natgillin/translations-raw huggingface dataset:
Since safety after giving both inoculations at the same site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.
Varnost dajanja obeh odmerkov na isto mesto ni raziskana, zato je pri drugem cepljenju odmerek priporočljivo dati na drugo mesto kot prvič.
The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Uvoz, prodaja, oskrba in/ali uporaba zdravila Porcilis Pesti je dovoljena samo pod določenimi pogoji, ki jih predpisuje zakonodaja Evropske skupnosti za nadzor nad KPK (Direktiva Sveta 80/217/EGS, z vsemi spremembami).
As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigen, other than E2.
Ker je uporabljena podenota, cepljenje ne povzroči nastanka protiteles proti drugim antigenom virusa KPK, razen proti E2.
Transient hyperthermia may occur post the second dose.
Po drugem cepljenju je možna prehodna hipertermija.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
Abscesses may be observed at the injection site.
Na mestu injiciranja se lahko pojavijo abscesi.
NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Pesti emulsion for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis Pesti, emulzija za injiciranje za prašiče
DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant: 941.4 mg
120 Elisa enot antigenskih podenot E2 virusa klasične prašičje kuge Tekoči parafin kot adjuvans: 941,4 mg
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN>IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
INDICATION(S) Vaccine against Classical Swine Fever
INDIKACIJE Cepivo proti klasični prašičji kugi
Active substance: Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa Units (EU)
Virus klasične prašičje kuge (KPK) - antigenska podenota E2: 120 Elisa enot (EU) Dodatek:
Manufacturer responsible for batch release
Izdelovalec, odgovoren za sprostitev serije:
A local and in most cases transient swelling at the injection site may occur up to 4 weeks after administration of each dose of the vaccine.
Do 4 tedne po vsakem odmerku cepiva se lahko pojavi lokalna in večinoma prehodna oteklina na mestu injiciranja.
METHOD AND ROUTE(S) OF ADMINISTRATION IM injection of 2 ml
NAČIN IN POT(I) UPORABE 2 ml i.m.
Can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
Lahko se uporablja v obdobju brejosti, vendar pa ne prepreči transplacentarnega prenosa naravnega virusa klasične prašičje kuge z matere na zarodke.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 120 Elisa Units CSF E2 antigen/2ml.
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) 120 Elisa enot antigena KPK E2/2 ml
The product can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
Zdravilo se lahko uporablja v obdobju brejosti, vendar pa ne prepreči transplacentarnega prenosa naravnega virusa klasične prašičje kuge z matere na zarodke.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 2 ml contains:
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Odmerek po 2 ml vsebuje:
PACKAGE SIZE 50 ml (25 doses) - 100 ml (50 doses) - 250 ml (125 doses)
VELIKOST PAKIRANJA 50 ml (25 odmerkov) - 100 ml (50 odmerkov) - 250 ml (125 odmerkov)
MINIMUM PARTICULARS TO APPEAR ON Bottle Label {50ml/100ml/250ml }
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA nalepki stekleničke {50 ml/100 ml/250 ml}
EXPIRY DATE <EXP {month/year}> Once broached, use within 3 hours.
DATUM IZTEKA ROKA UPORABNOSTI <EXP> {mesec/leto}
{DD/MM/YYYY}
DATUM REVIZIJE BESEDILA {DD/MM/LLLL}
Adjuvant: 941.4 mg liquid paraffin
941,4 mg tekočega parafina Pomožne snovi:
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 50 ml (25 doses) - 100 ml (50 doses) - 250 ml (125 doses)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 50 ml (25 odmerkov) - 100 ml (50 odmerkov) - 250 ml (125 odmerkov)
QUALITATIVE AND QUANTITATIVE COMPOSITION
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
Polysorbate 80
6.1 Seznam pomožnih snovi polisorbat 80 sorbitan oleat
50 ml/100 ml/250 ml multidose PET bottle
Večodmerna steklenička po 50 ml/100 ml/250 ml Večodmerna plastenka iz PET po 50 ml/100 ml/250 ml
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL-5831 AN Boxmeer Nizozemska
6.5 Nature and composition of immediate packaging Bottles of type I hydrolytic glass or polyethylene terephthalate (PET) containing 50 ml for 25 doses, 100 ml for 50 doses and 250 ml for 125 doses presentation.
Stekleničke iz stekla 1. hidrolitične skupine ali polietilen tereftalata (PET) po 50 ml za 25 odmerkov, po 100 ml za 50 odmerkov in po 250 ml za 125 odmerkov Stekleničke so zaprte z zamaški iz nitrilne gume in zaporkami iz aluminija s šifro.
Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
S tem se preprečuje smrtnost, zmanjšujejo pa se tudi klinični znaki klasične prašičje kuge.
Liquid paraffin : 941.4 mg
120 Elisa enot antigena KPK-E2 Tekoči parafin: 941,4 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGE {50ml Bottle/ 100ml Bottle/250ml Bottle}
PODATKI NA ZUNANJI OVOJNINI {steklenička po 50 ml/ steklenička po 100 ml/ steklenička po 250 ml}
ROUTE(S) OF ADMINISTRATION IM injection
POT(I) UPORABE ZDRAVILA
MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number}
ŠTEVILKA SERIJE <Serija> {številka}
It is important that your hands and the items you use are as clean as possible.
Pomembno je, da so vaše roke in predmeti, ki jih boste uporabljali, kolikor je mogoče čisti.
• Headache, feeling tired.
• glavobol, občutek utrujenosti.
Studies on carcinogenic potential were not performed.
Študij o kancerogenem potencialu niso izvedli.
Assemble everything you need.
Pripravite vse, kar potrebujete.
Multiple pregnancy may lead to medical complications for you and your babies.
Večplodna nosečnost lahko povzroči zdravstvene zaplete za vas in vašega otroka.
• Find a clean area and a flat surface.
• Poiščite čist prostor in ravno površino.
The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
V nadaljevanju se uporabljajo naslednje definicije navedbe pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (>1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
It is best to put it back into its original package.
Najbolje je, da ga položite nazaj v originalno ovojnino.
Clinical investigation in women for the indication of ART and anovulation was limited to one treatment cycle.
Klinične raziskave pri ženskah za indikacijo ART in anovulacijo so omejene na en ciklus zdravljenja.
However, the in-use stability has been demonstrated for 24 hours at + 2°C to 8°C.
Vendar pa je bila dokazana stabilnost pripravljene raztopine 24 ur pri +2 °C do 8 °C.
• Extrauterine pregnancy in the previous 3 months
• zunajmaternična nosečnost v zadnjih 3 mesecih
After opening, the medicinal product should be used immediately.
Po odprtju morate zdravilo takoj uporabiti.
OHSS was observed in approximately 4% of patients treated with Ovitrelle.
OHSS so opazili pri približno 4 % bolnic, zdravljenih z zdravilom Ovitrelle.
Dispose of all used items:
Odstranite vse uporabljene predmete:
This instructions for use was last revised in:
Navodilo za uporabo je bilo nazadnje revidirano:
In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Pri teh ženskah je treba prednosti dajanja gonadotropina pretehtati glede na tveganja.
Do not use Ovitrelle if any of the above applies to you.
Ne uporabljajte zdravila Ovitrelle, če kar koli od zgoraj navedenega velja za vas.
• Malformations of sexual organs incompatible with pregnancy
• malformacije spolnih organov, ki niso združljive z nosečnostjo,
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
It must be discarded if not used after these 30 days.
Raztopino morate zavreči, če je ne uporabite v teh 30 dneh.
OHSS due to excessive ovarian response can be avoided by withholding hCG administration.
OHSS zaradi čezmernega odziva jajčnikov se je mogoče izogniti z opustitvijo dajanja hCG.
If you do not see any liquid, you may try a second time (you may do this a maximum of two times) starting from step 1 of section “If you do not see a tiny drop(s) of fluid at or near the tip” above.
Če ne vidite tekočine, lahko poskusite še drugič (to lahko naredite največ dvakrat), pri čemer začnete s korakom 1 poglavja "Če prvič ne opazite drobnih kapelj na ali blizu konice igle" zgoraj.
