natgillin/translations-raw huggingface dataset:
Corbilta 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Corbilta 100 mg/25 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Corbilta contains sucrose (1.4 mg/tablet).
Zdravilo Corbilta vsebuje saharozo (1,4 mg/tableto).
EU/1/13/859/007 10 film-coated tablets EU/1/13/859/008 30 film-coated tablets EU/1/13/859/009 100 film-coated tablets EU/1/13/859/010 130 film-coated tablets EU/1/13/859/011 175 film-coated tablets
EU/1/13/859/007 10 filmsko obloženih tablet EU/1/13/859/008 30 filmsko obloženih tablet EU/1/13/859/009 100 filmsko obloženih tablet EU/1/13/859/010 130 filmsko obloženih tablet EU/1/13/859/011 175 filmsko obloženih tablet
Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 50 mg/12,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
- Each Corbilta 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
- Ena tableta zdravila Corbilta 200 mg/50 mg/200 mg vsebuje 200 mg levodope, 50 mg karbidope in 200 mg entakapona.
Corbilta 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Corbilta 200 mg/50 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 150 mg/37,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422)
Filmska obloga pri 50/12,5/200 mg, 100/25/200 mg in 150/37,5/200 mg: glicerol (85 odstotkov) (E422) hipromeloza (E464) magnezijev stearat polisorbat 80 (E433) rdeči železov oksid (E172) saharoza titanov dioksid (E171) rumeni železov oksid (E172)
While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Corbilta strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
To pomeni, da znaša maksimalni odmerek 10 tablet na dan zdravila Corbilta jakosti 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg in 150 mg/37,5 mg/200 mg.
EU/1/13/859/023 10 film-coated tablets EU/1/13/859/024 30 film-coated tablets EU/1/13/859/025 100 film-coated tablets EU/1/13/859/026 130 film-coated tablets EU/1/13/859/027 175 film-coated tablets EU/1/13/859/028 250 film-coated tablets
EU/1/13/859/023 10 filmsko obloženih tablet EU/1/13/859/024 30 filmsko obloženih tablet EU/1/13/859/025 100 filmsko obloženih tablet EU/1/13/859/026 130 filmsko obloženih tablet EU/1/13/859/027 175 filmsko obloženih tablet EU/1/13/859/028 250 filmsko obloženih tablet
EU/1/13/859/001 10 film-coated tablets EU/1/13/859/002 30 film-coated tablets EU/1/13/859/003 100 film-coated tablets EU/1/13/859/004 130 film-coated tablets EU/1/13/859/005 175 film-coated tablets EU/1/13/859/006 250 film-coated tablets
EU/1/13/859/001 10 filmsko obloženih tablet EU/1/13/859/002 30 filmsko obloženih tablet EU/1/13/859/003 100 filmsko obloženih tablet EU/1/13/859/004 130 filmsko obloženih tablet EU/1/13/859/005 175 filmsko obloženih tablet EU/1/13/859/006 250 filmsko obloženih tablet
EU/1/13/859/018 10 film-coated tablets EU/1/13/859/019 30 film-coated tablets EU/1/13/859/020 100 film-coated tablets EU/1/13/859/021 130 film-coated tablets EU/1/13/859/022 175 film-coated tablets
EU/1/13/859/018 10 filmsko obloženih tablet EU/1/13/859/019 30 filmsko obloženih tablet EU/1/13/859/020 100 filmsko obloženih tablet EU/1/13/859/021 130 filmsko obloženih tablet EU/1/13/859/022 175 filmsko obloženih tablet
EU/1/13/859/034 10 film-coated tablets EU/1/13/859/035 30 film-coated tablets EU/1/13/859/036 100 film-coated tablets EU/1/13/859/037 130 film-coated tablets EU/1/13/859/038 175 film-coated tablets
EU/1/13/859/034 10 filmsko obloženih tablet EU/1/13/859/035 30 filmsko obloženih tablet EU/1/13/859/036 100 filmsko obloženih tablet EU/1/13/859/037 130 filmsko obloženih tablet EU/1/13/859/038 175 filmsko obloženih tablet
EU/1/13/859/029 10 film-coated tablets EU/1/13/859/030 30 film-coated tablets EU/1/13/859/031 100 film-coated tablets EU/1/13/859/032 130 film-coated tablets EU/1/13/859/033 175 film-coated tablets
EU/1/13/859/029 10 filmsko obloženih tablet EU/1/13/859/030 30 filmsko obloženih tablet EU/1/13/859/031 100 filmsko obloženih tablet EU/1/13/859/032 130 filmsko obloženih tablet EU/1/13/859/033 175 filmsko obloženih tablet
EU/1/13/859/012 10 film-coated tablets EU/1/13/859/013 30 film-coated tablets EU/1/13/859/014 100 film-coated tablets EU/1/13/859/015 130 film-coated tablets EU/1/13/859/016 175 film-coated tablets EU/1/13/859/017 250 film-coated tablets
