natgillin/translations-raw huggingface dataset:
The guidance “Guideline on the excipients in the label and the package leaflet of medicinal products for human use” states that if the content of ethanol is 100 mg - 3g per dose, the following should be stated in the PL: ‘This medicinal product contains < > vol % ethanol (alcohol), i.e. up to < > mg per dose, equivalent to < > ml beer, < > ml wine per dose.
V navodilu „Smernice v zvezi s pomožnimi snovmi na nalepki in navodilu za uporabo zdravil v humani medicini“ je navedeno, da je treba v primerih, kadar vsebnost etanola znaša od 100 mg do 3 g na odmerek, v navodilu za uporabo navesti: „To zdravilo vsebuje <> vol % etanola (alkohola), tj. do <> mg na odmerek, kar ustreza <> ml piva, <> vina na odmerek.
Newborn infants, and children are not able to metabolize ethanol as efficiently as adults; as a consequence, they may be at higher risk of both acute and chronic alcohol-related toxicities.
Novorojenčki in otroci ne morejo tako učinkovito presnavljati etanola kot odrasli, zaradi česar so lahko izpostavljeni višjemu tveganju za akutno in kronično toksičnost, povezano z alkoholom.
The decentralised marketing authorisation application for the medicinal product Levothyroxine is a well-established use application according to Article 10(a) of Directive 2001/83/EC.
Vloga za pridobitev dovoljenja za promet z zdravilom po decentraliziranem postopku temelji na dejstvu, da je raba zdravila Levothyroxine že dobro uveljavljena v skladu s členom 10(a) Direktive 2001/83/ES.
As there is limited information on safe ethanol concentrations in paediatric formulations intended for chronic use, there are concerns with regard to chronic use of Levothyroxine Alapis in neonates/children, as ethanol represents an additional insult to brain development that is already compromised by congenital hypothyroidism.
Ker ni na voljo dovolj informacij o varnih koncentracijah etanola v pediatričnih pripravkih, namenjenih za kronično uporabo, se pojavljajo pomisleki v zvezi s kronično uporabo zdravila Levothyroxine Alapis pri novorojenčkih/otrocih, saj je etanol še dodatna ovira za razvoj možganov, ki je že tako ogrožen zaradi prirojenega hipotiroidizma.
The proposed indications for Levothyroxine Alapis are for: the treatment of hypothyroidism (congenital or acquired, including diffuse non-toxic goiter), hypothyroidism forms of Hashimoto's thyroiditis and thyroid carcinoma.
Predlagane indikacije zdravila Levothyroxine Alapis so: zdravljenje hipotiroidizma (prirojenega ali pridobljenega, vključno z difuzno netoksično golšo), hipotirotičnih oblik Hashimotovega tiroiditisa in karcinoma ščitnice.
The absence of robust user testing with representative members of the general public provides no reassurance that this dropper device will prove manageable and accurate in practice.
Ker ni bilo izvedeno neposredno preverjanje uporabnosti med tipičnimi predstavniki splošne javnosti, ni zagotovila, da se bo kapalka v praksi izkazala za obvladljivo in natančno.
The dosing errors due to the difficulty in accurately counting a large number of drops per dose (up to 20 drops) of Levothyroxine Alapis solution also remain a concern.
Zaskrbljenost vzbujajo tudi napake, ki nastanejo, ker je težko natančno prešteti veliko kapljic v enem odmerku (do 20 kapljic) raztopine zdravila Levothyroxine Alapis.
In light of the Applicant's failure to provide responses to the CHMP list of questions during the Article 29(4) referral procedure, the assessment was carried out on the data made available during the decentralised procedure and the CMDh referral procedure.
Ker predlagatelj med napotitvenim postopkom iz člena 29(4) ni predložil odgovorov na seznam vprašanj CHMP, je bila ocena izvedena na podlagi podatkov, ki so bili pridobljeni med decentraliziranim postopkom in napotitvenim postopkom skupine CMDh.
Two groups of infants were treated with two doses of propylene glycol; 0.3 g/day and 3 g/day in an IV multivitamin solution, during two consecutive 19month periods in a retrospective design.
