FrancophonIA/ELRC3.0 huggingface dataset:
English: However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Icelandic: Hins vegar má í undantekningartilvikum, hjá einstaklingum með blóðflagnafæð og blæðingasjúkdóma, gefa Ambirix undir húð, þar sem gjöf í vöðva gæti valdið blæðingu.
English: Skin and subcutaneous tissue disorders Rare: pruritus, rash
Icelandic: Húð og undirhúð Mjög sjaldgæfar: kláði, útbrot Koma örsjaldan fyrir: ofsakláði
English: It is not known whether Ambirix will prevent hepatitis A and hepatitis B in such cases.
Icelandic: Mögulegt er að bólusetningu beri upp á meðgöngutíma sýkingar af lifrarbólgu A eða lifrarbólgu B. Ekki er vitað hvort Ambirix kemur í veg fyrir lifrarbólgu A og lifrarbólgu B í slíkum tilvikum.
English: Ambirix should not be given if any of the above apply.
Icelandic: Ekki skal gefa Ambirix ef eitthvað af ofangreindu á við.
English: Nervous system disorders Syncope or vasovagal responses to injection, localised hypoaesthesia
Icelandic: Yfirlið eða æða- og skreyjutaugarviðbrögð (vasovagal responses) við inndælingu, staðbundin snertiskynsminnkun
English: • abnormal test results relating to the liver
Icelandic: Óeðlilegar niðurstöður lifrarprófa
English: - Hepatitis A virus (inactivated) 1,2
Icelandic: - Lifrarbólguveira A (deydd)1,2
English: Additional side effects that occurred during routine use of very similar combined or individual hepatitis A and hepatitis B vaccines were as follows:
Icelandic: Aðrar aukaverkanir sem komu fyrir við notkun á mjög sambærilegum samsettum eða eingildum bóluefnum gegn lifrarbólgu A og lifrarbólgu
English: It is not known exactly how long protection against infection with hepatitis A and B viruses will last, although protection against the hepatitis A virus probably lasts about 10 years.
Icelandic: Ekki er vitað með vissu hve lengi vörnin gegn lifrarbólguveirum A og B mun endast.
English: Package Leaflet: Information for the user Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Icelandic: Upplýsingar fyrir notanda lyfsins Ambirix stungulyf, dreifa í áfylltri sprautu Bóluefni gegn lifrarbólgu A (deydd veira) og lifrarbólgu B (rDNA), (aðsogað)
English: NAME OF THE MEDICINAL PRODUCT Ambirix - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Icelandic: Ambirix - Stungulyf, dreifa í áfylltri sprautu Bóluefni gegn lifrarbólgu A (deydd veira) og lifrarbólgu B (rDNA), (aðsogað).
English: The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
Icelandic: Þegar frumbólusetningin er hafin ætti að nota sama bóluefnið í öll skiptin.
English: It cannot protect against other infections that can affect the liver - even though these infections might have signs similar to those caused by the hepatitis A or B virus.
Icelandic: Ambirix getur einungis hjálpað til að verja þig gegn sýkingum af völdum lifrarbólguveira A eða B. Það verndar ekki gegn öðrum sýkingum sem hafa áhrif á lifrina - jafnvel þó þessar sýkingar valdi ámóta einkennum og sýkingar af völdum lifrarbólguveiru A eða B.
English: HAB vaccine
Icelandic: vöðvaverkir
English: • reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia),
Icelandic: • fækkun blóðflagna, sem eykur hættuna blæðingum eða mari (blóðflagnafæð), fjólubláir eða rauðbrúnir blettir sem sjást í gegnum húðina (blóðflagnafæðarpurpuri)
English: General disorders and administration site conditions Immediate injection site pain, stinging and burning sensation
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Bráðir verkir, stingir og brunatilfinning á stungustað
English: NAME OF THE MEDICINAL PRODUCT Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Icelandic: Ambirix stungulyf, dreifa í áfylltri sprautu Bóluefni gegn lifrarbólgu A (deydd veira) og lifrarbólgu B (rDNA), (aðsogað).
