natgillin/translations-raw huggingface dataset:
Glidipion 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Izgled zdravila Glidipion in vsebina pakiranja Tablete Glidipion 15 mg so bele, okrogle, ploščate, na obeh straneh izbočene tablete s premerom 5,5 mm, ki imajo na eni strani vtisnjeno oznako 'TZ15'.
The formation and presence of urinary calculi with subsequent irritation and hyperplasia was postulated as the mechanistic basis for the observed tumourigenic response in the male rat.
Domnevni mehanizem opaženega tumorigenega odziva pri podganjih samcih je nastajanje in prisotnost kamnov v sečilih s posledičnim zdravljenjem in hiperplazijo.
What Glidipion looks like and contents of the pack
Shranjevanje zdravila Glidipion Vsebina pakiranja in dodatne informacije
Renal and urinary disorders haematuria common glycosuria uncommon proteinuria uncommon
Bolezni sečil hematurija pogosto glikozurija občasno proteinurija občasno
Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Če je pioglitazon uporabljen v kombinaciji z insulinom, je treba bolnike spremljati glede znakov in simptomov srčnega popuščanja, povečanja telesne mase ali edemov.
Glidipion with food and drink
Zdravilo Glidipion skupaj s hrano in pijačo Tablete lahko vzamete s hrano ali brez nje.
Ear and labyrinth disorders vertigo uncommon
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica občasno
This summary was last updated in October 2015.
Povzetek je bil nazadnje posodobljen oktobra 2015.
The relative reduction in mastitis incidence was 26%.
Relativno zmanjšanje pojavnosti mastitisa je bilo 26%.
Symptomatic treatment may be required.
Lahko je potrebno simptomatsko zdravljenje.
The intervals between the two injections should not be less than 3 days or more than 17 days.
Interval dajanja ne sme biti krajši od 3 dni ali daljši od 17 dni.
The full EPAR for Imrestor can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila za zdravilo Imrestor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Other information about Imrestor
Druge informacije o zdravilu Imrestor
These clinical signs typically appear between 30 minutes and 2 hours after the first dose and resolve within 2 hours.
Ti klinični znaki se običajno pojavijo 30 minut do dve uri po prvem odmerku in minejo v dveh urah.
Headache and bone and muscle pain may occur.
Lahko se pojavijo glavobol in bolečine v kosteh in mišicah.
In a field trial involving 2465 cows the incidence of clinical mastitis during days 3 to 30 of milk production was 9.1% (113/1235) in the Imrestor-treated group compared with 12.4% (152/1230) in the group given a dummy injection.
V terenski študiji, v katero je bilo vključenih 2465 krav, je bila pojavnost kliničnega mastitisa med 3. in 30. dnem proizvodnje mleka 9,1% (113/1235) v skupini, zdravljeni z zdravilom Imrestor, v primerjavi z 12,4% (152/1230) v skupini, ki je prejela injekcijo brez zdravilne učinkovine.
This is a summary of the European public assessment report (EPAR) for Imrestor.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imrestor.
It is not intended to provide practical advice on how to use Imrestor.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Pegbovigrastim is a modified form of a natural protein, bovine granulocyte colony stimulating factor (bG-CSF), that stimulates the production and activity of a type of white blood cells called neutrophils.
Pegbovigrastim je modificirana oblika naravne beljakovine, faktor za spodbujanje nastanka kolonij govejih granulocitov (bG-CSF), ki spodbuja proizvodnjo in aktivnost belih krvnih celic, imenovanih nevtrofilci.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Imrestor's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Imrestor večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
A second injection is given within 24 hours after calving.
Druga injekcija se daje v 24 urah po telitvi.
People who are hypersensitive (allergic) to pegbovigrastim should avoid contact with Imrestor.
Osebe, ki so preobčutljive za (alergične na) pegbovigrastim, se morajo izogibati stiku z zdravilom Imrestor.
There may also be other effects including nausea (feeling sick), and rashes or other hypersensitivity reactions (e.g. breathing difficulties and low blood pressure).
