natgillin/translations-raw huggingface dataset:
A doctor must be consulted to rule out the presence of joint diseases for which other treatment should be considered.
Pred zdravljenjem se je treba posvetovati z zdravnikom, da se izključi možnost ostalih sklepnih bolezni, ki zahtevajo drugačno zdravljenje.
Patients treated with coumarin anticoagulants should therefore be monitored closely when initiating or ending glucosamine therapy.
Bolnike, ki se zdravijo s kumarinskimi antikoagulanti, je zato potrebno skrbno spremljati ob uvajanju in prenehanju zdravljenja z glukozaminom.
WHAT GLUCOMED IS AND WHAT IT IS USED FOR Glucomed belongs to the group of medicines called other anti-inflammatory and anti-rheumatic agents, non-steroids.
KAJ JE ZDRAVILO GLUCOMED IN ZA KAJ GA UPORABLJAMO Glucomed spada v skupino zdravil, ki jih imenujemo druga protivnetna in protirevmatična zdravila, nesteroida zdravila.
Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer.
Zdravljenje lahko traja nekaj tednov, v nekaterih primerih celo dlje, preden nastopi olajšanje simptomov (še posebej olajšanje bolečine).
Do not take Glucomed - if you are allergic (hypersensitive) to glucosamine or to any of the other ingredients of Glucomed.
Ne jemljite zdravila Glucomed - če ste alergični na (preobčutljivi za) glukozamin ali na katerokoli sestavino zdravila Glucomed.
Vollsveien 13 C, P.O. box 438, 1327 Lysaker, Norway Manufacturer:
Vollsveien 13 C, P.O. box 438, 1327 Lysaker, Norveška Izdelovalec:
Pack-sizes of 60 or 180 tablets.
Velikosti pakiranj: 60 ali 180 tablet.
Caution should be exercised if Glucomed has to be combined with other medicines, especially warfarin and tetracycline.
Previdnost je potrebna pri kombinacijah zdravila Glucomed z drugimi zdravili, še posebej z varfarinom in tetraciklini.
The efficacy in symptomatic relief of pain in osteoarthritis, of the existing alternatives, NSAIDs and paracetamol, is of similar magnitude as glucosamine (e.g. ref. review by Bjordal).
Učinkovitost simptomatskega lajšanja bolečine pri osteoartritisu je pri obstoječih alternativah (NSPVZ in paracetamolu) podobne magnitude kot pri glukozaminu (npr. Bjordalov pregled).
Animal experimental data relating to toxicity during repeated administration, reproduction toxicity, mutagenicity and carcinogenicity is lacking for glucosamine.
Eksperimentalnih podatkov na živalih o toksičnosti pri ponavljajočih se odmerkih, vplivu na sposobnost razmnoževanja, mutagenosti in karcinogenosti glukozamina niso pridobili.
NAME OF THE MARKETING AUTHORISATION HOLDER Navamedic ASA
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Navamedic ASA
In patients with mild to moderate osteoarthritis, in addition to physical exercise, paracetamol and NSAIDs are the only existing approved medicinal drug alternatives to obtain symptomatic relief of symptoms such as pain and stiffness.
Za bolnike z blagim do zmernim osteoartritisom so poleg telesne vadbe nesteroidna protivnetna zdravila (NSPVZ) in paracetamol edina odobrena alternativna zdravila za lajšanje simptomov, kot sta bolečina in otrdelost.
Glucosamine was mainly introduced on the world-wide market as a food-supplement but with the aim to improve symptoms in patients with osteoarthritis or joint pain or function.
Glukozamin se je večinoma začel tržiti po vsem svetu kot prehransko dopolnilo z namenom lajšanja simptomov pri bolnikih z osteoartritisom ali bolečinami v mišicah oz. izboljšanja funkcije sklepov.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Navamedic ASA, Vollsveien 13 C, P. O. box 438, 1327 Lysaker, Norway
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Navamedic ASA, Vollsveien 13 C, P. O. box 438, 1327 Lysaker, Norveška
Known hypersensitivity to glucosamine or to any of the excipients.
