natgillin/translations-raw huggingface dataset:
Indehaveren af markedsføringstilladelsen skal inden markedsføring af 20 ml hætteglas Revatio 0,8 mg/ml injektionsvæske i det pågældende medlemsland i samarbejde med de nationale myndigheder i de enkelte medlemslande blive enige om indholdet af informationen til sundhedspersonalet samt hvilken gruppe af sundhedspersonale der er relevant. 
The Marketing Authorisation Holder shall agree the Information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Lægemidlet bør derfor ikke anvendes til patienter med hereditær fructoseintolerans. 
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
En populationsfarmakokinetisk analyse af data fra kliniske studier med sildenafil hos voksne PAH-patienter, herunder et 12-ugers studie, der vurderede effekten og sikkerheden af 20 mg sildenafil oralt 3 gange dagligt som tillæg til en stabil dosis bosentan (62,5- 125 mg 2 gange dagligt), indikerede et fald i eksponeringen for sildenafil ved samtidig administration af bosentan, som svarede til det, der sås hos raske frivillige forsøgspersoner (se pkt. 
A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan (62.5 mg - 125 mg twice a day) indicated a decrease in sildenafil exposure with bosentan co-administration, similar to that observed in healthy volunteers (see sections 4.4 and 5.1).
Revatio 20 mg filmovertrukne tabletter 
Revatio 20 mg film-coated tablets
I de kliniske forsøg var de almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter): rødmen i ansigtet, hovedpine, lavt blodtryk og kvalme. 
In clinical trials the side effects reported commonly (may affect up to 1 in 10 people) were facial flushing, headache, low blood pressure and nausea.
Placebo-korrigeret stigning i 6MWD var 45 meter (p<0,0001), 46 meter (p<0,0001) og 50 meter (p<0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg. Der var ingen signifikant forskel i effekten mellem sildenafildoserne. 
Placebo corrected increases in 6MWD were 45 metres (p < 0.0001), 46 metres (p < 0.0001) and 50 metres (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively.
Almene symptomer og reaktioner på administrationsstedet Almindelig pyreksi *Disse bivirkninger/hændelser er rapporteret hos patienter, der tager sildenafil til behandling af erektil dysfunktion (MED). 
*These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
De patienter, der blev inkluderet i det pivotale studie (oralt administreret), var egnede til at indgå i et langvarigt, åbent, studie, der blev forlænget. 
Patients enrolled into the pivotal oral route study were eligible to enter a long term open label extension study.
En dosis på 10 mg Revatio injektionsvæske giver samme eksponering for sildenafil samt Ndesmethylmetabolitten og udviser sammenlignelig farmakologisk effekt som en oral dosis på 20 mg. 
A 10 mg dose of Revatio solution for injection is predicted to provide exposure of sildenafil and its N-desmethyl metabolite and pharmacological effects comparable to those of a 20 mg oral dose.
Hos patienter med en gangdistance på <325 m var behandlingseffekten 2,3 m til placebos fordel. 
For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Følgende alvorlige bivirkninger betragtes som forbundet med behandlingen og er ikke almindelige (det sker hos mellem 1 og 10 ud af 100 patienter): allergisk reaktion (såsom hududslæt, hævelser i ansigt, læber og tunge, hvæsende vejrtrækning, åndedrætsbesvær og synkebesvær), kramper, uregelmæssig puls, nedsat hørelse, åndenød, betændelseslignende reaktion i mave-tarmkanalen og hvæsende vejrtrækning pga. blokering af luftvejene. 
The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
Hos patienter med pulmonal arteriel hypertension er plasmakoncentrationerne af N-desmethylmetabolitten ca. 72% af sildenafils efter 20 mg 3 gange dagligt (overført til et 36% bidrag til sildenafils farmakologiske effekt). 
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72 % those of sildenafil after 20 mg three times a day dosing (translating into a 36 % contribution to sildenafil's pharmacological effects).
Hos raske frivillige forsøgspersoner gav cimetidin (800 mg), en CYP450-hæmmer og ikke specifik CYP3A4-hæmmer, en 56% stigning i plasmakoncentrationer af sildenafil ved oralt administreret indgift sammen med sildenafil (50 mg). 
Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with oral sildenafil (50 mg) to healthy volunteers.
Ved indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en moderat CYP3A4hæmmer, i steady-state (500 mg 2 gange daglig i 5 dage) ses en 182% stigning i optagelsen af sildenafil (AUC). 