• The dose number shown in the dose display will turn back to ‘0'.
• Številka, ki označuje nastavljeni odmerek v prikazu odmerka, se bo povrnila na "0".
Severe OHSS was reported in less than 0.5% of patients (see section 4.4).
O hudem OHSS so poročali pri manj kot 0,5 % bolnic (glejte poglavje 4.4).
• Local reactions at the injection site, such as pain, redness or swelling.
• lokalne reakcije na mestu injiciranja kot so bolečina, pordelost ali oteklina
Use each needle and pen only once.
Vsako iglo in peresnik uporabite samo enkrat.
• The dose display should show “250”, shown in the figure below.
• Prikaz odmerka mora kazati »250«, kot je prikazano na sliki spodaj.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 February 2001
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 02. februar 2001 Datum zadnjega podaljšanja: 02. februar 2006
Children and adolescents Ovitrelle is not for use in children and adolescents.
Otroci in mladostniki Zdravilo Ovitrelle ni primerno za uporabo pri otrocih in mladostnikih.
• Allergic reactions such as fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing, or serious breathing difficulty are very rare (may affect up to 1 in 10,000 people).
• Alergijske reakcije, kot so hiter ali neenakomeren utrip, oteklost jezika in grla, kihanje, sopenje ali resne težave z dihanjem so zelo redke (pojavijo se lahko pri največ 1 od 10.000 bolnikov).
Stop using Ovitrelle and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Takoj prenehajte uporabljati zdravilo Ovitrelle in pojdite k zdravniku, če opazite katerega koli od naslednjih resnih neželenih učinkov, saj morda potrebujete nujno medicinsko zdravljenje:
The effects of an overdose of Ovitrelle are unknown.
Učinki prevelikega odmerka zdravila Ovitrelle niso znani.
• Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely.
• Resni zapleti zaradi krvnih strdkov (trombembolični dogodki), ki so včasih neodvisni od OHSS, so zelo redki.
These are considered concomitant effects related to assisted reproductive techniques.
Te smatrajo za spremljajoči učinek, povezan s postopki asistirane reprodukcije.
5.3 Verify once more that the number in the dose display reads ‘250'.
5.3 Znova preverite, da kaže številka v prikazu odmerka "250".
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
Please note that alcohol swabs are not contained in the package.
Prosimo upoštevajte, da alkoholni blazinici nista priložena v pakiranju.
If you pass this position, simply turn the dose setting knob back to the dot (●).
Če ta položaj presežete, preprosto zasukajte gumb za nastavitev odmerka nazaj na piko (●).
In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Pri ženskah z nedavno ali obstoječo trombembolično boleznijo ali pri ženskah s splošno znanimi dejavniki tveganja za trombembolične dogodke, kot so osebna ali družinska anamneza, zdravljenje z gonadotropini lahko še bolj povečajo tveganje za poslabšanje ali pojav teh dogodkov.
• Gather everything you need and lay it out:
• Pripravite in razvrstite vse, kar potrebujete:
This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and the higher incidence of multiple pregnancies.
Menijo, da je vzrok v razlikah v značilnostih staršev (npr. starost matere, značilnosti sperme) in višji incidenci večplodnih nosečnosti.
“Instructions for use” provided in the carton.
»navodila za uporabo«, priložena v škatli.
This is justified, given the proteinous nature of the active substance and the negative outcome of the genotoxicity testing.
To je upravičeno glede na beljakovinsko naravo zdravilne učinkovine in negativen izid testiranja genotoksičnosti.
Very rare (may affect up to 1 in 10,000 people) • Mild skin allergic reactions such as rash.
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) • blaga kožna alergijska reakcija, kot je izpuščaj
Setting the dose to 250”).
Nastavitev odmerka na 250").
• To help release an egg from the ovary (ovulation induction) in women who cannot produce eggs (‘anovulation'), or women who produce too few eggs (‘oligo-ovulation').
• Kot pomoč pri sproščanju jajčeca iz jajčnika (induciranje ovulacije) pri ženskah, pri katerih jajčeca ne nastajajo ("anovulacija") ali ženskah, pri katerih nastaja premalo jajčec ("oligoovulacija").