Znana preobčutljivost za glukozamin ali katerokoli pomožno snov.
Common (≥1/100 to <1/10): headache, tiredness, nausea, abdominal pain, indigestion, diarrhoea, constipation.
Pogosto (≥1/100 do <1/10): glavobol, utrujenost, slabost, bolečina v trebuhu slaba prebava, driska, zaprtje.
Pharmacotherapeutic group: Other anti-inflammatory and anti-rheumatic agents, non-steroidal antiinflammatory drugs.
Farmakoterapevtska skupina: Druga nesteroidna protivnetna in protirevmatična zdravila, nesteroidna protivnetna zdravila
Data on possible drug interactions with glucosamine is limited, but increased INR with coumarin anticoagulants (warfarin and acenocoumarol) has been reported.
Podatki o možnem medsebojnem delovanju glukozamina in ostalih zdravil so omejeni, vendar so poročali o povečanem INR ob sočasni uporabi kumarinskih antikoagulantov (varfarin in acenokumarol).
If dizziness or drowsiness is experienced, car driving and the operating of machinery is not recommended.
Če se pojavita vrtoglavica ali zaspanost, se vožnja avtomobila ali upravljanje s stroji odsvetujeta.
Each tablet contains 625 mg of glucosamine (as glucosamine hydrochloride) - The other ingredients are microcrystalline cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose (L-HPC) and magnesium stearate.
Vsaka tableta vsebuje 625 mg glukozamina (v obliki glukozaminijevega klorida) - Pomožne snovi so mikrokristalna celuloza, hidroksipropilceluloza, delno substituirana hidroksipropilceluloza (L-HPC) in magnezijev stearat.
INFORMATION IN BRAILLE Glucomed
PODATKI V BRAILLOVI PISAVI Glucomed
There is no adequate data from the use of glucosamine in pregnant women.
Ni ustreznih podatkov o uporabi glukozamina pri nosečnicah.
Note: This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 29 referral for glucosamine hydrochloride containing medicinal products.
Opomba: Ta Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so bili priloženi k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu z členom 29, za zdravila, ki vsebujejo glukozaminijevega klorida.
The Summary of Product Characteristics, labelling and package leaflet are set out in Annex III of the opinion for Glucomed and associated names (see Annex I).
Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo so navedeni v Dodatku III mnenja za zdravilo Glucomed in z njim povezana imena (glejte Dodatek I).
Results from in vitro studies and in vivo studies in animals have shown that glucosamine reduces insulin secretion and induces insulin resistance, probably via glucokinase inhibition in the beta cells.
Podatki iz in vitro ter in vivo študij na živalih kažejo, da glukozamin zavira izločanje inzulina ter povzroča odpornost na inzulin, verjetno preko zaviranja glukokinaze v beta celicah.
Due to limited documentation on potential drug interactions with glucosamine, one should generally be aware of altered response or concentration of concurrently used medicinal products.
Zaradi omejenih podatkov o možnih interakcijah glukozamina z ostalimi zdravili se je v splošnem potrebno zavedati, da lahko pride ob hkratni uporabi drugih zdravil do spremenjenega učinka ali koncentracij.
PVC/PVDC-aluminium blisters packed in paper cartons.
PVC/PVDC-pretisni omoti iz aluminija pakirani v papirnatih škatlah.
In this leaflet:
- Ob upoštevanju naslednjega:
Taking Glucomed with food and drink You can take the tablets with or without food.
Uporaba zdravila skupaj s hrano in pijačo Zdravilo lahko zaužijete skupaj s hrano ali brez nje.
Glucomed is not recommended for use in children and adolescents below the age of 18, due to lack of data on safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Glucomed pri otrocih in mladostnikih pod 18 let ni priporočljiva.
Store below 30˚C.