V retrospektivno načrtovani študiji sta dve skupini dojenčkov prejeli različna odmerka propilen glikola, in sicer 0,3 g/dan in 3 g/dan v IV multivitaminski raztopini ter v dveh zaporednih 19-mesečnih obdobjih.
• The Committee was of the opinion that the chronic co-administration of the proposed quantities of the excipients ethanol and propylene glycol in children remains a safety concern.
• Odbor je menil, da kronično sočasna uporaba predlaganih količin pomožnih snovi etanola in propilen glikola pri otrocih še vedno vzbuja pomisleke v zvezi z varnostjo.
Nunn et al; Journal of Clinical Pharmacy and Therapeutics (2004) 29, 521-529
An assessment of dose-uniformity of samples delivered from paediatric oral droppers (Ocena o enotnosti odmerkov vzorcev iz pediatričnih kapalk za peroralno dajanje), A. J. Nunn et al; Journal of Clinical Pharmacy and Therapeutics, (2004)29, 521-529.
The possible medication errors caused by the dropper insert were discussed by the CHMP:
CHMP je obravnaval možne napake pri uporabi zdravila zaradi uporabe priloženega kapalnega vložka:
In addition there are also concerns in patients with hepatic impairment, epilepsy and in vulnerable adults such as those suffering from alcoholism.
Obstajajo tudi pomisleki pri bolnikih z okvaro jeter, epilepsijo in ranljivih populacijah odraslih, na primer alkoholikih.
Although propylene glycol is widely used as an excipient in oral and injectable medicines, literature data on its safety in children when administered chronically is sparse.
Čeprav se propilen glikol obsežno uporablja kot pomožna snov v zdravilih za peroralno dajanje in injiciranje, je v literaturi malo podatkov o njegovi varnosti za otroke pri kroničnem dajanju.
The study by MacDonald et al2, seems relevant as daily doses of propylene glycol similar to what can be expected from Levothyroxine Alapis were studied in one of the study arms.
Pri tem se zdi pomembna študija MacDonald et al2, saj so odmerki propilen glikola, ki so jih preučevali pri eni skupini bolnikov, podobni odmerkom, ki jih je mogoče pričakovati pri dajanju zdravila Levothyroxine Alapis.
In light of the failure to provide responses to the CHMP list of questions, , the available information was not considered to be sufficient to address the safety concerns of the chronic use of ethanol and the propylene glycol, in particular in the paediatric population.
Ker CHMP ni dobil odgovorov na svoj seznam vprašanj, informacije, ki so bile na voljo, niso štele za zadostne za odpravo pomislekov glede varnosti pri kronični rabi etanola in propilen glikola, zlasti pri pediatrični populaciji.
In conclusion given that Levothyroxine Alapis is a highly concentrated solution containing 100 mcg/ml the dropper device is considered to be unsuitable due to inaccuracies resulting from improper dropper orientation and miscounting, especially for paediatric initial doses less than 25 mcg.
Ker je zdravilo Levothyroxine Alapis visoko koncentrirana raztopina, ki vsebuje 100 mcg/ml, je bilo ugotovljeno, da kapalke ni mogoče šteti za primerne zaradi napak, ki nastanejo zaradi nepravilne usmerjenosti kapalke in napačnega štetja, kar zlasti velja za začetne odmerke v pediatriji, manjše od 25 mcg.
Medication errors caused by the administration device (dropper insert) Initially two different dropper inserts resulting in different drop sizes that would count up to 40 drops was proposed by the Applicant.
Napake pri uporabi zdravila zaradi pripomočka za dajanje (kapalni vložek) Predlagatelj je na začetku predlagal dva različna kapalna vložka, kar pomeni razliko v velikosti kapljic, ki lahko znaša tudi do 40 kapljic.
Combination of ethanol and propylene glycol
Kombinacija etanola in propilen glikola
This is a bibliographic application that refers to literature concerning several levothyroxin tablet formulations and solutions and thus no reference is made to a single unique formulation.
Vloga je bibliografska in se sklicuje na literaturo, ki se nanaša na več pripravkov v obliki tablet in raztopin levotiroksina, zaradi česar ni sklicevanja na posamično farmacevtsko obliko.
Inaccuracies due to miscounting
Napake zaradi napačnega štetja
Inaccuracies due to improper dropper orientation
Napake zaradi nepravilne usmerjenosti kapalke
The applicant then proposed to use: - a dropper insert for doses between 12.5 µg and 50 µg (5 to 20 drops) and - a 3 mL oral syringe for doses between 50 µg and 200 µg (0.5 to 2 mL) According to the proposed Summary of Product Characteristics (SmPC), the dropper insert will be mainly used for administration to paediatric patients as well as for initial dosing of adults and children over 12 years.
Predlagatelj je nato predlagal uporabo: - kapalnega vložka za odmerke med 12,5 µg in 50 µg (od 5 do 20 kapljic) ter - 3-mL brizge za peroralno dajanje za odmerke med 50 µg in 200 µg (od 0,5 do 2 mL).
The excipients are glycerol, propylene glycol, ethanol and purified water, which comply with the respective Ph.Eur monographs.
Pomožne snovi so glicerol, propilen glikol, etanol in prečiščena voda, ki so v skladu z ustreznimi monografijami Evropske farmakopeje.
This represents an impractical means of dosing babies and small infants, and will result in further variability in dosing volumes associated with use of a second administration device.
Ta način odmerjanja pri dojenčkih in majhnih otrocih ni praktičen ter zaradi uporabe dodatnega aplikatorja povzroča dodatno nihanje volumna odmerka.
Therefore any deviation from vertical orientation, such as an attempt to slow the drop rate will result in inaccurate drop volume.
Tako se pri vsakem odklonu od navpičnega položaja, če na primer skušamo upočasniti padanje kapljic,
Therefore, co-administration of ethanol and propylene glycol can lead to raised and potentially toxic levels of the latter.
Zaradi tega lahko sočasna uporaba etanola in propilen glikola pripelje do povišanih, potencialno toksičnih ravni propilen glikola.
As ethanol is used to solubilise levothyroxine, its use is not considered to be essential in this formulation, based on the relatively poor solubility of levothyroxine in ethanol when compared to propylene glycol.
Ker se za raztapljanje levotiroksina uporablja etanol, se njegova uporaba ne šteje za bistveno v tem pripravku, saj je levotiroksin sorazmerno slabše topen v etanolu kot v propilen glikolu.
Published literature highlights the potential for significant variability in both drop rate and volume for low viscosity solutions such as this product, where bottle orientation is not vertical.
V objavljeni literaturi je poudarjena možnost za precejšnje nihanje hitrosti in volumna kapljic pri raztopinah z nizko viskoznostjo, kot je npr. obravnavano zdravilo, kadar steklenička ni v navpičnem položaju.
Since both propylene glycol and ethanol share a common metabolic pathway the combination of ethanol and propylene glycol is a concern.
Ker imata propilen glikol in etanol enako metabolno pot, njuna kombinacija vzbuja zaskrbljenost.
Levothyroxine Alapis is a solution with low viscosity, which gives a fast drop rate.
Zdravilo Levothyroxine Alapis je raztopina z nizko viskoznostjo, zaradi česar kapljice padajo hitreje.
In addition there are concerns in vulnerable adults such as those suffering from alcoholism, as well as in patients with hepatic impairment and epilepsy.
Obstajajo tudi pomisleki v zvezi z ranljivimi populacijami odraslih, kot so alkoholiki, bolniki z okvaro jeter in epilepsijo;
Levothyroxine Alapis is an oral drop solution containing levothyroxine sodium as active substance (100 mcg/ml).
Zdravilo Levothyroxine Alapis je raztopina v obliki peroralnih kapljic, ki kot zdravilno učinkovino vsebuje natrijev levotiroksin (100 mcg/ml).
