natgillin/translations-raw huggingface dataset:
The summaries of the opinions of the Committee for Orphan Medicinal Products for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Povzetek mnenja Odbora za zdravila sirote o zdravilu Nexavar je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
The CHMP decided that Nexavar's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Nexavar večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Nexavar is used to treat patients who have the following diseases:
Zdravilo Nexavar se uporablja za zdravljenje bolnikov z naslednjimi boleznimi:
This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study.
Ta ugotovitev je temeljila na izidih študije pri vseh 903 bolnikih, vključno z 200 bolniki, ki so pred koncem študije s placeba prešli na zdravilo Nexavar.
• hepatocellular carcinoma (11 April 2006)
• hepatocelularni karcinom (11. april 2006)
Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.
Zdravljenje z zdravilom Nexavar mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
Nexavar has been compared with placebo (a dummy treatment) in three main studies.
Zdravilo Nexavar so primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah.
The first study involved 602 patients with hepatocellular carcinoma; the second involved 903 patients with advanced renal cell carcinoma in whom one previous anticancer treatment had stopped working; and the third study involved 417 patients with differentiated thyroid carcinoma that had progressed or spread locally or to other parts of the body and did not respond to treatment with radioactive iodine.
V prvi študiji sta sodelovala 602 bolnika s hepatocelularnim karcinomom, v drugi študiji 903 bolniki z napredovalim rakom ledvičnih celic, pri katerih predhodno zdravljenje proti raku ni bilo več učinkovito, tretja študija pa je zajela 417 bolnikov z diferenciranim karcinomom ščitnice, ki je bodisi napredoval, se razširil lokalno ali zajel tudi druge dele telesa in se ni odzval na zdravljenje z radioaktivnim jodom.
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 Nexavar.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For the full list of all side effects and restrictions with Nexavar, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Nexavar glejte navodilo za uporabo.
• renal cell carcinoma (29 July 2004)
• rak ledvičnih celic (29. julij 2004)
What benefit has Nexavar shown during the studies?
Kakšne koristi je zdravilo Nexavar izkazalo med študijami?
• hepatocellular carcinoma (a type of liver cancer);
• hepatocelularnim karcinomom (vrsto jetrnega raka);
These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Ti encimi so prisotni v nekaterih receptorjih na površini rakavih celic, kjer sodelujejo pri njihovi rasti in širjenju, ter v krvnih žilah, ki oskrbujejo tumorje, kjer sodelujejo pri nastanku novih krvnih žil.
• advanced renal cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin 2 has failed or cannot be used;
• napredovalim rakom ledvičnih celic (vrsto ledvičnega raka), če je bilo zdravljenje raka z interferonom alfa ali interlevkinom 2 neuspešno ali se ne more uporabiti;
The most common side effects with Nexavar are diarrhoea, rash, alopecia (hair loss), infection, hand foot skin reaction (rash and pain on the palms of the hands and soles of the feet) and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Nexavar so driska, izpuščaji, alopecija (izpadanje las), okužbe, reakcije na koži dlani in stopal (izpuščaji in bolečine na dlaneh in stopalih) ter utrujenost.
The most important serious side effects are myocardial infarction (heart attack) or ischaemia (reduced oxygen supply to the heart), gastrointestinal perforation (a hole that develops in the wall of the gut), drug-induced hepatitis (a disease of the liver), haemorrhage (bleeding) and hypertension or hypertensive crisis (high blood pressure).
Najpomembnejši resni neželeni učinki so miokardni infarkt (srčni napad) ali ishemija (zmanjšana oskrba srca s kisikom), gastrointestinalna perforacija (nastanek lukenj v črevesni steni), z zdravili povzročen hepatitis (obolenje jeter), krvavitve in hipertenzija (povišan krvni tlak) ali hipertenzivna kriza (nenadno povišanje krvnega tlaka).
The active substance in Nexavar, sorafenib, is a protein kinase inhibitor.
Zdravilna učinkovina v zdravilu Nexavar, sorafenib, je zaviralec proteinske kinaze.
