natgillin/translations-raw huggingface dataset:
The decision of the French Competent Authority was based on updated results of a Pharmacovigilance (PV) survey, preliminary data from 3 clinical studies (the retrospective case-control study performed in a Brest hospital, the REGULATE trial and the data from the French National Insurance Fund) and from a recent publication (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex, Eur Respir.
Odločitev francoskega pristojnega organa je temeljila na posodobljenih rezultatih raziskave farmakovigilance, predhodnih podatkih iz treh kliničnih študij (retrospektivne študije primerov in kontrol iz bolnišnice Brest, REGULATIVNEGA preskušanja ter podatkov francoskega nacionalnega zavarovalnega sklada) in nedavne objave (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex (Fenfluraminu podobni kardiovaskularni neželeni učinki benfluoreksa), Eur Respir.
Benfluorex has no action on insulin-secretion.
Benfluoreks ne učinkuje na izločanje inzulina.
The Committee noted that morphological and functional valvular heart abnormalities can be seen after an average of only 328 days of exposure.
Odbor je ugotovil, da je morfološke in funkcionalne nepravilnosti srčnih zaklopk mogoče videti povprečno že po 328 dneh izpostavljenosti.
• The Committee noted that morphological and functional valvular heart abnormalities can be seen after an average of only 328 days of exposure.
• Odbor je ugotovil, da je morfološke in funkcionalne nepravilnosti srčnih zaklopk mogoče videti povprečno že po 328 dneh izpostavljenosti.
FR - France
Francija
The imprecision regarding information about the diagnosis of cardiac valve disease and the limited number of patients identified as presenting cardiac valve disease and treated with benfluorex (35 patients) were pointed out by the MAH.
Imetnik dovoljenja za promet z zdravilom je poudaril netočnost informacij glede diagnoze bolezni srčnih zaklopk in omejeno število bolnikov, ki so bili zdravljeni z benfluoreksom (35 bolnikov) in pri katerih je bila ugotovljena bolezen srčnih zaklopk.
Marketing Authorisation Holder Invented Name
Izmišljeno ime
Finally, on the basis of the available data sources, the CHMP is of the opinion that the number of spontaneous reports of cardiac valvulopathies associated with benfluorex is significantly underestimated due to limitations of data collected from spontaneous reporting in this situation such as:
Nenazadnje CHMP na podlagi razpoložljivih virov podatkov meni, da je število spontanih poročil o srčnih valvulopatijah, povezanih z uporabo benfluoreksa, bistveno podcenjeno zaradi omejenih podatkov, zbranih pri spontanih poročilih v zvezi s tem, kot npr: - vrsta učinka benfluoreksa (valvulopatija, ki ostane klinično asimptomatska dolgo časa); - čas do dogodka (spremembe na zaklopkah se pojavijo šele po zelo dolgem času izpostavljenosti benfluoreksu).
CY - Cyprus
Ciper
150 mg coated tablet
Obložena tableta
Article 13 of Commission Regulation (EC) No. 1234/2008
Člen 13 Uredbe Komisije (ES) št. 1234/2008
The reference Member State (RMS) is France and 25 concerned Member States (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom.
Referenčna država članica je Francija, zadevnih pa je naslednjih 25 držav članic: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Finska, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija in Združeno kraljestvo.
The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013.
Postopek za spremembo (FR/V/0167/01/II/017) se je začel 28. januarja 2013.
The opinion was converted into a Decision by the European Commission on 5 December 2014.
Mnenje je bilo 5. decembra 2014 spremenjeno v sklep Evropske komisije.
The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Odbor je imenoval Cornelio Ibrahim za poročevalko in Michaela Holzhauser-Albertija za soporočevalca.
Oral explanations were given on 10 September 2014.
Ustna pojasnila so bila podana 10. septembra 2014.
International non-proprietary name (INN): florfenicol, flunixin
Mednarodno nelastniško ime (INN): florfenikol, fluniksin
Opinion following an Article 13
Mnenje v zvezi z napotitvijo v skladu s členom 13
The referral procedure started on 12 February 2014.
Napotitveni postopek se je začel 12. februarja 2014.
A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (2 mL/15 kg bw) is recommended.
