natgillin/translations-raw huggingface dataset:
Therefore, OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician.
Kontrastnega sredstva OPTISON se zato v nosečnosti ne sme uporabljati, razen če korist pretehta tveganje in je uporaba po presoji zdravnika nujna.
There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease.
Klinične izkušnje s kontrastnim sredstvom OPTISON so omejene pri bolnikih z določenimi hudimi stanji srčne, pljučne, ledvične ali jetrne bolezni.
Side effects to OPTISON are rare and usually not serious.
Neželeni učinki kontrastnega sredstva OPTISON so redki in običajno niso resni.
Do not use OPTISON after the expiry date which is stated on the label, after EXP.
Kontrastnega sredstva OPTISON ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%.
Kontrastno sredstvo OPTISON je sestavljeno iz perflutren vsebujočih mikrosfer toplotno obdelanega humanega albumina, ki so suspendirane v 1 % raztopini humanega albumina.
Alternately, the flushing may be performed by infusion.
Alternativno lahko spiranje izvedete z infuzijo.
- Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or precipitates before resuspension.
- Počakajte, da viala doseže sobno temperaturo in pred resuspendiranjem preglejte tekočo fazo na vsebnost delcev ali oborin.
- Immediately before injection a careful visual inspection of the syringe is mandatory in order to ensure complete resuspension of the microspheres.
- Tik pred injiciranjem morate obvezno natančno vizualno pregledati brizgo, da se prepričate o popolni resuspendiranosti mikrosfer.
OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
This medicinal product is intended for left ventricular opacification after intravenous administration.
To kontrastno sredstvo je namenjeno za opacifikacijo levega ventrikla po intravenski uporabi.
- OPTISON will segregate in an undisturbed syringe and must be resuspended before use.
- Kontrastno sredstvo OPTISON se bo v mirujoči brizgi ločilo in ga morate pred uporabo resuspendirati.
• Allergic type symptoms, for example, a severe allergic reaction or - shock (anaphylaxis), swelling of the face (face oedema), an itchy skin eruption (urticaria).
• simptomi alergijske vrste, na primer huda alergijska reakcija ali šok (anafilaksija), otekanje obraza (edem obraza), srbeč kožni izpuščaj (koprivnica),
The safety of OPTISON for use during human pregnancy has not been fully established.
Varnost uporabe kontrastnega sredstva OPTISON v nosečnosti pri človeku ni povsem potrjena.
The microspheres have a mean diameter of 2.5 - 4.5 microns and concentrations of 5-8 x 108 microspheres/ml.
Mikrosfere imajo povprečni premer 2,5 - 4,5 mikronov in koncentracijo 5-8 x 108 mikrosfer/ml.
In two uncontrolled studies including a total of 42 children and adolescents, aged 8 months to 19 years, the safety profile appeared to be similar to that seen in adults.
V dveh nenadzorovanih študijah, ki sta vključevali skupaj 42 otrok in mladostnikov, starih od 8
INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Do not use OPTISON - if you are allergic (hypersensitive) to perflutren or any of the other ingredients of OPTISON (listed in section 6).
Kaj morate vedeti, preden boste uporabili kontrastno sredstvo OPTISON Ne uporabljajte kontrastnega sredstva OPTISON - če ste alergični na perflutren ali katero koli sestavino tega kontrastnega sredstva (navedeno vpoglavju 6).
The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Čas trajanja uporabnega slikanja je 2,5 - 4,5 minut za odmerek 0,5 - 3,0 ml.
OPTISON contains microspheres (tiny gas bubbles) that after injection travel through the veins to the heart and fill the left heart chambers, allowing the doctor to visualise and asses the function of the heart.
Kontrastno sredstvo OPTISON vsebuje mikrosfere (majhne plinske mehurčke), ki po vbrizganju potujejo po venah v srce in napolnijo levi srčni votlini, kar zdravniku omogoči slikovno predstavo in ocenitev delovanja srca.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Pri zdravilih, ki so izdelana iz človeške krvi ali plazme, se z določenimi ukrepi preprečuje prenos okužbe na bolnike.
