natgillin/translations-raw huggingface dataset:
EQUEST, 18,92 mg/g, geriamasis gelis arkliams
EQUEST, 18,92 mg/g, geriamasis gelis arkliams moksidektin peroralni gel
A targeted sampling in the environment following the use of veterinary medicinal products as a pour-on solution containing 5 mg moxidectin per ml or as a solution for injection containing 100 mg moxidectin per ml in beef cattle in pasture animals for three consecutive years was considered necessary in order to obtain a better understanding of the actual environmental exposure.
Ocenili so, da je potrebno ciljno vzorčenje v okolju po uporabi zdravil za uporabo v veterinarski medicini v obliki kožnega poliva, raztopine, ki vsebuje 5 mg moksidektina na ml, ali raztopine za injiciranje, ki vsebuje 100 mg moksidektina na ml, pri pašnem govedu za prirejo mesa tri leta zaporedoma, da bi lahko bolje razumeli dejansko izpostavljenost okolja.
18,92 mg/g Horse
18,92 mg/g konji
in cattle, sheep and horses, taking into account the specific pattern of use in each target species and the maximum number of treatments that might be applied within one year.
Da bi lahko obravnavali emisije zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, v okolje, so za vse vrste zdravila (kožni poliv, z injekcijo, peroralno) izračunali najslabše možne primere pri govedu, ovcah in konjih ter pri tem upoštevali specifičen vzorec uporabe pri vsaki ciljni vrsti in največje število zdravljenj, ki jih je mogoče opraviti v enem letu.
3690 (cattle, solution for injection containing 100 mg moxidectin per ml)
0,239 (govedo, raztopina za injiciranje, ki vsebuje 100 mg moksidektina na ml)
In horses and ponies, oral administration of the monoproducts is intended for the treatment of large and small strongyles, ascarids and other parasites e.g. pinworm, throat bot.
Pri konjih in ponijih je peroralna uporaba zdravil z eno samo učinkovino namenjena za zdravljenje velikih in malih strongilidov, askaridov in drugih parazitov, npr. podančic in Gasterophilus haemorrhoidalis.
Considering that degradation mechanisms in soil are in place, together with the high immobility of moxidectin in soil, the marketing
Z upoštevanjem dejstva, da so v tleh vzpostavljeni mehanizmi razgradnje, in visoke imobilnosti moksidektina v tleh so imetniki dovoljenj za promet zaključili, da izpostavljenost površinskih vod moksidektinu ni verjetna oziroma je zelo majhna.
Cydectin 1 mg/mlLösung zum Eingeben für Schafe
Cydectin 1 mg/mlLösung zum Eingeben für Schafe moksidektin peroralna raztopina ovce
EQUEST GEL ORAL 18,92 mg/g
EQUEST GEL ORAL 18,92 mg/g moksidektin peroralni gel
Cydectin TriclaMox 5 mg/ml + 200 mg/ml kožni poliv, raztopina za govedo
Cydectin TriclaMox 5 mg/ml + 200 mg/ml kožni poliv, raztopina za govedo moksidektin, triklabendazol kožni poliv, raztopina
Pramoxiquest Oral Gel for Horses and Ponies
Pramoxiquest Oral Gel for Horses and Ponies moksidektin, prazikantel peroralni gel
In cattle, topical administration of the pour-on combination products (moxidectin in combination with triclabendazole) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, trematode (fluke) and certain arthropod infestations.
Pri govedu je topična uporaba kombiniranih zdravil v obliki kožnega poliva (moksidektin v kombinaciji s triklabendazolom) namenjena za zdravljenje glist v prebavilih, glist v dihalih, trematodov (metljajev) in določenih infestacij s členonožci.
