FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not be given Zoledronic Acid Hospira:
Danish: Du må ikke få Zoledronsyre Hospira: - hvis du ammer.
English: Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion
Danish: Zoledronsyre Hospira 4 mg/5 ml koncentrat til infusionsvæske, opløsning.
English: Uncommon Vertigo
Danish: Vertigo
English: Uncommon Insomnia
Danish: Sjælden Hypofosfatæmi
English: One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
Danish: En ml opløsning indeholder 0,05 mg zoledronsyre (som monohydrat).
English: tremor, syncope, dysgeusia
Danish: Letargi, paræstesi, somnolens (søvnlignende bevidsthedssvækkelse), tremor, synkope, dysgeusi
English: 4 mg
Danish: Zoledronsyre 4 mg
English: Breast-feeding
Danish: Pancytopeni
English: Osteonecrosis of the external auditory canal
Danish: Osteonekrose af øregangen
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for the treatment of postmenopausal osteoporosis.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) Uregelmæssig hjerterytme (puls), kaldet atrieflimren, er set hos patienter behandlet med zoledronsyre for post-menopausal osteoporose.
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion
Danish: Zoledronsyre Hospira 5 mg/100 ml infusionsvæske, opløsning.
English: Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Danish: Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning.
English: Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy)
Danish: Tabel 3: Effektresultater (patienter med prostatacancer i hormonbehandling) Enhver SRE (+TIH)
English: One vial contains 4 mg zoledronic acid (as monohydrate).
Danish: Et hætteglas indeholder 4 mg zoledronsyre (som monohydrat).
English: Each bag with 100 ml of solution contains 4 mg zoledronic acid (as monohydrate).
Danish: En pose med 100 ml opløsning indeholder 4 mg zoledronsyre (som monohydrat).
English: Psychiatric disorders Uncommon: Anxiety, sleep disturbance Rare:
Danish: Nervesystemet Almindelig: Hovedpine Ikke almindelig:
English: Pancytopenia Immune system disorders Uncommon: Hypersensitivity reaction Rare:
Danish: Nyrer og urinveje Almindelig: Nedsat nyrefunktion Ikke almindelig:
English: Bone pain, myalgia, arthralgia, generalised pain Uncommon: Muscle spasms, osteonecrosis of the jaw Very rare:
Danish: Almindelig: Takykardi Luftveje, thorax og mediastinum Almindelig: Nasopharyngitis Mave-tarm-kanalen Meget almindelig:
English: − As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter): - Som en konsekvens af lave calcium-værdier: Kramper, følelsesløshed og tetani (sekundære symptomer på hypokalcæmi).
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin og Zoledronsyre Hospira Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig.
English: − Chest pain.
Danish: - Nældefeber.
English: Each bag with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Danish: Hver pose indeholder 100 ml opløsning, indeholdende 5 mg zoledronsyre (som monohydrat).
English: Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Danish: Efter markedsføringen er følgende bivirkninger blevet rapporteret (hyppighed sjælden): Atypiske subtrokantære og diafyseale femurfrakturer (bisfosfonat klasseeffekt).
English: Psychiatric disorders Uncommon: Anxiety, sleep disturbance
Danish: Almindelig Kvalme, opkastning, diarré Ikke almindelig
English: Patients with hepatic impairment
Danish: Almindelig: Hovedpine
English: The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Danish: Denanbefalededosisvedhyperkalcæmi(albuminkorrigeretserumcalcium≥ 12,0mg/dleller
English: Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Danish: Under disse omstændigheder bør hensigtsmæssig og hurtig symptomatisk behandling administreres.
English: A third dose should be administered 2 months thereafter.
Danish: En tredje dosis skal gives to måneder derefter.
English: Cattle (cows and heifers).
Danish: Kvæg (køer og kvier).
English: This veterinary medicinal product contains mineral oil.
Danish: Dette veterinærlægemiddel indeholder mineralolie.
English: One dose (2 ml) contains:
Danish: En dosis (2 ml) indeholder:
English: ATCvet code: QI02AB17.
Danish: ATCvet-kode: QI02 AB17.
English: Date of first authorisation: 11/02/2009 Date of last renewal: 10/02/2014
Danish: Dato for første markedsføringstilladelse: 11/02/2009 Dato for seneste fornyelse af markedsføringstilladelse: 10/02/2014
English: Withdrawal period: Zero days.
Danish: Tilbageholdelsestid: Nul dage.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En beslutning om at bruge vaccinen før eller efter ethvert andet veterinært lægemiddel bør derfor træffes i hvert enkelt tilfælde.