Shranjujte pri temperaturi do 30˚C.
The most common adverse reactions associated with treatment with glucosamine are nausea, abdominal pain, indigestion, constipation, and diarrhoea.
Najpogostejši neželeni učinki, ki so povezani z zdravljenjem z glukozaminom so: slabost, abdominalna bolečina, slaba prebava, zaprtje in driska.
What Glucomed is and what it is used for Before you take Glucomed How to take Glucomed Possible side effects
Kaj je zdravilo Glucomed in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Glucomed Kako jemati zdravilo Glucomed Možni neželeni učinki
Keep the bottle or blister package tightly closed.
Stekleničko ali pretisni omot shranjujte tesno zaprt.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK IN POT UPORABE Pred uporabo preberite priloženo navodilo.
5 How to store Glucomed Further information
5 Shranjevanje zdravila Glucomed Dodatne informacije
Although data are not uniformly positive, it was concluded that taken together, glucosamine, both hydrochloride and sulphate, has shown efficacy, for the symptomatic relief in patients with mild to moderate osteoarthritis of the knee.
Čeprav vsi podatki niso enoznačno pozitivni, je bilo ob upoštevanju vseh podatkov zaključeno, da sta oba glukozamina (hidroklorid in sulfat) izkazala učinkovitost pri lajšanju simptomov pri bolnikih z blagim do zmernim osteoartritisom kolena.
Please contact your doctor for medical advice.
Prosimo, da se v zvezi s tem posvetujete z zdravnikom.
In patients with a known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine.
Pri bolnikih z znanim tveganjem za srčno-žilne bolezni je priporočljivo spremljanje koncentracije lipidov v krvi, ker je bila hiperholesterolemija opažena v nekaj primerih pri bolnikih, ki so se zdravili z glukozaminom.
Do not store above 30oC.
Shranjujte pri temperaturi do 30oC.
The available information on the pharmacokinetics of glucosamine is limited.
Podatki o farmakokinetičnih lastnostih glukozamina, ki so na voljo so omejeni.
Member State Marketing Authorisation Holder
Država članica Imetnik dovoljenja za promet Predlagatelj
the CHMP has recommended by majority the granting of the Marketing Authorisation of Glucomed and associated names for the following indication: “relief of symptoms in mild to moderate osteoarthritis of the knee”.
je CHMP z večino priporočil odobritev dovoljenja za promet z zdravilom Glucomed in z njim povezanih imen za naslednjo indikacijo: „lajšanje simptomov blagega do zmernega osteoartritisa kolena“.
Uncommon (≥1/1,000 to < 1/100): rash, itching, flushing.
Občasno (≥1/1.000 do < 1/100): izpuščaj, srbenje, pordelost kože.
Abdominal pain Indigestion Diarrhoea Constipation
Slabost Abdominalna bolečina Slaba prebava Driska
In addition, headache, tiredness, rash, itching, and flushing have been reported.
Poročali so tudi o glavobolu, utrujenosti, izpuščaju, srbenju in pordelosti kože.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg of glucosamine (as glucosamine hydrochloride).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 625 mg glukozamina (v obliki glukozaminijevega klorida).
HDPE tablet container with a silica gel desiccant in paper bags.
HDPE vsebnik tablet s sušilnim sredstvom silikagel v papirnatih vrečkah.
Low substituted hydroxypropyl cellulose (L-HPC) Magnesium stearate
Delno substituirana hidroksipropilceluloza (L-HPC) Magnezijev stearat
Glucosamine should not be used during pregnancy.
Glukozamina se med nosečnostjo ne sme uporabljati.
In vitro and in vivo studies have shown glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes.
In vitro ter in vivo študije so pokazale, da glukozamin preko hondrocitov stimulira sintezo fizioloških glikozaminoglikanov in proteoglikanov, preko sinoviocitov pa sintezo hialuronske kisline.
