FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Pharmathen S.A.
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dosage.
Danish: Hos de fleste patienter med alvorlig hyperkalcæmi (albuminkorrigeret serum-calcium* ≥3 mmol/l eller ≥ 12 mg/dl), vil 4 mg være passende som enkeltdosis.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Tal med Deres læge eller apotekspersonalet før De tager dette lægemiddel.
English: If you have breast cancer that has spread to your bones, then the recommended dose is 6 ampoules (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Danish: Hvis De lider af brystkræft, som har spredt sig til Deres knogler, er den anbefalede dosis 6 ampuller (6 mg) hver 3.-4. uge, givet som infusion i en blodåre i løbet af mindst 15 minutter.
English: • if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
Danish: De må ikke få Iasibon - hvis du er allergisk over for ibandronsyre eller et af de øvrige indholdsstoffer i Iasibon (angivet i punkt 6).
English: Hypersensitivity†, bronchospasm†, angioedema† anaphylactic reaction/shock†**
Danish: Overfølsomhed†, bronkospasme †, angioødem†, anafylaktisk reaktion/shock astmaeksacerbation†
English: • weakness
Danish: • svaghedsfølelse
English: Sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.
Danish: Natriumchlorid, eddikesyre (99%), natriumacetattrihydrat og vand til injektionsvæsker.
English: The median time to relapse (re-increase of serum albumin-corrected serum calcium above 3 mmol/l) was 1819 days for the 2 mg and 4 mg doses.
Danish: Mediantiden for tilbagefald (tilbagevendende stigning af serum albuminkorrigeret serum-calcium til over 3 mmol/l) var 18-19 dage for doserne 2 mg og 4 mg. Mediantiden for tilbagefald var 26 dage med en dosis på 6 mg.
English: Haemorrage, duodenal ulcer, gastritis, dysphagia, dry mouth
Danish: Hæmoragi, ulcus duodeni, gastritis, dysfagi, mundtørhed
English: Hypophosphatae mia
Danish: Hypofosfatæm i
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2).
Danish: For patienter med moderat nedsat nyrefunktion (CLcr = 30 og < 50 ml/min) eller svært nedsat nyrefunktion (CLcr < 30 ml/min), som behandles for at forebygge knoglerelaterede hændelser i forbindelse med brystkræft og knoglemetastaser, anbefales dosisjustering (se pkt.
English: A statistically significant improvement in bone pain score was shown for Ibandronate 50 mg compared to placebo.
Danish: Ibandronsyre 50 mg viste i sammenligning med placebo en statistisk signifikant forbedring i knoglesmertescore.
English: No data are available (see section 5.1 and section 5.2).
Danish: Der foreligger ingen data (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 50 mg ibandronsyre (som natriummonohydrat).
English: Care must be taken not to administer Iasibon concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Danish: Det skal omhyggeligt sikres, at Iasibon koncentrat til infusionsvæske, opløsning ikke administreres intraarterielt eller paravenøst, da det kan forårsage vævsskade.
English: • fluid build up and swelling (‘lymphoedema')
Danish: • ophobning af væske og hævelse (lymfeødem)
English: that is bleeding, or that your stomach is inflamed (gastritis)
Danish: Dette kan være tegn på, at du har et blødende sår i den første del af tarmen (tolvfingertarmen), eller at mavens slimhinde er betændt (gastritis).
English: Iasibon contains the active substance ibandronic acid.
Danish: Iasibon indeholder det aktive stof ibandronsyre, som tilhører en gruppe af lægemidler kaldet bisphosphonater.
English: Do not take your tablet with any drink other than water
Danish: Indtag ikke tabletten med andet end almindeligt vand.
English: INFORMATION IN BRAILLE Iasibon 6 mg
Danish: INFORMATION I BRAILLE-SKRIFT Iasibon 6 mg
English: What Iasibon is and what it is used for What you need to know before you receive Iasibon How to receive Iasibon
Danish: 1 Virkning og anvendelse 2 Det skal De vide, før De begynder at få Iasibon 3 Sådan får De Iasibon 4 Bivirkninger
English: Patients with hepatic impairment (see section 4.2)
Danish: Patienter med nedsat leverfunktion(se pkt.
English: All Skeletal Related Events (SREs) Placebo n=277
Danish: Placebo n=277
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteketspersonalet,, hvis der er noget De er i tvivl om.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment
Danish: For patienter med moderat nedsat nyrefunktion (kreatininclearance ≥30 og <50 ml/min)
English: If you have breast cancer that has spread to your bones, then the recommended dose is 1 vial (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Danish: Hvis De lider af brystkræft, som har spredt sig til Deres knogler, er den anbefalede dosis 1 hætteglas (6 mg) hver 3.-4. uge, givet som infusion i en blodåre i løbet af mindst 15 minutter.