Priporočeno je enkratno subkutano injiciranje 40 mg florfenikola in 2,2 mg fluniksina na kg telesne mase (2 ml/15 kg telesne mase).
Day 60 of the CMD(v) procedure was on 23 January 2014, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Šestdeseti dan postopka v skupini CMD(v) je bil 23. januarja 2014 in ker zadevne države članice niso dosegle soglasja, je bil postopek napoten na odbor CVMP.
Based on the evaluation of the available data the CVMP adopted by majority, on 7 October 2014, an opinion recommending the granting of the variation of the marketing authorisations for Resflor solution injectable and its associated names.
Na podlagi ocene razpoložljivih podatkov je odbor CVMP 7. oktobra 2014 z večino glasov sprejel mnenje, v katerem je priporočil odobritev spremembe dovoljenja za promet z zdravilom Resflor raztopina za injiciranje in povezanimi imeni.
On 24 January 2014, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
24. januarja 2014 je referenčna država članica, Francija, obvestila Evropsko agencijo za zdravila, da skupina CMD(v) ni dosegla soglasja, in zadevo v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008 napotila na odbor CVMP.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.
Seznam zadevnih imen zdravil je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, Priloga III pa vsebuje povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Written explanations were provided by the marketing authorisation holder on 12 May 2014 and 19 June 2014.
zdravilom je predložil pisna pojasnila 12. maja 2014 in 19. junija 2014.
On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 25 November 2013.
Ker ti pomisleki na 90. dan postopka še vedno niso bili rešeni, je bila zadeva 25. novembra 2013 v skladu s členom 13(1) Uredbe Komisije (ES) št. 1234/2008 napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek (zdravila za uporabo v veterinarski medicini) (CMD(v)).
The marketing authorisation holder Intervet International BV submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Imetnik dovoljenja za promet z zdravilom, Intervet International BV, je predložil vlogo za spremembo tipa II, da bi dodali bakterijo Mycoplasma bovis med ciljne patogene.
Potential serious risks to animal health were identified during the decentralised procedure by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.
Med decentraliziranim postopkom sta Danska in Nemčija opozorili na možna resna tveganja za zdravje živali, povezana z dokazovanjem učinkovitosti v kliničnih preskušanjih in utemeljitvijo priporočenega odmerka zdravila Resflor za zdravljenje okužb dihal, ki jih povzroča bakterija Mycoplasma bovis, saj bi lahko obstajalo povečano tveganje za razvoj protimikrobne odpornosti.
The CVMP concluded that the clinical benefit of Resflor in the treatment of respiratory infections associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance has been identified with the use of this product.
Odbor CVMP je zaključil, da je bila dokazana klinična korist zdravila Resflor pri zdravljenju okužb dihal, povezanih z bakterijo M. bovis, prav tako pa v povezavi z uporabo tega zdravila ni bilo ugotovljeno posebno tveganje za protimikrobno odpornost.
It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Zdravilo je indicirano za zdravljenje okužb dihal, ki jih povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni ter so povezane s povišano telesno temperaturo.
Resflor is a solution for injection for use in cattle containing florfenicol and flunixin as active ingredients.
Zdravilo Resflor je raztopina za injiciranje, namenjena za uporabo pri govedu, ki vsebuje zdravilni učinkovini florfenikol in fluniksin.
referral for Resflor solution injectable and associated names
za zdravilo Resflor raztopina za injiciranje in povezana imena
Opinion following an Article 13 referral for Resflor solution injectable and associated names
Mnenje v zvezi z napotitvijo v skladu s členom 13 za zdravilo Resflor raztopina za injiciranje in povezana imena stran 2/2
This overview was last updated in 03-2018.
Povzetek je bil nazadnje posodobljen 03-2018.
IN addition, no infections occurred during the study period.
Poleg tega se v času študije niso pojavile nove okužbe.
It is used to treat the following conditions:
Uporablja se za zdravljenje naslednjih bolezni:
Further information on Hizentracan be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Nadaljnje informacije za zdravilo Hizentra so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The dose may need to be adjusted depending on how well the medicine is working.
