natgillin/translations-raw huggingface dataset:
The 96 hour LC50 based on nominal test concentration was greater than 100 mg/l and correspondingly the NOEC was 100 mg/l.
96-urna vrednost LC50 na podlagi nominalne preskusne koncentracije je bila višja od 100 mg/l, ustrezna vrednost NOEC pa je bila 100 mg/l.
Using this approach Huvepharma NV concluded that the maximum predicted surface water concentration could be revised from 4.44 μg/l to 1.77 μg/l, leading to a TWA PEC/PNEC ratio of 0.42, indicating according to the applicant that Pharmasin 100% W/W Water Soluble Granules does not pose a risk for blue-green algae (cyanobacteria).
S tem pristopom so v družbi Huvepharma NV zaključili, da lahko največjo napovedano koncentracijo v površinskih vodah popravijo s 4,44 μg/l na 1,77 μg/l, kar da razmerje TWA PKO/PKBU 0,42 in po mnenju predlagatelja pokaže, da zdravilo Pharmasin 100% W/W Water Soluble Granules ne predstavlja tveganja za modrozelene alge (cianobakterije).
Concentrations of tylosin in surface water and groundwater were estimated using methods described in the CVMP Revised Guideline on Environmental Impact Assessment for Veterinary Medicinal Products (EMEA/CVMP/ERA/418282/2005).
2.2.1 Napoved koncentracij v površinskih vodah Koncentracije tilozina v površinskih in podzemnih vodah so ocenili z metodami, ki so opisane v popravljeni smernici CVMP za vrednotenje učinka veterinarskih zdravil na okolje (EMEA/CVMP/ERA/418282/2005).
• In pigs: for treatment and prevention of porcine intestinal adenomatosis (ileitis) associated with Lawsonia intracellularis and for the treatment and prevention of enzootic pneumonia caused by Mycoplasma hyopneumoniae and Mycoplasma hyorhinis;
• Pri prašičih: za zdravljenje in preprečevanje prašičje črevesne adenomatoze (ileitisa), ki je povezana z boleznijo Lawsonia intracellularis, ter za zdravljenje in preprečevanje enzootične pljučnice, ki jo povzročata Mycoplasma hyopneumoniae in Mycoplasma hyorhinis;
The study in five plant species, one monocotyledon (wheat) and four dicotyledons (courgette, French bean, radish and sunflower), was performed to assess the effects of tylosin tartrate, at concentrations of multiples of the maximum PEC for other Pharmasin products calculated at 7264.2 μg/kg, on seedling emergence and early growth of higher plants following exposure to the test substance in a sandy loam soil.
Študija je bila opravljena na petih rastlinskih vrstah, eni enokaličnici (pšenica) in štirih dvokaličnicah (bučke, navadni fižol, radič in sončnica), z namenom vrednotenja učinkov tilozin tartrata pri koncentracijah, ki so večkratniki izračunane največje vrednosti PKO za druga zdravila Pharmasin, tj. 7264,2 μg/kg, na kalitev in zgodnjo rast višjih rastlin po izpostavitvi preskušani snovi v peščeni ilovici.
The consideration of restricting the SPC by removing either indications alone or target species and indications is currently inappropriate as a conclusive assessment of the risk to the terrestrial and aquatic compartments cannot be carried out for the reasons given above.
Možnosti omejitve povzetka glavnih značilnosti zdravila z umikom posameznih indikacij ali kombinacij ciljnih živalskih vrst in indikacij so trenutno neprimerne, saj dokončne ocene tveganja za kopenski in vodni del okolja zaradi zgoraj navedenih razlogov ni mogoče izvesti.
Due to this apparent environmental risk Huvepharma NV undertook further investigations with the aim of refining the PEC estimates, using higher tier modelling and manure degradation data.
Zaradi tega očitnega tveganja za okolje je družba Huvepharma NV opravila dodatne raziskave, da bi izboljšala ocene PKO z večstopenjskim modeliranjem in podatki razkroja v gnoju.
However, based on the information provided on degradation in manure, the CVMP considers that the total residue approach cannot be abandoned for tylosin.