EU/1/13/859/012 10 filmsko obloženih tablet EU/1/13/859/013 30 filmsko obloženih tablet EU/1/13/859/014 100 filmsko obloženih tablet EU/1/13/859/015 130 filmsko obloženih tablet EU/1/13/859/016 175 filmsko obloženih tablet EU/1/13/859/017 250 filmsko obloženih tablet
Corbilta contains sucrose
Zdravilo Corbilta vsebuje saharozo
Tablet core:
PC: {številka}
The European Commission granted a marketing authorisation valid throughout the European Union for Protelos on 21 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom Protelos, veljavno po vsej Evropski uniji, izdala 21. septembra 2004.
What measures are being taken to ensure the safe and effective use of Protelos?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Protelos?
The full EPAR for Protelos 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 Protelos je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Protelos should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Zdravilo Protelos je treba vzeti najmanj dve uri po zaužitju hrane, mleka, mlečnih izdelkov ali kalcijevih dodatkov, najbolje pred spanjem.
The company will also conduct a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Družba bo izvedla tudi študijo, v kateri bo ocenjevala učinkovitost vzpostavljenih ukrepov za zmanjšanje tveganja za nastanek težav s srcem in obtočili.
This is a summary of the European public assessment report (EPAR) for Protelos.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Protelos.
Other information about Protelos
Druge informacije o zdravilu Protelos
Protelos is intended for long-term use.
Namenjeno je dolgotrajni uporabi.
What benefit has Protelos shown during the studies?
Kakšne koristi je zdravilo Protelos izkazalo med študijami?
A risk management plan has been developed to ensure that Protelos is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Protelos je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Protelos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Protelos preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Protelos (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Najpogostejši neželeni učinki zdravila Protelos (ki lahko prizadenejo več kot 1 osebo od 10) so preobčutljivostne (alergijske) kožne reakcije (izpuščaji, srbenje, urtikarija ali srbeči izpuščaji in otekanje pod kožo, znano kot angioedem) ter bolečine, ki prizadenejo mišice, kosti in sklepe.
What is the risk associated with Protelos?
Kakšna tveganja so povezana z zdravilom Protelos?
In order to reduce the risk of heart attack, Protelos must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Za zmanjšanje tveganja za srčni napad ga ne smejo jemati bolniki z visokim krvnim tlakom, ki ni ustrezno nadzorovan, ali bolniki, ki imajo trenutno ali so v preteklosti imeli katerega koli od naslednjih obolenj:
This showed that the risk of breaking a bone is reduced.
To je dokaz, da se je tveganje za nastanek zloma zmanjšalo.
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 Protelos.
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.
The CHMP decided that Protelos's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Protelos večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Protelos in preventing bone breaks.
Gledano v celoti, pa rezultati druge študije niso zadostno dokazali koristi zdravila Protelos pri preprečevanju zlomov kosti.
As there has been some data showing an increased risk of heart attack with Protelos, the decision to prescribe Protelos should take into account the patient's individual heart risk.
Ker nekateri podatki kažejo na povečano tveganje za srčni napad v povezavi z zdravilom Protelos, je treba pri predpisovanju zdravila upoštevati posameznikovo tveganje za srčni napad.
Protelos is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Zdravilo Protelos se uporablja za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi in moških, pri katerih obstaja veliko tveganje za zlom kosti in ki jih ni mogoče zdraviti z drugimi zdravili, odobrenimi za osteoporozo.
Protelos is taken as one sachet once a day.
Zdravilo Protelos se jemlje v odmerku ene vrečke enkrat na dan.