The effect of OPTISON on pulmonary haemodynamics was studied in a prospective, open-label study of 30 patients scheduled for pulmonary artery catheterisation, including 19 with an elevated baseline pulmonary arterial systolic pressure (PASP) (>35 mmHg; mean 70.1±33.0 mmHg; range 36.0-176.0
Učinek zdravila OPTISON na pljučno hemodinamiko so preučevali v perspektivni, odprti študiji na 30 bolnikih, naročenih na kateterizacijo pljučne arterije, vključno z 19 bolniki s povišanim sistolnim tlakom v pljučni arteriji (PASP) glede na izhodišče (>35 mmHg; povprečje 70,1 ± 33,0 mmHg; obseg 36,0-176,0 mmHg) in 11 bolniki z normalnim PASP (≤ 35 mmHg; povprečje 29,3 ± 4,6 mmHg; obseg
It is not known whether OPTISON is excreted in human milk.
Ni znano, ali se kontrastno sredstvo OPTISON pri ljudeh izloča v materino mleko.
5 x 3 ml presentation: EU/1/98/065/002
5 x 3 ml pakiranje: EU/1/98/065/002
It is a clear solution with white microsphere layer on top.
To je bistra raztopina z belo plastjo mikrosfer na vrhu.
• Dyspnoea (difficulty in breathing)
• dispnea (oteženo dihanje),
OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart chamber and fill the left heart chamber.
Kontrastno sredstvo OPTISON se uporablja v obliki intravenske injekcije, ki omogoča, da mikrosfere vstopijo v srčno komoro in napolnijo levi srčni prekat.
OPTISON consists of perflutren -containing microspheres.
Kontrastno sredstvo OPTISON vsebuje mikrosfere s perflutrenom.
Clear solution with white microsphere layer on top.
Bistra raztopina z belo plastjo mikrosfer na vrhu.
LIST OF EXCIPIENTS Excipients: Human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Pomožne snovi: humani albumin, natrijev klorid, N-acetiltriptofan, kaprilna kislina, natrijev hidroksid in voda za injekcije.
In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies given in the table below: very common (≥1/10); common (≥1/100 to <1/10);
V kliničnih preskušanjih s kontrastnim sredstvom OPTISON so o neželenih učinkih poročali z naslednjimi pogostnostmi, ki so navedene v spodnji preglednici: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000);
Paediatric population Efficacy and safety in patients below 18 years has not been studied.
Učinkovitost in varnost pri bolnikih, mlajših od 18 let, nista raziskani.
If injected otherwise OPTISON bubbles will be destroyed.
Če injicirate na drugačen način, bodo mikrosfere kontrastnega sredstva OPTISON uničene.
No interaction studies have been performed.
še nista bili proučeni.
Store upright in a refrigerator.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v pokončnem položaju v hladilniku .
The safety of OPTISON for use during human pregnancy has not been established.
Varnost uporabe kontrastnega sredstva OPTISON v nosečnosti pri človeku ni bila dokazana.
OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml.
Kontrastno sredstvo OPTISON je na voljo v naslednjih velikostih pakiranja: 1 viala po 3 ml ali 5 vial po 3 ml.
MARKETING AUTHORISATION NUMBERS 1 x 3 ml presentation: EU/1/98/065/001
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM 1 x 3 ml pakiranje: EU/1/98/065/001
OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation.
Kontrastno sredstvo OPTISON je transpulmonalno ehokardiografsko kontrastno sredstvo, ki se uporablja pri bolnikih s sumom na srčnožilno bolezen ali z že potrjeno srčnožilno boleznijo za zagotavljanje opacifikacije srčnih komor, ojačitve orisa endokardialnega roba levega ventrikla, kar izboljša vizualizacijo gibanja srčne stene.
When used in conjunction with diagnostic ultrasound, OPTISON provides opacification of cardiac chambers, improvement in delineation of endocardial borders, enhancement of the Doppler signal, and visualisation of wall motion and blood flow within the heart.
omogoča opacifikacijo srčnih komor, izboljšanje orisov endokardialnih robov, ojačitev Dopplerjevega signala in vizualizacijo gibanja srčne stene in krvnega pretoka v srcu.
- OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension.
- Kontrastno sredstvo OPTISON je treba v največ 1 minuti po resuspendiranju previdno odvzeti v brizgo.
OPTISON should only be administered by doctors experienced in the field of diagnostic ultrasound imaging.
Kontrastno sredstvo OPTISON smejo uporabljati samo zdravniki, izkušeni na področju diagnostičnega slikanja z ultrazvokom.
NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection
IME ZDRAVILA OPTISON 0,19 mg/ml disperzija za injiciranje
What OPTISON contains - The active substance is perflutren-containing microspheres of heat treated human albumin 58 x 108/ml, suspended in human albumin solution 1%.
