FrancophonIA/ELRC3.0 huggingface dataset:
English: *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Icelandic: ***Samkvæmt National Cancer Institute, CTC (v2,0; NCI 1998), eiga bragðtruflun og hárlos einungis að vera skráð sem 1. og 2. stigs.
English: Large Cell Carcinoma
Icelandic: Lækkun hemóglóbíns
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N=472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI=0.51-0.81, p=0.0002).
Icelandic: Aðalendapunktur rannsóknarinnar náðist og sýndi tölfræðilega marktækt bætta lifun án versnunar sjúkdóms hjá hópnum sem fékk pemetrexed samanborið við hópinn sem fékk lyfleysu (N=472, hópur metinn af óháðum aðila; miðgildi 3,9 mánuðir fyrir pemetrexed hópinn og 2,6 mánuðir fyrir hópinn sem fékk lyfleysu) (áhættuhlutfall=0,64; 95% CI=0,51-0,81; p=0,0002).
English: Pemetrexed Krka 100 mg contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium-free”.
Icelandic: Krka 100 mg inniheldur minna en 1 mmól (23 mg) af natríumi, þ.e.a.s. er sem næst natríumlaust.
English: Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Icelandic: Krka samhliða cisplatini er gefið sem fyrsta meðferðarúrræði til að meðhöndla sjúklinga með lungnakrabbamein sem ekki er af smáfrumugerð, staðbundið og langt gengið eða með meinvörpum, að frátöldum æxlum sem aðallega eru af flöguþekjugerð (sjá kafla 5.1).
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Icelandic: Krka 500 mg stofn fyrir innrennslisþykkni, lausn Hvert hettuglas inniheldur 500 mg af pemetrexedi (sem pemetrexed dínatríum hemipentahýdrat).
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI=0.56-0.88, p=0.002).
Icelandic: Að meðtaldri upphafsmeðferð var heildarlifun sjúklinga með NSCLC önnur en af yfirgnæfandi flöguþekjukrabbameinsvefjagerð, 18,6 mánuðir hjá hópnum sem fékk pemetrexed og 13,6 mánuðir hjá hópnum sem fékk lyfleysu (áhættuhlutfall=0,71, 95% CI=0,56-0,88, p=0,002).
English: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Icelandic: Klínískt marktæk CTC eituráhrif sem voru tilkynnt hjá >1% og 5% sjúklinga sem var slembiraðað á cisplatin og pemetrexed voru meðal annars: sýking án daufkyrningafæðar, daufkyrningafæð með hita, ofnæmistilvik/ofnæmiseinkenni, hækkað kreatínín, hreyfitaugakvilli, skyntaugakvilli, regnbogaroðasótt og kviðverkur.
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Icelandic: Krka 500 mg stofn fyrir innrennslisþykkni, lausn Blandið 500 mg hettuglas með 20 ml af natríumklóríði 9 mg/ml (0,9%) stungulyf, lausn án rotvarnarefna sem gefur lausn með 25 mg/ml af pemetrexedi.
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Icelandic: Krka 100 mg stofn fyrir innrennslisþykkni, lausn Hvert hettuglas inniheldur 100 mg af pemetrexedi (sem pemetrexed dínatríum hemipentahýdrat).
English: Median time to tumour progression (months) (95% CI)
Icelandic: Miðgildi-heildarlifun (mánuðir) (95 % CI)
English: Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Icelandic: Hvert hettuglas inniheldur 500 mg af pemetrexedi (sem pemetrexed dínatríum hemipentahýdrat).
English: Serious cardiovascular events, including myocardial infarction and cerebrovascular events, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Icelandic: Sjaldgæf dæmi voru um alvarleg hjarta- og æða meintilvik í klínískum rannsóknum með pemetrexedi, þar með talið hjartadrep og meintilvik í heilaæðum, venjulega þegar það var gefið með öðrum frumuskemmandi lyfjum.
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion pemetrexed
Icelandic: Krka 500 mg stofn fyrir innrennslisþykkni, lausn pemetrexed
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), Pemetrexed Krka should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Icelandic: Ef sjúklingar fá stig 3 eituráhrif sem koma ekki fram í breytingum á blóðmynd (að undanskildum eituráhrifum á taugar) ætti að bíða með Pemetrexed
English: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Icelandic: Klínísk marktæk CTC eituráhrif sem voru tilkynnt hjá - >1% og 5% sjúklinga sem var slembiraðað á cisplatin og pemetrexed voru meðal annars: nýrnabilun, sýking, sótthiti, daufkyrningafæð með hita, aukið AST, ALT og GGT, ofsakláði og brjóstverkur.
