FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration of Lonsurf with [14C]-tipiracil hydrochloride, at least 27% of the administered tipiracil hydrochloride was absorbed and 50% of the total radioactivity dose measured into faeces, suggestive of moderate gastrointestinal absorption of tipiracil hydrochloride.
Icelandic: 27% af gefnu tipiracíl hýdróklóríði frásogað og endurheimtust 50% af heildar geislavirkni skammtinum í hægðum, sem bendir til þess að tipiracíl hýdróklóríð sé frásogað í miðlungi miklum mæli í meltingarvegi.
English: • dry eyes
Icelandic: • eyrnaverkur
English: Candida infection Bacterial infection Infection
Icelandic: Smitandi garnabólga Lungnasýking
English: After oral administration of Lonsurf with [14C]-trifluridine, at least 57% of the administered trifluridine was absorbed and only 3% of the dose was excreted into faeces.
Icelandic: 57% af gefnu tríflúridíni frásogað og aðeins 3% af skammtinum skildust út í hægðum.
English: In a dedicated study the PK of trifluridine and tipiracil hydrochloride were evaluated in cancer patients with mild or moderate hepatic impairment (National Cancer Institute [NCI] Criteria Group B and C, respectively) and in patients with normal hepatic function.
Icelandic: Lyfjahvörf tríflúridíns og tipiracíl hýdróklóríðs voru metin í til þess gerðri rannsókn hjá krabbameinssjúklingum með vægt eða miðlungi alvarlega skerta lifrarstarfsemi (í flokki B og C samkvæmt viðmiðum
English: In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Table 2, Table 3 and Table 4.
Icelandic: Ef fram koma eituráhrif á blóðmynd eða önnur líffærakerfi á að fylgja skilyrðum fyrir skammtahléi, töku lyfsins aftur eftir hlé og skammtaminnkun sem sett eru fram í töflum 2, 3 og 4.
English: An OS analysis of the study, carried out as planned at 76% (N = 384) of events, demonstrated that Lonsurf plus BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with an hazard ratio (HR) of 0.69 (95% CI: 0.56, 0.85; 1- and 2-sided p-values were 0.0003 and 0.0006, respectively) corresponding to a 31% reduction in the risk of death in the Lonsurf group.
Icelandic: Greining á niðurstöðum rannsóknarinnar varðandi heildarlifun, sem gerð var samkvæmt áætlun þegar 76% sjúklinga (N = 384) höfðu látist, sýndi fram á tölfræðilega marktækan ávinning af Lonsurf ásamt bestu stuðningsmeðferð umfram lyfleysu ásamt bestu stuðningsmeðferð varðandi lifun, með áhættuhlutfall 0,69 (95% öryggismörk: 0,56; 0,85; einhliða p-gildi var 0,0003 og tvíhliða p-gildi var
English: Mucosal inflammation Malaise
Icelandic: Bragðtruflanir Útlægur taugakvilli
English: • vision troubles as blurred vision, double vision, decreased vision, cataracts
Icelandic: sjóntruflanir svo sem þokusýn, tvísýni, skert sjón, drer á auga
English: Based upon limited data with a considerable variability, no statistically significant differences were observed in the pharmacokinetics in patients with normal hepatic function versus patients with mild or moderate hepatic impairment.
Icelandic: Ekki var tölfræðilega marktækur munur á lyfjahvörfum sjúklinga með eðlilega lifrarstarfsemi samanborið við sjúklinga með vægt eða miðlungi alvarlega skerta lifrarstarfsemi, byggt á takmörkuðum gögnum með töluverðum breytileika.
English: INFORMATION IN BRAILLE Lonsurf 20 mg/8.19 mg
Icelandic: Lonsurf 20 mg/8,19 mg
English: Lonsurf 20 mg/8.19 mg film-coated tablets
Icelandic: Lonsurf 20 mg/8,19 mg filmuhúðaðar töflur
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg tablets trifluridine/tipiracil
Icelandic: Lonsurf 15 mg/6,14 mg töflur tríflúridín/tipiracíl
English: The signs include difficulty in breathing, shortness of breath, with cough or fever.
Icelandic: Einkennin eru m.a. öndunarerfiðleikar, mæði með hósta og hita.
