natgillin/translations-raw huggingface dataset:
The recommendation to wash exposed skin immediately was, however, considered a rational and proportionate measure, as was the advice to remove contaminated clothes in the absence of long term exposure studies in humans.
Vendar pa se je priporočilo glede umivanja izpostavljene kože upoštevalo kot racionalen in sorazmeren ukrep, kakor tudi nasvet glede odstranitve kontaminiranih oblek, glede na to, da ni dolgotrajnih študij pri ljudeh.
The CVMP further considered a recommendation to include a suggested antidote (atipamezole) not approved for use in humans, and, while not being in favour of recommending a treatment used only experimentally, concluded that symptoms should be treated symptomatically.
CVMP je poleg tega pretehtal tudi priporočilo o vključitvi predlaganega antidota (atipamezol), ki ni odobren za uporabo pri ljudeh, in ker ni naklonjen priporočanju zdravljenj, uporabljenih le eksperimentalno, zaključil, da je treba simptome zdraviti simptomatsko.
Therefore, the CVMP in the July 2008 plenary meeting agreed on 16 July 2008 to complete the procedure under Article 78 of Directive 2001/82/EC, as amended, for all marketing authorisations held in the EU for the 21 products containing alpha2-adrenoreceptor agonists initially notified and to revise the initial previous opinion accordingly.
Na plenarnem zasedanju v juliju 2008 se je zato CVMP dne 16. julija 2008 strinjal, da bo zaključil postopek skladno s členom 78 Direktive 2001/82/ES, kakor je bila spremenjena, za vsa dovoljenja za promet z zdravilom v EU za 21 zdravil, ki vsebujejo agoniste alfa-2 adrenoreceptorja in so bila prijavljena na začetku, ter da bo skladno s tem pregledal staro začetno mnenje.
AS Laboratórios Pfizer, Lda Lagoas Park, Edifício 10, 2740-271 Porto Salvo, PORTUGAL
AS Laboratórios Pfizer, Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo, PORTUGALSKA
161895/3 of 06.12.2002 (expired)
161895/3 z dne 6. 12. 2002 (zapadlo)
2.2 Skin contact
2.2 Stik s kožo
Having considered all available data, the CVMP concluded that the proposed precautionary measures regarding skin contact seem appropriate.
Po upoštevanju vseh podatkov na voljo je CVMP zaključil, da se zdijo previdnostni ukrepi glede stika s kožo primerni.
The sentence was clearly considered a precautionary measure applicable to all alpha2-adrenoreceptor agonists and therefore not related to one specific product or substance.
Stavek je bil očitno zasnovan kot varnostni ukrep, ki velja za vse agoniste alfa-2 adrenoreceptorja in zato ni povezan z enim določenim zdravilom ali eno snovjo.
Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40 AgualvaCacém, 2735-340 Agualva, Cacém, Lisbon, PORTUGAL
Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40 Agualva-Cacém, 2735-340 Agualva, Cacém, Lisbon, PORTUGALSKA
Remove contaminated clothes that are in direct contact with skin.
slecite onesnaženo obleko, ki je bila v neposrednem stiku s kožo.
The information on the approved United States New Drug Application (NDA) label for Precedex was considered, stating that dexmedetomidine should be used during pregnancy only if the potential benefits justify the potential risk to the foetus.
Odbor je pretehtal podatke na odobreni vlogi za novo zdravilo (NDA) za zdravilo Precedex v Združenih državah, kjer je navedeno, da se lahko dekmedetomidin uporablja med nosečnostjo samo, če morebitne koristi upravičujejo morebitna tveganja za fetus.
ANNEX I COUNTRY, PRODUCT INVENTED NAME, ACTIVE SUBSTANCE MARKETING AUTHORISATION NUMBER, MARKETING AUTHORISATION HOLDER CONCERNED BY THE PROCEDURE
DODATEK I DRŽAVA, IZMIŠLJENO IME ZDRAVILA, ZDRAVILNA UČINKOVINA ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM, IMETNIK DOVOLJENJA ZA PROMET, KI GA ZADEVA POSTOPEK
Wash the exposed skin immediately after exposure with large amounts of water.
Izpostavljeno kožo takoj po izpostavitvi umijte z obilico vode.
The CVMP considered the extrapolation of the proposed warnings to other alpha2-adrenoreceptor agonists justified, as all these substances have the same pharmacological mode of action and since several of the substances have shown similar effects in humans.
CVMP je menil, da je prenos predlaganih opozoril na druge agoniste alfa2-adrenoreceptorja upravičena, ker imajo te snovi enak farmakološki način delovanja in ker je več teh snovi izkazalo podobne učinke pri ljudeh.
The findings were, however, considered sufficient to support a warning against eye exposure and advice on how to act in the case of accidental eye exposure.
Ugotovitve pa so bile kljub temu zadostne za podporo opozorila o izpostavljanju oči in nasvet o primernemu ravnanju v primeru nenamerne izpostavitve oči.
In reference to information on contact hypersensitivity to detomidine and to 10 studies after subcutaneous, intramuscular, or intravenous exposure, the MAH concluded that the risk of sensitisation and contact dermatitis is minimal.
V pogledu informacij o kontaktni preobčutljivosti za detomidin in 10 študij po subkutanem, intramuskularnem ali intravenskemu izpostavljanju je imetnik dovoljenja za promet z zdravilom zaključil, da je tveganje pojava preobčutljivosti in kontaktnega dermatitisa minimalno.
Xylazine induced sedation, muscle relaxation and analgesia after a single intravenous dose of 0.27 or 0.68 mg/kg bw or after a single oral dose of 0.54 mg/kg bw.
Ksilazin je povzročil sedacijo, sproščanje mišic in analgezijo po enem samem intravenskem odmerku od 0,27 do 0,68 mg/kg telesne mase ali po enem samem peroralnem odmerku 0,54 mg/kg telesne mase.
In the absence of sufficient data concerning the human adverse reactions studies the CVMP did not support a recommendation concerning addition of information on irritation, sensitisation, contact dermatitis and systemic effects after skin contact.
Ker ni bilo zadostnih podatkov glede študij neželenih škodljivih učinkov pri ljudeh, CVMP ni podprl priporočila glede dodatnih podatkov o draženju, povečanju občutljivosti, kontaktnem dermatitisu in sistemskih učinkih po stiku s kožo.
Teratogenic effects were, however, not observed following administration of dexmedetomidine at subcutaneous doses up to 200 µg/kg in rats from day 5 to day 16 of gestation and intravenous doses up to 96 µg/kg in rabbits from day 6 to day 18 of gestation.
Teratogenih učinkov pa niso opazili po uporabi deksmedetomidina v subkutanemu odmerku do 200 µg/kg pri podganah od 5. do 16. dne gestacije in intravenskih odmerkih do 96 µg/kg pri zajcih od 6. dne do 18. dne gestacije.
Ventricular arrhythmias have also been reported.
Poročali so tudi o pojavu ventrikularnih aritmij.
The CVMP, having considered the risk to human health, the proposed precautionary measures and information on human adverse reactions in light of the data available, concluded that the following information should be reflected in the product literature of the concerned products within a reasonable timeframe:
CVMP je po upoštevanju tveganj za zdravje človeka, predlaganih previdnostnih ukrepih in podatkih o neželenih učinkih pri ljudeh v pogledu razpoložljivih podatkov zaključil, da mora gradivo o zadevnih zdravilih v primernem časovnem okviru vključevati tudi naslednje informacije:
In the following, each of the proposed precautionary measures and information on human adverse reactions is evaluated separately.
V nadaljevanju se ločeno ovrednoti vsak predlagan varnostni ukrep in informacije o neželenih škodljivih učinkih pri ljudeh.
221972/2 of 23.01.2004 (valid until 23.01.2009)
221972/2 z dne 23. 1. 2004 (veljavno do 23. 1. 2009)
The effect is reflected in the SPC of Sedaxylan, as a warning against the use in late pregnant animals, in particular cows and cats.
Učinek je naveden v povzetku glavnih značilnosti zdravila Sedaxylan kot opozorilo pred uporabo pri samicah v visoki brejosti, še posebej pri kravah in mačkah.
