FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about VarroMed?
Croatian: Ostale informacije o VMP-u VarroMed
English: VarroMed can be used on colonies with and without brood.
Croatian: VMP VarroMed može se koristiti u kolonija s leglom i bez njega.
English: For practical information about using VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a VarroMed vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For more information about treatment with VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om VarroMed vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: What benefits of VarroMed have been shown in studies?
Croatian: Koje su koristi VMP-a VarroMed utvrđene u ispitivanjima?
English: How does VarroMed work?
Croatian: Kako djeluje VarroMed?
English: How is VarroMed used?
Croatian: Kako se VarroMed koristi?
English: The activity of oxalic acid on mites is thought to be due to the acidity of the medicine.
Croatian: Smatra se da oksalna kiselina djeluje na grinje zbog kiselosti VMP-a.
English: Formic acid is thought to kill Varroa mites by blocking the ability of their cells to generate energy; it may also act on mite nerve cells.
Croatian: Smatra se da mravlja kiselina ubija grinje varoe onemogućavanjem sposobnosti njihovih stanica da stvaraju energiju.
English: VarroMed is trickled onto bees in the brood chamber of the hive.
Croatian: VarroMed se nakapava na pčele u plodištu košnice.
English: Accidental ingestion may cause adverse reactions.
Croatian: Nehotično gutanje proizvoda može uzrokovati nuspojave.
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vials (multipack)
Croatian: Veličina pakovanja bočica(staklo) 10 ml (3,5 mg/ml) 1 bočica bočica(staklo) 10 ml (3,5 mg/ml) 2 bočice bočica(staklo) 10 ml (3,5 mg/ml) 5 (5 x 1) bočica (višestruko pakiranje)
English: • At the request of the European Medicines Agency.
Croatian: • na zahtjev Europske agencije za lijekove;
English: But even if this happens, it is unlikely to cause any problems.
Croatian: Čak i ako se to dogodi, vjerojatno neće izazvati nikakve probleme.
English: This might cause you to move or cough at the end of the operation
Croatian: Ovo može prouzročiti pokrete ili kašljanje na kraju operacije
English: CV=coefficient of variation
Croatian: CV=koeficijent varijacije
English: • with pre-existing coagulopathies;
Croatian: • s već postojećim koagulopatijama;
English: This makes it easier for the surgeon to do the operation.
Croatian: To kirurgu olakšava izvođenje operacije.
English: The causality of adverse events is therefore difficult to assess.
Croatian: Stoga je teško procijeniti uzroke štetnih događaja.
English: Information on healthy volunteers:
Croatian: Podaci od zdravih dobrovoljaca:
English: No formal interaction studies have been performed.
Croatian: Nisu provedena formalna ispitivanja interakcija.
English: Mean Predicted PK parameters (CV%)
Croatian: Srednja vrijednost predviđenih PK parametara (CV%)
English: The above mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.
Croatian: Gore navedene interakcije za odrasle bolesnike i upozorenja navedena u dijelu 4.4 moraju se uzeti u obzir i u pedijatrijskoj populaciji.
English: When you have some types of operations, your muscles must be completely relaxed.
Croatian: Tijekom nekih vrsta operacija Vaši mišići moraju biti potpuno opušteni.
English: • toremifene (used to treat breast cancer).
Croatian: • toremifen (primjenjuje se u liječenju raka dojke).
English: For immediate reversal:
Croatian: Za neposrednu reverziju:
English: Toremifene:
Croatian: Toremifen:
English: You may still be given Bridion, but you need to discuss it first.
Croatian: I dalje možete primiti Bridion, ali o tome najprije trebate razgovarati s liječnikom.
English: Bridion can affect hormonal contraceptives
Croatian: Bridion može utjecati na hormonske kontraceptive
English: Gender: No gender differences were observed.
Croatian: Spol: Nisu primijećene razlike između spolova.
English: • if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na sugamadeks ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: A mass balance study demonstrated that > 90% of the dose was excreted within 24 hours.
Croatian: Ispitivanje masene bilance pokazalo je da se > 90% doze izluči unutar 24 sata.
English: The same dose recommendations as for adults should be followed.
