natgillin/translations-raw huggingface dataset:
Intra-abdominal infections Complicated skin and soft tissue infections Complicated urinary tract infections (including pyelonephritis)
bakterijski meningitis zunajbolnišnična okužba s pljučnico bolnišnična okužba s pljučnico akutno vnetje srednjega ušesa intraabdominalne okužbe zapletene okužbe sečil (vključno s pielonefritisom) okužbe kosti in sklepov zapletene okužbe kože in mehkih tkiv gonoreja sifilis bakterijski endokarditis
Ceftriaxone penetrates the meninges.
Ceftriakson prehaja skozi možganske ovojnice.
Talk to your doctor or pharmacist or nurse before your child is administered Rocephin if:
Preden vaš otrok prejme zdravilo Rocephin, se posvetujte z zdravnikom ali medicinsko sestro:
• Kidney problems caused by deposits of calcium ceftriaxone.
• težave z ledvicami, ki jih povzročajo usedline kalcij-ceftriaksona; pri odvajanju seča (urina)
For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age
za zdravljenje diseminirane oblike lymske borelioze (zgodnje (II.
• He/She has recently been given or is to be given a product that contains calcium into their vein.
• če je otrok pred kratkim v žilo prejel zdravilo, ki vsebuje kalcij, ali je predvideno, da bo prejel tako zdravilo.
Kernicterus
• izpuščaj
The following convention has been used for the classification of frequency:
Neželeni učinki so bili razvrščeni po naslednjem dogovoru o pogostnosti: Zelo pogosti (≥1/10)
There may be pain when passing water
lahko nastopijo bolečine ali pa se izloča malo urina
Oliguria Renal precipitation (reversible)
Bolezni sečil hematurija glikozurija oligurija obarjanje v ledvicah (reverzibilno)
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj pruritus urtikarija
• Loose stools or diarrhoea.
• redko blato ali driska
People with liver and kidney problems
Osebe z okvarjenim delovanjem jeter in ledvic
In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above
Za predoperativno profilakso okužb mesta kirurškega posega, za obravnavo nevtropeničnih bolnikov z zvišano telesno temperaturo, za katero se sumi, da je posledica bakterijske okužbe, za zdravljenje bolnikov z bakteriemijo, ki se pojavi v povezavi s katero od zgoraj naštetih okužb, ali se povezava z njimi sumi.
Haemolytic anaemiab
Zastoj žolča
Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem.
V pljučih in ledvicah so pri obdukciji odkrili oborine ceftriakson-kalcijeve soli.
Erythema multiforme Acute generalised exanthematous pustulosis
StevensJohnsonov sindromb toksična epidermalna nekrolizab multiformni eritem akutna generalizirana eksantemska pustuloza
Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis.
Hemodializa ali peritonealna dializa ne zmanjšata koncentracij ceftriaksona.
The signs may include bruising easily and pain and swelling of your joints.
• težave s strjevanjem krvi znaki lahko vključujejo hitro nastajanje modric in bolečine ter otekline sklepov
Nervous system disorders
Bolezni živčevja glavobol omotica konvulzije
Headache Dizziness
Litiaza žolča
Complicated skin and soft tissue infections Gonorrhoea
Infekcijske in parazitske bolezni glivična okužba spolovil psevdomembranski kolitisb superinfekcijab
Marketing Authorisation Holder and Manufacturer
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Intra-abdominal infections Complicated urinary tract infections (including pyelonephritis)
1-2 g enkrat na dan zunajbolnišnična okužba s pljučnico akutno poslabšanje kronične obstruktivne pljučne bolezni intraabdominalne okužbe zapletene okužbe sečil (vključno s pielonefritisom)
Acute otitis media
Akutno vnetje srednjega ušesa
Rocephin 250 mg Powder for Solution for Injection Malta, Netherlands, United Kingdom: Rocephin [See Annex I - To be completed nationally] This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Rocephin 250 mg prašek za raztopino za injiciranje Malta, Nizozemska, Velika Britanija: Rocephin
carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic
Bolezni jeter, žolčnika in žolčevodov zvišani jetrni encimi oborina v žolčnikub kernikterus
Pancreatitisb Stomatitis Glossitis
Bolezni prebavil driskab redko blato navzea bruhanje pankreatitisb stomatitis glositis
What measures are being taken to ensure the safe and effective use of Praxbind?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Praxbind?
The full EPAR and risk management plan summary for Praxbind can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Praxbind sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The medicine can only be obtained with a prescription and it is for use in hospital only.