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Icelandic: Blandið hvert 100 mg hettuglas með 4,2 ml af natríumklóríði 9 mg/ml (0,9%) stungulyfi, lausn án rotvarnarefna en þetta gefur lausn með 25 mg/ml af pemetrexedi.
English: Concomitant use contraindicated Yellow fever vaccine: Risk of fatal generalised vaccinale disease (see section 4.3).
Icelandic: Hætta á banvænum almennum bóluefnasjúkdómi (sjá kafla 4.3).
English: Administration of pemetrexed to male mice resulted in reproductive toxicity characterised by reduced fertility rates and testicular atrophy.
Icelandic: Hjá karlkyns músum olli pemetrexed eiturvirkni í æxlunarfærum, sem lýsti sér með minnkaðri frjósemi og rýrnun á eistum.
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Icelandic: Krka 100 mg stofn fyrir innrennslisþykkni, lausn Blandið 100 mg hettuglas með 4,2 ml af natríumklóríði 9 mg/ml (0,9%) stungulyf, lausn án rotvarnarefna sem gefur lausn með 25 mg/ml af pemetrexedi.
English: Pemetrexed Krka.
Icelandic: Pemetrexed í skammtinum
English: Pemetrexed Krka 100 mg:
Icelandic: Krka 100 mg:
English: Alopecia
Icelandic: Placebo
English: Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Icelandic: Hvert hettuglas inniheldur 100 mg af pemetrexedi (sem pemetrexed dínatríum hemipentahýdrat).
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion pemetrexed
Icelandic: Krka 100 mg stofn fyrir innrennslisþykkni, lausn pemetrexed
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Icelandic: Blandið hvert 500 mg hettuglas með 20 ml af natríumklóríði 9 mg/ml (0,9%) stungulyfi, lausn án rotvarnarefna en þetta gefur lausn með 25 mg/ml af pemetrexedi.
English: Haemoglobin decreased
Icelandic: Lystarleysi Algengar Uppköst
English: Uncommon (may affect up to 1 in 100 people) - Acute renal failure - Fast heart rate - Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/radiation therapy - Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) - Interstitial pneumonitis (scarring of the air sacs of the lung) - Oedema (excess fluid in body tissue, causing swelling) - Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy - Pancytopenia- combined low counts of white cells, red cells and platelets - Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Icelandic: - Blóðfrumnafæð - sambland af lágri talningu hvítra blóðfrumna, rauðra blóðkorna og blóðflagna - Millivefsbjúgbólga í lungum af völdum geislunar (örvefsmyndun í lungnablöðrum sem tengd er geislameðferð) getur komið fram hjá sjúklingum sem eru einnig meðhöndlaðir með geislun annaðhvort fyrir, á meðan eða eftir meðferð með pemetrexedi
English: Tabulated list of adverse reactions
Icelandic: Ráðlagður skammtur af Pemetrexed
English: Therefore, the use of pemetrexed in patients with creatinine clearance of <45 ml/min is not recommended (see section 4.2).
Icelandic: Þess vegna er gjöf pemetrexeds hjá sjúklingum með kreatínín úthreinsun <45 ml/mín.
English: Pemetrexed Krka 500 mg powder for concentrate pemetrexed
Icelandic: Pemetrexed Krka 500 mg Þykknisstofn pemetrexed i.v.
English: Cisplatin (N=222)
Icelandic: (N=222)
English: Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section
Icelandic: Krka er gefið eitt sér sem viðhaldsmeðferð til að meðhöndla sjúklinga með lungnakrabbamein sem ekki er af smáfrumugerð, staðbundið og langt gengið eða með meinvörpum, að frátöldum æxlum sem aðallega eru af flöguþekjugerð þegar sjúkdómur hefur ekki versnað strax í kjölfar krabbameinsmeðferðar sem inniheldur platínu.
