FrancophonIA/ELRC3.0 huggingface dataset:
English: • Management of IVT injection related adverse events
Icelandic: Meðferð við aukaverkunum sem tengjast inndælingu í glerhlaup.
English: • Key signs and symptoms of IVT injection related adverse events
Icelandic: Helstu einkenni aukaverkana sem tengjast inndælingu í glerhlaup.
English: • Intravitreal injection procedure pictogram
Icelandic: Aðferðir við inndælingu í glerhlaup.
English: Date of last renewal: 01/10/2009.
Icelandic: Nýjasta dagsetning endurnýjunar markaðsleyfis:.1. október 2009.
English: Do not smoke, eat or drink while handling the product.
Icelandic: Hvorki má reykja, borða né drekka meðan lyfið er meðhöndlað.
English: Butylated hydroxytoluene 0.08%.
Icelandic: Bútýlhýdroxýtólúen 0,08%
English: 3 pipettes 15 pipettes
Icelandic: 3 pípettur 15 pípettur
English: Administer Stronghold in accordance with the following table:
Icelandic: Notið Stronghold samkvæmt eftirfarandi töflu:
English: People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Icelandic: Fólk með viðkvæma húð eða þekkt ofnæmi fyrir dýralyfjum af þessari gerð verður að handleika dýralyfið með varúð.
English: Apply the tip of the Stronghold pipette directly to the skin without massaging.
Icelandic: Beinið Stronghold pípettunni beint á húðina án þess að nudda.
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: - 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: It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Stronghold has been administered monthly.
Icelandic: Einnig er ráðlagt að hundar séu prófaðir reglulega fyrir smiti af fullþroska hjartaormum, sem þáttur í áætlun til að koma í veg fyrir hjartaormasmit, jafnvel þótt Stronghold hafi verið gefið mánaðarlega.
English: The pipettes are colour coded as follows:
Icelandic: Pípetturnar eru litamerktar sem hér segir:
English: Stronghold was administered at 10 times the recommended dose, and no undesirable effects were observed.
Icelandic: Stronghold var gefið í tíföldum ráðlögðum skammti án þess að aukaverkanir kæmu fram.
English: • Treatment of biting lice infestations (Felicola subrostratus)
Icelandic: ● Meðhöndlun sýkinga af völdum bitlúsa (Felicola subrostratus)
English: • Treatment and prevention of flea infestations caused by Ctenocephalides spp.
Icelandic: ● Meðhöndlun og fyrirbygging flóasmits af völdum Ctenocephalides spp.
English: EU/2/99/014/003 (30 mg - 3 pipettes) EU/2/99/014/007 (30 mg - 6 pipettes) EU/2/99/014/004 (60 mg - 3 pipettes) EU/2/99/014/009 (60 mg - 6 pipettes) EU/2/99/014/005 (120 mg - 3 pipettes) EU/2/99/014/010 (120 mg - 6 pipettes) EU/2/99/014/006 (240 mg - 3 pipettes) EU/2/99/014/011 (240 mg - 6 pipettes) EU/2/99/014/015 (360 mg - 3 pipettes) EU/2/99/014/016 (360 mg - 6 pipettes)
Icelandic: EU/2/99/014/007 (30 mg - 6 pípettur) EU/2/99/014/004 (60 mg - 3 pípettur) EU/2/99/014/009 (60 mg - 6 pípettur) EU/2/99/014/005 (120 mg - 3 pípettur) EU/2/99/014/010 (120 mg - 6 pípettur) EU/2/99/014/006 (240 mg - 3 pípettur) EU/2/99/014/011 (240 mg - 6 pípettur) EU/2/99/014/015 (360 mg - 3 pípettur) EU/2/99/014/016 (360 mg - 6 pípettur)
English: For the full list of excipients, see section 6.1.
Icelandic: Bútýlhýdroxýtólúen 0,08% Sjá lista yfir öll hjálparefni í kafla 6.1.
English: Stronghold is available in packs of three pipettes (all pipette sizes), six pipettes (all pipette sizes except 15 mg selamectin), or fifteen pipettes (15 mg selamectin pipette size only).