Izdaja zdravila je le na recept in se uporablja samo v bolnišnicah.
What is Praxbind and what is it used for?
Kaj je zdravilo Praxbind in za kaj se uporablja?
At the time of authorisation Praxbind has not been associated with any specific side effects.
V času odobritve zdravilo Praxbind ni bilo povezano z nobenimi specifičnimi neželenimi učinki.
Praxbind has been investigated in three main studies involving 141 healthy adults who previously received dabigatran.
Zdravilo Praxbind so preučevali v treh glavnih študijah, ki so zajele 141 zdravih odraslih, ki so predhodno prejeli dabigatran.
No side effects have been identified.
Identificirali niso nobenih neželenih učinkov.
This is a summary of the European public assessment report (EPAR) for Praxbind.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Praxbind.
It is not intended to provide practical advice on how to use Praxbind.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Praxbind's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Praxbind večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What benefits of Praxbind have been shown in studies?
Kakšne koristi je zdravilo Praxbind izkazalo v študijah?
A risk management plan has been developed to ensure that Praxbind is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Praxbind je bil pripravljen načrt obvladovanja tveganj.
A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen).
Monoklonsko telo je vrsta beljakovine, ki je zasnovana tako, da v telesu prepozna posebno strukturo (imenovano antigen) in se veže nanjo.
Most patients in the study were taking Pradaxa to prevent stroke due to an ‘abnormal heart beat' (atrial fibrillation).
Večina bolnikov v študiji je zdravilo Pradaxa jemala za preprečevanje možganske kapi zaradi „nenormalnega srčnega utripa“ (atrijske fibrilacije).
In a still ongoing trial, an interim analysis showed similar results in 123 patients who had uncontrolled bleeding or required emergency surgery while using Pradaxa.
V preskušanju, ki še poteka, je vmesna analiza pokazala podobne rezultate pri 123 bolnikih, ki so med uporabo zdravila Pradaxa doživeli nenadzorovano krvavitev ali so potrebovali nujni kirurški poseg.
The main studies showed that Praxbind is effective at neutralising the effects of Pradaxa, and its action is rapid, complete and sustained.
Glavne študije so pokazale, da zdravilo Praxbind učinkovito nevtralizira učinek zdravila Pradaxa, njegovo delovanje pa je hitro, popolno in trajno.
A second 5-g dose may be given as two further injections or infusions, if needed.
Po potrebi se drugi 5-gramski odmerek lahko da v obliki dveh dodatnih injekcij ali infuzij.
The extent of Praxbind's benefit depends on the patient's overall health, the severity of bleeding and the location of bleeding.
Obseg koristi zdravila Praxbind je odvisen od splošnega zdravstvenega stanja bolnika, resnosti krvavitve in mesta krvavitve.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Praxbind, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Praxbind in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Praxbind, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Praxbind preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Praxbind approved?
Zakaj je bilo zdravilo Praxbind odobreno?
Results showed that Praxbind was able to completely neutralise Pradaxa's anticlotting effect within 5 minutes of use.
Rezultati so pokazali, da je zdravilo Praxbind popolnoma nevtraliziralo protistrjevalni učinek zdravila Pradaxa v petih minutah po uporabi.
Praxbind is available as a solution for injection or infusion (drip) into a vein.
Zdravilo Praxbind je na voljo kot raztopina za injiciranje ali infundiranje (kapalno infuzijo) v veno.
For practical information about using Praxbind, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Praxbind naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What are the risks associated with Praxbind?
Kakšna tveganja so povezana z zdravilom Praxbind?
The recommended dose of Praxbind is 5 g given into a vein as two injections or infusions, one after the other.
Priporočeni odmerek zdravila Praxbind je 5 g in se daje v veno v obliki dveh zaporednih injekcij ali infuzij.
In the studies, volunteers received either Praxbind or placebo (a dummy treatment) after treatment with Pradaxa for 3.5 days.
V študijah so prostovoljci po zdravljenju z zdravilom Pradaxa, ki je trajalo 3,5 dneva, prejeli bodisi zdravilo Praxbind ali placebo (zdravilo brez zdravilne učinkovine).
This rapidly stops dabigatran's anticlotting effect.
Tako se protistrjevalni učinek dabigatrana hitro zaustavi.
Praxbind works by attaching firmly to dabigatran, and forming a complex in the blood.
Zdravilo Praxbind deluje tako, da se trdno pripoji na dabigatran in v krvi z njim tvori kompleks.
