FrancophonIA/ELRC3.0 huggingface dataset:
English: Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Prašek saharoza glicin glutaminska kislina natrijev klorid polisorbat 80 natrijev hidroksid
English: 12 mg pack:
Slovenian: 12-miligramsko pakiranje:
English: 1/3 of the matrix
Slovenian: 1/3 matriksa
English: The proportion of patients with healed soft-tissue wounds was significantly higher at the 6-week post-treatment visit in the InductOs 1.5 mg/ml group compared with the standard-care group (83% versus 65%; P= 0.0010).
Slovenian: Ob kontrolnem pregledu 6 tednov po zdravljenju je bil delež bolnikov z zaceljenimi ranami mehkih tkiv v skupini, zdravljeni z 1,5 mg/ml zdravila InductOs, značilno večji kot v skupini s standardno oskrbo (83 % v primerjavi s 65 %; P=0,0010).
English: In long-bone fracture studies, 6.3% of patients receiving dibotermin alfa with bovine Type I collagen matrix developed antibodies to dibotermin alfa versus 1.3% in the control group.
Slovenian: V raziskavah zlomov dolgih kosti so se protitelesa proti diboterminu alfa pojavila pri 6,3 % bolnikov, ki so prejeli dibotermin alfa z matriksom iz govejega kolagena tipa I, v primerjavi z 1,3 % oseb v kontrolni skupini.
English: − If you get any side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4 mg dibotermin alfa
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 4 mg dibotermina alfa
English: 4 mg pack:
Slovenian: 4-miligramsko pakiranje:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mg dibotermin alfa
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 12 mg dibotermina alfa
English: Peel open the interior package of the matrices and leave the matrices in their trays.
Slovenian: Odprite notranjo ovojnino ogrodja in pustite ogrodje v njegovem pladnju.
English: Use of InductOs may cause heterotopic ossification at the site of implantation and/or the surrounding tissues, which may result in complications.
Slovenian: Uporaba zdravila InductOs lahko povzroči heterotopično kostenenje v okolnih tkivih, ki lahko povzroči zaplete.
English: Device dislocation can occur after the use of InductOs in spinal fusion surgery that may necessitate surgical revision (see section 4.8).
Slovenian: Po uporabi zdravila InductOs pri operacijah fuzije hrbtenice je možna migracija vstavka, zaradi česar utegne biti potrebna operativna revizija (glejte poglavje 4.8).
English: Increased breakdown of the bone
Slovenian: zvečana razgradnja kosti.
English: Bovine Type I collagen
Slovenian: Ogrodje goveji kolagen tipa I
English: Using the remaining syringe and needle from the pack, reconstitute the dibotermin alfa vial with 3.2 ml of solvent.
Slovenian: S pomočjo druge brizge in igle iz pakiranja pripravite dibotermin alfa v viali s 3,2 ml vehikla.
English: The safety and efficacy of InductOs in cervical spine surgery have not been established, and InductOs should not be used in this condition.
Slovenian: Varnosti in učinkovitosti zdravila InductOs pri operacijah vratne hrbtenice niso ugotovili in zdravila InductOs pri takih operacijah ne smemo uporabljati.
English: Bone resorption increased
Slovenian: Zvečana resorpcija kosti
English: Heterotopic ossification1, 3*
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva heterotopično kostenenje1,3*
English: Pre-Implantation
Slovenian: Pred implantacijo
English: When reconstituted, contains 1.5 mg/ml dibotermin alfa.
Slovenian: Po rekonstituciji vsebuje 1,5 mg/ml dibotermina alfa.
English: Using aseptic transfer technique and the syringe and needle from step 1, withdraw 8.0 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field, holding up the inverted vial to facilitate withdrawal.
Slovenian: Uporabljajoč tehniko aseptičnega prenosa in brizgo z iglo iz točke 1 izvlecite 8,0 ml pripravljene raztopine dibotermina alfa iz viale v nesterilnem območju.
English: The matrix is pre-cut in 2 pieces each of 2.5 x 5 cm.