Vendar CVMP na podlagi predloženih podatkov o razpadanju v gnoju ugotavlja, da pristopa skupnih ostankov v primeru tilozina ni mogoče opustiti.
However, using the maximum predicted surface water concentration for Pharmasin 100% W/W Water Soluble Granules (4.44 μg/l), the PEC/PNEC ratio was 1.1.
Vendar je bilo pri uporabi največje napovedane koncentracije zdravila Pharmasin 100% W/W Water Soluble Granules v površinskih vodah (4,44 μg/l) razmerje PKO/PKBU 1,1.
Similarly the study with terrestrial plants was considered inadequate and due to the uncertainty regarding the NOECs derived in the study a risk for plants could not be excluded.
Študija s kopenskimi rastlinami se je podobno štela za nezadostno, zaradi negotovosti glede vrednosti NOEC (koncentracij brez opaznega učinka), izpeljanih iz študije, pa prav tako ni bilo mogoče izključiti tveganja za rastline.
However, the PEC/PNEC ratio derived using the PEC for broilers (5.47 µg/l) was 1.30, indicating a risk of toxicity for cyanobacteria (blue-green algae).
Vendar je bilo razmerje PKO/PKBU, izpeljano iz PKO za pitovne piščance (5,47 µg/l), 1,30, kar kaže tveganje toksičnosti za cianobakterije (modrozelene alge).
Due to the unreliability of the data provided on the effects of tylosin on soil nitrification no conclusion can be drawn on the effects of Pharmasin 100% W/W Water Soluble Granules on soil microorganisms.
Zaradi nezanesljivosti predloženih podatkov o učinkih tilozina na nitrifikacijo v prsti zaključki o učinkih zdravila Pharmasin 100% W/W Water Soluble Granules na mikroorganizme v prsti niso mogoči.
Huvepharma NV also proposed to refine the risk assessment for plants by considering the degradation during litter storage.
Družba Huvepharma NV je predlagala tudi izboljšavo ocene tveganja za rastline z upoštevanjem razpada med shranjevanjem nastilja.
In addition, the refinement for the degradation in manure cannot be accepted and consequently, based on the available data, the Committee did not consider it appropriate to abandon the total residue approach in the assessment of Pharmasin 100% W/W Water Soluble Granules.
Poleg tega izboljšave zaradi razpadanja v gnoju ni mogoče sprejeti, zato je Odbor na podlagi razpoložljivih podatkov menil, da pri vrednotenju zdravila Pharmasin 100% W/W Water Soluble Granules ni primerno opustiti pristopa skupnih ostankov.
2.2 Risk to aquatic organisms
2.2 Tveganje za vodne organizme
A soil nitrogen transformation study was provided; the study was conducted based on OECD Guideline 216, however not according to GLP specifications and with some modifications to the test protocol.
2.1.2 Učinek na nastajanje nitrata zaradi mikroorganizmov v prsti Predložena je bila študija pretvorbe dušika v prsti; študijo so izvedli na podlagi smernice OECD št. 216, vendar ne v skladu s specifikacijami DLP ter z nekaj spremembami protokola preskusa.
EC50 values based on the geometric mean of test concentration were 1.5 mg/l for inhibition of growth rate and 0.42 mg/l for inhibition of yield.
Vrednosti EC50 na podlagi geometrijskega povprečja preskusnih koncentracij so bile 1,5 mg/l za zaviranje hitrosti rasti in 0,42 mg/l za zaviranje izplena.
The lowest EC50 determined in the study was for radish, and was 149.9 mg/kg, and the lowest NOEC and LOEC values were determined for courgette at 45.4 mg/kg and 90.8 mg/kg, respectively.
Najnižja ugotovljena vrednost EC50 v študiji je bila pri radiču in je znašala 149,9 mg/kg, najnižji vrednosti NOEC (koncentracija brez opaznega učinka) in LOEC (najnižja koncentracija z opaznim učinkom) pa sta bili določeni pri bučkah in sta znašali 45,4 mg/kg oz. 90,8 mg/kg.
A plant toxicity study based on OECD Guideline 208 but not conducted under GLP was provided.