Other information about Praxbind
Druge informacije o zdravilu Praxbind
The active substance in Praxbind, idarucizumab, is a monoclonal antibody fragment.
Zdravilna učinkovina v zdravilu Praxbind, idarucizumab, je fragment monoklonskega protitelesa.
How is Praxbind used?
Kako se zdravilo Praxbind uporablja?
Praxbind is a medicine used to neutralise the effects of dabigatran (the active substance of Pradaxa), a medicine that treats and prevents blood clots.
Zdravilo Praxbind se uporablja za nevtralizacijo učinkov dabigatrana (zdravilne učinkovine zdravila Pradaxa), zdravila za zdravljenje in preprečevanje krvnih strdkov.
Praxbind is used to rapidly stop the anticlotting effect of dabigatran, before emergency surgery or in case of life-threatening bleeding.
Zdravilo Praxbind se uporablja za hitro prekinitev protistrjevalnega učinka dabigatrana pred nujnim kirurškim posegom ali ob življenjsko nevarni krvavitvi.
For the information on the restrictions with Praxbind, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Praxbind glejte navodilo za uporabo.
How does Praxbind work?
Kako zdravilo Praxbind deluje?
However, this would be impossible to apply in field conditions.
Vendar pa bi bilo slednje težko uporabiti v terenskih pogojih.
It was not possible to analyse the data from both studies with the available statistical methods.
Podatkov iz obeh raziskav z razpoložljivimi statističnimi metodami ni bilo mogoče analizirati.
Therefore the study design was not optimal for this approach.
Zato načrt raziskave ni bil najbolj primeren za ta pristop.
This can be avoided by adding more categories, or even all possible dry period categories.
Temu se je mogoče izogniti z dodatkom večjega števila kategorij ali celo vseh mogočih kategorij presušitve.
However, the aim of the study provided was to investigate only cows with a very short dry period.
Vendar pa je bil cilj predložene raziskave raziskati le krave z zelo kratkim obdobjem presušitve.
2.1 Residue depletion in milk
2.1 Zmanjševanje ostankov v mleku
Intervet Portugal, Lda.
Portugalska Intervet Portugal, Lda.
For the reasons mentioned above the approach of the guideline is not valid for the dataset provided in this case.
Zaradi zgoraj omenjenih razlogov pristop, naveden v smernici, ne velja za nabor podatkov, ki je predložen za ta primer.
The MAHs disagreed with the outcome of the procedure and referred the issue to the EMEA.
Imetniki dovoljenja za promet z zdravilom se z izidom postopka niso strinjali in so vprašanje napotili na EMEA.
At the end of the variation procedure the withdrawal period recommended by the Member States involved in the procedure was:
Na koncu postopka za variacijo je bila karenca, ki so jo predlagale države članice, vključene v postopek:
Hence the withdrawal period calculated on the basis of such distributions is largely overestimated in this case.
Zato je karenca, izračunana na podlagi takih porazdelitev, v tem primeru zelo precenjena.
It may also appear illogical in some cases (comparing two withdrawal periods with slightly different dry periods but in different categories).
V nekaterih primerih se zdi celo nelogično (primerjava dveh karenc z malce drugačnimi dobami presušitve, vendar v drugačnih kategorijah).
ANNEX I LIST OF NAMES, PHARMACEUTICAL FORM OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK ZDRAVIL, ŽIVALSKIH VRST, NAČINOV UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Using the TTSC method where the TTSCs are expressed as time after treatment is on itself not wrong.
Uporaba TTSC metode v primeru, kjer se vrednosti TTSC izrazijo kot čas po zdravljenju, sama po sebi ni napačna.
The Committee also considered the study with dry periods between 40 to 59 days.
Odbor je pretehtal tudi študijo z obdobji presušitve med 40 in 59 dnevi.
Frequency Recommended dose
Priporočeni odmerek
Intervet Gesmbh Siemensstrasse 107 A-1210 Wien
Intervet Gesmbh Siemensstrasse 107 A-1210 Dunaj
Product invented name Pharmaceutical form Animal species
Farmacevtska oblika Živalska vrsta
It was therefore considered that a safety span should be included to take into account variation in the data.
Zato se je smatralo, da je potrebno vključiti varnostni razpon, da bi na ta način vračunali tudi variacije v podatkih.