The applicant was asked to demonstrate efficacy of glucosamine in the intended indication “relief of symptoms in mild to moderate osteoarthritis of the knee”.
Vlagatelj je bil naprošen, da dokaže učinkovitost glukozamina za predvideno indikacijo „lajšanje simptomov blagega do zmernega osteoartritisa kolena“.
Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans.
Glukozamin je endogena snov, običajen gradnik polisaharidne verige v hrustančnem matriksu in glikozaminoglikanov v sinovialni tekočini.
The following have been reported:
Poročali so o naslednjih neželenih učinkih:
White to light beige, oval tablet marked with “G” and a score line.
Bela do rahlo bež, ovalna tableta označena s črko “G” in razdelilno zarezo.
If you forget to take Glucomed
Če ste pozabili vzeti zdravilo Glucomed
- If you have a known risk factor for cardiovascular disease, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine.
- če imate znan dejavnik tveganja za srčno-žilno bolezen, ker je bila pri nekaj bolnikih, ki so se zdravili z glukozaminom, opažena hiperholesterolemija.
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA ZA PROMET [Izpolni država članica]
Relief of symptoms in mild to moderate osteoarthritis of the knee.
Lajšanje simptomov blagega do zmernega osteoartritisa kolena.
In patients with impaired glucose tolerance, monitoring of the blood glucose levels and, where relevant, insulin requirements is recommended before start of treatment and periodically during treatment.
Pri bolnikih z okvarjeno toleranco za glukozo je pred pričetkom zdravljenja in periodično med zdravljenjem potrebno spremljanje koncentracij glukoze v krvi ter, če je potrebno, dodajanje inzulina.
What Glucomed contains - The active substance is glucosamine.
Kaj vsebuje zdravilo Glucomed - Zdravilna učinkovina je glukozamin.
Rare (≥ 1/10,000 to
Redko (≥ 1/10.000 do
Glucomed should not be used during pregnancy.
Zdravila Glucomed se med nosečnostjo ne sme uporabljati.
- if you are allergic (hypersensitive) to shellfish, since glucosamine is manufactured from shellfish.
- če ste alergični na (preobčutljivi za) lupinarje (školjke, polže, rake), ker je glukozamin pridobljen iz lupinarjev.
If you stop taking Glucomed
Če ste prenehali jemati zdravilo Glucomed
Many published reviews, national therapy recommendations and other publications have discussed and evaluated the robustness of efficacy data.
Robustnost podatkov o učinkovitosti so obravnavali in vrednotili v mnogih preglednih prispevkih, nacionalnih priporočilih za zdravljenje ter drugih publikacijah.
Glucomed is used for the relief of symptoms in mild to moderate osteoarthritis of the knee.
Glucomed se uporablja za lajšanje simptomov blagega do zmernega osteoartritisa kolena.
Glucomed must not be given to patients who are allergic to shellfish as the active substance is obtained from shellfish.
Glucomed se ne sme dajati bolnikom, ki so alergični na lupinarje (školjke, polže ali rake), saj je učinkovina pridobljena iz lupinarjev.
HOW TO TAKE GLUCOMED
KAKO JEMATI ZDRAVILO GLUCOMED
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS Blister text
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Impaired renal and/or liver function
Bolniki z okvarjeno ledvično in jetrno funkcijo
This leaflet was last approved on: {date} [To be completed nationally]
Navodilo je bilo odobreno: [Izpolni država članica]
Do not use Glucomed after the expiry date which is stated on the blister/carton or tablet container.
Zdravila Glucomed ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Hydroxypropyl cellulose
Hidroksipropilceluloza
More frequent controls of your blood glucose levels may be necessary when starting treatment with glucosamine.
Ob začetku zdravljenja z glukozaminom bo mogoče pri vas potrebna pogostejša kontrola koncentracij glukoze v krvi.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 tablet contains: 625 mg of glucosamine (as glucosamine hydrochloride).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 tableta vsebuje: 625 mg glukozamina (v obliki glukozaminijevega klorida).
