natgillin/translations-raw huggingface dataset:
EPAR summary for the public pioglitazone 
Povzetek EPAR za javnost pioglitazon
For more information about treatment with Sepioglin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Sepioglin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Sepioglin. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sepioglin.
The active substance in Sepioglin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. 
Zdravilna učinkovina zdravila Sepioglin, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
It is used in addition to diet and exercise. 
Uporablja se kot dodatek k ustrezni prehrani in telesni vadbi.
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 Sepioglin. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sepioglin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The Committee recommended that Sepioglin be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Sepioglin odobri dovoljenje za promet.
Because Sepioglin 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 Sepioglin generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
The CHMP concluded that, in accordance with EU requirements, Sepioglin has been shown to have comparable quality and to be bioequivalent to Actos. 
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Sepioglin primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
Sepioglin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. 
Zdravilo Sepioglin se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
Sepioglin is a ‘generic medicine'. 
Zdravilo Sepioglin je „generično zdravilo“.
This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. 
Priporočeni začetni odmerek zdravila Sepioglin je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je potreben boljši nadzor glukoze (sladkorja) v krvi.
Sepioglin is a medicine that contains the active substance pioglitazone. 
Sepioglin je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
Because Sepioglin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos. 
Ker je zdravilo Sepioglin generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. 
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za vzdrževanje primerne ravni glukoze v krvi ali pri kateri ga telo ne more učinkovito izrabljati.
Other information about Sepioglin 
Druge informacije o zdravilu Sepioglin:
Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk. 
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Actos, odtehtajo znana tveganja.
Sepioglin should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). 
Zdravilo Sepioglin se ne sme uporabljati pri bolnikih na dializi (tehniki čiščenja krvi, uporabljeni pri bolnikih z obolenjem ledvic).
Why has Sepioglin been approved? 
Zakaj je bilo zdravilo Sepioglin odobreno?
At subsequent reviews prescribers should confirm that benefits to patients are maintained. 
Pri vseh nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali zdravilo še vedno zagotavlja enake koristi.
Sepioglin can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin. 
Zdravilo se lahko uporablja tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana zgolj z insulinom in za katere metformin ni primeren.
Sepioglin is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable. 
Zdravilo Sepioglin se uporablja kot samostojno zdravilo pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primerno.
Sepioglin can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy'). 
Lahko se uporablja tudi v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora, ali v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni), če metformin ni primeren (zdravljenje z dvema zdraviloma).
Sepioglin can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy'). 
Zdravilo Sepioglin se lahko uporablja tudi skupaj z metforminom in sulfonilsečnino hkrati pri bolnikih, pri katerih nadzor ni zadosten kljub dvojnemu peroralnemu zdravljenju (zdravljenje s tremi zdravili).
How has Sepioglin been studied? 
Kako je bilo zdravilo Sepioglin raziskano?
What is Sepioglin used for? 
Za kaj se zdravilo Sepioglin uporablja?
What is Sepioglin? 
Kaj je zdravilo Sepioglin?
How does Sepioglin work? 
Kako zdravilo Sepioglin deluje?
How is Sepioglin used? 
Kako se zdravilo Sepioglin uporablja?
(Invented) name Strength Pharmaceutical Form Route of Administration 
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
10 µg + 20 µg 
10 mcg + 20 mcg Raztopina za injiciranje
1 pre-filled pen + 1 pre-filled pen 
1 napolnjen injekcijski peresnik + 1 napolnjen injekcijski peresnik
Solution for injection 
2 napolnjena injekcijska peresnika
This summary was last updated in 09-2015. 
Povzetek je bil nazadnje posodobljen 09-2015.
The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997. 
Evropska komisija je dovoljenje za promet z zdravilom BeneFIX, veljavno po vsej Evropski uniji, izdala 27. avgusta 1997.
The full EPAR for BeneFIX 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 BeneFIX je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of BeneFIX? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila BeneFIX?
They include angioedema (swelling of the face and limbs), burning and stinging at the injection site, chills, flushing, urticaria (itchy rash), headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (fast heartbeat), tightness of the chest, tingling, vomiting and wheezing. 
Vključujejo angioedem (otekanje obraza in okončin), pekoč občutek in zbadanje na mestu injiciranja, mrzlico, rdečico, urtikarijo (srbeč izpuščaj), glavobol, koprivnico, hipotenzijo (nizek krvni tlak), letargijo, navzejo (slabost), nemir, tahikardijo (pospešen srčni utrip), tiščanje v prsnem košu, mravljinčenje, bruhanje in sopenje.