Two alternatives to express the milk withdrawal period were considered:
Preučeni sta bili dve alternativi za izražanje karence za mleko:
Cobactan DC and associated invented names (see Annex I) contains cefquinome, a fourth-generation cephalosporin, indicated for the treatment of subclinical mastitis at drying off and the prevention of new bacterial infections of the udder, during the dry period, in the dairy cows caused by the following sensitive bacteria: Streptococcus uberis, Streptococcus disgalactiae, Streptococcus agalactiae, Staphylococcus aureus and coagulase negative staphylococci.
Zdravilo Cobactan DC in povezana izmišljena imena (glejte Dodatek I) vsebuje cefkvinom, cefalosporin četrte generacije, ki je indiciran za zdravljenje subkliničnega mastitisa pri sušitvi in preprečevanju novih bakterijskih okužb vimen med presušitvijo pri kravah molznicah, katerih povzročitelji so: Streptococcus uberis, Streptococcus disgalactiae, Streptococcus agalactiae, Staphylococcus aureus in koagulaza negativni stafilokoki.
Although individual TTSCs can be calculated, the set of TTSCs does not show a normal or a lognormal distribution.
Čeprav se lahko izračuna posamezne čase do varne koncentracije (TTSC), pa nabor teh ne pokaže normalne ali logaritemsko normalne porazdelitve.
- 36 days after treatment when dry period is 5 weeks or less.
- 36 dni po zdravljenju, če je bilo obdobje presušitve dolgo 5 tednov ali manj.
The advantage of the TTSC method is that the shape of the depletion curve is not important.
Prednost TTSC metode je v tem, da oblika krivulje zmanjševanja ostankov ni pomembna.
The CVMP during its meeting of 19-20 April 2006 initiated a referral procedure under Article 6(13) of Commission Regulation (EC) No 1084/2003 for Cobactan DC containing cefquinome.
- 20. aprila 2006 sprožil napotitveni postopek v skladu s členom 6(13) Uredbe komisije (ES) št. 1084/2003 za Cobactan DC, ki vsebuje cefkvinom.
The Marketing Authorisation Holders (MAHs) submitted a type II variation subject to a mutual recognition procedure in September 2005 (FR/V/148/01/II/02) to reduce the established withdrawal period for milk.
Imetniki dovoljenja za promet z zdravilom so podali vlogo za variacijo tipa II, ki je predmet postopka medsebojnega priznavanja iz septembra 2005 (FR/V/148/01/II/02), za zmanjšanje ugotovljene karence za mleko.
Also during the dry period two milkings per day were counted although the animals were not milked.
Tudi za obdobja presušitve se je štelo, kot da sta bili opravljeni dve molzenji na dan, čeprav se živali dejansko ni molzlo.
Residue data should be obtained from a sufficient number of animals giving birth within a limited time interval.
Podatke o ostankih bi morali pridobiti od dovolj velikega števila živali, ki povržejo v danem časovnem intervalu.
Cobactan DC and associated invented names are approved in several Member States as an intramammary ointment, presented as a pre-filled syringe containing 150 mg of cefquinome (as sulphate).
Cobactan DC in povezana izmišljena imena so v nekaterih državah članicah odobrena kot intramamarno mazilo v obliki predhodno napolnjene injekcije, ki vsebuje 150 mg cefkvinoma (v obliki sulfata).
It is however clear that the dry period should be part of the expression of the withdrawal period.
Vendar pa je jasno, da bi morala biti presušitvena doba del izražanja karence.
The guideline proposes to use the TTSC method on the residue data from animals within a limited span of dry periods, assuming that limited differences in the dry period would have minor influence on the residues.
Smernica predlaga uporabo metode TTSC za podatke o ostankih pri živalih v omejenem razponu obdobij presušitve ob domnevi, da bi imele omejene razlike v obdobjih presušitve manjši vpliv na ostanke.
CVMP considerations
Zadržki CVMP
The resulting withdrawal period is valid for all animals, irrespective of the exact length of the dry period.
Dobljena karenca velja za vse živali, ne glede na natančno dolžino presušitve.
Therefore, the recommended withdrawal period for Cobactan DC is:
Zato znaša priporočena karenca za zdravilo Cobactan DC:
In cows with a dry period of less than 49 days, milk for human consumption may only be taken after 50 days after the last treatment”
Pri kravah, katerih presušitev traja manj kot 49 dni, se lahko mleko za človeško uporabo odvzame šele 50 dni po zadnjem zdravljenju“.
The Committee concluded that this study should also be considered for the establishment of the withdrawal period.
