FrancophonIA/ELRC3.0 huggingface dataset:
English: For a full list of all side effects reported with PRILACTONE, and for a list of all interactions with other medicines, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved PRILACTONE og interaktioner med andre lægemidler fremgår af indlægssedlen.
English: What is PRILACTONE?
Danish: Hvad er PRILACTONE?
English: The results of the studies showed that dogs with congestive heart failure caused by faulty heart valves that were given PRILACTONE tablets in addition to another heart medicine (‘standard therapy'), had a longer survival time than the dogs that received the standard therapy plus placebo tablets.
Danish: Resultaterne fra undersøgelserne viste, at hunde med kongestiv hjerteinsufficiens forårsaget af defekte hjerteklapper, som fik PRILACTONE tabletter som tillæg til anden hjertemedicin (‘standardbehandling'), havde en længere overlevelsestid end hunde, der fik standardbehandling plus placebotabletter.
English: What is PRILACTONE used for?
Danish: Hvad anvendes PRILACTONE til?
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af denforelagte dokumentation førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
English: As spironolactone can reduce the levels of some male hormones, male dogs which have not been neutered may show a shrinking of the prostate gland.
Danish: Da spironolacton kan nedsætte niveauet af visse mandlige hormoner, kan prostatakirtlen blive mindre hos hanhunde, der ikke er kastreret.
English: How has PRILACTONE been studied?
Danish: Hvordan blev PRILACTONE undersøgt?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of PRILACTONE outweigh its risks for use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs, and recommended that PRILACTONE be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) har fundet, at fordelene ved PRILACTONE er større end risiciene ved brug i kombination med standardbehandling (herunder vanddrivende behandling om nødvendigt) til behandling af kongestiv hjerteinsufficiens forårsaget af utætte hjerteklapper hos hunde.
English: What benefit has PRILACTONE shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved PRILACTONE?
English: How does PRILACTONE work?
Danish: Hvordan virker PRILACTONE?
English: belonging to the group called ‘ACE-inhibitors' and if needed a diuretic).
Danish: endvidere ‘standardbehandling' (normalt et andet lægemiddel i gruppen ‘ACE-hæmmere' og om nødvendigt vanddrivende behandling).
English: 518057, People's Republic of China
Danish: 518057, Folkerepublikken Kina
English: After first opening
Danish: Efter første åbning
English: • you are elderly (over 65 years old) and especially if you are over 75 years old
Danish: • hvis du er ældre (over 65 år) og især, hvis du er over 75 år
English: This is because it needs to be given as an injection.
Danish: Det skyldes, at det skal gives som en indsprøjtning.
English: Inhixa works in two ways.
Danish: Inhixa virker på to måder.
English: Prophylaxis should be continued until the patient no longer has significantly reduced mobility.
Danish: Profylaksen bør fortsættes, indtil patienten ikke længere har signifikant reduceret mobilitet.
English: These agents include medicinal products such as:
Danish: Disse lægemidler omfatter:
English: The benefit is not established for a treatment longer than 14 days.
Danish: Der er ikke påvist nogen fordel ved behandling ud over 14 dage.
English: The amount of Inhixa given to you will depend on your age and the kind of heart attack you have had.
Danish: Den dosis Inhixa, du får, afhænger af din alder og den type hjerteanfald, du har haft.
English: Benzyl alcohol may cause allergic reactions.
Danish: Benzylalkohol kan forårsage allergiske reaktioner.
English: • you are underweight or overweight
Danish: • hvis du er undervægtig eller overvægtig
English: It is recommended to prepare the dilution immediately before use.
Danish: Det anbefales at forberede opløsningen umiddelbart før anvendelse.
English: The minimum amount of benzyl alcohol at which toxicity may occur is not known.
Danish: Den minimale mængde af benzylalkohol, ved hvilken toksicitet kan opstå, er ikke kendt.
English: 00-725 Warsaw
Danish: 00-725 Warszawa
English: This amount is usually enough for a 4-hour session.