The use of glucosamine during breastfeeding is therefore not recommended as there is no data on the safety of the newborn.
Ker ni podatkov o varnosti pri novorojenčkih, uporaba glukozamina med dojenjem ni priporočljiva.
What Glucomed looks like and content of the pack Glucomed is a white to light beige, oval tablet marked with “G” and a score line.
Glucomed je bela do rahlo bež, ovalna tableta označena s črko “G” in razdelilno zarezo.
Headache Tiredness
Glavobol Utrujenost
NAME OF THE MEDICINAL PRODUCT Glucomed and associated names (see Annex I) 625 mg tablets [See Annex I - To be completed nationally]
Glucomed in povezana imena (Glejte Dodatek 1) 625 mg tablete [Glejte Dodatek I - Izpolni država članica]
No curative or disease-modifying treatment exists, apart from surgery with arthroplasty.
Razen kirurške artroplastike ne poznamo sredstva, ki bi omogočilo ozdravitev ali ki bi modificiralo bolezen.
The usual starting dose is 2 tablets (1250 mg glucosamine) once daily.
Običajen začetni odmerek je 2 tableti (1250 mg glukozamina) enkrat na dan. Glukozamin ni indiciran za zdravljenje akutnih bolečinskih simptomov.
No formal drug interaction studies have been performed with glucosamine-containing medicinal products.
Formalne raziskave medsebojnega delovanja med zdravili, ki vsebujejo glukozamin, niso bile izvedene, zaradi česar je predlagano, da se v SPC vključi splošno opozorilo.
NAME OF THE MEDICINAL PRODUCT Glucomed and associated names (see Annex I) 625 mg tablets [See Annex I - To be completed nationally] glucosamine
Glucomed in povezana imena (Glejte Dodatek 1) 625 mg tablete [Glejte Dodatek I - Izpolni država članica] glukozamin
In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed.
Pri bolnikih z okvarjeno ledvično ali jetrno funkcijo ali obojim niso bile opravljene posebne študije, zato pri tej skupini bolnikov ni posebnih priporočil glede odmerjanja.
HOW TO STORE GLUCOMED
SHRANJEVANJE ZDRAVILA GLUCOMED
If you have taken large quantities you must consult your doctor or a hospital.
Če ste vzeli večji odmerek zdravila Glucomed, kot bi smeli Če ste zaužili velike količine zdravila, se morate posvetovati z vašim zdravnikom ali pokličite v bolnišnico.
Always take Glucomed exactly as your doctor has told you.
Pri jemanju zdravila Glucomed natančno upoštevajte zdravnikova navodila.
- if you have kidney or liver dysfunction, since no studies have been performed in such patients dose recommendations cannot be given.
Zaradi pomanjkanja študij pri takšnih bolnikih ni posebnih priporočil za odmerjanje.
If you experience dizziness or drowsiness from the tablets, you should not be driving or operating machinery.
Ne upravljajte vozil ali strojev, če po zaužitju tablet občutite vrtoglavico ali zaspanost.
You should check with your doctor or pharmacist if you are not sure.
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
Applicant
Sklep
BEFORE YOU TAKE GLUCOMED
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO GLUCOMED
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Papirnate škatle za pretisne omote
Conclusion
Zaprtje
6 (3 x 2) pre-filled syringes (multipack)
1,5 ml (140 mg/ml) 6 (3 x 2) napolnjenih injekcijskih brizg (skupno pakiranje)
2 pre-filled syringes
1,5 ml (140 mg/ml) 2 napolnjeni injekcijski brizgi
9 and GL
9 in GL
The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain as concerned Member States.
Vloga za pridobitev dovoljenja za promet z zdravilom je bila predložena Združenemu kraljestvu kot referenčni državi članici ter zadevnim državam članicam Avstriji, Belgiji, Bolgariji, Cipru, Češki republiki, Danski, Estoniji, Franciji, Nemčiji, Grčiji, Madžarski, Irski, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemski, Poljski, Portugalski, Romuniji, Slovaški, Sloveniji in Španiji.
