natgillin/translations-raw huggingface dataset:
Shelf life after first opening the immediate packaging: use immediately.
Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
Single intramuscular injection of one dose (2 ml).
Ena intramuskularna injekcija enega odmerka (2 ml).
50 doses 125 doses
50 odmekov 125 odmerkov
Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Zelo pogosta je lokalna reakcija tkiva v obliki otekline na mestu injiciranja, ki lahko traja do 26 dni.
Special precautions for use in animals: Avoid stress in the animals before and after the time of vaccination.
Posebni previdnostni ukrepi za uporabo pri živalih: Izogibajte se stresu pri živalih pred in po cepljenju.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the 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 zahtevami.
0.1 mg * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
0,1 mg * Relativna Potenca enote določena s količino ELISA antigena (in vitro test potence) v primerjavi z referenčnim cepivom.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki.
Avoid stress in the animals before and after the time of vaccination.
Izogibajte se stresu pri živalih pred in po cepljenju.
One dose of 2 ml contains:
En odmerek po 2 ml vsebuje:
10 doses (20 ml)
10 odmerkov (20 ml)
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Suspension for injection
Suspenzija za injiciranje
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Vaccinate only healthy animals.
Cepite samo zdrave živali.
Duration of immunity: 19 weeks post-vaccination.
Trajanje imunosti: 19 tednov po cepljenju.
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
Do not use in breeding boars.
Ne uporabite pri plemenskih merjascih.
In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site.
V kliničnih študijah je post-mortem pregled mesta injiciranja 8 tednov po aplikaciji enega odmerka cepiva pokazal blago do zmerno granulomatozno vnetje mišičnih vlaken na mestu injiciranja.
Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Kartonska škatla s polietilenskimi plastenkami s klorobutilnim elastomernim zamaškom zaščitenim z aluminijasto zaporko.
Shelf life of the veterinary medicinal product as package for sale: 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
The use of a multi-dosing syringe is recommended.
Priporočljiva je uporaba brizge z večimi odmerki.
6 BATCH NUMBER
6 ŠTEVILKA SERIJE
Immediate mild hypersensitivity-like reactions may occur commonly after vaccination, resulting in transient clinical signs such as vomiting.
Takoj po cepljenju se lahko pogosto pojavijo blage reakcije, podobne preobčutljivostnim reakcijam, ki se kažejo s prehodnimi kliničnimi znaki kot je bruhanje.
Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine.
Farmakoterapevtska skupina: imunološka zdravila za prašiče (Suidae), inaktivirano virusno cepivo.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE SMISELNO
Exceptionally, a large proportion of animals may react in some specific herds after vaccination.
V izjemnih primerih se lahko v določenih čredah po cepljenju neželeni učinki pojavijo pri večini živali.
A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination.
V prvih 24 urah po cepljenju je zelo pogosto prehodno povišanje telesne temperature (do 1,7 °C), ki spontano izgine v 48 urah brez zdravljenja.
Do not mix with any other veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age.
Ena intramuskularna injekcija z enim odmerkom (2 ml) v vrat za uho prašičem starejšim od 21 dni.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Onset of immunity: from 3 weeks post-vaccination.
Nastop imunosti: od 3. tedna po cepljenju.
Administer one dose of 2 ml to piglets in the neck behind the ear.
Odmerek po 2 ml aplicirajte pujsku v vrat za uho.
Intramuscular use
intramuskularna uporaba
Zero days.
Nič dni.
Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Aktivna imunizacija prašičev, starejših od 3 tednov, proti prašičjemu cirkovirusu tipa 2 (PCV2) za zmanjšanje kopičenja virusa v krvi in limfoidnem tkivu ter zmanjšanje lezij v limfoidnem tkivu, povezanih z infekcijo z PCV2, kot tudi za zmanjšanje kliničnih znakov - vključno z izgubo dnevnega prirasta in mortalnosti povezane povezane z multisistemskim sindromom hiranja po odstavitvi (PMWS).
A milky white to pink opaque liquid, free from visible particles
Mlečno bela do rožnata motna tekočina, brez vidnih delcev.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:
PACKAGE LEAFLET: Suvaxyn PCV suspension for injection for pigs
NAVODILO ZA UPORABO: Suvaxyn PCV suspenzija za injiciranje za prašiče
Shake well before administration and intermittently during the process of vaccination.
Pred dajanjem in večkrat med cepljenjem dobro pretresite.