A. For veterinary medicinal products listed in Annex I as pour-on solution and administered to cattle containing 5 mg moxidectin per ml or 5 mg moxidectin and 200 mg triclabendazole per ml
A. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki kožnega poliva, raztopine, za dajanje govedu, in vsebujejo 5 mg moksidektina na ml ali 5 mg moksidektina in 200 mg triklabendazola na ml
Equimoxectin 18,92 mg/g
Equimoxectin 18,92 mg/g moksidektin peroralni gel
C. For veterinary medicinal products listed in Annex I as oral solution and administered to sheep containing 1 mg moxidectin per ml or 1 mg moxidectin and 50 mg triclabendazole per ml
C. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki peroralne raztopine, za dajanje ovcam, in vsebujejo 1 mg moksidektina na ml ali 1 mg moksidektina in 50 mg triklabendazola na ml
For the assessment of the potential for bioaccumulation, one GLP compliant laboratory study was provided.
V zvezi z oceno kopičenja v organizmih je bila predložena ena laboratorijska študija, skladna z dobro laboratorijsko prakso.
Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Podlaga za dopolnilo povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
EQUEST 18,92 mg/g peroralni gel za konje in ponije
EQUEST 18,92 mg/g peroralni gel za konje in ponije moksidektin peroralni gel
Equest 18,92 mg/g perorální gel
Equest 18,92 mg/g perorální gel moksidektin peroralni gel
EQUEST GEL ORALE Moxidectin Oral gel
Equest Gel Oral moksidektin peroralni gel
Iceland Zoetis Finland Oy Tietokuja 4
Islandija Zoetis Finland Oy Tietokuja 4
Equest 18.92 mg/g gel oral chevaux, poneys
Equest 18.92 mg/g gel oral chevaux, poneys moksidektin peroralni gel
19,5 mg/g 121,7 mg/g
19,5 mg/g 121,7 mg/g konji
D. For veterinary medicinal products listed in Annex I as solution for injection and administered to sheep containing 10 mg moxidectin per ml or 20 mg moxidectin per ml
D. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki raztopine za injiciranje, za dajanje ovcam, in vsebujejo 10 mg moksidektina na ml ali 20 mg moksidektina na ml
In sheep, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, larvae of bot fly and mange mites.
Pri ovcah je subkutana uporaba zdravil za injiciranje namenjena za zdravljenje in preprečevanje glist v prebavilih, glist v dihalih, ličink nosnih zoljev in govejih srbcev.
EQUEST 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys
EQUEST 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys moksidektin peroralni gel
In sheep, oral administration of the monoproducts is intended for the treatment and prevention of gastro-intestinal nematodes and respiratory tract nematodes.
Pri ovcah je peroralna uporaba zdravil z eno samo učinkovino namenjena za zdravljenje in preprečevanje glist v prebavilih in glist v dihalih.
In sheep, oral administration of the combination products is intended for the treatment of gastrointestinal nematodes, respiratory tract nematodes and trematode (fluke) infestations.
Pri ovcah je peroralna uporaba kombiniranih zdravil namenjena za zdravljenje glist v prebavilih, glist v dihalih in infestacij s trematodi (metljaji).
EQUEST PRAMOX, geriamasis gelis
EQUEST PRAMOX, geriamasis gelis moksidektin, prazikantel peroralni gel
In cattle, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice and mange mites.
Pri govedu je subkutana uporaba zdravil za injiciranje namenjena za zdravljenje in preprečevanje glist v prebavilih, glist v dihalih, govejih zoljev, uši in govejih srbcev.