Danish: Effekten af denne dosis er som regel tilstrækkelig for en 4-timers session.
English: Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
Danish: Må ikke gives til nyfødte babyer (op til 4 uger gamle), medmindre det anbefales af lægen.
English: As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol.
Danish: Da benzylalkohol kan krydse moderkagen, anbefales det at bruge en formulering, der ikke indeholder benzylalkohol.
English: Intra-patient and inter-patient variability is low.
Danish: Den intra- og interindividuelle variabilitet er lav.
English: • you have had an operation recently on your eyes or brain
Danish: • hvis du for nyligt er blevet opereret i øjnene eller hjernen
English: Before injecting yourself with Inhixa - Check the expiry date on the medicine.
Danish: Inden du giver dig selv en indsprøjtning med Inhixa - Undersøg udløbsdatoen på lægemidlet.
English: Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Danish: Enoxaparinnatrium bør kun anvendes under graviditet, hvis lægen har fastlagt, at der er et klart behov.
English: If you stop, you could get a blood clot which can be very dangerous.
Danish: Hvis du stopper med at bruge det, kan du få en blodprop, hvilket kan være meget farligt.
English: Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.
Danish: Må ikke anvendes i længere end 1 uge til små børn (mindre end 3 år gamle), medmindre det anbefales af lægen eller af apotekespersonalet.
English: These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see section 4.4).
Danish: Disse reaktioner har resulteret i varierende grader af neurologiske skader, inklusive langvarig eller permanent paralyse (se pkt.
English: • Your doctor will normally ask you to take acetylsalicylic acid as well.
Danish: • Normalt vil lægen anbefale, at du også får acetylsalicylsyre.
English: Inhixa is indicated in adults for:
Danish: Inhixa er indiceret til voksne til:
English: • If you have problems with your kidneys you may be given a smaller amount of Inhixa.
Danish: • Hvis du har problemer med nyrerne, vil du muligvis få en mindre dosis Inhixa.
English: • When you go home, you may need to continue to use Inhixa and give it yourself.
Danish: • Når du bliver udskrevet, skal du muligvis fortsætte med at bruge Inhixa og give det til dig selv.
English: Inhixa can be used to:
Danish: Inhixa kan anvendes til:
English: The contents of the bag should be gently mixed.
Danish: Indholdet i posen blandes forsigtigt.
English: If you are able to give this medicine to yourself, your doctor or nurse will show you how to do this.
Danish: Hvis du er i stand til at give dig selv lægemidlet, vil lægen eller en sygeplejerske vise dig, hvordan du skal gøre.
English: Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred.
Danish: Der blev foretaget bilateral venografi mellem dag 25 og dag 31 eller tidligere, hvis der opstod symptomer på venøs tromboemboli.
English: • if you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.
Danish: • Hvis du får et smertefuldt udslæt med mørkerøde pletter under huden, der ikke går væk, når man trykker på dem.
English: The recommended dosage adjustments do not apply to the haemodialysis indication.
Danish: De anbefalede dosisjusteringer gælder ikke for hæmodialyse indikationen.
English: • you have ever had a reaction to heparin that caused a severe drop in the number of your platelets
Danish: • hvis du har haft en reaktion over for heparin, som medførte et alvorligt fald i antallet af blodplader
English: For storage conditions after first opening and dilution of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold efter første åbning og fortynding af lægemidlet, se pkt.
English: Total VTE
Danish: · VTE totalt
English: Instructions on injecting yourself with Inhixa 1) Wash your hands and the area that you will inject with soap and water.
Danish: Vejledning i at give dig selv en indsprøjtning med Inhixa 1) Vask hænderne og det område, hvor du vil give indsprøjtningen, med sæbe og vand.
English: • Proximal DVT
Danish: • Proksimal DVT
English: Inhixa is a biosimilar medicinal product.
Danish: Inhixa er et biosimilært lægemiddel.
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal produktet, medmindre metoden til fortynding udelukker risikoen for mikrobiel kontaminering, anvendes straks.