English: Patients with hepatic impairment No dose adjustment is required (see section 5.2 ).
Danish: Patienter med nedsat leverfunktion: Dosisjustering er ikke nødvendig (se pkt.
English: PHARMACOLOGICAL PROPERTIES
Danish: 5 FARMAKOLOGISKE EGENSKABER
English: Glenmark Generics B.V. Tel: 0031 20 5226030
Danish: Tel: 0031 20 5226030
English: Paediatric population (see section 4.2 and section 5.2) The safety and efficacy of Iasibon in children and adolescents below the age of 18 years have not been established.
Danish: 4.2 og 5.2) Iasibons sikkerhed og virkning hos børn og unge under 18 år, er ikke klarlagt.
English: For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary.
Danish: For patienter med let nedsat nyrefunktion (kreatininclearance ≥50 og <80 ml/min) kræves ingen dosisjustering.
English: • mouth ulcers, swollen lips (‘cheilitis'), oral thrush
Danish: • mundsår, hævede læber (læbebetændelse), trøske
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere oplysninger om Iasibon findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with duration of 96 weeks.
Danish: Behandlingen med ibandronsyre 6 mg administreret intravenøst ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser blev vurderet i et randomiseret, placebokontrolleret fase III-studie, som varede i 96 uger.
English: A statistically significant improvement in bone pain score was shown for intravenous Ibandronate 6 mg compared to placebo.
Danish: Intravenøs ibandronsyre 6 mg viste i sammenligning med placebo en statistisk signifikant forbedring i knoglesmertescore.
English: Elderly (see section 4.2)
Danish: Ældre population (se pkt.
English: Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
Danish: Gastroenteritis , gastritis, sår i munden, dysfagi, cheilitis
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan forekomme hos 1 ud af 10 behandlede)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/659/004
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Danish: For patienter med brystkræft og knoglemetastaser med moderat nedsat nyrefunktion (kreatininclearance ≥ 30 og < 50 ml/min) eller svært nedsat nyrefunktion (kreatininclearance < 30 ml/min), som behandles for at forebygge knoglerelaterede hændelser, skal følgende dosisrekommendationer følges:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ampul med 2 ml koncentrat til infusionsvæske, opløsning indeholder 2 mg ibandronsyre (som natriummonohydrat).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/659/005
English: Method and route of administration Iasibon concentrate for solution for infusion should be administered as an intravenous infusion.
Danish: Dosering og indgivelsesmåde Iasibon koncentrat til infusionsvæske, opløsning skal gives som en intravenøs infusion.
English: Pharmathen S.A. Tlf: +30 210 66 04 300
Danish: Pharmathen S.A. Tél: +30 210 66 04 300
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/659/003
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate).
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ampul med 1 ml koncentrat til infusionsvæske, opløsning indeholder 1 mg ibandronsyre (som natriummonohydrat).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Iasibon 1 mg koncentrat til infusionsvæske, opløsning ibandronsyre i.v.
English: Dosage
Danish: Dosis
English: One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Danish: En ampul med 2 ml koncentrat til infusionsvæske, opløsning indeholder 2 mg ibandronsyre (som natrium monohydrat).
English: If you take too many tablets talk to a doctor or go to hospital straight away.
Danish: Tal straks med en læge eller tag på skadestuen med det samme, hvis De har indtaget for mange tabletter.
English: INFORMATION IN BRAILLE Iasibon 2 mg
Danish: 16 INFORMATION I BRAILLE-SKRIFT Iasibon 2 mg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Danish: 1 LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Iasibon 6 mg koncentrat til infusionsvæske, opløsning ibandronsyre i.v.
English: Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Water for injections
Danish: Natriumchlorid Eddikesyre (99%) Natriumacetattrihydrat Vand til injektionsvæsker
English: • Keep this medicine out of the sightand reachof children.
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: One ampoule with 1 ml of a concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate)
Danish: En ampul med 1 ml koncentrat til infusionsvæske, opløsning indeholder 1 mg ibandronsyre (som natriummonohydrat).
English: NAME OF THE MEDICINAL PRODUCT Iasibon 6 mg concentrate for solution for infusion
Danish: 1 LÆGEMIDLETS NAVN Iasibon 6 mg koncentrat til infusionsvæske, opløsning
English: Iasibon concentrate for solution for infusion should be administered as an intravenous infusion.
