natgillin/translations-raw huggingface dataset:
• Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing status potential o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if female with childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if female with childbearing potential) o pregnancy test dates and results
• Kartice za bolnike in/ali ustrezno orodje o potrdilo o ustreznem svetovanju o dokumentacijo o statusu plodnosti o kontrolno okence (ali podobno) kjer zdravnik potrdi, da bolnik uporablja učinkovito kontracepcijo (za ženske v rodni dobi) o potrdilo o začetnem negativnem testu nosečnosti pred začetkom zdravljenja (za ženske v rodni dobi) o datume testov nosečnosti in izide
• Neuropathy and adverse reaction reporting forms
• nevropatija in obrazci za poročanje neželenih učinkov
• That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception
• če želi ženska spremeniti ali zamenjati svojo kontracepcijsko metodo, mora obvestiti - zdravnika, ki je kontracepcijo predpisal, da jemlje talidomid - zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali spremenila svojo kontracepcijsko metodo
• The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment
• potrebno je izvesti teste nosečnosti pred zdravljenjem, vsake 4 tedne med zdravljenjem in po zdravljenju
• Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “Educational Healthcare Professional's Kit” (if applicable to a Member State)
• Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobreno, o odmerjanje, o najdaljše obdobje predpisovanja 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o opozorilo o teratogenosti in da je treba preprečiti izpostavljenost ploda o obveznosti za zdravstvene delavce, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, kar vključuje: obveznost izčrpnega svetovanja in vodenja bolnika bolniki morajo biti sposobni izpolnjevati zahteve za varno rabo talidomida obveznost oskrbeti bolnike z zadevnim izobraževalnim gradivom poročanje o vsaki nosečnosti, nevropatiji ali drugih neželenih učinkih podjetju Celgene in lokalnim zdravstvenim organom na obrazcu v „Izobraževalnem paketu za zdravstvene delavce“ (če je primerno za državo članico)
• That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for male patients should also include: Confirmation that the physician has discussed the following:
• ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu o Obrazci za začetek zdravljenja za moške bolnike morajo vsebovati tudi naslednje elemente: potrdilo, da se je zdravnik pogovoril o naslednjem:
• Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men
• opozorilo, da je v primeru suma na nosečnost, o tem treba nemudoma obvestiti zdravnika, ki vodi zdravljenje varnostne nasvete za moške
• That he should not donate semen during therapy and for one week following discontinuation of thalidomide o Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit”
• Opozorilo, da ne sme darovati sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida o Zahteve poročanja nosečnosti opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene napotitev k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji na svetovanje in oceno izpolnitev obrazca o poročanju nosečnosti, ki se nahaja v „Izobraževalnem paketu za zdravstvene delavce“ lokalne kontaktne podrobnosti za poročanje kakršnegakoli suma na nosečnost
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below.
Države članice se morajo z imetnikom dovoljenja za promet z zdravilom dogovoriti o podrobnostih za nadzorovani sistem distribucije v skladu z nacionalno ureditvijo in zdravstvenim sistemom in izvajati ta program na nacionalni ravni ter tako zagotoviti naslednje: o Pred uvedbo zdravila na trg morajo vsi zdravniki in farmacevti, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, prejeti Pismo za zdravstvene delavce, kot je opisano spodaj o Pred predpisovanjem vsi zdravstveni delavci, ki nameravajo predpisovati (in v skladu z dogovorom s pristojnimi nacionalnimi organi izdajati) zdravilo Thalidomide Celgene, prejmejo izobraževalni paket za zdravstvene delavce, ki vsebuje naslednje: Brošura za zdravstvene delavce Brošure za paciente Kartice za bolnike Povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
• That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for female patients with no childbearing potential should also include: Confirmation that the physician has discussed the following:
• ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu o Obrazci za začetek zdravljenja za ženske bolnice, ki ne morejo zanositi, morajo vsebovati tudi: potrdilo, da se je zdravnik pogovoril o naslednjem:
• That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception
• Opozorilo, da je talidomid prisoten v spermi in o potrebi zaščite s kondomom, če je spolna partnerica noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije
• That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom
• če partnerica zanosi, mora o tem takoj obvestiti zdravnika, ki ga zdravi, in vedno uporabljati kontom
• That he should not donate blood or semen during therapy and for one week following discontinuation of thalidomide
• ne sme darovati krvi ali sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida
• That she should not donate blood during therapy and for one week following discontinuation of thalidomide
• ne sme darovati krvi med zdravljenjem in še en teden po prekinitvi jemanja talidomida
• That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse
• Opozorilo, da je treba v primeru zanositve partnerice nemudoma obvestiti zdravnika, ki vodi zdravljenje, in vedno med odnosom uporabljati kondom
• That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not using effective contraception
• talidomid je prisoten v spermi, zato mora pri spolni partnerici, ki je noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije, uporabiti kondom
• The need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
• opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene
• That he should not donate semen during therapy and for one week following discontinuation of thalidomide.
