FrancophonIA/ELRC3.0 huggingface dataset:
English: CYP3A4 inhibitors potentially leading to increased tacrolimus blood levels Clinically, the following substances have been shown to increase tacrolimus blood levels: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole, voriconazole and isavuconazole, the macrolide antibiotic erythromycin, HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir) or Hepatitis C Virus (HCV) protease inhibitors (e.g. telaprevir, boceprevir, and the combination of ombitasvir and paritaprevir with ritonavir, when used with and without dasabuvir), the pharmacokinetic enhancer cobicistat, and the tyrosine kinase inhibitors nilotinib and imatinib.
Icelandic: Öflugar milliverkanir hafa komið í ljós við notkun sveppalyfja svo sem ketókónazóls, flúkónazóls, ítrakónazóls, vorikónazóls og ísavúkónazóls, makrólíð sýklalyfsins erýtrómýcíns, HIV próteasa hemla (t.d. ritónavírs, nelfinavírs, saquinavírs) eða HCV próteasa hemla (t.d. telaprevírs, boceprevírs, og samsetningar ombitasvírs og paritaprevírs með ritonavíri, við notkun með eða án dasabúvírs), lyfjahvarfavirkjans kóbísistats og týrósínkínasahemlanna nilotinibs og imatinibs.
English: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Icelandic: Því stuðla umbrotsefni ekki að lyfhrifum takrólímus.
English: Envarsus 0.75 mg prolonged-release tablets
Icelandic: Envarsus 0,75 mg forðatöflur takrólímus
English: - medicines known as “statins”, used to treat elevated cholesterol and triglycerides - phenytoin or phenobarbital, used to treat epilepsy - prednisolone and methylprednisolone, belonging to the class of corticosteroids and used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - carbamazepine, used to prevent and control seizures - metamizole, used to treat pain and high fever - nefazodone, used to treat depression - herbal preparations containing St. John's Wort (Hypericum perforatum)
Icelandic: diltíazem og verapamíl) - lyf við hjartsláttaróreglu (t.d. amíódarón) - lyf sem kölluð eru statín sem notuð eru til meðferðar á hækkuðu kólesteróli og þríglýseríðum - fenýtóín eða fenóbarbital sem notuð eru við flogaveiki - prednisólón og metýlprednisólón sem tilheyra flokki barkstera og eru notuð við bólgu eða til að bæla niður ónæmiskerfið (t.d. við höfnun ígræðslu) - karbamasepín sem notað er til að koma í veg fyrir og meðhöndla flog
English: Nervous system disorders headache, tremor nervous system disorders seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language ab-normalities, paralysis and paresis, amnesia hypertonia myasthenia
Icelandic: Taugakerfi höfuðverkur, skjálfti krampar vegna sjúkdóma í taugakerfi, truflanir á meðvitund, úttaugakvilli, sundl, náladofi og skyntruflanir, skriftruflanir heilakvilli, blæðingar í miðtaugakerfi og heilaslag, dá, truflanir á máli og málfari, lömun og máttminnkun (paresis), minnisleysi ofstæling (hypertonia)
English: Patients are also at an increased risk of infections with viral hepatitis (e.g. hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Icelandic: B og C og nýtilkomna sýkingu auk lifrarbólgu E, sem getur orðið langvinn).
English: Ear and labyrinth disorders tinnitus hypoacusis deafness neurosensory hearing impaired
Icelandic: Eyru og völundarhús suð fyrir eyrum væg heyrnarskerðing (hypoacusis)
English: In addition, synergistic/additive nephrotoxic effects can occur.
Icelandic: Að auki geta komið fram samlegðar-/aukin eituráhrif á nýru.
English: Gastrointestinal perforation has been reported in patients treated with tacrolimus.
Icelandic: Greint hefur verið frá rofi í meltingarvegi hjá sjúklingum á meðferð með takrólímus.
English: Hepatic impairment
Icelandic: Innkirtlar ofhæring
English: Eye disorders eye disorders, vision blurred, photophobia cataract blindness optic neuropathy
Icelandic: Augu augnkvillar, þokusýn, ljósfælni drer blinda sjóntaugarkvilli
English: Envarsus 4 mg prolonged-release tablets
Icelandic: Envarsus 4 mg forðatöflur takrólímus
English: This leaflet was last revised in. Other sources of information
Icelandic: Þessi fylgiseðill var síðast uppfærður.
