natgillin/translations-raw huggingface dataset:
Bilag IA: Lægemidler, der anbefales opretholdt, og ansøgninger om markedsføringstilladelse, for hvilke bioækvivalens med EUreferencelægemidlet er blevet fastlagt
Annex Ia: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established
Frankrig Sanofi Aventis France
Sanofi Aventis France
Frankrig ZYDUS France
ZYDUS France
Tyskland Hexal AG, Tyskland
Hexal AG, Germany
Belgien Sandoz n.v./s.a.
Belgium Sandoz n.v./s.a.
perindopril/indapamid
perindopril / indapamide
Carbocisteine 375 mg Capsules, Hard carbocistein
Carbocisteine 375 mg Capsules, Hard carbocisteine
Bendro-flumetiazid Alternova bendro-flumethiazid 2,5 mg Tablet
Bendro-flumetiazid Alternova bendro-flumethiazide 2.5 mg Tablet
Frankrig EG LABO - Laboratoires Eurogenerics
EG LABOLaboratoires Eurogenerics
Nederlandene Sandoz B.V.
The Netherlands Sandoz B.V.
Finland Orion Corporation Orion Pharma, Finland
Corporation Orion Pharma, Finland
Finland Sandoz A/S, Denmark
Sandoz A/S, Denmark
Spanien LABORATORIOS COMBIX, SLU
LABORATORIOS COMBIX, SLU
Kinedexe UK Limited (tidligere NRIM Limited)
United Kingdom Kinedexe UK Limited (previously
Spanien SANDOZ FARMACEUTICA, SA
SANDOZ FARMACEUTICA, SA
Metoklopramid Alternova metoclopramid
Metoklopramid Alternova metoclopramide
Bilag I Liste over nationalt godkendte lægemidler
Annex I List of medicinal products and presentations
Spanien LABORATORIOS AUROBINDO, SLU
LABORATORIOS AUROBINDO, SLU
Spanien AUROVITAS SPAIN, SAU
AUROVITAS SPAIN, SAU
Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (i Tyskland)
Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany)
Farmoz - Sociedade Técnico Medicinal, S.A.
FarmozSociedade Técnico Medicinal, S.A.
Frankrig Teva Sante
Teva Sante
Sodium Cromoglicate 100mg hard Capsules natriumcromoglicat
Sodium Cromoglicate 100mg hard Capsules sodium cromoglicate 100 mg Capsule, hard Oral use
Frankrig Arrow Génériques
Arrow Génériques
Ethinylestradiol/Levonorgeshel Famy Care
ethinylestradiol / levonorgestrel
Tyskland Mylan Dura GmbH
Mylan Dura GmbH
Spanien Strides Arcolab International Limited
United Kingdom Strides Arcolab International
Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-syre-ethylestere 90 1 000 mg Kapsel, blød Oral anvendelse
Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-acid-ethyl esters 90
Medreich PLC Gliclazide 40 mg tablets gliclazid
Medreich PLC Gliclazide 40 mg tablets gliclazide
Belgien Aurobindo Pharma BV
Belgium Aurobindo Pharma BV
Nederlandene Pharmascope Ltd.
The Netherlands Pharmascope Ltd.
Finland Aurobindo Pharma Ltd, Malta
Aurobindo Pharma Ltd, Malta
Maexeni 30 0,03 mg/0,15 mg Filmtabletten ethinylestradiol/levonorgestrel 0,03 mg/0,15 mg
Maexeni 30 0,03 mg/0,15 mg Filmtabletten ethinylestradiol / levonorgestrel mg/0.15 mg neuraxpharm Arzneimittel GmbH
Gliclazide 80mg Tablets gliclazid
Gliclazide 80mg Tablets gliclazide
Tyskland 1 A Pharma GmbH, Tyskland
1 A Pharma GmbH, Germany
Frankrig Mylan SAS
Mylan SAS
Gliclazide 40mg Tablets gliclazid
Gliclazide 40mg Tablets gliclazide
Nederlandene Aurobindo Pharma B.V.
