natgillin/translations-raw huggingface dataset:
Kriterie for doseringsafbrydelse 
Interruption criteria
• nedsat antal af de hvide blodlegemer, der kaldes leukocytter - kan øge din risiko for infektion 
• reduced white blood cells called leucocytes - can increase your risk for infection
Gastroøsofageal reflukssygdom Proktalgi 
Gastrooesophageal reflux disease Proctalgia
Hazard ratio for progression eller død, 0,57 (95 % CI, 0,47-0,70) p<0,0001 (1-sidet og 2-sidet) 
Hazard ratio for progression or death, 0.57 (95% CI, 0.47-0.70) P<0.0001 (1-sided and 2-sided)
Hazard ratio for død, 0,68 (95% CI, 0,58-0,81) P<0,0001 
Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Palmoplantar erytrodysæstesisyndrom c 
Palmar-plantar erythrodysaesthesia syndromec
• hoste, kortåndethed, infektion i bihuler, hals, luftveje eller lunger, brystinfektioner 
• cough, feeling short of breath, infection of the sinuses, throat, airway or lungs, chest infections
Trifluridins og tipiracilhydrochlorids halveringstider (t½) og akkumulationsratioer var sammenlignelige hos patienter med moderat eller let nedsat leverfunktion og normal leverfunktion. 
Half-life time (t1/2) and the accumulation ratio of trifluridine and tipiracil hydrochloride were similar between the moderate, mild and normal hepatic function patients.
Hudeksfoliering Urticaria 
Skin exfoliation Urticaria
Samlet overlevelse Antal døde, N (%) Median OS (måneder) 
Number of deaths, N (%) Median OS (months)a [95% CI]b
• inflammation eller betændelse i blæren 
• inflammation or infection in your bladder
Nedsat gastrisk tømning Abdominal udspiling Anal inflammation Mundsår 
Impaired gastric emptying Abdominal distension Anal inflammation Mouth ulceration Dyspepsia
Metastatisk gastrisk cancer 
Metastatic gastric cancer
En OS-analyse af studiet blev gennemført som planlagt ved 76 % (N = 384) af hændelserne og demonstrerede en klinisk relevant og statistisk signifikant forbedring af OS ved Lonsurf plus BSC sammenlignet med placebo og BSC med en hazard ratio (HR) på 0,69 (95 % CI: 0,56; 0,85; 1- og 2-sidede p-værdier var henholdsvis 0,0003 og 0,0006) svarende til en reduktion på 31 % i risikoen for død i Lonsurf-gruppen. 
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.
OS-fordelen ved Lonsurf blev opretholdt hos disse patienter (hazard ratio: 0,75, 95 % CI [0,59 til 0,94]). 
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
C]-trifluridin var den samlede kumulative udskillelse af radioaktivitet 60 % af den administrerede dosis. 
After single oral administration of Lonsurf with [14C]-trifluridine, the total cumulative excretion of radioactivity was 60% of the administered dose.
Tabletten er en blegrød, bikonveks, rund, filmovertrukket tablet med en diameter på 7,6 mm og en tykkelse på 3,2 mm, præget med ”20” på den ene side og ”102” og ”20 mg” på den anden side med gråt blæk. 
The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with ‘20' on one side, and ‘102' and ‘20 mg' on the other side, in grey ink.
OS-fordelen ved Lonsurf blev opretholdt hos disse patienter (hazard ratio: 0,69, 95 % CI [0,45 til 1,05]). 
Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.69, 95% CI [0.45 to 1.05]).
• følelsesløshed eller prikkende og stikkende fornemmelse i hænder eller fødder 
• feeling of numbness or pins and needles in hands or feet
Lonsurf indeholder: Lonsurf 15 mg/6,14 mg tablet 
What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Det er ikke nødvendigt at justere startdosis på baggrund i patientens race (se pkt. 
No adjustment of the starting dose is required on the basis of patient's race (see sections 5.1 and 5.2).
- Filmovertræk: Hypromellose, macrogol (8000), titandioxid (E171) og magnesiumstearat. 
- Film coat: hypromellose, macrogol (8000), titanium dioxide (E171), and magnesium stearate.