English: Results from clinical studies performed with once-daily tacrolimus
Icelandic: Niðurstöður úr klínískum rannsóknum með takrólímus einu sinni á sólarhring
English: - Collection of fluid around the heart - Acute breathlessness - Cyst formation in your pancreas, pre-stage of a blockage in your bowel - Problems with blood flow in the liver - Serious illness with blistering of skin, mouth, eyes and genitals; - Increased hairiness - Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Icelandic: - Alvarlegur sjúkdómur sem lýsir sér með blöðrumyndun í húð, munni, augum og á kynfærum; - Aukinn hárvöxtur - Þorsti, byltur, herpingur fyrir brjósti, minnkuð hreyfigeta, sár
English: • Summary of Product Characteristics and Patient Information Leaflet
Icelandic: Upplýsingar fyrir sjúkling
English: The overall incidence of fatal treatment emergent adverse events for the combined de novo and stable liver transplant population was not significantly different between the Envarsus group and the tacrolimus immediate-release group.
Icelandic: Ekki var marktækur munur á heildartíðni banvænna aukaverkana í sameinuðum rannsóknarhópi lifrarþega sem var að gangast undir lifrarígræðslu í fyrsta sinn og lifrarþega í jafnvægi milli hópsins sem fékk Envarsus og hópsins sem fékk skjótvirk takrólímushylki.
English: Common side effects (may affect up to 1 in 10 people): - reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests) - reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
Icelandic: - Fækkun blóðkorna (blóðflagna, rauðra eða hvítra blóðkorna), fjölgun hvítra blóðkorna, breytingar á fjölda rauðra blóðkorna (sést í blóðrannsóknum)
English: increased uric acid or lipids in the blood, decreased appetite, loss of appetite, increased acidity of the blood, other changes in the blood salts (seen in blood tests) - anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare,
Icelandic: - Minnkað magnesíum, fosfat, kalíum, kalsíum eða natríum í blóði, of mikill vökvi í líkamanum, aukin þvagsýra í blóði eða blóðfitur, minnkuð matarlyst, lystarleysi, súrara blóð, aðrar breytingar á blóðsöltum (sést í blóðrannsóknum)
English: Gastrointestinal disorders diarrhoea, nausea gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools acute and chronic pancreatitis, peritonitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying pancreatic pseudocyst, subileus
Icelandic: Meltingarfæri niðurgangur, ógleði einkenni frá meltingarvegi, uppköst, verkir í meltingarvegi og kvið, bólgusjúkdómar í meltingarvegi, blæðingar í meltingarvegi, sáramyndun eða rof í meltingarvegi, skinuholsvökvi, munnbólga og sáramyndun, hægðatregða, einkenni um meltingartruflanir, vindgangur, uppþemba og þan, linar hægðir bráð og langvarandi brisbólga, lífhimnubólga, garnalömun, bakflæðissjúkdómur, skert magatæming sýndarblaðra í brisi, væg garnastífla (subileus)
English: Administration should commence within 24 hours after the completion of surgery.
Icelandic: Hefja skal lyfjagjöf innan 24 klst.
English: Eye disorders
Icelandic: - Suð fyrir eyrum
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Icelandic: Aðeins eitt þessara óvirku umbrotsefna finnst í blóðrásinni í lítilli þéttni.
English: What Envarsus looks like and contents of the pack
Icelandic: Lýsing á útliti Envarsus og pakkningastærðir
English: Conversion of Prograf- or Advagraf-treated patients to Envarsus - allograft transplant patients Envarsus is not interchangeable with other existing tacrolimus containing medicinal products (immediate-release or prolonged-release) on an equal dose by dose basis.
Icelandic: Skipti sjúklinga sem fá meðferð með Prograf eða Advagraf yfir í Envarsus - líffæraþegar sem fá ósamgena líffæri
English: See section 4.
Icelandic: Dímetíkón 350.
English: Envarsus 1 mg prolonged-release tablets
Icelandic: Envarsus 1 mg forðatöflur takrólímus
English: Once daily.
Icelandic: 45 dagar.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to
Icelandic: Sjaldgæfar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum):
English: Blood trough levels of tacrolimus should also be closely monitored following conversion from tacrolimus products, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
Icelandic: breytingar á ónæmisbælandi meðferð og samhliða gjöf lyfja sem geta breytt þéttni takrólímus í heilblóði (sjá kafla 4.5).
English: Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Icelandic: Greint hefur verið frá mistökum við lyfjagjöf, þar á meðal skiptum milli skjótvirkra forma og forðalyfjaforma af takrólímus af gáleysi, óviljandi eða án eftirlits.
