FrancophonIA/ELRC3.0 huggingface dataset:
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF.
Slovenian: Aortitis je bil v večini primerov diagnosticiran s slikanjem CT in je na splošno izzvenel po ukinitvi G-CSF.
English: Instructions for use: Guide to parts Syringe before administration
Slovenian: Navodila za uporabo: Sestavni deli Brizga pred uporabo
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Grasustek.
Slovenian: Naključna izpostavljenost temperaturam v območju zmrzišča za enkratno obdobje do 24 ur nima neugodnega vpliva na stabilnost zdravila Grasustek.
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Slovenian: Spada v skupino beljakovin, imenovanih citokini, in je zelo podobna naravni beljakovini (granulocitne kolonije spodbujajočemu faktorju), ki nastaja v telesu.
English: If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Slovenian: Če bele krvničke padejo na nizko raven, jih lahko v telesu ne ostane dovolj, da bi se borile proti bakterijam,
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Slovenian: Potenciala za medsebojno delovanje z litijem, ki prav tako pospešuje sproščanje nevtrofilcev, niso posebej raziskali.
English: Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Slovenian: Zato morajo biti zdravniki previdni, kadar predpisujejo pegfilgrastim bolnikom s srpastimi celicami ali srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status ter biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
English: Your doctor has given you Grasustek to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Slovenian: Vaš zdravnik vam je predpisal zdravilo Grasustek, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki se vašemu telesu pomagajo boriti proti okužbam.
English: Κορίνθου 12, Ν. Ψυχικό, Ελλάδα τηλ 210 6776550-1
Slovenian: RAFARM A.E.B.E Κορίνθου 12, Ν. Ψυχικό, Ελλάδα τηλ 210 6776550-1
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common).
Slovenian: Neželena učinka, o katerih so najpogosteje poročali, sta bila bolečina v kosteh (zelo pogosto [≥1/10]) in mišičnoskeletna bolečina (pogosto).
English: See the end of section 4 for how to report side effects
Slovenian: Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.
English: Magyarország Aramis Pharma Kft 1095 Mester u. 28 Budapest Hungary
Slovenian: 1095 Mester u. 28 Budapest Hungary
English: Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials.
Slovenian: Možnih interakcij z drugimi hematopoetskimi rastnimi faktorji in citokini v kliničnih preskušanjih niso posebej raziskovali.
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Slovenian: • trebuh, razen v predelu 5 cm (2 palca) okrog popka;
English: There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Slovenian: Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko, zato tveganja za dojenega novorojenčka/otroka ne moremo izključiti.
English: Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Slovenian: Zaradi čezmernega stresanja se lahko pegfilgrastim aktivira, s čimer postane biološko neaktiven.
English: 2 This adverse reaction was identified through post-marketing surveillance of pegfilgrastim but not observed in randomised, controlled clinical trials in adults.
Slovenian: 2 Ti neželeni učinki so bili ugotovljeni med spremljanjem po obdobju trženja pegfilgrastima, niso pa jih opažali v randomiziranih, kontroliranih kliničnih preskušanjih pri odraslih.
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Slovenian: V kliničnih preskušanjih so pegfilgrastim varno dovajali 14 dni pred kemoterapijo.
English: What Grasustek is and what it is used for What you need to know before you use Grasustek How to use Grasustek
Slovenian: Kaj je zdravilo Grasustek in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Grasustek Kako uporabljati zdravilo Grasustek
English: Specific interaction or metabolism studies have not been performed; however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Slovenian: Posebnih študij medsebojnega delovanja ali presnove niso izvedli, vendar klinična preskušanja niso pokazala medsebojnega delovanja pegfilgrastima s katerim koli drugim zdravilom.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Slovenian: Tako kot pri drugih hematopoetskih rastnih faktorjih so tudi pri G-CSF pokazali, da in vitro spodbuja človeške endotelijske celice.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Grasustek therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Grasustek, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, še zlasti ne z raztopinami natrijevega klorida.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: • If you have sickle cell anaemia.
Slovenian: • če imate srpastocelično anemijo.
English: Grasustek is for use in adults aged 18 and over.
