natgillin/translations-raw huggingface dataset:
Cases of serious, sometimes fatal, allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Pri bolnikih zdravljenih z intravensko ibandronsko kislino so poročali o primerih resnih, včasih smrtnih, alergijskih reakcij.
Bondenza 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Dajanje zdravila Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi: Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi se daje intravensko 15 do 30 sekund.
After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
Po intravenskem dajanju odmerka 0,5 mg se je pri bolnikih s hudo ledvično okvaro celokupni očistek zmanjšal za 67 %, ledvični očistek za 77 %, neledvični očistek pa za 50 %.
One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
Ena filmsko obložena tableta vsebuje 150 mg ibandronske kisline (v obliki natrijevega monohidrata).
Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Peroralni difosfonati lahko povzročijo lokalno draženje sluznice zgornjega dela prebavil.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Pri ekstrapolaciji izpostavljenosti, ki je 35-krat presegala izpostavljenost pri človeku, na razvoj F1 potomcev podgan niso opazili škodljivih vplivov.
Most cases of adverse reactions did not lead to cessation of therapy
V večini primerov prekinitev terapije zaradi neželenih učinkov ni bila potrebna.
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05-BA06
Oznaka ATC: M05BA06
One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as sodium monohydrate).
Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline v 3 ml raztopine (v obliki natrijevega monohidrata).
Anaphylactic reaction/shock*†
Bolezni imunskega sistema preobčutljivostna reakcija anafilaktična reakcija/šok*†
The dose of Bondenza is one tablet once a month.
NAČRTOVANJE JEMANJA ZDRAVILA BONDENZA Odmerek zdravila Bondenza je ena tableta enkrat na mesec.
ibandronic acid 2.5 mg daily (N=977)
ibandronska kislina 2,5 mg enkrat na dan (n = 977)
At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Po dveh letih je 87,1 % (p < 0,001) bolnikov, ki so prejemali 150 mg enkrat na mesec, in 70,5 % bolnikov, ki so prejemali 2,5 mg na dan, zadostilo kriterijem za odzivnost.
You may develop low levels of calcium, phosphorus or magnesium in the blood.
Če so vam dali večji odmerek zdravila Bondenza, kot bi smeli To lahko povzroči nizke koncentracije kalcija, fosforja ali magnezija v krvi.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bondenza 3 mg solution for injection
IME ZDRAVILA IN POT(I) UPORABE Bondenza 3 mg raztopina za injiciranje ibandronska kislina
• muscle cramps, stiffness of your joints and limbs
• mišični krči, togost v sklepih ali okončinah.
How to take Bondenza
Kako jemati zdravilo Bondenza
At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Po dveh letih je bilo odzivnih 93,5 % bolnikov (p = 0,004), ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 86,4 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg enkrat na dan.
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Nemčija
What Bondenza is and what it is used for What you need to know before you receive Bondenza How to receive Bondenza
Kaj je zdravilo Bondenza in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Bondenza Kako prejemati zdravilo Bondenza Možni neželeni učinki
Table 1: Adverse reactions occurring in postmenopausal women receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM16549 and MF4411 and in postmarketing experience.
Preglednica 1: Neželeni učinki, ki so se pojavili pri postmenopavznih ženskah, ki so v študijah faze III BM16549 in MF4411 ter po prihodu zdravila na trg prejemale zdravilo Bondenza 150 mg enkrat na mesec ali ibandronsko kislino 2,5 mg na dan.
For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Razlik v incidenci neželenih učinkov v zgornjem delu prebavil pri teh bolnikih glede na jemanje 150 mg enkrat na mesec ali 2,5 mg enkrat na dan ni bilo.
.Table 1: Adverse reactions occurring in postmenopausal women receiving Bondenza 3 mg injection every 3 months or ibandronic acid 2.5 mg daily in the phase III studies BM16550 and MF 4411, and in post-marketing experience.
Preglednica 1: Neželeni učinki, ki so se pojavili pri postmenopavznih ženskah, ki so v študijah faze III BM16550 in MF4411 ter po prihodu zdravila na trg prejemale zdravilo Bondenza 3 mg v obliki injekcije vsake 3 mesece ali ibandronsko kislino 2,5 mg na dan.
If you get any of the side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bondenza 3 mg injection.
Tudi dveletno zdravljenje s 3-mg injekcijo zdravila Bondenza je pokazalo pričakovano zmanjšanje kostne premene, normalno kakovost kosti in odsotnost motenj mineralizacije.
No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo očistek kreatinina enak ali večji kot 30 ml/min, prilagajanje odmerkov ni potrebno.
BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
MKG - povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po 3 letih MKG - povprečna sprememba glede na izhodiščno vrednost za kolk po 3 letih
MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/005 1 pre-filled syringe EU/1/03/266/006 4 pre-filled syringes
ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/03/266/005 1 napolnjena injekcijska brizga
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 150 mg ibandronske kisline (v obliki natrijevega monohidrata).
Vascular disorders Gastrointestinal disorders
Bolezni prebavil gastritis, dispepsija,
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Drugi neželeni učinki ibandronske kisline v študijah vplivov na sposobnost razmnoževanja pri podganah so bili pričakovano značilni za to skupino zdravil (difosfonati).
dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
Pri podganah in kuncih, ki so peroralno prejemali ibandronsko kislino, niso opazili neposrednih škodljivih vplivov na plod ali teratogenega delovanja.
System Organ Class Common
Organski sistem Pogosti
Ocular inflammation
NAPOLNJENA INJEKCIJSKA BRIZGA
Check with your doctor or pharmacist if you are not sure.
Obvestite svojega zdravnika, če to ni mogoče.
General disorders and administration site conditions reactions, Asthenia
Splošne težave in spremembe na mestu aplikacije bolezen, podobna gripi*
ibandronic acid 2.5 mg daily (N=294)
ibandronska kislina 2,5 mg enkrat na dan (n = 334)
For total hip BMD, 90.0 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 76.7 % of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
MKG kolka se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 90,0 % (p < 0,001) bolnikov, ki so prejemali 150 mg enkrat na mesec, in 76,7 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
So be especially careful if you take painkillers or anti-inflammatories while you're taking Bondenza.
Če jemljete zdravila proti bolečini ali protivnetna zdravila med zdravljenjem z zdravilom Bondenza, bodite še posebno previdni.
ibandronic acid 2.5 mg daily
ibandronska kislina 2,5 mg enkrat na dan
*See further information below †Identified in post-marketing experience.
*Za nadaljnje informacije glejte spodnje besedilo.
Musculoskeletal and , connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice†
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati.
General disorders and administration site conditions *See further information below †Identified in post-marketing experience.
utrujenost *Za nadaljnje informacije glejte spodnje besedilo.
Musculoskeletal and connective tissue disorders
Žilne bolezni flebitis/ tromboflebitis
Lumbar spine L2-L4 BMD 3.9 [3.4, 4.3]
MKG ledvene hrbtenice L2-L4
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline (v obliki natrijevega monohidrata) v 3 ml raztopine.
Lactose monohydrate Povidone
Atipičen zlom stegnenice
- You should take calcium and vitamin-D supplements while receiving Bondenza.
- Med zdravljenjem z zdravilom Bondenza morate jemati dodatke kalcija in vitamina D.
EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do
Continuing to take Bondenza
PRETISNI OMOT
Angioedema, Face oedema, Urticaria
slaba prebava, slabost, driska,
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints.
občutjem neugodja, utrujenostjo, bolečino v kosteh in bolečimi mišicami ter sklepi.
At two years 93.4 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 93,4 % bolnikov (p < 0,001), ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 78,4 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg enkrat na dan.
Titanium dioxide (E 171)
Obloga tablete hipromeloza titanov dioksid (E171) smukec makrogol 6000
Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Pri bolnikih, zdravljenih z difosfonati, so poročali o osteonekrozi čeljustnic.
There is no relevant use of Bondenza in children below 18 years, and Bondenza was not studied in this population (see section 5.1 and 5.2).
Zdravila Bondenza pri tej populaciji bolnikov niso proučevali (glejte poglavji 4.4 in 5.2).
Ocular inflammation*†
Bolezni prebavil* ezofagitis,
• dizziness
• koprivnica.
At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
(p = 0,002), ki so prejemali 150 mg enkrat na mesec, in 65,6 % bolnikov, ki so jemali 2,5 mg enkrat na dan.
The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia and Sweden.
Referenčna država članica je bila Irska, zadevne države članice pa Avstrija, Bolgarija, Danska, Španija, Finska, Francija, Madžarska, Islandija, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovenija in Švedska.
During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the data presented to support the environmental risk assessment.
Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede podatkov, predloženih v podporo oceni tveganja za okolje.
The parent drug accounted for 79% of the total radioactive faecal residue.
Matično zdravilo je predstavljalo 79 % celotnega radioaktivnega ostanka v blatu.
• During this referral procedure in Ireland the marketing authorisation of the reference product
• Med napotitvenim postopkom na Irskem je bilo dovoljenje za promet z referenčnim zdravilom
The product has claims for persistent efficacy ranging from 21 to 49 days.
Učinek zdravila naj bi trajal v razponu od 21 do 49 dni.