Safety, efficacy and pharmacokinetics of Ovitrelle in patients with renal or hepatic impairment have not been established.
Varnosti, učinkovitosti in farmakokinetike zdravila Ovitrelle pri bolnikih z okvarjenim delovanjem ledvic ali jeter niso ugotavljali.
Clear, colourless to slightly yellow solution.
Bistra in brezbarvna do rahlo rumena raztopina.
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA08
Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, gonadotropini, oznaka ATC: G03GA08
This is when your follicles develop too much and become large cysts.
Do tega pride, ko se jajčniki preveč razvijejo in postanejo velike ciste.
CAUTION: If you do not see a tiny drop(s) at or near the needle tip, you must perform the steps on the next page.
POZOR: Če prvič ne opazite drobnih kapelj na ali blizu konice igle, morate izvesti korake na naslednji strani.
If you are developing OHSS, you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Če se pri vas razvija OHSS, vam bodo morda povedali, da se vsaj 4 dni vzdržite spolnih odnosov ali uporabljajte mehansko kontracepcijsko zaščito.
Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems.
Zdravljenje z zdravilom Ovitrelle mora potekati pod nadzorom zdravnika, izkušenega v zdravljenju težav s plodnostjo.
This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Povzročijo lahko bolečino v prsih, zasoplost, kap ali srčni napad (glejte tudi v poglavju 2 "Težave s strjevanjem").
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
• Be careful not to prick yourself with the needle.
• Pazite, da se ne zbodete z iglo.
Find a clean area and lay out everything: two alcohol swabs, one pre-filled syringe containing the medicinal product.
Poiščite čisto površino in vse razpostavite: dve alkoholni blazinici napolnjeno injekcijsko brizgo z zdravilom.
Following subcutaneous administration, choriogonadotropin alfa is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
Po subkutani uporabi se horiogonadotropin alfa izloča iz telesa s končnim razpolovnim časom približno 30 ur, absolutna biološka razpoložljivost pa je približno 40 %.
• Get a new needle - only use the ‘single use' needle supplied.
• Vzemite novo iglo - uporabljajte samo iglo za "enkratno uporabo", ki je priložena.
• if you have a tumour in a part of your brain called the ‘hypothalamus' or ‘pituitary gland'.
• če imate tumor v delu možganov, imenovanem "hipotalamus" ali "žleza hipofiza"
No specific interaction studies with Ovitrelle and other medicinal products have been performed; however, no clinically significant medicinal product interactions have been reported during hCG therapy.
Specifičnih študij medsebojnega delovanja zdravila Ovitrelle z drugimi zdravili niso izvedli, vendar pa ni poročil o klinično pomembnih interakcijah z drugimi zdravili med zdravljenjem s hCG.
If you do a pregnancy test with serum or urine after use of Ovitrelle, and up to ten days later, it may happen that you get a false positive test result.
Če opravite test nosečnosti na serumu ali urinu po uporabi zdravila Ovitrelle in še do deset dni po tem, se lahko pojavijo lažni pozitivni rezultati testa.
• Check that the peel-off seal on the outer needle cap is not damaged or loose.
• Preverite, da jeziček, ki se odlepi na zunanjem pokrovčku igle, ni poškodovan ali razrahljan.
• Breast pain.
• bolečina v prsih
There are no indications that choriogonadotropin alfa is metabolised and excreted differently than endogenous hCG.
Ni znakov, da bi se horiogonadotropin alfa presnavljal in izločal drugače kot endogeni hCG.
• Feeling depressed, irritable or restless.
• občutek depresivnosti, razdražljivosti ali nemirnosti
Posology The maximum dose is 250 micrograms.
Odmerjanje Največji odmerek je 250 mikrogramov.
For instructions on the administration with the pre-filled pen, see section 6.6 and the “Instructions for use” provided in the carton.
Za navodila o dajanju zdravila z napolnjenim injekcijskim peresnikom glejte poglavje 6.6 in „Navodila za uporabo“, priložena v škatli.
Take as much time as you need to inject all the solution.
Vzemite si dovolj časa, da boste injicirali vso raztopino.
• Postmenopausal women
• ženske po menopavzi
• if you have severe inflammation of your veins or blood clotting in your veins (active thromboembolic disorders).
• če imate hudo vnetje ven ali krvne strdke v venah (aktivno trombembolično bolezen)
Ovitrelle is expected to have no or negligible influence on the ability to drive and use machines.
Pričakuje se, da zdravilo Ovitrelle nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Studies on reproduction were not performed in animals.
Študij o vplivu na sposobnost razmnoževanja pri živalih niso izvedli.
Repeated exposure to Ovitrelle was investigated in male patients only.
Večkratno izpostavljanje zdravilu Ovitrelle so proučevali samo pri moških bolnikih.
• if you have unexplained vaginal bleeding
• če imate nepojasnjeno krvavitev iz nožnice
It should be noted, however, that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Vendar pa je treba opomniti, da nosečnost sama po sebi in OHSS zvečujeta tveganje za trombembolične dogodke kot so pljučna embolija, ishemična kap ali miokardni infarkt.
• If you see a tiny drop(s) of fluid proceed to Section 4: Setting the dose to 250.
• Če vidite majhne kaplje tekočine, nadaljujte s poglavjem 4: Nastavitev odmerka na 250
No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3).
Študij o vplivu horiogonadotropina alfa na sposobnost razmnoževanja pri živalih niso izvedli (glejte poglavje 5.3).
• To help develop and ripen several follicles (each containing an egg) in women undergoing Assisted Reproductive Techniques (procedure that may help you to become pregnant) such as ‘in vitro fertilisation'.
• Kot pomoč pri razvoju in zorenju več foliklov (od katerih vsako vsebuje jajčece) pri ženskah v postopku asistirane reprodukcije (postopek, ki vam lahko pomaga zanositi) kot je "in vitro oploditev".
Paediatric population There is no relevant use of Ovitrelle in the paediatric population.
Pediatrična populacija Zdravilo Ovitrelle ni primerno za uporabo pri pediatrični populaciji.
• Gynaecological haemorrhages of unknown aetiology
• ginekološke krvavitve neznane etiologije
The steady-state volume of distribution and the total clearance are 6 l and 0.2 L/h, respectively.
Volumen porazdelitve v stanju dinamičnega ravnotežja in celokupni očistek sta 6 l oziroma 0,2 l/uro.
It is important to have early ultrasound confirmation that a pregnancy is intrauterine, and to exclude the possibility of extrauterine pregnancy.
Pomembno je, da se z zgodnjim ultrazvokom potrdi, da je nosečnost maternična in izključi možnost zunajmaternične nosečnosti.
• if you have any condition that usually makes a normal pregnancy impossible, such as menopause or early menopause (ovarian failure), or malformations of sexual organs
• če imate katero koli stanje, ki običajno onemogoča normalno nosečnost, kot so menopavza ali zgodnja menopavza (odpoved jajčnikov), ali malformacijo spolnih organov
A comparative study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Primerjalna študija zmrzovalno sušene oblike zdravila in tekoče oblike je pokazala bioekvivalenco obeh oblik zdravila.
• Active thromboembolic disorders
• aktivne trombembolične motnje
• Press the dose knob down as far as it will go and hold it to complete the full injection.
• Gumb za odmerek pritisnite navzdol, dokler gre, in držite, dokler injiciranje ni končano.
If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if those happened in your family, then you might have a higher risk that these problems occur or become worse with Ovitrelle treatment.
Če ste imeli v preteklosti ali pred kratkim krvne strdke v nogah ali pljučih ali srčni napad ali kap, ali če se je to zgodilo komu v družini, ste morda izpostavljeni večjemu tveganju, da se bodo te težave pri zdravljenju z zdravilom Ovitrelle pri vas pojavile ali poslabšale, če jih že imate.
Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.
Samoinjiciranje zdravila Ovitrelle lahko izvajajo samo bolnice, ki so bile ustrezno podučene in imajo možnost nasveta strokovnjaka.