• nedsat antal af de hvide blodlegemer, som kaldes granulocytter og monocytter - kan øge risiko for infektion 
• reduced white blood cells called granulocytes or monocytes - can increase your risk for infection
• hævede hænder, ben eller fødder 
• swelling in your hands or legs or feet
• appetitløshed 
• decreased appetite
En opdateret OS-analyse blev udført ved 89 % (N = 712) af hændelserne og bekræftede den klinisk relevante og statistisk signifikante overlevelsesfordel ved Lonsurf plus BSC sammenlignet med placebo plus BSC (hazard ratio: 0,69; 95 % CI [0,59 til 0,81]; p < 0,0001) med en median OS på 7,2 måneder versus 5,2 måneder og en 1-årig overlevelsesrate på henholdsvis 27,1 % og 16,6 %. 
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.
• svedtendens, lysfølsomhed, negleproblemer 
• sweating more than normal, sensitivity to light, nail problems
< 75 x 10 
< 50 × 109/L
• inflammation og betændelse i tarmen 
• inflammation and infection in your gut
En OS-analyse af studiet blev gennemført som planlagt ved 72 % (N = 574) af hændelserne, og demonstrerede en klinisk relevant og statistisk signifikant overlevelsesfordel ved Lonsurf plus BSC sammenlignet med placebo plus BSC (hazard ratio: 0,68; 95 % konfidensinterval [CI] [0,58 til 0,81]; p < 0,0001) med en median OS på henholdsvis 7,1 måneder versus 5,3 måneder og en 1-årig overlevelsesrate på henholdsvis 26,6 % og 17,6%. 
An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p < 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Levertoksicitet Biliær dilatation 
Hyperbilirubinaemia Hepatotoxicity Biliary dilatation
Lonsurf 15 mg/6,14 mg filmovertrukne tabletter Lonsurf 20 mg/8,19 mg filmovertrukne tabletter trifluridin/tipiracil 
Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
I et dosis-responsstudie (15 til 35 mg/m to gange dagligt) var der tendens til, at AUC fra tid 0 til 10 timer (AUC0-10) for trifluridin steg mere end forventet ud fra stigningen i dosis. 
In a dose finding study (15 to 35 mg/m2 twice daily), the AUC from time 0 to 10 hours (AUC0-10) of trifluridine tended to increase more than expected based on the increase in dose; however, oral clearance (CL/F) and apparent volume of distribution (Vd/F) of trifluridine were generally constant at the dose range of 20 to 35mg/m2.
• nedsat antal blodplader (trombocytopeni), som er vigtige for at stoppe blødning. 
• a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries
Behandlingsrelateret proteinuri forekom oftere hos patienter behandlet med Lonsurf (1,8 %) end hos patienter i placebogruppen (0.9 %). 
Treatment-related proteinuria occurred more frequently in Lonsurf-treated patients (1.8%) compared to those receiving placebo (0.9%), all of which were Grade 1 or 2 in severity (see section 4.4).
2) hos patienter med avancerede solide tumorer var den tilsyneladende enkelt dosis Lonsurf (35 mg/m fordelingsvolumen (Vd/F) for trifluridin og tipiracilhydrochlorid henholdsvis 21 l og 333 l. 
Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the apparent volume of distribution (Vd/F) for trifluridine and tipiracil hydrochloride was 21 L and 333 L, respectively.
- Filmovertræk: Hypromellose, macrogol (8000), titandioxid (E171), jernoxid rød (E172) og magnesiumstearat. 
- Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) and magnesium stearate.
Det er ikke nødvendigt at justere startdosis hos patienter ≥ 65 år (se pkt. 
No adjustment of the starting dose is required in patients ≥ 65 years old (see sections 4.8, 5.1 and 5.2).
Mucosainflammation Utilpashed 
Mucosal inflammation Malaise
Lonsurf 15 mg/6,14 mg filmovertrukne tabletter 
Lonsurf 15 mg/6.14 mg film-coated tablets
• inflammation, hævelse eller blødning i indvoldene 
• inflammation, swelling or bleeding in your bowel
Figur 2 - Kaplan-Meier kurve for progressionsfri overlevelse hos patienter med metastatisk kolorektal cancer 
Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Tabel 4 - Dosisreduktioner ud fra kroppens overfladeareal (BSA) 
* Common terminology criteria for adverse events Table 4 - Dose reductions according to body surface area (BSA)
Nedsat synsskarphed Synsforstyrrelser Diplopi 
Visual acuity reduced Vision blurred Diplopia
2) hos patienter med fremskredne solide tumorer var den Efter en enkelt dosis af Lonsurf (35 mg/m orale clearance (CL/F) af trifluridin og tipiracilhydrochlorid henholdsvis 10,5 l /time og 109 l/time. 
Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the oral clearance (CL/F) for trifluridine and tipiracil hydrochloride were 10.5 L/hr and 109 L/hr, respectively.
