natgillin/translations-raw huggingface dataset:
The statement of noncompliance with GMP of PII clarifies that marketing authorisation holders are requested to contact the relevant National Competent Authority (NCA) to verify whether their products are considered medically critical to public health in their territory.
Izjava o neskladnosti z dobro proizvodno prakso za družbo PII vsebuje tudi poziv imetnikom dovoljenja za promet, naj stopijo v stik z ustreznim nacionalnim pristojnim organom, kjer lahko preverijo, ali njihova zdravila štejejo kot kritična za javno zdravje na njihovem ozemlju.
Dutasteride Actavis is a medicinal product containing the active substance dutasteride, a triple 5αreductase inhibitor.
Zdravilo Dutasteride Actavis vsebuje zdravilno učinkovino dutasterid, trojni zaviralec 5-alfa reduktaze.
PII is the only manufacturing site registered on the marketing authorisation for the manufacture of the finished products.
Družba PII je edini proizvodni obrat, ki je v dovoljenju za promet z zdravilom registrirano za izdelavo končnega zdravila.
However the non-compliance with good manufacturing practice presents a degree of unquantifiable risk which cannot be detected reliably through post-marketing data, hence the lack of any significant concerns cannot provide sufficient reassurance over the safety of the batches manufactured at PII.
Vendar pa neskladnost z dobro proizvodno prakso pomeni neopredeljivo tveganje, ki ga s podatki iz obdobja trženja ni mogoče zanesljivo zaznati, zato odsotnost pomembnih pomislekov ni zadostno zagotovilo o varnosti serij, proizvedenih v družbi PII.
The non-compliance with good manufacturing practice presents a degree of unquantifiable risk which cannot be detected reliably through postmarketing data; hence the lack of any significant concerns cannot provide sufficient reassurance over the safety of the batches manufactured at PII.
Neskladnost z dobro proizvodno prakso pomeni neopredeljivo tveganje, ki ga s podatki iz obdobja trženja ni mogoče zanesljivo zaznati, zato odsotnost pomembnih pomislekov ni zadostno zagotovilo o varnosti serij, proizvedenih v družbi PII.
The MHRA issued a corresponding certificate of GMP compliance for the site, limited to medicinal products confirmed by National Competent Authorities as being critical to public health.
Agencija MHRA je izdala ustrezen certifikat o skladnosti z dobro proizvodno prakso za proizvodni obrat družbe, ki pa velja samo za zdravila, za katera so pristojni nacionalni organi potrdili, da so kritičnega pomena za javno zdravje.
Notwithstanding the above, the CHMP takes note of the statement of non-compliance with GMP of PII by the Supervisory Authority which recommends that in Member States where the product is not considered critical to public health, all batches of Ammonaps from Pharmaceutics Internationals Inc. should be recalled and the supply from this manufacturing site prohibited.
Ne glede na zgoraj navedeno CHMP meni, da je treba upoštevati izjavo nadzornega organa o neskladnosti z dobro proizvodno prakso za družbo PII, v kateri se priporoča, da se v državah članicah, v katerih zdravilo ni kritičnega pomena za javno zdravje, vse serije zdravila Ammonaps, proizvedene v družbi Pharmaceutics Internationals Inc., odpokličejo in njihova dobava iz tega proizvodnega obrata prepove.
Dutasteride Actavis (and associated names)
Zdravilo Dutasteride Actavis (in povezana imena)
As a consequence, the CHMP is of the opinion that pursuant to Article 116 of Directive 2001/83/EC, the marketing authorisations of SoliCol D3 should be suspended.
Posledično odbor meni, da je treba v skladu s členom 116 Direktive 2001/83/ES dovoljenja za promet z zdravilom SoliCol D3 začasno umakniti.
• The CHMP noted that there are no batches of Dutasteride Actavis from Pharmaceutics international Inc. on the EU market.
• odbor CHMP ugotavlja, da na trgu EU ni serij zdravila Dutasteride Actavis iz družbe Pharmaceutics International Inc.;
No commercial batches of the product have been manufactured by PII, nor released in the EU market.
Družba PII ni proizvedla nobene komercialne serije zdravila, na trg EU pa tudi ni bila sproščena nobena komercialna serija iz te družbe.