1 During the decentralised procedure it was agreed that the authorisation of the generic product under the name "Dectomax" will not be issued until the reference product under the name "Dectomax" has either been withdrawn or renamed.
1 Med decentraliziranim postopkom je bilo dogovorjeno, da dovoljenje za promet generičnega zdravila z imenom „Dectomax“ ne bo izdano, dokler referenčno zdravilo z imenom „Dectomax“ ne bo umaknjeno ali preimenovano.
The following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Opozoriti je treba na naslednji dve spremembi prvotne vloge, do katerih je prišlo med decentraliziranim postopkom in napotitvenim postopkom pri CVMP:
INN/Strength Animal species
INN/Jakost Živalska vrsta
In general terms, as for the benefits, that except for the risks identified in particular by the referral (ERA) all other risks are expected to be the same as for the reference product and have not been discussed in any detail by CVMP.
Na splošno velja, tako kot pri koristih, da so z izjemo tveganj, ki so bila posebej opredeljena v napotitvenem postopku (ocena tveganja za okolje), vsa druga tveganja po pričakovanjih enaka kot pri referenčnem zdravilu, CVMP pa o njih ni podrobno razpravljal.
After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, the RQ remains above 1 for Daphnia.
Po izboljšavi PKOpovršinske vode z modelom FOCUS, kot priporoča smernica CVMP/ERA/418282/2005, količnik tveganja ostaja nad 1 za organizem Daphnia.
Two Concerned Member States (the Netherlands and France) considered that the authorisation of Dectomax 5 mg/ml pour-on solution for cattle may present a potential serious risk to the environment.
Dve zadevni državi članici (Nizozemska in Francija) sta menili, da utegne odobritev zdravila Dectomax 5 mg/ml, raztopina za kožni poliv za govedo, predstavljati možno resno tveganje za okolje.
An ERA was performed by the applicant in accordance with the VICH guidelines for Phase I and Phase II assessment adopted by the CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) as well as the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH Guidelines GL6 and GL38 (CVMP/ERA/418282/2005-corr).
Oceno tveganja za okolje je predlagatelj izvedel v skladu s smernicami VICH za oceno faze I in faze II, ki jih je sprejel CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final), in smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicam VICH GL6 in GL38 (CVMP/ERA/418282/2005-corr).
Doramectin is an antipatasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Doramektin je antiparazitik, izoliran pri fermentaciji izbranih sevov, ki izvirajo iz talnega organizma Streptomyces avermitilis.
The supplementary data provided did not allow ruling out a medium to longterm risk to dung insects.
Na podlagi predloženih dodatnih podatkov ni bilo mogoče izključiti srednje- do dolgoročnega tveganja za insekte, prisotne v gnoju.
As the risk for Daphnia could not be ruled out by PEC refinements Tier B assessment should be performed according VICH Guideline 38 be performed for which a Daphnia magna reproduction study is required.
Ker tveganja za organizem Daphnia z izboljšanjem PKO ni bilo mogoče izključiti, bi bilo treba izvesti ocenjevanje tveganja stopnje B v skladu s smernico VICH 38, za katero je potrebna študija vpliva na sposobnost razmnoževanja Daphnia magna.
Therefore, risk mitigation measures are considered necessary, as specified in the product information.
Iz tega razloga je bilo ocenjeno, da so nujni ukrepi za zmanjševanje tveganja, kot so navedeni v informacijah o zdravilu.
The concentration of total doramectin residues excreted in cattle faeces peaked at 21 days after administration (270 µg/kg) and declined thereafter, accounting for 52 µg/kg at 35 days and 3.9 µg/kg at 56 days.
Koncentracija celotnih ostankov doramektina, izločenih z blatom goveda, je dosegla najvišjo vrednost 21. dan po dajanju zdravila (270 µg/kg) ter se nato zmanjševala in 35. dan znašala 52 µg/kg, 56. dan pa 3,9 µg/kg.
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, karence, imetnikov dovoljenja za promet v državah članicah.
The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Prontax 5 mg/ml pour-on solution for cattle.
CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki so jih je izrazile zadevne države članice, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo.
In terms of environmental safety, in addition to the fact that the current data package does not allow to rule out bioaccumulation of doramectin, a risk to the aquatic compartment has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung out when the product is used in accordance with the recommended posology.
V zvezi z varnostjo za okolje je bilo poleg dejstva, da na osnovi trenutnega nabora podatkov ni mogoče izključiti biološkega kopičenja doramektina, na osnovi razpoložljivih podatkov o toksičnosti ugotovljeno tveganje za vodno okolje (akutna toksičnost za Daphnia magna) ter tveganje za organizme, prisotne v gnoju, ki so pri uporabi zdravila v skladu s priporočenim načinom odmerjanja izpostavljeni gnoju, ki vsebuje ostanke.