Danish: Iasibon koncentrat til infusionsvæske, opløsning skal efter fortynding gives som en intravenøs infusion.
English: Talk to your doctor or pharmacist before taking Iasibon:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Iasibon:
English: NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion
Danish: 1 LÆGEMIDLETS NAVN Iasibon 1 mg koncentrat til infusionsvæske, opløsning
English: Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Danish: Iasibon 6 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ampul med 1 ml koncentrat til infusionsvæske, opløsning indeholder 1 mg ibandronsyre (som natriummonohydrat).
English: Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Danish: Iasibon 1 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: Package leaflet: Information for the patient
Danish: Nedenstående oplysninger er til læger og sundhedspersonale
English: NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion
Danish: 1 LÆGEMIDLETS NAVN Iasibon 2 mg koncentrat til infusionsvæske, opløsning
English: Iasibon 2 mg concentrate for solution for infusion ibandronic acid
Danish: Iasibon 2 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: How to take Iasibon.
Danish: 3 Sådan skal de tage Iasibon
English: − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Hypocalcaemia
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 hætteglas med 6 ml koncentrat til infusionsvæske, opløsning indeholder 6 mg ibandronsyre (som natriummonohydrat).
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis for the jaw, and ocular inflammation (see paragraph “description of selected adverse reactions” and section 4.4).
Danish: De alvorligste rapporterede bivirkninger er anafylaktisk reaktion/shock, atypiske femurfrakturer, knoglenekrose i kæben og inflammation i øjet.
English: One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Danish: 1 hætteglas med 6 ml koncentrat til infusionsvæske, opløsning indeholder 6 mg ibandronsyre (som natriummonohydrat).
English: <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
Danish: Hos patienter med moderat nedsat nyrefunktion (CLcr ≥ 30 og < 50 ml/min) eller svært nedsat nyrefunktion (CLcr < 30 ml/min) anbefales dosisjustering (se pkt.
English: use
Danish: anvendelse
English: You can drive and use machines as it's expected that Iasibon affectshas no or negligible effect on your ability to drive and use machines.
Danish: Du kan køre bil og betjene maskiner, da det forventes at Bondronat ikke eller kun i ubetydelig grad påvirker din evne til at køre bil og betjene maskiner.Tal med din læge først, hvis De vil køre bil eller arbejde med maskiner.
English: Osteoarthritis, myalgia, arthralgia, joint disorder, bone pain
Danish: Osteoarthritis, myalgi, artralgi, ledsygdomme, knoglesmerter
English: The following information is intended for healthcare professionals only Dose: Prevention of skeletal events in patients with breast cancer and bone metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Danish: Den anbefalede dosis ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser er 6 mg administreret intravenøst hver 3-4. uge.
English: How to receive Iasibon
Danish: 3 Sådan får de Iasibon
English: NAME OF THE MEDICINAL PRODUCT Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Iasibon 6 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: The inhibition of endogenous bone resorption has also been documented by45 Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Danish: Ca kinetikstudier og ved frigivelse af radioaktivt tetracyklin, indbygget i skelettet.
English: NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion ibandronic acid
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Iasibon 2 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Iasibon 1 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: Bone pain *
Danish: Knoglesmerte*
English: • Keep this medicine out of the sightand reachof children
Danish: Opbevar lægemidlet utilgængeligt for børn
English: Possible side effects Like all medicines, this medicine can cause side effects although not everybody gets them.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som De har.
English: The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/l) was 1819 days for the 2 mg and 4 mg doses.
Danish: Mediantid til recidiv (stigning af albuminkorrigeret serum-calcium til niveauer over 3 mmol/l) var 18-19 dage for doser på 2 mg og 4 mg. Mediantiden til recidiv var 26 dage ved en dosis på 6 mg. Et begrænset antal patienter (50 patienter) har fået to infusioner mod hyperkalcæmi.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl altid lægen eller apotekspersonalet,, hvis du tager anden medicin eller har gjort det for nylig.
English: Authorisation Holder.
Danish: analyseformålet.
English: BATCH NUMBER Lot
Danish: 4 FREMSTILLERENS BATCHNUMMER Batch
English: ATCvet code: QI09AD03.
Danish: ATCvet-kode: QI09AD03
English: A single booster dose is given every 6 months.
Danish: En enkelt opfølgende dosis gives hver 6. måned.
English: Use vaccination devices according to the manufacturer's instructions.
Danish: Anvend vaccinationsudstyr i henhold til producentens anvisninger.
English: Date of first authorization: 24/08/2017.