Slovenian: 4-miligramsko pakiranje: Matriks je že narezan v 2 kosa po 2,5 x 5 cm.
English: • Powder in a vial (20 ml; Type I glass) with a stopper (bromobutyl rubber).
Slovenian: • prašek v viali (20 ml; steklo tipa I) z zamaškom (iz bromobutilne gume),
English: Dibotermin alfa was not detectable in serum.
Slovenian: Dibotermina alfa v vzorcih ni bilo zaznati.
English: Malignancy
Slovenian: Malignost
English: InductOs contains the active substance, dibotermin alfa.
Slovenian: Zdravilo InductOs vsebuje zdravilno učinkovino dibotermin alfa.
English: The safety and effectiveness of InductOs in spine surgery in the neck have not been established, and InductOs should not be used in this situation.
Slovenian: Varnost in učinkovitost uporabe zdravila InductOs pri operacijah vratne hrbtenice nista ugotovljeni, zato naj se zdravilo InductOs v takih primerih ne uporablja.
English: Using aseptic transfer technique and the syringe and needle from step 1, withdraw 2.8 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field, holding up the inverted vial to facilitate withdrawal.
Slovenian: Uporabljajoč tehniko aseptičnega prenosa in brizgo z iglo iz točke 1 izvlecite 2,8 ml pripravljene raztopine dibotermina alfa iz viale v nesterilnem območju.
English: Using the remaining syringe and needle from the pack, reconstitute the dibotermin alfa vial with 8.4 ml of solvent.
Slovenian: S pomočjo druge brizge in igle iz pakiranja pripravite dibotermin alfa v viali z 8,4 ml vehikla.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Powder, solvent and matrix for implantation matrix.
Slovenian: FARMACEVTSKA OBLIKA prašek, vehikel in ogrodje za matriks za implantacijo Prašek je bele barve.
English: • Powder in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
Slovenian: • prašek v viali (10 ml; steklo tipa I) z zamaškom (iz bromobutilne gume),
English: • used in surgical techniques other than lumbar interbody fusion To avoid exaggerated pharmacological effects of InductOs, care and caution should be used to prevent overfilling the lumbar interbody fusion device and/or the anterior portion of the intervertebral disc space.
Slovenian: Pri uporabi moramo biti previdni in pozorni, da preprečimo prekomerno napolnjenje vstavka za interkorpusno fuzijo ledvene hrbtenice in/ali prednjega dela medvretenčnega prostora, da se izognemo pretiranim farmakološkim učinkom zdravila InductOs.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 12 mg dibotermin alfa.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 12 mg dibotermina alfa.
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Post-Implantation
Slovenian: Po implantaciji
English: Generally, one 12 mg pack is used; however, a maximum of two 12 mg packs may be used.
Slovenian: Uporabiti se smeta največ dve 12-miligramski pakiranji.
English: The possibility of an immune response to the product should be considered in cases where an undesirable effect with immunological background is suspected.
Slovenian: V primerih, kjer obstaja sum, da so neželeni učinki imunskega porekla, je treba pomisliti na možnost avtoimunega odziva na zdravilo.
English: 2 needles
Slovenian: 2 igli
English: 1 vial with 4 mg dibotermin alfa 1 vial with 10 ml water for injections 2 sterile matrices (2.5 x 5 cm) 2 syringes (5 ml)
Slovenian: Prašek, vehikel in ogrodje za matriks za implantacijo vsebuje: 1 vialo s 4 mg dibotermina alfa 1 vialo z 10 ml vode za injekcije 2 sterilni ogrodji (2,5 x 5 cm)
English: Forceps should be used to handle InductOs.
Slovenian: Za rokovanje z zdravilom InductOs uporabite pinceto.
English: • Solvent in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
Slovenian: • vehikel v viali (10 ml; steklo tipa I) z zamaškom (iz bromobutilne gume),
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg dibotermin alfa.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 4 mg dibotermina alfa.