Per dose of 2 ml:
V 2 ml odmerku:
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE ZDRAVILA
Severe anaphylactic reactions are uncommon but may be lethal.
Hude anafilaktične reakcije se pojavijo občasno, vendar so lahko smrtne.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Store and transport refrigerated.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku.
Adjuvants:
Dodatki:
Specific pharmacovigilance requirements:
D. DRUGI POGOJI IN ZAHTEVEDOVOLJENJA ZA PROMET Z ZDRAVILOM Posebne farmakovigilančne zahteve:
Major incompatibilities: Do not mix with any other veterinary medicinal product.
InkompatibilnostiNe mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
Suvaxyn PCV suspension for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn PCV suspenzija za injiciranje za prašiče
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
MARKETING AUTHORISATION NUMBERS
ŠTEVILKA() DOVOLJENJA ZA PROMET
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 10 bottles of 10, 50 or 125 doses Boxes of 1 bottle of 10, 50 or 125 doses
PODATKI NA ZUNANJI OVOJNINI Škatla z 10 plastenkami z 10, 50 ali 125 odmerki Škatla z 1 plastenko z 10, 50 ali 125 odmerki
Minimum Essential Medium without phenol red Sodium bicarbonate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tiomersal minimalni esencialni medij brez fenolnega rdečega natrijev bikarbonat hepes kislina voda za injekcije
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 1.6 ≤ RP ≤ 5.3
KOLIČINA) UČINKOVIN(E) Inaktiviran rekombinanten prašičji cirkovirus tipa 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2 1.6 ≤ RP ≤ 5.3
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo.
The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein.
Sev v cepivu je inaktiviran rekombinanten prašičji cirkovirus tipa 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2.
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA(E) DOVOLJENJA ZA PROMET
Read the package leaflet before use.
NAČIN IN POT(I) UPORABE Pred uporabo preberite navodilo za uporabo.
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein
Inaktiviran recombinanten prašičji cirkovirus tip 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2
Pigs (piglets)
CILJNE ŽIVALSKE VRSTE Prašiči (pujski).
Box of 1 bottle of 10 doses Box of 1 bottle of 50 doses Box of 1 bottle of 125 doses
Škatla z 1 plastenko z 10 odmerki Škatla z 1 plastenko s 50 odmerki Škatla z 1 plastenko s 125 odmerki
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Kartonska škatla z 1 plastenko z 10 odmerki (20 ml), 50 odmerki (100 ml) ali 125 odmerki (250 ml).
No adverse reactions except those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov kot tistih, opisanih v poglavju 6.
Box of 10 bottles of 10 doses Box of 10 bottles of 50 doses Box of 10 bottles of 125 doses
Škatla z 10 plastenkami z 10 odmerki Škatla z 10 plastenkami s 50 odmerki Škatla z 10 plastenkami s 125 odmerki
Excipients:
Učinkovina:
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov kot tistih, opisanih v poglavju 4.6.
EXPIRY DATE
EXP {mesec/leto}
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zoetis Belgium SA
Pregnancy and lactation: Do not use during pregnancy and lactation.
Ne uporabite v obdobju brejosti in laktacije.
EXP {month/year} Once broached use immediately.
Načeto zdravilo uporabite takoj
Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Kartonska škatla z 10 plastenkami z 10 odmerki (20 ml), 50 odmerki (100 ml) ali 125 odmerki
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle label 50 and 125 doses
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Plastenka s 50 in 125 odmerki
QUANTITY OF THE ACTIVE SUBSTANCES
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali).
Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
IMETNIK DOVOLJENJA ZA PROMET Zoetis Belgium SA
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label 10 doses
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA UČINKOVIN(E)
Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
Izid postopka v skladu s členom 13 Uredbe (ES) št. 1234/2008
1 A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.
Postopek, po katerem odobritev zdravila v eni državi članici Evropske unije prizna druga država članica.
Why was Cardioxane reviewed?
Zakaj je bilo zdravilo Cardioxane pregledano?
ANSM did not agree to the changes as requested by the company.
Agencija ANSM se ni strinjala s spremembami, ki jih je vložila družba.
Its Committee for Medicinal Products for Human Use (CHMP) concluded that such a removal is acceptable.
Njen Odbor za zdravila za uporabo v humani medicini (CHMP) je razsodil, da je odprava sprejemljiva.
Cardioxane is authorised under a ‘mutual recognition' procedure1 based on an initial authorisation granted by France.
