FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with Zoledronic Acid Hospira should be given the package leaflet and the patient reminder card
Icelandic: Acid Hospira eiga að fá fylgiseðilinn og minnisspjaldið fyrir sjúklinga.
English: Blood creatinine and blood urea increased, hypocalcaemia Uncommon: Hypomagnesaemia, hypokalaemia Rare:
Icelandic: Blóðkreatininhækkun, óeðlilega tíð þvaglát, prótín í þvagi
English: Only clear solution free from particles and discoloration should be used.
Icelandic: Einungis skal nota tæra lausn sem ekki inniheldur agnir eða er mislituð.
English: The mechanism behind the increased incidence of atrial fibrillation is unknown.
Icelandic: Orsakir aukinnar tíðni gáttatifs eru óþekktar.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone
Icelandic: Vörn gegn sjúkdómseinkennum frá beinum hjá sjúklingum með langt gengna illkynja sjúkdóma er finnast í beinum
English: Figure 1: Mean changes from baseline in BPI scores.
Icelandic: Meðaltal breytinga á BPI skori miðað við upphafleg gildi.
English: − if you are breast-feeding.
Icelandic: - ef þú ert með barn á brjósti.
English: Common Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Icelandic: Inflúensulík einkenni, kuldahrollur, þreyta, þróttleysi, verkir, lasleiki, viðbrögð á stungustað
English: Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Icelandic: Zoledronic Acid Hospira 4 mg/5 ml innrennslisþykkni, lausn Zoledronsýra
English: Talk to your doctor before being given Zoledronic Acid Hospira:
Icelandic: Ræddu við lækninn áður en þér er gefið Zoledronic Acid Hospira: - ef þú ert með eða hefur verið með nýrnasjúkdóm.
English: − Conjunctivitis.
Icelandic: - Tárubólga.
English: From a microbiological point of view, the product should be used immediately.
Icelandic: Með hliðsjón af örverumengun skal nota lyfið strax.
English: Uncommon: Blurred vision, scleritis and orbital inflammation Rare:
Icelandic: Öndunarfæri, brjósthol og miðmæti Sjaldgæfar:
English: Each bag with 100 ml of solution contains 5 mg zoledronic acid anhydrous (as monohydrate).
Icelandic: Hver poki með 100 ml af lausn inniheldur 5 mg af vatnsfrírri zoledronsýru (sem einhýdrat).
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion Zoledronic acid
Icelandic: Zoledronic Acid Hospira 5 mg/100 ml innrennslislyf, lausn Zoledronsýra
English: Only clear solution free from particles and discolouration should be used.
Icelandic: Einungis skal nota tæra lausn, sem ekki inniheldur agnir eða er mislituð.
English: Cases of ONJ have been reported in the postmarketing setting for zoledronic acid.
Icelandic: Greint hefur verið frá beindrepi í kjálka eftir markaðssetningu zoledronsýru.
English: Check with your doctor or nurse if you are not sure.
Icelandic: - Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Icelandic: Aukaverkanir sem komu fram hjá börnum með alvarlegan beinstökkva Taugakerfi
English: One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Icelandic: Eitt hettuglas með 5 ml af þykkni inniheldur 4 mg af zoledronsýru (sem einhýdrat).
English: − Do not use Zoledronic Acid Hospira after the expiry date stated on the pack.
Icelandic: Acid Hospira eftir fyrningardagsetningu sem tilgreind er á umbúðunum.
English: Zoledronic acid should not be used during pregnancy.
Icelandic: Ekki skal nota zoledronsýru á meðgöngu.
English: After opening: 24 hours at 2
Icelandic: EXP Stöðugt í 24 klukkustundir við 2 oC - 8 oC eftir þynningu.
English: Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Icelandic: Zoledronic Acid Hospira 4 mg/100 ml innrennslislyf, lausn.
English: − The active substance of Zoledronic Acid Hospira is zoledronic acid.
Icelandic: - Virka innihaldsefnið er zoledronsýra.
English: TIH:
Icelandic: Eftir þynningu:
English: Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Icelandic: Acid Hospira lausn úr pokanum fyrir lyfjagjöf.
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Icelandic: Áður en zoledronsýra er gefin þarf að meta sjúklinginn til að ganga úr skugga um að vökvajafnvægi sé í lagi.
English: Pain in extremities, arthralgia, musculoskeletal pain General disorders and administration site conditions Very common:
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar:
English: Reproduction toxicity
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: Zoledronic acid is eliminated by renal excretion.
Icelandic: Brotthvarf zoledronsýru verður með útskilnaði um nýru.