Odmerek bo morda treba prilagoditi, odvisno od tega, kako dobro zdravilo deluje.
It may be given at home, while the side effects are manageable.
Daje se lahko doma, njegovi neželeni učinki pa so obvladljivi.
What measures are being taken to ensure the safe and effective use of Hizentra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hizentra?
It must not be injected into a blood vessel.
Ne sme se injicirati v krvno žilo.
The European Medicines Agency decided that Hizentra's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Hizentra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Other information about Hizentra
Druge informacije o zdravilu Hizentra
Normal immunoglobulin has been used as a medicine since the 1980s.
Polispecifični imunoglobulin se kot zdravilo uporablja od 80. let 20. stoletja.
It can also help to control the immune system when it is working abnormally such as in CIDP.
Pripomore lahko tudi k uravnavanju imunskega sistema pri njegovem nenormalnem delovanju, npr. pri CIDP.
Hizentra received a marketing authorisation valid throughout the EU on 14 April 2011.
Za zdravilo Hizentra je bilo 14. aprila 2011 izdano dovoljenje za promet, veljavno po vsej EU.
It contains mainly immunoglobulin G (IgG), which is composed of a range of antibodies involved in fighting organisms that can cause infection.
Vsebuje predvsem imunoglobulin G (IgG), ki ga sestavljajo različna protitelesa, udeležena v boju proti organizmom, ki lahko povzročajo okužbe.
The most common side effects with Hizentra (which may affect more than 1 in 10 people) are headache, rash, muscle and joint pain (including muscle spasm and weakness), reactions around the injection area (swelling, soreness, redness, pitting, warmth, itching, bruising and rash) and flu-like illness.
Najpogostejši neželeni učinki zdravila Hizentra (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so glavobol, izpuščaj, mišična in sklepna bolečina (vključno z mišičnimi krči in šibkostjo), reakcije v predelu injiciranja (otekanje, bolečine, luknjičavost, toplota, srbenje, podplutbe in izpuščaj) ter gripi podobna bolezen.
As for all medicines, data on the use of Hizentra is continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Hizentra stalno spremljajo.
Rarely patients may have a sudden drop in blood pressure or an anaphylactic shock (sudden, severe allergic reaction).
Redko lahko pri bolnikih nenadoma pade krvni tlak ali nastopi anafilaktični šok (nenadna, huda alergijska reakcija).
• chronic inflammatory demyelinating polyneuropathy (CIDP).
• kronični vnetni demielinizirajoči polinevropatiji (CIDP).
Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Zdravilo Hizentra se uporablja pri bolnikih, katerih kri ne vsebuje dovolj protiteles (beljakovin, ki pomagajo telesu v boju proti okužbam in drugim boleznim), znanih tudi kot imunoglobulini.
What benefits of Hizentra have been shown in studies?
Kakšne koristi zdravila Hizentra so se pokazale v študijah?
Side effects reported with Hizentra are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Hizentra, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hizentra have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Hizentra upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Hizentra authorised in the EU?
Zakaj je bilo zdravilo Hizentra odobreno v EU?
• primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
• sindromov primarne imunske pomanjkljivosti (pri ljudeh, ki se rodijo z nezmožnostjo proizvajanja zadostnega števila protiteles);
The patients received Hizentra for 28 weeks and the lowest IgG levels during treatment with Hizentra (average level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.
Bolniki so zdravilo Hizentra prejemali 28 tednov, najnižje ravni imunoglobulina IgG pri zdravljenju z njim (povprečna raven 8,1 g na liter) pa so bile primerljive z ravnjo, opaženo med predhodnim zdravljenjem z imunoglobulinom.
An overview of Hizentra and why it is authorised in the EU
Pregled zdravila Hizentra in zakaj je odobreno v EU
The dose and how often Hizentra infusion is given depend on the disease being treated.
Odmerek in pogostost infuzije sta odvisna od zdravljene bolezni.
Hizentra can only be obtained with a prescription and treatment should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems or CIDP.
Predpisovanje in izdaja zdravila Hizentra je le na recept, zdravljenje z njim pa mora uvesti zdravnik ali medicinska sestra, ki ima izkušnje z zdravljenjem bolnikov z oslabljenim imunskim sistemom ali CIDP.
For more information about using Hizentra, see the package leaflet or contact a doctor or pharmacist.
Za več informacij glede uporabe zdravila Hizentra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What is Hizentra and what is it used for?
Kaj je zdravilo Hizentra in za kaj se uporablja?
What are the risks associated with Hizentra?
Kakšna tveganja so povezana z zdravilom Hizentra?
It is given by subcutaneous infusion (very slow injection under the skin) through a device that controls the speed of infusion.
Daje se kot infuzija v podkožje (zelo počasno injiciranje v podkožje) s pripomočkom, ki uravnava hitrost infundiranja.
• low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections;
• nizke ravni protiteles v krvi bolnikov s kronično limfocitno levkemijo (rakom vrste belih krvnih celic) ali mielomom (rakom druge vrste belih krvnih celic) in pogosto ponavljajočimi se okužbami;
As human normal immunoglobulin has been used to treat these diseases for many years, in accordance with current guidelines, two small studies were needed to establish the effectiveness and safety of Hizentra in patients.
Ker se humani polispecifični imunoglobulin že dalj časa uporablja za zdravljenje teh bolezni, sta za potrditev učinkovitosti in varnosti zdravila Hizentra pri bolnikih v skladu z veljavnimi smernicami zadostovali le dve manjši študiji.
Patients received Hizentra or placebo (a dummy treatment) for 13 weeks and the study measured the proportion of patients in whom the disease came back within 13 weeks.
Bolniki so prejemali zdravilo Hizentra ali placebo (zdravilo brez učinkovine) 13 tednov, študija pa je merila delež bolnikov, pri katerih se je bolezen ponovila v 13 tednih.
Patients (or their carers) may inject Hizentra at home once they have been trained.
Bolniki ali njihovi skrbniki lahko po ustreznem usposabljanju zdravilo Hizentra injicirajo sami doma.
For patients on placebo, the disease came back in about 63% of patients, for patients on Hizentra, the disease came back in 33 and 39% of patients; depending on the dose used.
Bolezen se je ponovila pri približno 63 % bolnikov, zdravljenih s placebom, in pri 33 oziroma 39 % bolnikov, zdravljenih z zdravilom Hizentra, odvisno od uporabljenega odmerka.
Hizentra was shown to prevent serious bacterial infections in PID patients and reduce the chance of CIDP coming back.
Dokazano je, da zdravilo Hizentra preprečuje resne bakterijske okužbe pri bolnikih s primarno imunsko pomanjkljivostjo in zmanjšuje možnost za ponovitev CIDP.
In the second study Hizentra was studied in 172 patients with CIDP who had previously received human immunoglobulin treatment by injection into a vein.
V drugi študiji so zdravilo Hizentra proučevali pri 172 bolnikih s CIDP, ki so bili predhodno zdravljeni s humanim imunoglobulinom z injiciranjem v veno.
Hizentra must not be used in patients with hyperprolinaemia (a genetic disorder causing hgh levels of the amino acid proline in the blood).
Zdravilo Hizentra se ne sme uporabljati pri bolnikih s hiperprolinemijo (genetsko motnjo, ki povzroča visoke ravni aminokisline prolin v krvi).
For the full list of side effects and restrictions with Hizentra, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Hizentra glejte navodilo za uporabo.
It is given in the abdomen (belly), thigh, upper arm or hip.
Daje se v trebuh, stegno, nadlaket ali kolk.
The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from donated human blood.
Učinkovina v zdravilu Hizentra, humani polispecifični imunoglobulin, je temeljito prečiščena beljakovina, pridobljena iz darovane človeške krvi.
In the first study, Hizentra was investigated in 51 PID patients who had already received human immunoglobulin into a vein for at least six months.
V prvi študiji so zdravilo Hizentra proučevali pri 51 bolnikih s primarno imunsko pomanjkljivostjo, ki so humani imunoglobulin prejemali v veno že vsaj šest mesecev.
Hizentra is available as a solution for injection.
Na voljo je v obliki raztopine za injiciranje.
In this rare disease, the immune system (the body's defence system) works abnormally and destroys the protective covering over the nerves.
(obrambni sistem telesa) deluje nenormalno in uniči zaščitno ovojnico živcev.
How is Hizentra used?
Kako se zdravilo Hizentra uporablja?
How does Hizentra work?
Kako zdravilo Hizentra deluje?
Hizentra works by restoring abnormally low IgG levels to their normal range in the patient's blood.
Zdravilo Hizentra deluje tako, da nenormalno nizko koncentracijo imunoglobulina v bolnikovi krvi povrne v območje njene normalne vrednosti.
Hizentra contains the active substance human normal immunoglobulin.
Zdravilo Hizentra vsebuje učinkovino humani polispecifični imunoglobulin.
• low levels of antibodies in the blood in patients before or after allogeneic haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);
(postopkom, pri katerem se iz bolnikovega kostnega mozga odstranijo celice in nadomestijo z matičnimi celicami darovalca) ali po njej;
10 vials + 10 vials
10 vial + 10 vial
1 vial + 1 pre-filled syringe + 1 needle
1 viala + 1 napolnjena injekcijska brizga + 1 igla
10 vials + 10 prefilled syringes with attached needle
10 napolnjenih injekcijskih brizg z nameščenimi iglami
1 vial + 1 pre-filled syringe + 2 needles
1 napolnjena injekcijska brizga + 2 igli
1 vial + 1 pre-filled syringe without needle
1 napolnjena injekcijska brizga brez igle
1 vial + 1 pre-filled syringe with attached needle
1 napolnjena injekcijska brizga z nameščeno iglo
They must not give you any food or drink.
Ne smejo vam dajati hrane ali pijače.
Bear in mind that you could endanger yourself or others.
Vedite, da s tem lahko ogrozite sebe ali druge.
OTHER SPECIAL WARNINGS, IF NECESSARY
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
The exact mechanism of this interaction is not clear.
Natančen mehanizem te interakcije ni pojasnjen.
Date of first authorisation: 14/10/2009 Date of latest renewal: 22 August 2014
Datum prve odobritve: 14. oktober 2009 Datum zadnjega podaljšanja: 22 avgust 2014
• if you are under 18 or over 75 years of age.
- če ste mlajši od 18 ali starejši od 75 let.
It could choke you.
Lahko vas zaduši.
If you miss a dose, take the next dose as usual.
Če ste pozabili vzeti odmerek, naslednji odmerek vzemite kot ponavadi.
Very rare
zelo redki
The safety and efficacy of repaglinide in children below 18 years have not been established.
Varnost in učinkovitost repaglinida pri otrocih, mlajših od 18 let, še nista bili dokazani.
Repaglinide was detected in the milk of animals.
Repaglinid so zasledili v mleku živali.
• if you are about to have major surgery or you have recently suffered a severe illness or infection.
- če imate predvideno večjo operacijo ali ste pred kratkim preboleli hudo bolezen ali okužbo.
If this happens, medical assistance is needed immediately.
V takšnih primerih morate nemudoma poiskati zdravniško pomoč.
Combination with metformin
Kombinacija z metforminom
Summary of the safety profile
Povzetek profila varnosti
No safety concerns were raised.
Težav z varnostjo niso ugotovili.
- Diabetic ketoacidosis, with or without coma.
- Diabetična ketoacidoza s komo ali brez nje.
Data from animal studies investigating effects on embryofetal and offspring development as well as excretion in milk is described in section 5.3.
Podatki iz študij na živalih, ki so preučevale vplive na embrio-fetalni razvoj in razvoj potomstva ter izločanje v mleko, so opisani v poglavju 5.3.
Your doctor will advise you.
O tem vam bo svetoval zdravnik.
V. Holjevca 20/E 10450 Jastrebarsko Croatia
V. Holjevca 20/E 10450 Jastrebarsko Hrvaška
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If any change of your treatment is necessary contact your doctor first.
Če je potrebna kakršnakoli sprememba zdravljenja, se najprej posvetujte s svojim zdravnikom.
The dosage should be determined by the physician, according to the patient's requirements.
Odmerek mora določiti zdravnik glede na bolnikove potrebe.
Debilitated or malnourished patients
Oslabeli in podhranjeni bolniki