Protelos must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Zdravila ne smejo uporabljati bolniki, ki imajo ali so imeli vensko trombembolijo (težave zaradi nastajanja krvnih strdkov v venah, na primer v nogah ali pljučih).
However, when looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of breaks in the hip with Protelos.
Kljub temu so rezultati, dobljeni pri ženskah, starih 74 let ali več, ki so imele posebno šibki stegnenici, pokazali, da je zdravilo Protelos zmanjšalo tveganje za zlom kolka.
Protelos has been studied in almost 7,000 elderly women in two large studies.
Zdravilo Protelos so proučevali v dveh obsežnih študijah, ki sta vključevali skoraj 7 000 starejših žensk.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Protelos, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Protelos in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Protelos has also been compared with placebo in a main study involving 261 male patients at increased risk of breaking a bone.
Zdravilo Protelos so s placebom primerjali tudi v glavni študiji, ki je vključevala 261 bolnikov, pri katerih obstaja povečano tveganje za zlom kosti.
In addition, education materials are sent to patients and healthcare professionals prescribing Protelos reminding them of the risk of heart and circulatory problems with the medicine and of the need for regular monitoring.
Poleg tega bodo bolniki in zdravniki, ki bodo predpisovali zdravilo Protelos, prejeli izobraževalno gradivo z opozorilom, da obstaja pri jemanju zdravila tveganje za nastanek težav s srcem in obtočili ter da je treba bolnike redno spremljati.
Why has Protelos been approved?
Zakaj je bilo zdravilo Protelos odobreno?
Protelos is a medicine that contains the active substance strontium ranelate.
Protelos je zdravilo, ki vsebuje zdravilno učinkovino stroncijev ranelat.
In the first study, this was based on the number of patients who, over three years, developed a new break in the spine, and in the second study, it was based on the number of patients who had a new bone break due to osteoporosis at any site other than the spine.
V prvi študiji je bilo tako za osnovo vzeto število bolnic, pri katerih je v triletnem obdobju prišlo do novega zloma v hrbtenici, v drugi študiji pa število bolnic, pri katerih je prišlo do novega zloma kosti zaradi osteoporoze v katerem koli drugem predelu okostja razen v hrbtenici.
When looking at results of the two studies taken together, fewer women in the Protelos group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Protelos compared with 389 out of 3,256 for placebo).
Na podlagi rezultatov obeh študij skupaj je mogoče ugotoviti, da je do zlomov kosti na katerem koli predelu okostja razen hrbtenice (vključno s kolkom) prišlo pri manj ženskah iz skupine, ki je jemala zdravilo Protelos, kot pri tistih iz skupine, ki je jemala placebo (331 od 3 295 v skupini, ki je jemala zdravilo Protelos, v primerjavi s 389 od 3 256 v skupini, ki je jemala placebo).
In the first study, Protelos reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Protelos developed a new break in the spine, compared with 33% of the 723 who took placebo.
V prvi študiji je zdravilo Protelos v triletnem obdobju za 41 % zmanjšalo tveganje za nove zlome v hrbtenici: do novega zloma kosti v hrbtenici je prišlo pri 21 % od 719 žensk, ki so jemale zdravilo Protelos, v primerjavi s 33 % od 723 žensk, ki so jemale placebo.
In the study in male patients, the bone density in the lower part of the spine increased by 7% after one year of treatment in patients taking Protelos, compared with an increase of 1.7% in patients taking placebo.
V študiji, ki je vključevala moške bolnike, se je po enem letu zdravljenja gostota kosti v spodnjem delu hrbtenice pri tistih, ki so jemali zdravilo Protelos, povečala za 7 %, medtem ko se je pri bolnikih, ki so jemali placebo, povečala za 1,7 %.
In both studies, Protelos was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Protelos.
V obeh študijah so učinke zdravila Protelos primerjali z učinki placeba (zdravila brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo zmanjšanje tveganja za nove zlome ob jemanju zdravila.
The active substance in Protelos, strontium ranelate, acts on the bone structure.
Zdravilna učinkovina v zdravilu Protelos, stroncijev ranelat, učinkuje na zgradbo kosti.
For the full list of all side effects reported with Protelos, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Protelos, glejte navodilo za uporabo.