English: The full immunisation program should be repeated with each gestation.
Danish: Det komplette immuniseringsprogram bør gentages ved hver drægtighed.
English: Batch{number}
Danish: Batch {nummer}
English: The injections should be preferably administered on the alternate sides of the neck.
Danish: Injektionerne bør helst foretages på skiftevis den ene og den anden side af halsen.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Store and transport refrigerated (2 °C - 8 °C) and protected from light.
Danish: Opbevares og transporteres nedkølet (2 til 8 °C) og beskyttet mod lys.
English: Accidental injection is dangerous - read the package leaflet before use.
Danish: Uforsætlig injektion er farlig - læs indlægssedlen inden brug.
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 18 måneder.
English: The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection.
Danish: Det komplette immuniseringsprogram bevirker en immunitet fra ca. 13. dag efter første injektion til ca. 78. dag efter tredje injektion.
English: The whole herd should be immunised.
Danish: Hele besætningen bør immuniseres.
English: Benzyl alcohol Liquid paraffin Sorbitan monooleate Polysorbate 80
Danish: Benzylalkohol Flydende paraffin Sorbitanmonooleat Polysorbat 80
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre veterinære lægemidler.
English: In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
Danish: I visse tilfælde kan der også forekomme smerter på inokuleringsstedet, som forsvinder af sig selv efter højst 4 dage.
English: Very rare adverse reactions:
Danish: Meget sjældne bivirkninger:
English: Benzyl alcohol: 21 mg.
Danish: Benzylalkohol: 21 mg
English: Administer one dose (2 ml) by deep intramuscular injection in the neck muscles at 45 days before the expected parturition date and 1 month thereafter administer a second dose (at least 10 days before calving).
Danish: Indgiv en dosis (2 ml) ved dyb intramuskulær injektion i nakkemusklerne 45 dage før den forventede fødselsdato og en måned derefter administrér en anden dosis (mindst 10 dage før kælvning).
English: 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.
Danish: 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 MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Må ikke bruges efter den udløbsdato, der står på etiketten after UDL.D.
English: If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Danish: Hvis du ved et uheld injiceres med dette veterinærlægemiddel, skal du søge omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde, og tag indlægssedlen med dig.
English: Liquid paraffin: 18.2 mg
Danish: Flydende paraffin: 18,2 mg
English: Overdose (symptoms, emergency procedures, antidotes):
Danish: Overdosering (symptomer, nødforanstaltninger, modgift):
English: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
Danish: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spanien
English: Ivory-coloured homogeneous emulsion.
Danish: Elfenbensfarvet homogen emulsion.
English: They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most.
Danish: Det kan hovedsagelig dreje sig om: hævelser (op til 5 cm2 i gennemsnit), som forsvinder efter højst 1 til 2 uger.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) -.
English: Sodium alginate Calcium chloride, dihydrate Simeticone
Danish: Natriumalginat Calciumchlorid, dihydrat Simeticone
English: Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration.
Danish: Lad vaccinen nå en temperatur på mellem +15 og + 25 °C inden indgivelsen.
English: Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management practices.
Danish: Dette program bør tage højde for alle væsentlige faktorer, der påvirker yverets sundhed (f. eks. malketeknikker, aftørring og avlsstyring, hygiejne, ernæring, opstaldning, leje, koens komfort, luft- og vandkvalitet, overvågning af sundhedstilstanden) og andre forvaltningsmetoder.
English: Zero days.
Danish: Nul dage.
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: 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.
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Danish: Uforsætlig injektion/selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre, og kan i sjældne tilfælde medføre tab af den pågældende finger, hvis den ikke behandles omgående.
English: EU/2/08/092/001 1 glass vial 1 dose EU/2/08/092/002 10 glass vials 1 dose EU/2/08/092/003 20 glass vials 1 dose EU/2/08/092/004 1 glass vial 5 doses EU/2/08/092/005 10 glass vials 5 doses EU/2/08/092/006 1 glass vial 25 doses EU/2/08/092/007 10 glass vials 25 doses EU/2/08/092/008 1 PET vial of 5 doses
Danish: EU/2/08/092/002 10 glasflasker à 1 dosis EU/2/08/092/003 20 glasflasker à 1 dosis EU/2/08/092/004 1 glasflaske a 5 doser EU/2/08/092/005 10 glasflasker à 5 doser EU/2/08/092/006 1 glasflaske à 25 doser EU/2/08/092/007 10 glasflasker à 25 doser EU/2/08/092/008 1 PET hætteglas à 5 doser EU/2/08/092/009 1 PET hætteglas à 25 doser EU/2/08/092/010 1 PET hætteglas à 125 doser
English: Water for injections
Danish: Vand til injektionsvæske
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Danish: Der blev ikke iagttaget andre bivirkninger end de, der er nævnt i afsnit 4.6, efter indgivelse af en dobbelt dosis vaccine.
