natgillin/translations-raw huggingface dataset:
What TachoSil contains
Kaj vsebuje zdravilo TachoSil
The yellow, active side of the matrix is applied to the bleeding/leaking surface and held against it with a gentle pressure for 3-5 minutes.
Rumeno, učinkovito stran matriksa namestite na krvavečo/prepuščajočo površino in nato nanjo nežno pritiskajte od 3 do 5 minut.
• to use TachoSil immediately after opening the inner sterile package.
• da se zdravilo TachoSil uporabi takoj po odprtju stične sterilne ovojnine.
This procedure enables an easy adhesion of TachoSil to the wound surface.
Na ta način se zdravilo TachoSil zlahka sprime s površino rane.
The quantity of TachoSil to be applied is governed by the size of the wound area.
Uporabljena količina zdravila TachoSil je odvisna od velikosti poškodovane površine.
TachoSil can be cut to the correct size and shaped if too large.
Če je zdravilo TachoSil preveliko, ga lahko obrežete in oblikujete na ustrezno velikost.
TachoSil sealant matrix.
TachoSil matriks z lepilom za tkiva
To avoid TachoSil from being pulled loose it may be held in place at one end, e.g. with a pair of forceps.
Da zdravila TachoSil ne potegnete z rane, ga lahko na enem koncu fiksirate na mestu, npr. s prijemalko.
The efficacy of TachoSil was tested in a randomised controlled study in 726 patients (362 treated with TachoSil and 364 controls) undergoing skull base surgery as an adjunct to suture for sealing the dura mater, in which the efficacy outcome was measured post-operatively as verified cerebrospinal fluid (CSF) leaks or pseudomeningocoele, or treatment failure during surgery.
Učinkovitost zdravila TachoSil kot dodatka k šivom za tesnjenje dure mater so raziskali v randomizirani nadzorovani študiji pri 726 bolnikih (362 bolnikov v skupini z zdravilom TachoSil, 364 bolnikov v kontrolni skupini), pri katerih je bila opravljena operacija na lobanjskem dnu.
TachoSil sealant matrix human fibrinogen/human thrombin
TachoSil matriks z lepilom za tkiva humani fibrinogen/humani trombin
TachoSil is used under sterile conditions.
Zdravilo TachoSil morate uporabljati v sterilnih pogojih.
You should contact your doctor immediately if you discover any of these symptoms.
V primeru pojava katerega koli od teh simptomov, se nemudoma posvetujte z zdravnikom.
The product is available in different sizes and comes in packages with up to 5 units: Package with 1 matrix of 9.5 cm x 4.8 cm Package with 2 matrices of 4.8 cm x 4.8 cm Package with 1 matrix of 3.0 cm x 2.5 cm Package with 5 matrices of 3.0 cm x 2.5 cm Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Zdravilo je na voljo v različnih velikostih in pakiranjih, ki vsebujejo do največ 5 enot: Pakiranje z 1 matriksom velikosti 9,5 cm x 4,8 cm Pakiranje z 2 matriksoma velikosti 4,8 cm x 4,8 cm Pakiranje z 1 matriksom velikosti 3,0 cm x 2,5 cm Pakiranje s 5 matriksi velikosti 3,0 cm x 2,5 cm Pakiranje z 1 matriksom v že pripravljenem zvitku velikosti 4,8 cm x 4,8 cm
1 matrix of 3.0 cm x 2.5 cm
1 matriks velikosti 3,0 cm x 2,5 cm
How to store TachoSil
Shranjevanje zdravila TachoSil
9 DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije lepljenje
8 MARKETING AUTHORISATION NUMBER
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
It is possible that you could suffer an allergic reaction after TachoSil has been applied.
Po uporabi zdravila TachoSil se lahko pojavi alergijska reakcija.
There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies.
Razvoj protiteles proti humanemu fibrinogenu ali konjskemu kolagenu ni bil povezan s pojavom neželenih učinkov.