Danish: Dato for første markedsføringstilladelse: 24/08/2017
English: 25 doses 50 doses 125 doses
Danish: 25 doser 50 doser 125 doser
English: It stimulates active immunity against PRRS virus.
Danish: Den stimulerer aktiv immunitet over for PRRS-virus.
English: The solvent may be stored outside a refrigerator at 15 °C - 25 °C.
Danish: Solvens kan opbevares uden for køleskab ved 15 °C - 25 °C.
English: These resolve without treatment within few hours.
Danish: Disse forsvinder i løbet af nogle få timer uden behandling.
English: The most common spreading route is via direct contact but spreading via contaminated objects or via the air cannot be excluded.
Danish: Den mest almindelige spredningsvej er ved direkte kontakt, men spredning via forurenede genstande eller luften kan ikke udelukkes.
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIG ADVARSEL, OM NØDVENDIGT
English: 2 ml in the neck.
Danish: 2 ml i nakken.
English: The maximum size of the local reactions was bigger (2 cm) and the maximum duration was in general longer (up to 9 days in pre-breeding sows).
Danish: Den maksimale størrelse på lokale reaktioner var større (2 cm) og den maksimale varighed generelt længere (op til 9 dage for søer før avl).
English: It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards.
Danish: Det tilrådes, at alle tilsigtede svin i en bestand vaccineres i den alder, det tidligst anbefales, og derefter.
English: The reaction evolved to form hard tissue and formation of a scab, which very commonly lasted up to more than 44 days.
Danish: Reaktionen udviklede sig til hårdt væv og en skorpe, som i reglen varede i op til mere end 44 dage.
English: Lactation: The safety of the vaccine has not been established during lactation.
Danish: Laktation: Vaccinens sikkerhed under laktation er ikke fastlagt.
English: The vaccine strain can spread to in contact pigs.
Danish: Vaccinestammen kan spredes til kontaktsvin.
English: Vaccine (lyophilisate):
Danish: Vaccinen (lyofilisat):
English: The vaccine contains a modified live PRRS virus (genotype 1, subtype 1).
Danish: Vaccinen indeholder en modificeret levende PRRS-virus (genotype 1, undertype 1).
English: Store and transport refrigerated (2 °C - 8 °C).
Danish: Opbevares og transporteres nedkølet (2 °C -8 °C).
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 eventuel beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet veterinærlægemiddel skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: Vaccination schedule:
Danish: Vaccinationsplan:
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: The excipients 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 (inklusive adjuvanter) som er anført i punkt 6.1 af produktresuméet er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet eller ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof:
English: In cases where the vials containing the solvent and the lyophilisate are stored separately, verify prior to reconstituting the lyophilisate that the lot number mentioned on the vial containing the solvent is identical to the lot number mentioned on the vial containing the lyophilisate.
Danish: I tilfælde, hvor hætteglassene, der indeholder solvens og lyofilisat, opbevares særskilt, skal det kontrolleres inden rekonstitutionen, at det lotnummer, der er nævnt på hætteglasset, der indeholder solvens, er identisk med det lotnummer, der er nævnt på hætteglasset, der indeholder lyofilisat.
English: Vaccinated animals may excrete the vaccine strain for more than 16 weeks following vaccination.
Danish: Vaccinerede dyr kan udskille vaccinestammen i mere end 16 uger efter vaccination.
English: Local reactions, in the form of soft/hard swelling (below or equal to 0.7 cm diameter) without heat or pain, were very commonly observed at the injection site and resolved within 5 days.
Danish: Lokale reaktioner i form af en blød/hård hævelse (mindre end eller lig med 0,7 cm i diameter) uden varme eller smerte blev meget ofte observeret på injektionsstedet og forsvandt i løbet af 5 dage.
English: Pharmacotherapeutic group: immunologicals for Suidae, live viral vaccines.
Danish: Farmakoterapeutisk gruppe: immunologiske lægemidler til svin, levende virale vacciner.
English: Needles for administration should be appropriate for the size of the pig.
Danish: Kanyler til administration skal passe til dyrets størrelse.
English: The use of a multi-dosing syringe is recommended.
Danish: Det anbefales at bruge en flerdosissprøjte.
English: Each dose (2 ml) contains: Lyophilisate:
Danish: Én dosis (2 ml) indeholder: Lyofilisat:
English: 6.2 Major incompatibilities
Danish: 6.2 Væsentlige uforligneligheder
English: Use sterile syringes and needles.
Danish: Brug sterile sprøjter og nåle.
English: Sodium chloride Water for injections
Danish: Natriumchlorid Vand til injektioner