English: Dosing table for InductOs 12 mg pack Portion of InductOs wetted matrix (12 mg pack)
Slovenian: Delež navlaženega matriksa InductOs (12-miligramsko pakiranje)
English: The volume of InductOs to be implanted is determined by the fracture anatomy and the ability to close the wound without overly packing or compressing the product.
Slovenian: Od anatomije zloma in od zmožnosti, da boste zaprli rano, ne da bi zdravilo preveč natlačili ali stisnili, bo odvisno, kolikšen volumen zdravila InductOs boste implantirali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 12 MG PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA KOMPLETA ZA 12 MG PAKIRANJE
English: Morphogenetic Protein-2), 4 mg (4 mg pack) or 12 mg (12 mg pack).
Slovenian: Kaj vsebuje zdravilo InductOs - Zdravilna učinkovina v zdravilu InductOs je dibotermin alfa (imenovan tudi rekombinantni humani protein za morfogenezo kosti-2) v odmerku 4 mg (4-miligramsko pakiranje) ali 12 mg (12-miligramsko pakiranje).
English: Entire matrix
Slovenian: 8 mg celotni matriks
English: • Localised swelling, in some cases resulting in breathing difficulty, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine.
Slovenian: • Pri bolnikih, pri katerih so zdravilo InductOs uporabili pri operacijah na zgornjem (vratnem) delu hrbtenice, so poročali o lokaliziranem otekanju, ki je v nekaterih primerih povzročilo oteženo dihanje.
English: Lumbar interbody fusion surgery
Slovenian: Operacija za interkorpusno fuzijo ledvene hrbtenice
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 4 MG PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA KOMPLETA ZA 4 MG PAKIRANJE
English: After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa.
Slovenian: Po rekonstituciji zdravilo InductOs vsebuje 1,5 mg/ml dibotermina alfa.
English: Fractures of the shin bone
Slovenian: PEEK ali kosti;
English: The wetted matrix should be cut into 6 equal pieces (approximately 2.5 x 5 cm) as an aid for dose selection.
Slovenian: (približno 2,5 x 5 cm velikih) za pomoč pri izbiri odmerka.
English: 4 CLINICAL PARTICULARS
Slovenian: KLINIČNI PODATKI
English: The incidence of adverse reactions with InductOs was not affected by gender, age or race.
Slovenian: Spol, starost ali rasa ne vplivajo na incidenco neželenih učinkov z zdravilom InductOs.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TRAY TOP LID LABEL FOR 12 MG PACK
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA POKROVU PLADNJA ZA 12 MG PAKIRANJE
English: NAME OF THE MEDICINAL PRODUCT Matrix for InductOs 1.5 mg/ml Bovine Type I collagen
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ogrodje za InductOs 1,5 mg/ml goveji kolagen tipa I
English: InductOs is prepared immediately prior to use.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo InductOs se pripravlja neposredno pred uporabo.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TRAY TOP LID LABEL FOR 4 MG PACK
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA POKROVU PLADNJA ZA 4 MG PAKIRANJE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL PROTEIN LABEL FOR 4 MG PACK
Slovenian: NALEPKA NA VIALI S PROTEINOM ZA 4 MG PAKIRANJE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL PROTEIN LABEL FOR 12 MG PACK
Slovenian: NALEPKA NA VIALI S PROTEINOM ZA 12 MG PAKIRANJE
English: Powder:
Slovenian: PC:
English: 7 MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Cervical spine surgery
Slovenian: Operacija vratne hrbtenice
English: Localised oedema associated with the use of InductOs has been reported in patients undergoing cervical spine surgery.
Slovenian: Pri bolnikih, ki so imeli operacijo vratne hrbtenice, so poročali o lokaliziranem edemu, ki je bil povezan z uporabo zdravila InductOs.
English: Device dislocation
Slovenian: Migracija vstavka
English: OTHER
Slovenian: do
English: Disinfect the stoppers of the dibotermin alfa and solvent vials.
Slovenian: Razkužite zamaška vial z diboterminom alfa in vehiklom.