Predložena je bila študija toksičnosti za rastline na podlagi smernice OECD št. 208, ki pa ni bila opravljena skladno z DLP.
The assessment of the effects of Pharmasin 100% W/W Water Soluble Granules on soil invertebrates was based on a published study.
Vrednotenje učinkov zdravila Pharmasin 100% W/W Water Soluble Granules na nevretenčarje v prsti je temeljilo na objavljeni študiji.
Huvepharma NV also considered that a further refinement could be made to account for degradation during manure storage, as discussed above in relation to phytotoxicity.
Družba Huvepharma NV ravno tako meni, da so mogoče dodatne izboljšave z upoštevanjem razpadanja med shranjevanjem gnoja, kakor je bilo omenjeno zgoraj v zvezi s fitotoksičnostjo.
PECgroundwater values for pigs, broilers, turkeys and calves were calculated as 6.43, 16.4, 8.17 and 11.8 µg/l respectively.
Izračunana vrednost PKOpodzemne vode za prašiče je 6,43, za pitovne piščance 16,4, za purane 8,17 in za teleta 11,8 µg/l.
The plant study did not meet the requirements of the VICH Phase II guideline in respect of the assessment of the risk for plants.
Študija na rastlinah ni izpolnila zahtev smernice VICH za II.
The Committee also noted that, with regard to the cyanobacteria (blue-green algae) study, a refinement following Tier IIB recommendations, using the study NOEC with an AF of 10, would represent a more logical approach.
Odbor je izpostavil tudi, da je glede študije na cianobakterijah (modrozelenih algah) bolj logičen pristop izboljšava po priporočilih stopnje IIB z uporabo vrednosti NOEC iz študije in AF 10. 2.2.3 Učinki na vodne nevretenčarje
Based on the lowest reported EC10 of 149 mg/kg (dry weight) and applying an assessment factor (AF) of 10 a PNEC of 14.9 mg/kg for soil invertebrates can be derived.
Na podlagi najnižje objavljene vrednosti EC10 149 mg/kg (suha masa) in ob uporabi faktorja vrednotenja (AF) 10 se lahko za nevretenčarje v prsti določi PKBU (predvidena koncentracija brez učinka ) 14,9 mg/kg.
• In calves: for the treatment and prevention of pneumonia caused by Mycoplasma spp;
• Pri teletih: za zdravljenje in preprečevanje pljučnice, ki jo povzroča Mycoplasma spp.
The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Pharmasin 100% W/W Water Soluble Granules for all target species above 100 μg/kg, thus requiring a Phase II assessment.
V I. fazi ocenjevanja tveganja za okolje, upoštevajoč smernico VICH, so za zdravilo Pharmasin 100% W/W Water Soluble Granules pri vseh ciljnih živalskih vrstah ugotovili predvidene koncentracije v okolju (PKO) v prsti nad 100 μg/kg, kar zahteva II.
Test fish were exposed to an aqueous solution of tylosin tartrate at a single concentration of 100 mg/l for a period of 96 hours at a temperature of approximately 14 ºC under semi-static test conditions.
Preskusne ribe so bile 96 ur izpostavljene vodni raztopini tilozin tartrata pri eni koncentraciji, tj. 100 mg/l, pri temperaturi 14 °C in v polstatičnih preskusnih pogojih.
Using the above PNEC value and the estimated PECsurfacewater values, PEC/PNEC ratios derived for pigs, turkeys and calves were all below 1.
Pri uporabi zgornje vrednosti PKBU in ocenjenih vrednosti PKOpovršinske vode so bila vsa razmerja PKO/PKBU za prašiče, purane in teleta pod 1.
PECsurfacewater values for the same species were calculated as 2.14, 5.47, 2.72 and 3.93 µg/l respectively.
Izračunana vrednost PKOpovršinske vode za prašiče je 2,14, za pitovne piščance 5,47, za purane 2,72 in za teleta 3,93 µg/l.