Kaj vsebuje kontrastno sredstvo OPTISON - Zdravilna učinkovina so mikrosfere s perflutrenom iz toplotno obdelanega humanega albumina v koncentraciji 5-8 x 108/ml, suspendirane v 1-odstotni raztopini humanega albumina.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN
• Tinnitus (noises in the ear)
• tinitus (zvenenje v ušesih), • omotica,
The safety and efficacy of OPTISON in children and adolescents below 18 years has not been established.
Varnost in učinkovitost kontrastnega sredstva OPTISON pri otrocih in mladostnikih, mlajših od 18 let,
Rare side effects (affects 1 to 10 users in 10,000):
Redki neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov):
Allergic type symptoms (e.g. anaphylactoid reaction or -shock, face oedema, urticaria)
Bolezni imunskega sistema simptomi alergijske vrste (npr. anafilaktoidna reakcija ali šok, otekanje obraza, koprivnica)
Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml solution for injection or glucose 50 mg/ml solution for injection should be injected at a rate of 1 ml/s to optimise the effect of the contrast agent.
Takoj po injekciji kontrastnega sredstva OPTISON je treba injicirati 10 ml raztopine 9 mg/ml natrijevega klorida za injiciranje ali raztopine 50 mg/ml glukoze za injiciranje s hitrostjo 1 ml/s, da čimbolj izboljšamo učinek kontrastnega sredstva.
Sodium hydroxide (pH adjustment) Water for injections
N-acetiltriptofan kaprilna kislina natrijev hidroksid (za uravnavanje pH) voda za injekcije
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih ter genotoksičnosti, ne kažejo posebnega tveganja za človeka.
Dysgeusia (altered taste), headache Tinnitus, dizziness, paraesthesia
Bolezni živčevja disgevzija (motnje okušanja), glavobol tinitus, omotica, parestezije pogosti redki
Package leaflet: Information for the user OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres
Navodilo za uporabo: informacije za uporabnika OPTISON 0,19 mg/ml disperzija za injiciranje mikrosfere s perflutrenom
Pharmacotherapeutic group: Ultrasound contrast medium, ATC Code: V08D A01
Farmakoterapevtska skupina: Ultrazvočna kontrastna sredstva, Oznaka ATC: V08D A01 Kadar se kontrastno sredstvo OPTISON uporablja v povezavi z ultrazvočno diagnostično preiskavo,
Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection should be injected at a rate of 1 ml/s.
Takoj po injiciranju kontrastnega sredstva OPTISON je treba injicirati 10 ml 0,9 % raztopine (9 mg/ml) natrijevega klorida za injiciranje ali 5 % raztopine (50 mg/ml) glukoze za injiciranje s hitrostjo 1 ml/s.
The infusion should then be returned to a TKO rate.
Takrat infuzijsko hitrost ponovno naravnajte na TKO.
The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a ”to keep open” (TKO) rate.
Takrat je treba pritrditi infuzijski set na tripotni petelinček in pričeti z intravenskim infundiranjem s hitrostjo, da je pretok ravno odprt (TKO - 'to keep open').
MARKETING AUTHORISATION NUMBER(S) EU/1/98/065/001 EU/1/98/065/002 13.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/98/065/001
OPTISON is an ultrasound contrast agent that helps to obtain clearer pictures (scan) of the heart during an echocardiography (a procedure where an image of the heart is obtained by using ultrasound).
Kaj je kontrastno sredstvo OPTISON in za kaj ga uporabljamo Kontrastno sredstvo OPTISON je ultrazvočno kontrastno sredstvo, ki nam pomaga, da pri ehokardiografiji (postopek, pri katerem slikamo srce z ultrazvokom) dobimo razločnejše slike (sken) srca.
Common side effects (affects 1 to 10 users in 100):
Pogosti neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov):
In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Na splošno so uporabo humanega albumina povezovali s prehodnimi motnjami okušanja, navzeo, zardevanjem, izpuščajem, glavobolom, bruhanjem, mrazenjem in povišano telesno temperaturo.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
V enem ml kontrastnega sredstva OPTISON je približno 0,19 mg perflutren plina.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Trenutno v specifikacijah Evropske farmakopeje ni poročil o prenosu virusov preko albumina,
In general the administration of human albumin has been associated with transient (non lasting) altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Na splošno so uporabo humanih albuminov povezovali s prehodnimi (kratkotrajnimi) motnjami okušanja, navzeo, zardevanjem, izpuščajem, glavobolom, bruhanjem, mrazenjem in povišano telesno temperaturo.