The treatment is continued as long as the patient continues to benefit from it without too many side effects.
Zdravljenje traja tako dolgo, dokler še koristi bolniku oziroma dokler neželeni učinki zdravljenja niso prekomerni.
The main measures of effectiveness were how long the patients survived or how long the patients lived without their disease getting worse.
Glavni merili učinkovitosti sta bili čas preživetja ali čas preživetja brez napredovanja bolezni.
Nexavar was more effective than placebo in increasing how long the patients survived or how long the patients lived without their disease getting worse.
Zdravilo Nexavar je bilo učinkovitejše od placeba pri podaljševanju časa preživetja ali časa preživetja brez napredovanja bolezni.
The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months).
Pri bolnikih, ki so jemali zdravilo Nexavar, je bil čas preživetja brez napredovanja bolezni daljši (167 dni, približno pet mesecev in pol) kot pri bolnikih, ki so jemali placebo (84 dni, približno tri mesece).
What is the risk associated with Nexavar?
Kakšna tveganja so povezana z zdravilom Nexavar?
By blocking these enzymes, Nexavar can reduce the growth of cancer cells and cut off the blood supply that keeps cancer cells growing.
Zdravilo Nexavar lahko z blokiranjem teh encimov zavre rast in širjenje raka ter prekine dotok krvi do rakavih celic, ki omogoča njihovo rast.
• differentiated thyroid carcinoma (a type of cancer originating from the follicular cells of the thyroid gland) when the cancer has progressed or spread locally or to other parts of the body and does not respond to treatment with radioactive iodine.
• diferenciranim karcinomom ščitnice (vrsto raka, ki izvira iz folikularnih celic žleze ščitnice), kadar je rak napredoval ali se začel širiti lokalno ali v druge dele telesa in se ne odziva na zdravljenje z radioaktivnim jodom.
Nexavar is a cancer medicine that contains the active substance sorafenib.
Nexavar je zdravilo proti raku, ki vsebuje zdravilno učinkovino sorafenib.
Why has Nexavar been approved?
Zakaj je bilo zdravilo Nexavar odobreno?
• papillary thyroid cancer and follicular thyroid cancer (13 November 2013) The full EPAR for Nexavar 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 Nexavar je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
V študiji hepatocelularnega karcinoma so bolniki, ki so jemali zdravilo Nexavar, preživeli v povprečju 10,7 meseca, bolniki, ki so jemali placebo, pa 7,9 meseca.
In the study of renal cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo.
V študiji raka ledvičnih celic so bolniki, ki so jemali zdravilo Nexavar, preživeli v povprečju 19,3 meseca, bolniki, ki so jemali placebo, pa 15,9 meseca.
What is Nexavar used for?
Za kaj se zdravilo Nexavar uporablja?
In the study in differentiated thyroid carcinoma, the patients taking Nexavar lived for an average of 10.8 months without their disease getting worse, compared with 5.8 months in those taking placebo.
V študiji diferenciranega karcinoma ščitnice je bil pri bolnikih, ki so jemali zdravilo Nexavar, čas preživetja brez napredovanja bolezni v povprečju 10,8 meseca, pri bolnikih, ki so jemali placebo, pa 5,8 meseca.
What is Nexavar?
Kaj je zdravilo Nexavar?
How has Nexavar been studied?
Kako je bilo zdravilo Nexavar raziskano?
How does Nexavar work?
Kako zdravilo Nexavar deluje?
How is Nexavar used?
Kako se zdravilo Nexavar uporablja?
It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Na voljo je v obliki tablet (250, 500, 750 in 1 000 mg).
The full EPAR for Levetiracetam Actavis 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 Levetiracetam Actavis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Actavis on 3 October 2011.
Evropska komisija je dovoljenje za promet z zdravilom Levetiracetam Actavis, veljavno po vsej Evropski uniji, odobrila dne 3. oktobra 2011.
For more information about treatment with Levetiracetam Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Levetiracetam Actavis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This helps Levetiracetam Actavis to stabilise electrical activity in the brain and prevent seizures.