English: • Make sure you finish the complete course of two injections.
Icelandic: Gættu þess að þú fáir/barnið fái báðar inndælingarnar.
English: Psychiatric disorders Very common: irritability
Icelandic: Geðræn vandamál Mjög algengar: pirringur
English: Nederland GlaxoSmithKline BV
Icelandic: Suomi/Finland GlaxoSmithKline
English: Skin and subcutaneous tissue disorders Erythema multiforme, lichen planus
Icelandic: Húð og undirhúð Regnbogaroði, flatskæningur
English: The following adverse reactions were reported during post-marketing surveillance following vaccination with Ambirix.
Icelandic: Greint hefur verið frá eftirfarandi aukaverkunum eftir að bólusetningar hófust með Ambirix eftir markaðssetningu.
English: Concomitant immunoglobulin administration may result in lower antibody titres.
Icelandic: Samhliða gjöf immúnóglóbúlína getur leitt til lægri þéttni mótefna.
English: • numbness or weakness of the arms and legs (neuropathy)
Icelandic: • dofi eða máttleysi í hand- og fótleggjum (taugakvilli)
English: • you have previously had an allergic reaction to any vaccine against hepatitis A or hepatitis B diseases
Icelandic: ef um er að ræða ofnæmi fyrir einhverju bóluefni gegn lifrarbólgu A eða lifrarbólgu B.
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Icelandic: Í undantekningartilvikum, hjá sjúklingum með blóðflagnafæð eða blæðingasjúkdóma, má gefa bóluefnið undir húð.
English: • swelling of the spinal cord (myelitis)
Icelandic: • hrörnunarsjúkdómur í heila (heilakvilli)
English: Blood and lymphatic system disorders Rare: lymphadenopathy
Icelandic: Sjaldgæfar: vöðvaverkir Mjög sjaldgæfar: liðverkir
English: If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
Icelandic: B er mælt með að nota staðlaða þriggja skammta inndælingu með samsettu bóluefni, sem inniheldur 360 ELISA-einingar af lifrarbólguveiru A, deyddri með formalíni og 10 míkrógrömm af lifrarbólgu B-yfirborðsmótefnavakaraðbrigði.
English: Immune system disorders Allergic reactions including anaphylactic and anaphylactoid reactions
Icelandic: Ónæmiskerfi Ofnæmisviðbrögð þ.m.t. bráðaofnæmis- og bráðaofnæmislík viðbrögð
English: Cases of overdose with GlaxoSmithKline's combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance.
Icelandic: Greint hefur verið frá ofskömmtun af samsettu bóluefni frá GlaxoSmithKline gegn lifrarbólgu A og lifrarbólgu
English: • multiple sclerosis
Icelandic: • lystarleysi
English: • Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Icelandic: Sýking af völdum lifrarbólguveiru B getur valdið bólgu í lifrinni.
English: • immediate injection site pain, stinging and burning feeling
Icelandic: • bráður verkur, stingir eða sviðatilfinning á stungustað
English: Immune system disorders Allergic reactions including mimicking serum sickness, angioneurotic oedema
Icelandic: Ónæmiskerfi Ofnæmisviðbrögð, þ.m.t. sermisóttarlíkur sjúkdómur, ofsabjúgur
English: Protection against hepatitis B infections may not be obtained until after the second dose (see section Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course.
Icelandic: Þess vegna: - ætti einungis að nota Ambirix þegar tiltölulega lítil hætta er á sýkingu af völdum lifrarbólgu B
English: Gastrointestinal disorders Common: gastrointestinal symptoms
Icelandic: Meltingarfæri Algengar: einkenni frá meltingarvegi
English: Adverse reactions reported are listed according to the following frequency: Very common:
Icelandic: Aukaverkanir sem greint hefur verið frá eru tilgreindar í eftirfarandi tíðniflokkum:
English: What Ambirix contains
Icelandic: Ambirix inniheldur
English: • fever
Icelandic: • syfja
English: Vaccine group
Icelandic: Lifrarbólga
English: month schedules were 84.8% and 92.9%, respectively.