This linear extrapolation is questionable, since the processes involved are not linear.
Linearna ekstrapolacija je vprašljiva, saj vpleteni procesi niso linearni.
The risk to the environment can be reduced by adhering to the following measures.
Tveganje za okolje se lahko zmanjša ob upoštevanju naslednjih ukrepov.
Toxicity will depend on environmental conditions and habitat types.
Toksičnost je odvisna od okoljskih pogojev in habitatnih tipov.
The bioavailable fraction of zinc in soils is small (<1%).
Biološko uporaben delež cinka v tleh je majhen (< 1 %).
Other precautions regarding impact on the environment
Drugi previdnostni ukrepi glede vpliva na okolje
Add the following text in the relevant sections of the product information:
Dodati naslednje besedilo v ustreznih poglavjih glede informacije o zdravilu:
Since the issues raised by France and the Netherlands remained unresolved, the Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 30 September 2014 under Article 33(4) of Directive 2001/82/EC.
Ker pa so vprašanja, ki sta jih izpostavili Francija in Nizozemska, ostala nerazrešena, zadevne države članice niso uspele doseči soglasja v zvezi z zdravilom, zato je bila zadeva dne 30. septembra 2014 predložena odboru CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
IZJEMNO NEVARNO ZA RIBE IN ŽIVLJENJE V VODI.
The applicant provided the robust summaries of the additional peer-reviewed studies used in the effect assessment that were not included in the EU RAR (2010), including a conclusion on the reliability and validity of each study.
Predlagatelj je predložil prepričljive povzetke dodatnih strokovno pregledanih študij, uporabljenih pri ocenjevanju učinka, ki niso bile vključene v poročilo EU RAR (2010), vključno z zaključkom o zanesljivosti in veljavnosti vsake študije.
Zinc oxide is included in veterinary medicinal products currently authorised in several EU Member States for use in pigs.
Cinkov oksid je sestavina zdravil za uporabo v veterinarski medicini, ki so trenutno odobrena v več državah članicah EU za uporabo pri prašičih.
The level of accumulation and time dependency for the different environmental compartments were evaluated.
Ovrednoteni sta bili stopnja kopičenja in časovna odvisnost za različne dele okolja.
This supportive data suggests a buffer zone of 3 m or more could reduce the run-off by 3 to 5-fold.
Ti podporni podatki kažejo, da bi varovalni pas 3 m ali več lahko zmanjšal odtekanje cinka za 3- do 5-krat.
However, this measure would slow down the accumulation of zinc and, hence, reduce the risk for each environmental compartment.
Vendar pa bi s tem ukrepom upočasnili kopičenje cinka in s tem zmanjšali tveganje za posamezne dele okolja.
Having considered the above, it can be accepted that the PNECs proposed by the applicant can be used for the characterisation of risks (calculation of risk quotients).
Glede na zgoraj navedeno je sprejemljivo, da se vrednosti PNEC, ki jih je predlagal predlagatelj, uporabijo za opredelitev tveganja (izračun količnikov tveganja).
The CVMP was asked to give its opinion on the concerns raised by France and the Netherlands and to conclude on the benefit-risk balance for Gutal.
Odbor CVMP so zaprosili, naj poda svoje mnenje o vprašanjih, ki sta jih izpostavili Francija in Nizozemska, ter ugotovi, kakšno je razmerje med tveganji in koristmi zdravila Gutal.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Veljaven povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, dogovorjene med zasedanjem skupine za koordinacijo z naslednjimi spremembami:
Consequently an ‘ageing' factor of 3 has been established and is used in calculating site-specific PNECs.
Zato je bil določen faktor „staranja“ 3, ki se je uporabil pri izračunu vrednosti PNEC za določeno območje.