natgillin/translations-raw huggingface dataset:
NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Recocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje
Shelf-life after first opening the container: 28 days Once broached, use by ….
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Enkratna intramuskularna injekcija v odmerku po 0,4 mg meloksikama na kilogram telesne mase (to je 2,0 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem.
Meglumine
Presnavljanje
NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Recocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje meloksikam
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Terapevtske indikacije meloksikam meloksikam govedo, koze, prašiči, kunci, kopitarji µg/kg65 µg/kg 65 µg/kg mišice jetra ledvica
PACKAGE LEAFLET Recocam 20 mg/ml solution for injection for cattle, pigs and horses
NAVODILO ZA UPORABO Recocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje
Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Govedo: meso in organi: 15 dni, mleko: 5 dni.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial label for 10 ml
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Pigs: Meat and offal: 5 days
Prašiči: meso in organi: 5 dni.
STATEMENT OF THE MRLS
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
Do not use in pregnant or lactating mares.
Ne uporabljajte pri kobilah v obdobju brejosti in laktacije.
Excipient: Ethanol
4.11 Karenca
The name of the medicine was changed to Bondenza on 18 August 2004.
Ime zdravila je bilo 18. avgusta 2004 spremenjeno v Bondenza.
Other information about Bondenza
Druge informacije o zdravilu Bondenza
The full EPAR for Bondenza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bondenza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The tablet must always be taken after an overnight fast, one hour before any food or drink except for water, and with a full glass of plain water.
Tableto je treba vedno vzeti zjutraj na tešče, eno uro pred prvim obrokom ali pijačo (razen vode) s polnim kozarcem navadne vode.
Bondenza has been studied in three main studies involving women with osteoporosis.
Zdravilo Bondenza so raziskovali v treh glavnih študijah, v katere so bile vključene ženske z osteoporozo.
Patients taking Bondenza should also take vitamin D and calcium supplements if they do not get enough from their diet.
Bolnice, ki jemljejo zdravilo Bondenza, bi morale jemati tudi dodatke vitamina D in kalcija, če teh ne dobivajo v zadostni količini s prehrano.
For more information about treatment with Bondenza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Bondenza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Bondenza's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Bondenza večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Bondenza.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bondenza.
The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic Acid Roche on 23 February 2004.
Evropska komisija je dovoljenje za promet z zdravilom Ibandronic Acid Roche, veljavno po vsej Evropski uniji, odobrila dne 23. februarja 2004.
What benefit has Bondenza shown during the studies?
Kakšne koristi je zdravilo Bondenza izkazalo med študijami?
What is the risk associated with Bondenza?
Kakšna tveganja so povezana z zdravilom Bondenza?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bondenza.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Bondenza, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Previously known as Ibandronic Acid Roche.
Predhodno znano kot Ibandronic Acid Roche.
The 2.5-mg once-daily tablets used in the studies are no longer authorised.
V študiji uporabljene 2,5-miligramske tablete, ki se jemljejo enkrat dnevno, niso več odobrene.
The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour.
Tablet ne smejo jemati bolnice z nepravilnostmi v požiralniku ali bolnice, ki vsaj eno uro ne morejo stati ali sedeti vzravnano.
It must not be used in patients who have hypocalcaemia (low blood calcium levels).
Zdravilo se ne sme uporabljati pri bolnicah, ki imajo hipokalciemijo (nizke ravni kalcija).
Bondenza must not be used in people who are hypersensitive (allergic) to ibandronic acid or any of the other ingredients.
Zdravila Bondenza ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) ibandronsko kislino ali katero koli drugo sestavino zdravila.
Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
V študijah so dokazali učinek zdravila pri zmanjševanju tveganja za zlome hrbtenice, medtem ko njegov vpliv na tveganje za zlom stegneničnega vratu (zgornjega dela stegnenice) ni bil dokazan.
The most common side effects with Bondenza (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms.