English: Stomatitis/Pharyngitis Nausea
Icelandic: Uppköst Munnbólga/ Kokbólga
English: Patients should be regularly monitored for acute tubular necrosis, decreased renal function and signs and symptoms of nephrogenic diabetes insipidus (e.g. hypernatraemia).
Icelandic: Sjúklingar eiga að vera undir reglulegu eftirliti hvaða varðar brátt drep í nýrnapíplum, skerta nýrnastarfsemi og merki og einkenni um nýrnaþvaghlaup (t.d.
English: Cisplatin (N=163)
Icelandic: (N=163)
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm
Icelandic: Heildarfjöldi daufkyrninga (ANC) ætti að vera 1.500 frumur/mm
English: Calculate the dose and the number of Pemetrexed Krka vials needed.
Icelandic: Pemetrexed Krka hettuglasa sem þarf.
English: Pemetrexed is primarily eliminated unchanged by renal excretion.
Icelandic: Fallist hefur verið á rök fyrir undanþágu frá kröfu um blindraletur.
English: Leukocytes decreased Haemoglobin decreased 26.2 Platelets decreased
Icelandic: Fækkun hvítkorna 17,8 Fækkun blóðflagna
English: Blood and lymphatic system disorders
Icelandic: - Lækkun hemóglóbíns (blóðleysi)
English: Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident, and transient ischaemic attack, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Icelandic: Sjaldgæf dæmi voru um alvarleg hjarta og æða og heilaæða meintilvik í klínískum rannsóknum með pemetrexedi, þar með talið hjartadrep, hjartaöng, heilaáfall og skammvinn heilablóðþurrð, venjulega þegar það var gefið með öðrum frumuskemmandi lyfjum.
English: 50% of previous dose (both Pemetrexed Krka and cisplatin)
Icelandic: 50% af síðasta skammti (bæði Pemetrexed
English: Concomitant use not recommended
Icelandic: Líkur á lifun án versnunar
English: Grade 3
Icelandic: VIÐAUKI II
English: Haemoglobin decreased 33.0* Neutrophils/Granulocyte s decreased
Icelandic: Pemetrexed hefur dreifingarrúmmál 9 l/m2 við jafnvægi.
English: a Grade
Icelandic: Meðganga
English: Date of first authorisation: 22.
Icelandic: * Skilgreining á tíðni:
English: may occur in patients who are also treated with radiation either before, during or after their pemetrexed therapy - Extremity pain, low temperature and discolouration have been reported - Blood clots in the lung blood vessels (pulmonary embolism)
Icelandic: - Ristilbólga (bólga í yfirborði ristils, einnig getur fylgt blæðing í þörmum eða endaþarmi) - Millivefsbjúgbólga í lungum (örvefsmyndun í lungnablöðrum)
English: Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia, and anaemia.
Icelandic: Við ofskömmtun er hægt að búast við meðal annars beinmergsbælingu, sem lýsir sér með daufkyrningafæð, blóðflagnafæð og blóðleysi.
English: h-4197-AA-en
Icelandic: (Sér)heiti
English: ATCvet code: QI02AA04.
Icelandic: QI02AA04.
English: BOEHRINGER INGELHEIM ANIMAL HEALTH Netherlands B.V. Houtribweg 39
Icelandic: INGELHEIM ANIMAL HEALTH Netherlands B.V. Houtribweg 39
English: MERIAL Laboratoire Porte des Alpes Rue de l'aviation
Icelandic: Porte des Alpes Rue de l'aviation
English: Revaccination: every six months.
Icelandic: Endurbólusetning: á 6 mánaða fresti.
English: Mannide mono-oleate Polysorbate 80
Icelandic: Mannide mónó-óleat Pólýsorbat 80
English: O1 Manisa ................................................................................................................................. ≥ 6 PD50* O1 BFS ....................................................................................................................................... ≥ 6 PD50* O Taiwan 3/97 ........................................................................................................................... ≥ 6 PD50* A22 Iraq ..................................................................................................................................... ≥ 6 PD50* A24 Cruzeiro ............................................................................................................................. ≥ 6 PD50* A Turkey 14/98 ......................................................................................................................... ≥ 6 PD50* Asia 1 Shamir ............................................................................................................................. ≥ 6 PD50* SAT2 Saudi Arabia ................................................................................................................... ≥ 6 PD50*
Icelandic: ≥ 6 PD50* O Taiwan 3/97 ............................................................................................................................ ≥ 6 PD50* A22 Iraq ...................................................................................................................................... ≥ 6 PD50* A24 Cruzeiro .............................................................................................................................. ≥ 6 PD50* A Turkey 14/98 ..........................................................................................................................