English: Therefore, interactions resulting from displacement of highly protein-bound medicinal products are unlikely.
Icelandic: Milliverkanir vegna útruðnings lyfja sem eru mikið próteinbundin eru því ólíklegar.
English: Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Icelandic: Mjög sjaldgæfar Afbrigðileg neðanlærhnútubrot og brot á lærleggsbol † (aukaverkun af lyfjum í flokki bisfosfonata)
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Icelandic: Vísað er í töflu 1 hér fyrir neðan hvað varðar undirbúning minni skammta fyrir sjúklinga með CLcr ≤ 60 ml/min í upphafi.
English: If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Icelandic: Hafi lyfið verið geymt í kæli skal láta lausnina ná stofuhita fyrir notkun.
English: Cardiac disorders Common:
Icelandic: Meltingarfæri Algengar:
English: Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
Icelandic: Tíðni ekki þekkt** Vökvaskortur sem er afleiðing af einkennum eftir lyfjagjöf, svo sem hita, uppköstum og niðurgangi
English: − The bag does not require any specific storage conditions.
Icelandic: - Engin sérstök fyrirmæli eru um geymsluaðstæður pokans.
English: BPI mean change from baseline
Icelandic: Meðaltal breytingar á BPI skori miðað við upphafleg gildi
English: Uncommon: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Icelandic: Sundl, náladofi, bragðskynstruflun, tilfinningadofi í húð, tilfinninganæmi í húð, skjálfti, svefnhöfgi
English: Uncommon (may affect up to 1 in 100 people):− Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw discharge, numbness or a feeling of heaviness in the jaw or loosening of a tooth.
Icelandic: Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum) Þroti, roði, verkur og kláði í augum eða aukið næmi augna fyrir ljósi.
English: Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion
Icelandic: Zoledronic Acid Hospira 4 mg/5 ml innrennslisþykkni, lausn.
English: − The unopened vial does not require any specific storage conditions.
Icelandic: - Engin sérstök fyrirmæli eru um geymsluaðstæður óopnaðs hettuglass.
English: LIST OF EXCIPIENTS
Icelandic: Hvítuhýðisbólga (episcleritis)
English: 90 (3 x 30) tablets
Icelandic: 90 (3 x 30) töflur
English: (Invented) name
Icelandic: ESB markaðsleyfis- (Sér)heiti
English: Very rare adverse reactions:
Icelandic: Mjög sjaldgæfar aukaverkanir:
English: A third dose should be administered 2 months thereafter.
Icelandic: Þriðja skammt ber að gefa 2 mánuðum þar á eftir.
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Icelandic: Ef sársaukinn er ekki horfinn 12 klukkustundum frá læknisskoðun, skal aftur hafa samband við lækni.
English: One dose (2 ml) contains:
Icelandic: Einn skammtur (2 ml) inniheldur:
English: Cattle (cows and heifers).
Icelandic: Nautgripir (kýr og kvígur).
English: ATCvet code: QI02AB17.
Icelandic: QI02AB17
English: They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most.
Icelandic: Þau myndu helst vera: þroti (allt að 5 cm2 að meðaltali), sem hverfur innan að hámarki 1 eða 2 vikna.
English: Accidental injection is dangerous - read the package leaflet before use.
Icelandic: Inndæling fyrir slysni er hættuleg - lesið fylgiseðil fyrir notkun.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Icelandic: Ekki skal nota dýrlyfið eftir fyrningardagsetningu sem tilgreind er á miðanum á eftir EXP.
English: The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection.
Icelandic: Heildarónæmingaraðgerðaráætlunin framkallar ónæmi frá um það bil 13. degi eftir fyrstu inndælingu þar til um 78 dögum eftir þriðju inndælingu.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Icelandic: Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu (http://www.ema.europa.eu/).
English: Benzyl alcohol: 21 mg.
Icelandic: Benzýlalkóhól:21 mg
English: Date of first authorisation: 11/02/2009 Date of last renewal: 10/02/2014
Icelandic: 11/02/2009 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: 17170 Amer (Girona) SPAIN
Icelandic: 17170- AMER (Girona) SPÁNN
English: In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
Icelandic: Í sumum tilvikum gæti einnig komið fram verkur á stungustað sem hverfur af sjálfsdáðum innan að hámarki 4 daga.
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).
Icelandic: Gefið einn skammt (2ml) með sprautu djúpt í hálsvöðva 45 dögum áður en burðar er vænst og gefið einum mánuði eftir það annan skammt (eigi síðar en 10 dögum fyrir burð).