The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a “to keep open” (TKO) rate.
Takrat je treba pritrditi infuzijski set na tripotni petelinček in pričeti z intravenskim infundiranjem s hitrostjo, da je pretok ravno odprt (TKO-'to keep open').
Therefore, caution should be exercised when OPTISON is administered to breast-feeding women.
Zato je potrebna previdnost, ko se kontrastno sredstvo OPTISON uporablja pri doječih materah.
OPTISON contrast echocardiography should be accompanied by ECG monitoring.
Kontrastno ultrazvočno preiskavo srca s kontrastnim sredstvom OPTISON moramo spremljati s snemanjem EKG.
Therefore, caution should be exercised when OPTISON is administered to nursing women.
Zato je pri dajanju kontrastnega sredstva OPTISON doječim materam potrebna previdnost.
Excipient with known effect: Each ml contains 0.15 mmol (3.45 mg) of sodium.
En mililiter vsebuje 0,15 mmola (3,45 mg) natrija.
Concentration: Perflutren-containing microspheres, 5-8 x 108/ml with a mean diameter range of 2.54.5 µm.
Koncentracija: 5-8 x 108/ml mikrosfer humanega albumina s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains: Perflutren-containing microspheres 5 - 8 x 108, with a mean diameter range of 2.5 - 4.5 µm, equivalent to 0.19 mg perflutren gas per ml.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml vsebuje 5 - 8 x 108 mikrosfer s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm, kar ustreza 0,19 mg perflutren plina na ml.
The experience of OPTISON in severely ill patients is limited - if you have an artificial valve in your heart - if you have acute severe inflammation or sepsis - if you have a known blood clotting problem
- če imate umetno srčno zaklopko; - če imate hudo akutno vnetje ali sepso;
OTHER GE Healthcare
DRUGI PODATKI GE Healthcare
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres Intravenous use METHOD OF ADMINISTRATION
OVOJNINAH NALEPKA NA VIALI IME ZDRAVILA IN POT(I ) UPORABE OPTISON 0,19 mg/ml disperzija za injiciranje mikrosfere s perflutrenom intravenska uporaba POSTOPEK UPORABE
• Dizziness
• zardevanje,
• Dysgeusia (altered taste)
• disgevzija (motnje okušanja),
See the package leaflet for further information.
Dodatne informacije so navedene v navodilu za uporabo.
The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been penetrated.
Po predrtju gumijastega zamaška morate vsebino viale kontrastnega sredstva OPTISON uporabiti v 30 minutah.
Discard any unused portion.
Neuporabljeno kontrastno sredstvo je treba zavreči.
• Visual disturbances
• motnje vida.
Common Rare
Zardevanje pogosti
The product is supplied as 1 vial of 3 ml and 5 vials of 3 ml.
Kontrastno sredstvo je na voljo v naslednjih velikostih pakiranja: 1 viala po 3 ml in 5 vial po 3 ml. Na trgu ni vseh navedenih pakiranj.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg - The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
- Pomožne snovi so humani albumin, natrijev klorid, N-acetiltriptofan, kaprilna kislina, natrijev hidroksid in voda za injekcije.
Your heart activity and rhythm will be monitored when you get OPTISON.
Ko boste prejeli kontrastno sredstvo OPTISON, vam bodo spremljali delovanje srca in srčni ritem.
Eosinophilia
Eozinofilija občasni
• Feeling sick (nausea)
• občutek toplote, • občutek slabosti (navzea).
Anaphylactic reactions have been associated with the administration of human albumin products.
Z uporabo pripravkov s humanim albuminom so povezovali anafilaktične reakcije.
As OPTISON consists of microspheres that are stable and small enough for transpulmonary passage, it will also give enhanced echo signals in the left heart cavities.
Kontrastno sredstvo OPTISON povzroča tudi ojačitve ultrazvočnega signala v votlini levega srca, ker je sestavljeno iz mikrosfer, ki so dovolj obstojne in majhne za transpulmonalni prehod.
• Chest pain
• bolečine v prsih.
EXPIRY DATE
Dispnea občasni
MARKETING AUTHORISATION HOLDER GE Healthcare AS
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM GE Healthcare AS
• Paraesthesia (tingling sensations)
• parestezija (mravljinčenje),
Driving and using machines No effects are known.