In postmenopausal women, Protelos reduces the risk of vertebral and hip fractures.
Pri ženskah po menopavzi zdravilo zmanjša tveganje za zlom kosti v hrbtenici in kolkih.
What is Protelos used for?
Za kaj se zdravilo Protelos uporablja?
What is Protelos?
Kaj je zdravilo Protelos?
How is Protelos used?
Kako se zdravilo Protelos uporablja?
How has Protelos been studied?
Kako je bilo zdravilo Protelos raziskano?
How does Protelos work?
Kako zdravilo Protelos deluje?
These products are not widely authorised in the European Union and therefore availability of data is limited.
Ti izdelki v Evropski uniji niso splošno sprejeti, zato je razpoložljivost podatkov omejena.
The mechanism of action is not fully understood.
Mehanizem njegovega delovanja ni popolnoma pojasnjen.
Nevertheless, the picture of the mode of action remains incomplete until today.
Kljub temu do zdaj ostaja slika načina delovanja nepopolna.
Whilst metamizolecontaining medicinal products were withdrawn in several European countries and also in the USA due to the risk of agranulocytosis, in other countries such as Spain, Poland and Germany, metamizole is frequently used.
Čeprav so bila zdravila, ki vsebujejo metamizol, v več evropskih državah in tudi v ZDA zaradi tveganja za agranulocitozo umaknjena, se v drugih državah, kot so Španija, Poljska in Nemčija, metamizol pogosto uporablja.
Thus, the more intrusive intramuscular injections could be avoided as intravenous administration is seen as a suitable alternative option.
Tako bi se bilo mogoče izogniti bolj invazivnim intramuskularnim injekcijam, saj velja intravensko dajanje za primerno nadomestno možnost.
Some data suggest that metamizole and its main metabolite 4-methyl-amino-antipyrine (MAA) may have a combined central and peripheral mechanism of action.
Nekateri podatki kažejo, da imata metamizol in njegov glavni presnovek 4-metil-amino-antipirin (MAA) morda kombinirani osrednji in periferni mehanizem delovanja.
In addition, a general rejection of the use of metamizole for administration in infants below the age of 3 months is not considered to be justified based on the fact that no particular concerns arose from the studies which included patients in this age group.
Poleg tega se splošna zavrnitev uporabe metamizola za dajanje dojenčkom, mlajšim od treh mesecev, ne šteje za upravičeno zaradi dejstva, da se v študijah, v katere so bili vključeni bolniki iz te starostne skupine, niso pojavili nobeni posebni pomisleki.
However, it is appropriate to allow, if necessary, a parenteral single dose of 2500 mg metamizole and a maximum daily dose of 5000 mg metamizole.
Vendar pa je po potrebi primerno dovoliti posamezen parenteralni odmerek 2 500 mg metamizola in največji dnevni odmerek 5 000 mg metamizola.
Besides peripheral inhibition of PG synthesis, central activities have been supposed and documented.
Poleg perifernega zaviranja sinteze prostaglandinov je predpostavljeno in dokumentirano tudi osrednje delovanje.
With regards to pregnancy and lactation, although data is limited there is no evidence of teratogenic or embryotoxic effects of metamizole when used during the 1st trimester.
Kar zadeva nosečnost in dojenje, so podatki sicer omejeni, vendar ni dokazov o teratogenem ali embriotoksičnem učinku metamizola pri uporabi v prvem trimesečju.
The active substance is contraindicated in pregnancy and breastfeeding in some Member States, while in others it is contraindicated only in the third trimester of pregnancy and breastfeeding; furthermore, in some Member States it is contraindicated in the first and third trimester of pregnancy and breastfeeding.
Ta učinkovina je v nekaterih državah kontraindicirana med nosečnostjo in dojenjem, v drugih pa je kontraindicirana samo v tretjem trimesečju nosečnosti in pri dojenju; v nekaterih državah članicah je kontraindicirana v prvem in tretjem trimesečju nosečnosti ter pri dojenju.
Current indications for metamizole (as single ingredient) include acute severe pain after trauma or surgery, painful colic, tumour pain, other acute or chronic pain, if other therapeutic measures are contraindicated, and high fever, not responding to other measures.