English: Escherichia coli J5 inactivated ............................................................................. > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) ............. …………………………………………… > 50 RED80**
Icelandic: Escherichia coli J5 óvirkjaður ............................................................................. > 50 RED60 * Staphylococcus aureus (CP8) stofn SP 140 óvirkjaður, tjáir SAAC (slime associated antigenic complex) ......................................... …………………………………………… > 50 RED80 **
English: The full immunisation program should be repeated with each gestation.
Icelandic: Endurtaka skal alla ónæmingaráætlunina við hverja meðgöngu.
English: E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
Icelandic: E. coli J5 óvirkjaður > 50 RED60 (Rabbit effective dose) sem verkar hjá 60 % dýranna (skv. mótefnamælingu).
English: Laboratorios Hipra S.A. Avda.
Icelandic: Laboratorios Hipra S.A.
English: Store and transport refrigerated (2 °C - 8 °C).
Icelandic: Geymið og flytjið í kæli (+2°C til +8°C).
English: To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Icelandic: Til að örva virkt ónæmi gegn Staphylococcus aureus, kólíformum og kóagúlasa neikvæðum stafýlókokkum.
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
Icelandic: EU/2/08/092/003 20 gler hettuglös með 1 skammti EU/2/08/092/004 1 gler hettuglas með 5 skömmtum EU/2/08/092/005 10 gler hettuglös með 5 skömmtum EU/2/08/092/006 1 gler hettuglas með 25 skömmtum EU/2/08/092/007 10 gler hettuglös með 25 skömmtum EU/2/08/092/008 1 PET hettuglas með 5 skömmtum.
English: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
Icelandic: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Icelandic: Engar aukaverkanir aðrar en þær sem nefndar voru í kafla 4.6 komu fram eftir gjöf tvöfalds skammts af bóluefninu.
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)
Icelandic: 1 hettuglas með 1 skammti (2ml) 10 hettuglös með 1 skammti (2 ml) 20 hettuglös með 1 skammti (2 ml) 1 hettuglas með 5 skömmtum (10 ml) 10 hettuglös með 5 skömmtum (10 ml) 1 hettuglas með 25 skömmtum (50 ml) 10 hettuglös með 25 skömmtum (50 ml) 1 hettuglas með 125 skömmtum (250 ml) 125 skömmtum (250 ml)
English: 1 dose (2 ml) 5 doses (10 ml) 25 doses (50 ml)
Icelandic: 1 skammtur (2 ml) 5 skammtar (10 ml) 25 skammtar (50 ml)
English: The injections should be preferably administered on the alternate sides of the neck.
Icelandic: Bóluefnið skal helst gefa inn til skiptis sitthvoru megin á hálsi.
English: Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration.
Icelandic: Leyfið bóluefninu að ná +15°C til 25°C hita áður en það er gefið.
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.
Icelandic: Líta ber á ónæminguna sem einn þátt í margþættri áætlun til að hafa stjórn á júgurbólgu sem snertir alla mikilvæga þætti er varða júgurheilbrigði (t.d. tækni við mjólkun, uppþurrkunar- og kynbótatækni, hreinlæti, næringu, húsnæði, undirburð, vellíðan kúnna, gæði lofts og vatns, heilbrigðiseftirlit) og aðra búskaparþætti.
English: - Anaphylactic-type reactions may occur in some sensitive animals which might be life-threatening based on post-authorisation pharmacovigilance reporting.
Icelandic: - Bráðaofnæmisviðbrögð kunna að koma upp hjá sumum viðkvæmum dýrum og geta verið lífshættuleg, byggt á skýrslugjöf um lyfjagát eftir markaðssetningu.
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.
Icelandic: Til hjarðónæmingar hjá heilbrigðum kúm og kvígum, hjá hjörðum mjólkurkúa með endurtekin júgurbólguvandamál, til að draga úr tíðni duldrar júgurbólgu og tíðni og alvarleika klínískra einkenna sýnilegrar júgurbólgu af völdum Staphylococcus aureus, kólíforma og kóagúlasa neikvæðra stafýlókokka.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, PET vial (250 ml)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Pappaöskjur, PET hettuglas (250 ml)
English: One dose contains: E. coli J5 inactivated; S. aureus (CP8) strain SP 140 inactivated.
Icelandic: E.coli J5 óvirkjaðan; S.aureus (CP8) stofn SP140 óvirkjaðan.