Czech Republic Huvepharma NV Uitbreidingstraat 80
Češka republika Huvepharma NV Uitbreidingstraat 80
Due to the failure of the study on plant emergence and growth to satisfy any of the validity criteria for such a study no PNECs are available for plants and hence no conclusion can be drawn on the effects of Pharmasin 100% W/W Water Soluble Granules on terrestrial plants.
Ker študija pojava in rasti rastlin ni izpolnila nobenega merila veljavnosti za takšne študije, niso na voljo vrednosti PKBU za rastline, kar pomeni, da ni mogoče sklepati o učinkih zdravila Pharmasin 100% W/W Water Soluble Granules na kopenske rastline.
Huvepharma NV provided an environmental risk assessment for Pharmasin 100% W/W Water Soluble Granules that followed in general the established guidelines and recommendations.
Družba Huvepharma NV je za zdravilo Pharmasin 100% W/W Water Soluble Granules predložila oceno tveganja za okolje, ki je bila na splošno pripravljena v skladu z uveljavljenimi smernicami in priporočili.
Using the data from the above study and the estimated PECsurface water values, all PEC/PNEC ratios were below 1, indicating a low risk for fish.
Na podlagi podatkov iz zgornje študije in ocenjenih vrednosti PKOpovršinske vode so vsa razmerja PKO/PKBU pod 1, kar kaže majhno tveganje za ribe.
The aspects of the Phase II assessment considered in this referral are the effects on the terrestrial compartment and the effects on the aquatic compartment.
faze o učinkih na kopenski del in o učinkih na vodni del.
The PNEC
peroralna raztopina
Therefore, a PNEC of 1.499 mg/kg was established, based on the lowest EC50 of 149.9 mg/kg applying an AF of 100.
Zato je na podlagi najnižje EC50 149,9 mg/kg ob uporabi AF 100 določena vrednost PKBU 1,499 mg/kg.
Ireland1
Irska1
Based on this EC50 value a PNEC of 4.2 μg/l was calculated (PNEC equal to EC50/100); the assessment factor of 100 is in line with the VICH GL38 guideline.
Na podlagi te vrednosti EC50 so izračunali vrednost PKBU, ki je znašala 4,2 μg/l (PKBU je enako EC50/100); faktor vrednotenja 100 je skladen s smernico VICH GL38.
Using this data and the estimated PECsurface water values, all PEC/PNEC ratios were below 1, indicating a low risk for aquatic invertebrates.
Na podlagi teh podatkov in ocenjenih vrednosti PKOpovršinske vode so vsa razmerja PKO/PKBU pod 1, kar kaže majhno tveganje za vodne nevretenčarje.
The DT50 in manure reported in literature and the dissipation study were largely similar.
V literaturi in študiji izginevanja so ugotovili v bistvu podobni vrednosti DT50 v gnoju.
The Netherlands1 Huvepharma NV Uitbreidingstraat 80
Nizozemska1 Huvepharma NV Uitbreidingstraat 80
(EC50/1000) was therefore concluded to be 680 μg/l; the assessment factor of 1000 is in line with the VICH GL38 guideline.
Iz tega se izračuna vrednost PKBU (EC50/1000) 680 μg/l; faktor vrednotenja 1000 je skladen s smernico VICH GL38.
The EC50 from this study was concluded to be greater than 100 mg/l and PNEC (EC50/1000) was concluded to be greater than 100 μg/l; the assessment factor of 1000 is in line with the VICH GL38 guideline.
Zaključili so, da je vrednost EC50 iz te študije večja od 100 mg/l, vrednost PKBU (EC50/1000) pa večja od100 μg/l; faktor vrednotenja 1000 je skladen s smernico VICH GL38.
The other two acceptability criteria, seedlings not exhibiting visible phytotoxicity and identical environmental conditions were not met. From the information provided it cannot be shown that any of the required acceptance criteria for this type of study have been met.
Dve drugi merili sprejemljivosti (sadike, ki ne kažejo vidne fitotoksičnosti, in identični pogoji okolja) nista bili izpolnjeni.
A new study would be required with assessment of nitrate production continuing until after day 28 in order to draw a conclusion on the risk for soil microorganisms.