Bayer Portugal, S.A Rua da Quinta do Pinheiro 5, 2794-003 Carnaxide PORTUGAL
Bayer Portugal, S.A Rua da Quinta do Pinheiro 5, 2794-003 Carnaxide, PORTUGALSKA
Following consideration of the data available, the CVMP agreed on the relevance of this precautionary measure, recommending the following:
Po pretehtanju razpoložljivih podatkov se je CVMP strinjal o pomembnosti tega varnostnega ukrepa, ki priporoča naslednje:
Boehringer Ingelheim, Località Prulli 103/c, 50066 Regello, FINLAND
Boehringer Ingelheim Località Prulli 103/c, 50066 Regello, ITALIJA
221972/3 of 23.01.2004 (valid until 23.01.2009)
221972/3 z dne 23. 1. 2004 (veljavno do 23. 1. 2009)
2.3 Eye contact
2.3 Stik z očmi
BOEHRINGER INGELHEIM FRANCE
BOEHRINGER INGELHEIM FRANCIJA
In the rabbit study, detomidine was non-teratogenic and non-foetotoxic up to 2 mg/kg bw.
V študiji pri zajcih detomidin ni bil teratogen ali fetotoksičen v odmerku do 2 mg/kg telesne mase.
The findings were considered relevant for the more normal exposure occurring in a situation where medicine may accidentally splash into the eyes, e.g. when a syringe detaches from the needle.
Ugotovitve so bile pomembne za bolj normalno izpostavitev, do katere pride v situacijah, ko zdravilo po nesreči brizgne v oči, tj. ko se igla loči od injekcijske brizge.
In addition, the SPC for Sedaxylan states that no teratogenic or foetotoxic effects have been shown.
Poleg tega je v povzetku glavnih značilnosti zdravila za Sedaxylan navedeno, da niso opazili nikakršnih teratogenih ali fetotoksičnih učinkov.
Bayer, Viale Certosa 130, 20156 Milano, ITALY
Bayer, Viale Certosa 130,20156 Milano, ITALIJA
In the mutual recognition procedure concerning another product - Sedaxylan - containing an alpha2adrenoceptor agonist, a user safety evaluation was performed.
V postopku vzajemnega priznavanja drugega zdravila, Sedaxylana, ki prav tako vsebuje agonist alfa-2 adrenoreceptorja, so izvedli ocenjevanje varnosti uporabnika.
Virbac S.A., 1ère avenue, 2065 m, L.I.D., 06516 Carros Cedex, FRANCE
Virbac S.A. 1ère avenue - 2065 m - L.I.D., 06516 Carros Cedex, FRANCIJA
44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., GERMANY
44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., NEMČIJA
Química Farmacéutica Bayer
7532 A Química Farmacéutica Bayer
Furthermore, the results of the outcome of a European survey for alpha2-adrenoreceptor agonists were considered.
Nadalje je odbor pretehtal rezultate izida evropske ankete glede agonistov alfa-2 adrenoreceptorja.
Medetomidine, structurally related to detomidine, at an intravenous dose 0.67 µg/kg bw caused hypotension and sedation that lasted for at least 8 hours, as reported in the MRL Summary Report for detomidine.
Medetomidin, ki je strukturno soroden detomidinu, je pri intravenskem odmerku 0,67 µg/kg telesne mase povzročil hipotenzijo in sedacijo, ki sta trajali vsaj 8 ur, kot so poročali v zbirnem poročilu o najvišji dovoljeni količini zaostankov za detomidin.
In reference to the MRL Summary Report for detomidine, the effects of detomidine on pregnant cows seemed less than those described for xylazine, but in horses treated with 20 µg/kg bw, 4 out of 10 pregnancies showed diverse abnormalities with unclear significance.
Kar se tiče zbirnega poročila o najvišji dovoljeni količini zaostankov za detomidin, so se zdeli učinki detomidina na breje krave manj izraženi kot tisti, ki so bili opisani pri uporabi ksilazina, vendar pa je 4 od 10 konj, ki so jih zdravili z 20 µg/kg telesne mase, pokazalo različne abnormalnosti z nejasnim pomenom.
Oral exposure was not reported.
Poročil o peroralni izpostavitvi ni bilo.
Aesculaap BV, Mijlstraat 35, 5281 LJ Boxtel, THE NETHERLANDS
Aesculaap BV, Mijlstraat 35, 5281 LJ Boxtel, NIZOZEMSKA
Animal Health Division, Bayer House, Strawberry Hill Newbury, Berkshire RG14 1JA, UNITED KINGDOM
Animal Health Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, ZDRUŽENO KRALJESTVO
An oxytocin-like effect of xylazine on the uterus is well-known.