Zdravilo Cardioxane je bilo odobreno za promet po postopku medsebojnega priznavanja1 na podlagi prvotnega dovoljenja, ki ga je izdala Francija.
Cardioxane is authorised in the Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom.
Zdravilo Cardioxane ima dovoljenje za promet na Češkem, v Nemčiji, Franciji, Italiji, na Nizozemskem, Poljskem, v Španiji in Združenem kraljestvu.
The company wanted the changes to be recognised in Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom (the ‘concerned Member States').
Družba je želela, da se spremembe dovoljenja za promet z zdravilom, priznajo na Češkem, v Nemčiji, Franciji, Italiji, na Nizozemskem, Poljskem in v Združenem kraljestvu („zadevne države članice“).
On 18 May 2017, the European Medicines Agency completed an arbitration procedure for Cardioxane (dexrazoxane powder for solution for injection).
18. maja 2017 je Evropska agencija za zdravila končala postopek arbitraže za zdravilo Cardioxane (deksrazoksan prašek za raztopino za injiciranje).
What is Cardioxane?
Kaj je zdravilo Cardioxane?
However, as there are a small number of patients under 18 years who require high doses of anthracyclines and who are therefore at greater risk of harmful effects on the heart, the Committee agreed that the contraindication should be lifted for this group.
Ker pa obstaja majhno število bolnikov, mlajših od 18 let, ki potrebujejo velike odmerke antraciklinov, zaradi česar je tveganje za škodljive učinke na srce pri njih večje, se je odbor strinjal, da se kontraindikacija za to skupino odpravi.
Cardioxane is a medicine used in adults with breast cancer to prevent long-term harmful effects on the heart caused by treatment with the anthracycline cancer medicines doxorubicin and epirubicin.
Cardioxane je zdravilo, ki se uporablja za zdravljenje raka dojk pri odraslih za preprečevanje dolgoročnih škodljivih učinkov na srce, ki jih povzroča zdravljenje z antraciklinskima zdraviloma proti raku doksorubicinom in epirubicinom.
The company that markets the medicine is Clinigen Healthcare Limited.
To zdravilo trži družba Clinigen Healthcare Limited.
Because of concerns that it might increase the risk of second cancers developing long after treatment, the CHMP reviewed the medicine2 in September 2011 and recommended on the basis of the evidence at that time that use of medicines containing dexrazoxane to protect the heart should be explicitly contraindicated in children and adolescents.
Zaradi pomislekov, da bi lahko povečalo tveganje za sekundarne rake, ki se razvijejo dolgo po zdravljenju, je odbor CHMP septembra 2011 zdravilo pregledal2 in na podlagi tedanjih dokazov priporočil, da je treba uporabo zdravil, ki vsebujejo deksrazoksan, za zaščito srca izrecno kontraindicirati pri otrocih in mladostnikih.
Based on evaluation of the currently available data, and the scientific discussion within the Committee, the CHMP concluded that the benefits and risks of Cardioxane have not been established in children under the age of 18 years, in whom it is not licensed, particularly given that most young patients do not receive the high total doses of anthracyclines that can cause damage to the heart.
Na osnovi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je odbor CHMP zaključil, da koristi in tveganja zdravila Cardioxane pri otrocih, mlajših od 18 let, za katere zdravilo ni odobreno, niso bili ugotovljeni, zlasti glede na to, da večina mladih bolnikov ne prejema velikih skupnih odmerkov antraciklinov, ki bi lahko škodovali srcu.
In 2015, Clinigen submitted an application to the French medicines regulator ANSM for changes to the terms of the marketing authorisation, including removal of the contraindication in children and adolescents.
Družba Clinigen je leta 2015 francoski regulativni agenciji za zdravila ANSM predložila vlogo za spremembo pogojev dovoljenja za promet z zdravilom, vključno z odpravo kontraindikacije za otroke in mladostnike.
The way in which dexrazoxane protects the heart is not entirely clear, but may be linked to the way the medicine attaches to charged iron particles that are involved in the processes that make anthracyclines harmful to the heart muscle.
Način zaščitnega delovanja deksrazoksana na srce še ni povsem jasen, vendar je morda povezan s tem, kako se zdravilo veže na nabite železove delce, vključene v procese, zaradi katerih so antraciklini škodljivi za srčno mišico.
However ANSM and the concerned Member States were unable to reach agreement on whether the contraindication could be removed just for children and adolescents treated with high cumulative doses of anthracyclines, and, on 31 January 2017, France referred the matter to the CHMP for arbitration.