To omogoča zdravilu Levetiracetam Actavis, da stabilizira električno aktivnost v možganih in prepreči napade.
This means that Levetiracetam Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
To pomeni, da je „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Keppra.
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 Levetiracetam Actavis.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Levetiracetam Actavis, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Because Levetiracetam Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Levetiracetam Actavis generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Levetiracetam Actavis.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Levetiracetam Actavis.
What are the benefits and risks of Levetiracetam Actavis?
Kakšne so koristi in tveganja, povezani z zdravilom Levetiracetam Actavis?
Other information about Levetiracetam Actavis
Druge informacije o zdravilu Levetiracetam Actavis
Levetiracetam Actavis can also be used as an add-on to other anti-epileptic medicines to treat:
Zdravilo Levetiracetam Actavis se lahko uporablja kot dopolnilno zdravljenje k drugim zdravilom proti epilepsiji za zdravljenje:
The Committee recommended that Levetiracetam Actavis be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Levetiracetam Actavis odobri dovoljenje za promet.
Because Levetiracetam Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Ker je zdravilo Levetiracetam Actavis generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Keppra.
Levetiracetam Actavis can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Zdravilo Levetiracetam Actavis se lahko uporablja kot samostojno zdravilo pri bolnikih, starejših od 16 let, pri katerih so na novo odkrili epilepsijo, za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis has been shown to have comparable quality and to be bioequivalent to Keppra.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Levetiracetam Actavis primerljivo raven kakovosti kot zdravilo Keppra ter da mu je biološko enakovredno.
Levetiracetam Actavis is a ‘generic medicine'.
Levetiracetam Actavis je „generično zdravilo“.
Levetiracetam Actavis tablets are swallowed with liquid.
Tablete Levetiracetam Actavis je treba pogoltniti s tekočino.
Levetiracetam Actavis is a medicine that contains the active substance levetiracetam.
Levetiracetam Actavis je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
The active substance in Levetiracetam Actavis, levetiracetam, is an anti-epileptic medicine.
Zdravilna učinkovina zdravila Levetiracetam Actavis, levetiracetam, je zdravilo proti epilepsiji.
Why has Levetiracetam Actavis been approved?
Zakaj je bilo zdravilo Levetiracetam Actavis odobreno?
When Levetiracetam Actavis is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Začetni samostojni odmerek zdravila Levetiracetam Actavis je 250 mg dvakrat dnevno, po dveh tednih jemanja pa se poveča na 500 mg dvakrat dnevno.
How has Levetiracetam Actavis been studied?
Kako je bilo zdravilo Levetiracetam Actavis raziskano?
What is Levetiracetam Actavis used for?
Za kaj se zdravilo Levetiracetam Actavis uporablja?
How is Levetiracetam Actavis used?
Kako se zdravilo Levetiracetam Actavis uporablja?
When Levetiracetam Actavis is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Odmerki se lahko glede na bolnikov odziv še naprej povečujejo v dvotedenskih razmakih do največjega odmerka 1 500 mg dvakrat dnevno.Kadar se zdravilo Levetiracetam Actavis dodaja drugemu zdravilu proti epilepsiji, je začetni odmerek pri bolnikih, starejših od 12 let, ki tehtajo več kot 50 kg, 500 mg dvakrat dnevno.
What is Levetiracetam Actavis?
Kaj je zdravilo Levetiracetam Actavis?
How does Levetiracetam Actavis work?
Kako zdravilo Levetiracetam Actavis deluje?
You will also need 2 syringes:
Prav tako boste potrebovali 2 brizgi:
Date of first authorisation: 30 July 2018
Datum prve odobritve: 30. julij 2018
There might be local regulations for this.
Morda obstajajo lokalni predpisi.
• you are pregnant
• če ste noseči;
Throw it away and start again from step 1.
Zavrzite jo in začnite znova s 1. korakom.
Annual reports to be submitted as part of the annual re-assessment.
Letna poročila je treba predložiti kot del ponovne letne ocene.