Croatian: Treba se pridržavati istih preporuka za doziranje kao za odrasle bolesnike.
English: An increased risk of bleeding cannot be excluded in patients:
Croatian: Ne može se isključiti povećan rizik od krvarenja u bolesnika:
English: The usual dose is 2-4 mg per kg body weight.
Croatian: Uobičajena doza je 2-4 mg po kilogramu tjelesne težine.
English: Children and adolescents:
Croatian: Djeca i adolescenti:
English: For oestrogens, the effect is expected to be lower.
Croatian: Očekuje se da će učinak na estrogene biti manji.
English: The bolus injection should be given rapidly, within 10 seconds, into an existing intravenous line (see section 6.6).
Croatian: Bolusna injekcija mora se dati brzo, u roku od 10 sekundi, u postojeću intravensku liniju (vidjeti dio 6.6).
English: Severe allergic or allergic-like reactions can be life threatening.
Croatian: Teške alergijske reakcije ili reakcije nalik na alergijske mogu biti opasne po život.
English: • Return of muscle relaxation after the operation
Croatian: • ponovna relaksacija mišića nakon operacije
English: Allergic reactions were reported more commonly in healthy, conscious volunteers
Croatian: Alergijske reakcije prijavljene su češće u zdravih dobrovoljaca koji su bili pri svijesti.
English: • fusidic acid (an antibiotic).
Croatian: • fusidatnu kiselinu (antibiotik).
English: Volume of distribution at steady state (L)
Croatian: Volumen distribucije u stanju dinamičke ravnoteže (l)
English: Reports of suspected hypersensitivity were adjudicated by a blinded committee.
Croatian: Prijave sumnji na preosjetljivost procijenilo je zaslijepljeno povjerenstvo.
English: NL-5340 BH Oss The Netherlands
Croatian: NL-5340 BH Oss Nizozemska
English: Hormonal contraceptives:
Croatian: Hormonski kontraceptivi:
English: Routine reversal:
Croatian: Rutinska reverzija:
English: Manufacturer • N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Croatian: Organon, Kloosterstraat 6, 5349 AB Oss, Nizozemska
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB35
Croatian: Farmakoterapijska skupina: ostali terapijski pripravci, antidoti, ATK oznaka: V03AB35
English: Procedural Complication:
Croatian: Proceduralna komplikacija:
English: Some medicines reduce the effect of Bridion → It is especially important that you tell your anaesthetist if you have recently taken:
Croatian: Neki lijekovi umanjuju djelovanje lijeka Bridion → Osobito je važno da obavijestite anesteziologa ako ste nedavno uzimali:
English: Storage will be handled by healthcare professionals.
Croatian: Za čuvanje lijeka pobrinut će se zdravstveni radnici.
English: Bridion is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier.
Croatian: Bridion se koristi za ubrzanje oporavka mišićne funkcije nakon operacije, kako biste ranije mogli ponovno početi samostalno disati.
English: Animal studies to evaluate fertility do not reveal harmful effects.
Croatian: Istraživanja plodnosti na životinjama nisu otkrila štetne učinke.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i u pravilu ne bi trebali biti dulji od 24 sata pri temperaturi od 2°C do 8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: • your weight
Croatian: • Vaše tjelesne težine
English: What Bridion is and what it is used for What you need to know before Bridion is given How Bridion is given
Croatian: Što je Bridion i za što se koristi Što morate znati prije nego počnete primati Bridion Kako se primjenjuje Bridion Moguće nuspojave
English: Date of first authorisation: 25 July 2008 Date of latest renewal: 21 June 2013
Croatian: Datum posljednje obnove odobrenja: 21. lipnja 2013.
English: Bridion may affect other medicines or be affected by them.
Croatian: Bridion može utjecati na druge lijekove ili drugi lijekovi mogu utjecati na njega.
English: The dose of Bridion for children is 2 mg/kg (children and adolescents between 2-17 years old).
Croatian: Doza lijeka Bridion za djecu iznosi 2 mg/kg (djeca i adolescenti u dobi između 2-17 godina).
English: In patients receiving routine post-operative prophylactic anticoagulation this pharmacodynamic interaction is not clinically relevant.