English: Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Icelandic: Jafnvel þótt aðeins lítið magn hafi verið gefið með inndælingu, getur inndæling þess, fyrir slysni, valdið mjög miklum bólgum sem t.d. geta leitt til blóðþurrðardreps og jafnvel fingurmissis.
English: Store and transport refrigerated (2 °C - 8 °C) and protected from light.
Icelandic: Geymið og flytjið í kæli (2°C - 8°C) og varið ljósi.
English: No adverse reactions other than those mentioned in section “Adverse reactions” were observed after the administration of a double dose of vaccine.
Icelandic: Engar aukaverkanir aðrar en þær sem nefndar voru í kafla “Aukaverkanir” komu fram eftir gjöf tvöfalds skammts af bóluefninu.
English: EXP Once opened, use within a 10-hour period, stored at 15-25 ºC.
Icelandic: EXP Þegar umbúðir hafa verið opnaðar skal nota lyfið innan 10 klukkustunda, geymt við +1525°C.
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Icelandic: Ónæmislyf handa slíðurhyrningum (bovidae), óvirkjuð bakteríubóluefni handa nautgripum.
English: la Selva, 135
Icelandic: Avda. la Selva, 135 17170
English: Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Icelandic: Við slíkar aðstæður ber að meðhöndla einkennin á viðeigandi og skjótan hátt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Icelandic: STARTVAC stungulyf, fleyti fyrir nautgripi HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
English: Liquid paraffin: 18.2 mg
Icelandic: 18,2 mg
English: S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) > 50 RED80 (In 80% of the animals).
Icelandic: S. aureus (CP8) stofn SP140 óvirkjaður, tjáir SAAC > 50 RED 80 (Hjá 80 % dýranna).
English: The whole herd should be immunised.
Icelandic: Bólusetja skal alla hjörðina.
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.
Icelandic: Ef dýralyfinu hefur fyrir slysni verið sprautað í einhvern skal strax leita til læknis, jafnvel þótt um lítið magn sé að ræða og hafa skal fylgiseðilinn meðferðis.
English: - Slight to moderate transient local reactions may occur after the administration of one dose of vaccine based on post-authorisation pharmacovigilance reporting.
Icelandic: - Væg til miðlungi alvarleg staðbundin viðbrögð geta komið fram eftir gjöf eins skammts af bóluefni, byggt á skýrslugjöf um lyfjagát eftir markaðssetningu.
English: Batch{number}
Icelandic: Lotunr. {númer}
English: Polyethylene (PET) vials of 10, 50 and 250 ml.
Icelandic: Pólýetýlen (PET) hettuglös, 10, 50 og 250 ml.
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.
Icelandic: 1°C, í sumum kúm allt að 2°C, getur komið fram á fyrstu 24 klst.
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)
Icelandic: INNRI UMBÚÐUM PET hettuglös (10 ml, 50 ml) og gler hettuglös (2 ml, 10 ml, 50 ml)
English: la Selva, 135 17170 Amer (Girona) SPAIN
Icelandic: El Rieral 17170 Amer (Girona)
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.
Icelandic: Virka efnið sem er lífefni að uppruna og ætlað til að vekja virkt ónæmi fellur utan reglugerðar (EB) nr.
English: EU/2/08/092/009 1 PET vial of 25 doses EU/2/08/092/010 1 PET vial of 125 doses
Icelandic: EU/2/08/092/001 1 gler hettuglas með 1 skammti EU/2/08/092/002 10 gler hettuglös með 1 skammti
English: The vials are closed with a rubber stopper and aluminium cap.
Icelandic: Hettuglösin eru lokuð með gúmmítappa og álhettu.
English: Benzyl alcohol Liquid paraffin Sorbitan monooleate Polysorbate 80
Icelandic: Sorbitaneinóleat Pólýsorbat 80
English: Sodium alginate Calcium chloride, dihydrate Simeticone
Icelandic: Natríumalgínat Kalsíumklóríð, tvíhýdrat Símetikón
English: Laboratorios Hipra, S.A. Avda.
Icelandic: LABORATORIOS HIPRA, S.A. Avda. la Selva, 135
English: Type I colourless glass vials of 3, 10 and 50 ml.
Icelandic: Hettuglös úr litlausu gleri (gerð I), 2, 10 og 50 ml.
English: WITHDRAWAL PERIODS
Icelandic: FYRNINGARDAGSETNING
English: STARTVAC emulsion for injection for cattle
Icelandic: STARTVAC stungulyf, fleyti fyrir nautgripi.
English: * RED60: Rabbit effective dose in 60% of the animals (serology).