• ‘U' means ‘Units'.
• "U" pomeni "enote" (Units).
A minimum clinical response is defined as at least:
Najmanjši klinični odziv je opredeljen kot vsaj:
EXP After reconstitution: use immediately.
EXP Po rekonstituciji: porabiti takoj.
3) Wash your hands before preparing the medicine.
3) Pred pripravo zdravila si umijte roke.
Frequency not known*
Pogostost ni znana*
Generalised LD
Generalizirana LD
• loss of interest in food
• izguba zanimanja za hrano
Dose increases should not be made more frequently than every 4 weeks.
Odmerka ni priporočljivo povečevati pogosteje kot vsake 4 tedne.
This improves the ability of the body to control energy levels.
To izboljša sposobnost vašega telesa pri nadziranju ravni energije.
Details on how to access these are available from your doctor.
Podrobnosti o dostopu do teh informacij so na voljo pri vašem zdravniku.
This can help make the injections more comfortable.
Tako je lahko injiciranje bolj udobno.
Overall, the safety and tolerability of metreleptin are similar in children and adults.
Na splošno sta varnost in toleranca za metreleptin pri otrocih in odraslih podobni.
Step G: Throwing away used materials
Korak G: Odstranjevanje rabljenih materialov
• Then have your normal dose the next day.
• Nato naslednji dan vzemite svoj običajni odmerek.
The educational programme is aimed at increasing awareness among healthcare professionals and patients/carers about the important risks contained in the Risk Management Plan.
Izobraževalni program je namenjen povečanju ozaveščenosti zdravstvenih delavcev in bolnikov/skrbnikov o pomembnih tveganjih, vsebovanih v načrtu za obvladovanje tveganj.
The final study report should be submitted by 2022.
Končno poročilo o študiji je treba predložiti do leta 2022.
The co-primary efficacy endpoints in this study were defined as:
Glavni opazovani parametri učinkovitosti v tej študiji so bili opredeljeni, kot sledi:
SD = standard deviation
P SD = standardna deviacija
On a clean, well-lit work surface, place the following items:
Na čisto, dobro osvetljeno površino položite naslednje predmete:
If this happens, do not drive or use any tools or machines.
V tem primeru ne upravljajte vozil ali uporabljajte kakršnega koli orodja ali strojev.
• unusually heavy or long menstrual bleeding
• neobičajno močna ali dolga menstrualna krvavitev
• 15% reduction in triglycerides (TGs)
• 15-odstotno zmanjšanje trigliceridov (TG)
You might also see smaller air bubbles in the syringe.
Prav tako lahko v brizgi vidite manjše zračne mehurčke.
1) Get together all the materials you will need for your injection.
1) Pripravite ves material, ki ga boste potrebovali za injiciranje.
An example is given below for the different syringe sizes.
Spodaj je primer za različne velikosti brizg.
Your doctor might need to change your treatment.
Zdravnik vam bo morda moral zamenjati zdravljenje.
The final study report should be submitted by 2024.
Končno poročilo o študiji je treba predložiti do leta 2024.
If you cannot contact your doctor, you should seek emergency medical help:
Če ne morete stopiti v stik s svojim zdravnikom, poiščite ambulanto za nujno zdravniško pomoč:
All three patients had acquired generalised LD.
Vsi trije bolniki so imeli generalizirano LD.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
• 0.5% HbA1c reduction and/or 25% reduction in insulin requirements and / or
• 0,5-odstotno zmanjšanje HbA1c in/ali 25-odstotno zmanjšanje potrebe po insulinu in/ali
Step A: Setting up
Korak A: Nastavitev
• It is important to gradually reduce the dose over two weeks because this can help prevent a sudden increase in the levels of fat (called ‘triglycerides') in your blood.
• Pomembno je, da odmerek zmanjšujete postopoma v obdobju dveh tednov, saj tako pomagate preprečiti nenadno povišanje ravni maščob (imenovanih "trigliceridi") v vaši krvi.
• helping the insulin in your body manage sugar levels.