English: 1 dose (2 ml) 5 doses (10 ml) 25 doses (50 ml)
Danish: 1 dosis (2 ml) 5 doser (10 ml) 25 doser (50 ml)
English: STARTVAC is an ivory-coloured homogeneous emulsion for injection.
Danish: STARTVAC er en elfenbensfarvet homogen emulsion til injektion.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte veterinærlægemidler eller affald fra sådanne skal bortskaffes i overensstemmelse med de lokale regler.
English: la Selva, 135 17170 Amer (Girona) SPAIN
Danish: la Selva, 135 17170 Amer (Girona) SPANIEN
English: One dose contains: E. coli J5 inactivated; S. aureus (CP8) strain SP 140 inactivated.
Danish: En dosis indeholder: E.coli J5 inaktiveret, S.aureus (CP8) stamme SP140 inaktiveret.
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Danish: Farmakoterapeutisk gruppe: Immunologisk for dyr af oksegruppen, inaktiverede bakterielle vacciner til kvæg.
English: Type I colourless glass vials of 3, 10 and 50 ml.
Danish: Type I farveløst hætteglas på 3, 10 og 50 ml.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: The vials are closed with a rubber stopper and aluminium cap.
Danish: Hætteglassene er lukket med en gummiprop og aluminiumhætte.
English: S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) > 50 RED80 (In 80% of the animals).
Danish: S. aureus (CP8) stamme SP140 inaktiveret, der udtrykker slime associated antigenic complex (SAAC) > 50 RED80 (I 80 % af dyrene)
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed,laktation eller æglægning
English: - A mean transient increase in body temperature of about 1 °C, in some cows up to 2 °C, may occur in the first 24 hours after injection based on post-authorisation pharmacovigilance reporting.
Danish: - En forbigående forøgelse af legemstemperaturen på i gennemsnit ca. 1 °C, hos visse køer op til 2 °C, kan forekomme inden for de første 24 timer efter injektionen baseret på rapportering fra overvågning af sikkerheden efter markedsføring.
English: 17170 Amer (Girona) SPAIN
Danish: 17170 Amer (Girona)
English: To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Danish: Til stimulering af en aktiv immunitet over for Staphylococcus aureus, colibakterier og koagulasenegative stafylokokker.
English: Polyethylene (PET) vials of 10, 50 and 250 ml.
Danish: Polyethylen (PET) hætteglas på 10, 50 og 250 ml.
English: Do not mix with any other veterinary medicinal product.
Danish: Må ikke blandes med andre veterinærlægemiddel lægemidler.
English: For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Danish: Til immunisering af alle raske køer og kvier i malkekvægsbesætninger med tilbagevendende mastitisproblemer, med henblik på at reducere incidensen af subklinisk mastitis og incidensen og sværhedsgraden af de kliniske tegn på klinisk mastitis forårsaget af Staphylococcus aureus, Colibakterier og koagulase-negative stafylokokker.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
English: 1 vial of 1 dose (2 ml) 10 vials of 1 dose (2 ml) 20 vials of 1 dose (2 ml) 1 vial of 5 doses (10 ml) 10 vials of 5 doses (10 ml) 1 vial of 25 doses (50 ml) 10 vials of 25 doses (50 ml) 1 vial of 125 doses (250 ml) 125 doses (250 ml)
Danish: 1 flaske à 1 dosis (2ml) 10 flasker à 1 dosis (2 ml) 20 flasker à 1 dosis (2 ml) 1 flaske a 5 doser (10 ml) 10 flasker à 5 doser (10 ml) 1 flaske à 25 doser (50 ml) 10 flasker à 25 doser (50 ml) 1 flaske a 125 doser (250 ml) 125 doser (250 ml)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PET vials (10 ml, 50 ml) and glass vials (2 ml, 10 ml, 50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER PET glasflask (10 ml, 50 ml) og hætteglas af glas (2 ml, 10 ml, 50 ml)
English: E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
Danish: E. coli J5 inaktiveret > 50 RED60 (Effektiv dosis (kanin) i 60 % af dyrene (serologi)).