Za zaključke o tveganju za mikroorganizme v prsti je treba izvesti novo študijo z vrednotenjem nastajanja nitrata, ki bo trajala več kot 28 dni.
• restricting the SPC by removing either indications alone or target species and indications is currently inappropriate as a conclusive assessment of the risk to the terrestrial and aquatic compartments cannot be carried out; Therefore, the CVMP is of the opinion that the application for Pharmasin 100% W/W Water Soluble Granules and associated names does not satisfy the criteria for authorisation in respect of environmental risk as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC.
Je CVMP menil, da vloga za zdravilo Pharmasin 100% W/W Water Soluble Granules in z njim povezana imena ne izpolnjuje meril za odobritev dovoljenja za promet z zdravilom v zvezi s tveganjem za okolje, kakor so določena v členu 12(3)(j) direktive 2001/82/EC, spremenjene z direktivo 2004/28/EC.
Pharmasin 100% W/W Water Soluble Granules was assessed using the models developed by Forum for Co-ordination of Pesticide Models and their Use (FOCUS) as recommended in the CVMP Revised Guideline on Environmental
Zdravilo Pharmasin 100% W/W Water Soluble Granules so ovrednotili z modeli, ki jih je razvil Forum za koordinacijo modelov pesticidov in njihovo uporabo (Forum for Co-ordination of Pesticide Models and their Use - FOCUS), kar je priporočeno v popravljeni smernici CVMP za vrednotenje učinka veterinarskih zdravil na okolje (EMEA/CVMP/ERA/418282/2005).
Partial chlorosis, extensive chlorosis and extensive chlorosis with leaf wilt was seen with all plant species in at least one test concentration, however information on phytotoxicity was not presented for the controls, so it was concluded that this criterion was not met. As the results of the control seedlings were not reported it is not possible to conclude if the mean survival of emerged control seedlings is at least 90% for the duration of the study as required by the OECD guidance.
Pri vseh rastlinskih vrstah so pri vsaj eni preskusni koncentraciji opazili delno klorozo, obsežno klorozo in obsežno klorozo z venenjem listov, vendar niso bili predstavljeni podatki o fitotoksičnosti pri kontrolah, zato je bilo ugotovljeno, da to merilo ni izpolnjeno.
This may have been because of degradation of the substance, but could be due equally to the formation of bound residues which could become available in the soil.
Vendar je bilo v študiji razpadanja dokazano, da tilozina A ni bilo mogoče zaznati, To je lahko posledica razpada snovi ali pa tvorbe vezanih ostankov, ki se lahko sprostijo v prsti.
(CRD) caused by Mycoplasma gallisepticum and Mycoplasma synoviae and for the treatment and prevention of necrotic enteritis caused by Clostridium perfringens;
• Pri piščancih (pitovnih piščancih, kokoškah): za zdravljenje in preprečevanje kroničnih bolezni dihalnih poti, ki jih povzročata Mycoplasma gallisepticum in Mycoplasma synoviae, ter za zdravljenje in preprečevanje nekrotičnega enteritisa, ki ga povzroča Clostridium perfringens;
2.1.4 Summary of risk assessment to the terrestrial compartment
2.1.4 Povzetek ocene tveganja za kopenski del Predloženi podatki ne kažejo tveganja v zvezi z nevretenčarji v prsti.
2.1.1 Effects on soil invertebrates
2.1.1 Učinki na nevretenčarje v prsti
Huvepharma NV insisted on the use of the study NOECs and an AF of 10 for a tier B refinement.
Družba Huvepharma NV je vztrajala, da se v študiji uporabijo določene vrednosti NOEC in AF 10 za izboljšavo stopnje B. Predlagane vrednosti NOEC pa ni mogoče sprejeti, saj so bili podatki statistične analize predstavljeni le za tri rastlinske vrste.
• In chickens (broilers, pullets): for the treatment and prevention of chronic respiratory diseases
• Pri puranih: za zdravljenje in preprečevanje infekcijskega sinusitisa, ki ga povzroča
A low risk for fish and aquatic invertebrates is expected.