Ni znanih učinkov.
6.1 List of excipients
6.1 Seznam pomožnih snovi humani albumin natrijev klorid
Visual disturbances
Bolezni prebavil
• Eosinophilia (increased number of a type of white blood cells in the blood)
Občasni neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov): • eozinofilija (zvečano število ene od vrst belih krvničk v krvi),
Nervous system disorders
Ultrazvočno kontrastno sredstvo.
This is considered to represent a pragmatic approach, appropriate in the case of this referral.
To se šteje za pragmatičen pristop, ustrezen v primeru te napotitve.
The European reference product is Zanil which has been authorised for decades in several Member States of the European Union.
Evropsko referenčno zdravilo je Zanil, ki je že desetletja odobreno v več državah članicah Evropske unije.
When the products are administered at the recommended doses, the available data supported:
Če se zdravila dajejo v priporočenih odmerkih, so razpoložljivi podatki podprli:
These withdrawal periods are considered adequate to ensure consumer safety.
Te karence se štejejo kot ustrezne za zagotovitev varnosti potrošnikov.
Milk: 108 hours (4.5 days).
Mleko: 108 ur (4,5 dni).
Tissue samples were analysed using a HPLC-MS/MS analytical method.
Vzorci tkiva so bili analizirani z analitsko metodo HPLC-MS/MS.
Therefore, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC, for the veterinary medicinal products Zanil and associated names, and generic products thereof.
Tako je Francija 1. septembra 2016 začela postopek v skladu s členom 35 Direktive 2001/82/ES za zdravilo Zanil in povezana imena za uporabo v veterinarski medicini ter njegova generična zdravila.
Fasciola hepatica (common name: liver fluke), is the causative agent of fasciolosis, one of the most economically important helminth diseases of livestock worldwide.
Fasciola hepatica (splošno ime: veliki metljaj) je povzročitelj fascioloze, ene od gospodarsko najpomembnejših helmintskih bolezni živine na svetu.
Residues on day 21 were considered to be outliers and were excluded from the analysis.
Ostanki na 21. dan se štejejo za osamelce in so bili izključeni iz analize.
In the first study, a group of cows with very low milk yield was used (11 to 14 L/day) whereas in the second study, the lowest milk yield was 16.8 L/day/animal.
V prvi študiji je bila uporabljena skupina krav z zelo majhno mlečnostjo (od 11 do 14 l/dan), v drugi študiji pa je bila najmanjša mlečnost 16,8 l/dan/žival.
The 25 cows included in the study were at different stages of lactation with low to high milk yield.
V študijo je bilo vključenih 25 krav v različnih fazah laktacije z majhno do veliko mlečnostjo.
Recalculated fat data (at 2, 4 and 7 days after administration) were analysed using the EMA statistical software (WT 1.4).
Preračunane podatke za maščobe (2, 4 in 7 dni po uporabi zdravila) so analizirali z uporabo statističnega programa EMA (WT 1.4).
Where cattle, sheep and/or goats have already been approved as target species the wording below relating to the relevant species should be used:
Kadar je bila uporaba pri govedu, ovcah in/ali kozah že odobrena, je treba v zvezi z zadevnimi živalskimi vrstami uporabiti spodnje besedilo:
The CVMP considered this figure to represent a worst case scenario as it was derived from a group of animals that included low yielding cows, and that consequently the addition of a safety span was not necessary.
Odbor CVMP je menil, da ta številka predstavlja najslabši možni scenarij, saj izhaja iz skupine živali, v kateri so bile krave z majhno mlečnostjo, zato dodajanje varnostnega območja ni bilo potrebno.
The first time point at which all milk residues were below the MRL was 108 hours.
Prva časovna točka, pri kateri so bili vsi ostanki v mleku pod mejno vrednostjo ostankov, je bila 108 ur.
It was acknowledged that extrapolation from one major species to another is not discussed in current CVMP guidelines, that no species-specific half-life for sheep fat is available and that the half-life in cattle fat was calculated on the basis of a limited number of data points.
Ugotovljeno je bilo, da ekstrapolacija iz ene glavne živalske vrste na drugo v trenutnih smernicah CVMP ni omenjena, da ni razpoložljive vrstno specifične razpolovne dobe za ovčjo maščobo in da je bila razpolovna doba za govedo izračunana na podlagi omejenega števila podatkovnih točk.