English: The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (TAGS) in patients with previously treated metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction), who had been previously treated with at least two prior systemic treatment regimens for advanced disease, including fluoropyrimidine-, platinum-, and either taxane- or irinotecan-based chemotherapy, plus if appropriate human epidermal growth factor receptor 2 (HER2) -targeted therapy.
Icelandic: tvenns konar altæka meðferð við langt gengnum sjúkdómi, þ.m.t. lyfjameðferð með flúorópýrimidíni, platínusamböndum og annað hvort taxani eða írínótekani, auk meðferðar sem beindist að viðtaka 2 fyrir þekjufrumuvaxtarþátt hjá mönnum (human epidermal growth factor receptor 2, HER2) ef við átti.
English: Check with your doctor or pharmacist if you are not sure.
Icelandic: Ræddu við lækninn eða lyfjafræðing ef þú gleymir að taka skammt.
English: Neutrophils
Icelandic: Naglakvilli
English: Neurotoxicity Dysaesthesia Hyperaesthesia Hypoaesthesia Syncope
Icelandic: Eituráhrif á taugar Röskun á tilfinningu (dysaesthesia) Ofurnæmi (hyperaesthesia) Vannæmi (hypoaesthesia) Yfirlið
English: NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
Icelandic: Les Laboratoires Servier
English: Gastric cancer
Icelandic: (Candida) Bakteríusýking
English: An updated OS analysis, carried out at 89% (N = 712) of events, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.69; 95% CI [0.59 to 0.81]; p < 0.0001) and a median OS of 7.2 months vs 5.2 months; with 1-year survival rates of 27.1% and 16.6%, respectively.
Icelandic: Uppfærð greining á heildarlifun, sem gerð var þegar 89% sjúklinga (N = 712) höfðu látist, staðfesti klínískt mikilvægan og tölfræðilega marktækan ávinning af Lonsurf ásamt bestu stuðningsmeðferð umfram lyfleysu ásamt bestu stuðningsmeðferð varðandi lifun (áhættuhlutfall: 0,69; 95% öryggismörk [0,59 til 0,81]; p <0,0001) og var miðgildislengd heildarlifunar 7,2 mánuðir í hópnum sem fékk
English: Hypernatraemia
Icelandic: • nýrnabilun
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg tablets trifluridine/tipiracil
Icelandic: Lonsurf 20 mg /8,19 mg töflur tríflúridín/tipiracíl
English: Renal failure Cystitis noninfective Micturition disorder Haematuria Leukocyturia
Icelandic: Hjartaöng Hjartsláttartruflanir Hjartsláttarónot
English: Nervous system disorders
Icelandic: Meltingartruflanir Vélindabakflæði
English: • Severe gastrointestinal problems: abdominal pain (common), ascites (uncommon), colitis (uncommon), acute pancreatitis (uncommon), ileus (uncommon) and subileus (uncommon).
Icelandic: Alvarleg meltingarfæravandamál: kviðverkir (algengir), vökvasöfnun í kviðarholi (sjaldgæf), ristilbólga (sjaldgæf), bráð brisbólga (sjaldgæf), garnastífla (sjaldgæf) og garnastífluvottur (sjaldgæfur).
English: Colorectal cancer
Icelandic: Krabbameinstengdir verkir
English: Trifluridine was shown to be genotoxic in a reverse mutation test in bacteria, a chromosomal aberration test in mammal-cultured cells, and a micronucleus test in mice.
Icelandic: Í víxluðu stökkbreytingaprófi (reverse mutation test) hjá bakteríum, litningabrenglunarprófi í ræktuðum spendýrafrumum og örkjarnaprófi hjá músum var sýnt fram á að tríflúridín hefur eiturverkun á erfðaefni.
English: Figure 1- Kaplan-Meier curves of overall survival in patients with metastatic colorectal cancer
Icelandic: Mynd 1 - Kaplan-Meier graf yfir heildarlifun hjá sjúklingum með krabbamein í ristli eða endaþarmi með meinvörpum
English: • bloating, passing gas, indigestion
Icelandic: • uppþemba, vindgangur, meltingartruflanir
English: Lonsurf Placebo
Icelandic: Lonsurf Lyfleysa
English: • Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
Icelandic: Vægt skert nýrnastarfsemi (CrCl 60 til 89 ml/mín.)