Lahko se pojavijo tudi drugi učinki, vključno s slabostjo, izpuščajem na koži in drugimi preobčutljivostnimi reakcijami (npr. težave z dihanjem in nizek krvni tlak).
Neutrophils are part of the immune system (the body's natural defences) and help to fight infection.
Nevtrofilci so del imunskega sistema (naravna obramba telesa), ki pomagajo premagovati okužbe.
What benefits of Imrestor have been shown in studies?
Kakšne koristi je zdravilo Imrestor izkazalo v študijah?
What is Imrestor and what is it used for?
Kaj je zdravilo Imrestor in za kaj se uporablja?
Why is Imrestor approved?
Zakaj je bilo zdravilo Imrestor odobreno?
Gloves should be removed and hands and exposed skin washed after use.
Po uporabi si rokavice snemite ter si umijte roke in izpostavljeno kožo.
What are the risks associated with Imrestor?
Kakšna tveganja so povezana z zdravilom Imrestor?
What is the withdrawal period in food-producing animals?
Kako dolgo traja karenca pri živalih namenjenih za proizvodnjo hrane?
By giving Imrestor, the number of neutrophils in the blood is increased, which is an aid to reduce the risk of infections of the udder that might lead to mastitis.
Z dajanjem zdravila Imrestor se poveča število nevtrofilcev v krvi, kar pomaga pri zmanjševanju tveganja za okužbe vimen, ki lahko vodijo v mastitis.
The withdrawal period for meat and milk from cows treated with Imrestor is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso in mleko krav, zdravljenih z zdravilom Imrestor, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
The medicine can only be obtained with a prescription and is available as a solution for injection in pre-filled syringes.
Izdaja zdravila je le na recept in je na voljo kot raztopina za injiciranje v napolnjenih injekcijskih brizgah.
It contains the active substance pegbovigrastim.
Vsebuje zdravilno učinkovino pegbovigrastim.
The most common side effects with Imrestor (which may affect up to 1 in 100 cows) are non-typical anaphylactoid (allergic) reactions seen as swelling of mucous membranes (notably vulva and eyelid), skin reactions, increased respiration rate and salivation.
Najpogostejši neželeni učinki zdravila Imrestor (ki lahko prizadenejo največ 1 od 100 krav) so netipične anafilaktoidne (alergijske) reakcije, ki se kažejo kot oteklost sluznic (zlasti sluznice vulve in vek), kožne reakcije, zvišana frekvenca dihanja in slinjenje.
The content of a single pre-filled syringe is given by injection under the skin (subcutaneously) to a dairy cow/heifer preferably 7 days before the anticipated date of calving.
Vsebina ene napolnjene injekcijske brizge se injicira kravi molznici/telici pod kožo (subkutano) po možnosti 7 dni pred predvidenim datumom telitve.
Imrestor is a veterinary medicine used as an aid in a herd management programme, to reduce the risk of clinical mastitis (inflammation of the udder) in dairy cows and heifers (cows that have not produced a calf) during the 30 days following calving.
Zdravilo Imrestor se uporablja v veterinarski medicini kot pomoč pri programu upravljanja črede za zmanjševanje tveganja za klinični mastitis (vnetje vimena) pri kravah molznicah in telicah (krave, ki še niso skotile teleta) še 30 dni po telitvi.
For the full list of all side effects reported with Imrestor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Imrestor, glejte navodilo za uporabo.
How does Imrestor work?
Kako zdravilo Imrestor deluje?
For practical information about using Imrestor, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Imrestor naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Imrestor, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Imrestor naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
How is Imrestor used?
Kako se zdravilo Imrestor uporablja?
Personal protective equipment consisting of gloves should be worn when handling broken or damaged syringes.
Pri rokovanju z zlomljenimi ali poškodovanimi injekcijskimi brizgami nosite osebno zaščitno opremo, tj. rokavice.
The European Commission granted a marketing authorisation valid throughout the EU for Imrestor on
Evropska komisija je dovoljenje za promet z zdravilom Imrestor, veljavno po vsej Evropski uniji, izdala 09/12/2015.
This summary was last updated in June 2016.