Icelandic: Á þeim tímapunkti var hlutfall einstaklinga með HBs-mótefni ≥10 ma.e./ml 84,8% hjá einstaklingum sem voru bólusettir eftir 0, 6 mánaða áætluninni og 92,9% hjá þeim sem voru bólusettir eftir 0, 12 mánaða áætluninni.
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (1 ml)
Icelandic: 1 skammtur (1 ml) 1 áfyllt sprauta + 1 nál 1 skammtur (1 ml) 10 áfylltar sprautur 10 x 1 skammtur (1 ml) 10 áfylltar sprautur + 10 nálar 10 x 1 skammtur (1 ml) 50 áfylltar sprautur 50 x 1 skammtur (1 ml)
English: Metabolism and nutrition disorders
Icelandic: Mælingar á mótefnum gegn lifrarbólgu
English: General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Icelandic: Leifum bóluefnisins skal farga í samræmi við gildandi reglur.
English: Following widespread use of either GlaxoSmithKline's combined hepatitis A and hepatitis B vaccines or the monovalent hepatitis A and/or hepatitis B vaccines, the following adverse reactions have additionally been reported.
Icelandic: Auk þess hefur verið greint frá eftirfarandi aukaverkunum eftir víðtæka notkun bóluefna frá GlaxoSmithKline, bæði samsettra bóluefna gegn lifrarbólgu A og lifrarbólgu B og eingildra bóluefna gegn annað hvort lifrarbólgu A eða lifrarbólgu B.
English: Gastrointestinal disorders Common: diarrhoea, nausea Uncommon: vomiting, abdominal pain*
Icelandic: Algengar: niðurgangur, ógleði Sjaldgæfar: uppköst, kviðverkir*
English: Nervous system disorders Very common: headache Common: drowsiness
Icelandic: Mjög algengar: höfuðverkur Algengar: syfja
English: Common:
Icelandic: B:
English: List of adverse reactions
Icelandic: Listi yfir aukaverkanir
English: Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
Icelandic: Ekki er hægt að áætla tíðni þessara aukaverkana á óyggjandi hátt þar sem upplýsingar um þær fást með aukaverkanatilkynningum.
English: • reaction where the injection was given
Icelandic: LYFSINS ÞAR SEM VIÐ Á
English: Infections and infestations Uncommon: upper respiratory tract infection
Icelandic: Sýkingar af völdum sýkla og sníkjudýra Sjaldgæfar: sýking í efri hluta öndunarfæra
English: Mechanism of action
Icelandic: viðbrögð á stungustað
English: • Clinical trial data
Icelandic: Upplýsingar úr klínískum rannsóknum
English: Common (These may occur with up to 1 in 10 doses of the vaccine) :
Icelandic: Algengar (geta komið fyrir við allt að 1 af hverjum 10 skömmtum af bóluefninu):
English: Blood and lymphatic system disorders Thrombocytopenic purpura, thrombocytopenia
Icelandic: Blóð og eitlar Blóðflagnafæðarpurpuri, blóðflagnafæð
English: • Suspension for injection in a pre-filled syringe.
Icelandic: MEÐ BLINDRALETRI Fallist hefur verið á rök fyrir undanþágu frá kröfu um blindraletur.
English: These local reactions gradually reduce and disappear without need for treatment.
Icelandic: Þessi staðbundnu viðbrögð minnka smám saman og hverfa síðan án þess að þörf sé á meðferð.
English: No available data.
Icelandic: Engar upplýsingar liggja fyrir.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Icelandic: Ef vart verður við einhverjar hliðaverkanir/aukaverkanir, jafnvel þær sem hafa ekki þegar verið taldar upp í fylgiseðli þessarar pakkningar eða að þú telur að lyfið hefur ekki virkað, vinsamlegast tilkynntu það dýralækni þínum.
