natgillin/translations-raw huggingface dataset:
For practical information about using Brimica Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Brimica Genuair naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Brimica Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Zdravilo Brimica Genuair so proučevali v dveh glavnih študijah, v katerih je sodelovalo več kot 3 400 bolnikov s KOPB in v katerih so ga primerjali z aklidinijem kot samostojnim zdravilom, formoterolom kot samostojnim zdravilom in placebom (zdravilom brez zdravilne učinkovine).
However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Brimica Genuair than with formoterol alone.
Izboljšanje v primerjavi s formoterolom kot samostojnim zdravilom je bilo majhno in se ne šteje za klinično pomembnega: volumen FEV1, izmerjen zjutraj pred vdihavanjem, je bil pri uporabi zdravila Brimica Genuair za 68 ml večji kot pri uporabi formoterola kot samostojnega zdravila.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
KOPB je dolgotrajna bolezen, pri kateri postanejo dihalne poti in pljučni mešički poškodovani ali neprehodni, kar povzroča težave pri dihanju.
Brimica Genuair was also shown to increase the percentage of patients who had an improvement in breathlessness compared with placebo.
Prav tako je zdravilo Brimica Genuair povečalo odstotek bolnikov, pri katerih so opazili zmanjšanje zasoplosti, v primerjavi s placebom.
Brimica Genuair is available as an inhalation powder in a portable inhaler device.
Zdravilo Brimica Genuair je na voljo v obliki praška za inhaliranje v prenosnem inhalatorju.
This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic (also known as cholinergic) receptors, which control the contraction of muscles.
To pomeni, da z blokiranjem določenih receptorjev v pljučnih mišičnih celicah, imenovanih muskarinski (ali holinergični) receptorji, ki nadzorujejo krčenje mišic, razširi dihalne poti.
The CHMP noted that Brimica Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Brimica Genuair was compared with one of the components on its own, formoterol, was small.
Odbor CHMP je upošteval, da je zdravilo Brimica Genuair znatno izboljšalo delovanje pljuč pri bolnikih s KOPB v primerjavi s placebom, čeprav je bilo izboljšanje, opaženo pri primerjavi zdravila Brimica Genuair z eno od posamičnih učinkovin, tj. formoterolom, majhno.
Long-acting muscarinic antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Kombinacija dolgodelujočih muskarinskih antagonistov in dolgodelujočih agonistov adrenergičnih receptorjev beta-2 se pogosto uporablja za obvladovanje KOPB.
Brimica Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Zdravilo Brimica Genuair vsebuje dve zdravilni učinkovini: aklidinijev bromid in formoterolijev fumarat dihidrat.
For the full list of all side effects and restrictions with Brimica Genuair, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Brimica Genuair glejte navodilo za uporabo.
When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Z vezavo na omenjene receptorje sprošča mišice, kar odpre dihalne poti in bolniku olajša dihanje.
Brimica Genuair can only be obtained with a prescription.
Izdaja zdravila Brimica Genuair je le na recept.
The two active substances in Brimica Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Zdravilni učinkovini v zdravilu Brimica Genuair, aklidinijev bromid in formoterolijev fumarat dihidrat, delujeta tako, da pomagata ohranjati prehodnost dihalnih poti in tako bolniku olajšata dihanje.
How does Brimica Genuair work?
Kako zdravilo Brimica Genuair deluje?
How is Brimica Genuair used?
Kako se zdravilo Brimica Genuair uporablja?
When aclidinium bromide is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Aklidinijev bromid ob vdihu povzroči, da se mišice v dihalnih poteh sprostijo, kar pripomore k ohranjanju prehodnosti dihalnih poti in bolniku omogoča lažje dihanje.
Some of these cases have been fatal.
Nekateri od teh primerov so bili smrtni.
• History of HIT (>100 days)
• Anamneza HIT (> 100 dni)
You should tell your doctor straight away
Zdravniku morate nemudoma povedati
Thorinane works in two ways.
Thorinane deluje na dva načina.
It should be noted that the literature studies may have limitations.
Zavedati pa se je treba, da imajo v literaturi objavljene študije lahko svoje omejitve.
Your doctor should discuss this with you.
Zdravnik se mora z vami o tem pogovoriti.
A total of 1,102 patients were enrolled in the study, and 1,073 patients were treated.
Skupno sta bila v študijo vključena 1.102 bolnika in 1.073 bolnikov je bilo zdravljenih.