1 matrix of 9.5 cm x 4.8 cm 2 matrices of 4.8 cm x 4.8 cm 1 matrix of 3.0 cm x 2.5 cm 5 matrices of 3.0 cm x 2.5 cm 1 pre-rolled matrix of 4.8 cm x 4.8 cm
1 matriks velikosti 9,5 cm x 4,8 cm 2 matriksa velikosti 4,8 cm x 4,8 cm 1 matriks velikosti 3,0 cm x 2,5 cm 5 matriksov velikosti 3,0 cm x 2,5 cm 1 matriks v že pripravljenem zvitku velikosti 4,8 cm x 4,8 cm
The un-rolled TachoSil should then be moistened at the site of application with a moist pad and held in place under gentle pressure for 3-5 minutes.
Odvito zdravilo TachoSil morate nato na mestu namestitve navlažiti z vlažno blazinico in držati na mestu z nežnim pritiskom od 3 do 5 minut.
• to have a non-sterile person open the outer aluminium cover
• da zunanjo aluminijasto ovojnino odpre nesterilna oseba.
The outer aluminium foil sachet may be opened in a non-sterile operating area.
Zunanjo vrečico iz aluminijaste folije lahko odprete v nesterilnih pogojih, stični sterilni pretisni omot pa lahko odprete izključno v sterilnih pogojih operacijske dvorane.
Life threatening thromboembolic complications may occur if the preparation is applied intravascularly.
Če se zdravilo uporabi intravaskularno, se lahko pojavijo življenjsko nevarni trombembolični zapleti.
Vascular disorders
Žilne bolezni tromboza
TachoSil can be cut to the appropriate size and shaped to fit the wound.
Če je zdravilo TachoSil preveliko, ga lahko obrežete in oblikujete, da se prilega rani.
The pre-rolled TachoSil should not be pre-moistened before passing through the trocar or port.
Zdravila TachoSil v obliki že pripravljenega zvitka pred nameščanjem preko trokarja ali odprtine ne smete navlažiti.
The following adverse reactions have been reported with TachoSil during post marketing experience.
V nadaljevanju so navedeni neželeni učinki, o katerih so poročali med uporabo zdravila TachoSil po pridobitvi dovoljenja za promet.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Uvedeni ukrepi veljajo za učinkovite proti virusom z ovojnico kot so HIV, HBV in HCV ter proti virusu brez ovojnice HAV. Ti ukrepi pa imajo lahko le omejeno vrednost proti virusom brez ovojnice, kot je parvovirus B19.
1 matrix of 4.8 cm x 4.8 cm
1 matriks velikosti 4,8 cm x 4,8 cm
• to have a sterile person open the inner sterile package
• da stično sterilno ovojnino odpre sterilna oseba.
Package with 1 matrix of 9.5 cm x 4.8 cm Package with 2 matrices of 4.8 cm x 4.8 cm Package with 1 matrix of 3.0 cm x 2.5 cm Package with 5 matrices of 3.0 cm x 2.5 cm Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Pakiranje z 1 matriksom velikosti 9,5 cm x 4,8 cm Pakiranje z 2 matriksoma velikosti 4,8 cm x 4,8 cm Pakiranje z 1 matriksom velikosti 3,0 cm x 2,5 cm Pakiranje s 5 matriksi velikosti 3,0 cm x 2,5 cm Pakiranje z 1 matriksom v že pripravljenem zvitku velikosti 4,8 cm x 4,8 cm
TachoSil should be used immediately after opening the inner sterile cover.
Zdravilo TachoSil morate uporabiti takoj po odprtju stične sterilne ovojnine.
Application of TachoSil must be individualised by the treating surgeon.
Kirurg mora uporabo zdravila TachoSil prilagoditi posameznemu bolniku.
Pre-rolled TachoSil can be used for both open surgery and in minimally invasive surgery, and it can pass through a 10 mm or larger port or trocar.
Zdravilo TachoSil v obliki že pripravljenega zvitka lahko uporabite tako pri odprtih operacijah kot minimalno invazivnih kirurških posegih.
TachoSil contains per cm Human Fibrinogen 5.5 mg Human Thrombin 2.0 IU For a full list of excipients, see section 6.1.
Zdravilo TachoSil na cm vsebuje: humani fibrinogen 5,5 mg humani trombin 2,0 i.e.
1 matrix of 9.5 cm x 4.8 cm
1 matriks velikosti 9,5 cm x 4,8 cm
But please note that the matrix should cover 1-2 cm beyond the margins of the wound.