Odbor je zaključil, da bi bilo potrebno to raziskavo prav tako upoštevati za ugotavljanje karence.
Therefore, the Committee, for Medicinal Products for Veterinary Use recommends the variation of the terms of the Marketing Authorisations for Cobactan DC and associated names in order to set a withdrawal period for milk as follows: - 1 day after calving when dry period is more than 5 weeks; - 36 days after treatment when dry period is 5 weeks or less.
Zato Odbor za zdravila za uporabo v veterinarski medicini predlaga spremembo pogojev dovoljenja za promet z zdravilom Cobactan DC in povezanih imen, da bi spremenil karenco mleka, kot sledi: - 1 dan po otelitvi, če je bilo obdobje presušitve daljše od 5 tednov; - 36 dni po zdravljenju, če je bilo obdobje presušitve dolgo 5 tednov ali manj.
However, the guideline does not explicitly state how the derived withdrawal period should be expressed: as time after treatment or as time after calving.
Vendar pa smernica ne določa jasno, kako bi morala biti karenca izražena: kot čas po zdravljenju ali kot čas po otelitvi.
Furthermore the guideline on the summary of product characteristics for pharmaceutical veterinary medicinal products included in Volume 6C of the Rules Governing Medicinal Products in the European Union indicates that for dry cow products the withdrawal period for milk is determined by the date of the subsequent calving.
Poleg tega smernica o povzetku glavnih značilnosti zdravila za farmacevtska veterinarska zdravila, vključena v zvezku 6C Pravil, ki urejajo zdravila v Evropski uniji, navajajo, da se za proizvode krav med presušitvijo karenca za mleko določi z datumom sledeče otelitve.
The Committee concluded that the MAHs statistical analysis of the data from the new study was not optimal considering the combination of (1) the dependency of the TTSC's on the length of the dry period, and (2) the selection of cows with very short dry periods in the study.
Odbor je zaključil, da statistična analiza imetnika dovoljenja za promet z zdravilom na podatkih nove raziskave ni bila najboljša, če upoštevamo kombinacijo (1) odvisnosti vrednosti TTSC od dolžine obdobja presušitve in (2) izbire krav z zelo kratkimi obdobji presušitve v raziskavi.
The two phases of depletion in milk (i.e. during the dry period and post-calving) are interlinked and therefore the calculation of the withdrawal period based on the time after treatment can be considered more appropriate because it takes both phases of depletion into consideration.
Dve fazi zmanjševanja ostankov v mleku (t. j. med presušitvijo in po otelitvi) sta povezani, zato se lahko izračun karence na osnovi časa po zdravljenju smatra za ustreznejšega, ker upošteva obe fazi zmanjševanja.
Consequently, the estimated withdrawal period contains some uncertainty caused by the dependency on the length of the dry period.
Posledično so v ocenjeni karenci vključene nekatere nezanesljivosti, ki jih povzroča odvisnost od dolžine obdobja presušitve.
The withdrawal period initially established for milk was 49 days after treatment when the dry period was less than 49 days, and 1 day after calving when the dry period was 49 days.
Začetna ugotovljena karenca za mleko je znašala 49 dni po zdravljenju, ko je presušitev znašala manj kot 49 dni, in 1 dan po otelitvi, ko je presušitev znašala 49 dni.
Due to the fact that (1) there was a wide range of dry periods, and (2) there was a substantial depletion of residues from the quarters of the udders of cows during the dry period, the dry period does have a significant influence on the residues at the first milking after calving in this case.
Zaradi (1) širokega razpona obdobij presušitve in (2) znatnega zmanjševanja ostankov iz četrti vimen krav med presušitvijo, ima obdobje presušitve v tem primeru res znaten vpliv na ostanke pri prvi molži po otelitvi.
“Milk for human consumption may only be taken after 24 hours post calving with a dry period of more than 49 days.
„Mleko za človeško uporabo se lahko odvzame šele po preteku 24 ur od otelitve s presušitvijo daljšo od 49 dni.
Although the administration of the product to the cows was 28 days before the expected calf delivery, the dry periods varied substantially from 16 to 36 days.
Čeprav se je dajanje zdravila kravam opravilo 28 dni pred pričakovano otelitvijo, pa so se obdobja presušitve znatno razlikovala, in sicer od 16 do 36 dni.
In the study provided the dry period varied considerably, ranging from 16 to 36 days.
V predloženi študiji so obdobja presušitve znatno nihala in so znašala od 16 do 36 dni.