Out of 972 infusions, 84% were rated as bringing about ‘good' or ‘excellent' responses. 
Od 972 infundiranj je bil odziv pri 84 % primerov ocenjen kot „dober“ ali „odličen“.
During treatment, the doctor should regularly carry out blood tests to adjust the dose to be given. 
Med zdravljenjem mora zdravnik redno opraviti krvne preiskave za določitev ustreznega odmerka.
BeneFIX is intended for either short-term or long-term use. 
Zdravilo BeneFIX je namenjeno za kratkotrajno ali dolgotrajno uporabo.
The CHMP decided that BeneFIX's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila BeneFIX večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX. 
Pri predhodno zdravljenih bolnikih je 82 % od 693 zdravljenih epizod krvavitve izzvenelo po prvem dajanju zdravila BeneFIX.
Patients or their carers can give injections of BeneFIX, provided that they have been trained appropriately. 
Bolniki ali njihovi negovalci lahko sami injicirajo zdravilo BeneFIX, če so bili za to ustrezno usposobljeni.
The studies assessed the number of bleeding episodes that occurred and rated BeneFIX's effectiveness using a scale from ‘no response' to ‘excellent'. 
V študijah so beležili število krvavitev, ki so se pojavile, in vrednotili učinkovitost zdravila BeneFIX na podlagi lestvice z ocenami od „ni odziva“ do „odličen odziv“.
This document is a summary of the European Public Assessment Report (EPAR) for BeneFIX. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo BeneFIX.
A risk management plan has been developed to ensure that BeneFIX is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila BeneFIX je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with BeneFIX, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom BeneFIX preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
BeneFIX is used to replace the missing factor IX. 
Zdravilo BeneFIX se uporablja za nadomestitev manjkajočega faktorja IX.
Full details on how to calculate the dose are included in the summary of product characteristics. 
Podrobnosti o tem, kako izračunati ustrezni odmerek, so na voljo v povzetku glavnih značilnosti zdravila.
It has also been studied in patients who have not received any treatment for their haemophilia. 
Proučevali so ga tudi pri bolnikih, ki zaradi hemofilije še niso bili zdravljeni.
Other information about BeneFIX 
Druge informacije o zdravilu BeneFIX
Nonacog alfa is not extracted from human blood but produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce human coagulation factor IX. 
Nonakog alfa se ne pridobiva iz človeške krvi, temveč se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celice prejmejo gen (DNK), s katerim lahko tvorijo človeški koagulacijski faktor IX.
If antibodies develop, BeneFIX will not work effectively, which may result in a loss of bleeding control. 
Če se razvijejo protitelesa, zdravilo Benefix ne deluje več učinkovito, zaradi česar lahko pride do izgube nadzora nad krvavitvami.
The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs. 
Pomanjkanje faktorja IX povzroči težave pri strjevanju krvi, med drugim krvavenje v sklepe, mišice in notranje organe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BeneFIX, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It is available as a powder and solvent that are mixed together to form a solution for injection. 
Na voljo je v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje.
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 BeneFIX. 
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.
The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery, and on the patient's condition. 
Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo BeneFIX uporablja za zdravljenje ali preprečevanje krvavitev ali za zmanjšanje krvavitev med kirurškim posegom, in od bolnikovega stanja.
What benefit has BeneFIX shown during the studies? 
Kakšne koristi je zdravilo BeneFIX izkazalo med študijami?
For the full list of all side effects reported with BeneFIX, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila BeneFIX, glejte navodilo za uporabo.
BeneFIX is a medicine that contains the active substance nonacog alfa. 
BeneFIX je zdravilo, ki vsebuje zdravilno učinkovino nonakog alfa.
BeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder). 
Zdravilo BeneFIX se uporablja za zdravljenje in preprečevanje krvavitev pri odraslih in otrocih s hemofilijo B (prirojeno motnjo strjevanja krvi).
BeneFIX should be started by a doctor who has experience in the treatment of haemophilia. 
Zdravljenje z zdravilom BeneFIX mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
It corrects the factor IX deficiency and gives temporary control of the bleeding disorder. 
Zdravilo odpravi pomanjkanje faktorja IX in vzpostavi začasen nadzor nad krvavitvami.
Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting. 
Bolnikom s hemofilijo B primanjkuje beljakovine, imenovane faktor IX, ki sodeluje pri strjevanju krvi.
