natgillin/translations-raw huggingface dataset:
Omfanget af den analgetiske virkning af en 40 mg dosis er sammenlignelig med ketorolac 60 mg i.m.
The magnitude of analgesic effect of the 40 mg dose was comparable with that of ketorolac 60 mg IM or ketorolac 30 mg IV. After a single dose, the duration of analgesia was dose and clinical pain model dependent, and ranged from 6 to greater than 12 hours.
administration var eksponering af parecoxib ens, udtrykt i AUC.
Exposure to parecoxib was similar after IV or IM administration in terms of AUC.
• hvis De bruger medicin for at nedsætte blodets evne til at størkne (f.eks. warfarin/warfarin lignende antikoagulerende lægemidler eller nye antikoagulerende lægemidler, f.eks. apixaban,
▪ If you are dehydrated - this may happen if you have had diarrhoea or have been vomiting (being sick) or unable to drink fluids ▪ If you have an infection as it may hide a fever (which is a sign of infection) ▪ If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban, dabigatran, and rivaroxaban) ▪ If you use medicines called corticosteroids (e.g. prednisone) ▪ If you use a class of medicines used to treat depression called selective serotonin re-uptake inhibitors (e.g. sertraline)
- Aktivt stof: parecoxib (som parecoxibnatrium).
What Dynastat contains - The active substance is parecoxib (as parecoxib sodium).
Der er ikke fundet nogen påvirkninger efter parecoxib af fertiliteten hos han- og hunrotter.
No effects of parecoxib on male or female fertilities were found in rats.
• natriumchloridinjektions-/infusionsvæske 9 mg/ml (0,9%)
• sodium chloride 9 mg/ml (0.9%) solution for injection/infusion;
• Warfarin - eller andre warfarin-lignende lægemidler, som anvendes for at hindre blodet i at størkne, herunder nyere lægemidler som apixaban, dabigatran og rivaroxaban
▪ Acetylsalicylic acid (aspirin) or other anti-inflammatory medicines ▪ Fluconazole - used for fungal infections ▪ ACE inhibitors, Angiotensin-II inhibitors, beta blockers and diuretics - used for high blood pressure and heart conditions ▪ Ciclosporin or Tacrolimus - used after transplants ▪ Warfarin - or other warfarin like medicines used to prevent blood clots including newer medicines like apixaban, dabigatran, and rivaroxaban
• glucoseinfusionsvæske 50 mg/ml (5%) eller
• glucose 50 mg/ml (5%) solution for infusion; or
Almindelige bivirkninger: forekommer hos mellem 1 og 10 ud af 100 personer
Uncommon (1/1000 to <1/100)
Dynastat 40 mg pulver til injektionsvæske, opløsning parecoxib
Dynastat 40 mg powder for injection Parecoxib
Almen kirurgi
General surgery
- Spørg lægen eller sundhedspersonalet, hvis der er mere, De vil vide.
- If you have further questions, ask your doctor or nurse.
har ingen signifikant effekt på farmakokinetikken af hverken fentanyl i.v.
Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).
Metabolisme og ernæring Hypokalæmi
Metabolism and nutrition disorders Hypokalaemia Hyperglycaemia, anorexia
Sjældne bivirkninger: forekommer hos færre end 1 ud af 1000 personer
Rare (1/10,000 to <1/1000)
YDRE EMBALLAGE: 40 mg hætteglas
OUTER CARTON: 40 mg vials
• Personer over 65 år, der vejer mindre end 50 kg
Some people may be given lower doses: ▪ People with liver problems ▪ People with severe kidney problems ▪ Patients over 65 who weigh less than 50 kg ▪ People taking fluconazole.
Parecoxibnatrium hætteglas
Parecoxib sodium vials
Bivirkningsliste
Platelet studies
I.m.
SN:
Dynastat 40 mg pulver og solvens til injektionsvæske, opløsning.
Dynastat 40 mg powder and solvent for solution for injection
• Infektion i kæben (betændelse og smerte efter tandudtrækning)
▪ Dry socket (inflammation and pain after a tooth extraction) ▪ Increased sweating ▪ Low levels of potassium in blood test results
Amning
Dosing.