English: Tabulated list of adverse reactions
Icelandic: Fyrirbyggjandi gegn höfnun nýra
English: hallucination, mental disorders - fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - blurred vision, increased sensitivity to light, eye disorders - ringing sound in your ears - reduced blood flow in the heart vessels, faster heartbeat - bleeding, partial or complete blocking of blood vessels, reduced blood pressure - shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms - stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting,
Icelandic: Efnaskipti og næring sykursýki, blóðsykurshækkun, blóðkalíumhækkun lystarleysi, efnaskiptablóðsýring, önnur frávik í saltbúskap, blóðnatríumlækkun, ofvökvun (fluid overload), aukning þvagsýru í blóði, blóðmagnesíumlækkun, blóðkalíumlækkun, blóðkalsíumlækkun, minnkuð matarlyst, kólesterólhækkun í blóði, blóðfituhækkun, hækkun þríglýseríða í blóði, blóðfosfatlækkun ofþornun, blóðsykurslækkun, of lítið prótein í blóði, blóðfosfathækkun
English: For prophylaxis of transplant rejection in adult heart, lung, pancreas, or intestine allograft recipients clinical data are not yet available for Envarsus.
Icelandic: Klínískar upplýsingar eru ekki enn fyrirliggjandi um Envarsus, varðandi fyrirbyggjandi meðferð við höfnun eftir ígræðslu hjá fullorðnum hjarta-, lungna-, bris- eða þarmaþegum sem fara í ósamgena ígræðslu.
English: General disorders and administration site conditions febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature perception disturbed influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance fall, ulcer, chest tightness, thirst fat tissue increased
Icelandic: inflúensulík veikindi, taugaóstyrkur, óeðlileg líðan, fjöllíffærabilun, þyngsli fyrir brjósti, hitaóþol byltur, sár, herpingur fyrir brjósti, þorsti aukning á fituvef
English: fever, nausea or vomiting - an infection, leading to problems with your kidney or neurological symptoms - headache, altered mental status, seizures and visual disturbances - weakness, change in skin or eye colour, easy bruising, infection, cough, anaemia
Icelandic: - slappleika, breytingu á húð- eða augnlit, færð gjarnan marbletti, sýkingu, hósta, blóðleysi.
English: Musculoskeletal and connective tissue disorders arthralgia, back pain, muscle cramps, pain in limb joint disorders mobility decreased
Icelandic: Stoðkerfi og bandvefur liðverkir, bakverkur, sinadráttur, verkir í útlimum sjúkdómar í liðum minnkun hreyfanleika
English: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Icelandic: Fyrirbyggjandi gegn líffærahöfnun hjá ósamgena fullorðnum nýrna- og lifrarþegum.
English: A number of associated cases of transplant rejection have been reported.
Icelandic: Greint hefur frá allnokkrum tengdum tilvikum um höfnun ígrædds líffæris.
English: Infection including opportunistic infections
Icelandic: - Tíðaverkir og óeðlilegar tíðablæðingar
English: Uncommon side effects (may affect up to 1 in 100 people): - changes in blood clotting, reduction in the number of all types of blood cells (seen in blood tests) - dehydration, inability to urinate - psychotic behaviour, such as delusions, hallucinations, and confusion - abnormal blood test results: reduced protein or sugar, increased phosphate, increase of the enzyme lactate dehydrogenase - coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems - clouding of the eye lens, partial or total inability to hear - irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal - blood clot in a vein of a limb, shock - difficulties in breathing, respiratory tract disorders, asthma - acute or chronic inflammation of the pancreas, inflammation of the lining of the inner wall of the abdomen, obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach contents in your throat, delayed emptying of the stomach - inflammation of the skin, burning sensation in the sunlight - joint disorders - painful menstruation and abnormal menstrual bleeding - multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, weight loss
Icelandic: - Blóðtappi í bláæð útlims, lost - Öndunarerfiðleikar, öndunarfærakvillar, astmi - Bráð eða langvinn bólga í brisi, bólga í innra byrði kviðveggjar, stífla í þörmum, hækkun á þéttni ensímsins amýlasa í blóði, bakflæði magainnihalds upp í háls, seinkuð magatæming
English: Gastrointestinal disorders
Icelandic: skyntaugaheyrnarleysi heyrnarskerðing
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm count and motility was observed in rats.
Icelandic: Í rottum hafði takrólímus neikvæð áhrif á frjósemi karldýra að því leyti að sæðisfjöldi og hreyfanleiki minnkaði.