Croatian: U bolesnika koji primaju rutinsku poslijeoperacijsku antikoagulacijsku profilaksu, ova farmakodinamička interakcija nije klinički značajna.
English: Based on these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
Croatian: Na temelju tih podataka, ne očekuju se klinički značajne farmakodinamičke interakcije s drugim lijekovima, uz sljedeće izuzetke:
English: • Light anaesthesia - you may start to come out of deep sleep, so need more anaesthesia.
Croatian: • plitka anestezija - možda ćete se početi buditi iz dubokog sna te će Vam trebati dodatna količina anestetika.
English: Limited data does not indicate differences in pharmacokinetic parameters in Black or African Americans.
Croatian: Malobrojni podaci ne upućuju na to da se farmakokinetički parametri razlikuju u crnaca ili Afroamerikanaca.
English: Term newborn infants and infants:
Croatian: Terminska novorođenčad i dojenčad:
English: Talk to your doctor if your progesterone levels need to be tested on the same day you receive Bridion.
Croatian: Obavijestite svog liječnika ako razine progesterona morate provjeriti isti dan kada uzimate Bridion.
English: The following information is intended for healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of BRIDION.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Za detaljne informacije, vidjeti Sažetak opisa svojstava lijeka za BRIDION.
English: Median (minutes) Range
Croatian: Medijan (minute) Raspon
English: Do not use this medicine after the expiry date which is stated on the carton and on the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake 'EXP'.
English: The safety of sugammadex has been evaluated in 3,519 unique subjects across a pooled phase I-III safety database.
Croatian: Sigurnost primjene sugamadeksa ocijenjena je u 3519 pojedinačnih ispitanika kroz objedinjenu bazu podataka o sigurnosti primjene iz faza I-III.
English: From a microbiological point of view, the diluted product should be used immediately.
Croatian: S mikrobiološkog stajališta, razrijeđeni lijek se mora odmah primijeniti.
English: This is important as Bridion is removed from your body by the kidneys.
Croatian: To je važno, zbog toga što se Bridion uklanja iz tijela putem bubrega.
English: Children and adolescents This medicine is not recommended for infants less than 2 years of age.
Croatian: Ne preporučuje se primjena ovog lijeka u dojenčadi mlađe od 2 godine.
English: In this situation the patient must be ventilated.
Croatian: U takvoj se situaciji bolesniku mora primijeniti mehanička ventilacija.
English: See section 4.4 light anaesthesia.
Croatian: Vidjeti dio 4.4, plitka anestezija.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Croatian: Istraživanja na životinjama nisu ukazala na izravne ili neizravne štetne učinke na trudnoću, embriofetalni razvoj, okot ili postnatalni razvoj.
English: • Complications during your procedure such as changes in heart rate, coughing or moving
Croatian: • komplikacije tijekom zahvata kao što su promjene u brzini otkucaja srca, kašljanje ili pomicanje
English: Other medicines and Bridion → Tell your anaesthetist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Bridion → Obavijestite svog anesteziologa ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: These limited mean aPTT and PT(INR) prolongations were of short duration (≤ 30 minutes).
Croatian: Sve su te male srednje vrijednosti produljenja aPTV-a i PV-a (INR) bile kratkotrajne (≤ 30 minuta).
English: Selected patient characteristics
Croatian: Odabrane karakteristike bolesnika
English: In clinical trials of surgical patients these reactions were reported uncommonly and for post-marketing reports the frequency is unknown.
Croatian: U kliničkim ispitivanjima kirurških bolesnika, ove reakcije su prijavljene manje često, a za izvješća nakon stavljanja u promet učestalost nije poznata.
English: • on coumarin derivates and at an INR above 3.5;
Croatian: • koji se liječe derivatima kumarina i imaju INR veći od 3,5;
English: Delayed recovery:
Croatian: Kasniji (odgođeni) oporavak:
English: In general, Bridion does not have an effect on laboratory tests.
Croatian: Bridion općenito ne utječe na rezultate laboratorijskih pretraga.
English: Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see section 4.4).
Croatian: Premda će u starijih osoba vrijeme oporavka vjerojatno biti duže, treba se pridržavati istih preporuka za doziranje kao za odrasle bolesnike (vidjeti dio 4.4).