English: Do not warm the product before use.
Icelandic: Ekki hita lyfið fyrir notkun.
English: Schedule should be adjusted accordingly (see section 4.9).
Icelandic: Aðlaga skal bólusetningaráætlun eins og við á (sjá kafla 4.9).
English: These local reactions normally resolve over a period of four weeks post vaccination, but may persist for longer in a small number of animals.
Icelandic: Yfirleitt ganga þessi staðbundnu viðbrögð til baka á 4 vikum eftir bólusetningu, en geta verið þrálát hjá örfáum dýrum.
English: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Icelandic: Porte des Alpes Rue de l'Aviation 69800 Saint Priest Frakkland
English: 10 doses 25 doses
Icelandic: 10 skammtar 25 skammtar
English: Vaccination of cattle with strains O1 Manisa, O1 BFS, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia1 Shamir and SAT2 Saudi Arabia resulted in a reduction of clinical signs in animals exposed to infection.
Icelandic: O1 Manisa, O1 BFS, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir og SAT2 Saudi Arabia dró úr klínískum einkennum hjá dýrum sem voru útsett fyrir smiti.
English: Pigs from 2 weeks of age:
Icelandic: Svín frá 2 vikna aldri:
English: 10 doses 25 doses 50 doses 100 doses 150 doses 10 x 10 doses 10 x 25 doses 10 x 50 doses 10 x 100 doses 10 x 150 doses
Icelandic: 10 skammtar 25 skammtar 50 skammtar 100 skammtar 150 skammtar 10 x 10 skammtar 10 x 25 skammtar 10 x 50 skammtar 10 x 100 skammtar 10 x 150 skammtar
English: A slight increase of rectal temperature of up to 1.2 °C for 4 days post-vaccination with no other generalised clinical signs is commonly observed.
Icelandic: Örlítil hækkun allt að 1,2 °C á endaþarmshita í 4 daga eftir bólusetningu án annarra almennra klínískra einkenna er algeng.
English: Vaccinate healthy animals only.
Icelandic: Eingöngu má bólusetja heilbrigð dýr.
English: Each dose of 2 ml of emulsion contains:
Icelandic: Hver 2 ml skammtur af fleyti inniheldur:
English: Accidental injection is dangerous
Icelandic: Inndæling fyrir slysni er hættuleg
English: Maternal antibodies may interfere with vaccination.
Icelandic: Mótefni frá móður geta truflað bólusetningu.
English: * PD50 - 50% protective dose in cattle as described in Ph. Eur.
Icelandic: *PD50 - 50% verndandi skammtur fyrir nautgripi eins og er lýst í gæðalýsingu 0063 í Ph. Eur.
English: No antibodies to NSP were detected using the PrioCHECK FMDV NS test kit:
Icelandic: Engin mótefni fyrir próteinum sem eru ekki byggingarefni, komu fram við greiningu með PrioCHECK FMDV NS prófi:
English: Apply usual aseptic procedures.
Icelandic: Notið hefðbundnar smitgátaraðferðir.
English: Cattle, sheep: SC. Pigs: IM.
Icelandic: Nautgripir, sauðfé: s.c. Svín: i.m.
English: White emulsion after shaking.
Icelandic: Hvítt fleyti eftir að hafa verið hrist.
English: The number and type of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Icelandic: Fjöldi og tegund stofna sem verða í lokaafurðinni verður aðlagað að faraldsfræðilegum aðstæðum á þeim tíma sem lyfið er framleitt og mun koma fram á umbúðunum.
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose to calves, lambs and piglets.
Icelandic: Engar aukaverkanir aðrar en þær sem nefndar eru í kafla 4.6 komu í ljós eftir gjöf tvöfalds skammts hjá kálfum, lömbum og grísum.
English: Paraffin, liquid
Icelandic: Stungulyf, fleyti
English: Shelf life after first opening the immediate packaging: use immediately.
Icelandic: Geymsluþol eftir að umbúðir hafa verið rofnar: notið strax.
