natgillin/translations-raw huggingface dataset:
Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Zaradi eprinomektina v iztrebkih zdravljenih živali se lahko zmanjša število organizmov, ki se prehranjujejo z iztrebki, kar lahko vpliva na razgradnjo iztrebkov.
Annex I
Dodatek I
Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks.
Izločanje potencialno toksične koncentracije eprinomektina lahko traja še nekaj tednov po zdravljenju.
The use of the product poses a risk for aquatic organisms in groundwater and surface water as well as for dung fauna.
Uporaba zdravila predstavlja tveganje za vodne organizme v podzemni in površinski vodi ter
Additionally, risk mitigation measures (RMM) have been considered and proposed for the risk identified for dung insects.
Prav tako je obravnaval in predlagal ukrepe za zmanjšanje ugotovljenega tveganja za žuželke, prisotne v gnoju.
Therefore, the CVMP recommended the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Odbor CVMP je zato priporočil odobritev dovoljenja za promet z zdravilom Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, skupaj s spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
Based on available data, the P and T criteria are met and so the remaining B component should be fully assessed.
Razpoložljivi podatki kažejo, da snov izpolnjuje kriterija obstojnosti (P) in strupenosti (T), zato bi bilo treba natančno oceniti preostalo lastnost kopičenja v organizmih (B).
These characteristics are also addressed in the SPC and the package leaflet with the information "... is persistent in soils and may accumulate in sediments ".
Te lastnosti so izpostavljene tudi v povzetku glavnih značilnosti zdravila in navodilu za uporabo z navedbo „... je obstojen v zemlji in se lahko kopiči v usedlinah.“ Ta opozorila so ustrezna.
Evaluation of the benefit-risk balance
Ocena razmerja med tveganji in koristmi
Because eprinomectin is a parasiticide a Phase II assessment according to VICH GL38 was presented
Ker je eprinomektin paraziticid, je bila za zdravilno učinkovino predložena ocena II.
Based on the identified risks in the ERA RMM were proposed to address the risk.
Na podlagi tveganj, ugotovljenih v oceni tveganja za okolje, so bili predlagani ukrepi za zmanjšanje teh tveganj.
Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin, a synthetic avermectin.
Zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, vsebuje eprinomektin, ki je sintetični avermektin.
However, Germany considered no acceptable data in the environmental risk assessment has been provided on bioaccumulation in order to assess the B criterion.
Vendar pa je Nemčija menila, da v okviru ocene tveganja za okolje niso bili predloženi nobeni sprejemljivi podatki o kopičenju v organizmih, ki bi omogočali oceno kriterija B. Posledično je bila zadeva napotena na odbor CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
Scientific conclusions and grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Znanstveni zaključki in razlogi za odobritev dovoljenja za promet z zdravilom Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka
Pour-on solution Cattle Topical use
Kožni poliv, raztopina molznice Topikalna uporaba
An ERA was provided for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle which was in accordance with VICH and CVMP guidelines.
Za zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, je bila predložena ocena tveganja za okolje, skladna s smernicami VICH in odbora CVMP.
Overall summary of the scientific evaluation of Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Splošni povzetek znanstvenega vrednotenja zdravila Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka
The RMM and warnings in the summary of product characteristics (SPC) and package leaflet address the risk to dung fauna and aquatic organisms by advising on the frequency of re-treatments, the
Ukrepi za zmanjšanje tveganja in opozorila v povzetku glavnih značilnosti zdravila ter navodilu za uporabo bodo tveganje za živali, prisotne v gnoju, in vodne organizme poskušali zmanjšati z informacijami o pogostnosti ponovnega zdravljenja, trajanju izločanja eprinomektina in o tem, da je dva do pet tednov po zdravljenju treba preprečiti približevanje vodnim telesom.
The benefit-risk balance is considered positive for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Razmerje med tveganji in koristmi zdravila Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, je pozitivno.
Grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Podlaga za odobritev dovoljenja za promet z zdravilom Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka
Route of administration
Pot uporabe
Strength Pharmaceutical form
Jakost Farmacevtska oblika
MA (EU) Number
Številka (EU) dovoljenja za promet
Immediate packaging
Velikost pakiranja
Contact our press officer Monika Benstetter
Stopite v stik z našo tiskovno predstavnico Monika Benstetter
The review looked at data from a large number of studies including:
V pregledu so proučili podatke iz večjega števila študij, med drugim:
GFR should be assessed before initiation of treatment and at least annually thereafter.
GFR je treba oceniti pred začetkom zdravljenja, nato pa vsaj enkrat letno.
The review of metformin-containing medicines was initiated on 28 January 2016 at the request of the Netherlands, under Article 31 of Directive 2001/83/EC.
Pregled zdravil, ki vsebujejo metformin, se je začel 28. januarja 2016 na zahtevo Nizozemske v skladu s členom 31 Direktive 2001/83/ES.
The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), odgovoren za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel mnenje agencije.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 12/12/2016.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 12. decembra 2016 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Tel. +44 (0)20 3660 8427 E-naslov: press@ema.europa.eu
In these cases, stop taking metformin for a short time and speak with your doctor for further instruction.
V tem primeru za kratek čas prenehajte jemati metformin in se posvetujte z zdravnikom, ki vam bo dal nadaljnja navodila.
References
Referenčna literatura
• If you have any question or concern about your diabetes treatment or your kidney function level, speak with your doctor, nurse or pharmacist.
• Če imate vprašanja ali pomisleke o svojem zdravilu za zdravljenje sladkorne bolezni ali ravni delovanja ledvic, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
Information for patients
Informacije za bolnike
Medicines containing metformin alone have been authorised nationally in the EU since the 1960s, marketed as Glucophage and other tradenames.
Zdravila, ki vsebujejo samo metformin, so v EU odobrena z nacionalnimi postopki od 60. let 20. stoletja, tržijo pa se pod imenom Glucophage in drugimi trgovskimi imeni.
Clear dosing recommendations and monitoring before and during treatment aim to minimise any possible increased risk in these patients.
Jasna priporočila za odmerjanje zdravila in njegovo spremljanje pred in med zdravljenjem so namenjena zmanjševanju morebitnega povečanega tveganja pri teh bolnikih.
Information for healthcare professionals
Informacije za zdravstvene delavce
The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.
Trenutne informacije o zdravilu se med državami in zdravili v EU razlikujejo in niso skladne s kliničnimi smernicami.
The product information also details risk factors for lactic acidosis which should be reviewed prior to and during treatment.
V informacijah o zdravilu so podrobno opisani tudi dejavniki tveganja za laktacidozo, ki jih je treba preverjati pred in med zdravljenjem.
If you experience severe vomiting, diarrhoea or fever, are exposed to heat, or drink less fluid than normal, you could become dehydrated.
Če se pri vas pojavi hudo bruhanje, driska ali povišana telesna temperatura, če ste izpostavljeni toploti ali pijete manj kot običajno, lahko dehidrirate.
For further information about the centrally authorised medicines, see here.
Za več informacij o zdravilih, ki so pridobila dovoljenje za promet po centraliziranem postopku, glejte tu.
• Dehydration (significant loss of body fluids) increases the risk of developing lactic acidosis.
• Dehidracija (znatna izguba telesnih tekočin) poveča tveganje za pojav laktacidoze.
However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin.
Po preučitvi znanstvene literature, kliničnih podatkov, epidemioloških študij in kliničnih smernic zdravniških organov je agencija EMA zaključila, da lahko uporaba metformina koristi veliki populaciji bolnikov z zmerno okvaro delovanja ledvic.
The product information for metformincontaining medicines will be updated to reflect the new recommendations and to ensure that the same advice is given to all patients in the EU.
Informacije o zdravilu za zdravila, ki vsebujejo metformin, bodo posodobljene tako, da bodo vključevale nova priporočila in da bodo vsi bolniki v EU prejeli enake nasvete.