Učinek ksilazina na maternico, ki je podoben učinku oksitocina, je dobro znan.
Farma BV, Willeskop 206a, 4321 GW Oudewater, THE NETHERLANDS
Farma BV, Willeskop 206a, 4321 GW Oudewater, NIZOZEMSKA
The pharmacovigilance data evaluated by the Dutch competent regulatory authority that resulted in its intention to vary the authorisations is a published suspected adverse reaction (SAR) in a human being, reporting cardiovascular and central nervous system effects over a period of 3 days after accidental selfinjection of Sedivet (Reference: Hoyer, Mark J. Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie.
Farmakovigilančni podatek, ki ga je ovrednotil nizozemski pristojni regulatorni organ, zaradi česar je nato želel spremeniti dovoljenja, je bil objavljen sum na neželene učinke pri ljudeh, ki so poročali o učinkih v krvožilnem in osrednjem živčnem sistemu v obdobju treh dni po nenamernem samoinjiciranju zdravila Sedivet (Referenca: Hoyer, Mark J. Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie.
In conclusion, the precautionary measures should be reflected in the product literature of the concerned veterinary medicinal products containing alpha2-adrenoreceptor agonists.
Previdnostni ukrepi se morajo odražati v literaturi o zadevnih veterinarskih zdravilih, ki vsebujejo agoniste alfa-2 adrenoreceptorjev.
Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, THE NETHERLANDS
Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, NIZOZEMSKA
In general, it was concluded that xylazine hydrochloride is moderately irritating to the human skin after prolonged exposure although no reports on skin irritation were, however, available nor were reports on sensitisation of xylazine.
Splošna ugotovitev je bila, da je ksilazin hidroklorid zmerno dražeč za človeško kožo po dolgotrajnejši izpostavitvi, čeprav ni bilo poročil o draženju kože, pa tudi ni bilo poročil o pojavu preobčutljivosti na ksilazin.
Furthermore, the CVMP recommends inclusion of the agreed statements on precautionary measures for alpha2-adrenoreceptor agonists in the relevant guideline on Summary of Product Characteristics, to be implemented in accordance with the national regulatory framework.
CVMP poleg tega priporoča vključitev stavkov glede previdnostnih ukrepov pri agonistih alfa-2 adrenoreceptorjev, o katerih so prišli do soglasja, v povzetek glavnih značilnosti zdravila, kar se izvede skladno z nacionalnim regulativnim okvirom.
323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIA
323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIJA
In another reproductive study when dexmedetomidine was administered subcutaneously to pregnant rats from gestation day 16 through nursing, it caused lower pup weights at 8 and 32 µg/kg as well as foetal and embryocidal toxicity of second generation offspring at a dose of 32 µg/kg.
V drugi reproduktivni študiji so brejim podganam subkutano dajali deksmedetomidin od 16. dne do konca dojenja, kjer je zdravilo povzročilo manjše mase mladičev od 8 do 32 µg/kg ter tudi fetalno in embrionalno toksičnost mladičev druge generacije pri odmerku 32 µg/kg.
The MAHs were invited to comment and justify any counterproposals by 16 October 2006.
Odbor je imetnike dovoljenj za promet z zdravilom povabil, naj oddajo pripombe in utemeljijo morebitne protipredloge do 16. oktobra 2006.
Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, UNITED KINGDOM
Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, ZDRUŽENO KRALJESTVO
Finally, having considered the urgency of the matter, the CVMP concluded that since products containing alpha2-adrenoreceptor agonists have been on the market for a long time, although these new statements are clearly needed, urgent measures were not considered proportional.
Na koncu je CVMP glede nujnosti zadeve zaključil, da čeprav so ti novi stavki očitno potrebni, glede na dolgotrajno prisotnost zdravil z agonisti alfa-2 adrenoreceptorja na trgu, urgentni ukrepi niso sorazmerni.
Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, THE NETHERLANDS
Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, NIZOZEMSKA
In the MRL Summary Report for detomidine, two oral teratology studies were reported (rat and rabbit).
V zbirnem poročilu o najvišji dovoljeni količini zaostankov za detomidin so poročali o dveh študijah peroralne teratologije (podgana in zajec).
The CVMP considered published data on the effects of xylazine hydrochloride on intrauterine pressure in the cow, the oxytocic effect of xylazine on the canine uterus, effects of detomidine, romifidine and xylazine on intrauterine pressure and sedation in horses, and the effects of xylazine on intrauterine pressure, uterine blood flow, maternal and foetal cardiovascular and pulmonary function in pregnant goats.
CVMP je pretehtal objavljene podatke o učinkih ksilazin hidroklorida na intrauterini tlak pri kravah, na oksitocinski učinek ksilazina na maternico psic, učinke detomidina, romifidina in ksilazina na tlak v maternici in sedacijo konj ter učinke ksilazina na intramaternični tlak, maternični krvni pretok ter kardiovaskularno in pljučno funkcijo fetusa pri brejih kozah.
Bayer BV Animal Health, Postbus 80, 3640 AB Mijdrecht, THE NETHERLANDS
Bayer BV Animal Health, Postbus 80, 3640 AB Mijdrecht, NIZOZEMSKA
PFIZER GLOBAL MANUFACTURING, Rue Laid Burniat 1, 1348 Louvain La Nueve, BELGIUM (Variation IA,1 - pending Pfizer Animal Health MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ UNITED KINGDOM)
PFIZER GLOBAL MANUFACTURING, Rue Laid Burniat 1, 1348 Louvain La Nueve, BELGIUM (Sprememba IA,1 - v postopku Pfizer Animal Health MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ ZDRUŽENO KRALJESTVO)
The CVMP considered publicly available data on systemic toxicity after ocular exposure to xylazine hydrochloride in a human; corneal toxicity of xylazine and clonidine, in combination with ketamine, in the rat; and acute reversible cataract induced by xylazine and by ketamine-xylazine anesthesia in rats and mice.
CVMP je pretehtal javno razpoložljive podatke o sistemski toksičnosti po izpostavitvi človeških oči ksilazin hidrokloridu; kornealni toksičnosti ksilazina in klonidina v kombinaciji s ketaminom pri podganah; in akutni reverzibilni katarakti, ki jo sprožita ksilazin in anestezija s ketamin ksilazinom pri podganah in miših.
Pfizer Co. Ltd., 1123 Budapest, Alkotás u. 53, HUNGARY
Pfizer Co. Ltd., 1123 Budapest Alkotás u. 53, MADŽARSKA
The CVMP considered information provided by one MAH concerning the product's characteristics in relation to sensitisation and contact dermatitis.
CVMP je pretehtal informacije, ki jih je priskrbel eden od imetnikov dovoljenja za promet z zdravilom glede lastnosti zdravila v povezavi s povečanjem občutljivosti in kontaktnim dermatitisom.
The MRL Summary Report for detomidine does not mention this item.
Zbirno poročilo o najvišji dovoljeni količini zaostankov za detomidin te točke ne omenja.
Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, THE NETHERLANDS
Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, NIZOZEMSKA
Avoid skin, eye or mucosal contact.
Izogibajte se stiku s kožo, očmi ali sluznico.
Although the exact accidental injected exposure (dose) of the reported human adverse reaction (Hoyer, M.J., 2006) was unknown, it was concluded that the observed clinical effects - on day 1 being loss of consciousness (arousable), hallucinations, low heart rate and low blood pressure, vasoconstriction, and vasodilation; and on day 2 drowsiness, mild headache, loss of memory and tiredness - can be attributable to the product (Sedivet).
Čeprav v primeru nenamernega vbrizganja pri ljudeh (Hoyer, M.J., 2006), ko so poročali o pojavu neželenih škodljivih učinkov, izpostavitev (odmerek) ni bila natančno znana, so zaključili, da lahko opažene klinične učinke - na 1. dan vključujejo izgubo zavesti (razburljivost), halucinacije, nizek srčni utrip in nizek krvni tlak, vazokonstrikcijo in vazodilatacijo; na 2. dan so neželeni učinki vključevali zaspanost, blag glavobol, izgubo spomina in utrujenost - pripišemo zdravilu (Sedivet).
Boehringer Ingelheim, Postbus 8037, 1802 KA Alkmaar, THE NETHERLANDS
Boehringer Ingelheim, Postbus 8037, 1802 KA Alkmaar, NIZOZEMSKA
Bayer Hungária Ltd., 1123 Budapest, Alkotás u. 50, HUNGARY
Bayer Hungária Ltd., 1123 Budapest Alkotás u. 50, MADŽARSKA
Globalmed Ltd, Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, UNITED KINGDOM
Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, ZDRUŽENO KRALJESTVO
The CVMP agreed on 14 September 2006 to communicate the proposed precautionary measures and information on human adverse reactions to the concerned Marketing Authorisation Holders (MAHs).
CVMP se je dne 14. septembra 20006 strinjal, da zadevnim imetnikom dovoljenja za promet z zdravilom sporoči predloge previdnostnih ukrepov in informacije o neželenih učinkih pri ljudeh.
0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIUM
0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIJA
In the rat study, a NOEL of 0.1 mg/kg bw/day was based on foetal and maternal toxicity and teratogenicity.
Pri podganah je bila raven NOEL 0,1 mg/kg telesne mase/dan na temelju toksičnosti in teratogenosti pri fetusu in materah.
The CVMP considered that the proposed advice to doctors lists the most common pharmacological effects of alpha2-adrenoreceptor agonists, as could also be extracted from the MRL Summary Reports cited under section 2.1.
CVMP je upošteval, da predlagani nasvet za zdravnike navaja najbolj pogoste farmakološke učinke agonistov alfa-2 adrenoreceptorja, kakor jih je mogoče izluščiti tudi iz poglavja 2.1 zbirnega poročila o najvišji dovoljeni količini zaostankov.
Orion Corporation, Box 65, 02101 Esbo, FINLAND
Orion Corporation, Box 65, 02101 Esbo, FINSKA
Therefore, the CVMP concluded upon the following recommendation:
Zaradi tega je CVMP zaključil z naslednjim priporočilom:
Pfizer Animal Health BV, Postbus 37, 2900 AA Capell a/d Ijssel, THE NETHERLANDS
Pfizer Animal Health BV, Postbus 37, 2900 AA Capell a/d Ijssel, NIZOZEMSKA
The MAHs were invited to comment and submit any counterproposals by 16 September 2008.
Odbor je imetnike dovoljenj za promet z zdravilom povabil, naj oddajo pripombe in morebitne protipredloge do 16. septembra 2008.
In addition, any proprietary data submitted by MAHs was evaluated in support of the products investigated in those studies.
Poleg tega so bili v teh študijah pretehtani vsi lastniški podatki, ki so jih vložili imetniki dovoljenj za promet z zdravilom.
In the SPC for the medicinal product, Catapresin, it is stated that the active substance passes the bloodplacenta barrier.
V povzetku glavnih značilnosti zdravila za zdravilo Catapresin je navedeno, da zdravilna učinkovina prehaja krvno maternično pregrado.
In the MRL Summary Reports for xylazine and romifidine, it is stated that the compounds have not been tested for skin sensitising potential.
V zbirnih poročilih o najvišji dovoljeni količini zaostankov za ksilazin in romifidin je navedeno, da pri spojinah niso testirali morebitnega potenciala za povečanje preobčutljivosti kože.
In the Summary of Product Characteristics (SPC) for a medicinal product for use in humans, Catapresan, containing the alpha2-adrenoreceptor agonist clonidine (injectable and tablets), the dermal adverse reactions after an unknown route of exposure are listed as skin-rash, urticaria, pruritus, and hairloss with an incidence rate of 1/100 - 1/10000 in patients.
V povzetku glavnih značilnosti zdravila za zdravilo za uporabo v humani medicini, Catapresan, ki vsebuje agonist alfa-2 adrenoreceptorja klonidin (v obliki za injiciranje in v obliki tablet), so navedene neželene kožne reakcije, kot so kožni izpuščaj, urtikarija, pruritus in izguba las v deležu pogostnosti 1/100-1/10.000 pri bolnikih, pot izpostavitve pa ni bila znana.
The CVMP further considered proprietary data provided by another MAH concerning three of the products.
CVMP je poleg tega pretehtal lastniške podatke, ki jih je priskrbel drugi imetnik dovoljenja za promet z zdravilom za tri zdravila.
The CVMP further considered the published Maximum Residue Limit (MRL) Summary Reports for xylazine, detomidine and romifidine.
CVMP je upošteval tudi izdana zbirna poročila o najvišji dovoljeni količini zaostankov za ksilazin, detomidin in romifidin.