Icelandic: Stronghold er fáanlegt í pakkningum með þremur pípettum (allar pípettustærðir), sex pípettum (allar pípettustærðir nema 15 mg selamectin) og fimmtán pípettum (eingöngu 15 mg selamectin pípettur).
English: Stronghold may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with Stronghold.
Icelandic: Stronghold má gefa dýrum sem eru smituð af fullþroska hjartaormum, en hins vegar er mælt með að öll dýr sem eru 6 mánaða eða eldri sem eru í löndum þar sem smitberar eru til staðar, séu prófuð fyrir smiti af fullþroska hjartaormum áður en að meðferð hefst með Stronghold.
English: 4.2 Indications for use, specifying the target species Cats and dogs:
Icelandic: 4.2 Ábendingar fyrir tilgreindar dýrategundir Kettir og hundar:
English: EU/2/99/014/001 (3 pipettes) EU/2/99/014/012 (15 pipettes)
Icelandic: EU/2/99/014/001 (3 pípettur) EU/2/99/014/012 (15pípettur)
English: Stronghold should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Icelandic: Selamectin má ekki berast í vötn, ár eða læki þar sem það kann að vera skaðlegt fiski eða öðrum vatnalífverum.
English: Stronghold has been tested with no other adverse reactions in over 100 different pure and mixed breeds of dogs including Collies, and in mixed breeds and 16 pure breeds of cats.
Icelandic: Stronghold hefur verið prófað án þess að frekari aukaverkanir hafi komið fram í yfir 100 mismunandi hreinræktuðum og blönduðum tegundum hunda, þ. á m.
English: Date of first authorisation: 25/11/1999.
Icelandic: 25. nóvember 1999.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 15 mg (3 and 15 pipettes)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM MERKING Á ÖSKJU 15 mg (3 og 15 pípettur)
English: The veterinary medicinal product was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive Collies, and no undesirable effects were observed.
Icelandic: Dýralyfið var einnig gefið köttum og hundum sem notuð eru til undaneldis, þar á meðal kettlinga-/hvolpafullum dýrum og mjólkandi kvendýrum, í þreföldum ráðlögðum skammti og í Collie hundum sem þola illa ivermectin, í fimmföldum skammti án þess að aukaverkanir kæmu fram.
English: Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Icelandic: Þvoið hendur eftir notkun og ef lyfið kemst í snertingu við húð þá skal þvo hana strax með sápu og vatni.
English: EU/2/99/014/002 (3 pipettes) EU/2/99/014/008 (6 pipettes) EU/2/99/014/013 (3 pipettes) EU/2/99/014/014 (6 pipettes)
Icelandic: EU/2/99/014/002 (3 pípettur) EU/2/99/014/008 (6 pípettur) EU/2/99/013/013 (3 pípettur) EU/2/99/015/014 (6 pípettur)
English: Stronghold 15 mg for cats and dogs
Icelandic: Stronghold 15 mg fyrir ketti og hunda
English: The veterinary medicinal product is in translucent polypropylene single-dose pipettes in an aluminium and aluminium/PVC blister overwrap.
Icelandic: Dýralyfið er í hálfgagnsæjum stakskammta pípettum úr pólýpropýleni, í þynnupakkningum úr áli og áli/PVC.
English: This product is not effective against adult D. immitis.
Icelandic: Þetta dýralyf verkar ekki á fullþroska D.immitis.
English: • Treatment of biting lice infestations (Trichodectes canis)
Icelandic: ● Meðhöndlun sýkinga af völdum bitlúsa (Trichodectes canis)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg (3 and 6 pipettes)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM MERKING Á ÖSKJU 30 mg, 60 mg, 120 mg, 240 mg, 360 mg (3 og 6 pípettur)
English: If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
Icelandic: Ef svo gerist þá getur í örfáum tilfellum aukist munnvatnsmyndun hjá köttum í stuttan tíma.
English: Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg selamectin
Icelandic: Stronghold 15 mg blettunarlausn fyrir ketti og hunda ≤2,5 kg selamectin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 45 mg, 60 mg (3 and 6 pipettes)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM MERKING Á ÖSKJU 45 mg, 60 mg (3 og 6 pípettur)
English: • Treatment of ear mites (Otodectes cynotis).