English: Shelf life of the veterinary medicinal product not containing strain Asia1 Shamir as packaged for sale: 6 months.
Icelandic: Geymsluþol dýralyfsins sem inniheldur ekki Asia1 Shamir, í sölumbúðum: 6 mánuðir.
English: Pigs: for intramuscular use.
Icelandic: Svín: til notkunar í vöðva.
English: Schedule should be adjusted accordingly (see section “dosage”).
Icelandic: Aðlaga skal bólusetningaráætlun eins og við á (sjá kaflann „skammtar“).
English: Liquid paraffin 537 mg. White emulsion after shaking.
Icelandic: Paraffínolía 537 mg.
English: No adverse reactions except those mentioned in section “adverse reactions” were observed after the administration of a double dose to calves, lambs and piglets.
Icelandic: Engar aukaverkanir aðrar en þær sem nefndar eru í kaflanum „aukaverkanir“ komu í ljós eftir gjöf tvöfalds skammts hjá kálfum, lömbum og grísum.
English: Sheep from 2 weeks of age:
Icelandic: Sauðfé frá 2 vikna aldri:
English: Do not mix the vaccine by vigorous shaking because it leads to entrapment of air bubbles.
Icelandic: Ekki hrista glasið kröftuglega þar sem það getur valdið froðumyndun.
English: Sodium chloride Potassium dihydrogen phosphate Potassium chloride Disodium phosphate anhydrous Potassium hydroxide Water for injections.
Icelandic: Kalíumklóríð Vatnsfrítt tvínatríumfosfat Kalíumhýdroxíð Vatn fyrir stungulyf
English: Swellings (diameter of up to 12 cm in ruminants and 4 cm in pigs) occurred very commonly in most animals after administration of a dose of vaccine.
Icelandic: Bólga (þvermál allt að 12 cm hjá jórturdýrum og 4 cm hjá grísum) er mjög algeng hjá flestum dýrum eftir gjöf bóluefnis.
English: Pigs: 4 weeks after vaccination.
Icelandic: 4 vikum eftir bólusetningu.
English: In some cases ulceration may occur at the injection site.
Icelandic: Í sumum tilvikum getur myndast sár á stungustað.
English: In cattle, the antibody levels measured were above those shown to be protective.
Icelandic: Hjá nautgripum var mælt magn mótefna yfir því magni sem sýnt hefur verið að sé verndandi.
English: Vaccination of pigs with strains O Taiwan 3/97 and A22 Iraq resulted in a reduction of clinical signs in animals exposed to infection.
Icelandic: Bólusetning svína með stofnunum Q Taiwan 3/97 og A22 Iraq dró úr klínískum einkennum hjá dýrum sem voru útsett fyrir smiti.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
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: - 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: Shelf life of the veterinary medicinal product containing strain Asia1 Shamir as packaged for sale: 2 months.
Icelandic: Geymsluþol dýralyfsins sem inniheldur Asia1 Shamir, í sölumbúðum: 2 mánuðir.
English: When very young pigs (at 2 weeks old) have to be vaccinated, revaccination at 8-10 weeks is recommended.
Icelandic: Þegar bólusetja þarf mjög unga grísi (við 2 vikna aldur) er mælt með endurbólusetningu á 8-10. viku.
English: The safety of the veterinary medicinal product has not been established during lactation.
Icelandic: Ekki hefur verið sýnt fram á öryggi dýralyfsins við mjólkurgjöf.
English: - in cattle following administration of a double dose followed by a single dose 7 weeks later and a third vaccination with a single dose 13 weeks after the second dose, - in sheep following administration of a double dose followed by a single dose 5 weeks later and a third vaccination with a single dose 7 weeks after the second dose, - in pigs following administration of a double dose followed by a single dose 3 weeks later and a third vaccination with a single dose 7 weeks after the second dose.
Icelandic: - hjá sauðfé eftir tvöfaldan skammt sem fylgt var eftir með stökum skammti 5 vikum síðar og þriðja bólusetning með stökum skammti 7 vikum eftir annan skammt, - hjá svínum eftir tvöfaldan skammt sem fylgt var eftir með stökum skammti 3 vikum síðar og þriðja bólusetning með stökum skammti 7 vikum eftir annan skammt.