natgillin/translations-raw huggingface dataset:
Karton med blisterpakning (14, 21, 56, 84 og 100) og perforeret enkeltdosisblister pakning (100) til 50 mg kapsler
Carton of blister pack (14, 21, 56, 84 and 100) and perforated unit dose blister pack (100) for 50 mg hard capsules
1 gang dagligt eller fordelt på 2 daglige doser
BID or TID BID or TID Once Daily or BID Once Daily
Karton med blisterpakning (21, 84 og 100) og perforeret enkeltdosisblister pakning (100) til 100 mg kapsler
Carton of blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg hard capsules
Karton med blisterpakning (21, 84 og 100) og perforeret enkeltdosisblister pakning (100) til 200 mg kapsler
Carton of blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 200 mg hard capsules
Lyrica 225mg hårde kapsler Hver kapsel indeholder 24,75 mg lactosemonohydrat.
Each hard capsule also contains 24.75 mg lactose monohydrate.
• Hos nogle patienter, der tager Lyrica, er der set kronisk venstresidig hjertesvigt.
• There have been reports of heart failure in some patients when taking Lyrica; these patients were mostly elderly with cardiovascular conditions.
Flasken ligger i en karton, der også indeholder en plastikindpakning med en 5 ml oral sprøjte med markeringer og en tilpasningsprop.
The carton also contains, in a clear polyethylene wrap, a graduated 5 ml oral syringe and a press-in bottle adapter (PIBA).
Nyresvigt, oliguri, urinretention.
Renal failure, oliguria, urinary retention Reproductive system and breast disorders Common
Lyrica 75 mg hårde kapsler Hver kapsel indeholder 8,25 mg lactosemonohydrat.
Each hard capsule also contains 8.25 mg lactose monohydrate.
Det betyder, at det er identisk med et ”referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU).
This means that it is similar to one or more ‘reference medicines' already authorised in the European Union (EU).
Dette fører til mindre sygdomsaktivitet ved Pagets sygdom.
This leads to less disease activity in Paget's disease.
Der kan overvejes en yderligere infusion mindst et år efter den første, hvis patientens sygdom vender tilbage.
An additional infusion, given at least one year after the first one, can be considered if the patient's disease comes back.
Den fuldstændige EPAR for Zoledronic Acid Hospira findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Zoledronic Acid Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronic Acid Hospira den 19. november 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic Acid Hospira on 19 November 2012.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Zoledronic Acid Hospira.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic Acid Hospira.
Det er en langvarig sygdom, hvor den normale knoglevækst ændres, hvilket bevirker, at de berørte knogler bliver skrøbelige eller misdannede.
This is a long-term disease where the normal process of bone growth is altered, which causes bones to become weakened or deformed.
Der kan indhentes yderligere oplysninger om generiske og hybride lægemidler i dokumentet med spørgsmål og svar her.
For more information on generic and hybrid medicines, see the question-and-answer document here.
Hvis du ønsker yderligere oplysninger om behandling med Zoledronic Acid Hospira, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Zoledronic Acid Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronic Acid Hospira er sammenlignelig med Zometa og Aclasta.
The CHMP concluded that, in accordance with EU requirements, Zoledronic Acid Hospira has been shown to be comparable to Zometa and Aclasta.
Der er udarbejdet en risikostyringsplan for at sikre, at Zoledronic Acid Hospira anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Zoledronic Acid Hospira is used as safely as possible.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronic Acid Hospira.
This is a summary of the European public assessment report (EPAR) for Zoledronic Acid Hospira.
Ved forebyggelse af knoglekomplikationer kan denne gentages hver tredje til fjerde uge, og patienterne bør have tilstrækkelige tilskud af calcium og vitamin D.
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zoledronic Acid Hospira, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic Acid Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
Det leveres som et koncentrat (4 mg/5 ml), der blandes til en opløsning til infusion (drop) i en vene, og som en opløsning til infusion (4 mg/100 ml og 5 mg/100 ml).