Velikost potrebnega matriksa z lepilom za tkiva je odvisna od velikosti rane, vendar pa upoštevajte, da mora matriks segati od 1 do 2 cm preko robov rane.
POLYETHYLENE TEREPHTHALATE BLISTER
PRETISNI OMOT IZ POLIETILEN TEREFTALEATA
CARTON
Imunogenost
Sealant matrix
Matriks z lepilom za tkiva
Once the foil sachet is opened, use immediately.
Uporabite takoj po odprtju folijske vrečice.
Once the foil sachet is opened, TachoSil must be used immediately.
3 leta Zdravilo TachoSil je treba uporabiti takoj po odprtju folijske vrečice.
1 pre-rolled matrix of 4.8 cm x 4.8 cm
1 matriks v že pripravljenem zvitku velikosti 4,8 cm x 4,8 cm
It is recommended to remove the top part of the trocar prior to passing the pre-rolled TachoSil through the trocar.
Pred potiskom zdravila TachoSil v obliki že pripravljenega zvitka skozi trokar je priporočljivo odstraniti zgornji del trokarja.
Blood clots may occur if TachoSil is unintentionally applied inside a blood vessel.
V primeru nenamernega vnosa zdravila TachoSil v žilo se lahko pojavijo krvni strdki.
18 October 2013
18. oktober 2013
The final opinion was converted into a Decision by the European Commission on 18 October 2013.
Končno mnenje je bilo 18. oktobra 2013 spremenjeno v sklep Evropske komisije.
The Committee appointed Dr C. Ibrahim as rapporteur and Dr D. Murphy as co-rapporteur.
Odbor je imenoval dr. C. Ibrahima za poročevalca in dr. D. Murphyja za soporočevalca.
International non-proprietary name (INN): dexamethasone
Mednarodno nelastniško ime (INN): deksametazon
The referral started on 12 September 2012.
Napotitveni postopek se je začel 12. septembra 2012.
Written explanations were provided by the marketing authorisation holders on 10 December 2012and 21 May 2013.
Imetniki dovoljenja za promet z zdravilom so 10. decembra 2012 in 21. maja 2013 predložili pisna pojasnila.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Seznam zadevnih imen zdravila je naveden v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Prilogi III.
Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods.
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da je splošno razmerje med tveganji in koristmi za ta zdravila še vedno pozitivno, če se upoštevajo spremembe informacij o zdravilu, ki se nanašajo na uskladitev karenc.
Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, antiallergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Deksametazon je dolgo delujoči sintetični glukokortikoid, ki se uporablja proti vnetjem, alergijam in kot glukoneogena učinkovina za dajanje rejnim in domačim živalim.
The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products thereof are solutions for injection which contain 2 mg dexamethasone per ml.
Zdravilo za uporabo v veterinarski medicini Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila so raztopine za injiciranje, ki vsebujejo 2 mg deksametazona na militer.
On 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Dexadreson 2 mg/ml and associated names, and generic products thereof.
Nemčija je 22. avgusta 2012 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2011/82/ES za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila.
Therefore, the Committee adopted a positive opinion on 18 July 2013, recommending variations to the terms of the marketing authorisations for Dexadreson 2 mg/ml and its associated names and generic products thereof.
Zato je 18. julija 2013 sprejel pozitivno mnenje, vendar hkrati priporočil spremembo pogojev dovoljenj za promet z zdravilom Dexadreson 2 mg/ml in povezanimi imeni ter njegovimi generičnimi zdravili.
The CVMP was requested to evaluate the adequacy and consumer safety of the withdrawal periods for meat in cattle and horses and the withdrawal periods for milk in cattle for the concerned products.
CVMP so zaprosili, da oceni, ali so karence za goveje in konjsko meso ter karence za mleko govedi, določene za zadevna zdravila, zadostne in varne za potrošnike.
Opinion following an Article 350F referral for Dexadreson 2 mg/ml and associated names, and generic products thereof
Mnenje v zvezi z napotitvijo v skladu s členom 350F za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila
Opinion following an Article 351 referral for Dexadreson 2 mg/ml and associated names, and generic products thereof
za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila
United Kingdom Virbac S.A. 1ere avenue 2065 m L.I.D.
Združeno kraljestvo Virbac S.A. 1ere avenue 2065 m L.I.D.
During the mutual recognition procedure concerns were raised that Shotaflor 300 mg/ml solution for injection for cattle may present a potential serious risk to the environment.
Med postopkom z medsebojnim priznavanjem so se pojavili zadržki, da lahko zdravilo Shotaflor 300 mg/ml raztopina za injiciranje za uporabo pri govedu pomeni možno resno tveganje za okolje.
Because Shotaflor 300 mg/ml solution for injection for cattle is indicated for treatment only (i.e. it is indicated only for use in clinically ill animals not for preventative use) it was considered that, in this case, it was appropriate to use the disease incidence within the herd as the proportion of animals treated.
Ker je zdravilo Shotaflor 300 mg/ml raztopina za injiciranje za govedo indicirano le za zdravljenje (tj. indicirano je le za uporabo pri klinično bolnih živalih in ne za preventivno uporabo), se je ugotovilo, da je v tem primeru primerno uporabiti pojavnost bolezni znotraj črede kot delež živali, ki so zdravljene.
Svensson C., Hultgren J. and Oltenacu P. (2006) Morbidity in 3-7 month old dairy calves in south-western Sweden, and risk factors for diarrhoea and respiratory disease.
4 Svensson C., Hultgren J. in Oltenacu P. (2006) Morbidity in 3-7 month old dairy calves in south-western Sweden, and risk factors for diarrhoea and respiratory disease.
Shotaflor contains florfenicol, which is a broad-spectrum primarily bacteriostatic, antibiotic with a range of activity, including many Gram-negative and Gram-positive organisms.
Zdravilo Shotaflor vsebuje florfenikol, ki je širokospektralni, primarno bakteriostatični antibiotik s širokim spektrom delovanja, vključno z mnogimi gramnegativnimi in grampozitivnimi organizmi.
= Housing factor either 1 for animals housed throughout the year or 0.5 for animals housed for only 6 months (see Table 3 of the guideline.)
= Koeficient nastanitve je 1 za živali, ki so nastanjene celo leto, ali 0,5 za živali, ki so nastanjene le po 6 mesecev (glejte razpredelnico 3 v smernici) = Faktor menjave [1000 μg.mg-1]
• Commercial farms (several breeds and age): France - 15.7%, Germany - 20.3%, Italy - 15.2%,
• Komercialne kmetije (več pasem in starosti): Francija - 15,7 %, Nemčija - 20,3 %, Italija
3 Martin G., Partida E., Villalobos P., López C., López-Guerrero C. and Blanco A. (2007) Evaluation of Mass and Selective Metaphylaxis Medication with Florfenicol at Feedlot entry as a tool against Bovine Respiratory Disease Under Commercial Conditions in Spain.
3 Martin G., Partida E., Villalobos P., López C., López-Guerrero C. in Blanco A. (2007) Evaluation of Mass and Selective Metaphylaxis Medication with Florfenicol at Feedlot entry as a tool against Bovine Respiratory Disease Under Commercial Conditions in Spain.
The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC), provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Dokumentacija, predložena v napotitvenem postopku, izpolnjuje potrebne zahteve glede ocene tveganja za okolje (kot je določeno v členu 12(3)(j) Direktive 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/ES), ob upoštevanju, da se zdravilo uporablja le za terapevtsko zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
Spain - 17.1% (Godinho et al, 20055).
15,2 %, Španija - 17,1 % (Godinho et al, 20055).
However, given that the CVMP considers that no Phase II environmental risk assessment is required for this application (because the calculated PECsoil values are below the trigger value), the manure degradation study is not pivotal to the environmental risk assessment.
faza ocene tveganja za okolje ni potrebna za to vlogo (saj so vrednosti izračunanih PKOtla nižje od sprožitvene vrednosti), pa študija razkroja v gnoju ni ključna za oceno tveganja za okolje.
place-1.y-1] (see Table 3 of the guideline.)
mesto-1.leto-1] (glejte razpredelnico 3 v smernici)
The CVMP concluded that adequate evidence had been provided to demonstrate that the proportion of treated animals in a herd would not be higher than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and that the data justified the use of this figure of 38% as the value for the proportion of treated animals in a herd, for use in calculating the PECsoil.
CVMP je zaključil, da so predloženi zadostni dokazi, da delež zdravljenih živali v čredi ne bo višji od 38 % za zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni, in da podatki upravičujejo uporabo vrednosti 38 % kot deleža zdravljenih živali v čredi za izračun PKOtla.
The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1)).
Imetnik dovoljenja za promet z zdravilom je predložil podatke, da bi dokazal, da je odstotek črednih živali, ki jih bodo zdravili zaradi respiratorne bolezni goveda, manjši od privzete vrednosti 50 %, ki je navedena v zgoraj omenjenih smernici CVMP (EMEA/CVMP/ERA/418282/2005-Rev.1).
5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. and Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle.
74:162-179 5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. in Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle.
When such specific information is not available then the default values given in Table 2 of the CVMP guideline in support of VICH guidelines (Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005Rev.1 - also known as the Technical Guidance Document - TGD) should be used.
Kadar tovrstne specifične informacije niso na voljo, je treba uporabiti privzete vrednosti, navedene v razpredelnici 2 smernice CVMP v podporo smernicama VICH (Smernica o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1 - prav tako znane kot dokumenti tehničnih smernic (TGD)).
In particular, concerns were raised over the adequacy of the data provided by the Marketing Authorisation Holder on the incidence of bovine respiratory disease (BRD) within an infected herd and as a consequence objections were raised over the proposal to deviate from the default value of 50% specified in CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - (EMEA/CVMP/ERA/418282/2005-Rev.1) as the value for the proportion of infected animals for use in calculation of the Predicted Environmental Concentration in soil (PECsoil).
Zadržki so se pojavili zlasti glede primernosti podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom o pojavnosti respiratorne bolezni goveda v okuženi čredi, posledično pa so se pojavili ugovori na predlog odklona od privzete vrednosti 50 %, ki je določena v smernici CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) kot vrednost za delež okuženih živali, ki se uporabi za izračun predvidene okoljske koncentracije v tleh (PKOtla).
= Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline.)
= Delež zdravljene črede [vrednost med 0 in 1] (glejte razpredelnico 2 v smernici) = Specifična masa suhe prsti [kg.m-3]
6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S. (2008) Field
6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. in Cavirani S. (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
= Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline.)
= Menjava živali na mesto in leto [mesto-1.leto-1] (glejte razpredelnico 3 v smernici) = Meja širjenja dušika v EU [kg N.ha-1]
This summary was last updated in 11-2008.
Povzetek je bil nazadnje posodobljen 11-2008.
The maximum daily dose is 1.1 mg three times per day.
Največji dovoljeni dnevni odmerek je 1,1 mg trikrat na dan.
It is available as white, round tablets (0.088, 0.18, 0.35 and 0.7 mg).
Na voljo je v belih, okroglih tabletah (0,088, 0,18. 0,35 in 0,7 mg).
Pramipexole Teva tablets should be swallowed with water, with or without food.
Tablete Pramipexole Teva je treba pogoltniti z vodo, skupaj s hrano ali brez nje.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRAMIPEXOLE TEVA EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PRAMIPEXOLE TEVA Povzetek EPAR za javnost
Other information about Pramipexole Teva:
Druge informacije o zdravilu Pramipexole Teva:
Pramipexole Teva must be given less frequently in patients who have problems with their kidneys.
Zdravilo Pramipexole Teva je treba bolnikom, ki imajo težave z ledvicami, dajati manj pogosto.
This means that Pramipexole Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sifrol.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Sifrol.
The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B.V. on 18 December 2008.
Evropska komisija je dovoljenje za promet z zdravilom Pramipexole Teva, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma BV dne 18. decembra 2008.
Pramipexole Teva can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective.
Zdravilo Pramipexole Teva se lahko uporablja bodisi samostojno bodisi v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v katerem koli stadiju bolezni, vključno s poznim stadijem, ko začne učinek levodope popuščati.
In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Pri bolnikih s Parkinsonovo boleznijo pričnejo celice, ki proizvajajo dopamin, odmirati, zato se količina dopamina v možganih zmanjša.
The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Začetni odmerek je 0,088 mg trikrat na dan. Odmerek je treba povečevati vsakih pet do sedem dni, dokler simptomi niso pod nadzorom, ne da bi povzročili nevzdržne neželene učinke.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Pramipexole Teva primerljivo raven kakovosti kot zdravilo Sifrol ter mu je biološko enakovredno.