In addition to the above conclusions, the CHMP noted the recommendations from the Supervisory Authority in the statement of non-compliance with GMP of PII that all batches of Lutinus from Pharmaceutics Internationals Inc. should be recalled and the supply from this manufacturing site prohibited.
CHMP meni, da je treba poleg zgornjih ugotovitev upoštevati tudi priporočilo nadzornega organa v izjavi o neskladnosti z dobro proizvodno prakso za družbo PII, da bi bilo treba vse serije zdravila Lutinus, proizvedene v družbi Pharmaceutics Internationals Inc., odpoklicati in prepovedati njihovo dobavo iz tega proizvodnega obrata.
• Lutinus is currently manufactured at an alternative manufacturing site registered in their marketing authorisation;
• Zdravilo Lutinus se trenutno proizvaja v drugem proizvodnem obratu, registriranem v dovoljenju za promet z zdravilom;
• The CHMP considered the GMP compliance certificate for Pharmaceutics International Inc. issued by the MHRA on 15th June 2016 restricted to medicinal products considered critical to public health and valid until 30 June 2017; Ammonaps
• odbor CHMP je obravnaval certifikat o skladnosti z dobro proizvodno prakso za družbo Pharmaceutics International Inc., ki ga je izdala agencija MHRA 15. junija 2016 in je omejen na zdravila, ki so kritičnega pomena za javno zdravje, ter velja do 30. junija 2017.
Ammonaps is a centrally authorised product containing the active substance sodium phenylbutyrate.
Zdravilo Ammonaps, ki je dovoljenje za promet pridobilo po centraliziranem postopku, vsebuje zdravilno učinkovino natrijev fenilbutirat.
Dutasteride (and associated names)
Zdravilo Dutasteride (in povezana imena)
The benefits of Ammonaps in its approved indication of urea cycle disorders are well established.
Koristi zdravila Ammonaps pri odobreni indikaciji motenj v ciklusu sečnine so dobro uveljavljene.
The MAH should provide evidence by 30 June 2017 that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC (as amended) laying down the principles and guidelines of GMP as provided for in Article 8(3) of Directive 2001/83/EC, as this is a condition to the marketing authorisation.
Imetnik dovoljenja za promet z zdravilom mora do 30. junija 2017 predložiti dokaz, da je proizvodni postopek skladen z zahtevami Direktive Komisije 2003/94/ES (kakor je bila spremenjena) o določitvi načel in smernic dobre proizvodne prakse, kot je določeno v členu 8(3) Direktive 2001/83/ES, saj je to pogoj za izdajo dovoljenja za promet z zdravilom.
• Dutasteride Actavis is currently manufactured at an alternative manufacturing site registered in their marketing authorisation;
• Zdravilo Dutasteride Actavis se trenutno proizvaja v drugem proizvodnem obratu, registriranem v dovoljenju za promet z zdravilom;
On 15th June 2016 the MHRA issued a GMP Statement of Non-Compliance (SNC) for PII, recommending a restriction of supply in the EU and the recall of the medicinal products manufactured at this site unless considered critical to public health.
Agencija MHRA je 15. junija 2016 družbi PII izdala izjavo o neskladnosti z dobro proizvodno prakso in v njej priporočila omejitev dobave v EU ter odpoklic zdravil, proizvedenih v obratu družbe, razen v primeru, da so kritičnega pomena za javno zdravje.
• The CHMP considers that at present, the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC are incorrect.
• odbor meni, da so podatki in dokumenti iz člena 8(3) Direktive 2001/83/ES trenutno nepravilni.
• The CHMP considered the Statement of Non-Compliance with GMP for Pharmaceutics International Inc. issued by the MHRA on 15th June 2016 recommending a restriction of supply in the EU and the recall of the medicinal products manufactured at this site unless considered critical to public health;
• odbor CHMP je obravnaval izjavo o neskladnosti z dobro proizvodno prakso za družbo Pharmaceutics International Inc., ki jo je izdala agencija MHRA 15. junija 2016 in s katero je ta priporočila omejitev dobave v EU in odpoklic zdravil, proizvedenih v tem obratu, razen v primeru, da so kritičnega pomena za javno zdravje;
Also, in view of the statement of non-compliance that was issued for Pharmaceutics International Inc. on 15 June 2016, the CHMP considered that the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC are incorrect and that the terms of the marketing authorisation of Lutinus (and associated names) should be varied to remove Pharmaceutics International Inc. as manufacturing site.