English: • When you go home, you may need to continue to use Inhixa and give it yourself (see instructions below on how to do this).
Danish: • Når du bliver udskrevet, skal du muligvis fortsætte med at bruge Inhixa og give det til dig selv (se nedenstående anvisninger i, hvordan du skal gøre dette).
English: • you have high blood pressure
Danish: • hvis du har forhøjet blodtryk
English: Treatment should be maintained for a minimum of 2 days and continued until clinical stabilization.
Danish: Behandlingen bør gives i mindst 2 dage, og fortsætte indtil patienten er stabiliseret klinisk.
English: • Inhixa can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Danish: • Inhixa kan gives som en indsprøjtning i en vene (intravenøst) efter bestemte typer hjerteanfald eller operationer.
English: 75236 Uppsala Sweden
Danish: 75236 Uppsala Sverige
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Danish: Dette skyldes, at store mængder benzylalkohol kan ophobe sig i kroppen og medføre bivirkninger (metabolisk acidose).
English: Plasma potassium should be monitored regularly especially in patients at risk.
Danish: Plasmakalium bør monitoreres regelmæssigt, særligt hos patienter i risikogruppe.
English: This could be a liver problem.
Danish: Dette kan skyldes et problem med leveren.
English: Talk to your doctor or pharmacist before using Inhixa if:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Inhixa:
English: Ask your doctor or pharmacist for advice if you have a liver or kidney disease, or if you are pregnant or breast-feeding.
Danish: Spørg lægen eller apotekspersonalet til råds, hvis du har en lever- eller nyresygdom, eller hvis du er gravid eller ammer.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal henvende til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: The anticoagulant effects can be largely neutralized by the slow intravenous injection of protamine.
Danish: Den antikoagulerende virkning kan i stort omfang neutraliseres ved langsom intravenøs injektion af protamin.
English: • The maximum amount of Inhixa given for the first two injections is 7,500 IU (75 mg).
Danish: • Den højeste dosis Inhixa, der gives i de to første indsprøjtninger, er 7.500 IE (75 mg).
English: • you have diabetes or problems with blood vessels in the eye caused by diabetes (called diabetic retinopathy)
Danish: • hvis du har sukkersyge (diabetes) eller problemer med blodårerne i øjet/øjnene på grund af diabetes (kaldes diabetisk retinopati)
English: The oral absorption of enoxaparin sodium is unlikely.
Danish: Oral absorption af enoxaparinnatrium er usandsynlig.
English: Do not inject Inhixa into a muscle.
Danish: Inhixa må ikke sprøjtes ind i en muskel.
English: Animal studies did not show any effect on fertility (see section 5.3).
Danish: Dyrestudier viste ingen indvirkning på fertilitet (se pkt.
English: Elderly patients (especially patients eighty years of age and older) may be at an increased risk for bleeding complications with the therapeutic dosage ranges.
Danish: Ældre patienter (især patienter på80 år eller derover) kan have en øget risiko for blødningskomplikationer ved doser i de terapeutiske dosisintervaller.
English: The amount will depend on the reason it is being used.
Danish: Den mængde, du får, afhænger af, hvorfor du får det.
English: • Traceability
Danish: • Sporbarhed
English: Both enoxaparin sodium regimens were equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism (DVT and/or PE).
Danish: Begge enoxaparinnatrium-behandlinger var ækvivalente med behandling med standard-heparin med hensyn til at reducere risikoen for recidiverende venøs tromboemboli (DVT og/eller PE).
English: It is important for you to keep having Inhixa injections until your doctor decides to stop them.
Danish: Det er vigtigt, at du bliver ved med at få dette lægemiddel, indtil lægen siger, at du kan stoppe.
English: Let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.
Danish: 9) Slip derefter stemplet og lad sprøjten bevæge sig, indtil hele nålen er beskyttet og låst fast.
English: EXP The contents of the multidose vial should be used within 28 days of opening.
Danish: EXP Indholdet i flerdosishætteglasset skal bruges inden for 28 dage efter åbning.
English: Elimination appears monophasic with a half-life of about 5 hours after a single subcutaneous dose to about 7 hours after repeated dosing.
Danish: Eliminationen synes at være monofasisk med en halveringstid på ca. 5 timer efter en enkelt subkutan dosis til ca. 7 timer efter gentagen dosering.
English: Note for the pre-filled syringes fitted with an automatic safety system: The safety system is triggered at the end of the injection (see instructions in section 6.6).
Danish: Bemærkning til de fyldte injektionssprøjter, der er udstyret med et automatisk sikkerhedssystem: Sikkerhedssystemet udløses efter afslutning af injektionen (se instruktioner i pkt.
English: • Laboratory tests
Danish: • Laboratorieanalyser
English: Benzyl alcohol (see leaflet for further information) Water for injections
Danish: Benzylalkohol (se indlægssedlen for yderligere oplysninger) Vand til injektionsvæsker.
English: The whole length of the needle should be introduced vertically into a skin fold gently held between the thumb and index finger.
Danish: Kanylens fulde længde skal indføres vertikalt i en hudfold, som holdes mellem tommel- og pegefinger.
English: In lactating rats, the passage of enoxaparin or its metabolites in milk is very low.
Danish: Hos diegivende rotter er udskillelsen af enoxaparin og dets metabolitter i mælken meget lav.
English: • Itchy red skin.
Danish: • Kløende, rød hud.
English: See section “Do not use Inhixa”.
Danish: Se afsnittet ”Brug ikke Inhixa”.
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days below 25°C.
Danish: Fra et mikrobiologisk synspunkt kan produktet, når det er åbnet, opbevares i maksimalt 28 dage under 25 °C.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end de, der er nævnt i pkt.
English: Important information about some of the ingredients of Inhixa Inhixa contains benzyl alcohol (45 mg/3 mL; 75 mg/5 mL; 150 mg/10 mL).
Danish: Vigtige oplysninger om nogle af stofferne i Inhixa Inhixa indeholder benzylalkohol (45 mg/3 ml; 75 mg/5 ml; 150 mg/10 ml).
English: These are more likely to appear in the area you have been injected with Inhixa.
Danish: Dette ses oftest i det område, hvor Inhixa er blevet sprøjtet ind.
English: Prophylaxis in medical patients
Danish: Profylakse hos medicinske patienter
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Danish: Såfremt det ikke anvendes straks, er opbevaringstider og forhold under brug brugerens ansvar.
English: • If you are allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for enoxaparinnatrium eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Concomitant use with caution
Danish: Samtidig anvendelse kan ske med forsigtighed
English: Appropriate antiplatelet therapy such as oral acetylsalicylic acid (75 mg to 325 mg once daily) should be administered concomitantly unless contraindicated.
Danish: Passende trombocythæmmende behandling såsom oral acetylsalicylsyre (75 mg til 325 mg en gang dagligt) bør administreres samtidigt, medmindre der er kontraindikationer.
English: Prophylaxis of venous thromboembolic disease in medical patients with an acute illness expected to induce limitation of mobility
Danish: Profylakse af venøs tromboembolisk sygdom hos medicinske patienter med en akut sygdom, der forventes at medføre begrænset mobilitet
English: Acute infective endocarditis
Danish: Akut infektiøs endocarditis
English: Inhixa contains sodium
Danish: Inhixa indeholder natrium
English: In case of self-administration, patient should be advised to follow instructions provided in the patient information leaflet included in the pack of this medicine.
Danish: Ved selvadministration skal patienten informares om, at de skal følge anvisningerne i indlægssedlen, som ligger i pakningen sammen med lægemidlet.
English: All Treated Medical Patients During Acute Illness
Danish: Alle behandlede medicinske patienter under akut sygdom
English: After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (mL) = Patient weight (kg) x 0.1] or using the table below.
Danish: Efter fortynding kan den volumen, der skal injiceres, beregnes ved hjælp af følgende formel [Volumen af fortyndet opløsning (ml) = patientens vægt (kg) x 0,1] eller ved hjælp af nedenstående tabel.