English: Onset of immunity: 1 week.
Icelandic: Ónæmi myndast eftir: 1 viku.
English: Rabbits.
Icelandic: Kanínur.
English: Date of first authorisation: 22 September 2016
Icelandic: 22. september 2016.
English: Each dose of 0.5 ml contains:
Icelandic: Hver 0,5 ml skammtur inniheldur:
English: The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Icelandic: Bóluefnið veitir aðeins vörn gegn RHDV2, ekki hefur verið sýnt fram á víxlvernd gegn hefðbundinni RHDV.
English: ATCvet code: QI08AA
Icelandic: QI08AA
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Icelandic: Ekki skal nota dýralyfið eftir fyrningardagsetningu sem tilgreind er á umbúðum á eftir EXP.
English: Detailed information on this 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: If pain persists for more than 12hours after medical examination, seek medical advice again.
Icelandic: Ef sársaukinn er ekki horfinn 12 klukkustundum eftir læknisskoðun, skal aftur hafa samband við lækni.
English: Vial label (1, 10 or 40 doses)
Icelandic: Hettuglös (1, 10 eða 40 skammtar)
English: Rabbits
Icelandic: Kanínur
English: Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
Icelandic: Bólusetning á kanínum leiddi til mótefnamyndunar hemagglútínínhömlunar sem varaði í að minnsta kosti 12 mánuði.
English: This slight temperature increase resolves spontaneously without treatment by day 5 post vaccination.
Icelandic: Þessi lítilsháttar hitaaukning hefur gengið til baka án meðferðar á 5. degi eftir bólusetningu.
English: Laboratory studies in doe rabbits in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Icelandic: Rannsóknarstofu rannsóknir hjá kanínuhindum á síðasta þriðjungi meðgöngu hafa ekki leitt til vísbendinga um vansköpunarvaldandi og eiturverkandi áhrif á fóstur eða móður.
English: Revaccination: 12 months after vaccination.
Icelandic: 12 mánuðum eftir bólusetningu.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Icelandic: Gefið ekki dýrum sem hafa ofnæmi fyrir virka efninu, ónæmisglæðinum eða einhverju hjálparefnanna.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment) - 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).
Icelandic: - Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum 10 dýrum sem fá meðferð) - Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100 dýrum sem fá meðferð) - Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 1.000 dýrum sem fá meðferð) - Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 10.000 dýrum sem fá meðferð)
English: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer
Icelandic: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial
English: 1 x 40 doses (20 ml).
Icelandic: 1 x 40 skammtar (20 ml).
English: Nodules or swelling (< 2 cm) can be very commonly observed in the injection site, which may last 24 hours.
Icelandic: Mjög algengt er að vart verði við smáhnúða (< 2 cm) á staðnum þar sem var sprautað var, sem geta varað í 24 klukkustundir.
English: Mineral oil: ………………..104.125 mg
Icelandic: Paraffínolía: ………………104,125 mg
English: Shake well before administration.
Icelandic: Hristið vel fyrir notkun.
English: A transient temperature increase slightly above 40 ºC might very commonly occur between two or three days following vaccination.
Icelandic: Það er mjög algengt að það verði tímabundin hækkun hita yfir 40 ºC tveim til þrem dögum eftir bólusetningu.
English: Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses).
Icelandic: Hettuglös úr litlausu gleri af gerð I með 0,5 ml (1 skammti), 5 ml (10 skömmtum) og 20 ml (40 skömmtum).
English: Pregnant does should be handled with special care to avoid stress and risk of abortion
Icelandic: Þungaðar hindir skal meðhöndla með sérstakri aðgát til að forðast streitu og hættu á fósturláti
English: ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Icelandic: ≥70% bólusettra kanína skulu sýna cELISA mótefnatítra sem er jafngildur eða hærri en 40.