Slovenian: Zdravilo Grasustek je namenjeno uporabi pri odraslih, starih 18 let ali več.
English: How to use Grasustek
Slovenian: Kako uporabljati zdravilo Grasustek
English: Warning/Precaution: If the guard is not activated or only partially activated, discard the syringe without replacing the needle cover.
Slovenian: Opozorilo/previdnostni ukrep: Če varnostni ščitnik ni aktiviran ali pa je aktiviran le delno, brizgo zavrzite, ne da bi ponovno nameščali pokrovček igle.
English: The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Slovenian: Učinkovitosti tega zdravila ne gre primerjati z učinkovitostjo drugih pegiliranih ali nepegiliranih proteinov iz iste terapevtske skupine.
English: • general aches and pains in the joints and muscles.
Slovenian: • splošne bolečine ter bolečine v sklepih in mišicah;
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factors; ATC Code: L03AA13.
Slovenian: FARMAKOLOŠKE LASTNOSTI Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, kolonije spodbujajoči faktorji, oznaka ATC: L03AA13.
English: If you have a cough, fever and difficulty breathing please tell your doctor.
Slovenian: Če kašljate, imate vročino in težko dihate, o tem obvestite svojega zdravnika;
English: Dispose of the used medicine immediately in a Sharps container or as instructed by your healthcare provider.
Slovenian: Uporabljeno zdravilo takoj zavrzite v vsebnik za ostre odpadke ali ga zavrzite tako, kot vam je naročil vaš izvajalec storitev zdravstvenega varstva.
English: Syringe after administration (Guard is released and covers the needle)
Slovenian: Brizga po uporabi (Varnostni ščitnik je sproščen in prekriva iglo)
English: Grasustek is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Grasustek ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why, including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Slovenian: Če se ne odzivate več na zdravljenje s pegfilgrastimom ali z njim ni mogoče vzdrževati odziva, bo zdravnik preučil razloge za to, vključno s tem, ali so se vam pojavila protitelesa, ki nevtralizirajo delovanje pegfilgrastima.
English: Your doctor may monitor your condition more closely.
Slovenian: Zdravnik bo morda moral natančneje nadzirati vaše stanje;
English: Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Slovenian: Zdravljenje s pegfilgrastimom morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
English: Your doctor will check your blood and urine regularly as Grasustek can harm the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: Zdravnik bo redno pregledoval vašo kri in urin, saj lahko zdravilo Grasustek okvari drobne filtre v ledvicah (glomerulonefritis).
English: Step 3: Inject
Slovenian: 3. korak: Injiciranje
English: The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Slovenian: Neželeni dogodki so bili podobni tistim pri preiskovancih, ki so prejemali nižje odmerke pegfilgrastima.
English: Rates of generation of antibodies against pegfilgrastim are generally low.
Slovenian: Stopnje nastajanja protiteles proti pegfilgrastimu so v splošnem nizke.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Slovenian: Bolnike, pri katerih se pojavi simptom kapilarne prepustnosti, je treba natančno nadzorovati, deležni pa morajo biti tudi standardnega simptomatskega zdravljenja, ki lahko vključuje potrebo po intenzivni negi (glejte poglavje 4.8).
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/l) have been reported (see section 4.4).
Slovenian: Pogosto so poročali o primerih levkocitoze (število belih krvničk >100 × 109/l) (glejte poglavje 4.4).
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging findings.
Slovenian: Povečana hematopoetska aktivnost kostnega mozga kot odgovor na zdravljenje z rastnim faktorjem je bila povezana s prehodnimi pozitivnimi izvidi pri slikanju kosti.
English: Pinch your injection site to create a firm surface.
Slovenian: Stisnite mesto injiciranja, da boste ustvarili trdno površino.
English: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Slovenian: Pegfilgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic pri kumulativnih tedenskih odmerkih, ki so približno od 6- do 9-krat višji od priporočenega odmerka za človeka (na podlagi telesne površine) (glejte poglavje 5.3).
English: If you develop or are likely to develop cancers of the blood, you should not use Grasustek, unless instructed by your doctor.