Hypersensitivity (allergic) reactions have been seen in patients treated with products containing factor IX and may sometimes be severe. 
Pri bolnikih, ki so prejemali zdravila s faktorjem IX, so bile opažene preobčutljivostne (alergijske) reakcije, ki so lahko bile včasih hude.
The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot). 
Zdravilna učinkovina v zdravilu BeneFIX, nonakog alfa, je beljakovinski krvni koagulacijski faktor (snov, ki pomaga pri strjevanju krvi).
What is the risk associated with BeneFIX? 
Kakšna tveganja so povezana z zdravilom BeneFIX?
Patients with haemophilia B may also develop neutralising antibodies (inhibitors) to factor IX. 
Pri bolnikih s hemofilijo B se lahko razvijejo tudi nevtralizirajoča protitelesa (inhibitorji) proti faktorju IX.
The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery. 
Odmerek je treba prilagoditi glede na stopnjo resnosti in mesto krvavitve ali vrsto posega.
BeneFIX has been studied in previously treated patients with moderate or severe haemophilia B for prevention or to treat bleeding episodes during and after surgery. 
Zdravilo BeneFIX so pri predhodno zdravljenih bolnikih z zmerno ali hudo hemofilijo B proučevali kot zdravilo za preprečevanje ali zdravljenje krvavitev med kirurškim posegom ali po njem.
BeneFIX must not be used in people who are hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins. 
Zdravila BeneFIX ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rekombinantni koagulacijski faktor IX, katero koli drugo sestavino zdravila ali beljakovine hrčka.
Why has BeneFIX been approved? 
Zakaj je bilo zdravilo BeneFIX odobreno?
How has BeneFIX been studied? 
Kako je bilo zdravilo BeneFIX raziskano?
BeneFIX is given by a slow injection into a vein, usually at up to 4 ml per minute and should not be mixed with other infusion solutions or given using a kit other than the one supplied with the medicine. 
Zdravilo BeneFIX se v veno injicira počasi, običajno s hitrostjo infuzije do 4 ml na minuto.
How is BeneFIX used? 
Kako se zdravilo BeneFIX uporablja?
What is BeneFIX used for? 
Za kaj se zdravilo BeneFIX uporablja?
90 (3 x 30) tablets (multipack) 
90 (3 x 30) tablet (skupno pakiranje)
More information about Inovelon is available on EMA's website. 
Več informacij o zdravilu Inovelon je na voljo na spletni strani agencije EMA.
It is currently approved only for children aged 4 years or older. 
Trenutno je odobreno le za otroke, starejše od štirih let.
The CHMP considered that the data available at this point in time were not sufficient to recommend this change. 
Odbor CHMP je presodil, da podatki, ki so na voljo v tem trenutku, ne zadoščajo, da bi lahko priporočil to spremembo.
Inovelon contains the active substance rufinamide and has been authorised since January 2007. 
Zdravilo Inovelon vsebuje zdravilno učinkovino rufinamid in je odobreno od januarja 2007.
Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children. 
Lennox-Gastautov sindrom je ena najhujših oblik epilepsije pri otrocih.
By attaching to these channels, rufinamide prevents them from becoming activated. 
Z vezavo na te kanalčke rufinamid prepreči njihovo aktivacijo.
However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Inovelon's product information. 
Vendar pa je menil, da utegnejo biti podatki pomembni za zdravstvene delavce, in priporočil, da se ti vključijo v informacije o zdravilu Inovelon.
The active substance in Inovelon, rufinamide acts by attaching to special channels on the surface of brain cells (sodium channels), which control their electrical activity. 
Zdravilna učinkovina v zdravilu Inovelon, rufinamid, deluje tako, da se veže na posebne kanalčke na površini možganskih celic (natrijeve kanalčke), ki nadzorujejo njihovo električno aktivnost.
This reduces the likelihood of a seizure occurring. 
S tem se zmanjša verjetnost za epileptični napad.
Its signs and symptoms include multiple types of seizures (fits), abnormal electrical activity in the brain, learning disability and behavioural problems. 
Njegovi znaki in simptomi vključujejo več vrst epileptičnih napadov, nenormalno električno aktivnost v možganih, motnje pri učenju in vedenjske težave.
Inovelon is used for treating Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but can continue into adulthood. 
Zdravilo Inovelon se uporablja za zdravljenje Lennox-Gastautovega sindroma, redke vrste epilepsije, ki običajno prizadene otroke, vendar se lahko nadaljuje tudi v odrasli dobi.