Since no consensus could be reached on the issues relating to medication errors due to the method of administration of the oral drops and the safety of excipients ethanol and propylene glycol in the paediatric population, the CMDh referred the matter to the CHMP under Article 29(4) of Directive
Ker ni bilo mogoče doseči dogovora o vprašanjih, povezanih z napakami pri uporabi zdravila zaradi načina dajanja kapljic za peroralno uporabo in varnosti pomožnih snovi etanola in propilen glikola v pediatrični populaciji, je Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) zadevo v skladu s členom 29(4) Direktive 2001/83 predložila Odboru za zdravila za uporabo v humani medicini (CHMP).
The active substance levothyroxine, is an established active substance described in the European Pharmacopoeia.
Zdravilna učinkovina levotiroksin je uveljavljena zdravilna učinkovina, opisana v Evropski farmakopeji.
As mentioned previously, both ethanol and propylene glycol are initially metabolised by alcohol dehydrogenase.
Kot je bilo že navedeno, se etanol in propilen glikol na začetku presnavljata z alkoholno dehidrogenazo.
Safety of excipients (ethanol / propylene glycol) in paediatric population The excipients used in Levothyroxine Alapis are ethanol, propylene glycol, glycerol and water and comply with the Ph. Eur monographs.
Varnost pomožnih snovi (etanola/propilen glikola) za pediatrično populacijo V zdravilu Levothyroxine Alapis se uporabljajo pomožne snovi etanol, propilen glikol, glicerol in voda, ki so vse v skladu z monografijami Evropske farmakopeje.
Alcohol dehydrogenase preferentially metabolises ethanol prior to metabolising other alcohols, including propylene glycol.
Pri alkoholni dehidrogenazi se etanol metabolizira pred drugimi alkoholi, vključno s propilen glikolom.
Levothyroxine Alapis, which is formulated as a highly concentrated solution of a very potent active substance, is associated with adverse events with chronic over-dosing - particularly cardiovascular.
Zdravilo Levothyroxine Alapis, izdelano v obliki visoko koncentrirane raztopine zelo potentne zdravilne učinkovine, se povezuje z neželenimi učinki pri kroničnem predoziranju - zlasti kardiovaskularnimi.
Both ethanol and propylene glycol are initially metabolised by alcohol dehydrogenase.
Etanol in propilen glikol sta na začetku metabolizirana z alkoholno dehidrogenazo.
Levothyroxine Alapis, which is a highly concentrated solution of a highly potent medicinal product, is associated with adverse events with chronic over-dosing - particularly cardiovascular events.
Zdravilo Levothyroxine Alapis, ki je visoko koncentrirana raztopina zelo potentne zdravilne učinkovine, se povezuje z neželenimi dogodki pri kroničnem previsokem odmerjanjuzlasti kardiovaskularnimi.
And therefore the CHMP recommended the refusal of the granting of the marketing authorisation for Levothyroxine Alapis and associated names (see Annex I).
• Odbor je sklenil, da se razmerje med tveganjem in koristjo pri zdravilu Levothyroxine Alapis zato ne šteje za ugodno, je zato CHMP priporočil, da se izdaja dovoljenja za promet z zdravilom zavrne in da se začasno prekliče že odobreno dovoljenje za promet z zdravilom Levothyroxine Alapis in povezanimi imeni (glej Prilogo I).
Therefore there are major safety concerns due to the chronic use of the combination of ethanol and propylene glycol in neonates/children.
Zato kronična uporaba kombinacije etanola in propilen glikola pri novorojenčkih/otrocih sproža večje pomisleke o njeni varnosti.
Inaccuracy due to the miscounting of the large number of drops administered also contributes to the risk of medication error.
Tveganje za napako pri uporabi zdravila se še poveča zaradi nenatančnosti, ki so lahko posledica napačnega štetja velikega števila kapljic pri posameznem odmerku.
The national competent authorities, coordinated by the reference Member State, if applicable, shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
To be determined by Member States following EC decision
Rok določijo države članice na podlagi sklepa Evropske komisije.
The MAHs should circulate a DHPC in accordance with the agreed key messages.
Imetniki dovoljenja za promet z zdravilom bodo razposlali obvestilo za zdravstvene delavce (DHPC) v skladu z dogovorjenimi ključnimi sporočili.
0.5ml (1mg/ml) 14 Vials
Subkutana uporaba Viala (steklena) 0,5ml (1mg/ml)
Route of administration
14 Vial
These findings have since been verified.
Te ugotovitve so bile od takrat preverjene.
The assay time has been reduced to hours as opposed to almost two weeks needed for the conventional culture.
Čas poskusov se je skrajšal na nekaj ur v primerjavi s skoraj dvema tednoma, ki so potrebni za konvencionalne kulture.
Special media and atmosphere are required and the incubation period is long (7-10 days).
Potrebni so posebni mediji in okolje, inkubacijska doba pa je dolga (7-10 dni).
was as high as 53% (8/15) (Jasper (1977)).
), je znašal 53 % (8/15) (Jasper (1977)).
Monitoring the lack of efficacy is a part of the veterinary pharmacovigilance system.
Spremljanje pomanjkanja učinkovitosti je del sistema veterinarske farmakovigilance.
(or Mycoplasma bovis) which are currently authorised or pending authorisations in the European Union.
(ali Mycoplasma bovis), ki so trenutno odobrena ali čakajo na odobritev v Evropski uniji.
It may be administered by oral or parenteral routes.
Lahko se daje po peroralni ali parenteralni poti.
29% of the composite samples (81/280) and 43% of the quarter milk samples (433/1008) did not yield growth of Mycoplasma.
29 % sestavljenih vzorcev (81/280) in 43 % vzorcev mleka iz vimenske četrti (433/1008) ni povzročilo rasti mikoplazme.
Details of the treatment experiments are scarce, but altogether he described the results as unrewarding.
Podrobnosti o poskusih zdravljenja so redki, vendar je rezultate opisal kot v celoti nezadovoljive.
The clinical signs vary but the milk loss is usually significant.
Klinični znaki so različni, vendar je izguba mleka običajno precejšnja.
The authors concluded that the risk of misdiagnosis is increased if multiple milk samples are not tested.
Avtorji so ugotovili, da se tveganje za napačno diagnozo poveča, če se ne testira več vzorcev mleka.
Infected cows may remain externally normal with few clinical signs, even in severe cases.
Okužene krave lahko ostanejo navzven normalne z nekaj kliničnimi znaki, tudi v hudih primerih.
Mycoplasmas do not grow on conventional media; this hampers the diagnosis.
Mikoplazme ne rastejo na konvencionalnih medijih, kar ovira diagnozo.
Since then it has spread to cattle worldwide and is known to cause severe economic losses in the herds affected.
Od takrat se je razširila na govedo po vsem svetu in znano je, da povzroča hude gospodarske izgube v prizadetih čredah.
4.2 Indication(s) for use
4.2 Indikacija(e) za uporabo
A negative cultivation result after treatment could, before, have been falsely interpreted as bacteriological cure although at present it is known merely to be a characteristic of the infection.
Negativni rezultat kultivacije po zdravljenju se je v preteklosti lahko zmotno razlagal kot bakteriološka ozdravitev, čeprav je trenutno znano le, da je to značilnost okužbe.
is difficult.
težavno.
Furthermore, this indication should not be granted for the pending marketing authorisation applications (see Annex I).
Poleg tega ta indikacija ne sme biti odobrena za vloge v postopku pridobivanja dovoljenja za promet (glejte Prilogo I).
Affected milk may seem normal but it may also be purulent and/or have abnormal and discoloured secretions.
Prizadeto mleko se lahko zdi normalno, vendar je lahko tudi gnojno in/ali ima nenormalne in razbarvane izločke.
Current technologies such as Polymerase Chain Reaction (PCR) have enabled significantly quicker identification of M. bovis.
Sodobne tehnologije, kot je polimerazna verižna reakcija (PCR), so omogočile bistveno hitrejše prepoznavanje bakterije M. bovis.
It is a major problem for milk production and animal welfare in the herds affected, and causes severe economic losses.