When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC).
Dosisjustering af sildenafil til 10 mg 2 gange dagligt bør overvejes til patienter i behandling med CYP3A4-hæmmere som erythromycin eller saquinavir. 
A downward dose adjustment to 10 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir.
Ved oral indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en moderat CYP3A4hæmmer, i steady-state (500 mg 2 gange daglig i 5 dage) ses en 182% stigning i optagelsen af sildenafil (AUC). 
When a single 100 mg dose of oral sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC).
Hos patienter med pulmonal arteriel hypertension er plasmakoncentrationerne af N-desmethylmetabolitten ca. 72% af sildenafils efter 20 mg administreret oralt 3 gange dagligt (overført til et 36% bidrag til sildenafils farmakologiske effekt). 
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72 % those of sildenafil after 20 mg three times a day oral dosing (translating into a 36 % contribution to sildenafil's pharmacological effects).
Flasken med oral suspension omrystes grundigt i mindst 10 sekunder, før den angivne dosis udtages. 
Shake the closed bottle of constituted oral suspension vigorously for a minimum of 10 seconds before use.
Den sædvanlige dosis til børn og unge i alderen 1-17 år er 10 mg 3 gange dagligt ved legemsvægt 20 kg eller derunder og 20 mg 3 gange dagligt ved legemsvægt over 20 kg. Revatio kan tages sammen med eller uden mad. 
For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food.
- har for højt blodtryk i blodkarrene i lungerne. 
- have a problem with the pumping chambers of your heart - have high blood pressure in the blood vessels in the lungs.
Efter kronisk oral dosering på 80 mg 3 gange dagligt til patienter med pulmonal arteriel hypertension ses en mindre effekt i blodtryksreduktionen (en reduktion i både systolisk og diastolisk tryk på 2 mmHg). 
After chronic oral dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed (a reduction in both systolic and diastolic pressure of 2 mmHg).
Revatio 20 mg filmovertrukne tabletter Sildenafil 
Revatio 20 mg film-coated tablets Sildenafil
10 mg Revatio injektionsvæske giver samme eksponering for sildenafil og dets N-desmethylmetabolit og den kombinerede farmakologiske effekt er sammenlignelig med den for en oralt administreret dosis på 20 mg. 
A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Hos raske frivillige forsøgspersoner gav cimetidin (800 mg), en CYP450-hæmmer og ikke specifik CYP3A4-hæmmer, en 56% stigning i plasmakoncentrationer af sildenafil ved indgift sammen med sildenafil (50 mg). 
Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Placér spidsen af sprøjten mod indersiden af kinden og tryk LANGSOMT stemplet i bund. 
Point the tip of the oral dosing syringe towards the inside of the cheek.
Revatio 0,8 mg/ml injektionsvæske, opløsning Sildenafil 
Revatio 0.8 mg/ml solution for injection Sildenafil
(p=0,0051), -195 dyn.sek/cm 
(p=0.0017) and -320 dyne.sec/cm
Hver filmovertrukken tablet indeholder 20 mg sildenafil (som citrat). 
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Det anbefales, at en farmaceut blander Revatio oral suspension, inden den udleveres til Dem. 
Instructions to reconstitute the oral suspension It is recommended that your pharmacist reconstitutes (makes up) the oral suspension before giving it to you.
Sådan skal De tage Revatio 
How to take Revatio
De fleste forsøgspersoner var WHOfunktionsklasse I (75/234, 32%) eller II (120/234, 51%) ved baseline. 
Most subjects were WHO Functional Class I (75/234, 32 %) or II (120/234, 51 %) at baseline; fewer patients were Class III (35/234, 15 %) or IV (1/234, 0.4 %); for a few patients (3/234, 1.3 %), the WHO Functional Class was unknown.
1 flaske med rekonstitueret oral suspension (112 ml) indeholder 1,12 g sildenafil (som citrat). 
After reconstitution, each ml of the oral suspension contains 10 mg of sildenafil (as citrate) One bottle of reconstituted oral suspension (112 ml) contains 1.12 g of sildenafil (as citrate)
Virkninger af andre præparater på oralt administreret sildenafil 
Effects of other medicinal products on oral sildenafil
Vend flasken om igen stadig med sprøjten på plads og tag sprøjten ud af flasken. 