English: The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Icelandic: Í rannsóknum á eiturverkunum hjá rottum og bavíönum voru nýru og bris þau líffæri sem aðallega urðu fyrir eiturverkunum.
English: Vascular disorders hypertension thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders venous thrombosis deep limb, shock, infarction
Icelandic: Æðar háþrýstingur segareks- og blóðþurrðartilvik, lágur blóðþrýstingur (vascular hypotensive disorders), blæðingar, útæðakvillar segamyndun í djúpbláæðum útlima, lost, fleygdrep
English: Package size
Icelandic: Innri umbúðir Pakkningastærð
English: Keep the boxes tightly closed.
Icelandic: Geymið öskjurnar vel lokaðar.
English: The duration of protection is of at least 6 months.
Icelandic: Sjúkdómsvörn varir í minnst 6 mánuði.
English: 2 years at -20°C and 2 days at +25°C.
Icelandic: 2 ár við -20°C og 2 dagar við +25°C.
English: Manufacturing Authorisation issued on December 22 santé et de la protection sociale - Direction de la Pharmacie et du médicament - République Française.
Icelandic: Framleiðsluleyfi gefið út 22. desember 1997 af Ministère de la solidarité, de la santé et de la protection sociale - Direction de la pharmacie et du médicament - Lýðveldinu Frakklandi.
English: Store in a freezer at -40°C to -20°C.
Icelandic: Geymið í frysti við -40°C til -20°C.
English: The baits are successively packed in boxes of: - 200 units (4x50) - 400 units (2x200)
Icelandic: Beitunum er pakkað í umbúðir sem innihalda: - 200 einingar (4x50) - 400 einingar (2x200)
English: It is recommended to wear rubber gloves.
Icelandic: Mælt er með því að bera gúmmíhanska.
English: The safety of the vaccine in pregnant and lactating animals has not been investigated.
Icelandic: Öryggi bóluefnisins hjá þunguðum og mjólkandi dýrum hefur ekki verið kannað.
English: 8 log10 - CCID50*/dose
Icelandic: 8 log10 - CCID50*/skammtur
English: Dispose of waste material and any unplaced baits at the end of the day of distribution by boiling or incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Icelandic: Förgun á úrgangi og beitum sem ekki hefur verið komið fyrir í lok dreifingardags með suðu, brennslu eða dýfingu ofan í viðeigandi sótthreinsunarefni sem samþykkt er viðeigandi yfirvöldum.
English: Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Icelandic: Rauðrefir (Vulpes vulpes) og þvottabjarnarhundar (Nyctereutes procyonoides).
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Icelandic: Lyfjastofnunar Evrópu http://www.ema.europa.eu/
English: Appetent matrix (bait) :
Icelandic: Tálbeitumassi (beita):
English: Baits shall not be distributed in inhabited areas, roads and watery areas.
Icelandic: Beitum skal ekki dreift í byggð, á vegum eða votsvæðum.
English: Vomiting due to gastric intolerance (potentially due to the aluminium/PVC sachet as part of the bait vaccine), in dogs which have accidentally ingested the bait, has been reported.
Icelandic: Uppsölur vegna óþols í maga (mögulega vegna ál/PVC pokans sem er hluti af beitubóluefninu), hafa komið upp í hundum sem hafa étið beituna fyrir slysni.
English: MARKETING AUTHORISATION NUMBER EU/2/00/021/001
Icelandic: 15. MARKAÐSLEYFISNÚMER EU/2/00/021/001
English: PACKAGE SIZE 400 (2 x 200) vaccinal baits.
Icelandic: PAKKNINGASTÆRÐ 400 (2 x 200) bólusetningarbeitum.
English: The administration of the vaccine at 10 times the recommended dosage induced no undesirable effects.
Icelandic: Tíu sinnum stærri skammtur af bóluefninu en ráðlagður er olli ekki óæskilegum áhrifum.
English: The baits are distributed by land or by air within the framework of vaccination campaigns against rabies.
Icelandic: Beitum er dreift á landi eða úr lofti innan ramma bólusetningarátaks gegn hundaæði.
English: The intake of a single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
Icelandic: Inntaka einnar beitu nægir til þess að tryggja virka ónæmingu til þess að forðast sýkingu af hundaæðisveiru.
English: In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet or the label to the physician.
Icelandic: Ef einstaklingur snertir virka efni bóluefnisins ber strax að leita læknishjálpar og sýna lækninum fylgiseðilinn eða merkimiðann.
English: The active ingredient is a double low virulence mutant isolated from the SAD Bern strain of rabies virus by two successive selection steps in order to avoid natural reversion to the parental strain.
Icelandic: Virka innihaldsefnið er tvöfalt stökkbrigði með lágri meinvirkni sem einangrað er úr SAD Bern stofninum af hundaæðisveirunni með tveim valstigum til þess að forðast náttúrulegt afturhvarf til foreldrastofns.
English: Rabigen SAG2 is a live modified rabies vaccine for oral administration to red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Icelandic: Rabigen SAG2 er lifandi breytt hundaæðisbóluefni til inntöku fyrir rauðrefi (Vulpes vulpes) og þvottabjarnarhunda (Nyctereutes procyonoides).
English: 06516 Carros - France
Icelandic: 06516 Carros - Frakkland
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Icelandic: VARNAÐARORÐIN „DÝRALYF“ OG SKILYRÐI EÐA TAKMARKANIR Á AFGREIÐSLU OG NOTKUN, EF VIÐ
English: Any person intending to import, sell, supply and/or use the veterinary medicinal product must consult the relevant Member State's Competent Authority on the current vaccination policies prior to the import, sale, supply and/or use.
Icelandic: Sá sem ætlar að framleiða, flytja inn, hafa í sinni vörslu, selja, dreifa og/eða nota lyfið skal leita til viðkomandi yfirvalda til að fá upplýsingar um hvaða bólusetningarreglur gilda um dýr, áður en hafist er handa um framleiðslu, innflutning, vörslu, sölu, drefingu og/eða notkun.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Icelandic: 13. VARNAÐARORÐIN „GEYMIÐ ÞAR SEM BÖRN HVORKI NÁ TIL NÉ SJÁ“
English: PACKAGE SIZE 200 (4 x 50) vaccinal baits.
Icelandic: PAKKNINGASTÆRÐ 200 (4x50) bólusetningarbeitum.
English: VIRBAC SRL Via Ettore Bugatti 15 I-20142 Milano Tel: + 39 02 40 92 47 1
Icelandic: VIRBAC SRL Via Ettore Bugatti 15 I-20142 Milano
English: Excipients:
Icelandic: Upplýsingasími:
English: Immunocompromised/immunosuppressed individuals must not be allowed to handle this vaccine.
Icelandic: Einstaklingar með skert eða breytt ónæmi mega ekki handleika bóluefnið.
English: As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Icelandic: Þar sem bóluefnið inniheldur snefilmagn af gentamísíni og inniheldur tetrasíklín sem merkiefni, getur ofnæmisáhrifa orðið vart hjá húsdýrum sem hafa fyrir slysni gleypt beituna.
English: 06516 Carros - France tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48 e-mail: darprocedure@virbac.com
Icelandic: + 33 4 92 08 73 48 netfang: darprocedure@virbac.com
English: No adverse events have been reported in the target species.
Icelandic: Engar aukaverkanir hafa komið fram hjá tegundunum sem lyfið er ætlað.
English: For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
Icelandic: Til virkrar ónæmingar á rauðrefum og þvottabjarnarhundum til að koma í veg fyrir sýkingu af völdum hundaæðisveiru.
English: Palatable matrix (bait) containing a tetracycline biomarker
Icelandic: Tálbeitumassi (beita) sem inniheldur tetrasíklín markefni.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Icelandic: HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
English: Liquid vaccine contained within an aluminium/PVC sachet coated with an appetising matrix.
Icelandic: Fljótandi bóluefni í skammtapoka úr áli/PVC, umlukið tálbeitumassa.
English: The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package insert for further information.
Icelandic: Innflutningur, varsla, sala, dreifing og/eða notkun þessa dýralyfs er eða getur verið óheimil í aðildarríki, ýmist í ríkinu öllu eða hluta þess, sjá nánari upplýsingar í fylgiseðli.
English: 4.4 Special warnings for each target species
Icelandic: 4.4 Sérstök varnaðarorð fyrir hverja dýrategund Á ekki við.
English: Name and address of the manufacturer of the biological active substance
Icelandic: Heiti og heimilisfang framleiðenda líffræðilegra virkra efnia
English: Disodium phosphate - Potassium dihydrogen phosphate - Glutamic acid - Saccharose - GelatinTryptone - Lactalbumin hydrolysate - Sodium chloride - Water for injection
Icelandic: - Glútamiksýra - Sakkarósi - Gelatín
English: MINIMUM PARTICULARS TO APPEAR ON SACHETS
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á LITLUM