Povzetek je bil nazadnje posodobljen junija 2016.
It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Deluje tako, da preprečuje sproščanje živčnega prenašalca noradrenalina iz živčnih celic v telesu.
• as premedication (treatment given before inducing general anaesthesia).
• kot premedikacija (zdravilo, ki se daje pred uvedbo splošne anestezije).
The European Commission granted a marketing authorisation valid throughout the EU for Sedadex on 12 August 2016.
Evropska komisija je dovoljenje za promet z zdravilom Sedadex, veljavno po vsej Evropski uniji, izdala 12. avgusta 2016.
Dexmedetomidine is an alpha2-adrenoceptor agonist.
Deksmedetomidin je agonist alfa2-adrenoreceptorja.
The duration and depth of sedation and analgesia relate to the dose that is used.
Trajanje in globina sedacije in analgezije sta odvisna od uporabljenega odmerka.
Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Ker je noradrenalin udeležen pri vzdrževanju budnosti in vzdraženosti, zmanjšanje stopnje njegovega sproščanja zniža raven zavesti in občutek bolečine.
It is not intended to provide practical advice on how to use Sedadex.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Deksmedetomidin je tesno povezan z drugo snovjo, ki se uporablja za sedacijo živali, medetomidinom, ki ga v veterinarskih zdravilih uporabljajo že mnogo let.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Sedadex has been shown to have comparable quality to Dexdomitor.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Sedadex primerljivo raven kakovosti kot zdravilo Dexdomitor.
The full EPAR for Sedadex can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Sedadex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The company provided information on the quality and manufacture of Sedadex.
Družba je priskrbela podatke o kakovosti in proizvodnji zdravila Sedadex.
This is a summary of the European public assessment report (EPAR) for Sedadex.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sedadex.
What are the benefits and risks of Sedadex?
Kakšne so koristi in tveganja, povezani z zdravilom Sedadex?
A neurotransmitter is a substance that nerve cells use to communicate with neighbouring cells.
Živčni prenašalec je snov, ki omogoča medsebojno sporazumevanje sosednjih živčnih celic.
The dose in each species depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats, and on the use, type of injection and any other medicines that are being used.
Odmerek je odvisen od telesne površine pri psih (ki se izračuna s pomočjo telesne mase) in od telesne mase pri mačkah ter od uporabe, vrste injekcije in drugih uporabljenih zdravil.
The Committee recommended that Sedadex be approved for use in the EU.
Priporočil je, da se zdravilo Sedadex odobri za uporabo v EU.
Sedadex is a medicine used to sedate (calm down) and relieve pain in dogs and cats:
Zdravilo Sedadex se uporablja za sedacijo (pomirjanje) in lajšanje bolečine pri psih in mačkah:
In dogs, Sedadex is given by injection into a vein or a muscle.
Psom se zdravilo Sedadex daje z injekcijo v veno ali v mišico.
• when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia) but are non-invasive (do not involve breaking the skin or a body cavity).
• pri blago do zmerno bolečih posegih in pregledih, pri katerih so potrebni mirovanje in sedacija živali ter zmanjšanje občutljivosti za bolečino (analgezija), pri čemer so ti posegi in pregledi neinvazivni (ne vključujejo predrtja kože ali stene telesne votline);
Because Sedadex is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Sedadex generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
In cats, it is given by intramuscular injection.
Mačkam se zdravilo daje z intramuskularno
• Sedadex can also be used in dogs to provide pain relief and deep sedation when carrying out medical procedures and minor surgery where it is used in combination with butorphanol (a sedative and analgesic).
• Zdravilo Sedadex se lahko pri psih uporablja tudi za lajšanje bolečine in globoko sedacijo pri zdravstvenih in manjših kirurških posegih, in sicer v kombinaciji z butorfanolom (sedativom in analgetikom).
What is Sedadex and what is it used for?
Kaj je zdravilo Sedadex in za kaj se uporablja?
This means that Sedadex is similar to a ‘reference medicine' already authorised in the EU called Dexdomitor.
To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Dexdomitor.
The precautions are the same as for the reference medicine since Sedadex is a generic medicine.