The dose of metformin should be adapted depending on the patient's kidney function.
Odmerek metformina je treba prilagoditi glede na delovanje bolnikovih ledvic.
Recommendations for patients with kidney impairment updated in product information
Posodobljena priporočila za bolnike z ledvično okvaro v informacijah o zdravilu
In addition, the combination glibenclamide/metformin (Glucovance) has been nationally authorised.
Poleg tega je dovoljenje z nacionalnim postopkom prejela tudi kombinacija glibenklamid/metformin (Glucovance).
• Several fixed-dose combination products containing metformin are available in Europe (see below).
• V Evropi je na voljo več zdravil s fiksno kombinacijo odmerkov, ki vsebujejo metformin (glejte spodaj).
Companies marketing metformin-containing medicines will be requested to closely monitor and analyse future lactic acidosis cases and report these during upcoming periodic safety reviews in order to follow up on any changes in the frequency of this side effect.
Družbe, ki tržijo zdravila, ki vsebujejo metformin, bodo morale skrbno spremljati in analizirati prihodnje primere laktacidoze in o njih poročati v okviru naslednjih rednih pregledov varnosti, da bo tako omogočeno spremljanje sprememb pogostnosti tega neželenega učinka.
Use in patients with GFR<30 ml/min is still contraindicated.
Uporaba pri bolnikih z GFR < 30 ml/min je še vedno kontraindicirana.
If these products are used in patients with reduced kidney function, restrictions and efficacy regarding the other active substance in the combination, the feasibility of dose adjustment and the alternative of using individual tablets should be considered.
Če se ta zdravila uporabljajo pri bolnikih z okvaro delovanja ledvic, je treba upoštevati omejitve in učinkovitost druge zdravilne učinkovine v kombinaciji, izvedljivost prilagoditve odmerka in nadomestno možnost uporabe ločenih tablet.
The following medicines containing combinations of metformin with other diabetes medicines in the same tablet have been authorised centrally through EMA: pioglitazone/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) and empagliflozin/metformin (Synjardy).
Naslednja zdravila, ki v eni tableti vsebujejo kombinacijo metformina in drugega zdravila za zdravljenje sladkorne bolezni, so dovoljenja za promet z zdravilom dobila po centraliziranem postopku prek agencije EMA: pioglitazon/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saksagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), kanagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) in empagliflozin/metformin (Synjardy).
Metformin may increase the risk of a rare but serious complication called lactic acidosis, which occurs when naturally produced lactic acid builds up in the blood faster than it can be removed.
Metformin lahko poveča tveganje za redek, a resen zaplet, imenovan laktacidoza, ki se pojavi, ko se naravno prisotna mlečna kislina kopiči v krvi hitreje, kot jo telo lahko odstranjuje.
For example, dapagliflozin/metformin (Ebymect, Xigduo) is not recommended in patients with GFR<60 ml/min; canagliflozin/metformin (Vokanamet) and empagliflozin/metformin (Synjardy) are not recommended in patients with GFR<45 ml/min and should not be started in patients with GFR<60 ml/min.
Na primer kombinacija dapagliflozin/metformin (Ebymect, Xigduo) ni priporočena pri bolnikih z GFR < 60 ml/min, kombinaciji kanagliflozin/metformin (Vokanamet) in empagliflozin/metformin (Synjardy) pa nista priporočeni pri bolnikih z GFR < 45 ml/min in ju ne smemo uvesti pri bolnikih z GFR < 60 ml/min.
Metformin is a medicine used on its own or in combination with other medicines for the treatment of type 2 diabetes.
Metformin je zdravilo, ki se uporablja samostojno ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni tipa 2.
However, for patients with only moderately reduced kidney function any risk can be minimised by careful checking of dose and monitoring, allowing these patients to get the benefits these medicines can provide.