• opozorilo, da ne sme darovati sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida
• Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
• takoj po sumu na nosečnost mora prenehati uporabljati zdravilo Thalidomide Celgene
Aim of this document i.e. as stated in the PPP: “The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
• Obrazce za začetek zdravljenja o Obstajajo naj 3 vrste obrazcev za začetek zdravljenja: bolnica v rodni dobi bolnica, ki ne more zanositi moški bolnik o Vsi obrazci za začetek zdravljenja naj vsebujejo naslednje elemente: opozorilo o teratogenosti datum svetovanja potrdilo o bolnikovem razumevanju v zvezi s tveganjem talidomida in ukrepi PPN podatke bolnika, podpis in datum ime zdravnika, ki je zdravilo predpisal, podpis in datum namen dokumenta, tj. kot je zabeleženo v PPN : „Cilj obrazca za začetek zdravljenja je zaščititi bolnike in morebitne plode tako, da se zagotovi popolna obveščenost in razumevanje bolnikov glede tveganja teratogenosti in drugih neželenih učinkov, povezanih z uporabo talidomida.
That Thalidomide Celgene must not be given to any other person That the patient should not donate blood during therapy and for one week following discontinuation of thalidomide That the patient should tell their doctor about any adverse events That any unused capsules should be returned to the pharmacist at the end of the treatment o The following information should also be provided in the appropriate booklet Female patient of childbearing potential
o obstajajo lahko tri vrste brošur ali ena sama brošura za bolnike, ki kombinira informacije za vsak razred bolnikov: brošure za ženske v rodni dobi in njihove partnerje brošure za ženske, ki ne morejo zanositi brošure za moške bolnike o Vse brošure morajo zajemati naslednje informacije da je zdravilo Thalidomide Celgene teratogeno da lahko zdravilo Thalidomide Celgene povzroči trombembolizem, kardiovaskularne dogodke in nevropatijo opis kartice za bolnika in njeno uporabo v posameznih državah članicah nacionalne ali druge veljavne posebne dogovore za predpisovanje in izdajo talidomida da se zdravila Thalidomide Celgene ne sme dajati nikomur drugemu da bolniki ne smejo darovati krvi ali sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida da morajo bolniki svojega zdravnika obvestiti o vseh neželenih učinkih da je treba ob koncu zdravljenja vse preostale kapsule vrniti farmacevtu o Ustrezne brošure naj vsebujejo tudi naslednje podatke bolnica v rodni dobi:
Not to donate blood during treatment and for one week after treatment ends o Algorithm for Pregnancy Prevention Plan implementation This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures.