English: Colitis
Icelandic: Lyfleysa
English: No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Icelandic: Engin fylgni milli lyfjahvarfabreyta og AST eða/og heildar gallrauða í blóði sást fyrir tríflúridíns eða tipiracíl hýdróklóríð.
English: Hepatic impairment
Icelandic: Sjúklingur kúgast
English: Based on findings in animals, trifluridine may cause foetal harm when administered to pregnant women.
Icelandic: Niðurstöður dýrarannsókna benda til þess að tríflúridín geti valdið fósturskaða ef það er notað á meðgöngu.
English: Lower respiratory tract infection
Icelandic: Sýking í neðri hluta öndunarvegar
English: What you need to know before you take Lonsurf
Icelandic: Upplýsingar um Lonsurf og við hverju það er notað Áður en byrjað er að nota Lonsurf Hvernig nota á Lonsurf
English: Flatulence
Icelandic: INNIHALDSLÝSING
English: Figure 3- Kaplan-Meier curves of overall survival in patients with metastatic gastric cancer
Icelandic: Mynd 3 - Kaplan-Meier graf yfir heildarlifun hjá sjúklingum með magakrabbamein með meinvörpum
English: Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Icelandic: Vökvasöfnun í kviðarholi (ascites) Garnastífla (ileus) Garnastífluvottur (subileus) Ristilbólga
English: EU/1/16/1096/005 40 film-coated tablets
Icelandic: EU/1/16/1096/004 20 filmuhúðaðar töflur EU/1/16/1096/005 40 filmuhúðaðar töflur EU/1/16/1096/006 60 filmuhúðaðar töflur
English: mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups.
Icelandic: Heildartíðni aukaverkana var svipuð hjá sjúklingum með eðlilega nýrnastarfsemi (CrCl ≥90 ml/mín), vægt skerta nýrnastarfsemi (CrCl = 60 til 89 ml/mín.) og miðlungi alvarlega skerta nýrnastarfsemi (CrCl = 30 til 59 ml/mín.).
English: Blood creatinine increased
Icelandic: Hækkað gildi kreatíníns í blóði
English: • swelling or pain in your joints or big toes
Icelandic: • þroti eða verkur í liðum eða stórutá
English: Table 7 - Efficacy results from the Phase III (TAGS) clinical trial in patients with metastatic gastric cancer
Icelandic: Tafla 7 - Niðurstöður varðandi verkun hjá sjúklingum með magakrabbamein með meinvörpum í III.
English: • redness, itching of the eye, eye infections, watery eyes
Icelandic: roði eða kláði í augum, augnsýkingar, tárarennsli, augnkvillar
English: Lonsurf should be prescribed by physicians experienced in the administration of anticancer therapy.
Icelandic: Eingöngu læknar með reynslu af notkun krabbameinslyfja eiga að ávísa Lonsurf.
English: Conclusions presented by the European Medicines Agency on:
Icelandic: Niðurstaða Lyfjastofnunar Evrópu um: • Eins árs markaðsvernd
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lonsurf in all subsets of the paediatric population in refractory metastatic colorectal cancer and in refractory metastatic gastric cancer (see section 4.2 for information on paediatric use).
Icelandic: á Lonsurf hjá öllum undirhópum barna við krabbameini í ristli eða endaþarmi með meinvörpum eða magakrabbameini með meinvörpum, sem ekki svarar meðferð (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110
Icelandic: Tel: +353 (0)1 663 8110
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Icelandic: Lonsurf 20 mg/8,19 mg filmuhúðaðar töflur tríflúridín/tipiracíl
English: Subileus
Icelandic: Algengar
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets trifluridine/tipiracil
Icelandic: Lonsurf 15 mg/6,14 mg filmuhúðaðar töflur tríflúridín/tipiracíl
English: Treatment with Lonsurf plus BSC resulted in a statistically significant prolongation of PS <2 in comparison to placebo plus BSC.
Icelandic: Meðferð með Lonsurf ásamt bestu stuðningsmeðferð leiddi til tölfræðilega marktækrar lengingar á þeim tíma sem færnistuðull hélst <2, borið saman við lyfleysu ásamt bestu stuðningsmeðferð.
English: Septic shockb
Icelandic: B. FYLGISEÐILL
English: Table 6 - Efficacy results from the Phase III (RECOURSE) clinical trial in patients with metastatic colorectal cancer
Icelandic: Tafla 6 - Niðurstöður varðandi verkun hjá sjúklingum með krabbamein í ristli eða endaþarmi með meinvörpum í III.