Najpogostejši neželeni učinki zdravila Bondenza (opaženi pri 1 do 10 bolnic od 100) so artralgija (bolečine v sklepih) in gripi podobni simptomi.
It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
Bondenza can be given either as a tablet or as an injection into a vein.
Zdravilo Bondenza se daje bodisi s tabletami ali z injiciranjem v veno.
Why has Bondenza been approved?
Zakaj je bilo zdravilo Bondenza odobreno?
Bondenza is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Zdravilo Bondenza se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pojav zlomov.
Bondenza is a medicine that contains the active substance ibandronic acid.
Bondenza je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
For the full list of all side effects reported with Bondenza, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bondenza, glejte navodilo za uporabo.
The patient must not lie down for one hour after taking the tablet.
Eno uro po zaužitju tablete bolnica ne sme ležati.
In the first study, daily treatment with Bondenza 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
V prvi študiji je dnevno zdravljenje z 2,5-miligramskimi tabletami Bondenza v primerjavi s placebom za 62 % zmanjšalo tveganje za nove zlome hrbtenice.
ibandronic acid
Bondenza ibandronska kislina
The active substance in Bondenza, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Bondenza, ibandronska kislina, je difosfonat.
How has Bondenza been studied?
Kako je bilo zdravilo Bondenza raziskano?
The first study compared Bondenza 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
V prvi študiji so zdravilo Bondenza v obliki 2,5-miligramskih tablet, ki so jih bolnice jemale enkrat dnevno, primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skoraj 3 000 bolnicah in ugotavljali število novih zlomov hrbtenice pri bolnicah v triletnem obdobju študije.
The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip.
Drugi dve študiji sta pokazali, da so 150miligramske mesečne tablete in injekcije pri povečevanju kostne gostote v hrbtenici in kolkih učinkovitejše od 2,5-miligramskih tablet, ki se jemljejo enkrat na dan.
What is Bondenza used for?
Za kaj se zdravilo Bondenza uporablja?
How is Bondenza used?
Kako se zdravilo Bondenza uporablja?
What is Bondenza?
Kaj je zdravilo Bondenza?
How does Bondenza work?
Kako zdravilo Bondenza deluje?
Immediate Packaging Pack size pre-filled syringe (glass)
Stična ovojnina Velikost pakiranja raztopina za injicoranje intravitrealna uporaba napolnjena injekcijska brizga (steklo)
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Farmacevtska oblika Pot uporabe
vial (glass)
raztopina za injiciranje intravitrealna uporaba viala (steklo)
90 sachets (with a dosing spoon)
90 vrečic (z odmerno žličko)
Strength Pharmaceutical Form
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
1 vial + 1 ampoule
1 viala 1 ampula
3 vials + 3 ampoules
3 viale 3 ampule prašek: 7,5 mg; vehikel: 5 ml (1,5 mg/ml)
• are over 75 years old
• ste starejši od 75 let;
Drink the mixture.
Mešanico spijte.
E-mail: medinfo_de@eisai.net
E-pošta: medinfo_de@eisai.net
Date of first authorisation: 25 August 2016
Datum prve odobritve: 25. avgust 2016
Medical Dictionary for Regulatory Activities (MedDRA) version 17.1.
Medicinski slovar za regulativne dejavnosti (MedDRA) verzija 17.1.
The effects of Kisplyx in people younger than 18 years old are not known.
Učinki zdravila Kisplyx pri ljudeh, mlajših od 18 let, niso znani.
The time to onset was 69.6 weeks.
Čas do nastopa je bil 69,6 tedna.
Preferred terms have been reassigned to the SOC most relevant to the target organ.
Prednostni izrazi so bili prerazporejeni v SOC, ki najbolj ustreza tarčnemu organu.
The study consisted of a Phase 1b dose finding and a Phase 2 portion.
Študijo sta sestavljala del faze 1b za ugotavljanje odmerka in del faze 2.
Treatment should continue as long as there is clinical benefit or until unacceptable toxicity occurs.