Hvis du får bivirkninger, der påvirker din evne til at koncentrere dig og reagere, må du ikke køre bil eller betjene værktøj eller maskiner. 
Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.
Symptomerne inkluderer kortåndethed, træthed eller bleghed (se punkt 
The signs include feeling short of breath, tiredness or looking pale (see section 2).
Hver filmovertrukket tablet indeholder 15 mg trifluridin og 6,14 mg tipiracil (som hydrochlorid). 
Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride).
Blod og lymfesystem Neutropeni Leukopeni 
Blood and lymphatic system disorders
Figur 4 - Kaplan-Meier kurve for progressionsfri overlevelse hos patienter med metastatisk gastrisk cancer 
Figure 4 - Kaplan-Meier curves of progression-free survival in patients with metastatic gastric cancer
Behandling må ikke startes, hvis det absolutte neutrofiltal er < 1,5 ×10 
Treatment must not be started if the absolute neutrophil count is < 1.5 ×109/L, if the platelet counts are < 75× 109/L, or if the patient has an unresolved Grade 3 or 4 non-haematological clinically relevant toxicity from prior therapies.
Dehydrering Hyperglykæmi Hyperkaliæmi Hypokaliæmi Hypofosfatæmi Hypernatriæmi Hyponatriæmi Hypokalcæmi Gigt 
Neurotoxicity Dysaesthesia Hyperaesthesia Hypoaesthesia Syncope
/dosis to gange dagligt) hos patienter med fremskredne solide tumorer var de gennemsnitlige tider til maksimale plasmakoncentrationer (tmax) af trifluridin og tipiracilhydrochlorid omkring henholdsvis 2 timer og 3 timer. 
Following multiple doses of Lonsurf (35 mg/m2/dose twice daily) 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.
• Moderat eller svært nedsat leverfunktion 
• Moderate or severe hepatic impairment
Hver filmovertrukket tablet indeholder 20 mg trifluridin og 8,19 mg tipiracil (som hydrochlorid). 
Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride).
EU/1/16/1096/006 60 filmovertrukne tabletter 
EU/1/16/1096/006 60 film-coated tablets
Trifluridin er substrat for TPase, men metaboliseres ikke af CYP. 
Trifluridine is a substrate of TPase, but is not metabolised by cytochrome P450 (CYP).
Figur 3- Kaplan-Meier kurve for samlet overlevelse hos patienter med metastatisk gastrisk cancer 
Figure 3- Kaplan-Meier curves of overall survival in patients with metastatic gastric cancer
Infektiøs enteritis Lungeinfektion Infektion i galdevejene Influenza 
Biliary tract infection Influenza
Lonsurf 20 mg/8,19 mg filmovertrukne tabletter 
Lonsurf 20 mg/8.19 mg film-coated tablets
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 15 mg trifluridin og 6,14 mg tipiracil (som hydrochlorid). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg trifluridine and 6.14 mg of tipiracil (as hydrochloride).
• Blodpropper i lungerne (ikke almindelig): Symptomerne inkluderer kortåndethed og smerter i brystet eller i benene. 
• Pulmonary embolism (uncommon): blood clots in lungs.
Gingivalblødning Glossitis 
Gingival bleeding Glossitis
EU/1/16/1096/005 40 filmovertrukne tabletter 
EU/1/16/1096/005 40 film-coated tablets
Hvis du er i tvivl, så spørg lægen eller apotekspersonalet. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
LÆGEMIDLETS NAVN Lonsurf 20 mg/8,19 mg tabletter trifluridin/tipiracil 
NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg tablets trifluridine/tipiracil
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 20 mg trifluridin og 8,19 mg tipiracil (som hydrochlorid). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg trifluridine and 8.19 mg of tipiracil (as hydrochloride).
LÆGEMIDLETS NAVN Lonsurf 15 mg/6,14 mg tabletter trifluridin/tipiracil 
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg tablets trifluridine/tipiracil
Det er ikke nødvendigt at justere startdosis hos patienter med let nedsat leverfunktion (se pkt. 