Zermex 0.1% w/v Oral Solution for Sheep
Zermex 0.1% w/v Oral Solution for Sheep moksidektin peroralna raztopina ovce
EQUIMOXECTIN 18,92 mg/g gel oral para equino y ponis
EQUIMOXECTIN 18,92 mg/g gel oral para equino y ponis moksidektin peroralni gel
Cydectin 0.1% sol orale ovins
Cydectin 0.1% sol orale ovins moksidektin peroralna raztopina ovce
CYDECTIN 2% sheep Moxidectin Solution for injection
CYDECTIN 2% sheep moksidektin raztopina za injiciranje ovce subkutano
B. For veterinary medicinal products listed in Annex I as solution for injection and administered to cattle containing 10 mg moxidectin per ml or 100 mg moxidectin per ml
B. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki raztopine za injiciranje, za dajanje govedu, in vsebujejo 10 mg moksidektina na ml ali 100 mg moksidektina na ml
Romania Zoetis Belgium SA Rue Laid Burniat, 1
Romunija Zoetis Belgium SA Rue Laid Burniat, 1
Two GLP compliant studies on algae were performed in accordance with OECD guideline no. 2015.
Na algah sta bili opravljeni dve študiji, skladni z dobro laboratorijsko prakso in smernico OECD št.
Equest Pramox perorální gel
Equest Pramox perorální gel moksidektin prazikantel peroralni gel
The non-standard field studies indicated that the risk derived from laboratory tests may not fully reflect what is observed under field conditions of use; differences were shown in sensitivity of dung beetle and dung fly and additionally a lower toxicity of moxidectin compared to other avermectins.
Dokazali so razlike v občutljivosti iztrebkarja in jesenske muhe ter dodatno manjšo strupenost moksidektina v primerjavi z drugimi avermektini.
Equipramox perorální gel
Equimoxectin moksidektin peroralni gel
Zermex 1% w/v Solution for Injection for Sheep
Zermex 1% w/v Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
PECsurfacewater run-off (ng/l) 0.239 (cattle, solution for injection containing 100 mg moxidectin per ml)
PECtla_konstantna_vrednost (ng/kg) 3 690 (govedo, raztopina za injiciranje, ki vsebuje 100 mg moksidektina na ml)
Dung fauna
Organizmi v gnoju
CYDECTIN 5 mg/ml POUR-ON - Lösung zum Übergießen für Rinder
CYDECTIN 5 mg/ml POUR-ON - Lösung zum Übergießen für Rinder moksidektin kožni poliv, raztopina govedo topično - na hrbet živali
Zermex 100 mg/ml LA Solution for Injection for Cattle
Zermex 100 mg/ml LA Solution for Injection for Cattle moksidektin raztopina za injiciranje govedo subkutano
Equest orale gel, 18,92 mg/g, orale gel voor paarden en pony's
Equest orale gel, 18,92 mg/g, orale gel voor paarden en pony's moksidektin peroralni gel
EQUEST PRAMOX perorálny gél
EQUEST PRAMOX perorálny gél moksidektin, prazikantel peroralni gel
EQUIMOXECTIN 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys
EQUIMOXECTIN 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys moksidektin peroralni gel
CYDECTIN LA Cattle Moxidectin Solution for injection
CYDECTIN LA Cattle moksidektin raztopina za injiciranje govedo subkutano
Moxiquest 18.92 mg/g Oral Gel for Horses & Ponies
Moxiquest 18.92 mg/g Oral Gel for Horses & Ponies moksidektin peroralni gel
CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link OECD guideline for the testing of chemicals no. 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test - link OECD guideline for the testing of chemicals no. 202: Daphnia sp.
4 CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link lahko uporabi le kot podporna informacija, vendar ni del ocene obstojnosti, kopičenja v organizmih in strupenosti.
Following treatment of horses with the product, levels of moxidectin that are potentially toxic to dung beetles and flies may be excreted over a period of more than 1 week and may decrease dung fauna abundance.
Po zdravljenju konjev s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho in iztrebkarja, lahko izločajo več kot 1 teden in v tem obdobju lahko zmanjšajo številčnost organizmov v gnoju.
In cattle, topical administration of the pour-on monoproducts (moxidectin only) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice, mange mites and horn flies.
Pri govedu je topična uporaba zdravil v obliki kožnega poliva z eno samo zdravilno učinkovino (samo moksidektinom) namenjena za zdravljenje glist v prebavilih, glist v dihalih, govejih zoljev, uši, govejih srbcev in rogovih muh.