English: Oedema
Icelandic: Ofþornun
English: Lonsurf 20 mg/8.19 mg film-coated tablets Hypromellose
Icelandic: Lonsurf 20 mg/8,19 mg filmuhúðaðar töflur Hýprómellósi
English: Patients 65 years of age or older who received Lonsurf had a higher incidence of the following events compared to patients younger than 65 years: - metastatic colorectal cancer (RECOURSE): Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anaemia (26% vs 12%), Grade 3 or 4 leukopenia (26% vs 18%) and Grade 3 or 4 thrombocytopenia (9% vs 2%), - metastatic gastric cancer (TAGS): Grade 3 or 4 neutrophil count decrease (17.0% vs 6.6%), decreased appetite (37.3% vs 31.9%), asthenia (22.2% vs 17.0%) and stomatitis (7.2% vs 2.2%).
Icelandic: 3. eða 4. stigs daufkyrningafæð (48% borið saman við 30%), 3. stigs blóðleysi (26% borið saman við 12%), 3. eða 4. stigs hvítfrumnafæð (26% borið saman við 18%) og 3. eða 4. stigs blóðflagnafæð (9% borið saman við
English: In RECOURSE and TAGS studies, 9.4% and 17.3% of patients in the Lonsurf group respectively received G-CSF mainly for therapeutic use.
Icelandic: Í RECOURSE-rannsókninni var 9,4% þeirra sjúklinga sem fengu
English: Gingival bleeding Glossitis
Icelandic: Sinnuleysi (lethargy) Sundl
English: Proteinuria
Icelandic: Laktósaóþol
English: Cancer pain
Icelandic: Blóðflagnafjöldi
English: Figure 4 - Kaplan-Meier curves of progression-free survival in patients with metastatic gastric cancer
Icelandic: Kaplan-Meier graf yfir lifun án versnunar sjúkdóms hjá sjúklingum með magakrabbamein með meinvörpum
English: Impaired gastric emptying Abdominal distension Anal inflammation Mouth ulceration Dyspepsia
Icelandic: Náladofi (paraesthesia) Brunatilfinning
English: • liver disorder
Icelandic: • augnþurrkur
English: Lonsurf is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance [CrCl] < 30 mL/min or requiring dialysis, respectively), as Lonsurf has not been studied in these patients (see section 5.2).
Icelandic: Lonsurf er ekki ráðlagt til notkunar handa sjúklingum með alvarlega skerta nýrnastarfsemi (úthreinsun kreatíníns [CrCl] <30 ml/mín.)
English: Reflux gastritis
Icelandic: Víkkun gallganga
English: • constipation
Icelandic: • kuldatilfinning
English: • inflammation or increased acid in your stomach or gullet, reflux
Icelandic: bólga eða aukin sýrumyndun í maga eða vélinda, bakflæði
English: Skin exfoliation Urticaria
Icelandic: Slímhúðarbólga Lasleiki
English: Pharmacokinetic/pharmacodynamic relationship
Icelandic: V.J. Salomone Pharma
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC59 Mechanism of action
Icelandic: Æxlishemjandi lyf, andmetabólítar, ATC-flokkur:
English: • Severe renal impairment (CrCl below 30 mL/min) or end stage renal disease Administration is not recommended in patients with severe renal impairment or end stage renal disease as there are no data available for these patients (see section 4.4).
Icelandic: Ekki er ráðlagt að gefa sjúklingum með alvarlega skerta nýrnastarfsemi eða nýrnasjúkdóm á lokastigi lyfið þar sem ekki liggja fyrir gögn um notkun þess hjá þessum sjúklingum (sjá kafla 4.4).
English: Lonsurf caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia.
Icelandic: Lonsurf olli aukinni tíðni mergbælingar, þ.m.t. blóðleysi, daufkyrningafæð, hvítfrumnafæð og blóðflagnafæð.
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Icelandic: Eftir stakan skammt af Lonsurf (35 mg/m2) hjá sjúklingum með langt gengin föst æxli var tími þar til hámarksþéttni í plasma náðist (tmax) að meðaltali u.þ.b.