There is no need for a starting dose adjustment in patients with mild hepatic impairment (see section
Titandioxid (E171) 
Titanium dioxide (E171) Magnesium stearate
Stratificeret log-rank test (strata: KRAS-status, tid siden diagnosticering af første metastase, region) Figur 1- Kaplan-Meier kurve for samlet overlevelse hos patienter med metastatisk kolerektal cancer 
a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: KRAS status, time since diagnosis of first metastasis, region)
50 rue Carnot 
Marketing Authorisation Holder Les Laboratoires Servier 50 rue Carnot
• CTCAE* grad 4 neutropeni (< 0,5 x 10 
• CTCAE* Grade 4 neutropenia (< 0.5 x 109/L) or thrombocytopenia (< 25 × 109/L) that results in more than 1 week's delay in start of next cycle
Behandling med Lonsurf plus BSC resulterede i en statistisk signifikant forlængelse af tiden med ECOG-PS < 2 sammenlignet med placebo plus BSC. Mediantiden til PS ≥ 2 for Lonsurf-gruppen og placebo-gruppen var henholdsvis 5,7 måneder og 4,0 måneder med en hazard ratio på 0,66 (95 % CI: [0,56, 0,78]), p < 0,0001. 
The median time to PS ≥ 2 for the Lonsurf group and placebo group was 5.7 months and 4.0 months, respectively, with a hazard ratio of 0.66 (95% CI: [0.56, 0.78]), p < 0.0001.
2) til patienter med fremskredne solide tumorer var de Efter en enkelt dosis af Lonsurf (35 mg/m gennemsnitlige tider til maksimale plasmakoncentrationer (tmax) af trifluridin og tipiracilhydrochlorid omkring henholdsvis 2 timer og 3 timer. 
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.
Ubehag 
Discomfort
Lonsurf 15 mg/6,14 mg filmovertrukne tabletter Lonsurf 20 mg/8,19 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets
Herpes zoster Tinea pedis Candida infektion Bakteriel infektion Infektion 
Candida infection Bacterial infection Infection
LÆGEMIDLETS NAVN Lonsurf 15 mg/6,14 mg filmovertrukne tabletter trifluridin/tipiracil 
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets trifluridine/tipiracil
LÆGEMIDLETS NAVN Lonsurf 20 mg/8,19 mg filmovertrukne tabletter trifluridin/tipiracil 
NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Kriterie for doseringsgenoptagelse a 
Resumption criteriaa
Det er ikke nødvendigt at justere startdosis hos patienter med let eller moderat nedsat nyrefunktion (se pkt. 
No adjustment of the starting dose is recommended in patients with mild or moderate renal impairment (see sections 4.4 and 5.2).
Mave-tarm-kanalen Diarré Kvalme 
Diarrhoea Nausea Vomiting
Ikke-infektiøs cystitis Vandladningsforstyrrelser Hæmaturi 
Renal failure Cystitis noninfective Micturition disorder Haematuria Leukocyturia
Den globale bivirkningsforekomst er den samme hos undergrupper med normal nyrefunktion (CrCl ≥ 90 ml/min), let nedsat nyrefunktion (CrCl = 60-89 ml/min) eller moderat nedsat nyrefunktion (CrCl = 30-59 ml/min). 
mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups.
• oppustethed, luft fra tarmen, fordøjelsesbesvær 
• bloating, passing gas, indigestion
Hyperæstesi 
Hyponatraemia
Det skal du vide, før du begynder at tage Lonsurf Sådan skal du tage Lonsurf Bivirkninger 
What you need to know before you take Lonsurf 3.
Forhøjede leverenzymer Forhøjet alkalisk fosfatase 
Blood alkaline phosphatase increased Weight decreased
• svimmelhed, hovedpine 
• feeling dizzy, headache
Hypromellose Macrogol (8000) Titandioxid (E171) Magnesiumstearat 
Titanium dioxide (E171) Iron oxide red (E172) Magnesium stearate
Forhøjet blod-urinstof 
Blood urea increased
Cancersmerter 
Cancer pain
Administration anbefales ikke til patienter med svært nedsat nyrefunktion eller med terminal nyresygdom, da er ikke foreligger data for denne patientgruppe (se pkt. 
• 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).
Magnesiumstearat 
Herpes zoster
Sandsynlighed for overlevelse 
Overall Survival
Hypromellose 
Hypocalcaemia
• Lonsurf 15mg/6,14 mg mg er en hvid, bikonveks, rund, filmovertrukket tablet, præget med “15” 
• Lonsurf 15 mg/6.14 mg is a white, biconvex, round, film-coated tablet, printed with “15” on one side and “102” and “15 mg” on the other side in grey ink.