• insulinu v vašem telesu pomaga uravnavati ravni sladkorja.
• If you forget to inject a dose, inject it as soon as you remember.
• Če pozabite injicirati odmerek, ga injicirajte takoj, ko se spomnite.
You can inject this medicine into the following areas:
Zdravilo lahko injicirate v naslednja mesta:
It is anticipated that most children will require increasing per kg dose, especially as they reach puberty.
Predvideva se, da bo treba pri večini otrok odmerek na kg povečati, predvsem ob dosegu pubertete.
Your doctor will have prescribed the correct dose for you, based on the following:
Zdravnik vam bo predpisal primeren odmerek za vas na osnovi naslednjih dejstev:
If you are using a medicine such as insulin or other medicines to treat diabetes, your doctor will closely monitor your blood sugar.
Če uporabljate zdravila, kot so insulin ali druga zdravila za zdravljenje sladkorne bolezni, bo zdravnik pozorno spremljal vaš krvni sladkor.
• Your doctor will decide if you should use Myalepta and will monitor you during treatment.
• Zdravnik se bo odločil, ali boste uporabljali zdravilo Myalepta in vas med zdravljenjem nadziral.
This is because it is not known how this medicine will affect children under these ages.
Vzrok je ta, da ni znano, kakšne učinke bo zdravilo imelo pri otrocih teh starosti.
Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Pogostosti so opredeljene kot zelo pogosti (≤ 1/10); pogosti (≤ 1/100 do < 1/10); občasni (≤ 1/1.000 do < 1/100); redki (≤ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
No effects on the distribution of subcutaneous fat are expected.
Učinkov na distribucijo podkožnega maščevja ni pričakovati.
- Detailed instructions for use.
- Podrobna navodila za uporabo.
It is also aimed to guide prescribers about the appropriate management of these risks.
Njegov cilj je tudi dati napotke zdravnikom, ki predpisujejo zdravilo o ustreznem obvladovanju teh tveganj.
This leaflet was last revised in (month YYYY).
Navodilo je bilo nazadnje revidirano dne (mesec LLLL).
Draft protocol to be submitted 3 months after notification of the European Commission decision.
Osnutek protokola je treba predložiti 3 mesece po objavi sklepa Evropske komisije.
Do not shake or vigorously mix.
Ne stresajte ali močno mešajte.
• The syringe you need to use to inject this medicine depends on the dose prescribed for you.
• Brizga, ki jo morate uporabiti za injiciranje tega zdravila, je odvisna od predpisanega odmerka.
In particular, tell your doctor if you are taking any of the following medicines:
Zdravniku še posebej povejte, ali jemljete katero od naslednjih zdravil:
Data from clinical trials do not support safety and efficacy in patients with HIV-related LD.
Podatki iz kliničnih študij ne podpirajo varnosti in učinkovitosti pri bolnikih z LD v povezavi z virusom HIV.
Therefore, an additional non-hormonal contraceptive method should be considered during treatment.
Zato je treba med zdravljenjem razmisliti o dodatni, nehormonski metodi kontracepcije.
Serious and severe infections
Resne in hude okužbe
Additional training information
Dodatne informacije za usposabljanje
• an increase in ‘HbA1c' in your blood, shown in tests
• povišana raven "HbA1c" v krvi, ki se pokaže pri preiskavah
Possible side effects with this medicine:
Možni neželeni učinki pri tem zdravilu:
Do not use this medicine after the expiry date which is stated on the vial and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli.
While using this medicine, you or your child will be monitored by your doctor, who will decide the dose you or your child should use.
Med uporabo tega zdravila bo vas ali vašega otroka spremljal zdravnik, ki bo določil odmerek za vas ali vašega otroka.
The patient will receive a carton containing 1 or 30 vials of Myalepta, depending on the pack size, which should be stored in a refrigerator until the day of use.
Bolnik prejme škatlo z 1 ali 30 vialami zdravila Myalepta, odvisno od velikosti pakiranja, ki jo mora do dneva uporabe hraniti v hladilniku.