The Netherlands Aurobindo Pharma B.V.
metforminhydrochlorid
metformin hydrochloride
0,5 mg Kapsel, blød Oral anvendelse
0.5 mg Capsule, soft Oral use
Hydroxyzine hydrochloride 25mg film-coated tablets hydroxyzinhydrochlorid 25 mg Filmovertrukket tablet
Hydroxyzine hydrochloride 25mg film-coated tablets hydroxyzine hydrochloride
300 mg Tablet med modificeret udløsning
300 mg Modified-release tablet
Alternova A/S Hydrokortison Alternova hydrocortison 10 mg Tablet
Alternova A/S Hydrokortison Alternova hydrocortisone
Frankrig Biogaran hydroxyzine BIOGARAN hydroxyzin
Biogaran hydroxyzine BIOGARAN hydroxyzine
Metformine Almus metforminhydrochlorid
Metformine Almus metformin hydrochloride
Ungarn SVUS Pharma a.s.
Slovak Republic SVUS Pharma a.s.
Dawa Limited Carbimazole 5mg Tablets carbimazol
Dawa Limited Carbimazole 5mg Tablets carbimazole
Metformina Almus metforminhydrochlorid
Metformina Almus metformin hydrochloride
Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol / levonorgestrel
Tyskland PUREN Pharma GmbH & Co.
PUREN Pharma GmbH & Co. KG
Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol / levonorgestrel
Frankrig Cristers
Cristers
Tyskland Hormosan Pharma GmbH
Hormosan Pharma GmbH
Metformin 1000 mg Filmcoated tablet metforminhydrochlorid
Metformin 1000 mg Filmcoated tablet metformin hydrochloride
Carbimazole 5mg Tablets carbimazol
Carbimazole 5mg Tablets carbimazole
Metformin 850 mg Film-coated tablet metforminhydrochlorid
Metformin 850 mg Film-coated tablet metformin hydrochloride
375 mg Kapsel, hård Oral anvendelse
375 mg Capsule, hard Oral use
Danmark Orion Corporation, Finland
Corporation, Finland
Dawa Limited Carbimazole 20mg Tablets carbimazol
Dawa Limited Carbimazole 20mg Tablets carbimazole
Esters ethyliques d'acides omega-3 Strides omega-3-syre-ethylestere 90 1 g Kapsel, blød Oral anvendelse
Esters ethyliques d'acides omega-3 Strides omega-3-acid-ethyl esters 90
Tyskland HEC Pharm GmbH
United Kingdom HEC Pharm GmbH
Metformin 500 mg Film-coated tablet metforminhydrochlorid
Metformin 500 mg Film-coated tablet metformin hydrochloride
Paracetamol 1000 mg Film Coated Tablets paracetamol mg
Paracetamol 1000 mg Film Coated Tablets paracetamol
Carbimazole 20 mg Tablets carbimazol
Carbimazole 20 mg Tablets carbimazole
Oralcon 30 Microgramm/125 Microgramm Tabletten ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
Oralcon 30 Microgramm/125 Microgramm Tabletten ethinylestradiol / levonorgestrel
acide ursodesoxycholique Inopharm ursodeoxycholinsyre
acide ursodesoxycholique Inopharm ursodeoxycholic acid 500 mg Film-coated tablet
Beta-histina Bluefish betahistindihydrochlorid 24 mg Tablet
Beta- histina Bluefish betahistine dihydrochloride
250 mg Kapsel, hård Oral anvendelse
250 mg Capsule, hard Oral use
Carbimazole 20mg Tablets carbimazol
Carbimazole 20mg Tablets carbimazole
150 mg Kapsel, hård Oral anvendelse
150 mg Capsule, hard Oral use
500 mg Kapsel, hård Oral anvendelse
500 mg Capsule, hard Oral use
KG
1 g
Frankrig ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg / 1.25 mg
ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
0.03 mg / 0.125 mg
Bluefish Pharmaceuticals AB
Pharmaceuticals AB
Arrow Génériques amlodipine/valsartan Arrow amlodipin/ valsartan
Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg
Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipin/valsartan
Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg
Frankrig Sandoz
Sandoz
Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipin/valsartan
Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /80 mg
Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipin/valsartan
Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg
Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipin/valsartan
Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine / valsartan 10 mg/160 mg
Letland Proenzi s.r.o
Proenzi s.r.o
Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipin/valsartan
Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /160 mg
BETAHISTIN SANDOZ 8 MG betahistindihydrochlorid 8 mg Tablet
BETAHISTIN SANDOZ 8 MG betahistine dihydrochloride
Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipin/valsartan
Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg
Betahistyna Bluefish betahistindihydrochlorid 24 mg Tablet
Betahistyna Bluefish betahistine dihydrochloride
10 mg Smeltetablet
10 mg Oro-dispersible tablet
BETAHISTIN SANDOZ 24 MG betahistindihydrochlorid 24 mg Tablet
BETAHISTIN SANDOZ 24 MG betahistine dihydrochloride
BETAHISTIN SANDOZ 16 MG betahistindihydrochlorid 16 mg Tablet
BETAHISTIN SANDOZ 16 MG betahistine dihydrochloride
Litauen Proenzi s.r.o
Slovak Republic Proenzi s.r.o.
15 mg Smeltetablet
15 mg Oro-dispersible tablet
5 mg Smeltetablet
5 mg Oro-dispersible tablet
Omega 3 Strides Arcolab International omega-3-syre-ethylestere 90 1 000 mg Kapsel, blød Oral anvendelse
Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90
Amlodipina + Valsartan Aurovitas amlodipin/valsartan
Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /80 mg
Rumænien Proenzi s.r.o.
Czech Republic Proenzi s.r.o.
Styrke Lægemiddelfor m
Strength Pharmaceutical Form
Administration Emballage
Immediate Packaging
6 (3x2) fyldte penne (multipack)
0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack)
6 (3x2) fyldte injektionssprøjter med nålebeskyttelsesano rdning (multipack)
0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack)
2 fyldte injektionssprøjter med nålebeskyttelsesano rdning
0.8 ml (40 mg/0.8ml) 2 pre-filled syringes with needle safety device
Den 21. marts 2014
21 March 2014
Europa-Kommissionen traf en beslutning den 21. marts 2014.
The European Commission issued a decision on 21 March 2014.
Hvad er Rocephin?
What is Rocephin?
Rocephin markedsføres i følgende EU-medlemsstater: Belgien, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Luxembourg, Malta, Nederlandene, Portugal, Rumænien, Sverige, Det Forenede Kongerige samt Island.
Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland.
Rocephin blev godkendt i EU via nationale procedurer.
Rocephin is authorised in the EU via national procedures.
Den virksomhed, der markedsfører disse lægemidler, er Roche.
The company that markets these medicines is Roche.
Hvorfor blev Rocephin vurderet igen?
Why was Rocephin reviewed?
Dette forhindrer bakterierne i at danne cellevægge, så de til sidst dør.
This prevents the bacteria from building their cell walls, and eventually kills them.
Den 23. januar 2014 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Rocephin.
On 23 January 2014, the European Medicines Agency completed a review of Rocephin.
CHMP harmoniserede desuden andre afsnit af produktresuméet, herunder afsnit 4.3 (kontraindikationer), 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen) og 4.6 (graviditet og amning).
The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation).
Rocephin er et lægemiddel, der indeholder det aktive stof ceftriaxon.
Rocephin is a medicine that contains the active substance ceftriaxone.
Rocephin fås desuden i EU under andre handelsnavne: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
Spørgsmål og svar om Rocephin og relaterede navne (ceftriaxon, pulver til injektionsvæske/infusionsvæske, 250 mg, 500 mg, 750 mg, 1 g, 1,5 g, 2 g)
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion)
CHMP konkluderede, at Rocephin bør anvendes hos voksne og børn til følgende infektioner, der allerede var godkendt i flere, men ikke alle, EU-medlemsstater:
The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States:
• bakteriel meningitis
• bacterial meningitis;
Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, som det fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Hos voksne og børn over 12 år kan den anbefalede dosis være mellem 1 og 4 g Rocephin én gang dagligt, afhængigt af den behandlede infektion.