Tudi glede na izjavo o neskladnosti, izdano za družbo Pharmaceutics International Inc. dne 15. junija 2016, je odbor CHMP ocenil, da so podatki in dokumenti iz člena 8(3) Direktive 2001/83/ES nepravilni in da je treba pogoje dovoljenja za promet z zdravilom Lutinus (in povezanimi imeni) spremeniti tako, da se družba Pharmaceutics International Inc. kot proizvodni obrat izloči.
As a consequence, the CHMP recommends that the marketing authorisation for Lutinus (and associated names) should be varied to remove Pharmaceutical International Inc. as manufacturing site from their marketing authorisations.
Odbor posledično priporoča, da se dovoljenje za promet z zdravilom Lutinus (in povezanimi imeni) spremeni tako, da se družba Pharmaceutics International Inc. izloči iz dovoljenj za promet z zdravilom kot proizvodni obrat.
• There is no alternative manufacturing site registered in the marketing authorisation of Ammonaps;
• V dovoljenju za promet z zdravilom Ammonaps ni registriran noben drug proizvodni obrat;
As a consequence, the CHMP recommends that the marketing authorisation for Dutasteride Actavis (and associated names) should be varied to remove Pharmaceutical International Inc. as manufacturing site from their marketing authorisations.
Odbor posledično priporoča, da se dovoljenje za promet z zdravilom Dutasteride Actavis (in povezanimi imeni) spremeni tako, da se družba Pharmaceutics International Inc. izloči iz dovoljenj za promet z zdravilom kot proizvodni obrat.
For the suspension of SoliCol D3 to be lifted, the marketing authorisation holder shall provide evidence that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC (as amended) laying down the principles and guidelines of GMP as provided for in Article 8(3) of Directive 2001/83/EC.
Za preklic začasnega umika dovoljenja za promet z zdravilom SoliCol D3 mora imetnik dovoljenja za promet z zdravilom predložiti dokaz, da je proizvodni postopek skladen z zahtevami Direktive Komisije 2003/94/ES (kot je bila spremenjena) o določitvi načel in smernic dobre proizvodne prakse, kot je določeno v členu 8(3) Direktive 2001/83/ES.
In view of the certificate of non-GMP compliance issued for Pharmaceutics International, Inc., the CHMP considered that the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC are incorrect and therefore, pursuant to Article 116 of Directive 2001/83/EC, the marketing authorisations of SoliCol D3 should be suspended.
Glede na izjavo o neskladnosti z dobro proizvodno prakso, izdano za družbo Pharmaceutics International Inc., je odbor CHMP ocenil, da so podatki in dokumenti iz člena 8(3) Direktive 2001/83/ES nepravilni, zato je treba v skladu s členom 116 Direktive 2001/83/ES dovoljenja za promet z zdravilom SoliCol D3 začasno umakniti.
• The CHMP considers that in the absence of GMP compliance of the manufacturing site Pharmaceutics International Inc., the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC for Lutinus are incorrect.
• odbor CHMP meni, da so zaradi neskladnosti proizvodnega obrata družbe Pharmaceutics International Inc. z dobro proizvodno prakso podatki in dokumenti iz člena 8(3) Direktive 2001/83/ES za zdravilo Lutinus nepravilni.
Ammonaps
Zdravilo Ammonaps
For the suspension of SoliCol D3 to be lifted, the marketing authorisation holder(s) shall provide evidence that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC laying down the principles and guidelines of GMP as provided for in Article 8(3) of Directive 2001/83/EC.
Za preklic začasnega umika dovoljenja za promet z zdravilom SoliCol D3 mora imetnik oziroma morajo imetniki dovoljenja za promet z zdravilom predložiti dokaz, da je proizvodni postopek skladen z zahtevami Direktive Komisije 2003/94/ES o določitvi načel in smernic dobre proizvodne prakse, kot je določeno v členu 8(3) Direktive 2001/83/ES.
• The CHMP considers that in the absence of GMP compliance of the manufacturing site Pharmaceutics International Inc., the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC for Dutasteride Actavis are incorrect.
• odbor CHMP meni, da so zaradi neskladnosti proizvodnega obrata družbe Pharmaceutics International Inc. z dobro proizvodno prakso podatki in dokumenti iz člena 8(3) Direktive 2001/83/ES za zdravilo Dutasteride Actavis nepravilni.