• natriumchlorid 4,5 mg/ml (0,45%) og glucose 50 mg/ml (5%) injektions-/infusionsvæske eller
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion; or
• natriumchlorid 4,5 mg/ml (0,45%) og glucose 50 mg/ml (5%) injektions-/infusionsvæske
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion
• Misfarvning af huden eller blå mærker
or muscle tissue.
Akut nyresvigt Nyresvigt Almene symptomer og reaktioner på administrationsstedet Perifere ødemer
General disorders and administration site conditions Oedema peripheral
Dynastat 40 mg pulver til injektionsvæske, opløsning.
Dynastat 40 mg powder for solution for injection
• Kortåndethed.
Hepatic impairment
3 x (1 hætteglas +1 fyldt injektionssprøj te +1 stempelstang +1 adapter +1 kanyle) (multipakning)
3 x (1 vial + 1 prefilled syringe + 1 plunger rod + 1 vial adapter + 1 needle) (multipack)
2 hætteglas +2 fyldte injektionssprøjter + 2 stempelstænger +2 adaptere + 2 kanyler
2 vials +2 pre-filled syringes +2 plunger rods + 2 vial adapters + 2 needles
1 hætteglas +1 fyldt injektionssprøjte +1 stempelstang +1 adapter +1 kanyle
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 needle
MF (EU)-nummer
MA (EU) Number Invented name Strength Pharmaceutical Form Route of Administration
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Twynsta den 7. oktober 2010.
The European Commission granted a marketing authorisation valid throughout the EU for Twynsta on 7 October 2010.
Den maksimale dosis er én tablet med den højeste styrke (80/10 mg) én gang dagligt.
The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Twynsta.
This is a summary of the European public assessment report (EPAR) for Twynsta.
De er begge blodtrykssænkende lægemidler, der har været tilgængelige på markedet i Den Europæiske Union (EU) siden 1990'erne.
Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s.
Den fuldstændige EPAR for Twynsta findes på agenturets websted under under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Twynsta can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Da både telmisartan og amlodipin har været anvendt i mange år, fremlagde virksomheden oplysninger fra den videnskabelige litteratur og resultater af nye undersøgelser foretaget af virksomheden selv.
Because telmisartan and amlodipine have been used for many years, the company presented information from scientific literature as well as results from new studies that the company had carried out.
Det fås som tabletter (40 mg telmisartan/10 mg amlodipin, 40 mg telmisartan/5 mg amlodipin, 80 mg telmisartan/10 mg amlodipin og 80 mg telmisartan/5 mg amlodipin).
It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).
Andre oplysninger om Twynsta:
Other information about Twynsta:
Det blokerer særlige kanaler på celleoverfladen kaldet calciumkanaler, igennem hvilke calciumionerne normalt kommer ind i cellerne.
It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Twynsta telmisartan/amlodipin
Twynsta telmisartan / amlodipine
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, hvordan Twynsta skal anvendes.
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 Twynsta.
I de tilfælde, hvor det er relevant, kan det overvejes at skifte direkte til Twynsta.
When appropriate, direct switch to Twynsta may be considered.
Udvalget fandt, at fordelene ved Twynsta opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det primære effektmål i de tre undersøgelser var faldet i det diastoliske blodtryk (blodtrykket målt mellem to hjerteslag) efter otte uger.
The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.
Ved at sænke blodtrykket reduceres risiciene i forbindelse med højt blodtryk, såsom slagtilfælde.
By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
CHMP bemærkede, at patienter, som får de to aktive stoffer i separate tabletter, sandsynligvis vil følge deres behandling bedre, hvis de får Twynsta.
The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Twynsta.
Telmisartan er en "angiotensin II-receptorantagonist", hvilket betyder, at det blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Hvis du ønsker yderligere oplysninger om behandling med Twynsta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De hyppigste bivirkninger ved Twynsta (som ses hos op til 1 ud af 10 patienter) er svimmelhed og perifert ødem (hævelse, især på ankler og fødder).
The most common side effects with Twynsta (seen in up to 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Twynsta tages gennem munden som en tablet én gang dagligt.
Twynsta is taken by mouth as one tablet once a day and is used for long-term treatment.