Iceland Continental Farmaceutica Rue Laid Burniat 1,
Islandija Continental Farmaceutica Rue Laid Burniat 1,
Moxidectin, triclabendazole
Cydectin TriclaMox moksidektin, triklabendazol peroralna raztopina
EQUEST GEL ORAL 18,92 mg/g, gel oral para caballos y ponis
EQUEST GEL ORAL 18,92 mg/g, gel oral para caballos y ponis moksidektin peroralni gel
18,92 mg Horse and pony
18,92 mg konji in poniji
Based on the excretion profile of moxidectin when administered as the oral formulation to sheep, treated animals should not have access to watercourses during the first 3 days after treatment.
Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki peroralne formulacije pri ovcah, zdravljene živali v prvih 3 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
Based on the excretion profile of moxidectin when administered as the injectable formulation to sheep, treated animals should not have access to watercourses during the first 11 days after treatment.
Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki formulacije z injiciranjem pri ovcah, zdravljene živali v prvih 11 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
Dung flies were shown to be the most sensitive species as demonstrated in laboratory tests and in field studies.
Kot so pokazali laboratorijski testi in terenske študije, je bila jesenska muha najobčutljivejša vrsta.
Topical - on the back of the animal
moksidektin kožni poliv, raztopina govedo topično - na hrbet živali
Zermex 20 mg/ml LA Solution for Injection for Sheep
Zermex 20 mg/ml LA Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
Moxidectin triclabendazole
moksidektin triklabendazol peroralna raztopina
Equest Oral Gel 18.92 mg/g Oral Gel for Horses and Ponies
Equest Oral Gel 18.92 mg/g Oral Gel for Horses and Ponies moksidektin peroralni gel
Equest Pramox 19,5 mg/g + 121,7 mg/g peroralni gel
Equest Pramox 19,5 mg/g + 121,7 mg/g moksidektin prazikantel peroralni gel
Symec 1 mg/ml oral solution for sheep
Symec 1 mg/ml oral solution for sheep moksidektin peroralna raztopina ovce
Moxodectin 1 mg/ml oral solution for sheep
Moxodectin 1 mg/ml oral solution for sheep moksidektin peroralna raztopina ovce
Based on the excretion profile of moxidectin when administered as the injectable formulation, treated animals should not have access to watercourses during the 10 days after treatment.
Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki formulacije za injiciranje, zdravljene živali v 10 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
EQUEST GEL ORAL, 18,92 mg/g, gel oral para cavalos e póneis
EQUEST GEL ORAL, 18,92 mg/g, gel oral para cavalos e póneis moksidektin peroralni gel
Based on the excretion profile of moxidectin when administered as the injectable formulation, treated animals should not have access to watercourses during the first 10 days after treatment.
Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki formulacije za injiciranje, zdravljene živali v prvih 10 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
Based on the excretion profile of moxidectin when administered as the pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.
Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki kožnega poliva, zdravljene živali v prvem tednu po zdravljenju ne smejo imeti dostopa do vodotokov.
EQUEST ORAL GEL, 18.92 mg/g, oral gel for horses and ponies
EQUEST ORAL GEL, 18.92 mg/g, oral gel for horses and ponies moksidektin peroralni gel
EQUEST PRAMOX 19,5 mg/g + 121,7 mg/g Gel zum Eingeben für Pferde
EQUEST PRAMOX 19,5 mg/g + 121,7 mg/g Gel zum Eingeben für Pferde moksidektin, prazikantel peroralni gel
Cydectin 0,1% w/v orale oplossing voor schapen
Cydectin 0,1% w/v orale oplossing voor schapen moksidektin peroralna raztopina ovce
Equimoxectin 18,92 mg/g orale gel voor paarden en ponies
Equimoxectin 18,92 mg/g orale gel voor paarden en ponies moksidektin peroralni gel
*-PEC calculation for direct excretion by sheep is not necessary as per CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) but was calculated by a marketing authorisation holder to cover every possible scenario.