This is to make sure the needle stays clean (sterile).
S tem zagotovite, da igla ostane čista (sterilna).
If you forget to give yourself a dose, have it as soon as you remember.
Če si pozabite dati odmerek, ga morate dati, čim se spomnite.
Do not put it in the household rubbish.
Ne odložite ga med gospodinjske odpadke.
This is because they are not exactly the same and do not have the same activity and instructions for use.
Ta zdravila namreč niso povsem enaka ter nimajo enake aktivnost in navodil za uporabo.
The patients were followed for three months.
Bolnike so spremljali tri mesece.
In some cases the bleeding may not be obvious.
V nekaterih primerih takšne krvavitve niso očitne.
• Laboratory tests
• Laboratorijske preiskave
You may have bleeding in your stomach.
Morda imate krvavitev v trebuhu.
Treatment continued for 6 to 14 days (median duration 7 days).
Zdravljenje se je nadaljevalo od 6 do 14 dni (mediano trajanje 7 dni).
These agents include medicinal products such as:
Med takšna zdravila spadajo na primer:
If such use is considered absolutely necessary, the decision must be made only after a careful individual benefit risk assessment.
Če je takšna uporaba popolnoma nujna, se je zanjo treba odločiti le po skrbni individualni oceni koristi in tveganja.
Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required.
Zato sta potrebni posebna pozornost in upoštevanje navodil za uporabo, specifičnih za vsako lastniško zdravilo.
The efficacy data are provided in the table below.
Podatki o učinkovitosti so prikazani v spodnji preglednici.
Concomitant use not recommended:
Sočasna uporaba ni priporočljiva:
Prophylaxis should be continued until the patient no longer has significantly reduced mobility.
S profilakso je treba nadaljevati, dokler bolnikova mobilnost ni več bistveno zmanjšana.
• When you go home, you may need to continue to use Thorinane and give it yourself (see instructions below on how to do this).
• Ko boste odšli domov, boste morda morali še naprej uporabljati zdravilo Thorinane in si ga boste morali dajati sami (glejte spodnja navodila, kako to naredite).
Instruct patients to report immediately if they experience any of the above signs or symptoms.
Bolnikom naročite, da morajo nemudoma povedati, če občutijo katerega od omenjenih znakov ali simptomov.
The patients had to be followed up to 30 days.
Bolnike so morali spremljati do 30 dni.
The usual duration of treatment is 2 to 8 days.
Običajno traja zdravljenje od 2 do 8 dni.
Your doctor may decide to keep you under closer observation or change your medicine.
Zdravnik se lahko odloči, da vas bo natančno nadzoroval, ali da vam bo spremenil zdravilo.
This could be a sign of bleeding in the brain.
To je lahko znak krvavitve v možganih.
Circulating antibodies may persist several years.
Protitelesa v obtoku lahko ostanejo prisotna več let.
Do not give yourself a double dose on the same day to make up for a forgotten dose.
Ne dajte si na en dan dvojnega odmerka, da bi nadomestili pozabljenega.
The amount of Thorinane given to you will depend on your age and the kind of heart attack you have had.
Količina zdravila Thorinane, ki jo boste dobili, bo odvisna od vaše starosti in od vrste srčnega infarkta, ki ste jo imeli.
Operations and anesthetics
Operacije in anestezija
• If you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.
• Če imate boleč izpuščaj s temno rdečimi podkožnimi pegami, ki ne izginejo, če nanje pritisnete.
8) Remove the needle by pulling it straight out.
8) Odstranite iglo tako, da jo izvlečete naravnost ven.
• Severe allergic reaction.
• Huda alergijska reakcija.
• Traceability
• Sledljivost
How much will be given to you
Koliko zdravila boste dobili
Treatment should be maintained for a minimum of 2 days and continued until clinical stabilization.
Zdravljenje mora trajati vsaj 2 dni, nadaljevati ga je treba do klinične stabilizacije.
There is no information available concerning the first trimester.
O prehajanju v prvem trimesečju ni podatkov.
• If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
• Če imate predvideno operacijo, boste prvo injekcijo po navadi dobili 2 uri ali 12 ur pred operacijo.
Do not use this medicine after the expiry date which is stated on the label and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki ali škatli.
- Decide where you are going to inject the medicine.
- Odločite se, kam boste injicirali zdravilo.
Some of these cases were pregnant women in whom thrombosis led to maternal and foetal death.