Trenutne indikacije za metamizol (kot edino učinkovino) vključujejo akutno hudo bolečino po poškodbi ali operaciji, boleče kolike, tumorsko bolečino, drugo akutno ali kronično bolečino, če so drugi terapevtski ukrepi kontraindicirani, in visoko vročino, ki se ne odzove na druge ukrepe.
In view of the known risks associated with the use of metamizole, the differences between the product information of metamizole-containing medicines across the EU Member States raise concern.
Glede na poznana tveganja, povezana z uporabo metamizola, vzbujajo zaskrbljenost razlike v informacijah o zdravilu za zdravila, ki vsebujejo metamizol, med posameznimi državami članicami EU.
No data was available to support a change in posology recommendations for the suppository formulations dosed at 100 mg and 200 mg, as well as for the combination products.
Na voljo ni bil noben podatek, ki bi podprl spremembo priporočil za odmerjanje pripravkov v obliki svečk z odmerkom 100 mg ali 200 mg ali kombiniranih zdravil.
An inhibition of prostaglandin (PG) synthesis is known, based on interaction with different cyclooxygenases (COX), resulting in changes in the arachidonic acid metabolism.
Znano je tudi zaviranje sinteze prostaglandinov (PG), ki temelji na medsebojnem delovanju z različnimi ciklooksigenazami (COX), ki povzroča spremembe presnove arahidonske kisline.
In children and adolescents up to 14 years old, a dose of 8-16 mg metamizole per kg body weight as a single dose is recommended.
Pri otrocih in mladostnikih, starih do vključno 14 let, se priporoča odmerek od 8 do 16 mg metamizola na kilogram telesne mase v obliki posameznega odmerka.
It is available as monocomponent but also available in several combination products.
Na voljo je v monokomponentni obliki (z eno samo učinkovino), pa tudi v obliki več kombiniranih zdravil.
This single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Ta posamezen odmerek se lahko jemlje do štirikrat dnevno v presledkih od 6 do 8 ur.
The CHMP further noted that two recent studies showed that single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 400 infants younger than 1 year (Fieler M et al. 20151, Sümpelmann R et al. 20172).
Odbor CHMP je poleg tega upošteval, da so se posamezni intravenski odmerki metamizola, ki se uporabljajo za zdravljenje pooperacijske bolečine, izkazali kot varni v dveh nedavnih študijah pri več kot 400 dojenčkih, mlajših od enega leta (Fieler, M. et al., 20151, Sümpelmann, R. et al. 20172).
Metamizole has been associated with agranulocytosis and anaphylactic shock.
Metamizol je povezan z agranulocitozo in anafilaktičnim šokom.
Age appropriate formulations (oral drops, solution for injection) are available.
Na voljo so starosti primerne formulacije (peroralne kapljice, raztopina za injiciranje).
As a result of this investigation, it was observed that the maximum daily dose of metamizole reflected in the Product Information of the different medicinal products varies from 1,5 g to 6 g. With regards to contraindication in pregnancy and breastfeeding, discrepancies were also noted.
Pri tej preiskavi je bilo ugotovljeno, da se največji dnevni odmerek metamizola, ki je naveden v informacijah o zdravilu, za različna zdravila giblje od 1,5 g do 6 g. Kar zadeva kontraindikacije med nosečnostjo in dojenjem, so bile ugotovljene tudi neskladnosti.
However, there is evidence of fetotoxicity in terms of fetal renal impairment and ductus arteriosus constriction when used in the third trimester and so the Committee considered metamizole should be contraindicated during the third trimester.
Obstajajo pa dokazi o fetotoksičnosti v smislu okvare ledvic pri plodu in konstrikcije arterioznega duktusa ob uporabi v tretjem trimesečju, zato je odbor presodil, da mora biti metamizol v tretjem trimesečju kontraindiciran.
In view of the above, the Committee considers that the benefit-risk balance of metamizole-containing medicinal products remains unchanged subject to the agreed amendments to the product information.
Glede na zgoraj navedeno je odbor menil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo metamizol, ostaja nespremenjeno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
In case of a single administration of metamizole, breastmilk should be discarded for a 48-hour period before breastfeeding can be resumed.
Ob posameznem odmerku metamizola je treba v naslednjih 48 urah materino mleko zavreči, preden se lahko dojenje nadaljuje.