(EMEA/CVMP/ERA/418282/2005-Rev.1) ni potrebno, vendar jo je imetnik dovoljenja za promet z zdravilom izračunal, da bi vključil vsak možen scenarij.
Equipramox 19,5 mg/g + 121,7 mg/g peroralni gel
Equipramox 19,5 mg/g + 121,7 mg/g moksidektin prazikantel peroralni gel
Cydectin 0.1% w/v Oral Solution for Sheep
Cydectin 0.1% w/v Oral Solution for Sheep moksidektin peroralna raztopina ovce
Moxigro 1 mg/ml Oral Solution for Sheep
Moxigro 1 mg/ml Oral Solution for Sheep moksidektin peroralna raztopina ovce
Equipramox 19,5 mg/g +121,7 mg/g Gel zum Eingeben für Pferde
Equipramox 19,5 mg/g +121,7 mg/g Gel zum Eingeben für Pferde moksidektin, prazikantel peroralni gel
Subcutaneous
Strupenost
Moxidectin praziquantel
Equipramox moksidektin prazikantel peroralni gel
The CVMP considered that assessment of secondary poisoning can only be used as supportiveinformation but is not part of the PBT assessment.
Odbor CMVP je presodil, da se ocena sekundarne zastrupitve
Equipramox perorálny gél
Equipramox perorálny gél moksidektin, prazikantel peroralni gel
Cydectin 1% w/v Solution for Injection for Sheep
Cydectin 1% w/v Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
18,92 mg/g Horse and Pony
18.92 mg/g konji in poniji
CYDECTIN 1% Moxidectin Solution for injection
Cydectin 1% Injektionslösung moksidektin raztopina za injiciranje govedo subkutano
CYDECTIN 10% LA Moxidectin Solution for injection
Cydectin 10% LA Solution for Injection for Cattle moksidektin raztopina za injiciranje govedo subkutano
Moxidectin, praziquantel
Equipramox moksidektin, prazikantel peroralni gel
The first study with the common carp (Cyprinus carpio), was performed in accordance with OECD guideline no. 2039 and a LC50 value for moxidectin was established as 0.11 µg/l based on geometric mean of measured test concentrations.
Koncentracija brez opaženega učinka (NOEC) je bila določena kot ≥ 0,11 mg/l na podlagi geometrične srednje vrednosti izmerjenih testnih koncentracij.
5 mg/ml 200 mg/ml
1 mg/ml 50 mg/ml ovce
Cydectin 20 mg/ml LA Solution for Injection for Sheep
Cydectin 20 mg/ml LA Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of 4 days and may decrease dung fly abundance during that period.
Po zdravljenju ovc s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 4 dni in v tem obdobju lahko zmanjšajo številčnost jesenske muhe.
EQUIPRAMOX 19,5 mg/g + 121,7 mg/g, geriamasis gelis
EQUIPRAMOX 19,5 mg/g + 121,7 mg/g, geriamasis gelis moksidektin, prazikantel peroralni gel
Equest Pramox 19.5 mg/g + 121.7 mg/g Oral Gel
Equest Pramox 19.5 mg/g + 121.7 mg/g Oral Gel moksidektin peroralni gel
Lithuania Continental Farmaceutica Rue Laid Burniat 1,
Slovaška Continental Farmaceutica Rue Laid Burniat 1,
Sweden Zoetis Finland Oy Tietokuja 4
Norveška Zoetis Finland Oy Tietokuja 4
Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period.
Po zdravljenju ovc s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 4 tedne in v tem obdobju lahko zmanjšajo številčnost jesenske muhe.