V nekaterih takšnih primerih je šlo za nosečnice, pri katerih je tromboza povzročila smrt matere in ploda.
This amount is usually enough for a 4-hour session.
Ta količina po navadi zadošča za 4-urno dializo.
• Common: Allergic reaction
• Pogosti: Alergijska reakcija
These patients should be observed carefully for signs and symptoms of thromboembolism.
Te bolnike je treba natančno opazovati glede znakov in simptomov trombembolij.
• Acute infective endocarditis
• Akutni infekcijski endokarditis
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe, and in such case the volume shall be rounded up to the nearest graduation.
Ne pozabite, da v nekaterih primerih zaradi graduacije na brizgi ni mogoče nastaviti točnega odmerka; v takšnem primeru je treba količino zaokrožiti na najbližjo graduacijo.
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).
Opomba za napolnjene injekcijske brizge, opremljene z avtomatskim varnostnim sistemom: Varnostni sistem se sproži na koncu injiciranja (glejte navodila v poglavju 6.6).
• you have had an operation recently on your eyes or brain • you are elderly (over 65 years old) and especially if you are over 75 years old
• če ste pred kratkim imeli operacijo oči ali možganov • če ste starejša oseba (ste starejši od 65 let), še zlasti, če ste starejši od 75 let
Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physician.
Bolniki se morajo zavedati, da se lahko pojavijo takšni simptomi, in vedeti, da morajo v takšnem primeru obvestiti svojega splošnega zdravnika.
The amount will depend on the reason it is being used.
Količina bo odvisna od razloga, zaradi katerega dobivate zdravilo.
This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of 15%).
To zmanjšanje skupne incidence se je ohranilo po 30 dneh (s 23,3 na 19,8 %, relativno zmanjšanje tveganja 15 %).
If you are able to give this medicine to yourself, your doctor or nurse will show you how to do this.
Če si lahko zdravilo injicirate sami, vam bosta zdravnik ali medicinska sestra pokazala, kako to opraviti.
• A feeling of tenderness and swelling in your stomach.
• Občutek občutljivosti in oteklosti v trebuhu.
This is more likely to happen in people with kidney problems or diabetes.
To je verjetneje pri osebah, ki imajo težave z ledvicami ali sladkorno bolezen.
Different doses and formulations and dosing regimens can be used.
Uporabiti je mogoče različne odmerke in oblike ter odmerne sheme.
All patients were also treated with acetylsalicylic acid for a minimum of 30 days.
Vsi bolniki so poleg tega vsaj 30 dni dobivali tudi acetilsalicilno kislino.
These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see section 4.4).
Te reakcije so povzročile različno stopnjo nevroloških okvar, vključno z dolgotrajno ali trajno paralizo (glejte poglavje 4.4).
• you have high level of potassium in your blood (this may be checked with a blood test)
• če imate v krvi visoko koncentracijo kalija (to je mogoče preveriti s preiskavo krvi)
• Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
• Zelo pogosti: Zvišanje jetrnih encimov (v glavnem transaminaz na > 3-kratno zgornjo mejo normalnih vrednosti)
Steady-state is achieved on the second day of treatment.
Stanje dinamičnega ravnovesja je doseženo drugi dan zdravljenja.
The benefit is not established for a treatment longer than 14 days.
Korist zdravljenja, daljšega od 14 dni, ni ugotovljena.
• If you have problems with your kidneys you may be given a smaller amount of Thorinane.
• Če imate težave z ledvicami, boste lahko dobili manjšo količino zdravila Thorinane.
• Rare: Alopecia*
• Redki: Alopecija*
Renal clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments 40% of the dose.
Ledvični očistek aktivnih fragmentov predstavlja okrog 10 % uporabljenega odmerka, celotno ledvično izločanje aktivnih in neaktivnih fragmentov pa 40 % odmerka.
Keeping a diary will help to make sure you do not miss a dose.
Vodenje dnevnika vam bo pomagalo, da ne boste izpustili nobenega odmerka.
Once you have removed the cap, do not allow the needle to touch anything.
Po odstranitvi pokrovčka pazite, da se igla ne dotakne ničesar.
A total of 900 patients were randomized in the study and all patients were treated.
Skupno je bilo v študiji randomiziranih 900 bolnikov in vsi so bili zdravljeni.
Use in children and adolescents The safety and efficacy of Thorinane has not been evaluated in children or adolescents.