Agencija ANSM in zadevne države članice niso dosegle soglasja o odpravi kontraindikacije samo za otroke in mladostnike, ki se zdravijo z velikimi kumulativnimi odmerki antraciklinov, zato je Francija 31. januarja 2017 zadevo napotila na odbor CHMP v arbitražo.
The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Cardioxane on 19/07/2017.
Evropska komisija je dne 19/07/2017 izdala končno pravno zavezujočo odločbo za vse države članice EU, da uvedejo priporočila odbora CHMP o zdravilu Cardioxane.
CHMP therefore concluded that the product information should state that the medicine is contraindicated in patients under 18 years old who are intended to receive a total cumulative dose of less than 300 mg of doxorubicin per m2 body surface or an equivalent dose of another anthracycline medicine.
Odbor CHMP je torej zaključil, da morajo informacije o zdravilu navajati, da je zdravilo kontraindicirano pri bolnikih, mlajših od 18 let, pri katerih je načrtovan kumulativni odmerek manj kot 300 mg doksorubicina na m2 telesne površine oziroma ustrezen odmerek drugega antraciklinskega zdravila.
The grounds for the referral were the concerns of the UK that removing the contraindication in patients less than 18 years old receiving a high cumulative dose of anthracyclines was not justified given the remaining uncertainties regarding the safety and effectiveness of Cardioxane in this population, particularly given the previous decision of the CHMP regarding dexrazoxane medicines.
Razlog za napotitev so bili pomisleki Združenega kraljestva, da odprava kontraindikacije pri bolnikih, mlajših od 18 let, ki prejemajo velike kumulativne odmerke antraciklinov, ni utemeljena, saj obstajajo nejasnosti o varnosti in učinkovitosti zdravila Cardioxane pri tej populaciji, zlasti glede na predhodno odločitev odbora CHMP v zvezi z zdravili, ki vsebujejo deksrazoksan.
The Agency had been asked to arbitrate on the removal of the contraindication for children and adolescents treated with high cumulative doses of cancer medicines called anthracyclines.
Agencija je bila zaprošena, naj razsodi glede odprave kontraindikacije za otroke in mladostnike, ki se zdravijo z velikimi kumulativnimi odmerki zdravil proti raku, imenovanimi antraciklini.
The contraindication should however remain in children and adolescents who are given lower cumulative doses of anthracyclines.
Kontraindikacija pa mora ostati pri otrocih in mladostnikih, ki prejemajo majhne kumulativne odmerke antraciklinov.
It contains the active substance dexrazoxane.
Vsebuje zdravilno učinkovino deksrazoksan.
20 January 2012
20. januar 2012
The European Commission issued a decision on 20 January 2012.
Evropska komisija je odločbo izdala dne 20. januarja 2012.
It has been used to treat:
Uporablja se za zdravljenje:
Systemic nimesulide medicines are available in the following Member States: Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Sistemska zdravila, ki vsebujejo nimesulid, so na voljo v naslednjih državah članicah: Bolgarija, Češka republika, Ciper, Francija, Grčija, Madžarska, Italija, Latvija, Litva, Malta, Poljska, Portugalska, Romunija, Slovaška in Slovenija.
1 Article 107 of Directive 2001/83/EC as amended.
1 Člen 107 Direktive 2001/83/ES, kakor je bila spremenjena.
What is nimesulide?
Kaj je nimesulid?
• acute (short-term) pain,
• akutnih (kratkotrajnih) bolečin,
• Patients who have any questions should speak to their doctor or pharmacist.
• Bolniki, ki imajo kakršna koli vprašanja, naj se pogovorijo z zdravnikom ali farmacevtom.
Medicines containing nimesulide have been available since 1985 and are authorised in a number of Member States.
Zdravila, ki vsebujejo nimesulid, se uporabljajo od leta 1985 in so odobrena v številnih državah članicah.
They are only available with a prescription.
Dobijo se samo na recept.
Which data has the CHMP reviewed?
Katere podatke je CHMP pregledal?
Nimesulide-containing medicines are authorised but not marketed in Austria and in Ireland.
Zdravila, ki vsebujejo nimesulid, so odobrena, vendar se ne tržijo, v Avstriji in na Irskem.
Why was nimesulide reviewed?
Zakaj je bil nimesulid pregledan?
All information can be found on the Agency website under Regulatory > Human medicines > Referral procedures> Final decisions
Za več informacij glejte spletno stran Evropske agencije za zdravila Regulatory > Human medicines > Referral procedures > Final decisions.