English: What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Icelandic: Lonsurf 15 mg/6,14 mg töflur
English: You and your partner should use effective methods of contraception while taking this medicine.
Icelandic: Þú og maki þinn þurfið að nota öruggar getnaðarvarnir meðan lyfið er tekið og í 6 mánuði eftir að töku þess er hætt.
English: 6.6 Special precautions for disposal and other handling Hands should be washed after handling the tablets.
Icelandic: Þvo á hendur eftir að töflurnar eru meðhöndlaðar.
English: • increased lactate dehydrogenase level in your blood
Icelandic: hækkað gildi ensímsins laktat dehýdrógenasa í blóði
English: • The other ingredients are: - Tablet core: lactose monohydrate, starch pregelatinised (Maize) and stearic acid.
Icelandic: - Töflukjarni - laktósaeinhýdrat, forgelatíneruð sterkja (maís) og stearínsýra.
English: • Neutropenia (very common), febrile neutropenia (common) and septic shock (uncommon).
Icelandic: Daufkyrningafæð (mjög algeng), daufkyrningafæð með hita (algeng) og blóðsýkingarlost (sjaldgæft).
English: Adverse drug reactions are grouped according to their frequencies.
Icelandic: Aukaverkanir voru flokkaðar eftir tíðni.
English: Platelets
Icelandic: Sýkingar
English: • passing out (syncope)
Icelandic: • almenn vanlíðan (lasleiki)
English: 15 mg/6.14 mg 20 mg/8.19 mg Level 1 dose reduction: From 35 mg/m2 to 30 mg/m2 30 mg/m2
Icelandic: Úr 35 mg/m2 í 30 mg/m2 30 mg/m2
English: Resumption criteriaa
Icelandic: 14. AFGREIÐSLUTILHÖGUN
English: Cardiac disorders
Icelandic: á hjartarafriti
English: Visual acuity reduced Vision blurred Diplopia
Icelandic: Sýkingar af völdum sýkla og sníkjudýra
English: Pain
Icelandic: Andremma
English: Infections
Icelandic: Höfuðverkur
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 April 2016
Icelandic: 25. apríl 2016
English: Oesophagitis
Icelandic: Tannholdskvilli
English: Nail Disorder
Icelandic: Skert magatæming
English: Gastrointestinal toxicity
Icelandic: stigs klinísku rannsókninni
English: The global incidence of adverse events (AEs) is similar in normal renal function (CrCl ≥ 90 mL/min),
Icelandic: Alvarlega skert nýrnastarfsemi (CrCl minni en 30 ml/mín.)
English: Within each frequency group, adverse drug reactions are presented in order of decreasing seriousness.
Icelandic: Innan hvers tíðniflokks eru alvarlegustu aukaverkanirnar taldar fyrst.
English: • weight loss
Icelandic: • prótein í þvagi
English: Herpes zoster
Icelandic: Stoðkerfi og stoðvefur
English: Neutropenia Leukopenia Anaemia
Icelandic: Daufkyrningafæð Hvítfrumnafæð Blóðleysi
English: The median OS was 5.7 months (95% CI: 4.8, 6.2) for the Lonsurf group versus 3.6 months (95% CI: 3.1, 4.1) for the placebo group; with 1-year survival rates of 21.2% and 13.0%, respectively.
Icelandic: 4,8; 6,2) en 3,6 mánuðir í hópnum sem fékk lyfleysu (95% öryggismörk:
English: Renal impairment
Icelandic: Ógleði Uppköst
English: Amitraz is a formamidine acaricide.
Icelandic: Amitraz er formamidinacaricid.
English: Most lice are killed within 7 days.
Icelandic: Flestar lýs drepast innan 7 daga.
English: Do not use after the expiry date stated on the carton after “EXP”.
Icelandic: Notið ekki eftir fyrningardagsetningu á öskju eftir „EXP“.
English: Weight Range of Dog (kg)
Icelandic: Þyngd hundsins (kg)
English: Children should not have access to used pipettes.
Icelandic: Börn mega ekki hafa aðgang að notuðum pípettum.
English: *Due to limited space on the packaging, the abbreviations "S", "M", "M/L", "L" and "XL", which represent "small", “medium”,” medium/large”, “large” and “extra large”, respectively, are used on the blister foil and applicator pipettes.
