FrancophonIA/ELRC3.0 huggingface dataset:
English: Single doses of up to 100 microlitres dispersion/kg and multiple doses up to 150 microlitres dispersion/kg were tolerated well in Phase I clinical trials.
Slovenian: V kliničnih preskušanjih I. faze so bolniki dobro prenesli posamične odmerke do 100 mikrolitrov disperzije/kg in večkratne odmerke do 150 mikrolitrov disperzije/kg.
English: • itching,
Slovenian: • omotica,
English: Total lung clearance (CLlung) of perflutren was shown to be no different in healthy subjects compared to COPD subjects.
Slovenian: Ugotovljeno je, da se celotni pljučni očistek (CLpljučni) perflutrena med zdravimi preiskovanci in preiskovanci s KOPB ne razlikuje.
English: Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity.
Slovenian: Po uporabi zdravila Luminity so poročali o pojavu resnih takojšnjih preobčutljivostnih reakcij (npr. anafilaksija, anafilaktični šok in anafilaktoidne reakcije, hipotenzija ter angioedem).
English: Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter range of 1.1-2.5 μm (approximately 150 microlitres perflutren gas per ml).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En mililiter vsebuje največ 6,4 x 109 perflutren vsebujočih lipidnih mikrosfer s povprečnim razponom premera od 1,1 do 2,5 μm (približno 150 mikrolitrov plina perflutrena na mililiter).
English: Luminity is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion (drip solution) after being diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Slovenian: Zdravilo Luminity se daje v veno kot injiciranje »bolusa« (celotni odmerek se vbrizga naenkrat) ali kot infundiranje (kapalna raztopina) po redčenju z raztopino za injiciranje z 9 mg/ml natrijevega klorida (0,9 %) ali 50 mg/ml glukoze (5 %).
English: Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code: V08DA04
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: ultrazvočna kontrastna sredstva, mikrosfere fosfolipidov,
English: Patients with adult respiratory distress syndrome, endocarditis, prosthetic heart valves, systemic inflammation, sepsis, hyperactive coagulation and/or recurrent thromboembolism Luminity should be used only after careful consideration and such use should be monitored closely during administration in patients with adult respiratory distress syndrome, endocarditis, a heart with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation and/or recurrent thromboembolism.
Slovenian: Zdravilo Luminity se sme uporabljati le po skrbnem premisleku pri bolnikih s sindromom dihalne stiske pri odraslem, z endokarditisom, umetnimi srčnimi zaklopkami, akutnimi stanji sistemskega vnetja ali sepso, znanimi stanji hiperaktivnosti sistema koagulacije in/ali ponavljajočo se trombembolijo.
English: Excipients: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, water for injections
Slovenian: Pomožne snovi: 1,2-dipalmitoil-sn-glicero-3-fosfatidilholin (DPPC), 1,2-dipalmitoil-sn-glicero-3fosfatidilna kislina, mononatrijeva sol (DPPA), N-(metoksipolietilenglikol 5000 karbamoil)-1,2dipalmitoil-sn-glicero-3-fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol, voda za injekcije
English: Before administering the product, it must be activated by using the Vialmix, a mechanical shaking device.
Slovenian: Pred apliciranjem je treba zdravilo Luminity aktivirati z Vialmixom, mehanično napravo za stresanje.
English: - The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
Slovenian: Pomožne snovi so 1,2-dipalmitoil-sn-glicero-3-fosfatidilholin (DPPC), 1,2-dipalmitoil-sn-glicero-3fosfatidilna kislina, mononatrijeva sol (DPPA), N-(metoksipolietilenglikol 5000 karbamoil)-1,2dipalmitoil-sn-glicero-3-fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol in voda za injekcije.
English: The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Slovenian: Priporočeni odmerek intravenske infuzije je 1,3 ml disperzije, dodane 50 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopine glukoze za injiciranje.
English: Luminity should only be administered by trained physicians with technical expertise in performing and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be available in case of cardiopulmonary or hypersensitivity reactions (see section 4.4).
Slovenian: Zaradi možnega pojava kardiopulmonalnih ali preobčutljivostnih reakcij je pri uporabi zdravila Luminity treba imeti na voljo ustrezno opremo za oživljanje (glejte poglavje 4.4).
English: • peripheral coldness,
Slovenian: • hladne okončine,
English: How to store Luminity
Slovenian: Shranjevanje zdravila Luminity
English: Abnormal respiration, heart rate changes and decreased activity were observed soon after intravenous injection of Luminity at doses ≥ 0.3 ml/kg in single and repeat-dose toxicity studies in rats and monkeys.
Slovenian: V študijah toksičnosti posamičnih in ponavljajočih se odmerkov pri podganah in opicah so po intravenskem injiciranju zdravila Luminity v odmerkih ≥ 0,3 ml/kg opažali nenormalno dihanje,
English: Therefore, caution should be exercised when Luminity is administered to breast-feeding women.
Slovenian: V primeru uporabe zdravila Luminity pri doječih ženskah je zato potrebna previdnost.
English: Microspheres in the 1 to < 10 µm diameter size range contribute to the contrast effect by generating strongly enhanced echoes.
Slovenian: < 10 µm močno ojačijo odboj in tako pripomorejo h kontrastnemu učinku.
English: Rare: Arthralgia, flank pain, neck pain, muscle cramp Not known: Muscle spasm, musculoskeletal pain, musculoskeletal discomfort, myalgia, hypertonia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni: bolečina v hrbtu redki: artralgija, bolečina v bokih, bolečina v vratu, mišični krč neznana pogostnost: mišični spazem, mišičnoskeletna bolečina, mišičnoskeletno neudobje, mialgija, hipertonija
English: As Luminity consists of microspheres that are stable and small enough for transpulmonary passage, enhanced echo signals in the left heart and systemic circulation are obtained.
Slovenian: Zdravilo Luminity sestavljajo mikrosfere, ki so stabilne in dovolj majhne, da preidejo skozi pljuča.
English: Before activation (shaking) the contents of the vial, Luminity appears as a colourless, uniformly clear to translucent liquid.
Slovenian: (stresanjem) vsebine viale je zdravilo Luminity brezbarvna, enakomerno bistra do prosojna tekočina.
English: Uncommon: Pruritus, increased sweating Rare: Rash, urticaria, erythema, erythematous rash
Slovenian: Bolezni kože in podkožja občasni: srbenje, močnejše znojenje redki: izpuščaj, urtikarija, eritem, eritematozen izpuščaj
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μm).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter vsebuje največ 6,4 x 109 lipidnih mikrosfer, ki vsebujejo perflutren; povprečni razpon premera mikrosfer je od 1,1 do 2,5 mikrometra (μm).
English: For such patients monitoring should include vital sign measurements, electrocardiography, and, if clinically appropriate, cutaneous oxygen saturation.
Slovenian: elektrokardiografijo in saturacijo s kisikom (perkutano), če je to klinično potrebno.
English: Hepatic impairment Pharmacokinetics has not been specifically studied in the hepatic disease patients.
Slovenian: Farmakokinetike pri bolnikih z boleznimi jeter niso posebej preučevali.
English: Bolus intravenous injection using fundamental imaging technique at rest:
Slovenian: Bolusno intravensko injiciranje z uporabo nelinearnega načina kontrastnega slikanja v mirovanju in med obremenitvijo:
English: Uncommon: Chest Pain, fatigue, feeling hot, injection site pain Rare: Pyrexia, rigors
Slovenian: Splošne težave in spremembe na mestu aplikacije občasni: bolečina v prsih, utrujenost, občutek vročine, bolečina na mestu injiciranja redki: pireksija, mrzlica
English: - Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Slovenian: - Zdravilo Luminity lahko razredčite z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali s 50 mg/ml (5 %) raztopino glukoze za injiciranje.
English: Renal impairment Pharmacokinetics has not been specifically studied in the renal disease patients.
Slovenian: Okvara ledvic Farmakokinetike pri bolnikih z boleznimi ledvic niso posebej preučevali.
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Slovenian: Luminity 150 mikrolitrov/ml plin in vehikel za disperzijo za injiciranje/infundiranje perflutren
English: Bolus intravenous injection using non-linear contrast imaging technique at rest and stress: The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection to maintain optimal contrast enhancement.
Slovenian: Priporočeni odmerek je več injekcij od 0,1 do 0,4 ml disperzije, ki jim sledi bolus od 3 do 5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopine glukoze za injiciranje za ohranitev optimalne ojačitve kontrasta.
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion
Slovenian: Luminity 150 mikrolitrov/ml plin in vehikel za disperzijo za injiciranje/infundiranje
English: Immune system disorders Not known: Allergic type reactions, anaphylaxis, anaphylactic shock and anaphylactoid type reactions, hypotension, angioedema, lip swelling, bronchospasm, rhinitis, upper airway swelling, throat tightness, facial swelling, eye swelling
Slovenian: angioedem, otekanje ustnic, bronhospazem, rinitis, otekanje zgornjih dihal, tesnost grla, otekanje obraza, otekanje očesa
English: Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained with noncontrast echocardiography is not optimal.
Slovenian: ki oskrbujejo srčno mišico) ali sumom nanjo, kadar slika, ki se pridobi z ehokardiografijo brez kontrastnega sredstva, ni optimalna.
English: Store in a refrigerator (2°C - 8°C) For storage conditions after activation of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po aktiviranju zdravila glejte poglavje 6.3.
English: If necessary, a second 10 microlitre dispersion/kg dose followed by a second 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection may be administered 5 minutes after the first injection to prolong contrast enhancement.
Slovenian: Če je potrebno, lahko za podaljšanje ojačitve kontrasta 5 minut po prvi injekciji aplicirate drugi odmerek 10 mikrolitrov disperzije/kg, ki mu sledi drugi 10-ml bolus 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopine glukoze za injiciranje.
English: Rare: Respiratory Distress, Cough, Dry Throat Not known: Respiratory arrest, decreased oxygenation, hypoxia, Gastrointestinal disorders Uncommon: Abdominal Pain, diarrhoea, nausea, vomiting,
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni: dispneja, draženje žrela redki: dihalna stiska, kašelj, suho žrelo neznana pogostnost: zastoj dihanja, zmanjšana oksigenacija, hipoksija
English: Rare: Paraesthesia
Slovenian: • otrplost obraza
English: Eye disorders
Slovenian: • otekanje oči
English: Do not store the vial above 30°C following activation.
Slovenian: Po aktiviranju hranite vialo pri temperaturi do 30 °C.
English: Propylene glycol
Slovenian: Okvara jeter
English: Package leaflet: Information for the user Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Slovenian: Navodilo za uporabo Luminity 150 mikrolitrov/ml plin in vehikel za disperzijo za injiciranje/infundiranje perflutren
English: Patients with unstable cardiopulmonary status
Slovenian: Bolniki s srčnimi spoji (šanti)
English: Luminity has not been specifically studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter uporabe zdravila Luminity niso posebej proučevali.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: supraventrikularna tahikardija, supraventrikularna aritmije
English: The recommended dose is 10 microlitre dispersion/kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Slovenian: 10-ml bolus 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopine glukoze za injiciranje.
English: Luminity has not been specifically studied in elderly patients.
Slovenian: Pri starostnikih uporabe zdravila Luminity niso posebej proučevali.
English: Luminity has not been specifically studied in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic uporabe zdravila Luminity niso posebej proučevali.
English: Driving and using machines
Slovenian: Način uporabe in postopek mehanske aktivacije
English: The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose.
Slovenian: Priporočeni odmerek je 500 mg enkrat na mesec ter dodaten 500-miligramski odmerek, ki se da dva tedna po začetnem odmerku.
English: The full EPAR for Fulvestrant Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fulvestrant Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen.
Slovenian: Fulvestrant Mylan je antiestrogensko zdravilo, ki se uporablja za zdravljenje napredovalega ali metastatskega raka dojke (raka, ki se je razširil na druge dele telesa) pri ženskah po menopavzi z vrsto raka dojke, imenovano „rak s pozitivnimi estrogenskimi receptorji“, ki se pred tem niso hormonsko zdravile ali pri katerih se je rak po zdravljenju z drugim antiestrogenom ponovil.
English: This is a summary of the European public assessment report (EPAR) for Fulvestrant Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fulvestrant Mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Fulvestrant Mylan primerljivo z zdravilom Faslodex.
English: Because Fulvestrant Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Fulvestrant Mylan generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What measures are being taken to ensure the safe and effective use of Fulvestrant Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fulvestrant Mylan?
English: The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.
Slovenian: Odmerek se daje z dvema injekcijama v mišico, po eno injekcijo v vsako stran zadnjice, v trajanju ene do dveh minut.
English: This means that Fulvestrant Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Faslodex.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Faslodex.
English: As for every medicine, the company provided studies on the quality of Fulvestrant Mylan.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Fulvestrant Mylan.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Faslodex, and do not need to be repeated for Fulvestrant Mylan.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Faslodex, zato jih za zdravilo Fulvestrant Mylan ni treba ponoviti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulvestrant Mylan have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fulvestrant Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about treatment with Fulvestrant Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Fulvestrant Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Fulvestrant Mylan
Slovenian: Druge informacije o zdravilu Fulvestrant Mylan
English: The Agency recommended that Fulvestrant Mylan be approved for use in the EU.
Slovenian: Priporočila je, da se zdravilo Fulvestrant Mylan odobri za uporabo v EU.
English: Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg).
Slovenian: Predpisovanje in izdaja zdravila je le na recept, na voljo pa je v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah (250 mg).
English: What are the benefits and risks of Fulvestrant Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Fulvestrant Mylan?
English: Fulvestrant Mylan is a ‘generic medicine'.
Slovenian: Zdravilo Fulvestrant Mylan je „generično zdravilo“.
English: This is because the composition of Fulvestrant Mylan is the same as the reference medicine and when given by injection into the muscle, the active substance in both products is expected to be absorbed in the same way.
Slovenian: Razlog za to je dejstvo, da je sestava zdravila Fulvestrant Mylan enaka kot pri referenčnem zdravilu, zato se pričakuje, da se zdravilna učinkovina v obeh zdravilih pri injiciranju v mišico enako absorbira.
English: The active substance in Fulvestrant Mylan, fulvestrant, is an antioestrogen.
Slovenian: Zdravilna učinkovina v zdravilu Fulvestrant Mylan, fulvestrant, je antiestrogen.
English: There was no need for ‘bioequivalence' studies to investigate whether Fulvestrant Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Slovenian: Izvedba študij biološke enakovrednosti, s katerimi se proučuje, ali se zdravilo Fulvestrant Mylan absorbira podobno kot referenčno zdravilo in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
English: For practical information about using Fulvestrant Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Fulvestrant Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is not intended to provide practical advice on how to use Fulvestrant Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Therefore, the Agency's view was that, as for Faslodex, the benefit outweighs the identified risk.
Slovenian: Zato je menila, da njegove koristi enako kot pri zdravilu Faslodex odtehtajo znana tveganja.
English: What is Fulvestrant Mylan and what is it used for?
Slovenian: Kaj je zdravilo Fulvestrant Mylan in za kaj se uporablja?
English: Why is Fulvestrant Mylan approved?
Slovenian: Zakaj je bilo zdravilo Fulvestrant Mylan odobreno?
English: Fulvestrant Mylan contains the active substance fulvestrant.
Slovenian: Zdravilo Fulvestrant Mylan vsebuje zdravilno učinkovino fulvestrant.
English: How has Fulvestrant Mylan been studied?
Slovenian: Kako je bilo zdravilo Fulvestrant Mylan raziskano?
English: How is Fulvestrant Mylan used?
Slovenian: Kako se zdravilo Fulvestrant Mylan uporablja?
English: How does Fulvestrant Mylan work?
Slovenian: Kako zdravilo Fulvestrant Mylan deluje?
English: Solution for injection Subcutaneous use pre-filled syringe 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga
English: Such medicines include:
Slovenian: Takšna zdravila vključujejo:
English: Case reports of efficacy are also available in literature.
Slovenian: Posamezna poročila o učinkovitosti so opisana tudi v literaturi.
English: The frequencies are not known (cannot be estimated from the available data).
Slovenian: Pogostnost ni znana (iz razpoložljivih podatkov je ni mogoče oceniti).
English: Date of first authorisation: 06 May 2011 Date of latest renewal: 08 February 2016
Slovenian: Datum prve odobritve: 6 maj 2011 Datum zadnjega podaljšanja: 8 februar 2016
English: This discolouration is expected and will disappear after the treatment has ended
Slovenian: To obarvanje je pričakovano in bo izginilo po končanem zdravljenju
English: Use immediately on opening.
Slovenian: Uporabite takoj po odprtju.
English: When indicated, the frequency is based on a very small sample size.
Slovenian: Kjer je tako navedeno, pogostnost temelji na zelo majhni velikosti vzorca.
English: Lower doses (<1 mg/kg) may be needed.
Slovenian: Morda bodo potrebni nižji odmerki (<1 mg/kg).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6.6.
English: Alternative treatment options should be considered.
Slovenian: Proučiti je treba druge možnosti zdravljenja.
English: A second dose may be given after one hour if required.
Slovenian: Po preteku ene ure se lahko da drugi odmerek, če je potrebno.
English: The clinical consequence is not known.
Slovenian: Klinične posledice niso znane.
English: In rats, increased resorption rates have been observed.
Slovenian: Pri podganah so bile opažene povečane stopnje resorpcije.
English: These features resolve generally within 2-12 hours of the injection.
Slovenian: Ta stanja na splošno izzvenijo v 2-12 urah po injiciranju.
English: It is also well absorbed by the oral route.
Slovenian: Tudi po peroralni poti se dobro absorbira.