English: • you have liver problems
Danish: • hvis du har leverproblemer
English: • Acute infective endocarditis
Danish: • Akut infektiøs endocarditis
English: In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 IU/mL (3 mg/mL).
Danish: For at sikre nøjagtigheden af det lille volumen, der skal injiceres, anbefales det at fortynde lægemidlet til 300 IE/ml (3 mg/ml).
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • you have had a recent stroke
Danish: • hvis du for nyligt har haft et slagtilfælde
English: Likewise, consider not using enoxaparin sodium until at least 4 hours after the spinal/epidural puncture or after the catheter has been removed.
Danish: På samme måde bør det overvejes ikke at anvende enoxaparinnatrium før mindst 4 timer efter spinal/epidural punktur eller efter fjernelse af kateteret.
English: If you think that you have used too much or too little Inhixa, tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Danish: Hvis du tror, at du har fået for meget eller for lidt Inhixa, skal du straks fortælle det til lægen, sundhedspersonalet eller apotekspersonalet, også selvom du ikke har tegn på, at der er et problem.
English: This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions).
Danish: Dette resulterer i variationer i deres farmakokinetik og biologiske aktivitet (f.eks. antitrombin-aktivitet og trombocytinteraktioner).
English: • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
Danish: • Akut koronarsyndrom: - Behandling af ustabil angina pectoris og myokardieinfarkt uden ST-segment-elevation (NSTEMI) i kombination med oral acetylsalicylsyre.
English: • Inhixa is usually given by injection underneath the skin (subcutaneous).
Danish: • Inhixa gives normalt som en indsprøjtning under huden (subkutant).
English: High volumes of medicinal products containing benzyl alcohol should be used with caution and only if necessary in patients with liver or kidney impairment, or in pregnant women, because of the risk of accumulation of benzyl alcohol and its toxicity (metabolic acidosis).
Danish: Store mængder af lægemidler indeholdende benzylalkohol bør anvendes med forsigtighed hos patienter og kun om nødvendigt hos patienter med nedsat lever- eller nyrefunktion eller gravide på grund af risikoen for ophobning af benzylalkohol og dets toksicitet (metabolisk acidose).
English: The Inhixa pre-filled syringes are for single dose use only.
Danish: De fyldte Inhixa-sprøjter er kun til brug til en enkelt dosis.
English: Additional bolus for PCI when last subcutaneous administration was given more than 8 hours before balloon inflation
Danish: o Yderligere bolus ved PCI, når sidste subkutane administration blev givet mere end 8 timer før ballonudvidelsen
English: 4,716 patients underwent percutaneous coronary intervention receiving antithrombotic support with blinded study drug.
Danish: 4.716 patienter gennemgik perkutan koronar intervention og fik antitrombotika med det blindede studielægemiddel.
English: Stop using Inhixa and talk to a doctor or nurse at once if you get any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
Danish: Du skal straks stoppe med at bruge Inhixa og kontakte lægen eller sundhedspersonalet, hvis du får tegn på en alvorlig allergisk reaktion (såsom vejrtrækningsbesvær, hævelse af læber, mund, svælg eller øjne).
English: - Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).
Danish: - Behandling af akut myokardieinfarkt med ST-segment-elevation (STEMI) inklusive patienter, som skal i medicinsk behandling eller efterfølgende gennemgå perkutan koronar intervention (PCI).
English: Enoxaparin sodium treatment is prescribed for an average period of 10 days.
Danish: Behandling med enoxaparinnatrium ordineres i gennemsnit i en periode på i 10 dage.
English: Inhixa can be used during breastfeeding.
Danish: Inhixa kan anvendes i ammeperioden.
English: If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are using Inhixa.
Danish: Hvis du skal have foretaget en rygmarvspunktur eller en operation, hvor du skal have en rygmarvsbedøvelse eller epidural bedøvelse, skal du fortælle lægen, at du får Inhixa.