English: la Selva, 135 17170 Amer (Girona) SPAIN
Icelandic: Avda. la Selva, 135 17170- AMER (Girona) SPÁNN
English: La Selva, 135 17170 Amer SPAIN
Icelandic: La Selva, 135 17170
English: Mineral oil…………104.125 mg
Icelandic: ………104,125 mg
English: Lethargy and/or inappetence may be observed very rarely in the first 48 hours after injection, based on post-authorisation pharmacovigilance reporting.
Icelandic: Samkvæmt skýrslu lyfjagátar eftir veitingu markaðsleyfis getur í mjög sjaldgæfum tilfellum orðið vart við sinnuleysi og/eða lystarleysi innan fyrstu 48 klukkustundanna frá því sprauta var fengin.
English: ADVICE ON CORRECT ADMINISTRATION
Icelandic: LEIÐBEININGAR UM RÉTTA LYFJAGJÖF
English: Before use allow the vaccine to reach room temperature.
Icelandic: Fyrir notkun skal láta bóluefnið ná stofuhita.
English: For the full list of excipients, see section 6.1.
Icelandic: Tíómersal………………0,05 mg Sjá lista yfir öll hjálparefni í kafla 6.1.
English: Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall.
Icelandic: Gefið kanínunum frá 30 daga aldri einn skammt (0,5 ml) af dýralyfinu með inndælingu undir húð hliðlægt í brjóstholsvegg.
English: Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
Icelandic: Óvirkjað veirubóluefni handa dýrum af héraætt (Leporidae), óvirkjað veirubóluefni handa kanínum.
English: Expert, prompt, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Icelandic: TAFARLAUS þörf er á sérfræðingi í skurðlækningum þar sem nauðsynlegt getur verið að skera í og skola stungustað, sérstaklega ef um er að ræða fingurgóm eða sin.
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 …..≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Icelandic: Óvirkjuð lifrardrepsveira af tegund 2 (rabbit haemorrhagic disease type 2 virus (RHDV2)), stofn V-1037……≥70% cELISA40* (*) ≥70% bólusettra kanína skulu sýna cELISA mótefnatítra sem er jafngildur 40 eða hærri.
English: Thiomersal…………0.05 mg
Icelandic: Tíómersal: ………………0,05 mg Hvítleitt fleyti.
English: 10 x 1 dose (0.5 ml).
Icelandic: 10 x 1 skammtur (0,5 ml) 1 x 10 skammtar (5 ml).
English: Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Icelandic: 15. HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA Laboratorios Hipra, S.A.
English: Sorbitan mono-oleate Polysorbate 80
Icelandic: Sorbítan einóleat Pólýsorbat 80
English: Cardboard box of 1 glass vial of 40 doses (20 ml).
Icelandic: Pappaaskja með 1 hettuglasi úr gleri með 40 skömmtum (20 ml).
English: To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
Icelandic: Til að örva virkt ónæmi gegn lifrardrepsveiru af tegund 2 (RHDV2).
English: Mineral oil
Icelandic: Kalíumtvívetnisfosfat
English: ERAVAC emulsion for injection for rabbits
Icelandic: ERAVAC stungulyf, fleyti fyrir kanínur
English: Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant.
Icelandic: Mælt er með bólusetningu þar sem RHDV2 er landlæg.
English: Duration of immunity: 12 months demonstrated by challenge
Icelandic: 12 mánuði sýnt fram á með reynsluprófun.
English: Cardboard box of 10 glass vials of 1 dose (0.5 ml).
Icelandic: Pappaaskja með 10 hettuglösum úr gleri með 1 skammti (0,5 ml).
English: For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Icelandic: Til virkrar ónæmingar hjá kanínum frá 30 daga aldri til þess að draga úr dánartíðni af völdum lifrardrepsveira af tegund 2.
English: ERAVAC Emulsion for injection for rabbits.
Icelandic: ERAVAC stungulyf, fleyti fyrir kanínur.