It is available as a concentrate (4 mg/5 ml) to be made up into a solution for infusion (drip) into a vein, and as solutions for infusion (4 mg/100 ml and 5 mg/100 ml).
Der krævedes ingen supplerende undersøgelser, eftersom Zoledronic Acid Hospira indgives ved infusion og indeholder det samme aktive stof som referencelægemidlerne Zometa og Aclasta.
No additional studies were needed as Zoledronic Acid Hospira is given by infusion and contains the same active substance as the reference medicines, Zometa and Aclasta.
Virksomheden har fremlagt data fra den offentliggjorte faglitteratur om zoledronsyre.
The company provided data from the published literature on zoledronic acid.
Zoledronic Acid Hospira er et “generisk” og ”hybridt” lægemiddel.
Zoledronic Acid Hospira is a ‘generic' and a ‘hybrid' medicine.
Zoledronic Acid Hospira 4 mg/5 ml koncentrat og 4 mg/100 ml opløsning anvendes til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne.
Zoledronic Acid Hospira 4 mg/5 ml concentrate and 4 mg/100 ml solution are used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Ved forebyggelse af knoglekomplikationer og behandling af hypercalcæmi, der skyldes tumorer, er den sædvanlige dosis Zoledronic Acid Hospira 4 mg givet som en infusion, der varer mindst 15 minutter.
For the prevention of bone complications and treatment of hypercalcaemia caused by tumours, the usual dose of Zoledronic Acid Hospira is one infusion of 4 mg over at least 15 minutes.
Ved behandling af Pagets knoglesygdom gives Zoledronic Acid Hospira som en infusion, der varer mindst 15 minutter.
For the treatment of Paget's disease of the bone, Zoledronic Acid Hospira is given as one infusion lasting at least 15 minutes.
Da Zoledronic Acid Hospira indgives ved infusion og indeholder det samme aktive stof som referencelægemidlerne, anses benefit/risk-forholdet for at være det samme som for disse.
Because Zoledronic Acid Hospira is given by infusion and contains the same active substance as the reference medicines, its benefits and risks are taken as being the same as the reference medicines'.
De kan også anvendes til behandling af forhøjet calciumindhold i blodet, der skyldes tumorer (svulster).
They can also be used to treat the hypercalcaemia caused by tumours.
Idet Zoledronic Acid Hospira forebygger nedbrydningen af knoglerne, hjælper det samtidig med at reducere den mængde calcium, der afgives til blodet.
By preventing the breakdown of bones, Zoledronic Acid Hospira also helps to reduce the amount of calcium released into the blood.
Det aktive stof i Zoledronic Acid Hospira, zoledronsyre, er et bisphosphonat.
The active substance in Zoledronic Acid Hospira, zoledronic acid, is a bisphosphonate.
Zoledronic Acid Hospira er et lægemiddel, der indeholder det aktive stof zoledronsyre.
Zoledronic Acid Hospira is a medicine that contains the active substance zoledronic acid.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronic Acid Hospira?
What measures are being taken to ensure the safe and effective use of Zoledronic Acid Hospira?
Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronic Acid Hospira.
The Committee recommended that Zoledronic Acid Hospira be given marketing authorisation.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici, ligesom for Zometa og Aclasta.
Therefore, the CHMP's view was that, as for Zometa and Aclasta, the benefit outweighs the identified risks.
Hvilke fordele og risici er der forbundet med Zoledronic Acid Hospira?
What are the benefits and risks of Zoledronic Acid Hospira?
Referencelægemidlet for 4 mg/5 ml-koncentratet og 4 mg/100 ml-opløsningen er Zometa.
The reference medicine for the 4 mg/5 ml concentrate and 4 mg/100 ml solution is Zometa.
Andre oplysninger om Zoledronic Acid Hospira
Other information about Zoledronic Acid Hospira
Zoledronic Acid Hospira zoledronsyre
Zoledronic Acid Hospira zoledronic acid
5 mg/100 ml-opløsningen anvendes også til behandling af Pagets knoglesygdom hos voksne.
Zoledronic Acid Hospira 5 mg/100 ml solution is used to treat Paget's disease of the bone in adults.
Referencelægemidlet for 5 mg/100 ml-opløsningen er Aclasta.
Aclasta is the reference medicine for the 5 mg/100 ml solution.
Hvorfor blev Zoledronic Acid Hospira godkendt?
Why has Zoledronic Acid Hospira been approved?
Hvordan blev Zoledronic Acid Hospira undersøgt?
How has Zoledronic Acid Hospira been studied?
Hvad er Zoledronic Acid Hospira?
What is Zoledronic Acid Hospira?
Hvordan anvendes Zoledronic Acid Hospira?
How is Zoledronic Acid Hospira used?
Hvad anvendes Zoledronic Acid Hospira til?
What is Zoledronic Acid Hospira used for?
Hvordan virker Zoledronic Acid Hospira?
How does Zoledronic Acid Hospira work?
24 timer.
48 hours.
Nyligt behandlede dyr bør ikke sove sammen med deres ejere, især ikke med børn.
Recently treated animals should not sleep with owners, especially children.
Vask hænder straks efter brug.
Wash hands immediately after use.
Dato for første markedsføringstilladelse: 04/12/2013 Dato for seneste fornyelse af markedsføringstilladelse: 24/09/2018
Date of first authorisation: 04/12/2013 Date of latest renewal: 24/09/2018
Korrekt applikation vil minimere forekomsten af sådanne tilfælde (se punkt 4.9).
Correct application will minimise the occurrence of such events (see section 4.9).
ATCvet-kode: QP54AA54.
ATC vet code: QP54AA54.
Undgå at ryge, drikke eller spise under påføringen.
Do not smoke, drink or eat during application.
Overdosis (symptomer):
Overdose (symptoms):
Må ikke anvendes til kaniner.
Do not use in rabbits.
Gennemsnitlig halveringstid for dette stof er 4,75 dage.
The average half-life for this compound is 4.75 days.
Klar, farveløs til gul til rød/brun opløsning.
Clear colourless to yellow to red/brown solution.
Andre dyr i samme husholdning bør også behandles med et passende præparat.
Other animals living in the same household should also be treated with a suitable product.
Per dosis: Fipronil
Per dose: Fipronil
Gennemsnitlig halveringstid for praziquantel er 3,08 dage.
The average half-life for praziquantel is 3.08 days.
Brug handsker ved håndtering af veterinærlægemidlet.
Wear gloves when handling the veterinary medicinal product.
Hvis dette sker, skal hænderne vaskes med sæbe og vand.
If this occurs, wash off with soap and water.
Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på den ydre emballage efter EXP.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
I meget sjældne tilfælde kan det være nødvendigt at give symptomatisk behandling.
On very rare occasions, symptomatic treatment can be required.
Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
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).
Virkningen af shamponering/badning i vand af dyret er ikke undersøgt og bør undgås.
The effect of shampooing or immersion in water of the animal has not been tested and should be avoided.
Til forskel fra andre arter dannes fipronilsulfon ikke i katten.
Unlike other species, fipronil sulfone is not formed in cat.
Børn bør ikke gives lov til at lege med det behandlede dyr i den periode.
Children should not be allowed to play with treated animals during this period.
BROADLINE eller tom emballage må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
BROADLINE or empty container should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Opløste og delvist fordøjede fragmenter kan lejlighedsvis ses i fæces.
Disintegrated and partially digested fragments may occasionally be seen in the faeces.
Applikator
Applicator
Praziquantel har moderat vævsdistribution, og ca. 64-84 % praziquantel bindes til plasmaproteiner.
Praziquantel has a moderate tissue distribution, and about 64-84% of praziquantel is bound to plasma proteins.
Ved behandling mod Aelurostrongylus abstrusus anbefales eventuelt en opfølgende administration en måned efter den første behandling.
For treatment against Aelurostrongylus abstrusus, a second administration one month after the initial treatment may be recommended.
Derfor bør der tages hensyn til epidemiologiske oplysninger om gældende følsomhed hos målarterne for at begrænse muligheden for fremtidig selektion for resistens.
Therefore, epidemiological information about current susceptibility of the target species should be taken into account in order to limit the possibility of a future selection for resistance.
Fipronilsulfon, som et fotonedbrydningsprodukt af fipronil, er også fundet i pelsen.
Fipronil sulfone, as a photodegradation product of fipronil, is also found on the hair.
Maksimal plasmakoncentration af den absorberede del af fipronil og (S)-methopren nås inden for 8-9 timer.
The peak plasma concentrations of the absorbed fraction of fipronil and (S)-methoprene are reached within 8 to 9 hours.
Behandling bør ikke ekstrapoleres fra et dyr til et andet uden dyrlægens vurdering.
Treatment should not be extrapolated from one animal to the other without veterinary opinion.
Der foreligger ingen data for, hvordan badning/shamponering påvirker veterinærlægemidlets virkning hos kat.
No data on the effect of bathing/shampooing on the efficacy of the veterinary medicinal product in cats is available.
Undgå at præparatet kommer i kontakt med kattens øjne.
Avoid contact with the cat's eyes.
Veterinærlægemidlet er udelukkende indiceret når der behandles samtidigt for alle tre grupper.
The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.
Veterinærlægemidlet er ikke beregnet til hunde.
The veterinary medicinal product is not intended for use in dogs.
Når eprinomectin er absorberet bindes det især til plasmaproteiner (>99 %), har en lav blodclearance og distribueres godt i væv.
Once absorbed, eprinomectin is highly bound to plasma proteins (> 99%), has low clearance from blood, and distributes well into tissues.
Ekinokok-infektion er farlig for mennesker, og sygdommen er anmeldepligtig ifølge World Organisation for Animal Health (OIE).
Echinococcosis represents a hazard for humans, and is a notifiable disease to the World Organisation for Animal Health (OIE).
Kattens vægt
Cat weight
Vælg den applikatorstørrelse (eller kombination af applikatorer, til katte >7,5 kg) som passer til kattens vægt.
Select the applicator size (or combination of applicators, for cats >7.5 kg) adapted to the cat's weight.
Den ektoparasitære aktivitet af fipronil og (S)-methopren sker via direkte kontakt med ektoparasitterne snarere end via systemisk eksponering.
The ectoparasitic activity of fipronil and (S)-methoprene is mediated by direct contact with the ectoparasites rather than by systemic exposure.
I tilfælde af massivt loppeangreb samt ved starten af behandlingen skal omgivelserne derfor behandles med et egnet bekæmpelsesmiddel og derefter støvsuges regelmæssigt.
In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable environmental product and then vacuumed regularly.
4 Chemin du Calquet 31000 Toulouse FRANKRIG
4 Chemin du Calquet, 31000 Toulouse FRANCE
I disse tilfælde kan anden samtidig behandling blive nødvendig.
In these severe cases concomitant treatment may be necessary.
Nogle katte med persisterende Joyeuxiella spp.
Some cats with patent Joyeuxiella spp.
Symptomatisk behandling kan være nødvendig hvis disse symptomer ikke forsvinder spontant inden for 24 timer.
Symptomatic treatment can be required if the signs do not resolve spontaneously within 24 hours.
Når veterinærlægemidlet påføres, skal man ved behandling af langhårede racer være særlig opmærksom på, at det påføres direkte på huden og ikke i pelsen, da dette kan føre til en lavere biotilgængelighed af de aktive stoffer og dermed reduceret virkning.
When applying the veterinary medicinal product, special attention should be paid in long hair breeds in order to ensure that it is applied directly to the skin and not on the hair, as this could lead to a lower bioavailability of the active substances and thus, to a reduced efficacy.
(S)-methopren metaboliseres og udskilles meget hurtigt efter absorption.
(S)-methoprene, once absorbed, is very quickly metabolised and excreted.
Må ikke anvendes til syge eller afkræftede dyr.
Do not use in sick or convalescent animals.
Den topikale applikation, hvor der kan forekomme oral eksponering via soignering, medfører ligeledes en delvis systemisk eksponering som aftager over tid.