Predstavlja veliko težavo za proizvodnjo mleka in dobro počutje živali v prizadetih čredah in povzroča hude gospodarske izgube.
He reported testing various antimicrobials, including tylosin.
Poročal je o testiranju različnih protimikrobnih zdravil, vključno z tilozinom.
The Committee concluded that indications for use should preferably be restricted to those for which efficacy has been proven and general indications without a solid clinical basis should be avoided.
Odbor je sklenil, da je treba indikacije za uporabo prednostno omejiti na tiste, za katere je bila dokazana učinkovitost, in da se je treba izogibati splošnim indikacijam
The dose 3 g/cow/day is within the dose range widely authorised in Europe i.e. 4-10 mg/kg/day i.m.
Odmerek 3 g/kravo/dan je v razponu, splošno odobrenem v Evropi, tj. 4-10 mg/kg/dan i.m.
The pathogen is highly contagious and causes severe economic losses.
Patogen je zelo nalezljiv in povzroča velike gospodarske izgube.
It is active mostly against Gram-positive bacteria and mycoplasmas.
Deluje predvsem proti po Gramu pozitivnim bakterijam in mikoplazmam.
These veterinary medicinal products are also indicated for the treatment of several other diseases including respiratory and gastrointestinal infections, but these indications fall outside the scope of this referral procedure.
Ta zdravila za uporabo v veterinarski medicini so navedena tudi za zdravljenje nekaterih drugih bolezni, vključno z dihalnimi in gastrointestinalnimi okužbami, vendar te indikacije ne sodijo na področje uporabe tega napotitvenega postopka.
Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Tilozin in njegove fosfatne in tartratne soli se uporabljajo v veterinarski medicini za zdravljenje stanj, ki jih povzročajo občutljivi organizmi.
Instead several comprehensive review articles dealing with mycoplasma mastitis have been published (Pfützner and Sachse (1996)4, Nicholas and Ayling (2003)5, Gonzalez and Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
Namesto tega je bilo objavljenih več obsežnih preglednih člankov, ki obravnavajo mikoplazmatski mastitis (Pfützner in Sachse (1996)4, Nicholas in Ayling (2003)5, Gonzalez in Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
(see Annex I)
(glejte Prilogo I)
Jasper was also one of the first to question the efficacy of antimicrobials in the treatment of mycoplasma mastitis.
Jasper je bil tudi eden izmed prvih, ki je dvomil o učinkovitosti protimikrobnih zdravil pri zdravljenju mikoplazmatskega mastitisa.
(see Annex I) in order to amend the summary of product characteristics, labelling and package leaflet in line with recommended changes in the product information as set out in Annex III.
(glejte Prilogo I), in sicer je treba popraviti povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
In 1977 Jasper 2 described natural resolution of the disease as unpredictable and recognised the danger of intermittently shedding cows.
Leta 1977 je Jasper2 opisal naravni potek bolezni kot nepredvidljiv in prepoznal nevarnost pri kravah, pri katerih se patogen izloča občasno.
In case of old products where data are sparse indications should be reviewed and revised, based on the current scientific knowledge, where appropriate.
Pri starih zdravilih, kjer so podatki skopi, je treba, kjer je to potrebno, indikacije pregledati in spremeniti na podlagi obstoječega strokovnega znanja.
The major pathogen among the genera is Mycoplasma bovis that was first isolated from bovine mastitis in the USA in the 1960s.
Glavni patogen iz rodu je bakterija Mycoplasma bovis, ki je bila prvič izolirana iz mastitisa pri govedu v ZDA v 60. letih 20. stoletja.
For the same reasons sensitivity testing of Mycoplasma spp.
Iz istih razlogov je preizkušanje občutljivosti Mycoplasma spp.
In addition to the spread to other quarters, hematologic dissemination of mycoplasma to other parts of the body, e.g. joints, respiratory tract and ears, is possible.
Poleg širjenja na druge vimenske četrti je mogoče hematološko širjenje mikoplazme na druge dele telesa, npr. sklepe, dihala in ušesa.