Uporaba pri otrocih in mladostnikih Varnost in učinkovitost zdravila Thorinane pri otrocih in mladostnikih nista bili ocenjeni.
It is not known whether unchanged enoxaparin is excreted in human breast milk.
Ni znano, ali se nespremenjeni enoksaparin pri človeku izloča v materinem mleku.
Intra-patient and inter-patient variability is low.
Intraindividualna in interindividualna variabilnost sta majhni.
- Make sure you know how much you are going to inject.
- Prepričajte se, da veste, koliko zdravila si morate injicirati.
Treatment in patients with acute STEMI
Zdravljenje bolnikov z akutnim STEMI
As with other anticoagulants, bleeding may occur at any site.
Tako kot pri drugih antikoagulansih se lahko kjer koli v telesu pojavi krvavitev.
4,716 patients underwent percutaneous coronary intervention receiving antithrombotic support with blinded study drug.
4.716 bolnikom so naredili perkutano koronarno intervencijo in dobili so antitrombotično podporo s slepljenim raziskovanim zdravilom.
The beneficial effect of enoxaparin sodium on the primary end point observed during the first 30 days was maintained over a 12 month follow-up period.
Ugodni učinek natrijevega enoksaparinata na primarni opazovani dogodek, ugotovljen v prvih 30 dneh, se je ohranil med 12-mesečnim obdobjem spremljanja.
SC, IV and extracorporeal use
SC, IV in izventelesna uporaba
LMWHs are biological medicinal products.
NMH so biološka zdravila.
Shenzhen Techdow Pharmaceutical Co., Ltd No.19, Gaoxinzhongyi Road, Hi-tech Industrial Park Nanshan District
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin) Shenzhen Techdow Pharmaceutical Co., Ltd No.19, Gaoxinzhongyi Road, Hi-tech Industrial Park Nanshan District
If you think that you have used too much or too little Thorinane, tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Če menite, da ste uporabili preveč ali premalo zdravila Thorinane, nemudoma obvestite svojega zdravnika, medicinsko sestro ali farmacevta, tudi če nimate nobenih težav.
This difference persisted at three months [13.8% vs. 5.5% (n=23 vs 9), p=0.01].
Ta razlika se je ohranila tudi po treh mesecih [13,8 % v primerjavi s 5,5 % (n = 23 v primerjavi z 9), p = 0,01].
• The maximum amount of Thorinane given for the first two injections is 7,500 IU (75 mg).
• Največji odmerek zdravila Thorinane, uporabljen v prvih dveh injekcijah, je 7.500 i.e. (75 mg).
It is recommended to prepare the dilution immediately before use.
Raztopino je priporočljivo pripraviti tik pred uporabo.
These included major haemorrhages, reported at most in 4.2 % of the patients (surgical patients).
Vključno s hudimi krvavitvami, opisanimi pri največ 4,2 % bolnikov (kirurški bolniki).
These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dosage and clinical efficacy and safety.
Ta zdravila se med seboj razlikujejo po postopku izdelave, molekulski masi, specifični aktivnosti anti-Xa in anti-IIa, enotah, odmerjanju ter klinični učinkovitosti in varnosti.
Date of first authorisation: 15/09/2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15/09/2016
It is important for you to keep having Thorinane injections until your doctor decides to stop them.
Pomembno je, da injekcije zdravila Thorinane uporabljate, dokler vam zdravnik ne naroči, da prenehajte.
Thorinane is indicated in adults for:
Zdravilo Thorinane je indicirano pri odraslih za:
If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots.
Če ste noseči in imate mehansko srčno zaklopko, imate lahko večje tveganje za nastanek krvnih strdkov.
This will send the medicine into the fatty tissue of the stomach.
S tem boste vbrizgali zdravilo v maščobno tkivo trebuha.
The recommended duration of treatment is 8 days or until hospital discharge, whichever comes first.
Priporočeno trajanje zdravljenja je 8 dni ali do odpusta iz bolnišnice, kar od tega je prej.
• Sudden severe headache.
• Nenaden hud glavobol.
The recommended dosage adjustments do not apply to the haemodialysis indication.
Priporočene prilagoditve odmerjanja ne veljajo, če je indikacija hemodializa.
No major bleeding occurred.
Ugotovili niso tudi nobene večje krvavitve.
Retroperitoneal and intracranial haemorrhages were always considered major.
Retroperitonealne in intrakranialne krvavitve so bile vedno ocenjene kot hude.