Icelandic: *Vegna takmarkaðs pláss á pakkningunum eru skammstafanirnar „S“, „M“, „M/L“, „L“ og „XL“, sem standa fyrir „small“ (litlir), „medium“ (meðalstórir), „medium/large“ (meðalstórir/stórir), „large“ (stórir) og „extra large“ (mjög stórir), notaðar á þynnum og pípettum.
English: Recently treated animals should not be allowed to sleep with the owners, especially children.
Icelandic: Ekki ber að leyfa nýlega meðhöndluðum dýrum að sofa við hlið eigenda sinna, sérstaklega ekki hjá börnum.
English: No adverse effects were observed in healthy dogs and puppies aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Icelandic: Engar aukaverkanir komu fram hjá heilbrigðum hundum og hvolpum 8 vikna og eldri sem meðhöndlaðir voru 7 sinnum, með tveggja vikna millibili með 3-5 földum ráðlögðum skammti.
English: Most of these signs are due to alpha-2adreno-receptor agonist effects.
Icelandic: Flest þessara einkenna eru af völdum hvetjandi áhrifa á alfa-2-adrenoviðtaka.
English: It is important to apply the dose to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
Icelandic: Mikilvægt er að bera dýralyfið á svæði þar sem dýrið getur ekki sleikt það af og gætið þess að dýrin sleiki dýralyfið ekki hvort af öðru eftir meðferð með því.
English: Pipette size to be used
Icelandic: Stærð pípettu sem á að nota
English: The following table defines the size of pipette to be used according to the weight of the dog.
Icelandic: Í eftirfarandi töflu er sýnt hvaða stærð af pípettu þarf að nota í samræmi við þyngd hundsins.
English: Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.
Icelandic: Ekki er mælt með notkun annarra dýralyfja sem innihalda amitraz meðan hundurinn er í meðferð með ProMeris Duo blettunarlausn handa hundum.
English: Where possible, treatment should not be discontinued until skin scrapings are negative on at least two monthly occasions.
Icelandic: Þegar unnt er á ekki að hætta meðferð fyrr en húðskrap hefur verið neikvætt að minnsta kosti tvisvar með mánaðar millibili.
English: Do not administer to cats.
Icelandic: Ekki má nota dýralyfið handa köttum.
English: Both components were still measurable in the hair 56 days following treatment.
Icelandic: Bæði efnin voru enn mælanleg í feldinum 56 sólarhringum eftir meðferð.
English: In these cases do not treat more frequently than once a fortnight.
Icelandic: Í slíkum tilvikum má ekki meðhöndla dýrið oftar en á tveggja vikna fresti.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001-010
Icelandic: MARKAÐSLEYFISNÚMER EU/2/06/065/001-010
English: Do not administer to sick or debilitated dogs or dogs suffering from heat stress.
Icelandic: Ekki má nota dýralyfið handa veikum eða veikluðum hundum eða hundum sem eru undir hitaálagi.
English: For dogs more than 50 kg, use a combination of two pipettes that most closely matches the body weight.
Icelandic: Handa hundum sem eru þyngri en 50 kg skal nota saman tvær pípettur sem komast næst því að jafngilda líkamsþyngdinni.
English: For treatment of biting lice a single dose should be sufficient.
Icelandic: Til meðferðar við feldlús ætti stakur skammtur að nægja.
English: Metaflumizone is an insecticide belonging to the semicarbazone group of compounds.
Icelandic: Metaflumizon er lyf gegn útvortis sníklum sem tilheyrir semicarbazonflokknum.
English: If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/kg bodyweight by intramuscular injection to reverse these side-effects.
Icelandic: Ef einkennin eru alvarleg eða viðvarandi má nota alfa-2-adrenoviðtakablokkann atipamezolhýdróklóríð, 0,2 mg/kg líkamsþunga með inndælingu í vöðva til að draga úr aukaverkununum.
English: The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.
Icelandic: Hætta á aukaverkunum getur hins vegar aukist við ofskömmtun og því skal alltaf meðhöndla dýr með réttri stærð af pípettu í samræmi við líkamsþyngd.
English: As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Icelandic: Þar sem hársekkjamaurakláði er margþættur sjúkdómur er, þegar unnt er, ráðlegt að meðhöndla jafnframt alla undirliggjandi sjúkdóma á viðeigandi hátt.