Turn the bottle back upright with the oral dosing syringe still in place.
Få patienter var klasse I (3/267, 1%) eller IV (16/267, 6%) ved baseline. 
Most patients were WHO Functional Class II (68/267, 26 %) or III (175/267, 66 %); fewer patients were Class I (3/267, 1 %) or IV (16/267, 6 %) at baseline; for a few patients (5/267, 2 %), the WHO Functional Class was unknown.
Revatio 0,8 mg/ml injektionsvæske, opløsning 
Revatio 0.8 mg/ml solution for injection
Efter kronisk oral dosering af 80 mg 3 gange dagligt til patienter med systemisk hypertension ses et gennemsnitlig fald fra baseline i det systoliske og diastoliske blodtryk på hhv. 9,4 mmHg og 9,1 mmHg. 
After chronic oral dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9.4 mmHg and 9.1 mm Hg respectively.
Sæt låget på flasken igen. 
Replace the cap on the bottle.
Druesmag: 
Grape flavour:
Et 20 ml hætteglas indeholder 12,5 ml (10 mg sildenafil som citrat) 
Each 20 ml vial contains 12.5 ml (10 mg sildenafil, as citrate).
1 ml indeholder 0,8 mg sildenafil (som citrat). 
Each ml of solution contains 0.8 mg of sildenafil (as citrate).
I et placebo-kontrolleret studie af Revatio som tillæg til intravenøs epoprostenol ved pulmonal arteriel hypertension blev i alt 134 patienter behandlet med oralt administreret Revatio (i en fastsat dosistitrering, der startede fra 20 mg 3 gange dagligt til 40 mg og herefter 80 mg 3 gange dagligt alt efter hvor godt det blev tolereret) og epoprostenol; 131 patienter blev behandlet med placebo og epoprostenol. 
In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with oral Revatio (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day as tolerated) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
I et placebo-kontrolleret studie af Revatio som tillæg til intravenøs epoprostenol ved pulmonal arteriel hypertension blev i alt 134 patienter behandlet med Revatio (i en fast dosistitrering, der startede fra 20 mg 3 gange dagligt til 40 mg og herefter 80 mg 3 gange dagligt alt efter, hvor godt det blev tolereret) og epoprostenol; 131 patienter blev behandlet med placebo og epoprostenol. 
In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with Revatio (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day as tolerated) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
Et 20 ml hætteglas indeholder 10 mg sildenafil (som citrat). 
One 20 ml vial contains 10 mg of sildenafil (as citrate).
Samtidig indgift med HIV-proteasehæmmeren, ritonavir, som er en meget potent P450 hæmmer, ved steady-state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma AUC på 1.000% (11 gange). 
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300 % (4-fold) increase in sildenafil Cmax and a 1,000 % (11-fold) increase in sildenafil plasma AUC.
Samtidig indgift med HIV-proteasehæmmeren, ritonavir, som er en meget potent P450 hæmmer, ved steady-state (500 mg 2 gange dagligt) og enkeltdosis af oralt administreret sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma AUC på 1.000% (11 gange). 
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with oral sildenafil (100 mg single dose) resulted in a 300 % (4-fold) increase in sildenafil Cmax and a 1,000 % (11-fold) increase in sildenafil plasma AUC.
Samtidig indgift med HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady-state (1200 mg 3 gange dagligt) og enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%. 
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter) omfatter: nedsat skarpsyn, dobbeltsyn, unormal følelse i øjet, blødning fra penis, blod i sæden og/eller urinen og forstørrelse af brysterne hos mænd. 
Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Samtidig indgift med HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady-state (1.200 mg 3 gange dagligt) og oralt administreret enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%. 
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with oral sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Hvis De har fået for meget Revatio 
If you miss a dose of Revatio
Bivirkninger, der forekommer hos >1% af Revatio-behandlede patienter, og som er hyppigere (>1% forskel) for Revatio i pivotal-studiet eller i det Revatiokombinerede datasæt for begge placebokontrollerede studier med pulmonal arteriel hypertension i oralt administrerede doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor. 
Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at oral doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1000 to ≤ 1/100) and not known (cannot be estimated from the available data).
Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter) omfatter: nedsat skarpsyns, dobbeltsyn, unormal følelse i øjet, blødning fra penis, blod i sæden og/eller urinen og forstørrelse af brysterne hos mænd. 