Pri bolnikih z le zmerno okvaro delovanja ledvic se tveganje s skrbnim preverjanjem odmerka in spremljanjem lahko zmanjša, s tem pa imajo lahko ti bolniki koristi od teh zdravil.
• Up to now, metformin medicines were not recommended for patients with moderate to severe reduction of kidney function.
• Do zdaj zdravila z metforminom niso bila priporočena za bolnike z zmerno do hudo okvaro delovanja ledvic.
The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
Informacije o zdravilu za ta zdravila bodo posodobljena tako, da bodo trenutne kontraindikacije popravljene, navedene pa bodo informacije o odmerkih, spremljanju in previdnostnih ukrepih pri bolnikih z okvaro delovanja ledvic.
• These latest recommendations will result in harmonisation of product information about the use of metformin in patients with reduced kidney function and the precautions for lactic acidosis across the EU.
• S temi najnovejšimi priporočili se bodo uskladile informacije o zdravilu po vsej EU glede uporabe metformina pri bolnikih z okvaro delovanja ledvic in previdnostnih ukrepov pri laktacidozi.
Currently, the product information states that metformin must not be used in patients with reduced kidney function because these patients are considered to be at a higher risk of developing lactic acidosis as their kidneys do not remove metformin efficiently enough.
Trenutno informacije o zdravilu navajajo, da se metformin ne sme uporabljati pri bolnikih z okvaro delovanja ledvic, ker velja, da je pri teh bolnikih tveganje za pojav laktacidoze večje, saj njihove ledvice metformina ne odstranjujejo dovolj učinkovito.
Metformin is used together with diet and exercise to improve control of blood glucose (sugar) levels.
Uporablja se skupaj z dieto in telesno vadbo za boljše uravnavanje ravni glukoze (sladkorja) v krvi.
• Metformin is used on its own or with other medicines, together with diet and exercise, for the treatment of type 2 diabetes.
• Metformin se uporablja samostojno ali skupaj z drugimi zdravili, hkrati z dieto in telesno vadbo, za zdravljenje sladkorne bolezni tipa 2.
• Some fixed-dose combination products are still not recommended in patients with moderately reduced kidney function because the other active substance in the combination should not be used in these patients.
• Nekatera zdravila s fiksno kombinacijo odmerkov še vedno niso priporočena pri bolnikih z zmerno okvaro delovanja ledvic, ker se druga zdravilna učinkovina v kombinaciji pri teh bolnikih ne sme uporabljati.
• Patients with reduced kidney function may be at higher risk of lactic acidosis, a rare but serious side effect of metformin medicines caused by build-up of lactic acid in the blood.
• Pri bolnikih z okvaro delovanja ledvic lahko obstaja večje tveganje za pojav laktacidoze, tj. redkega, a resnega neželenega učinka zdravil z metforminom, ki se pojavi zaradi kopičenja mlečne kisline v krvi.
• Reduced doses should be considered for patients with moderate reduction of kidney function according to dosage recommendations provided in the updated product information.
• Pri bolnikih z zmerno okvaro delovanja ledvic je treba razmisliti o zmanjšanem odmerku v skladu s priporočili za odmerjanje, navedenimi v posodobljenih informacijah o zdravilu.
The recommendations were the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.
Pregled je opravila agencija EMA, sledil pa je pomislekom, da trenutni znanstveni dokazi ne utemeljujejo kontraindikacije pri bolnikih z zmerno okvaro delovanja ledvic.
Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am Geriatr Soc, 2013, Vol. 61, p. 1253.
Solini, A. et al., „Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study“, J Am Geriatr Soc, 2013, zv.
Roussel, R. et al., ‘Metformin use and mortality among patients with diabetes and atherothrombosis', Arch Intern Med, 2010, Vol. 170, p. 1892.
Roussel, R. et al., „Metformin use and mortality among patients with diabetes and atherothrombosis“, Arch Intern Med, 2010, zv.
On 13 October 2016, the European Medicines Agency (EMA) concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate] = 30-59 ml/min) for the treatment of type 2 diabetes.