The topical application, with additional potential oral exposure from grooming, also results in partial systemic exposure that decreases over time.
Til udvortes brug på huden (spot-on).
For topical application onto the skin (spot-on).
Dets metabolitter er begrænsede og udskilles hovedsagelig uforandret i fæces.
Its metabolism is limited, and it is mainly excreted unchanged in the faeces.
Den anbefalede minimumsdosis er 10 mg/kg kropsvægt for fipronil, 12 mg/kg for (S)-methopren, 0,5 mg/kg for eprinomectin og 10 mg/kg for praziquantel.
The recommended minimum doses are 10 mg/kg bodyweight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel.
- Forebyggelse af hjerteorm (Dirofilaria immitis larver) i en måned.
- Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
Placer applikatorens spids på huden og anbring hele indholdet direkte på huden på ét og samme sted.
Place the tip of the applicator on the skin and apply the entire content directly onto the skin in one spot.
(S)-methopren er en insektvækstregulator (IGR) der tilhører stofgruppen ”juvenile hormon-analoger”, som hæmmer udviklingen af immature insektstadier.
(S)-Methoprene is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues that inhibit the development of immature stages of insects.
Korrekt påføring vil minimere forekomsten af sådanne tilfælde (se DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ).
Correct application will minimise the occurrence of such events (see section DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION).
Særlige advarsler for hver dyreart: Undgå at dyr slikker hinanden efter behandling.
Special warnings for each target species: Avoid animals licking each other following treatment.
Opbevar applikatoren i blisterpakningen for at beskytte mod lys.
Store the applicator in the blister package in order to protect from light.
Mennesker med kendt overfølsomhed over for fipronil, (S)-methopren, eprinomectin eller praziquantel eller over for nogen af hjælpestofferne bør undgå kontakt med veterinærlægemidlet.
People with a known hypersensitivity to fipronil, (S)-methoprene, eprinomectin or praziquantel or to any of the excipients should avoid contact with the veterinary medicinal product.
Den ovicide effekt af (S)-methopren på dyret skyldes enten direkte penetration gennem skallen af det nylagte æg eller absorption gennem den voksne loppes cuticula.
The on-animal ovicidal activity of (S)-methoprene results from either direct penetration of the eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas.
Efter behandling dræbes flåter sædvanligvis inden for 48 timer efter infestation uden at have fået et blodmåltid.
After treatment, ticks will generally be killed within 48 hours after infestation without having a blood meal.
Dette fører til alvorlige skader i parasittens integument, kontraktion og paralyse, afbrudt metabolisme og endelig til parasittens død og udstødelse.
This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death and expulsion of the parasite.
Bændelorm - Behandling af infestationer med bændelorm (Dipylidium caninum, Taenia taeniaeformis,
Cestodes - Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis,
Farmakoterapeutisk gruppe: antiparasitære midler, insekticider, avermectiner, eprinomectinkombinationer.
Pharmacotherapeutic group: antiparasitic products, insecticides, avermectins, eprinomectin in combinations.
Fipronil er et insekticid og acaricid hørende til phenylpyrazolfamilien.
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family.
Begræns håndtering af behandlede dyr indtil påføringsstedet er tørt.
Handling of treated animals should be limited until the application site is dry.
Tilhæftning af enkelte flåter kan imidlertid forekomme, og overførsel af infektiøse lidelser kan ikke helt udelukkes, hvis betingelserne er ugunstige.
However there may be attachment of single ticks and transmission of infectious diseases cannot thus be completely excluded if conditions are unfavourable.
For at reducere risikoen for re-infestation med nyligt klækkede lopper anbefales det, at alle katte i husholdningen behandles.
To reduce re-infestation from emergence of new fleas, it is recommended that all cats in a household be treated.
Lopper dræbes inden for
Elimination of ticks within
Echinococcus multilocularis, Joyeuxiella pasqualei (voksne), Joyeuxiella fuhrmanni (voksne)).
Echinococcus multilocularis, Joyeuxiella pasqualei (adult), Joyeuxiella fuhrmanni (adult)).