2.2.5 Povzetek ocene tveganja za vodne organizme Pričakuje se majhno tveganje za ribe in vodne nevretenčarje, vendar na podlagi predloženih podatkov tveganja za cianobakterije ni mogoče izključiti.
4 years.
4 leti
< PC: {number} SN: {number} NN: {number}>
< PC: {številka} SN: {številka} NN: {številka} >
Additional standard treatment may be required (see section 4.5).
Morda bo potrebno dodatno standardno zdravljenje (glejte poglavje 4.5).
23.4 g
gel 23,4 g
The Phase III studies were blindly evaluated, prospective, intra-individually controlled, randomised, multicentre trials.
Študije faze III so bila slepo ocenjena, prospektivna, intraindividualno nadzorovana, randomizirana, multicentrična preskušanja.
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Repeated critical assessment of burn depth and healing progression is needed.
Potrebna je ponavljajoča kritična ocena debeline opekline in napredovanja celjenja.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene na seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The single-use tube is packed in a cardboard box.
Tuba za enkratno uporabo je pakirana v kartonski škatli.
Pregnancy No studies in pregnant women have been conducted.
Nosečnost Študij na nosečnicah niso izvedli.
Your doctor or nurse will tell you for how long you should use the gel.
Vaš zdravnik ali medicinska sestra vam bo povedala, kako dolgo gel uporabljajte.
Carcinogenicity and reproductive and developmental toxicity studies have not been performed.
Študij karcinogenosti in toksičnih vplivov na razmnoževanje ter razvoj niso izvedli.
Sunflower oil, refined.
Sončnično olje, rafinirano.
The safety and efficacy of Episalvan in children and adolescents under 18 years have not yet been established.
Varnost in učinkovitost zdravila Episalvan pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani.
This makes overdose very unlikely, even if applied to large skin areas and for a long period of time.
Tako je malo verjetno, da bi prišlo do prevelikega odmerjanja, tudi če se nanaša na večje površine kože in v daljšem časovnem obdobju.
Patients with deeper burn wounds (Grade 2b) were not included.
Bolnikov z globljimi opeklinami (stopnje 2b) v študijo niso vključili.
Table 2: Overview of Efficacy Results: Intra-patient difference in time to wound closure
Preglednica 2: Pregled rezultatov učinkovitosti: Razlika med bolniki v času do zaprtja rane
Difference in time to wound closure was set to 0 for photo series rated as ‘not evaluable'.
Razlika v času do zaprtja rane je bila nastavljena na 0 za serijo fotografij, označenih kot „niso za ocenjevanje“.
Discard the tube after first use.
Tubo zavrzite po prvi uporabi.
Since no biologically relevant levels of betulin were found in patients, no further studies related to distribution, biotransformation and elimination were performed.
Ker pri bolnikih niso odkrili biološko pomembnih ravni betulina, nadaljnjih študij, povezanih s porazdelitvijo, biotransformacijo in izločanjem, niso izvedli.
Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers; ATC code: D03AX13 .
Farmakoterapevtska skupina: Zdravila za oskrbo ran in razjed oznaka, oznaka ATC: D03AX13.
Episalvan can be used during pregnancy.
Zdravilo Episalvan se lahko uporablja med nosečnostjo.
CI: 95% confidence interval; MTWDC: mean time to wound dressing change; N: number of patients in the analysis set; STSG Split-thickness skin graft
CI: 95-odstotni interval zaupanja; MTWDC: povprečen čas med zamenjavo povoja rane; N: število bolnikov, vključenih v nabor za analizo; STSG: presadek delne debeline kože.
Do not use Episalvan - if you are allergic to birch bark or any of the other ingredients of this medicine (listed in section 6).
Zdravila Episalvan ne uporabljajte - če ste alergični na skorjo breze ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
SPECIAL STORAGE CONDITIONS Store below 30°C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30°C.
In consequence a substantial number of photographs were excluded and not presented in the primary blinded read because of apparent gel residues.
Tako so veliko število fotografij izključili in jih niso preložili v primarnem slepem branju, saj so bili na njih vidni očitni ostanki gela.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1069/001
EU/1/15/1069/001