natgillin/translations-raw huggingface dataset:
The classic rheumatology disorders were investigated in 26 studies with 3,621 patients: 12 studies in rheumatoid arthritis (RA), 8 studies in osteoarthritis (OA), 3 in both indications and 3 in other rheumatology indications (i.e. ankylosing spondylitis (AKS), non-arthritic rheumatism and acute gout).
Klasične revmatološke bolezni so preučevali v 26 raziskavah s 3621 bolniki: 12 raziskavah revmatoidnega artritisa (RA), 8 raziskavah osteoartritisa (OA), 3 v obeh indikacijah in 3 v drugih revmatoloških indikacijah (npr. ankilozni spondilitis (AKS), neartritični revmatizem in akutni urični artritis).
After oral administration about 50% is excreted in the faeces and 42% through the kidneys, mainly as 5-hydroxylornoxicam.
Pri peroralnem dajanju se približno 50 % odmerka izloči v blatu in 42 % preko ledvic, v glavnem kot 5-hidroksilornoksikam.
Nycomed Pharma GmbH, Edisonstrasse 16, 85716 Unterschleissheim, Germany
Nycomed Pharma GmbH, Edisonstrasse 16, 85716 Unterschleissheim, Nemčija
4 of 7 studies investigated the efficacy in third molar surgery pain (and three of these studies were already included in meta-analysis
V 4 od 7 raziskav je bila preučevana učinkovitost glede bolečine pri operativni odstranitvi modrostnih zob (tri od teh raziskav so bile že vključene v 1. metaanalizo).
Treatment of osteoarthritis has been approved by 14/16 Member States (AT, BE, CZ, DE, DK, ES, GR, HU, LT, LV, PT, SE, UK).
Zdravljenje osteoartritisa je odobrilo 14 od 16 držav članic (AT, BE, CZ, DE, DK, ES, GR, HU, LT, LV, PT, SE, UK).
Powder: Yellow, solid substance
Prašek: rumena trdna snov
Lornoxicam is found in the plasma in unchanged form and as its hydroxylated metabolite.
Lornoksikam se nahaja v plazmi v nespremenjeni obliki ter kot hidroksiliran presnovek.
The duration of blinded treatment was 4 weeks for studies CT18 and CT80 and 12 weeks for CT33 and CT63.
Slepo zdravljenje je pri raziskavah CT18 in CT80 trajalo 4 tedne, pri raziskavah CT33 in CT63 pa 12 tednov.
Very rare: Hepatocellular damage.
Zelo redki: hepatocelične poškodbe.
Data from 103 clinical studies were included in the SDB including 57 double-blind studies, 4 singleblind studies and 50 open studies of which 8 were follow-up to randomised studies.
V zbirko podatkov o varnosti so bili vključeni podatki iz 103 kliničnih raziskav, vključno s 57 dvojno slepimi raziskavami, 4 enojno slepimi raziskavami in 50 odprtimi raziskavami, od katerih jih je bilo 8 nadaljevanje randomiziranih raziskav.
Thus meta-analysis 3 does not essentially contribute to the MAH's claim for an unrestricted use of lornoxicam in the treatment of pain.
Zato 3. metaanaliza ne prispeva bistveno k zahtevi imetnika dovoljenja za promet za neomejeno uporabo lornoksikama pri zdravljenju bolečin.
It increased by duration of treatment (0.3%, 0.5% and 1.9% for short-, medium- and long-term treatment, respectively) and was influenced by the vulnerability of patients with chronic diseases in long-term treatment: The majority of patients with SADR had RA or were elderly patients included in post-operative pain studies such as hip replacement.
Povečevala se je s trajanjem zdravljenja (0,3 % pri kratkoročnem zdravljenju, 0,5 % pri srednjeročnem zdravljenju in 1,9 % pri dolgoročnem zdravljenju); nanjo je vplivala občutljivost bolnikov s kroničnimi boleznimi pri dolgoročnem zdravljenju: Večina bolnikov z resnimi neželenimi učinki je imela RA oz. so bili starejši bolniki, ki so bili vključeni v postoperativne raziskave bolečin, npr. po zamenjavi kolka.
Rare: Dermatitis, purpura.
Redki: dermatitis, pupura.
Pregnancy and lactation - Section 4.6
Nosečnost in dojenje - poglavje 4.6
More than 12,000 patients were included in the 103 studies of which 43 were classified as phase I with 810 patients.
V 103 raziskavah, od katerih jih je bilo 43 uvrščenih med raziskave I. faze z 810 bolniki, je sodelovalo več kot 12.000 bolnikov.
Gastrointestinal disorders can for example be treated with a prostaglandin analogue or ranitidine.
Prebavne težave lahko na primer zdravimo s prostaglandinskim analogom ali ranitidinom.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco galaktoze, pomanjkljivostjo laktaze Lapp ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
The absolute bioavailability of Xefo Rapid film-coated tablets is 90-100 % which is equivalent to Xefo film-coated tablet.
Absolutna biološka razpoložljivost zdravila Xefo Rapid filmsko obložene tablete je 90-100 %, kar je enakovredno absolutni biološki razpoložljivosti zdravila Xefo filmsko obložene tablete.
Compatibilities
Združljivosti
CYP2C9 is involved in this biotransformation of lornoxicam.
V tem postopku biotransformacije lornoksikama sodeluje CYP2C9.
The submitted efficacy data on pain focus on meta-analyses from 12 placebo-controlled pain studies (including partly also active controls) [See Table below].
Predloženi podatki o učinkovitosti glede bolečin so osredotočeni na metaanalizo 12 raziskav bolečin, kontroliranih s placebom (delno so vključene tudi primerjalne učinkovine) [Glejte spodnjo tabelo].
PHARMACEUTICAL FORM AND CONTENTS 250 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 250 filmsko obloženih tablet
The most commonly observed adverse events of NSAIDs are gastrointestinal in nature.
Najpogosteje opaženi neželeni učinki NSAID so gastrointestinalne narave.
Therefore serum lithium levels require monitoring, especially during initiation, adjustment and withdrawal of treatment.
Spremljanje koncentracije litija v serumu je zato potrebno, še zlasti med začetkom, ob prilagoditvi in prenehanju zdravljenja.
The divergences between the MS in the wording of the description of the pharmacokinetic properties have been harmonised.
Razhajanja med državami članicami pri besedilu opisa farmakokinetičnih lastnosti so bila usklajena.
Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy.
Podatki iz epidemioloških študij kažejo zvišano tveganje splava in srčnih okvar po uporabi zaviralca sinteze prostaglandinov v zgodnji nosečnosti.
The mean elimination half-life is 3-4 hours.
Povprečna razpolovna doba eliminacije je približno 3-4 ure.
Lornoxicam is excreted in milk of lactating rats in relatively high concentrations.
Pri podganah v obdobju laktacije se lornoksikam izloča v mleku v relativno visokih koncentracijah.
For several drugs causing interaction and which possibly increase the risk of toxicity in combination with NSAIDs/lornoxicam, the recommendation regarding drug monitoring (for methotrexate, lithium and cyclosporine) has been included in the SPC.
Za nekatera zdravila, ki povzročajo medsebojno delovanje in ki utegnejo v kombinaciji z NSAID/lornoksikamom povečati tveganje za toksičnost, je v SPC priloženo priporočilo v zvezi s terapevtskim spremljanjem (za metotreksat, litij in ciklosporin).
The risk is believed to increase with dose and duration of therapy.
Tveganje naj bi se povečevalo odvisno od odmerka in trajanja zdravljenja.
Solvent: One ampoule contains 2 ml water for injection
Vehikel: Ena ampula vsebuje 2 ml vode za injekcije.
Studies not investigating the recommended doses of either 4 mg tid or 8 mg bid were excluded from the analysis.
Raziskave, ki niso preučevale priporočenih odmerkov 4 mg trikrat dnevno ali 8 mg dvakrat dnevno, so bile izključene iz analize.
Recommended dose: 8 mg intravenous or intramuscular.
Priporočeni odmerek: 8 mg intravensko ali intramuskularno.
Pharmacokinetic properties - Section 5.2
Farmakokinetične lastnosti - poglavje 5.2
6.6 Special precautions for disposal and other handling The solution for injection is prepared by dissolving the content of one vial in water for injection from the accompanying ampoule, immediately prior to use.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Raztopino za injiciranje pripravimo neposredno pred uporabo z raztapljanjem vsebine ene viale v vodi za injekcije iz ampule, ki je priložena.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Bolniki z anamnezo toksičnosti za prebavila, zlasti starostniki, morajo sporočiti vse nenavadne abdominalne simptome (zlasti krvavitev v prebavilih), še posebej v začetnih fazah zdravljenja.
Maximum plasma concentrations are achieved after approximately 1-2 hours.
Najvišje plazemske koncentracije doseže po približno 1-2 urah.
Therefore, the use of lornoxicam is contraindicated during the third trimester of pregnancy (see section 4.3).
Zato je uporaba lornoksikama v tretjem tromesečju nosečnosti kontraindicirana (glejte poglavje 4.3).
4.5 Interaction with other medicinal products and other forms of interaction Concomitant administration of lornoxicam and - Cimetidine: Increased plasma concentrations of lornoxicam.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Sočasna uporaba lornoksikama in - Cimetidina: Zvišane plazemske koncentracije lornoksikama.
Gastrointestinal disorders
Gastrointestinalni
The second meta-analysis included seven studies (CT01, CT02, CT03, CT14, CT32, CT78 and CT85) with orally applied lornoxicam including a total of 1581 patients.
Druga metaanaliza je vključevala sedem raziskav (CT01, CT02, CT03, CT14, CT32, CT78 in CT85) s peroralno dajanim lornoksikamom s skupno 1581 bolniki.
Three of the lornoxicam patients participated in a study investigating the efficacy of lornoxicam in pain due to bone metastases in prostate cancer, which was the cause of death for two.
Trije bolniki, zdravljeni z lornoksikamom, so sodelovali v raziskavi, ki je preučevala učinkovitost lornoksikama pri bolečinah zaradi kostnih metastaz pri raku prostate, zaradi česar sta umrla dva bolnika.
For all the pharmaceutical forms and strengths of lornoxicam It was agreed that the following contraindications would be included: - The third trimester of pregnancy (see section 4.6)
Za vse farmacevtske oblike in jakosti lornoksikama Dogovorjeno je bilo, da se vključijo naslednje kontraindikacije: - Tretje trimesečje nosečnosti (glejte poglavje 4.6)
Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Podoben premislek je potreben pred začetkom dolgoročnega zdravljenja bolnikov z dejavniki tveganja za kardiovaskularne bolezni (npr. hipertenzija, hiperlipidemija, sladkorna bolezen, kajenje).
From clinical trial data there is no evidence of accumulation of lornoxicam after repeated administrations, when given according to recommended dosage.
Podatki iz kliničnih preskusov ne kažejo akumulacije lornoksikama po ponovljenem dajanju priporočenih odmerkov.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EMEA
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Maintenance dose should not exceed 16 mg lornoxicam daily.
Vzdrževalni odmerek ne sme biti večji od 16 mg lornoksikama na dan.
injection use sufficiently long needle for a deep intramuscular injection.
injekcijo morate uporabiti iglo, ki je dovolj dolga za globoko intramuskularno injiciranje.
- Quinolone antibiotics: Increased risk of seizures.
- Kinolonski antibiotiki: Zvišano tveganje napadov.
Keep vial in the outer carton.
Vialo shranjujte v zunanji škatli.
Although a considerable number of patients have been treated with lornoxicam so far, only few of the known serious reactions to other NSAIDs have been reported for lornoxicam.
Čeprav je bilo z lornoksikamom zdravljenih že veliko bolnikov, so doslej pri lornoksikamu poročali o le nekaj znanih resnih učinkih NSAID.
- Known inducers and inhibitors of CYP2C9 isoenzymes: Lornoxicam (as other NSAIDs depending on the cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9 isoenzymes (see section 5.2 Biotransformation).