Icelandic: (Rabbit effective dose) sem verkar hjá 60 % dýranna (skv. mótefnamælingu).
English: Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 ºC.
Icelandic: EXP Rofna pakkningu skal nota innan 10 klukkustunda, geymt við +15 til +25°C.
English: ** RED80: Rabbit effective dose in 80% of the animals (serology).
Icelandic: (Rabbit effective dose) sem verkar hjá 80 % dýranna (skv. mótefnamælingu).
English: Cardboard box with 20 glass vials of 1 dose.
Icelandic: -Pappaaskja með 20 gler hettuglösum með 1 skammti.
English: Pack sizes: - Cardboard box with 1, 10 and 20 glass vials of 1 dose.
Icelandic: -Pappaaskja með 1, 10 og 20 gler hettuglösum með 1 skammti.
English: - Cardboard box with 1 and 10 glass vials of 25 doses.
Icelandic: -Pappaaskja með 1 og 10 gler hettuglösum með 25 skömmtum.
English: - Cardboard box with 1 PET vial of 125 doses.
Icelandic: -Pappaaskja með 1 PET hettuglasi með 125 skömmtum.
English: Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Icelandic: Sími. +34 972 430660
English: - Cardboard box with 1 and 10 glass vials of 5 doses.
Icelandic: -Pappaaskja með 1 og 10 gler hettuglösum með 5 skömmtum.
English: Cardboard box with 10 glass vials of 25 doses.
Icelandic: -Pappaaskja með 10 gler hettuglösum með 25 skömmtum.
English: STARTVAC is an ivory-coloured homogeneous emulsion for injection.
Icelandic: STARTVAC er beinhvítt, einsleitt stungulyf, fleyti
English: Ivory-coloured homogeneous emulsion.
Icelandic: Beinhvítt, einsleitt fleyti.
English: Cardboard box with 10 glass vials of 1 dose.
Icelandic: -Pappaaskja með 10 gler hettuglösum með 1 skammti.
English: Emulsion for injection.
Icelandic: Paraffínolía.
English: Cardboard box with 10 glass vials of 5 doses.
Icelandic: -Pappaaskja með 10 gler hettuglösum með 5 skömmtum.
English: Cardboard box with 1 glass vial of 1 dose.
Icelandic: -Pappaaskja með 1 gler hettuglasi með 1 skammti.
English: Cardboard box with 1 glass vial of 25 doses.
Icelandic: -Pappaaskja með 1 gler hettuglasi með 25 skömmtum.
English: Cardboard box with 1 glass vial of 5 doses.
Icelandic: -Pappaaskja með 1 gler hettuglasi með 5 skömmtum.
English: - Cardboard box with 1 PET vial of 25 doses.
Icelandic: -Pappaaskja með 1 PET hettuglasi með 25 skömmtum.
English: - Cardboard box with 1 PET vial of 5 doses.
Icelandic: -Pappaaskja með 1 PET hettuglasi með 5 skömmtum.
English: Special precautions for use in animals: Vaccinate healthy animals only.
Icelandic: Sérstakar varúðarreglur við notkun hjá dýrum:
English: Special warnings for each target species: The whole herd should be immunised.
Icelandic: Sérstakar varúðarreglur fyrir hverja dýrategund:
English: An additional 5 deaths were reported subsequently.
Icelandic: Síðar var tilkynnt um 5 dauðsföll til viðbótar.
English: 1047 Budapest Hungary
Icelandic: 1047 Budapest Ungverjaland
English: In vivo studies
Icelandic: In vivo rannsóknir
English: In vitro studies
Icelandic: In vitro rannsóknir
English: Date of first authorisation: 14th November 2016
Icelandic: 14. nóvember 2016
English: It is not possible to determine whether these events are related directly to these factors or to other factors.
Icelandic: Ekki er unnt að kveða upp úr um það hvort þessi atvik tengjast þessum þáttum beint eða öðrum þáttum.
English: The duration of treatment was 16 weeks.
Icelandic: Meðferðartíminn var 16 vikur.
English: Alpha-blockers
Icelandic: Alfa-blokkar
English: Do not stop taking Granpidam unless your doctor tells you to.
Icelandic: Ekki hætta að nota Granpidam nema læknirinn hafi ráðlagt það.
English: The duration of treatment was 12 weeks.
Icelandic: Meðferðartími var 12 vikur.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Icelandic: Eins og á við um öll lyf getur þetta lyf valdið aukaverkunum en það gerist þó ekki hjá öllum
English: Elderly (≥65 years)
Icelandic: Aldraðir (≥65 ára)