The potential serious risks regarding the environment identified by France and the Netherlands are risks to dung fauna and Daphnia in accordance with the proposed instructions for use and a risk identified by the Netherlands due to the bioaccumulation potential linked to the determination of the log KOW by using a test method, which was not considered appropriate for the active ingredient.
Možna resna tveganja za okolje, ki sta jih izpostavili Francija in Nizozemska, so tveganja za organizme, prisotne v gnoju, in organizem Daphnia glede na predlagano navodilo za uporabo ter tveganje, ki ga je izpostavila Nizozemska, glede možnosti biološkega kopičenja v povezavi z določitvijo log KOW s testno metodo, ki je bila ocenjena za neustrezno za to zdravilno učinkovino.
The product is applied topically along the mid-line of the back in a narrow strip between the withers and tailhead.
Zdravilo nanašamo topikalno po sredini hrbta v ozkem pasu od pleč do korena repa.
Further PEC refinement considering that peak excretion of total residues occurred on day 21 after administration and accounted for 2.3% of the administered dose, as well as based on sediment partitioning lead to a PECsw-refined-direct of 0.00037 µg/l, resulting in a RQ for Daphnia (3.7) still higher than 1.
Nadaljnje izboljšanje PKO ob upoštevanju, da je bilo izločanje celotnih ostankov največje 21. dan po dajanju zdravila in je ustrezalo 2,3 % uporabljenega odmerka, ter na podlagi porazdelitve sedimenta je privedlo do izboljšane PKOpovršinske vode za neposredno izločanje 0,00037 µg/l, kar pomeni, da je količnik tveganja za organizem Daphnia (3,7) še vedno večji od 1.
The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 5 mg/ml pour-on solution for cattle.
Predlagatelj družba Pfizer Limited je predložil vlogo za decentralizirani postopek za zdravilo Dectomax 5 mg/ml, raztopina za kožni poliv za govedo.
The benefit-risk evaluation is deemed to be positive provided that the recommended risk mitigation measures are added to the product literature regarding risk to aquatic organisms and dung fauna.
Ocena razmerja med tveganji in koristmi velja za pozitivno pod pogojem, da se v dokumentacijo izdelka vključijo priporočeni ukrepi za zmanjševanje tveganja v zvezi s tveganjem za vodne organizme in organizme, prisotne v gnoju.
Based on the Predicted No Effect Concentrations (PNECs) derived from the LC50 of 1.34 µg/kg soil for horn flies (Haematobia irritans) and the NOEC of 4.0 µg/kg soil for dung beetles (Ontophagus gazelle) the resulting risk quotients for both species were high (20149 and 675, respectively, based on the amount of total residues in dung at day 21 after administration), indicating a high acute risk to dung insects in Tier A. Consequently a Tier B assessment should be performed.
Na osnovi predvidenih koncentracij brez učinka (PKBU), izpeljanih iz vrednosti LC50 1,34 µg/kg prsti za muho Haematobia irritans, in koncentracije brez opaznega učinka (KBOU) 4,0 µg/kg prsti za govnača (Ontophagus gazelle) sta bila izračunana količnika tveganja (RQ) za obe vrsti visoka (20149 za Haematobia irritans oziroma 675 za Ontophagus gazelle, na osnovi celotnih ostankov v gnoju 21. dan po dajanju zdravila), kar kaže na visoko akutno tveganje za insekte, prisotne v gnoju, na stopnji A. Posledično bi bilo treba izvesti oceno stopnje B. Vendar pa je znano, da usklajena navodila za izvedbo ocenjevanja tveganja v stopnji B za insekte, prisotne v gnoju, trenutno niso na voljo.
The outcome of the ERA indicates that RQ are higher than 1 in the Tier A assessment in two cases, namely daphnids (following direct excretion scenario) and dung fauna.
Izid ocene tveganja za okolje kaže, da je količnik tveganja pri ocenjevanju v stopnji A večji od 1 v dveh primerih, in sicer pri dafnidih (pri scenariju neposrednega izločanja) in pri organizmih, prisotnih v gnoju.
The referral for Prontax 5 mg/ml pour on solution for cattle relates to the potential serious risks raised by France and the Netherlands regarding the environmental risk assessment (ERA).
Napotitveni postopek za zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, se nanaša na možno resno tveganje v zvezi z oceno tveganja za okolje, na katero sta opozorili Francija in Nizozemska.
Sweden (Applicant) Pfizer Limited Veterinary Medical Research &
Švedska (Applicant) Pfizer Limited Veterinary Medical Research &
A Phase II, Tier A assessment was required.
Potrebno je bilo ocenjevanje stopnje A faze II.