English: Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Danish: +34 972 430661 E-mail: hipra@hipra.com
English: No adverse reactions other than those mentioned in section “Adverse reactions” were observed after the administration of a double dose of vaccine.
Danish: Der blev ikke iagttaget andre bivirkninger end de, der er nævnt i afsnit “ Bivirkninger”, efter indgivelse af en dobbelt dosis vaccine.
English: - Anaphylactic-type reactions may occur in some sensitive animals which might be life-threatening based on post-authorisation pharmacovigilance reporting.
Danish: - Anafylaktiske reaktioner kan forekomme for nogle følsomme dyr, som kan være livstruende baseret på rapportering fra overvågning af sikkerheden efter markedsføring.
English: Escherichia coli (J5) inactivated .......................................................................... > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC)........................................................................ ........................................ > 50 RED80** * RED60: Rabbit effective dose in 60% of the animals (serology).
Danish: Escherichia coli (J5) inaktiveret .......................................................................... > 50 RED60 * Staphylococcus aureus (CP8) stamme SP 140 inaktiveret, der udtrykker slime associated antigenic complex (SAAC) ................................................................................................ > 50 RED80 ** * RED60: Effektiv dosis (kanin) i 60 % af dyrene (serologi).
English: Escherichia coli J5 inactivated ............................................................................. > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) ............. …………………………………………… > 50 RED80**
Danish: Escherichia coli J5 inaktiveret ............................................................................. > 50 RED60 * Staphylococcus aureus (CP8) stamme SP 140 inaktiveret, der udtrykkerslime associated antigenic complex (SAAC) ................................................................................................. > 50 RED80 **
English: Benzyl alcohol…………….......................................................... 21 mg. For the full list of excipients, see section 6.1.
Danish: Benzylalkohol ........................................................................................ 21 mg Alle hjælpestoffer er anført under pkt.
English: - Slight to moderate transient local reactions may occur after the administration of one dose of vaccine based on post-authorisation pharmacovigilance reporting.
Danish: - Forbigående lette til moderate lokale reaktioner kan forekomme efter indgivelse af en dosis vaccine baseret på rapportering fra overvågning af sikkerheden efter markedsføring.
English: ** RED80: Rabbit effective dose in 80% of the animals (serology).
Danish: ** RED80: Effektiv dosis (kanin) i 80 % af dyrene (serologi).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, PET vial (250 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papkasse PET hætteglas (250 ml)
English: * RED60: Rabbit effective dose in 60% of the animals (serology).
Danish: * RED60: Effektiv dosis (kanin) i 60 % af dyrene (serologi).
English: PACKAGE LEAFLET FOR: STARTVAC emulsion for injection for cattle
Danish: INDLÆGSSEDDEL: STARTVAC injektionsvæske, emulsion til kvæg
English: Intramuscular use.
Danish: Indgives intramuskulært.
English: Liquid paraffin.............................................................................. 18.2 mg
Danish: Flydende paraffin ................................................................................ 18,2 mg
English: Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 ºC.
Danish: Opbevaringstid efter anbrud af indre emballage: 10 timer ved opbevaring mellem +15 og +25 ºC.
English: Pack sizes: - Cardboard box with 1, 10 and 20 glass vials of 1 dose.
Danish: Pakningsstørrelser: - Papkasse med 1, 10 og 20 glasflasker à 1 dosis.
English: EU/2/08/092/009 1 PET vial of 25 doses EU/2/08/092/010 1 PET vial of 125 doses
Danish: EU/2/08/092/001 1 glasflaske à 1 dosis
English: STARTVAC emulsion for injection for cattle
Danish: STARTVAC injektionsvæske, emulsion til kvæg.
English: 4.11 Withdrawal period(s)
Danish: 10. TILBAGEHOLDELSESTID(er)
English: EXP Once opened, use within a 10-hour period, stored at 15-25 ºC.
Danish: Efter anbrud, anvendes inden for en periode på 10 timer ved opbevaring mellem +15 og +25 °C.
English: Name and address of the manufacturer of the biological active substances
Danish: Navn og adresse på fremstilleren af de biologisk aktive stoffer Laboratorios Hipra, S.A.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren med ansvar for batchfrigivelse Laboratorios Hipra, S.A.
English: Cardboard box with 20 glass vials of 1 dose.
Danish: - Papkasse med 20 glasflasker à 1 dosis.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Danish: Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter) Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes De kontakte Deres dyrlæge.
English: - Cardboard box with 1 PET vial of 125 doses.
Danish: - Papkasse med 1 PET hætteglas à 125 doser.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Vaccinér kun raske dyr Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr