natgillin/translations-raw huggingface dataset:
I placebo-kontrollerede kliniske forsøg med voksne patienter var quetiapin forbundet med en øget forekomst af ekstrapyramidale symptomer (EPS) sammenlignet med placebo hos patienter, som blev behandlet for depressive episoder inden for bipolar lidelse og unipolar depression (se pkt.
In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in bipolar disorder and major depressive disorder (see sections 4.8 and 5.1).
I kliniske forsøg med quetiapin er der set stigninger i triglycerider, LDL- og totalkolesterol, og fald i HDL-kolesterol (se pkt.
Increases in triglycerides, LDL and total cholesterol, and decreases in HDL cholesterol have been observed in clinical trials with quetiapine (see section 4.8).
Selvmordstanker og forværring af din depression
• Disturbance in speech and language • Thoughts of suicide and worsening of your depression
Seroquel Prolong bør tages én gang dagligt uden samtidig fødeindtagelse.
Seroquel XR should be administered once daily, without food.
Quetiapins farmakokinetik ændredes ikke ved samtidig adminitrering af cimetidin.
The pharmacokinetics of quetiapine were not altered following co-administration with cimetidine.
• Øget sultfornemmelse.
• Feeling more hungryIncreased appetite
Blodglukose steget til hyperglykæmiske niveauer7
Elevations in serum transaminases (ALT, AST)3, decreased neutrophil count, blood glucose increased to hyperglycaemic levels 7
I kliniske forsøg med quetiapin er der set alvorlig neutropeni (neutrofiltal <0,5 x 109/l) med hyppigheden ikke almindelig.
Severe neutropenia (neutrophil count <0.5 X 109/L) has been uncommonly reported in quetiapine clinical trials.
10 depottabletter 30 depottabletter 50 depottabletter 60 depottabletter 100 depottabletter
10 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 60 prolonged-relaease tablets 100 prolonged-release tablets
Imidlertid er virkning og sikkerhed ved monoterapi hos voksne patienter blevet evalueret ved langtidsforsøg (se nedenfor).
Long-term efficacy and safety in patients with MDD has not been evaluated as add-on therapy, however long-term efficacy and safety has been evaluated in adult patients as monotherapy (see below).
I placebokontrollerede, kliniske korttids-monoterapiforsøg med patienter med unipolar depression var den samlede forekomst af ekstrapyramidale symptomer 5,4 % for Seroquel Prolong og 3,2 % for placebo.
In short-term, placebo-controlled monotherapy clinical trials in major depressive disorder the aggregated incidence of extrapyramidal symptoms was 5.4% for Seroquel XR and 3.2% for placebo.
1 blister á 10 tabletter
1 blister of 10 tablets
Quetiapin kan inducere ortostatisk hypotension, især i den indledende dosistitreringsperiode.
Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period and therefore dose reduction or more gradual titration should be considered if this occurs.
Gulsot6
Jaundice6
- Efter en vurdering af Seroquels sikkerhedsprofil konkluderede CHMP, at benefit/risk-forholdet var positivt for Seroquel XR som tillægsbehandling af svære depressive episoder hos patienter med svær depression, der har responderet suboptimalt på indledende antidepressiv monoterapi,
- The CHMP concluded on a positive benefit risk ratio for Seroquel XR as add-on treatment of major depressive episodes in patients with major depressive disorder, who have had suboptimal response to initial antidepressant monotherapy further to consideration of the safety profile of Seroquel.
Almindelig (sker hos færre end 1 ud af 10 personer):
Common (affects less than 1 in 10 people):
- Drenge og piger kan få øget brystudvikling og uventet produktion af brystmælk - Piger kan få manglende eller uregelmæssig menstruationen Øget appetit
• Boys and girls to have swelling of breasts and unexpectedly produce breast milk
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
• Medicines should not be disposed of via wastewater or household waste.
Køn: Der er ingen forskel mellem mænd og kvinder hvad angår quetiapins kinetik.
The pharmacokinetics of quetiapine does not differ between men and women.
Imidlertid er virkning og sikkerhed ved monoterapi hos voksne patienter blevet evalueret ved langtidsforsøg (se pkt.
Long-term efficacy and safety in patients with MDD has not been evaluated as add-on therapy, however long-term efficacy and safety has been evaluated in adult patients as monotherapy (see Section 5.1).
Meget sjælden (sker hos færre end 1 ud af 10.000 personer):
Very rare (affects less than in 10,000 people):
Ikke almindelig (sker hos færre end 1 ud af 100 personer):
Uncommon (affects less than 1 in 100 people):
o Til forebyggelse af tilbagevendende sygdomsepisoder hos patienter med bipolar lidelse,
For preventing recurrence in bipolar disorder
Øjne Almindelig:
Eye Disorders Common:
NAVN
TRADE NAME
NL-Holland
NLNetherlands
Det skal du vide, før du begynder at tage Seroquel Prolong Sådan skal du tage Seroquel Prolong Bivirkninger
What Seroquel XR is and what it is used for Before you take Seroquel XR How to take Seroquel XR Possible side effects
Afhængigt af klinisk respons og tolerabilitet hos den enkelte patient, kan dosis øges trinvist med 50 mg/dag, indtil effektiv dosis er opnået.
The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.
10 blistre á 5 tabletter
10 blisters of 5 tablets
Seponering:
Seizures:
Indehaver af markedsføringstilladelsen AstraZeneca A/S
DK - Denmark AstraZeneca A/S Roskildevej 22
Kardiovaskulære symptomer:
Cardiac disorders Common:
Følgende forsøg blev gennemført med Seroquel Prolong som monoterapi.
The following studies were conducted with Seroquel XR as monotherapy treatment, however Seroquel XR is only indicated for use as add-on thereapy:
Følgende bivirkninger er set oftere hos børn og unge:
The following side effects have been seen more often in children and adolescents: Very Common (affects more than 1 in 10 people):
5 blistre á 10 tabletter
5 blisters of 10 tablets
50 mg, 150 mg
50 mg, 150 mg 200 mg, 300 mg and 400 mg tablets
• Hurtig hjerterytme (puls)..
• Rapid heartbeat.
Hvar tablet indeholder 200 mg quetiapin (som fumarat)
Each tablet contains 200 mg quetiapine (as fumarate)
6 blistre á 10 tabletter
6 blisters of 10 tablets
Hvar tablet indeholder 150 mg quetiapin (som fumarat)
Each tablet contains 150 mg quetiapine (as fumarate)
(16) Prolaktinniveauer (patienter >18 år): >20 μg/l (>869,56 pmol/l) hankøn: >30 μg/l (>1304,34 pmol/l) hunkøn ved ethvert tidspunkt.
(13) See text below (14) Platelets ≤100 x 109/L on at least one occasion (15) Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome (16) Prolactin levels (patients >18 years of age): >20 μg/L (>869.56 pmol/L) males; >30 μg/L (>1304.34 pmol/L) females at any time.
Du bør derfor tage tabletterne mindst 1 time før et måltid eller ved sengetid.
• Seroquel XR can be affected by food and you should therefore take your tablets at least one hour before a meal or prior to bedtime.
Hvar tablet indeholder 300 mg quetiapin (som fumarat)
Each tablet contains 300 mg quetiapine (as fumarate)
• behandling af bipolar lidelse: o Til behandling af moderate til svære maniske episoder inden for bipolar lidelse.
• treatment of bipolar disorder : o For the treatment of moderate to severe manic episodes in bipolar disorder o For the treatment of major depressive episodes in bipolar disorder o For the prevention of recurrence in patients with bipolar disorder, in patients whose manic or depressive episode has responded to quetiapine treatment .
Hvar tablet indeholder 400 mg quetiapin (som fumarat)
Each tablet contains 400 mg quetiapine (as fumarate)
10 blistre á 10 tabletter
10 blisters of 10 tablets
Du må ikke drikke grapefrugtjuice, når du tager Seroquel Prolong, da det kan påvirke den måde, medicinen virker.
• Do not drink grapefruit juice while you are taking Seroquel XR .
Der kan være en øget risiko ved overdosering hos patienter med kendt alvorlig kardiovaskulær sygdom (se pkt.
Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose.
Tal med din læge med det samme, hvis du: - Får feber, alvorlig muskelstivhed, svedtendens eller nedsat bevidsthed (en lidelse, som hedder
Fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”).