English: Fluid collections
Slovenian: Kopičenje tekočine
English: BATCH NUMBER Lot
Slovenian: ŠTEVILKA SERIJE Serija
English: Excipients
Slovenian: InductOs.
English: 6 PHARMACEUTICAL PARTICULARS
Slovenian: FARMAKOLOŠKE LASTNOSTI
English: Dosing table for InductOs 4 mg pack InductOs wetted matrices (4 mg pack)
Slovenian: NALEPKA NA MATRIKSU ZA 4 MG PAKIRANJE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TRAY UNDERSIDE OF LID STICKER FOR 4 MG PACK
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA NOTRANJI STRANI POKROVA PLADNJA ZA 4 MG PAKIRANJE
English: Posology
Slovenian: DRUGI PODATKI
English: The matrix is in 1 piece of 7.5 cm x 10 cm.
Slovenian: 12-miligramsko pakiranje: Matriks je iz 1 kosa velikosti 7,5 cm x 10 cm. Razrežite navlaženi matriks na 6 enakih kosov
English: No impact on fertility was detected in non-clinical studies.
Slovenian: Predklinične študije niso pokazale vpliva na sposobnost razmnoževanja.
English: Dried bilberry fruit should only be used in adults and children over the age of 12 years.
Slovenian: Suh plod borovnice se sme uporabljati samo pri odraslih in otrocih, starejših od 12 let.
English: Dried bilberry fruit EMA/895398/2015
Slovenian: Suh plod borovnice EMA/685398/2015
English: This summary is not intended to provide practical advice on how to use medicines containing dried bilberry fruit.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo suh plod borovnice.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of dried bilberry fruit.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo suhega ploda borovnice.
English: Further information on the risks associated with dried bilberry fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo suh plod borovnice, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC noted the lack of clinical studies with dried bilberry fruit for these uses.
Slovenian: Odbor HMPC je ugotovil pomanjkanje kliničnih študij s suhim plodom borovnice pri teh vrstah uporabe.
English: Dried bilberry fruit is the common name for the dried fruit of the plant Vaccinium myrtillus L. Dried bilberry fruit preparations are obtained by comminuting (reducing into tiny pieces) the ripe, dry fruit.
Slovenian: Suh plod borovnice je splošno ime za suh plod rastline Vaccinium myrtillus L. Pripravki s suhim plodom borovnice se pridobivajo z drobljenjem (zmanjševanjem na majhne delce) zrelega, suhega plodu.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing dried bilberry fruit.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo suh plod borovnice.
English: Information on the use and licensing of dried bilberry fruit medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo suh plod borovnice, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Herbal medicines containing dried bilberry fruit are usually available as herbal tea to be drunk or used to rinse the mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo suh plod borovnice, so navadno na voljo kot zdravilni čaj, ki se popije ali uporabi za izpiranje ust.
English: Dried bilberry fruit can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Suh plod borovnice je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Further information on the HMPC assessment of dried bilberry fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo suh plod borovnice, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing dried bilberry fruit have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo suh plod borovnice, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: How are dried bilberry fruit medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo suh plod borovnice, odobrena v EU?
English: The HMPC conclusions on the use of dried bilberry fruit medicines for treating mild diarrhoea and minor inflammation of the lining of the mouth are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo suh plod borovnice, za zdravljenje blage driske in blažjega vnetja ustne sluznice temeljijo na njihovi „tradicionalni uporabi“.
English: What is dried bilberry fruit?
Slovenian: Kaj je suh plod borovnice?
English: Dried bilberry fruit
Slovenian: Suh plod borovnice
English: Results from laboratory studies, although limited, indicate that the tannins in dried bilberry fruit have antimicrobial and astringent properties which can explain the traditional use of the dried fruit for treating mild diarrhoea and minor inflammation of the lining of the mouth.
Slovenian: Rezultati laboratorijskih študij, čeprav jih je malo, kažejo, da imajo tanini v suhem plodu borovnice protimikrobne in adstringentne lastnosti, s katerimi lahko pojasnimo tradicionalno uporabo suhega plodu pri zdravljenju blage driske in blažjega vnetja ustne sluznice.
English: Detailed instructions on how to take dried bilberry fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo suh plod borovnice, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Other information about dried bilberry fruit medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo suh plod borovnice
English: What evidence supports the use of dried bilberry fruit medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo suh plod borovnice?
English: For more information about treatment with dried bilberry fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo suh plod borovnice, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with dried bilberry fruit medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo suh plod borovnice?
English: The HMPC concluded that, on the basis of its long-standing use, dried bilberry fruit can be used for the treatment of mild diarrhoea and minor inflammation of the lining of the mouth.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko suh plod borovnice uporablja za zdravljenje blage driske in blažjega vnetja ustne sluznice.
English: For practical information about using dried bilberry fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: At the time of the HMPC assessment, no side effects had been reported with dried bilberry fruit medicines.
Slovenian: V času ocene odbora HMPC v zvezi z zdravili, ki vsebujejo suh plod borovnice, ni bilo poročil o neželenih učinkih.
English: A doctor or a qualified healthcare practitioner should be consulted if symptoms persist for more than 3 days when treating mild diarrhoea or for more than 1 week for inflammation of the lining of the mouth.
Slovenian: Če simptomi med zdravljenjem blage driske trajajo dlje kot 3 dni ali več kot 1 teden pri vnetju ustne sluznice, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: Similar analyses were performed.
Slovenian: Izvedene so bile podobne analize.
English: 95% Confidence Interval
Slovenian: 95-odstotni interval zaupanja
English: The rest of the studies have been submitted in the form of published literature.
Slovenian: Preostale študije so bile predložene v obliki objavljene literature.
English: UPA has been approved in 73 countries worldwide and it is being marketed for five years.
Slovenian: UPA je odobren v 73 državah po vsem svetu in je na trgih na voljo pet let.
English: LNG is a synthetic progestagen.
Slovenian: LNG je sintetični progestogen.
English: Ulipristal acetate (UPA)
Slovenian: Ulipristalacetat (UPA)
English: Benefit -risk balance
Slovenian: Razmerje med tveganji in koristmi
English: For emergency contraception one tablet of 1.5 mg LNG needs to be taken, or two tablets of 0.75 mg LNG at once.
Slovenian: Za urgentno kontracepcijo je treba vzeti eno tableto, ki vsebuje 1,5 mg LNG, ali dve tableti, ki vsebujeta 0,75 mg LNG, hkrati.
English: Table 3: Meta-analysis on four clinical studies conducted with UPA
Slovenian: Razpredelnica 3: Metaanaliza štirih kliničnih študij, izvedenih z UPA
English: However, the analyses are based on a limited number of women, especially in the highest body weight/BMI categories, which subsequently result in very wide and overlapping 95% confidence limits.
Slovenian: Vendar so analize temeljile na omejenem številu žensk, zlasti v skupinah z največjimi telesnimi masami/najvišjimi ITM, kar je povzročilo zelo široke in prekrivajoče se meje 95-odstotnega intervala zaupanja.
English: Further, in all women emergency contraception should be taken as soon as possible after unprotected intercourse.
Slovenian: Poleg tega morajo vse ženske urgentni kontraceptiv vzeti čim prej po nezaščitenem spolnem odnosu.
English: It is unknown what the explanation is for the contradicting results in both meta-analyses.
Slovenian: Kakšen je vzrok za nasprotujoče si rezultate obeh metaanaliz, ni znano.
English: The data used in the analyses of effect of UPA in relation to weight/BMI are partly based on the same studies two abovementioned studies for LNG, and another randomised controlled study (HRA2914-507, HRA2914-508, HRA2914-513) as well as an open label study (HRA2914-509).
Slovenian: Podatki, ki so bili uporabljeni v analizah učinka UPA glede na telesno maso/ITM, delno temeljijo na istih dveh študijah, ki sta opisani zgoraj za LNG, ter na še eni randomizirani kontrolirani študiji (HRA2914507, HRA2914-508, HRA2914-513) in eni odprti študiji (HRA2914-509).