18,92 mg/g Horse and pony
18,92 mg / g konji in poniji
Cydectin 1% w/v Injectable Solution for Sheep
Cydectin 1% w/v Injectable Solution for Sheep moksidektin raztopina za injiciranje ovce subkutano
Moxidectin, Praziquantel
moksidektin, prazikantel peroralni gel
Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 2 weeks and may decrease dung fly abundance during that period.
Po zdravljenju goveda s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 2 tedna in lahko v tem obdobju zmanjšajo številčnost jesenske muhe.
Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period.
Po zdravljenju goveda s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 4 tedna in v tem obdobju lahko zmanjšajo številčnost jesenske muhe.
EQUEST PRAMOX 19,5 mg/g en 121,7 mg/g orale gel
EQUEST PRAMOX 19,5 mg/g en 121,7 mg/g orale gel moksidektin, prazikantel peroralni gel
Cydectin 1% w/v Solution for Injection for Cattle
Cydectin 1% w/v Solution for Injection for Cattle moksidektin raztopina za injiciranje govedo subkutano
Cydectin 0.1% orale Lösung für Schafe
Cydectin 0.1% orale Lösung für Schafe moksidektin peroralna suspenzija ovce
Denmark Continental Farmaceutica Rue Laid Burniat 1,
Madžarska Continental Farmaceutica Rue Laid Burniat 1,
Equimoxectin 18.92 mg/g, Oral Gel for Horses and Ponies
Equimoxectin 18.92 mg/g, Oral Gel for Horses and Ponies moksidektin peroralni gel
Two GLP compliant studies on acute toxicity to daphnids were provided.
V zvezi z akutno strupenostjo za vodne bolhe sta bili predloženi dve študiji, skladni z dobro laboratorijsko prakso.
These measures will help to protect the environment.
Na ta način boste pomagali zaščiti okolje.
What Prevora is and what it is used for.
Kaj je Prevora in za kaj se uporablja.
Consequently, the signs and symptoms have not been identified.
Posledično, znaki in simptomi niso bili odkriti.
Detailed information on this medicinal product is available on the website of
Podrobne informacije o tem zdravilu so na voljo na spletni strani
You may need to read it again.
Utegnete jih ponovno rabiti.
4.8 Undesirable effects
4.8 Nezaželeni učinki
After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Po odločitvi Komisije bodo pristojni organi držav članic v povezavi z referenčno državo članico posodobili informacije o zdravilu skladno z zahtevami.
5.3 Preclinical safety data Preclinical data reveal no special hazard for humans.
5.3 Predklinični podatki o varnosti Predklinični podatki ne kažejo nobenega posebnega tveganja za človeka.
Further information.
Dodatne informacije.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so nezaželeni učinki predstavljeni po padajoči resnosti.
Possible side effects.
Mogoči stranski učinki.
MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
ŠTEVILKA(E) DOVOLJENJA ZA PROMET Z ZDRAVILOM <[se izpolni na nacionalni ravni]>
This leaflet was last approved in
Ta navodila so bila nazadnje odobrena
6.2 Incompatibilities
6.2 Nekompatibilnosti
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of First Authorisation: 5th May 2006.
Datum prvotnega dovoljenja: 5. maj 2006.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
POSEBNO OPOZORILO, DA JE POTREBNO ZDRAVILO SHRANJEVATI IZVEN
To preserve this coating on your teeth for as long as possible, eat soft foods at your next meal (e.g. soup).
Da ohranite ta premaz na vaših zobeh kakor dolgo je mogoče, jejte za vaš naslednji obrok mehko hrano (npr. juho).
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Interakcija z drugimi zdravili in druge interakcije
If overdose should occur, treat symptomatically.
Če bi prišlo do prevelikega odmerjanja je zdravljenje simptomatsko.
OTHER SPECIAL WARNING(S), IF NECESSARY Not applicable
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Se ne nanaša
For a list of full excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6.1
If the drug product comes into contact with the eyes, wash out promptly and thoroughly with water.
Če pride izdelek v stik z očmi, jih nemudoma in temeljito izperite z vodo.