Luftveje, thorax og mediastinum Almindelig:
Orthostatic hypotension 4, 17 Venous thromboembolism1 Respiratory, thoracic and mediastinal disorder Common:
Afhængigt af det klinske respons og tolerabiliteten hos den enkelte patient, bør dosis justeres inden for det effektive doseringsinterval mellem 400 mg og 800 mg pr. dag.
The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerability of the patient.
Seroquel XL Denne indlægsseddel blev senest revideret {MM/YYYY}.
Seroquel XR should be administered prior to bedtime.
Vægtøgning
Coating
Din læge vil bestemme hvilken dosering, du skal starte med, og hvor mange Seroquel Prolong tabletter, du skal tage om dagen.
Your doctor will decide on your starting dose.
Ortostatisk hypotension4,17
Syncope 4, 17
(7) Mindst ét tilfælde af fastende blodglukose ≥126 mg/dl (≥7,0 mmol/l) eller ikke fastende blodglukose ≥200 mg/dl (≥11,1 mmol/l).
(6) Calculation of Frequency for these ADR's have only been taken from postmarketing data with the immediate release formulation of Seroquel (7) Fasting blood glucose ≥126mg/dL(≥7.0 mmol/L) or a non fasting blood glucose ≥200mg/dL (≥11.1 mmol/L) on at least one occasion (8) An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression (9) Based on >7% increase in body weight from baseline.
• Overfølsomhedsreaktioner med f.eks hævelse af hals, ansigt og læber.
• Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
Seroquel Prolong 50 mg tabletter er ferskenfarvede og præget med ”XR 50” på den ene side.
Seroquel XR 50 mg tablets are peach-coloured and engraved with “XR 50” on one side Seroquel XR 150 mg tablets are white and engraved with “XR 150” on one side Seroquel XR 200 mg tablets are yellow and engraved with “XR 200” on one side Seroquel XR 300 mg tablets are pale yellow and engraved with “XR 300” on one side Seroquel XR 400 mg tablets are white and engraved with “XR 400” on one side
Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
General disorders and administration site conditions Very common Withdrawal (discontinuation) symptoms 1, 10
• Fald i blodtryk når du rejser dig op. Du kan føle dig svimmel eller besvime (kan medføre fald).
This may make you feel dizzy or faint (may lead to falls).
Der er rapporteret dysfagi med quetiapin (se pkt.
Dysphagia (See section 4.8 Undesirable effects) has been reported with quetiapine.
De forhåndenværende beviser fra placebo-kontrollerede kliniske forsøg med Seroquel er anført i pkt.
The available evidence from placebo-controlled clinical trials with Seroquel is presented in sections 4.4, 4.8, 5.1 and 5.2..
AstraZeneca A/S, Albertslund, Danmark 12.
IS - Iceland AstraZeneca A/S Roskildevej 22
Den absolutte biotilgængelighed er 88 %.
The absolute bioavailability is 88%.
Disse tilfælde var generelt selvbegrænsende og kortvarige.
These occurrences were generally self-limiting and of short duration.
Kun negative dyr skal behandles.
Only negative animals should be treated.
ATCvet-kode: QP54AB51.
ATC vet code: QP54AB51.
For at etablere en behandlingsrutine anbefales det at behandle samme dag eller dato i hver måned.
To establish a treatment routine, it is recommended that the same day or date be used each month.
Dato for første markedsføringstilladelse: 15/01/2015 Dato for seneste fornyelse af markedsføringstilladelse:
Date of first authorisation: 15/01/2015 Date of last renewal:
Terminal plasmahalveringstid er ca. 2 uger hos hund.
The terminal plasma half-life is approximately 2 weeks in dogs.
Den systemiske absorption af afoxolaner er høj.
The systemic absorption of afoxolaner is high.
Det veterinærmedicinske lægemiddel skal indgives i henhold til følgende tabel:
The veterinary medicinal product should be administered in accordance with the following table:
Der blev ikke observeret bivirkninger hos raske, otte uger gamle hvalpe efter 6 behandlinger med op til 5 gange den maksimale dosis.
No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.
Den anbefalede dosis bør overholdes nøje for collier eller beslægtede racer.