• If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
• Če ste alergični na heparin ali druge nizkomolekularne heparine, npr. na nadroparin, tinzaparin ali dalteparin.
Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Natrijev enoksaparinat naj bi med nosečnostjo uporabljali le, če zdravnik ugotovi, da je to res potrebno.
Renal impairment (see sections 4.4 and 5.2)
Okvara ledvic (glejte poglavji 4.4 in 5.2)
Treatment of DVT and PE
Zdravljenje GVT in PE
They resolve after a few days and should not cause treatment discontinuation.
Ti po nekaj dnevih izginejo in zdravljenja zaradi njih bi smeli prekiniti.
At higher doses, increases in activated partial thromboplastin time (aPTT), and activated clotting time (ACT) may occur.
Med uporabo večjih odmerkov se lahko pojavi podaljšanje aktiviranega parcialnega tromboplastinskega časa (aPTČ) in aktiviranega časa strjevanja (ACT - activated clotting time).
Injection volume and dose concentration over the range 100-200 mg/mL does not affect pharmacokinetic parameters in healthy volunteers.
Injicirana količina in koncentracija odmerka v razponu od 100 do 200 mg/ml pri zdravih prostovoljcih ne vplivata na farmakokinetične parametre.
• Warfarin - used for thinning the blood
• Varfarin - uporablja se za redčenje krvi.
If not, use another syringe.
V nasprotnem primeru uporabite drugo injekcijsko brizgo.
Animal data have shown that enoxaparin passage through the placenta is minimal.
Podatki pri živalih so pokazali, da je prehajanje enoksaparina skozi placento minimalno.
Do not inject Thorinane into a muscle.
Zdravila Thorinane ne injicirajte v mišico.
Your doctor will be able to check this by carrying out a blood test.
Zdravnik lahko to preveri s preiskavo krvi.
Investigations • Rare: Hyperkalaemia* (see sections 4.4 and 4.5).
Preiskave • Redki: Hiperkaliemija* (glejte poglavji 4.4 in 4.5)
The safety and efficacy of prophylactic doses in obese patients (BMI >30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Varnost in učinkovitost profilaktičnih odmerkov pri debelih bolnikih (ITM > 30 kg/m2) nista povsem ugotovljeni in soglasja glede prilagoditve odmerkov ni.
Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
Bolezni mišično-skeletnega sistema in vezivnega tkiva • Redki: Osteoporoza* po dolgotrajnem zdravljenju (več kot 3 mesece)
Overall list of possible side effects: Very common (may affect more than 1 in 10 people)
Celotni seznam možnih neželenih učinkov: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
• Arterial line injection:
• Injiciranje v arterijsko linijo:
• Common: Urticaria, pruritus, erythema
• Pogosti: Urtikarija, srbenje, eritem
The anticoagulant effects can be largely neutralized by the slow IV injection of protamine.
Antikoagulantni učinek je mogoče v veliki meri nevtralizirati s počasnim intravenskim injiciranjem protamina.
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.
V primeru samoinjiciranja je treba bolniku naročiti, naj upošteva navodila v navodilu za uporabo, priloženem v pakiranju zdravila.
• Moderate and mild renal impairment
• Zmerna in blaga okvara ledvic
Like other similar medicines (medicines to reduce blood clotting), Thorinane may cause bleeding which may potentially be life-threatening.
Tako kot druga podobna zdravila (zdravila proti strjevanju krvi) lahko tudi zdravilo Thorinane povzroči krvavitve, ki so lahko celo smrtno nevarne.
• Tingling, numbness and muscular weakness (particularly in the lower part of your body) when you have had a spinal puncture or a spinal anaesthetic.
• Mravljinčenje, omrtvičenost in mišična šibkost (predvsem v spodnjem delu telesa), če ste imeli spinalno punkcijo ali spinalno anestezijo.
The skin fold should not be released until the injection is complete.
Kožne gube ne smete izpustiti, dokler injiciranje ni končano.
If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell you doctor that you are using Thorinane.
Če imate predvideno spinalno punkcijo ali operacijo, pri kateri se uporablja spinalna ali epiduralna anestezija, morate zdravniku povedati, da uporabljate zdravilo Thorinane.
• You notice yellowing of your skin or eyes and your urine becomes darker in colour.
• Če opazite porumenelost kože ali očesnih beločnic ali če urin postane temnejše barve.