami?