natgillin/translations-raw huggingface dataset:
Staphylococci (including -lactamase producing strains) Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis) Arcanobacteria (including A. pyogenes)
Kombinacija amoksicilina in klavulanske kisline deluje in vitro proti širokemu spektru klinično pomembnih bakterij, vključno z naslednjimi običajnimi povzročitelji mastitisa pri govedu: stafilokoki (vključno s sevi, ki proizvajajo β-laktamazo), streptokoki (vključno s S. agalactiae, S. dysgalactiae in S. uberis), Arcanobacteria (vključno z A. pyogenes)
- 2nd injection: after 3-4 weeks.
- Drugi odmerek: po 3-4 tednih.
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila ovirala izvajanje nacionalnega programa za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, država članica v skladu z nacionalno zakonodajo prepove ali lahko prepove proizvodnjo, uvoz, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Združeno kraljestvo
The import, sale, supply and/or use of BTVPUR AlSap 8 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ali uporaba BTVPUR AlSap 8 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/or use BTVPUR AlSap 8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati BTVPUR AlSap 8, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred vnosom/uvozom, prodajo, oskrbo in/ali uporabo.
Each dose of 1 ml of vaccine contains:
Vsak odmerek (1 ml) cepiva vsebuje:
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 32 cm²), ki hitro izgine (v največ 14 dneh).
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po EXP.
In cattle and sheep - 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young cattle and sheep born to immune animals).
Govedo in ovce - Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri potomcih imunih krav in ovc).
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št. 470/2009.
BATCH NUMBER Lot{number}
ŠTEVILKA SERIJE Lot {številka}
The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Trajanje imunosti pri govedu in ovcah je eno leto po osnovnem cepljenju.
Aluminium hydroxide Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection
Aluminijev hidroksid Prečiščen saponin Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer Voda za injiciranje
Sheep and cattle
Ovce in govedo.
TARGET SPECIES Sheep and cattle.
CILJNE ŽIVALSKE VRSTE Ovce in govedo.
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
Drugi učinki, razen tistih ki so navedeni v poglavju 4.6, niso bili opaženi po dajanju dvakratnega odmerka cepiva.
A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1.1 °C.
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Farmakoterapevtska skupina: cepivo proti virusu modrega jezika; oznaka ATCvet QI04AA02 (ovce) in QI02AA08 (govedo).
MARKETING AUTHORISATION NUMBER(S) EU/2/09/094/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/094/001
Can be used during pregnancy and lactation in cows.
Lahko se uporablja v obdobju brejosti in laktacije pri kravah.
4.11 Withdrawal period Zero days.
4.11 Karenca Nič dni.
Shelf life after first opening the immediate packaging: immediately after broaching.
Rok uporabnosti po prvem odpiranju stične ovojnine: takoj po prvem odpiranju.
The safety and the efficacy of the vaccine has not been established in breeding males.
Varnost in učinkovitost cepiva nista bili ugotovljena pri plemenjakih.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti cepiva ob istočasnem dajanju katerega koli drugega zdravila za uporabo v veterinarski medicini.
* (below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission)
* (pod stopnjo detekcije z validirano metodo RT-PCR pri 3,14 log10 RNA kopijah/ml, ni prenosavirusa)
*below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission
*pod stopnjo detekcije z validirano metodo RT-PCR pri 3,14 log10 RNA kopijah/ml, ni prenosa virusa
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C-8 °C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
Polypropylene bottle of 50 or 100 ml with butyl elastomere closure.
50 ali 100 ml polipropilenska plastenka z butil elastomerno zaporko.
No adverse reactions except those mentioned in section ‘Adverse Reactions' were observed after the administration of a double-dose of vaccine.
Drugi učinki, razen tistih, ki so navedeni v poglavju neželeni učinki, niso bili opaženi po dajanju dvojnega odmerka cepiva.
The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Za pomožne snovi, navedene v poglavju 6.1 SPC , tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
1 bottle of 10 doses (1 x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
1 steklenička z 10 odmerki (1 x 10 ml) 1 plastenka s 50 odmerki (1 x 50 ml) 10 plastenk s 50 odmerki (1 x 50 ml) 1 plastenka s 100 odmerki (1 x 100 ml) 10 plastenka s 100 odmerki (1 x 100 ml)
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami kompetentnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
Shelf life of the veterinary medicinal product as package for sale (50-ml and 100-ml bottles): 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo (50 ml in 100 ml stekleničke): 2 leti.
Type I glass bottle of 10 ml with butyl elastomere closure.
10 ml steklenička (steklo tipa I) z butil elastomerno zaporko.
SC. Read the package leaflet before use.
SC. Pred uporabo preberite navodilo za uporabo.
Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants:
Virus modrega jezika, serotip 8, antigen .................................................................. ≥ 2,1 log10 pikslov* (*) Vsebnost antigena (VP2 protein) z imunološkim preskusom Dodatki:
Box of 1 bottle of 10 ml Box of 1 bottle of 50 ml, Box of 10 bottles of 50 ml, Box of 1 bottle of 100 ml, Box of 10 bottles of 100 ml
Škatla z 1 stekleničko z 10 ml Škatla z 1 plastenko s 100 ml Škatla z 10 plastenkami po 100 ml Škatla z 1 plastenko s 50 ml Škatla z 10 plastenkami 50 ml
Shelf life of the veterinary medicinal product as package for sale (10-ml bottle): 18 months.
Rok uporabnosti zdravila v pakiranju za prodajo (10 ml stekleničke): 18 mesecev.
The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Cepivo vsebuje inaktiviran virus modrega jezika, serotip 8, z aluminijevim hidroksidom in saponini kot adjuvansi.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (**) Haemolytic units
Aluminijev hidroksid ...................................................................................................................... 2,7 mg Saponin ........................................................................................................................................ 30 HU** (**) Hemolizne enote
NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 8 suspension for injection
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI BTVPUR AlSap 8 suspenzija za injiciranje
Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (*) antigen content (VP2 protein) by immuno-assay (**) Haemolytic units
Virus modrega jezika, serotip 8, antigen .................................................................. ≥ 2,1 log10 pikslov* Aluminijev hidroksid ..................................................................................................................... 2,7 mg Saponin ....................................................................................................................................... 30 HU** (*) Vsebnost antigena (VP2 protein) v imunološkem preskusu (**) Hemolizne enote
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains Bluetongue virus serotype 8 antigen ................. ≥ 2.1 log10 pixels
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsak odmerek (1 ml) cepiva vsebuje: virus modrega jezika, serotip 8, antigen ...................................................................... ≥ 2,1 log10 pikslov
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains: BTV8 antigen............................................... ≥ 2.1 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsak odmerek (1 ml) cepiva vsebuje: antigen BTV8 ............................................... ≥ 2,1 log10 pikslov* Aluminijev hidroksid, Saponin q.s.
PACKAGE LEAFLET FOR: BTVPUR AlSap 8 suspension for injection
NAVODILO ZA UPORABO BTVPUR AlSap 8 suspenzija za injiciranje
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue virus serotype 8 (BTV 8).
Aktivna imunizacija ovac in goveda proti virusu modrega jezika, serotip 8 (BTV8), za preprečitev viremije* in zmanjšanje kliničnih znakov.
It induces an active and specific immunity against Bluetongue virus serotype 8 in the vaccinated animal.
Pri cepljeni živali sproži nastanek aktivne in specifične imunosti proti virusu modrega jezika, serotip 8.
Box of 1 bottle of 10 doses (1 x 10 ml).
Škatlica z 1 stekleničko z 10 odmerki (1 x 10 ml).
It induces an active and specific immunity against bluetongue virus serotype 8 in the vaccinated animal.
Pri cepljeni živali povzroči nastanek aktivne in specifične imunosti proti virusu modrega jezika, serotip 8.
4.2 Indications for use, specifying the target species Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Aktivna imunizacija ovac in goveda proti virusu modrega jezika, serotip 8, za preprečitev viremije* in zmanjšanje kliničnih znakov.
Box of 10 bottles of 50 doses (10 x 50 ml).
Škatla z 10 plastenkami s 50 odmerki (10 x 50 ml).
Box of 1 bottle of 50 doses (1 x 50 ml).
Škatla z 1 plastenko s 50 odmerki (1 x 50 ml).
Shake gently immediately before use.
Po odprtju uporabite takoj.
Box of 10 bottles of 100 doses (10 x 100 ml).
Škatla z 10 plastenkami s 100 odmerki (10 x 100 ml).
Box of 1 bottle of 100 doses (1 x 100 ml).
Škatla z 1 plastenko s 100 odmerki (1 x 100 ml).
WITHDRAWAL PERIOD Zero days.
KARENCA Nič dni.
QUANTITY OF THE ACTIVE SUBSTANCE(S) BTV 8 antigen ...................................................................................................... ≥ 2.1 log10 pixels/dose
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Antigen BTV8 ..............................................................................................≥ 2,1 log10 pikslov/odmerek
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Plastenka s 100 ml
The Reference Member States were Portugal, Slovenia, and the United Kingdom.
Zadevne države članice so bile Portugalska, Slovenija in Združeno kraljestvo.
During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names, that the objections raised by should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
The scope of the referral was to agree whether Doxazosin Retard “Arrow” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names (Doxazosin) is is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem in povezana imena (Doxazosin) vsebujejo snov, ki blokira receptor alfa in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
Arrow Generics UK Ltd submitted applications for mutual recognition of Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Družba Arrow Generics UK Ltd je podala vloge za medsebojno priznavanje zdravila Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Danska dne 30. septembra 2002.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Doxazosin Retard “Arrow” 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
What measures are being taken to ensure the safe and effective use of Actos?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Actos?
Further studies also looked at long-term use of Actos.
V nadaljnjih študijah so proučevali tudi dolgoročno uporabo zdravila Actos.
Other information about Actos:
Druge informacije o zdravilu Actos:
The European Commission granted a marketing authorisation valid throughout the European Union, for Actos on 13 October 2000.
Evropska komisija je dovoljenje za promet z zdravilom Actos, veljavno po vsej Evropski uniji, izdala 13. oktobra 2000.
Almost 7,000 patients received Actos in all of the studies combined.
V vseh študijah skupaj je zdravilo Actos prejemalo skoraj 7 000 bolnikov.
The full EPAR for Actos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Actos je na voljo na spletni strani agencije:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Treatment with Actos should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Zdravljenje z zdravilom Actos je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, ukiniti.
What benefit has Actos shown during the studies?
Kakšne koristi je zdravilo Actos izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Actos.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Actos.
Actos is a medicine that contains the active substance pioglitazone.
Actos je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
For more information about treatment with Actos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Actos preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Actos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Actos večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
If Actos is used in combination with other diabetes medicines, other side effects may occur.
Če se zdravilo Actos uporablja v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, se lahko pojavijo še drugi neželeni učinki.
The company that markets Actos will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Družba, ki trži zdravilo Actos, bo zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in bo vključevalo možno tveganje za srčno popuščanje ter rak sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebo po redni oceni zdravljenja ter prekinitvi zdravljenja, če bolnikom ne koristi več.
Actos is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Zdravilo Actos se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
The most common side effects with Actos (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight.
Najpogostejši neželeni učinki zdravila Actos (opaženi pri 1 do 10 bolnikih od 100) so okužba zgornjih dihal (prehladi), hipestezija (zmanjšan občutek za dotik), motnje vida, zlomi kosti in povečanje telesne mase.
It must also not be used in patients who have or have had bladder cancer or those with blood in the urine that has not yet been investigated.
Poleg tega ga ne smejo uporabljati bolniki, ki imajo ali so imeli rak sečnega mehurja, ali bolniki, ki imajo kri v urinu, vendar preiskave v zvezi s tem še niso bile opravljene.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Actos.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.