Twynsta anvendes til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne over 18 år.
Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
De virker på samme måde og sænker blodtrykket ved at få blodkarrene til at afslappes.
They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Ved at blokere de receptorer, som angiotensin II normalt binder sig til, standser telmisartan virkningen af hormonet og gør det muligt for blodkarrene at udvide sig.
By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Twynsta må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, chok (kraftigt blodtryksfald), obstruktion af blodgennemstrømningen fra venstre side af hjertet, eller til patienter med hjerteinsufficiens efter myokardieinfarkt (hjertetilfælde).
Twynsta must not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).
I en hovedundersøgelse blev 1 461 voksne med hypertension behandlet med kombinationer af telmisartan og amlodipin, med telmisartan eller amlodipin alene eller med placebo (en virkningsløs behandling).
In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment).
Når der kommer calciumioner ind i muskelcellerne i blodkarrenes vægge, forårsager det en sammentrækning.
When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Der blev desuden gennemført undersøgelser for at vise, at Twynsta-tabletterne optages i kroppen på samme måde som de separate tabletter med amlodipin og telmisartan.
Studies were also carried to show that Twynsta tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.
Desuden viste undersøgelserne, at lægemidlet var effektivt hos patienter, hvis blodtryk ikke kontrolleres tilstrækkeligt med amlodipin alene.
In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone.
Ved at reducere mængden af calcium til cellerne forhindrer amlodipin cellerne i at trække sig sammen, hvilket får blodkarrene til at afslappes.
By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Hvilken risiko er der forbundet med Twynsta?
What is the risk associated with Twynsta?
Twynsta kan også anvendes i stedet for behandling med telmisartan og amlodipin hos patienter, der får de to lægemidler i separate tabletter.
Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
I to andre hovedundersøgelser blev 1 978 voksne med hypertension, hos hvem amlodipin ikke havde virket tilfredsstillende, behandlet med enten Twynsta eller fortsatte med amlodipin i samme dosis eller i en højere dosis.
In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Twynsta or continued to take amlodipine at the same or a higher dose.
Hvorfor blev Twynsta godkendt?
Why has Twynsta been approved?
I den første undersøgelse var faldet i det diastoliske blodtryk hos patienter, der tog kombinationer af telmisartan og amlodipin, større end hos de patienter, der udelukkende tog et af de aktive stoffer eller placebo.
In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.
Twynsta må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for telmisartan, amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater" eller over for andre af indholdsstofferne.
Twynsta must not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients.
Twynsta i kombination med lægemidler, der indeholder aliskiren (som desuden anvendes til behandling af essentiel hypertension), må heller ikke anvendes til patienter med type 2-diabetes eller moderat eller alvorlig nyresygdom.
Twynsta must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Den fuldstændige liste over de indberettede bivirkninger ved Twynsta fremgår af indlægssedlen.
For the full list of all side effects reported with Twynsta, see the package leaflet.
Twynsta er et lægemiddel, som indeholder de to aktive stoffer telmisartan og amlodipin.
Twynsta is a medicine that contains two active substances, telmisartan and amlodipine.
Hvad er Twynsta?
What is Twynsta?
Twynsta anvendes til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende ved hjælp af amlodipin alene.
Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone.
For patienter, der har fået telmisartan og amlodipin i separate tabletter, afhænger dosen af Twynsta af de doser telmisartan og amlodipin, patienterne fik tidligere.
For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Twynsta to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.
Twynsta indeholder de to aktive stoffer telmisartan og amlodipin.
Twynsta contains two active substances, telmisartan and amlodipine.
Hvad anvendes Twynsta til?
What is Twynsta used for?
Der bør anvendes separate tabletter med amlodipin og telmisartan til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin, for at justere dosis inden der skiftes til Twynsta.
For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Twynsta.
Hvordan blev Twynsta undersøgt?
How has Twynsta been studied?
Afhængigt af styrkerne af Twynsta og amlodipin var faldet i det diastoliske blodtryk mellem 1,4 mmHg og 4,9 mmHg større hos patienter, som fik Twynsta.