English: CONTRAINDICATIONS
Icelandic: FRÁBENDINGAR
English: België/Belgique/Belgien
Icelandic: België/Belgique/Belgien HIPRA BENELUX NV Tél/Tel:
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
Icelandic: Óvirkjuð lifrardrepsveira af tegund 2 (rabbit haemorrhagic disease type 2 virus (RHDV2)), stofn V-1037….
English: Overdose (symptoms, emergency procedures, antidotes): No available data.
Icelandic: Ofskömmtun (einkenni, bráðameðferð, móteitur):
English: Whitish emulsion.
Icelandic: Hvítleitt fleyti.
English: Cardboard box of 1 glass vial of 10 doses (5 ml).
Icelandic: Pappaaskja með 1 hettuglasi úr gleri með 10 skömmtum (5 ml).
English: Batch{number}
Icelandic: Lot {númer}
English: Inactivated RHDV2, strain V-1037: ………….≥70% cELISA40
Icelandic: Óvirkjuð RHDV2, stofn V-1037:
English: Adjuvant:
Icelandic: FYLGISEÐILL:
English: The frequency of adverse reactions is defined using the following convention: -very common (more than 1 in 10 animals treated displaying adverse reaction (s) -common (more than 1 but less than 10 animals in 100 animals treated) -uncommon (more than 1 but less than 10 animals in 1,000 animals treated) -rare (more than 1 but less than 10 animals in 10,000 animals treated) -very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Icelandic: - Koma örsjaldan fyrir (koma fyrir hjá færri en 1 af hverjum 10.000 dýrum, sem fá meðferð þ.m.t. einstök tilvik)
English: Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections
Icelandic: Tvínatríumfosfatdódekahýdrat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE
Icelandic: YTRI UMBÚÐUM OG INNRI UMBÚÐUM PAPPAASKJA
English: Pack size syringes (multipack)
Icelandic: 6 (3 x 2) áfylltir lyfjapennar (fjölpakkning)
English: (Invented) name Strength Pharmaceutical form
Icelandic: ESB markaðsleyfisnúmer (Sér)heiti Styrkleiki Lyfjaform Íkomuleið Innri umbúðir <Innihald (þéttni)>
English: • If you are under 18 or over 75 years of age.
Icelandic: Ef þú ert yngri en 18 ára eða eldri en 75 ára.
English: Manufacturer Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow,
Icelandic: Accord Healthcare Limited Sage House, 319, Pinner Road North Harrow,
English: No clinical studies have been conducted in patients >75 years of age.
Icelandic: Engar klínískar rannsóknir hafa verið gerðar á sjúklingum >75 ára.
English: • If you eat more than usual
Icelandic: Ef þú borðar meira en venjulega.
English: Date of latest renewal: 19th September 2016
Icelandic: 19 September 2016
English: Diabetes mellitus type 1, C-peptide negative.
Icelandic: Sykursýki tegund 1, C-peptíð neikvæð.
English: Be aware that the desired effect is not achieved if you stop taking Repaglinide Accord.
Icelandic: Hafðu í huga að tilætluð áhrif nást ekki ef þú hættir að taka Repaglinide Accord.
English: Middlesex, HA1 4HF United Kingdom
Icelandic: Middlesex HA1 4HF Bretland
English: 100 tablets in a HDPE bottle.
Icelandic: 100 töflur í HDPE lyfjaglasi.
English: Repaglinide Accord with alcohol
Icelandic: Notkun Repaglinide Accord með áfengi
English: Your body's response to Repaglinide Accord may change if you take other medicines, especially these:
Icelandic: Svörun líkamans við Repaglinide Accord getur breyst ef þú tekur önnur lyf samhliða, sérstaklega eftirtalin lyf:
English: Do not take more Repaglinide Accord than your doctor has recommended.
Icelandic: Ekki á að taka stærri skammt af Repaglinide Accord en læknirinn hefur ráðlagt.
English: • If you have a severe liver disease.
Icelandic: Ef þú ert með alvarlegan lifrarsjúkdóm.