Evropska agencija za zdravila (EMA) je 13. oktobra 2016 zaključila, da se zdravila, ki vsebujejo metformin, od zdaj naprej lahko uporabljajo za zdravljenje sladkorne bolezni tipa 2 tudi pri bolnikih z zmerno okvaro delovanja ledvic (GFR [hitrost glomerulne filtracije] = 30-59 ml/min).
The contraindication for patients with severely reduced kidney function will remain (GFR less than 30 ml/min).
Kontraindikacija za bolnike s hudo okvaro delovanja ledvico bo ostala (GFR pod 30 ml/min).
These medicines should still not be used in patients with severely reduced kidney function (GFR less than 30 ml/min).
Ta zdravila se še vedno ne smejo uporabljati pri bolnikih s hudo okvaro delovanja ledvic (GFR pod 30 ml/min).
• The review of metformin-containing medicines concluded that they can now be used in patients with moderately reduced kidney function (GFR=30-59 ml/min).
• Pregled zdravil, ki vsebujejo metformin, je pokazal, da se ta zdravila lahko zdaj uporabljajo tudi pri bolnikih z zmerno okvaro delovanja ledvic (GFR=30-59 ml/min).
et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
et al., „Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, zv.
et al., ‘Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study', Diabetes Care, 2014, Vol. 37 (8), p. 2218.
et al., „Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study“, Diabetes Care, 2014, zv.
et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
et al., „Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study“, Diabetes Care, 2014, zv.
This recommendation has now changed to allow their use in patients with moderately reduced kidney function (GFR=30-59 ml/min).
To priporočilo se je zdaj spremenilo, zato se ta zdravila lahko sedaj uporabljajo pri bolnikih z zmerno okvaro delovanja ledvic (GFR = 30-59 ml/min).
10 vials
10 vial
Type 2 (MEF-1)
tip 2 (sev MEF-1)
(Polyribosylribitol Phosphate) conjugated to Tetanus protein
(poliribozilribitol fosfat) konjugiran na tetanusno beljakovino
3 Produced on Vero cells
3 Pridobljen na celicah Vero.
Type 3 (Saukett)
tip 3 (sev Saukett)
Hepatitis B surface antigen5
površinski antigen hepatitisa B5
Pack size vial (glass)
Velikost pakiranja viala (steklo)
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
1 Adsorbiran na hidratirani aluminijev hidroksid (0,6 mg Al3+).
Haemophilus influenzae type b polysaccharide
polisaharid hemofilusa influence tipa b
1 pre-filled syringe
1 napolnjena injekcijska brizga
10 pre-filled syringes
10 napolnjenih injekcijskih brizg
4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
5 Pridobljeno v celicah kvasovke Hansenula polymorpha s tehnologijo rekombinantne DNA.
--1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
--1 En odmerek1 (0,5 ml) vsebuje: davični toksoid tetanusni toksoid antigene Bordetelle pertussis toksoid oslovskega kašlja filamentozni hemaglutinin poliovirus (inaktiviran)3 tip 1 (sev Mahoney)
1 pre-filled syringe + 1 needle
brizga 1+ 1 igla
1 pre-filled syringe + 2 needles
brizga + 2 igli
Bordetella pertussis antigens Pertussis Toxoid
Pot uporabe Stična ovojnina
EMA Number
Številka (EU) dovoljenja za promet
National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure the following:
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, kadar je to ustrezno morajo zagotoviti naslednje:
• Intracranial aneurysm and intracranial haemorrhage
• intrakranialna anevrizma in intrakranialna krvavitev.
The MAHs should submit/update the Risk Management Plans for all somatropin medicinal products to reflect the following potential risks:
Imetniki dovoljenja za promet z zdravilom morajo predložiti/posodobiti načrte za obvladovanje tveganj za vsa zdravila, ki vsebujejo somatropin, tako da bodo v teh načrtih navedena naslednja možna tveganja: