natgillin/translations-raw huggingface dataset:
Ceftaroline should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics (e.g. penicillins or carbapenems).
Pri bolnikih z anamnezo blagih preobčutljivostnih reakcij za katere koli druge betalaktamske antibiotike (npr. peniciline ali karbapeneme) je potrebna previdnost pri uporabi ceftarolina.
Zinforo is an antibiotic medicine that contains the active substance ceftaroline fosamil.
Vsebuje zdravilno učinkovino, ki se imenuje fosamilceftarolin.
• Streptococcus pneumoniae
Grampozitivni mikroorganizmi • Streptococcus pneumoniae
Zinforo 600 mg powder for concentrate ceftaroline fosamil
Zinforo 600 mg prašek za koncentrat fosamilceftarolin i.v.
There is insufficient information to recommend dosage adjustments in paediatric patients < 2 years with moderate or severe renal impairment or ESRD.
Za pediatrične bolnike do < 2 leti z zmerno ali hudo okvaro ledvic ali končno odpovedjo ledvic ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
What Zinforo is
Kaj je zdravilo Zinforo
Table 4 Dosage in paediatric patients with impaired renal function, creatinine clearance
Preglednica 4 Odmerjanje pri pediatričnih bolnikih z okvarjenim delovanjem ledvic, očistek kreatinina (CrCL - creatinine clearance) ≤ 50 ml/min
Community-acquired pneumonia
Zunajbolnišnična pljučnica
• Raised itchy rash (hives)
• dvignjen srbeč izpuščaj (koprivnica)
Hepatobiliary disorders
Žilne bolezni flebitis
There is insufficient information to recommend dosage adjustments in paediatric patients aged < 2 years with moderate or severe renal impairment or ESRD.
Za pediatrične bolnike, stare < 2 leti, z zmerno ali hudo okvaro ledvic ali končno odpovedjo ledvic, ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
Talk to your doctor or nurse before using Zinforo:
Pred začetkom uporabe zdravila Zinforo se posvetujte z zdravnikom ali medicinsko sestro:
There is insufficient information to recommend dosage adjustments in adolescents with ESRD aged from 12 to < 18 years and with bodyweight < 33 kg and in children with ESRD aged from 2 to < 12 years.
Pri mladostnikih s končno odpovedjo ledvic, starih od 12 do < 18 let in s telesno maso < 33 kg, ter pri otrocih s končno odpovedjo ledvic, starih od 2 do < 12 let, ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
Table 3 Dosage in adults with impaired renal function, creatinine clearance (CrCL)
Preglednica 3 Odmerjanje pri odraslih z okvarjenim delovanjem ledvic, očistek kreatinina (CrCL - creatinine clearance) ≤ 50 ml/min
• Itching, skin rash
• srbenje, izpuščaj na koži
The patient will usually take their medicine for at least 6 to 12 months, and treatment may last several years.
Bolnik običajno jemlje zdravilo vsaj 6 do 12 mesecev, zdravljenje pa lahko traja tudi več let.
The full EPAR for Vemlidy 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 Vemlidy je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Vemlidy?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vemlidy?
This is a summary of the European public assessment report (EPAR) for Vemlidy.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vemlidy.
For the full list of side effects and restrictions see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev glejte navodilo za uporabo.
The most common side effects with Vemlidy are headache (11% of patients), nausea (6% of patients) and tiredness (6% of patients).
Najpogostejši neželeni učinki zdravila Vemlidy so glavobol (11 % bolnikov), navzea (6 % bolnikov) in utrujenost (6 % bolnikov).
Vemlidy tenofovir alafenamide
Vemlidy alafenamidtenofovirat
These results suggest that the comparator medicine might be more effective in ‘e-antigen positive' cases but differences seen are small.
Ti rezultati kažejo, da je primerjalno zdravilo pri primerih, pozitivnih za antigen e, morda učinkovitejše, vendar so razlike majhne.
Other information about Vemlidy
Druge informacije o zdravilu Vemlidy
This result was similar to that in patients taking another form of tenofovir (tenofovir disoproxil fumarate) where 93% had very low viral DNA levels.
Rezultat je bil podoben kot pri bolnikih, ki so jemali drugo obliko tenofovirja (dizoproksiltenofovirat fumarat) in med katerimi jih je 93 % imelo zelo nizko raven virusne DNK.
What benefits of Vemlidy have been shown in studies?
Kakšne koristi je zdravilo Vemlidy izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vemlidy have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vemlidy upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Vemlidy outweigh its risks and recommended its approval in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Vemlidy odtehtajo z njim povezana tveganja, in priporočil, da se odobri za uporabo v EU.
Vemlidy is available as 25 mg tablets which are taken by mouth (one tablet a day) with food.
Zdravilo Vemlidy je na voljo v obliki 25-miligramskih tablet, ki se jemljejo peroralno (ena tableta na dan) s hrano.
For more information about treatment with Vemlidy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vemlidy preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Vemlidy and what is it used for?
Kaj je zdravilo Vemlidy in za kaj se uporablja?
Vemlidy is an antiviral medicine for treating chronic (long-term) hepatitis B, an infectious disease that affects the liver.
Vemlidy je protivirusno zdravilo za zdravljenje kroničnega (dolgotrajnega) hepatitisa B, nalezljive bolezni, ki prizadene jetra.
For practical information about using Vemlidy, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Vemlidy naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What are the risks associated with Vemlidy?
Kakšna tveganja so povezana z zdravilom Vemlidy?
In addition, Vemlidy is effective at a lower dose than tenofovir disoproxil fumarate and may lead to reduced side effects in the kidneys and bones.
Poleg tega je zdravilo Vemlidy pri manjšem odmerku učinkovitejše od dizoproksiltenofovirata in utegne imeti manjše neželene učinke na ledvice in kosti.
It is not intended to provide practical advice on how to use Vemlidy.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Vemlidy approved?
Zakaj je bilo zdravilo Vemlidy odobreno?
It is converted in the body into its active compound tenofovir, which blocks the activity of reverse transcriptase, an enzyme made by the hepatitis B virus that allows it to reproduce itself in the cells it has infected.
V telesu se pretvori v zdravilno učinkovino tenofovir, ki zavira delovanje reverzne transkriptaze, encima, ki ga tvori virus hepatitisa B in ki virusu omogoča, da se razmnožuje v celicah, ki jih je okužil.
In a second study of 875 patients with ‘e-antigen positive' chronic hepatitis, 64% of patients taking Vemlidy and 67% of those taking tenofovir disoproxil fumarate had very low levels of viral DNA after 48 weeks.
V drugi študiji z 875 bolniki s kroničnim hepatitisom, pozitivnim za antigen e, je imelo po 48 tednih zdravljenja zelo nizko raven virusne DNK 64 % bolnikov, zdravljenih z zdravilom Vemlidy, in 67 % bolnikov, zdravljenih z dizoproksiltenofovirat fumaratom.
Vemlidy suppresses levels of hepatitis B virus in the body, and its effectiveness is comparable to that of another tenofovir medicine (tenofovir disoproxil fumarate).
Zdravilo Vemlidy zmanjšuje količino virusa hepatitisa B v telesu, njegova učinkovitost pa je primerljiva z učinkovitostjo drugega zdravila, ki vsebuje tenofovir (dizoproksiltenofovirat fumarat).
The terms ‘e-antigen positive' and ‘e-antigen negative' refer to the presence or absence of e-antigen, a hepatitis B viral protein.
Izraza „pozitiven za antigen e“ in „negativen za antigen e“ se nanašata na prisotnost oziroma odsotnost antigena e, beljakovine virusa hepatitisa B. Če je ta beljakovina prisotna, se virus razmnožuje hitreje in virusno breme je lahko večje.
With regard to its risks, the side effects of Vemlidy are manageable.
Kar se tiče tveganj, so neželeni učinki zdravila Vemlidy obvladljivi.
In a study of 426 patients with ‘e-antigen negative' chronic hepatitis, 94% of patients on Vemlidy had very low levels of viral DNA after 48 weeks of treatment.
Zdravilo Vemlidy pri večini bolnikov zmanjšuje ravni virusa hepatitisa B. V študiji s 426 bolniki s kroničnim hepatitisom, negativnim za antigen e, je imelo 94 % bolnikov, zdravljenih z zdravilom Vemlidy, po 48 tednih zdravljenja zelo nizko raven virusne DNK.
How does Vemlidy work?
Kako zdravilo Vemlidy deluje?
The active substance in Vemlidy, tenofovir alafenamide, works by stopping the hepatitis B virus in the liver from multiplying.
Zdravilna učinkovina v zdravilu Vemlidy, alafenamidtenofovirat, virusu hepatitisa B v jetrih preprečuje razmnoževanje.
This medicine is used in patients aged 12 years and older weighing at least 35 kg.
To zdravilo se uporablja pri bolnikih, starejših od 12 let, s telesno maso vsaj 35 kg. Vsebuje zdravilno učinkovino alafenamidtenofovirat.
How is Vemlidy used?
Kako se zdravilo Vemlidy uporablja?
Vemlidy can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Vemlidy je le na recept.
These reactions usually regress within one week.
Reakcije navadno minejo v enem tednu.
Dogs (pregnant bitches)
Psi (breje psice)
Date of first authorisation: 26.03.2001 Date of last renewal: 18.04.2006
Datum pridobitve dovoljenja za promet: 26.03.2001 Datum podaljšanja dovoljenja za promet: 18.04.2006
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance :
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina:
This product contains mineral oil.
To zdravilo vsebuje mineralno olje.
Special precautions for use in animals: Vaccinate only healthy animals.
Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
Revaccination: during each pregnancy, according to the same schedule.
Ponovno cepljenje: v času vsake brejosti po enakem razporedu
Pharmacotherapeutic group : Inactivated viral vaccines ATCvet code: QI07AA06
Farmakoterapevtska skupina: Inaktivirana virusna cepiva Oznaka ATC vet: QI07AA06
Second injection: 1 to 2 weeks before the expected date of whelping.
Drugi odmerek: 1 do 2 tedna pred pričakovano kotitvijo.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
Solvent : homogeneous white emulsion
Vehikel: homogena bela emulzija
This vaccine is specifically indicated during pregnancy.
To cepivo je specifično indicirano za uporabo v času brejosti.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP.
EU/2/01/029/001 10 doses: powder (10 bottles) + solvent (10 bottles) EU/2/01/029/002 50 doses: powder (50 bottles) + solvent (50 bottles) EU/2/01/029/003 1 dose: powder (1 bottle) + solvent (1 bottle)
EU/2/01/029/001 10 odmerkov: prašek (10 vial) + vehikel (10 vial) EU/2/01/029/002 50 odmerkov: prašek (50 vial) + vehikel (50 vial) EU/2/01/029/003 1 odmerek: prašek (1 viala) + vehikel (1 viala)
EXP {month/year} Once reconstituted use immediately.
EXP {mesec/leto} Rekonstituirano zdravilo uporabite takoj.
Following reconstitution of the powder with the solvent, inject one dose (1ml) of the vaccine via the subcutaneous route, according to the following schedule:
Subkutano injiciranje enega odmerka (1ml) rekonstituiranega cepiva po naslednjem razporedu:
In order for immunity to be conferred to the puppies, sufficient intake of colostrum is required.
Za zagotovitev prenosa imunosti na mladiče, je potreben zadosten vnos kolostruma.
These are rare and appropriate symptomatic treatment should be administered.
Lahko se pojavi preobčutljivostna reakcija, ki je redka in jo je treba ustrezno simptomatično zdraviti.
First injection: Either during heat or 7 -10 days after the presumed date of mating.
Prva odmerek: ali v času estrusa ali 7 do 10 dni po verjetnem datumu parjenja.
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin)
Type I glass bottle containing powder for 1-dose and glass bottle containing 1-ml of solvent.
Viala iz stekla tipa I, ki vsebuje 1 odmerek praška in viala, ki vsebuje 1 ml vehikla.
Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg For the full list of excipients, see section 6.1.
Lahko parafinsko olje .................................................................................................. 224,8 do 244,1 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
The vaccine may commonly cause transient oedema at the site of injection.
Vnos cepiva lahko pogosto povzroči nastanek edema prehodnega značaja na mestu injiciranja.
- common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
- občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Powder and solvent for emulsion for injection Lyophilisate : white pellet.
Prašek in vehikel za emulzijo za injiciranje Liofilizat: bel pelet
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom razen s topilom, ki je priloženo za uporabo s tem cepivom.
No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of several doses.
Po vnosu večkratnih odmerkov niso opazili nobenih drugih neželenih učinkov, razen tistih navedenih v poglavju „Neželeni učinki“.
Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Škatla z 2 x 1 vialo, 2 x 10 vialami in 2 x 50 vialami.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Manufacturer responsible for batch release: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, France
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, Francija
Adjuvant:
Brejost:
Light paraffin oil
Lahko parafinsko olje
Overdose:
Preveliko odmerjanje:
This veterinary medicinal product contains mineral oil.
Namenjeno uporabniku: To zdravilo vsebuje mineralno olje.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim
Special precautions to be taken by the person administrating the veterinary medicinal product to animals:
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim: Namenjeno uporabniku:
Eurican Herpes 205 solvent
Eurican Herpes 205, vehikel
10 doses: powder (10 bottles) + solvent (10 bottles) 50 doses: powder (50 bottles) + solvent (50 bottles)
1 odmerek: prašek (1 viala) + vehikel (1 viala) 10 odmerkov: prašek (10 vial) + vehikel (10 vial) 50 odmerkov: prašek (50 vial) + vehikel (50 vial)
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life through passive immunity.
Aktivna imunizacija psic, za preprečevanje smrtnosti, kliničnih znakov in poškodb mladičev (s pasivno imunostjo), ki so posledica okužbe mladičev s pasjim herpesvirusom v prvih dneh življenja.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije MERIAL
Powder and solvent for emulsion for injection.
Prašek in vehikel za emulzijo za injiciranje
Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg Lyophilisate : white pellet.
Lahko parafinsko olje …………………………………………………………..…224,8 do 244,1 mg Liofilizat: bel pelet
Once reconstituted use immediately.
Uporabite takoj po rekonstituciji.
Abortion and premature parturition can occur as a result of CHV infection in bitches, the protection of the bitch against infection has not been studied for this vaccine.
Zaščita psice pred okužbo z virusom ni bila preučena za to cepivo.
Purified subunit vaccine for the active immunisation of pregnant bitches to induce passive immunity in puppies against herpesvirus-induced fatal neonatal disease.
Prečiščena podskupina cepiva za aktivno imunizacijo brejih psic in pasivno zaščito mladičev proti smrtnim neonatalnim boleznim, ki jih povzroča herpes virus.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGE(IH) SNOVI Zdravilna učinkovina
Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ............................................... 0.3 to 1.75 µg* *expressed in µg of gB glycoproteins
v 1- ml odmerku: antigeni pasjega herpesvirusa (sev F205) ........................................... 0,3 do 1,75 μg*
The reconstituted content shall be a milky emulsion.
Rekonstituirano cepivo je mlečno bela emulzija.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali)
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni) Po vnosu večkratnih odmerkov niso opazili nobenih drugih neželenih učinkov, razen tistih navedenih v poglavju „Neželeni učinki“.
SPECIAL WARNING(S), IF NECESSARY
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Nenamerno samoinjiciranje je nevarno.