Slovenian: Če se vam bodo pojavili ali je verjetno, da se vam bodo pojavili krvni raki, ne smete uporabljati zdravila Grasustek, razen če vam to naroči zdravnik.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Slovenian: splošnem so se dogodki glomerulonefritisa razrešili po zmanjšanju odmerka ali prenehanju jemanja filgrastima in pegfilgrastima.
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Slovenian: Pokazali so, da v živalskih modelih sočasna uporaba pegfilgrastima in 5-fluorouracila (5-FU) ali drugih antimetabolitov okrepi mielosupresijo.
English: Important Before you use a Grasustek pre-filled syringe with automatic needle guard, read this important information:
Slovenian: Pred uporabo napolnjene injekcijske brizge z avtomatičnim ščitnikom igle preberite naslednje pomembne informacije:
English: Pegfilgrastim has no or negligible influence on the ability to drive and use machines.
Slovenian: Pegfilgrastim nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Slovenian: Pegfilgrastim je kovalenten konjugat rekombinantnega človeškega G-CSF (r-metHuG-CSF) z eno samo molekulo 20 kd polietilenglikola (PEG).
English: What Grasustek is and what it is used for
Slovenian: Kaj je zdravilo Grasustek in za kaj ga uporabljamo
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, this medicinal product should be discontinued immediately.
Slovenian: Če število belih krvničk po pričakovanem padcu nato preseže vrednost 50 × 109/l, je treba zdravljenje s tem zdravilom takoj ukiniti.
English: Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Slovenian: Vzemite podlogo z napolnjeno injekcijsko brizgo iz pakiranja in pripravite opremo, potrebno za injiciranje: alkoholne robčke, kosem vate ali zloženec gaze, obliž in vsebnik za ostre odpadke (ni priloženo).
English: • Grasustek is given as an injection into the tissue just under the skin (subcutaneous use).
Slovenian: • Zdravilo Grasustek se injicira v tkivo tik pod kožo (subkutana uporaba).
English: Pull the needle cover straight off as shown, and handle the guard to avoid injuries or bending the needle.
Slovenian: Pokrovček igle povlecite naravnost dol, kot prikazuje slika, ter s pomočjo ščitnika pazite, da se ne poškodujete ali da igle ne upognete.
English: Do not shake Grasustek vigorously as this may affect its activity.
Slovenian: Zdravila Grasustek ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
English: The youngest age group (0-5
Slovenian: V najmlajši starostni skupini
English: Push the plunger while grasping the finger flanges.
Slovenian: Potiskajte bat in obenem držite oprijemalo za prste.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Slovenian: *Izdelano v celicah Escherichia coli s tehnologijo rekombinantne DNA, ki ji sledi konjugacija s polietilen glikolom (PEG).
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Slovenian: Dokazali so, da imata pegfilgrastim in filgrastim enak način delovanja, saj v 24 urah povzročita izrazito zviševanje števila nevtrofilcev v periferni krvi, medtem ko je zvišanje monocitov in/ali limfocitov manjše.
English: Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Slovenian: Opis izbranih neželenih učinkov Občasno so poročali o primerih Sweetovega sindroma, vendar ima v nekaterih primerih lahko pri tem vlogo osnovna maligna hematološka bolezen.
English: Grasustek may be used if it is accidentally frozen for a single period of less than 24 hours.
Slovenian: Zdravilo Grasustek smete uporabiti, če je bilo pomotoma zamrznjeno eno samo obdobje, krajše od 24 ur.
English: • Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
Slovenian: • Sweetov sindrom (izbočene, boleče spremembe slivove barve na okončinah in včasih tudi na obrazu in vratu s povišano telesno temperaturo), vendar na to lahko vplivajo tudi drugi dejavniki;
English: • The grey needle cap is missing or not securely attached.
Slovenian: • sivi pokrovček igle manjka ali pa ni trdno nameščen;
English: Grasustek is a biosimilar medicinal product.
Slovenian: Zdravilo Grasustek je biološko podobno zdravilo.
English: Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia.
Slovenian: Posebna previdnost je potrebna med dovajanjem posameznih zdravil za kemoterapijo ali njihovih kombinacij, za katera je znano, da povzročajo hudo trombocitopenijo.
English: • if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
Slovenian: • če se vam pojavijo nenadni znaki alergije, kot so izpuščaj, srbečica ali koprivnica na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, kratka sapa, piskajoče ali oteženo dihanje.
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Slovenian: Pojav pljučnih znakov, kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov, in poslabšanje pljučne funkcije skupaj z zvečanim številom nevtrofilcev utegnejo biti preliminarni znaki sindroma dihalne stiske odraslih (ARDS - Adult Respiratory Distress Syndrome).
English: • If you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia).
Slovenian: • če ste seznanjeni z morebitnimi spremembami števila krvnih celic (npr. s povečanjem števila belih krvničk ali anemijo) ali z zmanjšanim številom krvnih ploščic v krvi, kar zmanjša sposobnost strjevanja krvi (trombocitopenija).
English: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Slovenian: Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - Absolute Neutrophil Count) pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6miligramski injekciji
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Slovenian: Izločanje pegfilgrastima je glede na odmerek nelinearno; serumski očistek pegfilgrastima se z naraščajočim odmerkom zmanjšuje.
English: The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Slovenian: Varnost in učinkovitost pegfilgrastima za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Slovenian: Navzeo in glavobole so pri bolnikih, ki so prejemali kemoterapijo, opazili zelo pogosto.
English: Use a new prefilled syringe and call your doctor or healthcare provider.
Slovenian: Uporabite novo napolnjeno injekcijsko brizgo in se obrnite na svojega zdravnika ali izvajalca storitev zdravstvenega varstva.
English: The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Slovenian: Varnost in učinkovitost uporabe zdravila Grasustek pri bolnikih z de novo AML, mlajših od 55 let, in s citogenetiko t(15;17), nista dokazani.
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.
Slovenian: To zdravilo se ne sme uporabljati za povečevanje odmerka citotoksične kemoterapije preko odmerkov iz uveljavljenih shem odmerjanja.
English: Grasustek may be exposed to room temperature (not above 30 °C) for a maximum single period of up to 72 hours.
Slovenian: Zdravilo Grasustek je lahko izpostavljeno sobni temperaturi (vendar ne temperaturi nad 30 °C) za enkratno obdobje, ki ne sme preseči 72 ur.
English: In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Slovenian: V takem primeru je treba pegfilgrastim po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje (glejte poglavje 4.8).
English: • damage to the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: • okvara drobnih filtrov v ledvicah (glomerulonefritis);
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Slovenian: Varnost in učinkovitost pegfilgrastima pri bolnikih z mielodisplastičnim sindromom, kronično mielogeno levkemijo in s sekundarno AML nista raziskani, zato ga pri takšnih bolnikih ne smete uporabljati.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Slovenian: To je lahko znak sindroma akutne dihalne stiske (ARDS);
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Slovenian: Skladno s kliničnimi učinki in potencialom za levkocitozo je treba med zdravljenjem v rednih presledkih preverjati število belih krvničk.
English: If you have forgotten a dose of Grasustek, contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste si pozabili injicirati zdravilo Grasustek Če ste si pozabili injicirati odmerek zdravila Grasustek, se morate posvetovati z zdravnikom, da se bosta dogovorila, kdaj si morate injicirati naslednji odmerek.
English: Your doctor may want to monitor you more closely
Slovenian: Zdravnik vas bo morda moral natančneje nadzirati;
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Slovenian: Po enem samem subkutanem odmerku pegfilgrastima se najvišja serumska koncentracija pegfilgrastima pojavi od 16 do 120 ur po odmerku, serumske koncentracije pegfilgrastima pa se vzdržujejo v obdobju nevtropenije po mielosupresivni kemoterapiji.
English: Open the blister by peeling back the top layer all the way off the blister as shown.
Slovenian: Odprite pretisni omot tako, da z njega v celoti odlepite zgornji sloj, kot kaže slika.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Examine the injection site.
Slovenian: Preglejte mesto injiciranja.
English: Grasustek has not been tested in pregnant women.
Slovenian: Zdravila Grasustek pri nosečnicah niso preskusili.