In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat.
Den 9. december 2011 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Rocephin i EU.
On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin in the EU.
Foruden indikationerne harmoniserede CHMP også anbefalingerne for brug af Rocephin hos voksne og børn.
Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Rocephin in adults and children.
Rocephin bør fortrinsvis gives ved injektion i en vene i løbet af 5 minutter eller med drop (infusion) i løbet af mindst 30 minutter, eller ved dyb injektion i en muskel.
Rocephin should preferably be given into a vein by injection over a period of 5 minutes or by infusion (drip) over at least 30 minutes, or else by deep intramuscular injection.
Ceftriaxon tilhører gruppen cefalosporiner og virker ved at bindes til proteiner på bakteriernes overflade.
Ceftriaxone belongs to the group ‘cephalosporins'; it works by attaching to proteins on the surface of bacteria.
Endvidere kan det anvendes til behandling af dissemineret Lyme-borreliose (en bakterieinfektion, der overføres til mennesker gennem inficerede flåter) hos voksne og børn, herunder nyfødte fra 15-dages alderen.
It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age.
Det er et antibiotikum, der anvendes til behandling af en bred vifte af bakterielle infektioner, herunder lungebetændelse (pneumoni) og meningitis (infektion af hinderne omkring hjernen og rygmarven).
It is an antibiotic used to treat a wide range of bacterial infections including pneumonia (infection of the lungs) and meningitis (infection of the membranes around the brain and spine).
Ud fra de forelagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméer, etikettering og indlægssedler bør harmoniseres i EU.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Rocephin i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Rocephin in the European Union (EU).
Hos børn under 12 år afhænger den anbefalede dosis af Rocephin af legemsvægten og den behandlede sygdom.
In children below 12 years of age, the recommended dose of Rocephin depends on body weight and the condition it is used to treat.
• komplicerede urinvejsinfektioner, herunder nyrebetændelse (pyelonefritis)
• complicated urinary tract infections, including pyelonephritis (kidney infection);
Rocephin kan anvendes til behandling af patienter, der har for lavt indhold af hvide blodlegemer af typen neutrofile (neutropeni) og desuden har feber, som formodes at skyldes bakteriel infektion, patienter med blodforgiftning (bakteriæmi), der formodes at skyldes en af ovennævnte infektioner, samt til forebyggende behandling af infektioner i operationssår.
Rocephin may be used to manage patients with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection, patients with bacteraemia (when the bacteria are detected in the blood) suspected to be caused by any of the infections mentioned above, and for the pre-operative prevention of surgical site infections.
CHMP fandt, at Rocephin ikke længere burde anvendes til behandling af bihulebetændelse (sinuitis), betændelse i svælget (faryngitis) eller betændelse i blærehalskirtlen (prostatitis), da der ikke findes tilstrækkelige kliniske data til støtte for disse indikationer.
The CHMP agreed that Rocephin should no longer be used to treat sinusitis (inflammation of the sinuses), pharyngitis (sore throat) and prostatitis (inflammation of the prostate, a gland of the male reproductive system) because not enough clinical data are available to support these indications.
Rocephin kan desuden anvendes ved akut forværring af KOL (kronisk obstruktiv lungesygdom) hos voksne.
Rocephin may be used to treat acute exacerbations (flare-ups) of chronic obstructive pulmonary disease in adults.
• kønssygdommene gonoré og syfilis
• the sexually transmitted infections gonorrhoea and syphilis;
CMD(h) (Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human) fandt det nødvendigt at harmonisere Rocephin.