o Varnostne nasvete, pomembne za vse bolnike opis in upravljanje trombembolitičnih in kardiovaskularnih dogodkov in periferna nevropatija napotke za odstranjevanje odvečnega zdravila opozorilo, da bolniki ne smejo darovati krvi med zdravljenjem in en teden po koncu zdravljenja o Algoritem za izvajanje programa za preprečevanje nosečnosti ta naj pomaga pri razvrstitvi bolnikov in določanju zahtevanega preprečevanja nosečnosti in merilih testiranja o Podatke programa za preprečevanje nosečnosti opredelitev žensk v rodni dobi (ŽRD) in ukrepov za zdravnika, ki zdravilo predpiše, če status rodnosti ni jasen informacije o učinkoviti kontracepciji varnostne nasvete za ŽRD
• The need to contact their doctor immediately upon suspicion of pregnancy
• opozorilo, da mora v primeru suma na nosečnost o tem nemudoma obvestiti svojega zdravnika
Confirmation that the physician has discussed the following:
o Obrazci za začetek zdravljenja za ženske bolnice v rodni dobi morajo vsebovati tudi naslednje elemente: Potrdilo, da se je zdravnik pogovoril o naslednjem:
If such a reaction occurs, appropriate treatment should be administered without delay.
Če se pojavi takšna reakcija, je potrebno nemudoma pričeti z ustreznim zdravljenjem.
In very rare cases transient hyperthermia may occur for up to 2 days.
Zelo redko se lahko pojavi prehodna hipertermija, ki traja do 2 dni.
Vaccination may interfere with existing sero-epidemiological surveys.
Cepljenje lahko ovira obstoječe sero-epidemiološke postopke.
It is therefore recommended not to vaccinate foals of less than 6 months of age.
Zato ni priporočljivo cepiti žrebet, mlajših od 6 mesecev.
• Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
• Revakcinacija: zadostna stopnja zaščite je dosežena po letni vzdrževalni injekciji enega 1 ml odmerka cepiva, čeprav ta program ni popolnoma validiran.
The vaccine stimulates active immunity against West Nile virus.
Cepivo stimulira aktivno imunost proti virusu West Nile.
• Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later.
• Prvi krog cepljenja: prva injekcija od 6 meseca starosti, druga injekcija 3-5 tednov kasneje.
SP oil
SP olje
As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Zato ni mogoče izključiti, da prehodna imunodepresija, ki se lahko pojavi med brejostjo, interferira z učinkovitostjo cepiva.
b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
b) Bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna
a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) Bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih kužnih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Če na infekcijo sumite zaradi pozitivnega IgM odgovora, so potrebni dodatni testi, da se ugotovi ali je bila žival okužena ali cepljena.
CONTRAINDICATIONS None.
KONTRAINDIKACIJE Niso znane.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/11/2008
Datum pridobitve dovoljenja za promet: 21/11/2008 Datum podaljšanja dovoljenja za promet: 12/09/2013
No specific studies have been conducted to demonstrate absence of interferences from maternally derived antibodies on vaccine take.
Narejene niso bile nobene študije, ki bi dokazale, da ni interference med maternalnimi protitelesi in odzivom na cepljenje.
However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile virus.
Vendar pa je porast IgM po cepljenju redek, zato je pozitiven ELISA rezultat IgM močan pokazatelj naravne infekcije z virusom West Nile.
The use of Equip WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
Uporaba Equip WNV zniža število konjev z viremijo po naravni infekciji, je pa ne prepreči.
Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Celotno vsebino brizge (1 ml) aplicirajte globoko intramuskularno na področje vratu po naslednjem programu:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
As with any vaccine rare, occasional hypersensitivity reactions may occur.
Kot pri vsakem cepljenju se lahko pojavijo preobčutljivostne reakcije.
SPECIAL WARNING(S) Special precautions for use in animals: Vaccinate healthy animals only.
POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave konje.
Single-dose (1 ml) pre-filled type I glass syringe closed with bromobutyl rubber tip.
Enoodmerna (1 ml) napolnjena steklena brizga iz stekla tipa I zaprta z zamaškom iz bromobutilne gume.