English: Talk to your anaesthetist before Bridion is given
Croatian: Obratite se svom anesteziologu prije nego primite Bridion
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity potential, and toxicity to reproduction, local tolerance or compatibility with blood.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i reproduktivne toksičnosti, lokalne podnošljivosti ili kompatibilnosti s krvlju.
English: Other routine reversal situations have not been investigated and are therefore not recommended until further data become available.
Croatian: Rutinska reverzija u drugim situacijama nije se ispitivala pa se stoga ne preporučuje dok se ne prikupe dodatni podaci.
English: No recurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fusidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days.
Croatian: Ne očekuje se ponovna pojava neuromuskularne blokade u poslijeoperacijskoj fazi, jer se infuzija fusidatne kiseline daje tijekom nekoliko sati i razine u krvi su kumulativne tijekom 2-3 dana.
English: For re-administration of sugammadex see section 4.2.
Croatian: Za ponovnu primjenu sugamadeksa, vidjeti dio 4.2.
English: Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.
Croatian: Budući da ti lijekovi opuštaju i dišne mišiće, trebat će Vam pomoć pri disanju (mehanička ventilacija) tijekom i nakon operacije, sve dok ponovno ne budete mogli sami disati.
English: After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C.
Croatian: Nakon prvog otvaranja i razrjeđivanja, dokazana je kemijska i fizikalna stabilnost lijeka u primjeni tijekom 48 sati na temperaturi od 2°C do 25°C.
English: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see Information on healthy volunteers below).
Croatian: Reakcije preosjetljivosti, uključujući anafilaksiju, javile su se u nekolicine bolesnika i dobrovoljaca (za podatke o dobrovoljcima, vidjeti "Podaci o zdravim dobrovoljcima" u daljnjem tekstu).
English: Marked bradycardia:
Croatian: Značajna bradikardija:
English: However, it may affect the results of a blood test for a hormone called progesterone.
Croatian: Ipak, može utjecati na rezultate krvnih pretraga na hormon progesteron.
English: The observed steady-state volume of distribution of sugammadex is approximately 11 to 14 litres in adult patients with normal renal function (based on conventional, non-compartmental pharmacokinetic analysis).
Croatian: Opaženi volumen distribucije sugamadeksa u stanju dinamičke ravnoteže iznosi približno 11 do 14 litara u odraslih bolesnika s normalnom funkcijom bubrega (na temelju konvencionalne, nekompartmentalne farmakokinetičke analize).
English: Use in Intensive Care Unit (ICU):
Croatian: Primjena u jedinicama intenzivnog liječenja (JIL):
English: A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.
Croatian: U odraslih se može primijeniti doza od 16 mg/kg ako je neophodan hitan oporavak od učinaka mišićnog relaksansa.
English: What Bridion is and what it is used for
Croatian: Što je Bridion i za što se koristi
English: Additional information on special populations
Croatian: Dodatne informacije za posebne populacije
English: • if you have fluid retention (oedema).
Croatian: • ako zadržavate tekućinu (edemi).
English: Elimination half-life (hr)
Croatian: Poluvijek eliminacije (h)
English: Interference with laboratory tests:
Croatian: Utjecaj na rezultate laboratorijskih pretraga:
English: In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed.
Croatian: U ispitivanju provedenom u zdravih Japanaca i bijelaca nisu opažene klinički značajne razlike u farmakokinetičkim parametrima.
English: • Allergic (drug hypersensitivity) reactions - such as a rash, red skin, swelling of your tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in a serious decrease of blood pressure.
Croatian: • alergijske reakcije (reakcije preosjetljivosti na lijek), kao što su osip, crvenilo kože, oticanje jezika i/ili grla, nedostatak zraka, promjene krvnog tlaka ili brzine otkucaja srca, što ponekad dovodi do ozbiljnog pada krvnog tlaka.
English: No dose related adverse events nor serious adverse events were reported.
Croatian: Nisu prijavljeni štetni događaji povezani s veličinom doze, kao ni ozbiljne nuspojave.
English: If more Bridion is given to you than recommended As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Bridion.