Icelandic: Meðhöndlun sýkinga af völdum eyrnamaura (Otodectes cynotis)
English: Stronghold 45 mg for cats
Icelandic: Stronghold 45 mg fyrir ketti
English: Holding the pipette upright, firmly depress the cap to puncture the applicator seal, then remove the cap
Icelandic: Haldið pípettunni uppréttri, þrýstið þétt á hettuna til að rjúfa innsiglið, fjarlægið síðan hettuna.
English: The veterinary medicinal product is ovicidal for 3 weeks after administration.
Icelandic: Lyfið verkar á egg flónna í þrjár vikur eftir gjöf.
English: Interactions with other medicinal products and other forms of interaction:
Icelandic: Aðferð við lyfjagjöf og íkomuleið:
English: • Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Icelandic: ● Meðhöndlun sýkinga af völdum fullþroska krókorma í meltingarvegi (Ancylostoma tubaeforme).
English: Remove the Stronghold pipette from its protective package.
Icelandic: Fjarlægið Stronghold pípettuna úr umbúðunum
English: Avoid contact between the product and your fingers.
Icelandic: Forðist að snerta dýralyfið með fingrunum.
English: On rare occasions in cats and dogs, application of the veterinary medicinal product may produce a local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder.
Icelandic: Í mjög sjaldgæfum tilfellum getur verið að hár klístrist tímabundið og/eða hvítt duft myndast á notkunarstað dýralyfsins hjá köttum og hundum.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL LABEL, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg
Icelandic: INNRI UMBÚÐUM MERKING Á ÁLÞYNNU 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg
English: Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg selamectin
Icelandic: Stronghold 45 mg blettunarlausn fyrir ketti 2,6-7,5 kg Stronghold 60 mg blettunarlausn fyrir ketti 7,6-10,0 kg selamectin
English: The veterinary medicinal product was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed.
Icelandic: Dýralyfið var gefið köttum og hundum sem voru smituð af fullorðnum hjartaormum í þreföldum ráðlögðum skammti án þess að aukaverkanir kæmu fram.
English: Part the hair at the base of your animal's neck in front of the shoulder blades to expose a small area of skin.
Icelandic: Skiptið hárunum á feldi dýrsins á aftanverðum hálsinum framan við herðablöðin til að komast að húðinni.
English: When concurrent infestations or infections in the same animal are to be treated with the veterinary medicinal product, only one application of the recommended 6 mg/kg dose should be administered at any one time.
Icelandic: Þegar meðhöndla á önnur smit eða sýkingar samtímis í sama dýrinu með dýralyfinu er einungis mælt með einni gjöf staks skammts 6 mg/kg skammt á hverjum tíma.
English: Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA
Icelandic: Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt Zoetis Belgium SA
English: In extensive field testing no interactions between Stronghold and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Icelandic: Í yfirgripsmikilli vettvangsprófun sáust engar milliverkanir milli Stronghold og hefðbundinna dýralyfja eða skurðaðgerða.
English: • Treatment of adult roundworms (Toxocara cati)
Icelandic: ● Meðhöndlun sýkinga af völdum fullþroska þráðorma (Toxocara cati)
English: Avoid contact between the veterinary medicinal product and your fingers.
Icelandic: Forðist að snerta lyfið með fingrunum.
English: Pipettes with rose caps contain 0.25 ml of 6% w/v solution and deliver 15 mg of selamectin Pipettes with blue caps contain 0.75 ml of 6% w/v solution and deliver 45 mg of selamectin Pipettes with taupe caps contain 1.0 ml of 6% w/v solution and deliver 60 mg of selamectin Pipettes with violet caps contain 0.25 ml of 12% w/v solution and deliver 30 mg of selamectin Pipettes with brown caps contain 0.5 ml of 12% w/v solution and deliver 60 mg of selamectin Pipettes with red caps contain 1.0 ml of 12% w/v solution and deliver 120 mg of selamectin Pipettes with green caps contain 2.0 ml of 12% w/v solution and deliver 240 mg of selamectin Pipettes with plum caps contain 3.0 ml of 12% w/v solution and deliver 360 mg of selamectin.