In the two other studies, Twynsta was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the fall in diastolic blood pressure was greater in patients taking Twynsta by between 1.4 mmHg and 4.9 mmHg.
Hvordan anvendes Twynsta?
How is Twynsta used?
Hvilken fordel viser undersøgelserne, at der er ved Twynsta?
What benefit has Twynsta shown during the studies?
Hvordan virker Twynsta?
How does Twynsta work?
Dato for første markedsføringstilladelse: 23/02/2005 Dato for seneste fornyelse af markedsføringstilladelsen: 25/01/2010
Date of first authorisation: 23/02/2005 Date of last renewal: 25/01/2010
ATCvet-kode: QI06AH09
ATCvet code: QI06AH09.
Laboratoires Porte des Alpes Rue de l'Aviation
Laboratoire Porte des Alpes Rue de l'aviation
Fremstiller ansvarlig for batchfrigivelse: MERIAL
Manufacturer responsible for the batch release: MERIAL
Vand til injektion ......................................................................................................................... q.s.
Water for injection ....................................................................................................................... q.s.
Der er ikke iagttaget andre symptomer end de, der er nævnt under punkt 4.6 ”Bivirkninger”, bortset fra hypertermi, der i sjældne tilfælde kan vare op til 5 dage.
No effects other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
EU/2/04/052/001 Lyofilisat (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) EU/2/04/052/002 Lyofilisat (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
EU/2/04/052/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/052/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Injicer subkutant en dosis (1 ml) af vaccinen efter opløsning af den frysetørrede pille i solvens, i henhold til følgende vaccinationsprogram:
Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Der foreligger oplysninger om sikkerhed og virkning der viser, at denne vaccine kan blandes og gives med Merials vaccine uden adjuvans mod felin leukæmi og/eller anvendes den samme dag men ikke blandes med Merials vaccine med adjuvans mod rabies.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Aktiv immunisering af katte, der er 8 uger eller ældre: - mod felin viral rhinotracheitis for at reducere kliniske tegn, - mod calicivirus infektion for at reducere kliniske tegn, - mod felin panleukopeni til forebyggelse af dødsfald og kliniske tegn.
Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs.
1 ml 1 cellekultur infektiøs dosis 50%.
1 ml 1 cell culture infective dose 50%.
Ved mistanke om tilstedeværelse af høje værdier af maternelle antistoffer over for rhinotracheitis, calicivirus eller panleukopeni komponenterne (fx hos 9-12 uger gamle killinger født af hunkatte, der var vaccineret før drægtighed, og/eller ved kendskab til eller mistanke om, at moderdyret har været udsat for de pågældende patogener), bør basisvaccination udsættes, til killingerne er 12 uger gamle.
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Revaccination: - den første revaccination skal foretages et år efter basisvaccinationen, - efterfølgende revaccinationer skal foretages med intervaller på op til tre år for rhinotracheitis,
Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Varigheden af immunitet efter sidste revaccination er 3 år for rhinotracheitis, calicivirus og panleukopeni komponenterne.
The duration of immunity after the last re-vaccination is 3 years for rhinotracheitis, calicivirosis and panleucopenia components.
Purevax RCP solvens.
Purevax RCP solvent
EXP {MM/ÅÅÅÅ} Anvendes straks efter rekonstituering .
EXP (mm/yyyy) Once reconstituted use immediately.
Vaccine mod felin viral rhinotracheitis, felin calicivirus og felin panleukopeni.
Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia.
Stimulerer aktivt immuniteten over for felin rhinotracheitis virus, felin calicivirus og felin panleukopeni virus.
Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, and feline panleucopenia virus.
Efter administration af flere doser er der ikke iagttaget andre symptomer end de, der er nævnt under ”Bivirkninger”, bortset fra forhøjet temperatur, der i sjældne tilfælde kan vare op til 5 dage.
No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Gentamycin max............................................................................................................................... 16,5 µg Solvens:
Gentamicin, at most ....................................................................................................................... 16.5 µg Solvent:
Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus og panleukopeni.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for the rhinotracheitis, calicivirus and panleucopenia components.
Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ..................................... ≥ 2,0 ELISA U. Svækket felin panleukopeni virus (PLI IV) ...................................................................... ≥ 103,5 CCID501
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501