Croatian: Ako primite više lijeka Bridion nego što se preporučuje Budući da će anesteziolog pomno nadzirati Vaše stanje, mala je vjerojatnost da ćete dobiti previše lijeka Bridion.
English: Based upon clinical studies, sugammadex concentrations in plasma are reduced by up to 70% after a 3 to 6-hour dialysis session.
Croatian: Na temelju saznanja iz kliničkih ispitivanja, koncentracije sugamadeksa u plazmi se nakon dijalize u trajanju od 3 do 6 sati smanjuju do 70%.
English: Clearance (mL/min)
Croatian: Klirens (ml/min)
English: For this, the general anaesthetic you are given includes medicines to make your muscles relax.
Croatian: Zbog toga u sklopu opće anestezije dobivate lijekove koji opuštaju mišiće.
English: If there is a medical need to give sugammadex to these patients the anaesthesiologist needs to decide if the benefits outweigh the possible risk of bleeding complications taking into consideration the patients history of bleeding episodes and type of surgery scheduled.
Croatian: Postoji li medicinski opravdan razlog da se sugamadeks primijeni tim bolesnicima, anesteziolog mora odlučiti je li korist veća od mogućeg rizika za komplikacije s krvarenjem, uzimajući u obzir postojanje epizoda krvarenja u anamnezi i vrstu planirane operacije.
English: Solution for injection 10 vials
Croatian: Otopina za injekciju 10 bočica
English: The recommended dose does not depend on the anaesthetic regimen.
Croatian: Preporučena doza ne ovisi o vrsti primijenjenih anestetika.
English: • Decreased blood pressure due to the surgical procedure
Croatian: • sniženi krvni tlak uslijed operativnog zahvata.
English: Frequency not known
Croatian: Nepoznata učestalost
English: As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
Croatian: Kao i u svih bolesnika s plućnim komplikacijama u anamnezi, liječnik mora imati na umu moguću pojavu bronhospazma.
English: • Bridion can make hormonal contraceptives - including the ‘Pill', vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone.
Croatian: • Bridion može umanjiti djelotvornost hormonskih kontraceptiva - uključujući kontracepcijske tablete, vaginalni prsten, implantate ili hormonski intrauterini uložak - jer smanjuje količinu hormona progestagena dobivenu iz kontraceptiva.
English: What you need to know before Bridion is given
Croatian: Što morate znati prije nego počnete primati Bridion
English: The data for the paediatric population are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2).
Croatian: Podaci za pedijatrijsku populaciju su ograničeni (provedeno je samo jedno ispitivanje reverzije blokade izazvane rokuronijem pri ponovnoj pojavi T2).
English: → If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.
Croatian: → Ako koristite druge oblike hormonske kontracepcije (primjerice, vaginalni prsten, implantat ili intrauterini uložak), morate primjenjivati dodatnu nehormonsku kontracepcijsku metodu (kao što je kondom) tijekom sljedećih 7 dana te slijediti savjete navedene u Uputi o lijeku.
English: Population pharmacokinetic analysis of adult and elderly patients showed no clinically relevant relationship of clearance and volume of distribution with body weight.
Croatian: Populacijska farmakokinetička analiza provedena u odraslih i starijih bolesnika nije pokazala da postoji ikakva klinički važna povezanost klirensa i volumena raspodjele s tjelesnom težinom.
English: Demographics
Croatian: Demografski podaci
English: Re-administration of sugammadex:
Croatian: Ponovna primjena sugamadeksa:
English: These reactions varied from isolated skin reactions to serious systemic reactions (i.e. anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.
Croatian: Ove su se reakcije kretale od izoliranih kožnih reakcija do ozbiljnih sistemskih reakcija (tj. anafilaksije, anafilaktičkog šoka) i javile su se u bolesnika koji prethodno nisu bili izloženi sugamadeksu.
English: • if you have diseases which are known to give an increased risk of bleeding (disturbances of blood clotting) or anticoagulation medication.
Croatian: • ako bolujete od bolesti zbog kojih je povećan rizik od krvarenja (poremećaji zgrušavanja krvi)
English: Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.
Croatian: Fizikalna inkompatibilnost prijavljena je s verapamilom, ondanzetronom i ranitidinom.