Icelandic: Pípettur með bleika hettu innihalda 0,25 ml af 6% w/v lausn og gefa 15 mg af selamectin Pípettur með bláa hettu innihalda 0,75 ml af 6% w/v lausn og gefa 45 mg selamectin Pípettur með grábrúna hettu innihalda 1,0 ml af 6% w/v lausn og gefa 60 mg selamectin Pípettur með fjólubláa hettu innihalda 0,25 ml af 12% w/v lausn og gefa 30 mg af selamectin.
English: Stronghold 120 mg for dogs
Icelandic: Stronghold 120 mg fyrir hunda
English: Stronghold 240 mg for dogs
Icelandic: Stronghold 240 mg fyrir hunda
English: On very rare occasions transient focal irritation may also be observed.
Icelandic: Í einstaka tilfellum má einnig greina lítils háttar skammvinna staðbundna ertingu.
English: Stronghold 30 mg for dogs
Icelandic: Stronghold 30 mg fyrir hunda
English: Treatment of biting lice infestations (Felicola subrostratus) Treatment of adult roundworms (Toxocara cati) Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Icelandic: Meðhöndlun sýkinga af völdum fullþroska þráðorma (Toxocara cati) Meðhöndlun sýkinga af völdum fullþroska krókorma í meltingarvegi (Ancylostoma tubaeforme)
English: Stronghold 60 mg for cats
Icelandic: Stronghold 60 mg fyrir ketti
English: Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.
Icelandic: Meðhöndluð dýr mega ekki fara í ár eða vötn fyrr en a.m.k. tveimur tímum eftir gjöf lyfsins.
English: Stronghold 360 mg for dogs
Icelandic: Stronghold 360 mg fyrir hunda
English: The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Icelandic: Lyfið má nota sem hluta af meðhöndlun húðofnæmis af völdum flóa og með því að verka deyðandi á egg og lirfur getur það stuðlað að því að halda því flóasmiti sem fyrir er í umhverfinu í skefjum á svæðum sem dýrið hefur aðgang að.
English: • Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Icelandic: - Fyrirbygging hjartaormaveiki af völdum Dirofilaria immitis.
English: Dogs weighing 20.1-40.0 kg.
Icelandic: Hundar 20,1 - 40,0 kg.
English: Stronghold 60 mg for dogs
Icelandic: Stronghold 60 mg fyrir hunda
English: Stronghold can be used in breeding, pregnant and lactating cats and dogs.
Icelandic: Stronghold má gefa köttum og hundum sem notuð eru til undaneldis, á meðgöngu og á meðan mjólkurgjöf stendur yfir.
English: 6% w/v solution selamectin 15 mg
Icelandic: 6% w/v lausn selamectin
English: Dogs weighing 2.6-5.0 kg.
Icelandic: Hundar 2,6 - 5,0 kg.
English: The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Icelandic: Dýralyfið má nota sem hluta af meðhöndlun húðofnæmis af völdum flóa og með því að verka deyðandi á egg og lirfur getur það stuðlað að því að halda því flóasmiti sem fyrir er í umhverfinu í skefjum á svæðum sem dýrið hefur aðgang að.
English: 12% w/v solution selamectin 30 mg
Icelandic: 12% w/v lausn selamectin
English: Dogs weighing 5.1-10.0 kg.
Icelandic: Hundar 5,1 - 10,0 kg.
English: Rose
Icelandic: Bleikur Blár
English: Dogs weighing 10.1-20.0 kg.
Icelandic: Hundar 10,1 - 20,0 kg.
English: Dogs weighing 40.1-60.0 kg.
Icelandic: Hundar 40,1 - 60,0 kg.
English: Cats (kg) Pipette cap colour mg of selamectin dispensed
Icelandic: Litur á hettu pípettunnar mg selamectin gefin
English: Cats weighing 2.6-7.5 kg. Cats weighing 7.6-10.0 kg.