The recommended dose should be strictly observed in collies or related breeds.
- Præparatet kan forårsage gastrointestinale forstyrrelser, hvis det indtages.
- This product may cause gastrointestinal disturbances if ingested.
Den absolutte biotilgængelighed er hhv. 81 % og 65 % for A3 og A4 formen.
The absolute bioavailability is 81% and 65% for the A3 and A4 forms, respectively.
Til hunde, som vejer over 60 kg, skal der anvendes en passende kombination af tyggetabletter.
For dogs above 60 kg appropriate combinations of chewable tablets should be used.
Yderligere behandling kan være nødvendig igennem hele loppe- og/eller flåtsæsonen.
Further treatments may be indicated throughout the flea and/or tick season.
For at minimere risikoen for resistensudvikling anbefales det, at hunde undersøges for både cirkulerende antigener og for mikrofilarier i blodet ved sæsonstart for forebyggende behandling.
To minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season of preventative treatment.
Sikkerhedserfaringer efter markedsføring
Post-marketing safety experience
Hundens kropsvægt (kg)
Bodyweight (kg) of dog
Dette fører til hyperpolarisering af neuromuskulærmembranen med deraf følgende paralyse og død hos parasitterne.
This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.
Det er et fermentationsprodukt fra Streptomyces milbemycinicus.
It is a fermentation product of Streptomyces milbemycinicus.
Det kan være nødvendigt at give yderligere månedlige behandlinger baseret på klinisk vurdering og hudskrab.
Further monthly administrations of the product may be required based on clinical assessment and skin scrapings.
Særlige advarsler for hver dyreart:
Special warnings for each species:
Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-riskforholdet.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Samtidig behandling med andre P-gp substrater kan derfor føre til forøget giftighed.
Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.
Da demodecose er en multi-faktuel sygdom, anbefales det at behandle underliggende sygdom på passende måde, hvor det er muligt.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
En tyggetablet indeholder følgende aktive stoffer:
Each chewable tablet contains the active substances:
Milbemycinoxim indeholder to hovedkomponenter, A3 og A4 (i forholdet 20:80 for A3: A4).
Milbemycin oxime contains two major components, A3 and A4 (ratio of 20:80 for A3:A4).
Resistens hos parasitter kan udvikles over for enhver klasse af antiparasitære lægemidler ved hyppig anvendelse af et stof fra samme klasse.
Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class.
NEXGARD SPECTRA er ikke beregnet til udryddelse af mikrofilarier fra positive hunde.
NEXGARD SPECTRA is not indicated for removal of microfilariae from positive dogs.
I tilfælde af selvindgivelse ved hændeligt uheld, især til børn, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
- In case of accidental ingestion, particularly in the case of children, seek medical advice immediately and show the package leaflet or the label to the physician.
Da der ikke foreligger data, skal behandling af hvalpe yngre end 8 uger og hunde, som vejer under 2 kg, baseres på den ansvarlige dyrlæges vurdering af benefit-risk-forholdet.
In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Middel maksimal koncentration (Cmax) er 1822 ± 165 ng/ml i plasma påvist 2-4 timer (Tmax) efter en dosis på 2,5 mg/kg afoxolaner.
The mean maximum concentration (Cmax) is 1822 ± 165 ng/ml in plasma found 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
Isoxazoliner, blandt chloridkanalmodulatorerne, bindes til et bestemt og unikt område i insektets GABACl , hvorved de blokerer den præ- og postsynaptiske overførsel af chloridioner over cellemembraner.
Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Milbemycinoxim er et substrat for P-glycoprotein (P-gp) og kan derfor interagere med andre P-gp substrater (for eksempel digoxin og doxorubicin) eller andre makrocykliske laktoner.
Milbemycin oxime is a substrate for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
En tablet indeholder:
Each chewable tablet contains:
Maksimal milbemycinoxim plasmakoncentrationer nås hurtigt inden for de første 1-2 timer (Tmax), hvilket indikerer at absorptionen fra tyggetabletterne er hurtig.
Milbemycin oxime plasma concentrations peak quickly within the first 1-2 hours (Tmax) indicating that absorption from the chewable tablets is fast.