Udseende og pakningsstørrelser 
What Lonsurf looks like and contents of the pack
• udslæt, kløende eller skællet hud 
• rash, itchy or flaky skin
Hypæstesi 
Hypokalaemia
Carnaubavoks 
Oesophagitis
Refluksgastritis 
Reflux gastritis
Lactosemonohydrat 
Hypernatraemia
• generel følelse af utilpashed 
• feeling generally out of sorts (malaise)
Amning 
Gout
• væskemangel 
• liver disorder
Niveau 1-dosisreduktion: Fra 35 mg/m til 30 mg/m 
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
Artralgi 
Flatulence
Ελλάδα 
Bone pain
Nedre luftvejsinfektion Septisk shock b 
Lower respiratory tract infection
Den maksimale virkningsgrad opnås inden for 48 timer. 
Maximum efficacy is achieved within 48 hours.
Begge stoffer var stadig målelige i hår 56 dage efter behandlingen. 
Both components were still measurable in the hair 56 days following treatment.
Må ikke anvendes efter den udløbsdato, som er angivet på æsken efter ”EXP”. 
Do not use after the expiry date stated on the carton after “EXP”.
Disse symptomer er forbigående og reversible, hvis der gives omgående og hensigtsmæssig behandling. 
These signs are transient and reversible if prompt and appropriate treatment is administered.
Dyr, som er behandlet for nylig, må ikke sove sammen med deres ejere, især ikke sammen med børn. 
Recently treated animals should not be allowed to sleep with the owners, especially children.
Dette veterinærlægemiddel må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet. 
The veterinary medicinal product should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.
Hvis der forekommer pemphigus-lignende symptomer, bør fortsat anvendelse af produktet undgås. 
If pemphigus-like signs occur, further use of the product should be avoided.
I disse tilfælde behandles ikke hyppigere end hver 14. dag. 
In these cases do not treat more frequently than once a fortnight.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktive stoffer: 
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances
Behandlingen bør så vidt muligt fortsættes, indtil hudskrab er negative i mindst 2 måneder. 
Where possible, treatment should not be discontinued until skin scrapings are negative on at least two monthly occasions.
Der bør udvises omhyggelighed for at sikre, at indholdet i pipetten eller den afgivne dosis ikke kommer i kontakt med øjnene eller munden på hunden og/eller andre dyr. 
Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.
Der er ikke observeret bivirkninger hos raske hunde og 8 uger gamle hvalpe, der blev behandlet 7 gange hver 14. dag med 3-5 gange den anbefalede dosis. 
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.
Følgende tabel angiver den pipettestørrelse, der skal anvendes i overensstemmelse med hunden vægt. 
The following table defines the size of pipette to be used according to the weight of the dog.
Maksimumkoncentrationer i hår blev generelt nået 2-7 dage efter behandlingen og mindskedes gradvist i løbet af 56 dage efter behandlingen. 
Maximum concentrations in the hair were generally reached between 2 to 7 days post treatment and gradually declined through 56 days post treatment.
Må ikke anvendes til syge eller svækkede hunde eller hunde, der er varmepåvirkede. 
Do not administer to sick or debilitated dogs or dogs suffering from heat stress.
Risikoen for bivirkninger kan dog øges ved overdosering, så derfor bør dyr altid behandles med den korrekte størrelse pipette i forhold til deres legemsvægt. 
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.
Hundens vægtklasse (kg) 
Weight Range of Dog (kg)
Det er vigtigt, at præparatet påføres et område, hvor dyret ikke kan slikke det af, og at dyr ikke slikker hinanden efter behandlingen. 
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.
Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år. 
Shelf life of the veterinary medicinal product as package for sale:2 years.
Eftersom demodicose er en multifaktor-sygdom, tilrådes det desuden at behandle den eventuelle underliggende sygdom, så vidt det er muligt. 
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Ved hyppig kontakt med vand kan virkningsvarigheden nedsættes. 
In cases of frequent water exposure the duration of activity may be reduced.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Storbritannien 
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Tag en pipette ud af pakningen. 
Remove the pipette from the package.
Der kan i sjældne tilfælde opstå forbigående irritation på applikationsstedet. 
In rare cases, transient irritation may occur at the site of product application.
Farmakoterapeutisk gruppe: Ectoparasiticider til udvortes brug, ATCvet-kode:QP 53AD51 
Pharmacotherapeutic group: Ectoparasiticides for topical use, ATC Vet Code QP 53AD51
Børn bør ikke have adgang til brugte pipetter. 
Children should not have access to used pipettes.
Hunde bør ikke svømme i vandløb og floder 24 timer efter behandlingen. 
Dogs should be prevented from accessing streams and rivers for the 24-hour period following treatment.
Metaflumizon er et insecticid, der tilhører gruppen af semicarbazon-forbindelser. 
Metaflumizone is an insecticide belonging to the semicarbazone group of compounds.