Icelandic: Kettir sem vega 2,6 kg - 7,5 kg (Stronghold 45 mg blettunarlausn fyrir ketti 2,6-7,5 kg)
English: Butylated hydroxytoluene Dipropylene glycol methyl ether Isopropyl alcohol
Icelandic: Bleikur Fjólublár Brúnn
English: 15 mg selamectin 30 mg selamectin 45 mg selamectin 60 mg selamectin 120 mg selamectin 240 mg selamectin 360 mg selamectin
Icelandic: 15 mg selamectin 30 mg selamectin 45 mg selamectin
English: Store in the unopened foil package in a dry place.
Icelandic: Geymið við lægri hita en 30° C. Geymið í óopnuðum upprunalegum umbúðum á þurrum stað.
English: Stronghold should be administered as a single application of a single dose delivering a minimum of 6 mg/kg selamectin.
Icelandic: Stronghold á að bera á í eitt skipti sem stakan skammt sem inniheldur a.m.k.
English: The product is ovicidal for 3 weeks after administration.
Icelandic: Dýralyfið verkar á egg flóa í þrjár vikur eftir gjöf.
English: Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Icelandic: Stronghold 30 mg blettunarlausn fyrir hunda 2,6-5,0 kg Stronghold 60 mg blettunarlausn fyrir hunda 5,1-10,0 kg Stronghold 120 mg blettunarlausn fyrir hunda 10,1-20,0 kg Stronghold 240 mg blettunarlausn fyrir hunda 20,1-40,0 kg Stronghold 360 mg blettunarlausn fyrir hunda 40,1-60,0 kg selamectin
English: Stronghold should be administered topically as a single application of a single-dose delivering a minimum of 6 mg/kg selamectin.
Icelandic: Stronghold á að bera á útvortis sem stakan skammt sem inniheldur a.m.k.
English: Stronghold 15 mg spot-on for cats and dogs ≤ 2.5 kg Stronghold 30 mg spot-on for dogs 2.6-5.0 kg Stronghold 45 mg spot-on for cats 2.6-7.5 kg Stronghold 60 mg spot-on for cats 7.6-10.0 kg Stronghold 60 mg spot-on for dogs 5.1-10.0 kg Stronghold 120 mg spot-on for dogs 10.1-20.0 kg Stronghold 240 mg spot-on for dogs 20.1-40.0 kg Stronghold 360 mg spot-on for dogs 40.1-60.0 kg selamectin
Icelandic: Stronghold 15 mg blettunarlausn fyrir ketti og hunda ≤2,5 kg Stronghold 30 mg blettunarlausn fyrir hunda 2,6 - 5,0 kg Stronghold 45 mg blettunarlausn fyrir ketti 2,6 - 7,5 kg Stronghold 60 mg blettunarlausn fyrir ketti 7,6 - 10,0 kg Stronghold 60 mg blettunarlausn fyrir hunda 5,1 - 10,0 kg Stronghold 120 mg blettunarlausn fyrir hunda 10,1 - 20,0 kg Stronghold 240 mg blettunarlausn fyrir hunda 20,1 - 40,0 kg Stronghold 360 mg blettunarlausn fyrir hunda 40,1 - 60,0 kg selamectin
English: PACKAGE LEAFLET: Stronghold spot-on solution
Icelandic: VARNAÐARORÐIN „DÝRALYF“
English: Cats and dogs weighing 2.5 kg or less (Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg) Dogs weighing 2.6 kg-5.0 kg (Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg) Cats weighing 2.6 kg-7.5 kg (Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg) Cats weighing 7.6 kg-10.0 kg (Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg) Dogs weighing 5.1 kg-10.0 kg (Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg) Dogs weighing 10.1 kg-20.0 kg (Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg) Dogs weighing 20.1 kg-40.0kg (Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg) Dogs weighing 40.1 kg-60.0 kg (Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg)
Icelandic: Stronghold 15 mg blettunarlausn fyrir ketti og hunda ≤2,5 kg Stronghold 30 mg blettunarlausn fyrir hunda 2,6 - 5,0 kg Stronghold 45 mg blettunarlausn fyrir ketti 2,6 - 7,5 kg Stronghold 60 mg blettunarlausn fyrir ketti 7,6 - 10,0 kg Stronghold 60 mg blettunarlausn fyrir hunda 5,1 - 10,0 kg Stronghold 120 mg blettunarlausn fyrir hunda 10,1 - 20,0 kg Stronghold 240 mg blettunarlausn fyrir hunda 20,1 - 40,0 kg Stronghold 360 mg blettunarlausn fyrir hunda 40,1 - 60,0 kg
English: This should be taken into consideration.