Side effects reported uncommonly (may affect upto 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Hvert 20 ml hætteglas indeholder 12,5 ml injektionsvæske (10 mg sildenafil som citrat). 
Each 20 ml vial contains 12.5 ml of solution (10 mg of sildenafil, as citrate).
Efter rekonstituering: Opbevares ved temperaturer under 30 
After reconstitution: Store below 30°C or in refrigerator at 2°C to 8°C.
oC eller i køleskab (2 oC-8 
Store below 30°C or in refrigerator at 2ºC to 8°C.
Hvert 20 ml hætteglas indeholder 10 mg sildenafil (som citrat). 
Each 20 ml vial contains 10 mg sildenafil (as citrate).
Bivirkninger, der forekommer hos >1% af Revatio-behandlede patienter, og som er hyppigere (>1% forskel) for Revatio i pivotal-studiet eller i det Revatiokombinerede datasæt for begge placebokontrollerede studier med pulmonal arteriel hypertension i doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor. 
Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Samtidig anvendelse af bosentan (en moderat induktor af CYP3A4, CYP2C9 og muligvis af CYP2C19) 125 mg 2 gange dagligt og sildenafil 80 mg 3 gange dagligt (ved steady-state) i 6 dage gav et fald i sildenafils AUC på 63% hos raske frivillige forsøgspersoner. 
Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with oral sildenafil 80 mg three times a day (at steady state)
Sådan får De Revatio 
How Revatio is given
Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 patienter) set i kliniske studier med Revatio-tabletter er hovedpine, rødmen i ansigtet, mavebesvær, diarré og smerter i arme og ben. 
In clinical trials with Revatio tablets side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.
Peg spidsen af sprøjten mod indersiden af kinden og tryk LANGSOMT stemplet i bund. 
Push the plunger back in to the syringe.
oppustet abdomen, mundtørhed 
burning sensation, hypoaesthesia
Revatio er en klar, farveløs injektionsvæskep. 
Clear, colourless solution.
Hvis De får for meget Revatio kan det øge risikoen for at få bivirkninger. 
Revatio can cause a serious increase in the effects of these medicines.
In vivo studier Samtidig anvendelse af sildenafil og intravenøs epoprostenol er undersøgt (se pkt. 
Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated (see sections 4.8 and 5.1).
Det skal De vide, før De begynder at tage Revatio Sådan skal De tage Revatio Bivirkninger 
What Revatio is and what it is used for What you need to know before you take Revatio How to take Revatio
Efter opblanding indeholder 1 ml suspension indeholder 10 mg sildenafil (som citrat). 
Each ml of the reconstituted suspension contains 10 mg of sildenafil (as citrate).
Bivirkningerne er angivet efter klasse og frekvens (meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1000 til <1/100), ikke kendt (kan ikke bestemmes ud fra tilgængelige data)). 
Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension,, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
50 mg. 
80 mg TID, respectively.
Det reproduktive system og mammae Ikke almindelig blødning fra penis, hæmatospermi, gynækomasti 
Reproductive system and breast disorders Uncommon penile haemorrhage, haematospermia, gynaecomastia
(“poppers”). 
(CYPRUS BRANCH)
Ikke kendt retinablødning, nedsat syn, sløret syn, fotofobi, chromatopsia, cyanopsia, øjenirritation, okulær hyperæmi uskarpt syn, dobbeltsyn, usædvanlig følelse i øjet non-arteritis anterior iskæmisk opticusneuropati (NAION)*, vaskulær okklusion i retina*, synsfeltdefekt* 
Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
- medicin, der indeholder perikon (naturmedicin), rifampicin (mod tuberkulose), carbamazepin, 
• Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
Europa-Kommissionen traf en afgørelse den 25. september 2017. 
The European Commission issued a decision on 25 September 2017.
Resultat af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/116) 
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/116)
Hvad er moxidectin? 
What is moxidectin?
Dette omfattede data fra firmaer og litteratur udgivet om emnet. 
These included data from companies and from the published literature.
Hvorfor blev veterinærlægemidler, der indeholder moxidectin, gennemgået? 
Why were veterinary medicines containing moxidectin reviewed?
Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at lægemidlerne kan have en langsigtet indvirkning på miljøet på grund af deres vedvarende, bioakkumulerende og giftige (PBT) egenskaber. 
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these medicines might have a longterm impact on the environment due to their persistent, bioaccumulative and toxic (PBT) properties.