Previdnostni ukrepi so enaki kot pri referenčnem zdravilu, saj je zdravilo Sedadex generično zdravilo.
Sedadex contains the active substance dexmedetomidine and is a ‘generic medicine'.
Zdravilo Sedadex vsebuje zdravilno učinkovino deksmedetomidin in je „generično zdravilo“.
Other information about Sedadex?
Druge informacije o zdravilu Sedadex
Why is Sedadex approved?
Zakaj je bilo zdravilo Sedadex odobreno?
Safety information has been included in the summary of product characteristics and the package leaflet for Sedadex, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
For practical information about using Sedadex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Sedadex naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Sedadex is available as a solution for injection and can only be obtained with a prescription.
Zdravilo Sedadex je na voljo v obliki raztopine za injiciranje, predpisovanje in izdaja zdravila je le na recept.
Therefore, the CVMP's view was that, as for Dexdomitor, the benefits outweigh the identified risks.
Zato je menil, da njegove koristi enako kot pri zdravilu Dexdomitor odtehtajo znana tveganja.
How does Sedadex work?
Kako zdravilo Sedadex deluje?
How has Sedadex been studied?
Kako je bilo zdravilo Sedadex raziskano?
How is Sedadex used?
Kako se zdravilo Sedadex uporablja?
No additional studies were needed as Sedadex is a generic medicine that is given by injection, is similar in composition to, and contains the same active substance as, the reference medicine, Dexdomitor.
Ker je zdravilo Sedadex generično zdravilo, ki se daje z injekcijo, je po sestavi podobno referenčnemu zdravilu Dexdomitor in vsebuje isto zdravilno učinkovino kot zdravilo Dexdomitor, niso bile potrebne nobene dodatne študije.
For more information about treatment with Sedadex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Sedadex preberite navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
pre-filled syringe (glass) without blister pre-filled pen (glass) (SureClick)
Za subkutano uporabo (stekleni) napolnjeni injekcijski peresnik (SureClick)
1 pre-filled pen
1 napolnjeni injekcijski peresnik
Package size pre-filled syringe (glass)
Za subkutano uporabo (steklena) napolnjena brizga
Packaging
Vsebnost
Strength Pharmaceutical Form Route of Administration
Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja o ā
This also applies to children.
To velja tudi za otroke.
This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
To je indikacija, ki jo sedaj predlaga predlagatelj ter je registrirana v 15 državah EU.
Stabilisation of the circulatory system should be given priority.
Prednost je treba dati stabilizaciji cirkulacijskega sistema.
You may need urgent medical attention or hospitalisation.
Lahko da potrebujete nujno zdravniško pomoč ali zdravljenje v bolnišnici.
The clinical relevance of this effect is unknown.
Klinični pomen tega učinka ni znan.
The combination should be administered with caution, especially in the elderly.
Kombinacijo je treba uporabljati previdno, še posebej pri starejših.
Patients were followed up for up to 4.6 years (3.4 years on average).
Bolnike so spremljali do 4,6 let (povprečno 3,4 leta).
Do not take a double dose to make up for a forgotten tablet.
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
This indication is primarily based on the results of the clinical trials ELITE I and II.
Ta indikacija temelji v prvi vrsti na rezultatih kliničnih preskušanj ELITE I in II.
Afterwards, close monitoring of the vital parameters should be performed.
Potem je potrebno pozorno spremljanje vitalnih parametrov.
These findings were regarded as clinically relevant for this group of patients.
Te ugotovitve so bile ocenjene kot klinično pomembne za to skupino bolnikov.
ELITE I and ELITE II Study
Študiji ELITE I in ELITE II
Do not open the blister pack until you are ready to take the medicine.
Pretisnega omota ne odprite, preden niste pripravljeni vzeti zdravila.
You should try to take your daily dose at about the same time each day.
Dnevni odmerek poskusite vzeti vsak dan ob približno istem času.
Vital parameters should be corrected if necessary.
Vitalne parametre je treba po potrebi zdraviti.
Electrolyte imbalances
Elektrolitsko neravnovesje
DATE OF REVISION OF THE TEXT {MM/YYYY}
DATUM ZADNJE REVIZIJE BESEDILA {MM/LLLL}
11415 Tallinn Estonia
11415 Talin, Estonija
Other warnings and precautions
Druga opozorila in previdnostni ukrepi
The mean length of follow up was 4.8 years.
Spremljanje je povprečno trajalo 4,8 let.
The volume of distribution of losartan is 34 litres.
Volumen porazdelitve losartana je 34 litrov.
28 day initiation pack
28-dnevno začetno pakiranje
• if you are, think you may be or are planning to become pregnant (see also “Pregnancy and breast-feeding”),
• če ste noseči, mislite, da ste noseči ali če nameravate zanositi (glejte tudi poglavje "Nosečnost in dojenje")
28027 Madrid
28027 MADRID, Španija
Blood pressure was significantly lowered to similar levels in the two groups.
Krvni tlak se je pomembno znižal v obeh skupinah na podobno raven.
Therefore, losartan should be used with caution in these patient groups.
Zato je treba losartan pri teh skupinah bolnikov previdno uporabljati.
H-1123 Budapest
H-1123 Budimpešta, Madžarska
- the CHMP concluded that the Marketing Authorisation could be harmonised on the following indications:
- CHMP je zaključil, da je dovoljenje za promet z zdravilom mogoče uskladiti za naslednje indikacije:
When comparing preschool children with adolescents these differences became statistically significant.
Pri primerjavi predšolskih otrok z mladostniki so te razlike postale statistično značilne.
Your doctor will decide on the appropriate dose of Cozaar, depending on your condition and whether you are taking other medicines.
Zdravnik vam bo predpisal ustrezen odmerek zdravila Cozaar glede na vaše stanje in glede na to, ali jemljete še katera druga zdravila.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, vključno s tistimi, ki ste jih dobili brez recepta ali zdravili rastlinskega izvora in naravnimi izdelki.
Consequently, there is no potentiation of undesirable bradykininmediated effects.
Posledično ne potencira z bradikininom povezanih neželenih učinkov.
The primary endpoint of this prospective study was the all-cause mortality.
Primarni opazovani dogodek v tej prospektivni študiji je bila celokupna smrtnost.
No experience with overdose in man is available so far.
Izkušenj s prevelikim odmerjanjem pri ljudeh do sedaj ni na voljo.
Lindenplatz 1 85540, Haar, Germany
Lindenplatz 1 85540, Haar, Nemčija
Measures are depending on the time of drug intake and kind and severity of symptoms.
Ukrepi so odvisni od časa zaužitja ter vrste in jakosti simptomov.
75114 Paris Cedex 08 France
75114 Paris Cedex 08, Francija
• reduced number of thrombocytes,
• zmanjšano število trombociov
Losartan selectively blocks the AT1 receptor.
Losartan selektivno blokira AT1 receptor.
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
• vnetje krvnih žil (vaskulitis, vključno s Henoch-Schonlein purpuro)
The CHMP considered that the data from these trials may not be sufficient to demonstrate the claimed benefit.
CHMP je menil, da utegnejo biti podatki iz teh preskušanj nezadostni, da bi dokazali zatrjevano korist.
• reduced number of red blood cells (anaemia),
• zmanjšano število rdečih krvnih celic (anemija)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENE OCENE ZDRAVILA COZAAR IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
2770-192 Paço d' Arcos Portugal
2770-192 Paço d' Arcos, Portugalska
• other blood pressure lowering medicines as they may additionally reduce your blood pressure.
• druga zdravila za zniževanje krvnega tlaka, ker lahko še dodatno znižajo vaš krvni tlak.
Losartan should not be initiated during pregnancy.
Zdravljenja z losartanom se ne sme začeti med nosečnostjo.
Exposure in infants/ toddlers was comparatively high.
Izpostavljenost pri dojenčkih/malčkih je bila primerljivo visoka.
If you accidentally miss a daily dose, just take the next dose as normal.
Če ste slučajno pozabili vzeti dnevni odmerek, vzemite naslednjega kot običajno.