natgillin/translations-raw huggingface dataset:
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.
Based on Predicted Environmental Concentrations (PEC) for surface water PECsw of 0.0026 µg doramectin/l surface water (run-off scenario) and PECsw of 0.5225 µg doramectin/l surface water (direct excretion) an acute risk for Daphnia was identified in Tier A for both exposure scenarios with PEC/PNEC risk quotients (RQ) of 26 and 5225, respectively. 
Na osnovi predvidenih koncentracij v okolju (PKO) za površinske vode PKOpovršinske vode 0,0026 µg doramektina/l površinske vode (scenarij odtekanja) oziroma PKOpovršinske vode 0,5225 µg doramektina/l površinske vode (neposredno izločanje) je bilo ugotovljeno akutno tveganje za organizem Daphnia na stopnji A pri obeh scenarijih izpostavljenosti s količnikoma tveganja (RQ) 26 za prvi scenarij oziroma 5225 za drugi scenarij.
Overall summary of the scientific evaluation of Prontax 5 mg/ml pour-on solution for cattle and associated names 
Splošni povzetek znanstvenega vrednotenja zdravila Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezanih imen
• On the basis of environmental risk assessment data submitted with the application it was considered that in order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation risk mitigation measures should be applied; the CVMP concluded that the objections raised by the Netherlands and France should not prevent the granting of a marketing authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names (see annex I) as the overall benefit-risk balance for the product is positive subject to the recommended changes in the product information set out in annex III. 
prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem uporabiti ukrepe za zmanjševanje tveganja; je CVMP zaključil, da ugovori Nizozemske in Francije ne smejo preprečiti odobritve dovoljenja za promet z zdravilom Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezanimi imeni (glejte prilogo I), saj je celokupno razmerje med tveganji in koristmi za zdravilo, ob upoštevanju priporočenih sprememb informacij o zdravilu, ki so navedene v prilogi III, pozitivno.
The product is intended for the treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle. 
Zdravilo je namenjeno za zdravljenje infestacij z želodčno-črevesnimi glistami, pljučnimi črvi, očesnimi črvi, ličinkami zolja, sesajočimi ušmi, garjami in muhami Haematobia irritans pri govedu.
Elanco Animal Health, Eli Lilly and Company Limited and the name of the reference product in 
Ireland na družbe Elanco Animal Health, Eli Lilly in Company Limited, ime referenčnega zdravila na Irskem pa je bilo spremenjeno v Zearl 5 mg/ml, raztopina za kožni poliv za govedo.
Denmark Pfizer Limited Veterinary Medical Research & 
Nizozemska Pfizer Limited Veterinary Medical Research &
Prontax 5 mg/ml pour-on solution for cattle and associated names is a clear, colourless pour-on solution containing doramectin. 
Zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezana imena je bistra, brezbarvna raztopina za kožni poliv, ki vsebuje doramektin.
The reference product for this generic application was Dectomax 5 mg/ml pour-on solution for cattle. 
Referenčno zdravilo pri tej generični vlogi je bilo zdravilo Dectomax 5 mg/ml, raztopina za kožni poliv za govedo.
Prontax 5 mg/ml pour-on solution for cattle contains doramectin as active ingredient. 
Zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, vsebuje zdravilno učinkovino doramektin.
Dectomax 5 mg/ml pour-on solution for cattle was transferred from Pfizer Healthcare Ireland to 
Dectomax 5 mg/ml, raztopina za kožni poliv za govedo, preneseno z družbe Pfizer Healthcare
Add the following text in the relevant sections of the product information: 
Naslednje besedilo je treba vključiti v oddelek 5.3 povzetka glavnih značilnosti zdravila (okoljski podatki):
Slovenia 
Latvija
In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended: The following text is proposed in section 4.5 of the SPC(special precautions for use): Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments. 
Za obravnavo opredeljenih tveganj za vodne organizme in organizme, prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem, se priporočajo naslednji ukrepi za zmanjševanje tveganja: