natgillin/translations-raw huggingface dataset:
Elaprase 2 mg/ml concentrate for solution for infusion 
Elaprase 2 mg/ml koncentrat za raztopino za infundiranje
What Elaprase contains 
Kaj vsebuje zdravilo Elaprase
Concentrate for solution for infusion (sterile concentrate). 
koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra do rahlo opalescentna, brezbarvna raztopina.
Each vial of Elaprase contains 6 mg of idursulfase. 
Vsaka viala zdravila Elaprase vsebuje 6 mg idursulfaze.
Idursulfase treatment resulted in up to 60% reduction in urine output of glycosaminoglycans and in reductions of liver and spleen size: results were comparable to those found in study TKT024. 
Zdravljenje z idursulfazo je povzročilo do 60-odstotno zmanjšanje izločanja glikozaminoglikanov z urinom ter zmanjšanje velikosti jeter in vranice.
Idursulfase 
Občasni
Elaprase 2 mg/ml concentrate for solution for infusion idursulfase 
Elaprase 2 mg/ml koncentrat za raztopino za infundiranje idursulfaza
This medicinal product contains 0.482 mmol sodium (or 11.1 mg) per vial. 
To zdravilo vsebuje 0,482 mmol natrija (ali 11,1 mg) na vialo, kar je enako 0,6 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
If you experience an allergic side effect following administration of this medicine, you should contact your doctor immediately. 
Če po dajanju tega zdravila opazite tako reakcijo, takoj povejte zdravniku.
All patients received weekly idursulfase up to 3.2 years in an extension to this study (TKT024EXT). 
V podaljšku te študije (TKT024EXT) so vsi bolniki idursulfazo prejemali do 3,2 leta enkrat na teden.
Anaphylactoid/ anaphylactic reaction 
Bolezni imunskega sistema anafilaktoidne/anafilaktične reakcije
Specific Obligation 5 - To evaluate the following long term clinical endpoints primarily through the HOS. 
Posebna obveznost 5 - Oceniti naslednje dolgotrajne klinične opazovane dogodke, predvsem z raziskavo HOS: ti podatki se bodo ponovno ocenili vsako leto, rezultati pa se bodo poročali in obravnavali z vsakoletnimi ponovnimi ocenami.
A total of 108 male Hunter syndrome patients with a broad spectrum of symptoms were enrolled in the two randomized, placebo-controlled clinical studies, 106 continued treatment in two open-label, extension studies. 
V dveh randomiziranih, s placebom nadzorovanih kliničnih študijah je sodelovalo 108 moških bolnikov s Hunterjevim sindromom s širokim spektrom simptomov.
Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion . 
Skupen volumen potrebnega koncentrata za raztopino za infundiranje Elaprase razredčite v 100 ml raztopine natrijevega klorida za infundiranje (9 mg/ml; 0,9 %).
Do not freeze 
Ne zamrzujte.
Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Wheezing, dyspnoea 
Bolezni dihal, prsnega koša in mediastinalnega prostora sopenje, dispneja hipoksija, bronhospazem, kašelj tahipneja
Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use. 
Zdravilo Elaprase je namenjeno intravenskemu infundiranju in ga je treba pred uporabo razredčiti v 0,9-odstotni raztopini (9 mg/ml) natrijevega klorida za infundiranje.
Speak with your healthcare professional if you are not sure. 
Če ste negotovi, se posvetujte z zdravstvenim delavcem.
Assessment of long term pulmonary morbidity (e.g., incidence of infections, pulmonary function status) and mortality Assessment of long term cardiovascular morbidity (e.g., incidence of events, and echocardiography data, where available) and mortality Assessment of long term urinary GAG excretion patterns Assessment of long term antibody levels, isotype and correlation to other therapeutic parameters 
Ocena dolgotrajne kardiovaskularne obolevnosti (npr. incidenca dogodkov in podatkov o ehografiji, kadar so na razpolago) in umrljivosti.
• Chest pain 
• bolečine v prsnem košu
Patients with renal or hepatic impairment There is no clinical experience in patients with renal or hepatic insufficiency. 
Bolniki z ledvično in jetrno okvaro Kliničnih izkušenj pri bolnikih z ledvično ali jetrno insuficienco ni (glejte poglavje 5.2).
Nervous system disorders Headache 
Bolezni živčevja glavobol vrtoglavica, tremor
• Swollen tongue, indigestion 
• otečen jezik, prebavne motnje
Each ml contains 2 mg of idursulfase. 
Vsak ml vsebuje 2 mg idursulfaze.
Infusion-site swelling, face oedema, oedema peripheral Injury, poisoning and procedural complications Infusion-related reaction 
Poškodbe in zastrupitve in zapleti pri posegih učinki, povezani z infundiranjem
• Infusion-site swelling, swelling of the extremities, facial swelling 
• otekanje na mestu infundiranja, otekanje okončin, otekanje obraza
How to store Elaprase 
Shranjevanje zdravila Elaprase
- The total volume required of Elaprase should be diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. 
- Razredčite skupen potreben volumen zdravila Elaprase v 100 ml 0,9-odstotne raztopine natrijevega klorida za infundiranje (9 mg/ml).
Each ml contains 2 mg of idursulfase*. 
En mililiter vsebuje 2 mg idursulfaze*.
- The number of vials to be diluted should be determined based on the individual patient's weight and the recommended dose of 0.5 mg/kg. 
- Glede na bolnikovo telesno maso in priporočeni odmerek 0,5 mg/ml določite število vial, ki jih morate razredčiti.
Weight (kg) 
Vss (ml/kg)
Each vial contains 6 mg of idursulfase. 
Ena viala vsebuje 6 mg idursulfaze.
Pharmacokinetic parameters at week 1 as a function of body weight in studies TKT024 and HGT-ELA-038 
Farmakokinetični parametri v 1. tednu študij TKT024 in HGT-ELA-038 v odvisnosti od telesne mase Telesna masa (v kg)
Elaprase has to be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion before use. 
Zdravilo Elaprase je treba pred uporabo razredčiti v 0,9-odstotni raztopini natrijevega klorida za infundiranje (9 mg/ml).
LIST OF EXCIPIENTS 
Vodenje evidence
What you need to know before you use Elaprase 3. 
Kaj je zdravilo Elaprase in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Elaprase Kako uporabljati zdravilo Elaprase Možni neželeni učinki
Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) Mean ± SD CL (mL/min/kg) Mean ± SD Vss (mL/kg) Mean ± SD 
AUC0-∞ (min*μg/ml) Srednja vrednost ± SD
After dilution 
Po razredčitvi
Elaprase is administered at a dose of 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4). 
Zdravilo Elaprase se daje v odmerku 0,5 mg/kg telesne mase vsak teden kot triurna intravenska infuzija.
Gastrointestinal disorders Abdominal pain, nausea, diarrhoea, vomiting 
Bolezni prebavil bolečine v trebuhu, navzea, driska, bruhanje otečen jezik, dispepsija
The solution should be inspected visually for particulate matter and discolouration prior to administration. 
Raztopino pred uporabo vizualno preglejte in preverite, ali so v njej delci in ali je spremenila barvo.
Skin and subcutaneous tissue disorders Urticaria, rash, pruritus, erythema Musculoskeletal and connective disorders Arthralgia General disorders and administration site conditions Pyrexia, chest pain 
Splošne težave in spremembe na mestu aplikacije pireksija, bolečine v prsnem košu otekanje na mestu infundiranja,
Swollen tongue, dyspepsia 
edem obraza, periferni edem
- Keep this leaflet. 
Raztopine ne pretresajte.
BACKGROUND INFORMATION 
DODATNE INFORMACIJE
European Medicines Agency Evaluation of Medicines for Human Use 
Država članica Imetnik dovoljenja za promet z zdravilom
This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product. 
Nesoglasja, ki so privedla do tega napotitvenega postopka v skladu s členom 29(4) Direktive 2001/83/ES, zadevajo: 1- terapevtsko indikacijo, ki bi naj bila razširjena na nerakave bolnike s hudo kronično bolečino 2- izbor tabel za prehod z drugih analgetikov, ki bi naj bile vključene v povzetek glavnih značilnosti zdravila 3- vprašanje, ali naj bosta dojenje in sočasna uporaba z delnimi opioidnimi agonisti kontraindicirana 4- bioekvivalenčne študije, potrebne za dokazovanje ekvivalentnosti z referenčnim izdelkom.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. 
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
The arbitration procedure started on 24 January 2007 with the adoption of a list of questions. 
Učinek se doseže v roku 24 ur po namestitvi prvega obliža, po odstranitvi pa postopoma izzveni.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged 
Albert-SchweitzerGasse 3, 1140 WIEN, Avstrija µg/h transdermales Matrixpflaster vsebuje 4,125 mg fentanila (ustreza hitrosti sproščanja učinkovine 25 mikrogramov/h)
1 Article 29(4) of Directive 2001/83/EC, as amended. 
(glejte poglavje 4.8).
London, 23 October 2007 EMEA/338591/2007 
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanija
Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics. 
V tem smislu je CHMP sprejel indikacijo „Huda kronična bolečina, ki jo je mogoče ustrezno obvladati le z opioidnimi analgetiki“.
Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern. 
Znaki zastrupitve so globoka sedacija, ataksija, mioza, epileptični napadi in respiratorna depresija, ki je najpomembnejši simptom.
Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006. 
Fentanyl ratiopharm 25 µg/uur, pleister voor transdermaal gebruik Velika Britanija Telfanyl 25 microgram/hr Transdermal patch
During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. 
Glede shem za odmerjanje za prehod z drugih analgetikov, ki so na voljo v povzetku glavnih značilnosti zdravila za prehod s peroralnega morfina na transdermalni fentanil je CHMP na podlagi razpoložljivih podatkov izoblikoval mnenje, da je treba v povzetku glavnih značilnosti zdravila (tabela 4.2) navesti obe tabeli: konzervativno shemo za prehod (150:1), navedeno v obstoječem povzetku glavnih značilnosti zdravila za zdravilo Fentanyl ratiopharm za bolnike, ki potrebujejo rotacijo opioidov, ter shemo za prehod 100:1 (Donnerjevo tabelo) za bolnike s stabilnim zdravljenjem z opioidi, ki ga bolniki dobro prenašajo.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names International Non-Proprietary Name (INN): fentanyl 
NAVODILO ZA UPORABO Fentanyl-ratiopharm 25 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
The final opinion was converted into a Decision by the European Commission on 23 October 2007. 
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom. 
Spanija ratiopharm España, S.A.
The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie. 
tahikardija, bradikardija
The majority of these reactions were mild or moderate. 
Večina teh reakcij je bila blagih ali zmernih.
The European Commission granted a marketing authorisation valid throughout the European Union for Revestive on 30 August 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Revestive, veljavno po vsej Evropski uniji, izdala 30. avgusta 2012.
The company will provide more data about the medicine's safety from a registry of patients. 
Družba bo zagotovila več podatkov o varnosti zdravila iz registra bolnikov.
If a benefit is not observed, treatment should be stopped. 
Če ni prišlo do izboljšanja, je treba zdravljenje prekiniti.
What measures are being taken to ensure the safe and effective use of Revestive? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Revestive?
Patients or their carers can inject the medicines once they have received adequate training. 
Bolniki ali njihovi negovalci lahko zdravilo injicirajo sami, ko so bili za to ustrezno usposobljeni.
Furthermore, Revestive showed an acceptable safety profile. 
Poleg tega je bilo dokazano, da ima zdravilo Revestive sprejemljiv varnostni profil.
It is not intended to provide practical advice on how to use Revestive. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Other information about Revestive 
Druge informacije o zdravilu Revestive
This is a summary of the European public assessment report (EPAR) for Revestive. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Revestive.
What are the risks associated with Revestive? 
Kakšna tveganja so povezana z zdravilom Revestive?
What is Revestive and what is it used for? 
Kaj je zdravilo Revestive in za kaj se uporablja?
The CHMP therefore concluded that Revestive's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini je zato zaključil, da so koristi zdravila Revestive večje od z njim povezanih tveganj, in priporočil, naj se zanj izda dovoljenje za promet.
The summary of the opinion of the Committee for Orphan Medicinal Products for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote za zdravilo Revestive je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revestive have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Revestive upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It must not be used in patients who have had a gastrointestinal cancer (cancer of the stomach, gut or liver) in the last five years. 
Ne smejo ga uporabljati bolniki, ki so v zadnjih petih letih imeli raka prebavil (želodca, črevesa ali jeter).
The most commonly reported side effects with Revestive (which may occur in more than 1 in 10 patients) were respiratory tract infections (infections of the throat, sinuses, airways or lungs), headache, belly ache and swollen stomach, nausea, vomiting, and reddening, pain or swelling at the site of the injection. 
Najpogostejši neželeni učinki zdravila Revestive (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe dihal (okužba žrela, sinusov, dihalnih poti ali pljuč), glavobol, bolečine v trebuhu in napet trebuh, navzeja, bruhanje ter pordelost, bolečina ali oteklina na mestu injiciranja.
In a second study in children, 53% (8 out of 15) of those who received Revestive had their parenteral nutrition at 12 weeks reduced by at least a tenth, while none (0 out of 5) of the patients who received a standard treatment achieved the same. 
V drugi študiji se je pri 53 % (8 od 15) otrok, ki so prejemali zdravilo Revestive, količina parenteralne prehrane po 12 tednih zmanjšala za vsaj desetino, medtem ko se to ni zgodilo pri nobenem (0 od 5) bolniku, ki so prejemali standardno zdravljenje.
Why is Revestive approved? 
Zakaj je bilo zdravilo Revestive odobreno?
What benefits of Revestive have been shown in studies? 
Kakšne koristi je zdravilo Revestive izkazalo v študijah?
In one study in adults, 63% (27 out of 43) of those who received Revestive had their parenteral nutrition at 20 weeks reduced by at least a fifth and maintained this reduced intake at 24 weeks. 
V eni študiji pri odraslih se je pri 63 % (27 od 43) bolnikov, ki so prejemali zdravilo Revestive, količina parenteralne prehrane po 20 tednih zmanjšala za vsaj petino, pri čemer se je zmanjšani vnos ohranil tudi po 24 tednih.
Revestive is a medicine for treating short bowel syndrome (or short gut) in adults and children aged 1 year and above. 
Revestive je zdravilo za zdravljenje sindroma kratkega črevesa pri odraslih in otrocih, starejših od enega leta.
The medicine can only be obtained with a prescription, and treatment should be started under the supervision of a doctor with experience in treating short bowel syndrome. 
Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje zdravljenjem sindroma kratkega črevesa.
For more information about treatment with Revestive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Revestive preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s zdravnikom ali farmacevtom.
Patients who need high volumes of parenteral nutrition may benefit from a significant reduction, whereas patients in need of low amounts may have the chance to be weaned off completely. 
Bolniki, ki potrebujejo velike količine parenteralne prehrane, bodo mogoče te potrebovali znatno manj, pri bolnikih, ki potrebujejo majhne količine, pa bo mogoče možna popolna ukinitev tovrstne prehrane.
Because the number of patients with the condition is low, the disease is considered ‘rare', and Revestive was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December 
Ker je bolnikov s sindromom kratkega črevesa malo, velja ta bolezen za redko, zato je bilo zdravilo Revestive 11. decembra 2001 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Revestive must not be used in patients who have, or are suspected to have, cancer. 
Zdravilo Revestive se ne sme uporabljati pri bolnikih, ki imajo raka oziroma pri katerih obstaja sum, da ga imajo.
Revestive has been shown in 2 studies to reduce the amount of parenteral nutrition that patients need. 
V dveh študijah je bilo ugotovljeno, da zdravilo Revestive zmanjšuje količino parenteralne prehrane, ki jo bolniki potrebujejo.
Patients with short bowel syndrome are usually given nutrients as an infusion directly into their veins (parenteral nutrition). 
Bolniki s sindromom kratkega črevesa običajno prejmejo hranila z infuzijo neposredno v vene (parenteralna prehrana).
The full EPAR for Revestive 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 Revestive je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In addition, patients with a stoma (an artificial opening at the front of the abdomen to collect faeces or urine) commonly experienced complications, such as swelling of the stoma. 
Poleg tega je pri bolnikih s stomo (umetno odprtino na sprednji strani trebuha za zbiranje blata in urina iz telesa) pogosto prišlo do zapletov, kot je oteklina stome.
The active substance in Revestive, teduglutide, is similar to human glucagon-like peptide 2 (GLP-2), a hormone made in the gut that increases absorption of nutrients from the intestine. 
Zdravilna učinkovina v zdravilu Revestive, teduglutid, je podobna človeškemu glukagonu podobnemu peptidu 2 (GLP-2), tj. hormonu, ki se tvori v črevesu in povečuje absorpcijo iz črevesa.
Teduglutide works in a similar way to GLP-2 and increases intestinal absorption by: increasing blood flow to and from the gut, reducing the speed at which food passes through and reducing acid secretions in the stomach which can interfere with absorption in the intestine. 
Teduglutid deluje podobno kot GLP-2 in povečuje absorpcijo iz črevesa tako, da poveča pretok krvi v črevo in iz njega, zmanjša hitrost, s katero hrana potuje po njem, ter zmanjša izločanje želodčne kisline, ki lahko ovira absorpcijo v črevesu.
For practical information about using Revestive, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Revestive naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed. 
Sindrom kratkega črevesa je motnja, pri kateri črevo hranilnih snovi in tekočine ne absorbira pravilno, do česar običajno pride po kirurški odstranitvi velikega dela tankega črevesa.
Revestive contains the active substance teduglutide. 
Zdravilo Revestive vsebuje zdravilno učinkovino teduglutid.
Revestive is given as an injection under the skin of the abdomen. 
Zdravilo Revestive se daje z injiciranjem pod kožo trebuha.
This compares with 30% (13 out of 43) of those given placebo (a dummy treatment). 
Ta delež je pri bolnikih, ki so prejemali placebo (zdravilo brez zdravilne učinkovine), znašal 30 % (13 od 43).
Studies show that Revestive is beneficial for patients with short bowel syndrome as it significantly reduces the amount of parenteral nutrition they need. 
Študije so pokazale, da je zdravilo Revestive koristilo bolnikom s sindromom kratkega črevesa, saj je pomembno pripomoglo k zmanjšanju količine parenteralne prehrane.
For the full list of all side effects reported with Revestive, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Revestive, glejte navodilo za uporabo.
Teduglutide has the advantage of lasting longer than GLP-2 in the body. 
Njega prednost v primerjavi z GLP-2 je, da se v telesu obdrži dlje.
The recommended dose is 0.05 mg per kilogram body weight once a day, with the daily dose reduced by half in patients with moderate or severely reduced kidney function. 
Priporočeni odmerek znaša 0,05 mg na kilogram telesne mase enkrat na dan.
How is Revestive used? 
Kako se zdravilo Revestive uporablja?
How does Revestive work? 
Kako zdravilo Revestive deluje?
The protocol shall be submitted to the National Competent Authorities: 
Protokol je treba predložiti pristojnim nacionalnim organom:
The final study report shall be submitted to the National Competent Authorities: 
Končno poročilo o študiji se predloži nacionalnim pristojnim organom:
The educational materials should ensure that healthcare professionals and patients/carers are able to successfully administer the product based on the instructions in the product information. 
Izobraževalna gradiva morajo zagotavljati, da bodo zdravstveni delavci in bolniki/negovalci sposobni uspešno uporabiti zdravilo v skladu z navodili v informacijah o zdravilu.