DATE OF THE REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
MARKETING AUTHORISATION NUMBER(S) EU/2/08/086/004 (2 single-dose glass syringes) EU/2/08/086/005 (4 single-dose glass syringes) EU/2/08/086/006 (10 single-dose glass syringes)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/08/086/004 (2 enoodmerni stekleni brizgi) EU/2/08/086/005 (4 enoodmerne steklene brizge) EU/2/08/086/006 (10 enoodmernih steklenih brizg)
Onset of immunity: 3 weeks after primary vaccination course.
Začetek imunosti: 3 tedne po prvem krogu cepljenja.
For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.
Za aktivno imunizacijo konjev, starih 6 mesecev ali več, proti virusu bolezni West Nile (VWN), z zmanjševanjem števila viremičnih konj po infekciji z VWN linije 1 ali 2 ter za zmanjšanje trajanja in resnosti kliničnih znakov okužbe z VNW linije 2.
Name and address of the manufacturer of the biological active substance: Zoetis Inc.
Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin): Zoetis Inc.
Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses.
Farmakoterapevtska skupina: Imunološka zdravila za ekvide, inaktivirana virusna cepiva za konje.
Shelf life of the veterinary product as packaged for sale: pre-filled glass syringe: 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo: Napolnjena steklena brizga: 2 leti.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja, zaužitja ali razlitja po koži se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Inactivated West Nile virus, strain VM-2
Inaktiviran virus West Nile, sev VM-2
Any person intending to manufacture, import, possess, sell, supply and use Equip WNV must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati Equip WNV, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
MARKETING AUTHORISATION NUMBERS EU/2/08/086/004-006
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/08/086/004 - 006
Minimum essential medium (MEM) Phosphate buffered saline
Minimum essential medium (MEM)
Duration of immunity: 12 months after primary vaccination course for WNV lineage 1 strains.
Trajanje imunosti: 12 mesecev po prvem krogu cepljenja za VNW linije 1.
The manufacture, import, possession, sale, supply and/or use of Equip WNV may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba Equip WNV je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
RP* 1.0-2.2 *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
*Relativna učinkovitost (Relative Potency) pri in vitro metodi v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri konjih.
The vaccine can be used during pregnancy and lactation.
Cepivo se lahko uporablja v obdobju brejosti in laktacije.
In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
V primeru nenamernega samo-injiciranja, zaužitja ali razlitja po koži se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Packaging: box of 2, 4 or 10 single-dose syringes with needles.
Pakiranje: škatla z 2, 4 ali 10 enoodmernimi brizgami z iglami.
For WNV lineage 2 strains the duration of immunity has not been established.
trajanja imunosti niso določili.
PACKAGE SIZE 2 single-dose syringes 4 single-dose syringes 10 single-dose syringes
2 enooddmerni brizgi 4 enoodmerne brizge
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intramuscular use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
Luxembourg/ Luxemburg Zoetis Belgium SA Tél/Tel.
Tél/Tel.
The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba tega zdravila je lahko državi članici prepovedana v na njenem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glejte navodilo za uporabo.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated West Nile virus, strain VM-2.
1 ml vsebuje: Inaktiviran virus West Nile, sev VM-2
6.2 Incompatibilities
Inkompatibilnosti:
Transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days and that are sometimes associated with pain and mild depression were reported in very rare cases.
Zelo redko so poročali o prehodnih lokalnih reakcijah v obliki blage lokalne otekline ne mestu injiciranja (maksimalno 1 cm v premeru), ki izginejo sponatno v 1 do 2 dneh.
Active substance:
Zdravilo učinkovino:
Following the administration of a double dose of vaccine, no adverse reactions other than those described under section 4.6 have been observed.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov razen tistih, opisanih v poglavju 4.6.
Name and address of the manufacturers responsible for batch release: Zoetis Belgium SA
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega(odgovornih) za sprostitev serije: Zoetis Belgium SA
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2, 4 or 10 single-dose pre-filled syringes
PODATKI NA ZUNANJI OVOJNINI Škatla z 2,4, 5, 10, ali 25 enoodmernimi napolnjemi brizgami