• In view of the nature of the disease and the fact that alternatives are not available in all Member States;the CHMP considers Ammonaps critical to public health; The CHMP, as a consequence, considers that the benefit-risk balance of Ammonaps remains favourable for critical use and therefore recommends that the marketing authorisations be varied and subject to the condition that the marketing authorisation holder for Ammonaps provides evidence by 30 June 2017 that the manufacturing process complies with the requirements of Commission Directive
Odbor CHMP posledično meni, da razmerje med tveganji in koristmi zdravila Ammonaps pri kritični uporabi ostaja ugodno, in zato priporoča, da se dovoljenja za promet z zdravilom spremenijo, izpolnjen pa mora biti pogoj, da imetnik dovoljenja za promet z zdravilom Ammonaps do 30. junija 2017 predloži dokaz, da je proizvodni postopek skladen z zahtevami Direktive Komisije 2003/94/ES o določitvi načel in smernic dobre proizvodne prakse, kot je določeno v členu 8(3) Direktive 2001/83/ES.
In view of the statement of non-compliance that was issued for Pharmaceutics International Inc. on 15 June 2016, is the CHMP considered that the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC are incorrect and that the terms of the marketing authorisation of Dutasteride
Glede na izjavo o neskladnosti, izdano za družbo Pharmaceutics International Inc. dne 15. junija 2016, je odbor CHMP ocenil, da so podatki in dokumenti iz člena 8(3) Direktive 2001/83/ES nepravilni in da je treba pogoje dovoljenja za promet z zdravilom Dutasteride Actavis (in povezanimi imeni) spremeniti tako, da se družba Pharmaceutics International Inc. kot proizvodno mesto izloči.
This summary was last updated in April 2016.
Povzetek je bil nazadnje posodobljen aprila-2016.
It works by increasing the levels of certain neurotransmitters, serotonin and noradrenaline, in the central nervous system.
Deluje tako, da poveča ravni nekaterih živčnih prenašalcev, serotonina in noradrenalina, v osrednjem živčnem sistemu.
A neurotransmitter is a substance that relays signals from a nerve cell to another cell.
Živčni prenašalec je snov, ki prenaša signale od ene živčne celice do druge.
The full EPAR for Clomicalm can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Clomicalm je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
If a child accidentally swallows the medicine, this could cause serious reactions.
Če otrok nenamerno zaužije zdravilo, lahko to povzroči hude reakcije.
The European Commission granted a marketing authorisation valid throughout the EU for Clomicalm on 1 April 1998.
Evropska komisija je dovoljenje za promet z zdravilom Clomicalm, veljavno po vsej Evropski uniji, izdala 1. aprila 1998.
This is a summary of the European public assessment report (EPAR) for Clomicalm.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clomicalm.
Clomicalm is available as tablets (5, 20 and 80 mg) and can only be obtained with a prescription.
Zdravilo Clomicalm je na voljo v obliki tablet (5 mg, 20 mg in 80 mg) in se izdaja le na recept.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clomicalm's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Clomicalm večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Since low levels of these neurotransmitters can be linked to depression and anxiety, increasing them can help the dogs feel calmer so improving the behavioural signs in dogs with separation related problems.
Ker so lahko nizke ravni teh živčnih prenašalcev povezane z depresijo in anksioznostjo, lahko njihovo zvišanje psom pomaga, da so mirnejši, in tako izboljša vedenjske znake pri psih s težavami, povezanimi z ločitvijo.
Clomicalm must not be used in dogs with a known hypersensitivity to clomipramine and related medicines (known as tricyclic antidepressants).
Zdravilo Clomicalm se ne sme uporabljati pri psih z znano občutljivostjo za klomipramin in povezana zdravila (znana kot triciklični antidepresivi).
The tablets are given twice a day with or without food and usually 2 - 3 months is sufficient to control the condition although some dogs may need longer treatment.
Ustrezna jakost tablete se določi glede na telesno maso psa. Tablete se dajejo dvakrat na dan s hrano ali brez nje, dva- do trimesečno zdravljenje pa navadno zadostuje za nadzor nad motnjo, čeprav je za nekatere pse potrebno daljše zdravljenje.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (lack of energy) or an elevation in liver enzymes which is reversible when treatment is stopped.
Zelo redko lahko zdravilo Clomicalm povzroči bruhanje, spremembo teka, letargijo (pomanjkanje energije) ali povečanje ravni jetrnih encimov, ki minejo ob prenehanju jemanja zdravila.
Liver effects have been reported particularly in dogs with existing liver problems.
Zabeleženi so bili učinki na jetra, zlasti pri psih z že obstoječimi obolenji jeter.
Vomiting may be reduced by giving the tablets with a small quantity of food.
Bruhanje se lahko omili z dajanjem zdravila skupaj z manjšim obrokom hrane.
It is not intended to provide practical advice on how to use Clomicalm.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Clomicalm is a veterinary medicine used as an aid in the treatment of dogs with behavioural problems when separated from their owners, their home or other dogs.
Zdravilo Clomicalm se uporablja kot pripomoček pri zdravljenju psov z vedenjskimi motnjami ob ločitvi od lastnikov, običajnega doma ali drugih psov.
What are the risks associated with Clomicalm?
Kakšna tveganja so povezana z zdravilom Clomicalm?
What benefits of Clomicalm have been shown in studies?
Kakšne koristi je zdravilo Clomicalm izkazalo v študijah?
What is Clomicalm and what is it used for?
Kaj je zdravilo Clomicalm in za kaj se uporablja?
It contains the active substance clomipramine hydrochloride.
Vsebuje zdravilno učinkovino klomipramin hidroklorid.
Why is Clomicalm approved?
Zakaj je bilo zdravilo Clomicalm odobreno?
Other information about Clomicalm:
Druge informacije o zdravilu Clomicalm
For more information about treatment with Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Clomicalm naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Clomicalm naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
to be effective in reducing behavioural problems in dogs associated with separation anxiety and was more effective than behavioural therapy alone on the basis of a broad spectrum of behavioural signs of anxiety including signs of high attachment to the owner.
Terenske študije, izvedene v ZDA in Evropi, so pokazale, da lahko zdravilo Clomicalm ob uporabi z vedenjsko terapijo učinkovito zmanjša vedenjske motnje pri psih, povezane z ločitveno anksioznostjo, in je bilo učinkovitejše od zdravljenja samo z vedenjsko terapijo pri zdravljenju širokega spektra vedenjskih znakov anksioznosti, vključno z znaki velike navezanosti na lastnika.
How does Clomicalm work?
Kako zdravilo Clomicalm deluje?
Such problems may include destruction of property and inappropriate defaecation and urination in the home. Clomicalm should only be given in combination with behavioural therapy.
Te motnje lahko obsegajo uničevanje lastnine in neprimerno odvajanje blata ali vode doma.
How is Clomicalm used?
Kako se zdravilo Clomicalm uporablja?
Immediate Packaging
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
These local reactions gradually reduce and disappear without need for treatment
Te lokalne reakcije se postopoma zmanjšajo in izginejo ne da bi bilo zdravljenje potrebno.
Very common: a transient temperature increase slightly above 40 ºC might occur between two or three days following vaccination.
Zelo pogosti: prehoden porast telesne temperature rahlo nad 40 ºC lahko nastopi med dvema ali tremi dnevi po cepljenju.
Keep the bottle in the outer carton in order to protect from light.
Stekleničke shranjujte v zunanji ovojnini za zaščito pred svetlobo.
6.2 Major incompatibilities
6.3 Glavne inkompatibilnosti
Duration of immunity: 9 months demonstrated by challenge
Trajanje imunosti: 9 mesecev prikazano s challenge testom
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite stranske učinke, ki niso navedeni v teh navodilih, ali menite, da zdravilo ni učinkovalo, o tem obvestite svojega veterinarja.
Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
Farmakoterapevtska skupina: Inaktivirana virusna cepiva za leporide, inaktivirano virusno cepivo za kunce.
Revaccination: 9 months after vaccination.
Ponovno cepljenje: 9 mesecev po cepljenju.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
Cepljenje zajcev je sprožilo proizvajanje protiteles za inhibicijo hemaglutinacije, ki so učinkovala vsaj 12 mesecev.
- very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Before use allow the vaccine to reach room temperature.
Pred uporabo počakajte, da se temperatura cepiva izenači s sobno temperaturo.