Icelandic: Þetta ber að hafa í huga.
English: Your doctor will work out the right dose for you.
Icelandic: Læknirinn mun reikna út réttan skammt fyrir þig.
English: Over 52 weeks
Icelandic: Í 52 vikur
English: Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better.
Icelandic: EKKI hætta meðferð með CINQAERO nema læknirinn segi fyrir um það, jafnvel þó þér líði betur.
English: LT-08409 Vilnius Lithuania
Icelandic: LT-08409 Vilnius Litháen
English: The overall reduction was 54%.
Icelandic: Heildarlækkunin var 54%.
English: Over 16 weeks
Icelandic: Í 16 vikur
English: Always follow the instructions exactly as your doctor has told you.
Icelandic: Notið lyfið alltaf eins og læknirinn hefur sagt til um.
English: This medicine is NOT intended for use in children and adolescents below the age of 18 years.
Icelandic: Þetta lyf er EKKI ætlað börnum og unglingum yngri en 18 ára.
English: CINQAERO will be given every 4 weeks.
Icelandic: CINQAERO verður gefið á 4 vikna fresti.
English: Date of first authorisation: 16 August 2016.
Icelandic: 16. ágúst 2016.
English: *** Patients weighing more than 188 kg were not studied.
Icelandic: *** Sjúklingar sem vega meira en 188 kg voru ekki rannsakaðir.
English: There are limited data available on the use of reslizumab in patients older than 75 years of age.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um notkun reslizumabs hjá sjúklingum sem eru eldri en 75 ára.
English: If you miss a scheduled dose of CINQAERO, ask your doctor when to schedule your next treatment.
Icelandic: Ef venjulegur skammtur af CINQAERO fellur niður skaltu spyrja lækninn hvenær þú þurfir að áætla næstu meðferð.
English: Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Icelandic: Bráðaofnæmisviðbrögð (sjá kafla 4.4) komu fram hjá færri en 1% sjúklinga.
English: In this short period, a risk to the suckling child cannot be excluded.
Icelandic: Á þessu stutta tímabili er ekki hægt að útiloka hættu fyrir brjóstmylkinginn.
English: The active substance in this medicine may pass into breast milk but only during the first few days after birth.
Icelandic: Virka efnið í lyfinu getur borist í brjóstamjólk en aðeins á fyrstu dögunum eftir fæðingu.
English: NAb a FEV1=forced expiratory volume in 1 second b NA=not available c The GINA classification is based on the Global Initiative for Asthma (GINA) definition:
Icelandic: b a FEV1=þvingað útöndunarrúmmál í 1 sekúndu b NA=liggur ekki fyrir c GINA flokkunin er byggð á skilgreiningu Global Initiative for Asthma (GINA):
English: Treatment duration CINQAERO is intended for long-term treatment.
Icelandic: Lengd meðferðar CINQAERO er ætlað til langtímameðferðar.
English: In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity.
Icelandic: In vitro upplýsingar gefa til kynna að ólíklegt sé að IL-5 og reslizumab hafi áhrif á virkni CYP1A2, 3A4 eða 2B6.
English: Patients below 35 kg or above 199 kg
Icelandic: Sjúklingar undir 35 kg eða yfir 199 kg
English: These cases resulted in the discontinuation of treatment.
Icelandic: Þessi tilvik ollu því að hætta þurfti meðferð.
English: There are limited safety data in non-white ethnic populations.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um öryggi hjá þýði sem ekki er af hvíta kynþættinum.
English: Results were supported by the secondary efficacy endpoints and were in line with the overall population.
Icelandic: Niðurstöður voru studdar af aukalegum verkunarendapunktum og voru í samræmi við heildarþýðið.