Zdravljenje naj se nadaljuje, dokler je klinično koristno ali dokler se ne pojavi nesprejemljiva toksičnost.
The Efron method was used for correction for tied events.
Efronova metoda je bila uporabljena za popravek povezanih dogodkov.
Resolves to less than 2 gm / 24 hours.
Izboljša se na manj kot 2 g/24 ur.
Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggests that it is in the order of 85%.
Absolutne biološke uporabnosti pri ljudeh niso določili, vendar podatki iz študije masnega ravnovesja kažejo, da je približno 85 %.
If you forget to take Kisplyx Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Kisplyx Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), da bi nadomestili pozabljeni odmerek.
See detailed guidance in Table 3 in section 4.4.
Glejte podrobne smernice v preglednici 3 v poglavju 4.4.
The combination should be used in patients with severe hepatic impairment only if the anticipated benefit exceeds the risk.
Kombinacija naj se uporablja pri bolnikih s hudo okvaro jeter le, če je pričakovana korist večja od tveganja.
Grade 4 (despite medical management)
stopnja 4 (kljub medicinski obravnavi)
Juvenile animal toxicity studies
Študije toksičnosti na mladičih živali
The study was not powered for the OS analysis.
Študija ni imela ustrezne moči za analizo OS.
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Nemudoma povejte zdravniku, če opazite katerega od naslednjih neželenih učinkov - mogoče boste potrebovali nujno zdravljenje:
Percentages are based on the total number of subjects in the Full Analysis Set within relevant treatment group.
Odstotni deleži temeljijo na celotnem številu preiskovancev v celotnem naboru za analizo (Full Analysis Set) znotraj zadevne skupine zdravljenja.
• Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »EXP«.
Metastases were present in 95% of the patients and unresectable advanced disease was present in 5%.
Metastaze so bile prisotne pri 95 % bolnikov, neresektabilna napredovala bolezen pa je bila prisotna pri 5 %.
How long to takeKisplyx You will usually carry on taking this medicine as long as you are getting benefit.
Kako dolgo jemljite zdravilo Kisplyx Navadno boste jemali to zdravilo tako dolgo, kolikor vam bo koristilo.
Name and address of the manufacturer responsible for batch release Eisai Manufacturing Ltd.
Ime in naslov proizvajalca, odgovornega za sproščanje serij Eisai Manufacturing Ltd.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja.
Symptoms would depend on where the fistula is located.
Simptomi so odvisni od lokacije fistule.
Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or the BSEP.
Lenvatinib ni substrat za OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2 ali BSEP.
Diarrhoea was the most frequent cause of dose interruption/reduction and recurred despite dose reduction.
Driska je bila najpogostejši vzrok prekinitve/zmanjšanja odmerjanja in se je ponovila kljub zmanjšanju odmerka.
Your doctor will discuss the results of these tests with you and decide whether you can be given Kisplyx.
Zdravnik se bo pogovoril z vami o rezultatih teh preiskav in se odločil, ali vam lahko da zdravilo Kisplyx.
• headache and back pain
• glavobol in bolečine v hrbtu,
Concomitant administration of lenvatinib, carboplatin, and paclitaxel has no significant impact on the pharmacokinetics of any of these 3 substances.
Sočasna uporaba lenvatiniba, karboplatina in paklitaksela ni pomembno vplivala na farmakokinetiko katere koli od teh treh snovi.
Therefore mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs.
Zato lahko smrtnost pripišemo zapletom, povezanim s primarnimi duodenalnimi lezijami, z možnim prispevkom dodatnih toksičnosti v nezrelih ciljnih organih.
Benefit-risk in these patients has not been evaluated.
Razmerja med koristmi in tveganji pri teh bolnikih niso ovrednotili.
The treatment effect of the combination on PFS and ORR was also supported by a post-hoc retrospective independent blinded review of scans.
Zdravilni učinek kombinacije zdravil na PFS in ORR je podprl tudi post-hoc retrospektivni neodvisen slep pregled radioloških slik.
The minimal washout period in clinical trials was of 4 weeks.
Najkrajše obdobje spiranja v kliničnih preskušanjih je bilo obdobje 4 tednov.
No events of hypocalcaemia required dose reduction or interruption, and no patients discontinued treatment due to hypocalcaemia.
Noben dogodek hipokalciemije ni zahteval zmanjšanja odmerka ali prekinitve odmerjanja in pri nobenem bolniku niso ukinili zdravljenja zaradi hipokalciemije.
GI perforation or fistula Grade 3
GI perforacija ali fistula stopnja 3
The mean terminal exponential half-life of lenvatinib is approximately 28 hours.
Povprečna končna eksponencialna razpolovna doba lenvatiniba je približno 28 ur.
What Kisplyx is and what it is used for
Kaj je zdravilo Kisplyx in za kaj ga uporabljamo
Figure 2: Kaplan-Meier Plot of Overall Survival
Slika 2: Kaplan-Meierjeva krivulja celotnega preživetja
Genotoxicity Lenvatinib was not genotoxic.
Genotoksičnost Lenvatinib ni bil genotoksičen.
Patients with high ECOG performance status
Bolniki z visokim stanjem zmogljivosti po ECOG
In most cases, gastrointestinal perforation and fistulae occurred in patients with risk factors such as prior surgery or radiotherapy.
Pri večini primerov so gastrointestinalna perforacija in fistule nastale pri bolnikih z dejavniki tveganja, na primer predhodnim kirurškim posegom ali radioterapijo.
The capsules can be swallowed whole with water.
Kapsule je mogoče pogoltniti cele z nekaj vode.
If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
Če bolnik pozabi vzeti odmerek in ga ne more vzeti v naslednjih 12 urah, naj tisti odmerek preskoči in ob običajnem času uporabe vzame naslednji odmerek.
Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness.
Lenvatinib ima blag vpliv na sposobnost vožnje in upravljanja s stroji, in to zaradi neželenih učinkov, kot sta utrujenost in omotica.
Similarly, no induction of P-gp mRNA expression was observed.
Prav tako niso opazili nikakršne indukcije ekspresije P-gp mRNA.
Please see distribution section.
Glejte poglavje o porazdelitvi.
All patients had a baseline ECOG PS of either 0 (55%) or 1 (45%) with similar distribution across the 3 treatment arms.
Vsi bolniki so imeli ECOG PS bodisi 0 (55 %) ali 1 (45 %) s podobno porazdelitvijo po vseh 3 skupinah zdravljenja.
The mechanism of action for the worsening of hypercholesterolemia with the combination has not been studied directly and is not fully elucidated.
Mehanizma delovanja za poslabšanje hiperholesterolemije pri kombinaciji zdravil niso raziskovali neposredno in ni povsem pojasnjen.
When necessary, manage hypertension as recommended in Table 3.
Po potrebi zdravite hipertenzijo po priporočilih v preglednici 3.
Data cut-off date = 13 Jun 2014
Datum zaključka zbiranja podatkov = 13. junij 2014.
The early detection and effective management of hypertension are important to minimise the need for lenvatinib dose interruptions and reductions.
Zgodnje odkrivanje in učinkovito zdravljenje hipertenzije sta pomembna, da se kar najbolj zmanjša potreba po prekinitvah odmerjanja in zmanjševanjih odmerka lenvatiniba.
The median time to onset was 6.7 weeks.
Mediani čas do začetka je bil 6,7 tedna.
Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of 2 or higher were excluded from the RCC study (see section 5.1).
Bolniki s stanjem zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2 ali več so bili izključeni iz študije RCC (glejte poglavje 5.1).
• Do not take Kisplyx if you are planning to become pregnant during your treatment.
• Ne jemljite zdravila Kisplyx, če načrtujete zanositev med zdravljenjem.
The daily doses of lenvatinib and, if necessary, everolimus are to be modified as needed according to the dose/toxicity management plan.
Dnevni odmerek lenvatiniba in po potrebi tudi everolimusa spreminjajte po potrebi v skladu z načrtom za obvladovanje odmerka/toksičnosti.
• The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30, 60 or 90 hard capsules.
• Kapsule so na voljo v pretisnih omotih iz poliamida/aluminija/PVC, prekritih z aluminijevo folijo za predrtje, v kartonskih škatlah s po 30, 60 ali 90 trdimi kapsulami.
Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known)
Neznana pogostnost (o naslednjih neželenih učinkih so poročali, odkar je prišel lenvatinib na trg, vendar pogostnost, s katero se pojavljajo, ni znana):
**:These adverse reactions occur more frequently with combination therapy compared to lenvatinib monotherapy.
**: Ti neželeni učinki se pojavljajo pogosteje pri kombinirani terapiji kot pri monoterapiji z lenvatinibom.
In vitro studies indicate that lenvatinib is a substrate for P-gp and BCRP.
In vitro študije kažejo, da je lenvatinib substrat za P-gp in BCRP.
Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with a median latency of about 3 months.
O reakcijah so poročali ob različnih časovnih točkah med zdravljenjem, od dveh tednov do več kot enega leta po uvedbi lenvatiniba, mediana latenca je bila okrog 3 mesece.
Resolves to Grade 0, 1 or 2.
Izboljša se na stopnjo 0, 1 ali 2.
Other medicines and Kisplyx
Druga zdravila in zdravilo Kisplyx
The European Medicines Agency has waived the obligation to submit the results of studies with lenvatinib in all subsets of the paediatric population in Renal Cell Carcinoma (RCC).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z lenvatinibom za vse podskupine pediatrične populacije s karcinomom ledvičnih celic (RCC).
The Phase 2 portion enrolled a total of 153 patients with unresectable advanced or metastatic RCC following 1 prior VEGF-targeted treatment.
V delu faze 2 je bilo vključenih vsega skupaj 153 bolnikov z neresektabilnim napredovalim ali metastatskim RCC po enem predhodnem zdravljenju, usmerjenem v VEGF.
The suspension is to be swallowed.
Suspenzijo naj spije.
• high levels of protein in the urine and urinary infections (increased frequency in urination and pain in passing urine)
• zvišana raven beljakovin v urinu in okužbe sečil (pogostnejše uriniranje in bolečine pri uriniranju),
What you need to know before you take Kisplyx
Kaj morate vedeti, preden boste vzeli zdravilo Kisplyx
You may need to have additional treatment with other medicines, to take a lower dose of Kisplyx, or to take extra care due to an increased risk of side effects.
Mogoče se boste morali dodatno zdraviti z drugimi zdravili, jemati manjši odmerek zdravila Kisplyx ali pa biti zaradi zvečanega tveganja neželenih učinkov še posebej pazljivi.
Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Skrbniki bolnikov naj ne odpirajo kapsul, da se bodo izognili ponavljajočemu se izpostavljanju vsebini kapsul.
Before taking Kisplyx, your doctor may carry out some blood tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood.
Pred začetkom jemanja zdravila Kisplyx vam lahko zdravnik naredi nekatere krvne preiskave, lahko vam na primer kontrolira krvni tlak in delovanje jeter ali ledvic in se prepriča, ali imate nizko raven soli in visoko raven tirotropnega hormona v krvi.
Of the 153 patients randomly allocated, 73% were male, the median age was 61 years, 37% were 65 years or older, 7% were 75 years or older, and 97% were Caucasian.
Od 153 randomiziranih bolnikov je bilo 73 % moških, mediana starost je bila 61 let, 37 % jih je bilo starih 65 let ali več, 7 % jih je bilo starih 75 let ali več, 97 % pa jih je bilo bele rase.
• weigh less than 60 kg
• tehtate manj kot 60 kg;