Eurican Herpes 205 powder for injection
Eurican Herpes 205, prašek za injiciranje
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles
PODATKI NA ZUNANJI OVOJNINI Škatla s po 2x1 vialo, 2x10 vial in 2x50 vial
Shelf life of the veterinary medicinal product as packaged for sale: 24 months.
Rok uporabnosti zdravila v pakiranju za prodajo: 24 mesecev Rok uporabnosti po rekonstituciji v skladu z navodili: Uporabite takoj po rekonstituciji.
PACKAGE LEAFLET FOR: Eurican Herpes 205 powder and solvent for emulsion for injection
NAVODILO ZA UPORABO ZA: Eurican Herpes 205, prašek in vehikel za emulzijo za injiciranje
Eurican Herpes 205 powder and solvent for emulsion for injection
Eurican Herpes 205, prašek in vehikel za emulzijo za injiciranje
Polyoxyethylene fatty acids Ether of fatty alcohols and of polyols Triethanolamine
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi saharoza sorbitol dekstran 40 hidrolizirani kazein hidrolizirani kolagen soli polioksietilenske maščobne kisline eter maščobnih kislin in poliolov trietanolamin
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
DODATEK II A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA,
Aseptically reconstitute the contents of the powder with the solvent supplied with this vaccine.
Aseptično rekonstituirajte prašek in vehikel.
Shelf life after reconstitution: use immediately
EXP {mesec/leto} Uporabite takoj po rekonstituciji.
The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Viale so zaprte z butil elastomernim zamaškom in zaščitene z aluminijasto zaporko.
Casein hydrolysate Collagen hydrolysate Salts
*izraženo v μg gB glikoproteinov
Sorbitol
OVOJNINAH Viala
Withdrawal period
Ovojnina Vsebina
The European Commission granted a marketing authorisation valid throughout the European Union for Enviage to Novartis Europharm Limited on 22 August 2007.
Evropska komisija je dovoljenje za promet z zdravilom Enviage, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 22. avgusta 2007.
Enviage is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Zdravilo Enviage ni priporočeno za uporabo pri bolnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej starostni skupini.
Other information about Enviage:
Druge informacije o zdravilu Enviage:
It is available as tablets (pink and round: 150 mg; red and oval: 300 mg).
Na voljo je v obliki tablet (rožnate in okrogle: 150 mg; rdeče in ovalne: 300 mg).
‘Essential' means that the hypertension has no obvious cause.
Izraz „esencialna“ pomeni, da ni očitnega vzroka za hipertenzijo.
The medicine's effects were maintained for up to a year in two of the studies.
V dveh študijah so učinkovanje zdravila vzdrževali do enega leta.
Its use during the first three months of pregnancy and in women planning to become pregnant is not recommended.
Njegova uporaba ni priporočena v prvih treh mesecih nosečnosti ali pri ženskah, ki načrtujejo zanositev.
The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Krvni tlak so merili v „milimetrih živega srebra“ (mmHg).
This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients taking placebo.
Rezultate so primerjali z znižanjem za 5,8 mmHg od vrednosti 99,3 mmHg pri bolnikih, ki so jemali placebo.
The effects of Enviage were first tested in experimental models before being studied in humans.
Učinki zdravila Enviage so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The Committee recommended that Enviage be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Enviage odobri dovoljenje za promet.
It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Enviage.
Vzeti ga je treba z lahkim obrokom, najbolje vsak dan ob istem času, vendar pa se zdravilo Enviage ne sme vzeti skupaj s sokom grenivke.
Enviage was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Zdravilo Enviage so raziskali v 14 glavnih študijah, v katere je bilo vključenih več kot 10 000 bolnikov z esencialno hipertenzijo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ENVIAGE EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) ENVIAGE Povzetek EPAR za javnost
What is the risk associated with Enviage?
Kakšna tveganja so povezana z zdravilom Enviage?
What benefit has Enviage shown during the studies?
Kakšne koristi je zdravilo Enviage izkazalo med študijami?