Behandlingsinterval: Behandlingsintervallet skal baseres på dyrlægens diagnose og på den lokale epidemiologiske status.
The treatment schedule should be based on veterinary diagnosis and on the local epidemiological situation.
Opretholdelse af de makrocykliske laktoners virkning er afgørende for at kunne kontrollere Dirofilaria immitis.
Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control.
NEXGARD SPECTRA er ikke indiceret til udryddelse af mikrofilarier.
NEXGARD SPECTRA is not indicated for microfilariae clearance.
Det veterinærmedicinske lægemiddel skal administreres i en dosis på 2,50-5,36 mg/kg afoxolaner og 0,50-1,07 mg/kg milbemycinoxim i henhold til følgende tabel:
The veterinary medicinal product should be administered at a dose of 2.50-5.36 mg/kg of afoxolaner and 0.50-1.07 mg/kg of milbemycin oxime in accordance with the following table:
Der er ikke påvist nogen terapeutisk virkning mod voksne Dirofilaria immitis.
No therapeutic effect against adult Dirofilaria immitis has been established.
Farmakoterapeutisk gruppe: antiparasitære midler, endektocider, milbemycinkombinationer.
Pharmacotherapeutic group: antiparasitic products, endectocides, milbemycin combinations.
Terminale halveringstider og maksimale koncentrationer (Cmax) efter oral administration er 1,6 ± 0,4 dage og 42 ± 11 ng/ml for A3 formen, 3,3 ± 1,4 dage og 246 ± 71 ng/ml for A4 formen.
The terminal half-lives and maximum concentrations (Cmax) following oral administration are 1.6 ± 0.4 days and 42 ± 11 ng/ml for the A3 form, 3.3 ± 1.4 days and 246 ±71 ng/ml for the A4 form.
Langvarig afoxolanerinduceret hypereksitation resulterer i en ukontrolleret aktivitet i centralnervesystemet med deraf følgende drab af insekter og mider.
Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines.
Til oral administration.
For oral use.
Begge former har lav systemisk clearance (75 ± 22 ml/t/kg for A3 formen og 41 ± 12 ml/t/kg for A4 formen).
Both forms have low systemic clearance (75 ± 22 ml/h/kg for the A3 form and 41 ± 12 ml/h/kg for the A4 form).
Når det erstatter et andet præparat til forebyggelse af hjerteorm, bør første behandling med NEXGARD SPECTRA starte på den dato, hvor det tidligere præparat skulle have været givet.
When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with NEXGARD SPECTRA should start on the date when the former medication was due to have been administered.
Spørg dyrlægen til råds om fortsat loppe- og flåtbehandling.
Ask your veterinarian how to continue flea and tick treatment.
Afoxolaner virker som en antagonist på ligand-styrede chloridkanaler, især de der styres af neurotransmitteren gamma-aminosmørsyre (GABA).
Afoxolaner acts as an antagonist at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA).
Behandlingen bør fortsætte i en måned efter sidste myggeeksponering.
Treatment should continue until 1 month after the last exposure to mosquitoes.
Baseret på dyrlægens skøn bør infesterede hunde behandles med et adulticid til at udrydde voksne hjerteorm.
At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms.
Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please inform your veterinary surgeon.
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) - Ualmindelige (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 sjælden (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).
Afoxolaner dræber lopper før ægproduktion og forebygger derfor smittespredning til omgivelserne.
Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination.
Derfor bør anvendelsen af dette præparat baseres på en individuel vurdering af hvert enkelt tilfælde samt på lokale epidemiologiske informationer om målarternes aktuelle følsomhed for at begrænse sandsynligheden for fremtidig resistensudvikling.
Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Tyggetabletter Læs indlægssedlen inden brug.
Chewable tablets Read the package leaflet before use.
Derfor skal præparatet anvendes med regelmæssige månedlige intervaller i den periode, hvor vektorerne er til stede, med opstart inden for en måned efter første forventede myggeeksponering.
Therefore, the product should be administered at regular monthly intervals during the time of the year when mosquitoes are present, starting in the month after the first expected exposure to them.
Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Præparatet kan forårsage forstyrrelser i mave-tarmkanalen, hvis det indtages.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: - This product may cause gastrointestinal disturbances if ingested.