Rocephin was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
• komplicerede infektioner i hud og underliggende væv
• complicated skin and soft tissue infections;
• betændelser i bughulen (intraabdominale infektioner)
• intra-abdominal infections (infections within the abdomen);
• akut mellemørebetændelse (otitis media)
• acute otitis media (infection of the middle ear);
• infektioner i knogler og led
• infections of bones and joints;
• bakteriel hjertehindebetændelse (endokarditis)
• bacterial endocarditis (an infection in the heart).
• lungebetændelse, der er hospitalserhvervet eller samfundserhvervet
• hospital- and community-acquired pneumonia (infection of the lungs caught in or outside the hospital);
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 08 juli 2005 / 27 juli 2010
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 08 July 2005 / 27 July 2010
5 x 1 dosis 10 x 1 dosis
1 dose 5 x 1 dose 10 x 1 dose
potency testen
potency test
Kun raske dyr bør vaccineres.
Only healthy animals should be vaccinated.
Lad vaccinen opnå rumtemperatur før brug.
Allow the vaccine to reach room temperature before use.
Poligono El Montalvo I
Poligono Ind. El Montalvo I
En tredje vaccination med Equilis Prequenza Te bør gentages mindst 4 uger senere.
A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
Sideløbende aktiv og passiv immunisering (nødvaccination)
Concurrent active and passive immunisation (emergency vaccination)
I meget sjældne tilfælde kan en lokal reaktion opstå, som overstiger 5 cm og muligvis vedvarer længere end 2 døgn.
In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
Equin influenzavirus stammer:
Equine influenza virus strains:
Opbevares ved 2-8°C, beskyttet mod lys.
Store at 2-8°C, protected from light.
Det anbefales at man kun administrerer en enkel dosis som booster til heste som allerede har modtaget grundvaccination hvor anvendte vacciner indeholder samme type equin influenza virus som er inkluderet i denne vaccine.
It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine.
Den anden vaccinedosis (V2) bør gives 4 uger senere.
The second dose of the vaccine (V2) should be administered 4 weeks later.
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/05/057/001-004
MARKETING AUTHORISATION NUMBER(S) EU/2/05/057/001-004
Læs indlægssedlen inden brug.
Read package leaflet before use.
En grundvaccination kan anses for nødvendig hos heste som ikke er blevet hensigtsmæssigt grundvaccineret.
A primary vaccination course may be considered necessary in horses that have not been suitably primed.
FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pr. dosis af 1 ml:
QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml:
TEKSTEN “TIL DYR” OG BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG, om nødvendigt
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Hjælpestofferne (inclusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRLværdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009,
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Kartonæske(r) med 1, 5 eller 10 præfyldte sprøjter med kanyler.
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
375 mikrogram
375 micrograms
Der foreligger ingen oplysninger om sikkerhed og effekt af vaccinen ved samtidig brug med andre lægemidler til dyr end dem, der er nævnt ovenfor.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Denne revaccination giver en immunitet mod equin influenza, der varer i mindst 12 måneder.
This revaccination results in immunity to equine influenza lasting at least 12 months.
62,5 mikrogram
62.5 micrograms
1 Antigen enheder
1 Antigenic units
I sjældne tilfælde kan der opstå smerter på injektionsstedet, som kan resultere i forbigående dysfunktion (stivhed).
Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Phosphatidylcholin
Phosphatidylcholine
månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter på 3 års mellemrum.
The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
125 mikrogram
125 micrograms
Kartonæske med 10 hætteglas af 1 ml.
Cardboard box with 10 glass vials of 1 ml.
Aktive stoffer
Active substances
I meget sjældne tilfælde kan der forekomme feber, sommetider ledsaget af sløvhed og nedsat ædelyst i et døgn og i usædvanlige tilfælde op til 3 døgn.
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
{måneder/år}
Lot {number}
BATCHNUMMER Batch {nummer}
BATCH NUMBER
• Grundvaccination: Første vaccination fra 6 måneders alderen, anden vaccination 4 uger senere.
• Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Tetanus toksoid
Tetanus toxoid
Pakningsstørrelse:
Package size:
Flokkulations ækvivalenter; svarende til ≥ 30 IE/ml marsvineserum i Ph.Eur.
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur.