natgillin/translations-raw huggingface dataset:
The mean baseline LDL-C was 225 mg/dl equivalent to 5,8 mmol/l (range: 148-343 mg/dl equivalent to 3.8-8.9 mmol/l).
Povprečna koncentracija LDL holesterola ob izhodišču je bila 225 mg/dl, kar ustreza 5,8 mmol/l (v obsegu 148-343 mg/dl, kar ustreza 3,8-8,9 mmol/l).
HOW TO TAKE LESCOL/LESCOL XL
KAKO JEMATI ZDRAVILO LESCOL/LESCOL XL
Lescol and Lescol XL can be taken with or without meals.
Tako zdravilo Lescol kot Lescol XL lahko jemljete skupaj z obrokom hrane ali brez njega.
Very rare:
glavobol zelo redki:
140 00 Praha 4 - Nusle, Czech Republic
13000 Prague 3 Češka
80 mg Film-coated tablet
80 mg filmsko obložena tableta peroralna uporaba
Colchicines
Kolhicini
One prolonged-release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
Ena tableta s podaljšanim sproščanjem zdravila Lescol XL vsebuje 84,24 mg natrijevega fluvastatinata, kar ustreza 80 mg proste kisline fluvastatina.
Starting and maintenance doses should be individualized according to the baseline LDL-C levels and the treatment goal to be accomplished.
Začetne in vzdrževalne odmerke je treba prilagoditi posameznemu bolniku glede na njegove izhodiščne koncentracije LDL holesterola in zastavljeni cilj zdravljenja.
MARKETING AUTHORISATION HOLDER [See Annex 1 - To be completed nationally]
IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek I - Izpolni država članica]
However, since an increased risk of myopathy has been observed in patients receiving other HMG-CoA reductase inhibitors together with fibrates or niacin, these combinations should be used with caution.
Vendar je treba te kombinacije uporabljati previdno zaradi dokazanega večjega tveganja miopatij pri bolnikih, ki so prejemali druge zaviralce HMG-CoA-reduktaze sočasno s fibrati ali niacinom.
Dyslipidaemia
nespečnost
Caution should be exercised when Lescol/Lescol XL is administered to patients with a history of liver disease or heavy alcohol ingestion.
Pri uporabi zdravila Lescol/Lescol XL pri bolnikih z anamnezo jetrne bolezni in pri bolnikih, ki zaužijejo večje količine alkohola, je potrebna previdnost.
Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Finland
Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Finska
The mean baseline LDL-C was 226 mg/dl equivalent to 5.8 mmol/l (range: 137-354 mg/dl equivalent to 3.6-9.2 mmol/l).
Povprečna koncentracija LDL holesterola ob izhodišču je bila 226 mg/dl, kar ustreza 5,8 mmol/l (v obsegu 137-354 mg/dl, kar ustreza 3,6-9,2 mmol/l).
The recommendation that Lescol capsules can be taken regardless of meals is largely consistent across the EU Member States.
Časovna razporeditev jemanja zdravila in obrokov Skoraj vse države članice EU so zagovarjale priporočilo, da se kapsule Lescol jemljejo ne glede na obroke.
Given as a single daily dose of 80 mg, Lescol XL significantly reduced total-C, LDL-C, triglycerides (TG) and Apo B (see Table 2).
Zdravilo Lescol XL, ki so ga bolniki jemali v obliki enega 80miligramskega odmerka enkrat na dan, je pomembno znižalo koncentracije skupnega holesterola, LDL holesterola, trigliceridov in apolipoproteina B (glejte preglednico 2).
Uncommon: affects 1 to 10 users in 1,000
Občasni: pojavijo se pri 1 do 10 od 1.000 uporabnikov.
Histamine H2-receptor antagonists and proton pump inhibitors Concomitant administration of fluvastatin with cimetidine, ranitidine or omeprazole results in an increase in the bioavailability of fluvastatin, which, however, is of no clinical relevance.
Sočasna uporaba fluvastatina s cimetidinom, ranitidinom ali omeprazolom povzroči povečanje biološke uporabnosti fluvastatina, ki pa nima nikakršnega kliničnega pomena.
6.1 List of excipients [To be completed Nationally]
6.1 Seznam pomožnih snovi [Izpolni država članica]
To maintain the benefits of your treatment, do not stop taking Lescol/ Lescol XL unless your doctor tells you to. You must continue to take Lescol/Lescol XL as directed to keep the levels of your ‘bad' cholesterol down.
Zdravilo Lescol/Lescol XL morate jemati še naprej tako, kot vam naroči zdravnik, da bo raven vašega‘slabega' holesterola ostala nizka.
The mean achieved LDL-C was 161 mg/dl equivalent to 4.2 mmol/l (range: 74-336 mg/dl equivalent 1.9-8.7 mmol/l).
Povprečna dosežena koncentracija LDL holesterola je bila 161 mg/dl, kar ustreza 4,2 mmol/l (v obsegu od 74 do 336 mg/dl, kar ustreza od 1,9 do 8,7 mmol/l).
This leaflet was last approved in [To be completed nationally]
Navodilo je bilo odobreno [Izpolni država članica]
Children and adolescents with heterozygous familial hypercholesterolaemia Prior to initiating treatment with Lescol/Lescol XL in children and adolescents aged 9 years and older with heterozygous familial hypercholesterolaemia, the patient should be placed on a standard cholesterollowering diet, and continued during treatment.
Otroci in mladostniki s heterozigotno familiarno hiperholesterolemijo Otroci in mladostniki, ki so stari 9 let ali več in imajo heterozigotno familiarno hiperholesterolemijo, morajo začeti s standardno dieto za zniževanje koncentracije holesterola pred začetkom zdravljenja z zdravilom Lescol/Lescol XL in z njo nadaljevati tudi med zdravljenjem.
Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland
Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finska
20 mg Capsules, hard
20 mg kapsule, trde
Use reliable contraception for the whole time that you are taking Lescol / Lescol XL.
Ves čas zdravljenja z zdravilom Lescol/Lescol XL uporabljajte zanesljivo kontracepcijsko metodo.
Myalgia, muscle weakness, myopathy
mialgija, mišična oslabelost, miopatija zelo redki:
80 mg prolonged-release tablets Member State
80 mg tablete s podaljšanim sproščanjem država članica zdravilo
Whilst on treatment
Med zdravljenjem:
Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800
Medialaan, 40 bus 1 1800 Vilvoorde Belgija
40 mg Capsules, hard
40 mg kapsule, trde
Starting and maintenance dose of fluvastatin should be as low as possible when combined with ciclosporin.
Pri sočasni uporabi s ciklosporinom je treba uporabiti karseda nizek začetni in vzdrževalni odmerek fluvastatina.
40 mg capsules Member State
40 mg kapsule država članica zdravilo
The recommended starting dose is one 20 mg Lescol capsule.
Priporočeni začetni odmerek je ena kapsula zdravila Lescol 20 mg. Odmerek je treba prilagajati v presledkih po 6 tednov.
In the Lipoprotein and Coronary Atherosclerosis Study (LCAS), the effect of fluvastatin on coronary atherosclerosis was assessed by quantitative coronary angiography in male and female patients (35 to
V študiji lipoproteinov in koronarne ateroskleroze (Lipoprotein and Coronary Atherosclerosis StudyLCAS) so ocenjevali učinek fluvastatina na koronarno aterosklerozo s kvantitativno koronarno angiografijo pri bolnikih in bolnicah (starih od 35 do 75 let) s koronarno boleznijo srca in z izhodiščno koncentracijo LDL holesterola od 3,0 do 4,9 mmol/l (115 do 190 mg/dl).
Excipients: [To be completed nationally]
Pomožne snovi: [Izpolni država članica]
When to take Lescol/ Lescol XL
Kdaj je treba jemati zdravilo Lescol/Lescol XL
Myotoxicity, including muscle pain and weakness and rhabdomyolysis, has been reported in isolated cases with concomitant administration of colchicines.
Pri sočasni uporabi kolhicinov so poročali o posameznih primerih toksičnega delovanja na mišice, vključno z bolečinami v mišicah, šibkostjo mišic in rabdomiolizo.
Novartis Pharma B.V. Raapopseweg 1 ,6824 DP Arnhem,
6824 DP Arnhem
Impaired liver function
Bolniki z okvarjenim delovanjem ledvic
Biochemical abnormalities of liver function have been associated with HMG-CoA reductase inhibitors and other lipid-lowering agents.
Zaviralce reduktaze HMG-CoA in druge hipolipemike povezujejo z odstopanjem od normalnih vrednosti biokemičnih parametrov delovanja jeter.
Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).
Sekundarno preprečevanje koronarnih dogodkov pri bolnikih s koronarno srčno boleznijo Sekundarno preprečevanje pomembnih neželenih koronarnih dogodkov pri odraslih s koronarno srčno boleznijo po perkutanem koronarnem posegu (glejte poglavje 5.1).
Dose titration intervals
Presledki pri prilagajanju odmerka
Do not take Lescol/Lescol XL
SHRANJEVANJE ZDRAVILA LESCOL/LESCOL XL
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex 1 - To be completed nationally]
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica]
Lescol® Capsule, hard 20mg
Lescol® Capsule, hard 20 mg 20 mg kapsula, trda
Thus routine monitoring of phenytoin plasma levels is sufficient during co-administration with fluvastatin.
Pri sočasni uporabi s fluvastatinom je vpliv na farmakokinetične lastnosti fenitoina le majhen in nima kliničnega pomena, zato v takih primerih zadošča rutinsko spremljanje koncentracije fenitoina v plazmi.
Lescol capsules and Lescol XL tablets can be taken with or without meals and should be swallowed as whole with a glass of water.
Kapsule zdravila Lescol in tablete zdravila Lescol XL je mogoče jemati s hrano ali brez nje.
Lescol® Capsule, hard 40mg
Lescol® Capsule, hard 40 mg 40 mg kapsula, trda
Lactation
Dislipidemija
- if you are pregnant or breast-feeding (see “pregnany and breast-feeding”).
(aminotransferaz), - če ste noseči ali če dojite (glejte “Nosečnost in dojenje”).
Read the following explanations before you take Lescol/Lescol XL.
Te diete se držite tudi v času jemanja zdravila Lescol/Lescol XL.
Keep Lescol/Lescol XL out of the reach and sight of children.
[Izpolni država članica] Zdravilo Lescol/Lescol XL shranjujte nedosegljivo otrokom!
Steady-state plasma concentrations show no evidence of fluvastatin accumulation following administration of 80 mg daily.
Po jemanju odmerka 80 mg na dan koncentracije v plazmi v stanju dinamičnega ravnovesja ne kažejo znakov kopičenja fluvastatina.
The overall magnitude of the changes in phenytoin pharmacokinetics during co-administration with fluvastatin is relatively small and not clinically significant.
Farmakokinetika fluvastatina pri bolnikih z blago do hudo ledvično insuficienco ni spremenjena.
GENERAL CLASSIFICATION FOR SUPPLY [ To be completed nationally]
NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
This summary was last updated in February 2012.
Povzetek je bil nazadnje posodobljen februarja 2012.
It is given once only, two to four hours before surgery, and its effects will last for at least four days.
Daje se samo enkrat, dve do štiri ure pred operativnim posegom, učinkuje pa vsaj štiri dni.
It is given by a veterinarian.
Zdravilo daje veterinar.
The European Commission granted a marketing authorisation valid throughout the European Union, for Recuvyra on 6 October 2011.
Evropska komisija je dovoljenje za promet z zdravilom Recuvyra, veljavno po vsej Evropski uniji, odobrila dne 06/10/2011.
What benefit has Recuvyra shown during the studies?
Kakšne koristi je zdravilo Recuvyra izkazalo med študijami?
The recommended dose is 2.6 mg per kilogram bodyweight applied with a specially designed syringe to the skin between the shoulder blades of the dog.
Priporočeni odmerek je 2,6 mg na kilogram telesne mase in se nanaša s posebej oblikovano brizgo na kožo med lopatici pri psu.
Other side effects include mild reductions in body temperature, heart rate and breathing rate for up to three days following use.
Med drugimi neželenimi učinki so blago znižanje telesne temperature, hitrosti srčnega utripa in dihanja, ki trajajo do tri dni po uporabi.
What is the risk associated with Recuvyra?
Kakšna tveganja so povezana z zdravilom Recuvyra?
However, small children (15kg or less) should not touch the dog for three days after the medicine has been applied, as they may be exposed to a large amount of fentanyl.
Majhni otroci (ki imajo 15 kg ali manj) se ne smejo dotikati psa tri dni po nanosu zdravila, saj so lahko izpostavljeni večji količini fentanila.
If symptoms develop as a result of exposure to Recuvyra, medical advice should be sought immediately.
Če se zaradi izpostavljenosti zdravilu Recuvyra pojavijo simptomi, se nemudoma posvetujte z zdravnikom.
It is available as a transdermal solution (a solution applied to the skin).
Na voljo je v obliki transdermalne raztopine (raztopina, ki se nanaša na kožo).
Recuvyra must not be used on skin that is broken or damaged due to injury or disease.
Zdravilo Recuvyra se ne sme uporabljati na razpokani ali poškodovani koži zaradi poškodbe ali bolezni.
The CVMP decided that the benefits of Recuvyra outweighed its risks and recommended that it be given a marketing authorisation.
CVMP je sklenil, da koristi zdravila Recuvyra odtehtajo z njim povezana tveganja, in priporočil odobritev dovoljenja za promet z zdravilom.
Recuvyra was shown to be as effective as the comparator medicines with the added advantage of being easy to apply.
Zdravilo Recuvyra se je pokazalo enako učinkovito kot primerjalna zdravila, njegova dodatna prednost pa je enostavna uporaba.
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Razmerje med koristmi in tveganji lahko najdete v znanstveni razpravi tega evropskega javnega poročila o oceni zdravila (EPAR).
The person administering Recuvyra should avoid contact with their skin as the medicine can be absorbed by human skin and may cause reactions in people, including skin irritation.
Oseba, ki daje zdravilo Recuvyra, naj se izogiba stiku s kožo, saj lahko človeška koža zdravilo absorbira, le to pa lahko povzroči reakcije pri ljudeh, vključno z draženjem kože.
Recuvyra very commonly causes sleepiness which may last for more than 24 hours after applying the medicine, and which can be associated with reduced food and water intake, decreased stool production and transient weight loss.
Zdravilo Recuvyra zelo pogosto povzroča zaspanost, ki lahko traja tudi več kot 24 ur po nanosu zdravila in na katero lahko vplivajo tudi manjši vnos hrane in vode, manjše izločanje blata in prehodna izguba telesne mase.
Contact with the dog's skin after application of Recuvyra should not cause problems for adults.
Stik s kožo psa po nanosu zdravila Recuvyra pri odraslih ne bi smel povzročati težav.
The studies compared the two medicines in terms of failure rate (dogs that had to be taken off treatment due to lack of pain control) and the need for additional treatment to counteract the harmful effects of opioid medicines.
V študijah so primerjali obe zdravili v smislu stopnje osipa (psi, pri katerih so prenehali z zdravljenjem, ker zdravilo ni zadovoljivo lajšalo bolečine) in potrebe po dodatnem zdravljenju za izničenje škodljivih učinkov opioidnih zdravil.
Why has Recuvyra been approved?
Zakaj je bilo zdravilo Recuvyra odobreno?
Recuvyra must not be use in dogs that are allergic to the active substance or any other ingredient.
Zdravilo Recuvyra se ne sme uporabljati pri psih, alergičnih na zdravilno učinkovino ali katero koli drugo sestavino.
Recuvyra is a medicine that contains the active substance fentanyl.
Recuvyra je zdravilo, ki vsebuje zdravilno učinkovino fentanil.
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Ko fentanil pride v krvni obtok, začne delovati na receptorje v možganih in hrbtenjači ter blažiti bolečino.
The active substance in Recuvyra, fentanyl, is an opioid painkiller.
Zdravilna učinkovina zdravila Recuvyra je fentanil, močan opioidni analgetik.
When applied to the skin of dogs, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels below the skin.
Po nanosu na kožo psa se odmerek fentanila skozi krvne žile pod kožo hitro absorbira v krvni obtok.
What is Recuvyra used for?
Za kaj se zdravilo Recuvyra uporablja?
In both studies Recuvyra was as effective as the comparator medicine in treating pain in dogs following orthopaedic or soft tissue surgery.
V obeh študijah je bilo zdravilo Recuvyra enako učinkovito kot primerjalno zdravilo pri lajšanju bolečine pri psih po ortopedskem operativnem posegu ali operativnem posegu na mehkih tkivih.
What is Recuvyra?
Kaj je zdravilo Recuvyra?
How does Recuvyra work?
Kako zdravilo Recuvyra deluje?
In two main studies, dogs undergoing orthopaedic or soft tissue surgery were either given Recuvyra or buprenorphine (another opioid painkiller) in advance of surgery to control their pain.
V dveh glavnih študijah so psi pred ortopedskim operativnim posegom ali operativnim posegom na mehkem tkivu za nadzorovanje bolečine prejeli zdravilo Recuvyra ali buprenorfin (drugi opioidni analgetik).
The most common symptoms associated with fentanyl overdose in people include respiratory depression, sleepiness and myosis (narrowing of the pupil in the eye).Protective equipment of clothing should be used when handling the medicine.
Najpogostejši simptomi, povezani s prevelikim odmerjanjem fentanila pri ljudeh, vključujejo depresijo dihanja, zaspanost in miozo (zoženje zenic v očesu).
Recuvyra is used to control pain in dogs that have undergone major orthopaedic (bone) or soft tissue surgery.
Zdravilo Recuvyra se uporablja za nadzorovanje bolečine pri psih po večjih ortopedskih operativnih posegih (na kosteh) ali operativnih posegih na mehkih tkivih.
Diarrhoea and vomiting are also common side effects.
Pogosta neželena učinka sta tudi driska in bruhanje.
15 March 2012
15. Marec 2012
It was to be available as an oral suspension (125 mg/ml).
Na voljo naj bi bilo v obliki peroralne raztopine (125 mg/ml).
In its letter notifying the Agency of the withdrawal of application, the company stated that its withdrawal was due to the prioritisation of its activities.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je vlogo umaknila zaradi prednostne razvrstitve svojih dejavnosti.
This means that it was intended to be similar to a ‘reference medicine' called Megace which is already authorised in the European Union and contains the same active substance.
To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“ Megace, ki je že odobreno v Evropski uniji in ki vsebuje isto zdravilno učinkovino.
Because Megestrol Alkermes was assessed as a hybrid generic medicine, the company presented the results of studies carried out to investigate whether it is bioequivalent to the reference medicine, Megace.
Ker je bilo zdravilo Megestrol Alkermes ovrednoteno kot hibridno generično zdravilo, je družba predložila rezultate študij, ki so bile opravljene za proučitev, ali je zdravilo biološko enakovredno referenčnemu zdravilu Megace.
The active substance in Megestrol Alkermes, megestrol, is similar to a naturally occurring hormone called progesterone and is used in the treatment of certain cancers.
Zdravilna učinkovina v zdravilu Megestrol Alkermes, megestrol, je podobna naravno prisotnemu hormonu progesteronu in se uporablja za zdravljenje nekaterih vrst raka.
Both medicines are oral suspensions but Megestrol Alkermes was formulated so that it could be given at a lower dose to obtain the same effect.
Obe zdravili sta peroralni raztopini, vendar je bilo zdravilo Megestrol Alkermes zasnovano tako, da se lahko daje v nižjem odmerku za dosego istega učinka.
Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Megestrol Alkermes could not have been approved.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih zastavil CHMP, je ta ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Megestrol Alkermes ni mogoče odobriti.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Megestrol Alkermes.
Zato je CHMP ob umiku vloge menil, da družba ni predložila dovolj podatkov v podporo vlogi za zdravilo Megestrol Alkermes.
On 6 March 2012, Alkermes Pharma Ireland Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Megestrol Alkermes, intended to treat weight loss and loss of appetite in patients with cancer or AIDS.
Družba Alkermes Pharma Ireland Ltd. je dne 6. marca 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Megestrol Alkermes, namenjenim zdravljenju izgube telesne mase in teka pri bolnikih z rakom ali aidsom.
The company also presented a study investigating the effectiveness of Megestrol Alkermes in the treatment of weight loss and loss of appetite in patients with AIDS and data from the scientific literature supporting the use of megestrol in the treatment of weight loss and loss of appetite in patients with cancer and AIDS.
Družba je predstavila tudi študijo, s katero je proučevala učinkovitost zdravila Megestrol Alkermes pri zdravljenju izgube telesne mase in teka pri bolnikih z aidsom, ter podatke iz znanstvene literature, ki podpirajo uporabo megestrola pri zdravljenju izgube telesne mase in teka pri bolnikih z rakom in aidsom.
Based on the data submitted, the CHMP was of the opinion that the studies did not show that Megestrol Alkermes was bioequivalent to the reference medicine and therefore cannot be considered to have the same effectiveness as Megace in reversing weight loss and loss of appetite in patients with cancer and AIDS.
Na podlagi predloženih podatkov je namreč menil, da študije niso dokazale, da je zdravilo Megestrol Alkermes biološko enakovredno referenčnemu zdravilu in se zato zanj ne more šteti, da je enako učinkovito kot zdravilo Megace pri zmanjševanju izgube telesne mase in teka pri bolnikih z rakom ali aidsom.
Megestrol Alkermes was assessed as a ‘hybrid generic medicine'.
Zdravilo Megestrol Alkermes je bilo ovrednoteno kot „hibridno generično zdravilo“.
The exact way that megestrol works in the treatment of weight loss and appetite loss is not understood but megestrol may act on certain messenger substances and pathways that affect appetite.
Natančen način delovanja megestrola pri zdravljenju izgube telesne mase in teka še ni znan, a bi ta lahko vplival na nekatere prenašalce in telesne procese, ki vplivajo na tek.
Megestrol Alkermes is a medicine that contains the active substance megestrol.
Megestrol Alkermes je zdravilo, ki vsebuje zdravilno učinkovino megestrol.
Megestrol Alkermes was expected to be used to treat weight loss and loss of appetite in patients with cancer or AIDS.
Zdravilo Megestrol Alkermes naj bi se uporabljalo za zdravljenje izgube telesne mase in teka pri bolnikih z rakom ali aidsom.
What is Megestrol Alkermes?
Kaj je zdravilo Megestrol Alkermes?
Megestrol Alkermes is expected to work in the same way as the reference medicine, Megace.
Zdravilo Megestrol Alkermes naj bi delovalo enako kot referenčno zdravilo Megace.
What was Megestrol Alkermes expected to be used for?
Za kaj naj bi se zdravilo Megestrol Alkermes uporabljalo?
How is Megestrol Alkermes expected to work?
Kako naj bi zdravilo Megestrol Alkermes delovalo?
A risk to the suckling child cannot be excluded.
Tveganje za dojenega otroka zato ni izključeno.
See section 4.2 for information on paediatric use.
Glejte poglavje 4.2 za informacije o pediatrični uporabi.
The expiry date refers to the last day of that month.
Rok uporabnosti se izteče zadnji dan navedenega meseca.
An updated RMP should be submitted:
Poleg tega je treba posodobljen RMP predložiti:
- if you have serious heart disease or recently had a heart attack within the last 90 days.
- imate resno srčno obolenje ali ste v zadnjih 90 dneh preboleli srčni infarkt.
Across all clinical studies, reports of changes in colour vision were rare (< 0.1%).
V vseh kliničnih študijah so bila poročila o spremembah barvnega vida redka (< 0,1 %).
Adverse events were similar to those seen at lower doses.
Neželeni dogodki so bili podobni tistim, opaženim pri nižjih odmerkih.
Date of first authorisation: 21 November 2014 Date of latest renewal: 31 July 2019
Datum pridobitve dovoljenja za promet: 21 November 2014 Datum zadnjega podaljšanja: 31 Julij 2019
- if you have low blood pressure or uncontrolled high blood pressure.
- imate nizek krvni tlak ali nekontroliran visok krvni tlak.
Adult men
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