- Znani induktorji in zaviralci izoencimov CYP2C9: Lornoksikam (kakor ostala nesteroidna protivnetna zdravila, ki so odvisna od citokroma P450 2C9 (izoencim CYP2C9)) ima interakcije z znanimi induktorji in zaviralci izoencimov CYP2C9 (glejte poglavje 5.2 Biotransformacija).
Lornoxicam has shown compatibility with 0.9% NaCl, 5% dextrose (glucose) and Ringer's solution.
Za zdravilo Lornoxicam je dokazana združljivost z raztopinama 0,9 % NaCl, 5 % dekstroze (glukoze) in Ringerjevo raztopino.
As outlined by the MAH this meta-analysis was restricted to placebo-controlled studies as the purpose of the analysis was to estimate a difference to placebo [Tab.
Kot je navedel imetnik dovoljenja za promet, je bila metaanaliza omejena na s placebom kontrolirane raziskave, ker je bil namen analize ugotoviti razliko v primerjavi s placebom [Tabela 4].
Should any such abnormality prove significant or persist the administration of lornoxicam should be stopped and appropriate investigations prescribed.
Če ugotovite, da so takšne nenormalnosti pomembne ali da ne izzvenijo, morate zdravljenje z lornoksikamom prekiniti in naročiti ustrezne preiskave.
The safety database (SDB) included all lornoxicam studies under the control of Nycomed Pharma (studies performed by third parties were excluded) comprised a total of 12,570 patients of who 7,427 received lornoxicam.
Zbirka podatkov o varnosti, število bolnikov in izpostavljenost V zbirko podatkov o varnosti so bile vključene vse raziskave lornoksikama pod nadzorom družbe Nycomed Pharma (raziskave, ki so jih izvedle tretje strani, so bile izključene) s skupno 12.570 bolniki, od katerih jih je 7427 prejemalo lornoksikam.
Approximately 20% of patients treated with lornoxicam can be expected to experience adverse reactions.
Neželene učinke lahko pričakujemo pri približno 20 % bolnikov, ki se zdravijo z lornoksikamom.
No data are available on simultaneous intake of Xefo Rapid film-coated tablets with meals, but based on data for Xefo film-coated tablets a reduction of Cmax, an increase in Tmax, and a reduction in the absorption (AUC) of lornoxicam may be expected.
Ni razpoložljivih podatkov o sočasnem vnosu zdravila Xefo Rapid filmsko obložene tablete skupaj z obrokom, vendar podatki za zdravilo Xefo filmsko obložene tablete kažejo, da je pričakovati zmanjšanje Cmax, podaljšanje Tmax in zmanjšanje absorpcije (AUC) lornoksikama.
Eight patients died after lornoxicam treatment and three patients after treatment with comparators, and no case was reported after parenteral lornoxicam.
Po zdravljenju z lornoksikamom je umrlo osem bolnikov, po zdravljenju s primerjalnimi zdravili trije bolniki, po parenteralni uporabi lornoksikama pa niso poročali o nobenem smrtnem primeru.
Eight placebo- and/or reference drug controlled clinical studies were performed in patients suffering from OA.
Izvedenih je bilo osem s placebom in/ali referenčnim zdravilom kontroliranih kliničnih raziskav na bolnikih z osteoartritisom (OA).
Intravenous use Intramuscular use
Intravenska uporaba Intramuskularna uporaba
Contraindications - Section 4.3
Kontraindikacije - poglavje 4.3
Study CTX 87 was excluded since single doses of 4-20 mg LNX were administered i.m.
Raziskava CTX 87 je bila izključena, ker so bili enkratni odmerki 4-20 mg lornoksikama dajani intramuskularno.
- Sulphonylureas: Increased risk of hypoglycaemia.
- Sulfonilsečnina: Zvišano tveganje hipoglikemije.
Powder: Mannitol, Trometamol, Disodium edetate
Prašek: manitol, trometamol, dinatrijev edetat
Special warnings and precautions for use - Section 4.4
Posebna opozorila in previdnostni ukrepi - poglavje 4.4
All deaths reported for lornoxicam were considered unrelated to treatment by the responsible investigator and may reflect the multimorbid patients taking part in these studies.
Noben smrtni primer, o katerem so poročali pri lornoksikamu, ni bil povezan z zdravljenjem, ki ga je izvajal odgovorni raziskovalec, kar lahko kaže na to, da so v teh raziskavah sodelovali bolniki z več boleznimi.
6.5 Nature and contents of container Aluminium/Aluminium blister.
6.5 Vrsta ovojnine in vsebina Pretisni omot aluminij/aluminij.
0.9% sodium chloride solution 5% dextrose (glucose) solutions
0,9-% raztopino natrijevega klorida 5-% raztopino dekstroze (glukoze)
Lornoxicam reduces platelet aggregation and prolongs bleeding time and consequently care should be taken when administering to patients with increased bleeding tendency.
Zdravilo Lornoxicam zmanjša sposobnost agregacije trombocitov in podaljša čas krvavitve, zato je potrebna previdnost pri predpisovanju zdravila bolnikom, ki so bolj nagnjeni h krvavitvam.
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Xefo and associated names (see Annex I).
je CHMP priporočil dopolnitev dovoljenj(a) za promet, za katere(ga) so Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo podani v Dodatku III za zdravilo Xefo in z njim povezana imena (glejte Dodatek I).
There are no data on the excretion of lornoxicam in human breast milk.
Ni podatkov o izločanju lornoksikama v materino mleko.
In rat, lornoxicam impaired fertility (effects on ovulation and implantation), and affected the pregnancy and delivery.
Pri podganah je lornoksikam okvaril plodnost (vpliv na ovulacijo in nidacijo) in vplival na nosečnost ter skotitev.
For all the pharmaceutical forms and strengths of lornoxicam It was agreed that the following additional undesirable effects: weight changes, ecchymosis, prolonged bleeding time, bronchospasm, rhinitis, perforated peptic ulcer, pupura, increase in blood urea nitrogen and creatinine levels.
Za vse farmacevtske oblike in jakosti lornoksikama Usklajeni so bili naslednji dodatni neželeni učinki: spremembe teže, ekhimoza, podaljšan čas krvavitve, bronhospazem, rinitis, perforirani peptični ulkus, purpura, povečanje koncentracije dušika sečnine in kreatinina v krvi.
Osteoarthritis and Rheumatoid arthritis
Osteoartritis in revmatski artritis
The hydroxylated metabolite exhibits no pharmacological activity.
Hidroksiliran presnovek ni farmakološko aktiven.
A plateau of efficacy was obtained with 8mg bid; this dosage regimen is thus considered the maximum dose for lornoxicam in RA.
Plato učinkovitosti je bil dosežen z odmerkom 8 mg dvakrat dnevno; ta shema odmerjanja zato velja za največji odmerek lornoksikama pri RA.
Water for injection, 2 ml: Clear glass ampoule
vodo za injekcije, 2 ml: ampula iz prozornega stekla.
In the literature, incidences of SADRs for NSAIDs vary between 0.3% and 4.7% indicating that the risk of developing SADRs with lornoxicam is similar to that of other NSAIDs.
V literaturi se pogostost resnih neželenih učinkov zdravila pri NSAID giblje med 0,3 % in 4,7 %, kar kaže, da je tveganje za pojav resnih neželenih učinkov pri lornoksikamu podobno kot pri drugih NSAID.
The plasma protein binding of lornoxicam is 99 % and not concentration dependent.
Vezava lornoksikama na plazemske beljakovine je 99 % in je neodvisna od koncentracije.
Apart from reduced clearance, there is no significant change in the kinetic profile of lornoxicam in elderly patients.
Poleg zmanjšanega očistka drugih pomembnih razlik v kinetičnem profilu lornoksikama pri starostnikih ni.
• Quality issues
Vidiki kakovosti
Overall discussion on the meta-analyses
Splošna razprava o metaanalizi
Lornoxicams mode of action is mainly related to the inhibition of the prostaglandin synthesis (inhibition of the cyclooxygenase enzyme) leading to desensitisation of peripheral nociceptors and consequently inhibition of inflammation.
Način delovanja lornoksikama je v glavnem vezan na zaviranje sinteze prostaglandinov (zaviranje enima ciklooksigenaze), ki povzroči desenzibilizacijo perifernih nociceptorjev in posledično zaviranje vnetja.
Infections and infestations Rare: Pharyngitis.
Infekcijske in parazitske bolezni Redki: faringitis.
Shelf life after reconstitution: 24 hours at 21°C (±2 °C)
Rok uporabnosti po pripravi: 24 ur pri 21 °C (± 2 °C)
White to yellowish round biconvex film-coated tablet.
Bela do rumenkasta okrogla bikonveksna filmsko obložena tableta.
Serious Adverse Drug Reactions
Resni neželeni učinki zdravila
6.3 Shelf life 5 years
6.3 Rok uporabnosti 5 let
Two studies on third molar surgery were excluded from meta-analysis 1.
Dve raziskavi o operativni odstranitvi modrostnih zob sta bili izključeni iz 1. metaanalize.
The use of Xefo may impair fertility and is not recommended in women attempting to conceive.
Zdravilo Xefo lahko okvari plodnost, zato uporaba ni priporočljiva pri ženskah, ki želijo zanositi.
- Diuretics: Decreased diuretic and antihypertensive effect of loop diuretics and thiazide diuretics.
- Diuretiki: Zmanjšan diuretični in antihipertenzivni učinek diuretikov Henlejeve zanke in tiazidnih diuretikov.
Lornoxicam (Xefo and its associated names) is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class approved and marketed for treatment of moderate to severe pain.
Lornoksikam (zdravilo Xefo in z njim povezana imena) je nesteroidno protivnetno sredstvo (NSAID) iz skupine oksikamov, ki je odobreno in dano na tržišče za zdravljenje zmernih do močnih bolečin.
An initial dose of 16 mg lornoxicam administered i.m., followed by a subsequent dose of 8 mg has shown to be effective and safe in patients with pain after surgery (study CT89).
Začetni odmerek 16 mg intramuskularno dajanega lornoksikama, ki mu sledi nadaljnji odmerek 8 mg, se je izkazal za učinkovitega in varnega pri bolnikih z bolečinami po operaciji (raziskava CT89).
Pack sizes: 250 and 500 film-coated tablets.
Pakiranji: 250 in 500 filmsko obloženih tablet.
Prostaglandin synthesis inhibitors administered during the third trimester of pregnancy may expose the foetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction which may lead to renal failure and hence a reduced quantity of amniotic fluid.
Zaradi uporabe zaviralcev sinteze prostaglandinov v tretjem tromesečju nosečnosti se lahko pri plodu razvijejo kardiopulmonalni toksični učinki (prezgodnje zaprtje arterioznega duktusa in pljučna hipertenzija) in ledvična disfunkcija, ki lahko povzroči popuščanje ledvic in s tem zmanjšano količino amnijske tekočine.
- Methotrexate: Increased serum concentration of methotrexate.
- Metotreksat: Zvišane serumske koncentracije metotreksata.
If not used immediately, in-use storage times and conditions prior to use is the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Če se zdravilo ne porabi nemudoma, je uporabnik odgovoren za trajanje shranjevanja in pogoje shranjevanja pred uporabo, pri čemer shranjevanje običajno ne bi smelo biti daljše od 24 ur ob shranjevanju pri 2-8 °C, razen če sta bila priprava ali redčenje opravljena v kontroliranih in validiranih aseptičnih pogojih.
or intravenous (i.v.)
ali intravenski (i.v.)
For storage conditions of the reconstituted medicinal product, see section 6.3
Pogoji shranjevanja pripravljenega zdravila so opisani v poglavju 6.3.
At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the foetus to increased bleeding time and inhibition of uterine contractions, which may delay or prolong the labour.
Na koncu nosečnosti lahko zaviralci sinteze prostaglandinov pri materi in plodu povzročijo podaljšanje časa krvavitve ter zavrejo krčenje maternice, kar lahko zakasni ali podaljša porod.