What is happening with Inovelon for the treatment of other diseases? 
Kaj to pomeni za nadaljnjo uporabo zdravila Inovelon za zdravljenje drugih bolezni?
The study investigated the safety of Inovelon and also its impact on the child's behavioural and emotional development assessed by the patient's parent or guardian on a standardised scoring system. 
V študiji so proučevali varnost zdravila Inovelon in njegov učinek na otrokov vedenjski in čustveni razvoj, kot so ga po standardiziranem sistemu točkovanja ocenili bolnikovi starši oziroma skrbniki.
However, the CHMP considered that including the data obtained in these children in Inovelon's product information could help the healthcare professionals who manage them. 
Vendar pa je menil, da bi z vključitvijo podatkov, pridobljenih pri teh otrocih, v informacije o zdravilu Inovelon pomagali zdravstvenim delavcem, ki jih vodijo.
While the study showed that the safety of Inovelon in patients aged 1 to less than 4 years was consistent with the known safety profile in older children, the CHMP concluded that the study was too small to make conclusions on the medicine's effectiveness. 
Študija je sicer pokazala, da je varnost zdravila Inovelon pri otrocih, starih od enega do manj kot štiri leta, skladna z znanim varnostnim profilom pri starejših otrocih, vendar je odbor CHMP zaključil, da je študija premajhna, da bi lahko sprejeli zaključke o učinkovitosti zdravila.
Inovelon was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 20 October 2004 for Lennox-Gastaut syndrome. 
Zdravilo Inovelon je bilo dne 20. oktobra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje Lennox-Gastautovega sindroma.
Regarding the data that the company used to make predictions for use in children aged 1 to less than 4 years, the CHMP considered that further analyses were needed in order to make dosing recommendations in the younger age group. 
V zvezi s podatki, ki jih je družba uporabila pri napovedovanju uporabe pri otrocih, starih od enega do manj kot štiri leta, je odbor CHMP presodil, da so potrebne nadaljnje analize, na podlagi katerih bi lahko oblikovali priporočila za odmerjanje v mlajši skupini.
There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Inovelon. 
Odobritev ali zavrnitev te vloge nima nobenih posledic za bolnike, ki trenutno sodelujejo ali bodo morda sodelovali v kliničnih preskušanjih zdravila Inovelon.
The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil pregled vloge za razširitev uporabe zdravila Inovelon za zdravljenje epilepsije na otroke, stare od enega do štirih let.
The company presented data from a study in which 37 children aged between 1 and 4 years with Lennox-Gastaut syndrome received either Inovelon or another epilepsy medicine in addition to their existing treatment. 
Družba je predložila podatke študije, v kateri je 37 otrok, starih od enega do štirih let, z LennoxGastautovim sindromom prejemalo poleg obstoječega zdravila še zdravilo Inovelon ali drugo zdravilo za zdravljenje epilepsije.
What was Inovelon expected to be used for? 
Za kaj naj bi se zdravilo Inovelon uporabljalo?
The CHMP therefore concluded that based on the currently available data, Inovelon could not be approved for patients with Lennox-Gastaut syndrome aged less than 4 years. 
Na podlagi trenutno razpoložljivih podatkov je zaključil, da zdravila Inovelon ni mogoče odobriti za bolnike z Lennox-Gastautovim sindromom, mlajše od štirih let.
How does Inovelon work? 
Kako zdravilo Inovelon deluje?
and prevents abnormal electrical activity from spreading through the brain. 
Tako zmanjša aktivnost možganskih celic in prepreči, da bi se nenormalna električna aktivnost širila po možganih.
What is Inovelon? 
Kaj je zdravilo Inovelon?
The company that markets Inovelon applied for it to be used to treat Lennox-Gastaut syndrome in children aged 1 to 4 years. 
Družba, ki trži zdravilo Inovelon, je vložila vlogo, na podlagi katere naj bi se zdravilo uporabljalo za zdravljenje Lennox-Gastautovega sindroma pri otrocih, starih od enega do štirih let.
The company also proposed a way to make predictions on the use of Inovelon in children aged between 1 and 4 years based on existing data in patients aged 4 years and older. 
Družba je na podlagi obstoječih podatkov pri bolnikih, starejših od štirih let, tudi predlagala način napovedovanja uporabe zdravila Inovelon pri otrocih, starih od enega do štirih let.