natgillin/translations-raw huggingface dataset:
WHAT IS PIROXICAM [Invented name] AND WHAT IT IS USED FOR …. []… “ Before prescribing piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects.
''Preden vam bo zdravnik predpisal piroksikam, bo ocenil koristi, ki bi jih lahko imeli od zdravljenja s tem zdravilom, glede na vaše individualno tveganje za razvoj neželenih učinkov.
Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs) .” …. []…
Zdravnik vam bo piroksikam predpisal le, če vam simptomov niso dovolj ublažili drugi nesteroidni antirevmatiki. ''
DO NOT TAKE PIROXICAM: …. []… • “ If you previously had a stomach or intestinal ulcer, bleeding or perforation. • If you currently have stomach or intestinal ulcer, bleeding or perforation. • If you have or have had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn’ s disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/ pockets in the colon). • If you are taking other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid, a substance present in many medicines used to relieve pain and lower fever. • If you are taking anticoagulants, such as warfarin, to prevent blood clots. • If you previously had a serious allergic drug reaction to piroxicam, other NSAIDs and other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reactions (Stevens-Johnson syndrome, a condition with red blistered, eroded, bloody or crusted skin) and toxic epidermal necrolysis, (a disease with blistering and peeling of the top layer of skin) .” …. []… • “ If any of these applies to you, you should not be given piroxicam.
• če ste imeli v preteklosti želodčno ali črevesno razjedo, krvavitev ali predrtje; • če imate želodčno ali črevesno razjedo, krvavitev ali predrtje; • če imate ali ste imeli anamnezo o boleznih prebavil (želodčno ali črevesno vnetje), ki povečajo nevarnost krvavitve, kot so na primer ulcerozni kolitis, Crohnova bolezen, rak prebavil, divertikulitis (vnetje ali okužba žepastih mešičkov v kolonu); • če jemljete druge nesteroidne antirevmatike, vključno s takšnimi, ki delujejo selektivno na ciklooksigenazo 2 in acetilsalicilno kislino, učinkovino, ki jo vsebujejo številna zdravila za lajšanje bolečine in proti vročini; • če jemljete antikoagulanse, na primer varfarin, za preprečevanje nastajanja krvnih strdkov; • če ste v preteklosti imeli resno alergijsko reakcijo na piroksikam, kateri drugi nesteroidni antirevmatik ali druga zdravila, zlasti resne kožne reakcije (ne glede na to, kako hude so bile), na primer eksfoliativni dermatitis (izrazito kožno rdečico, pri kateri se koža lušči v obliki lusk ali plasti), vezikulo- bulozne reakcije (Stevens- Johnsonov sindrom, obolenje z rdečo, mehurjasto, razjedeno, krvavo ali krastavo kožo) in toksično epidermalno nekrolizo (bolezen, pri kateri nastajajo na koži mehurji in se lušči njen vrhnji sloj). ''
Tell your doctor immediately .” …. []…
Nemudoma obvestite zdravnika. ''
TAKE SPECIAL CARE WITH… …. []… “ Take special care with [Invented name] and always tell your doctor before using [Invented name]: like all non-steroidal-anti-inflammatory drugs, [Invented name] can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration, and perforation.
Kot vsi nesteroidni antirevmatiki lahko tudi [izmišljeno ime] povzroči resne zaplete v želodcu in črevesu, na primer bolečino, krvavitev, razjedo in predrtje.
If you are over 70 years old, or you are taking other medicines like corticosteroids or certain drugs for depression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clotting, your doctor may like to prescribe you together with [Invented name] a medicine for protecting your stomach and intestines.
Če ste stari več kot 70 let ali jemljete tudi druga zdravila, na primer kortikosteroide ali zdravila proti depresiji iz skupine selektivnih zaviralcev ponovnega privzema serotonina (SSRI), ali acetilsalicilno kislino za preprečitev nastajanja krvnih strdkov, vam lahko zdravnik hkrati s/ z [izmišljeno ime] predpiše zdravilo z zaščitnim učinkom na želodec ali črevo.
Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription .” …. []…
Zdravnika obvestite o vseh drugih zdravilih, ki jih jemljete, tudi če ste jih kupili brez recept.. ''
TAKING OTHER MEDICINES …. []… “ Tell your doctor about any other medicines you are taking or took recently (in the last week) – even medicines you bought yourself without a prescription.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
It’ s especially important to mention:
Posebej pomembno je, da poveste:
- if you are taking aspirin or other non-steroidal anti-inflammatory drugs for pain relief
- če jemljete aspirin ali katere druge nesteroidne antirevmatike za lajšanje bolečine;
- if you are taking corticosteroids, which are drugs given to treat a variety of conditions such as
- če jemljete kortikosteroid; to so zdravila za zdravljenje različnih bolezni, na primer alergij in
allergies and hormone imbalances
hormonskih motenj;
- if you are taking anticoagulants such as warfarin to prevent blood clots
- če jemljete antikoagulanse, na primer varfarin, za preprečevanje nastajanja krvnih strdkov;
- if you are taking certain drugs for depression called selective serotonin re-uptake inhibitors (SSRI)
- če jemljete zdravila proti depresiji iz skupine selektivnih zaviralcev ponovnega privzema serotonina
- if you are taking any drugs, such as acetylsalicylic acid to prevent platelet clumping
- če jemljete katerakoli zdravila za preprečevanje zlepljanja trombocitov;
…. []…
... [] …
- If any of these applies to you tell your doctor immediately .”
- Če jemljete katerokoli od naštetih zdravil, nemudoma obvestite svojega zdravnika. ''
HOW TO TAKE PIROXICAM …. []… “ Always use piroxicam exactly as your doctor has told you.
KAKO JEMATI PIROKSIKAM... [] … ''Pri jemanju piroksikama natančno upoštevajte zdravnikova navodila.
Do not increase the dose If you feel that the medicine is not very effective, always talk to your doctor.
Če menite, da je zdravilo premalo učinkovito, se posvetujte z zdravnikom.
If you have any further questions on the use of this product, ask your doctor .” …. []… ANNEX IV
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom.... [] … DODATEK IV
CONDITIONS OF THE MARKETING AUTHORISATION National Competent Authorities (NCA) shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM Pristojni nacionalni organi morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
- A Direct Healthcare Professional Communication (DHPC) must be sent to all Health Care
- Vsem zdravstvenim delavcem, ki predpisujejo piroksikam v skladu z nacionalno prakso, mora
Professionals who prescribe piroxicam according to national practice.
biti poslano neposredno sporočilo za zdravstveno osebje (Direct Healthcare Professional Communication - DHPC).
London, 20 September 2007 EMEA/ 380917/ 2007
London, 20. september 2007 EMEA/ 470118/ 2007
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL
MNENJE ODBORA ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP), V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 31( 2) ZA
However a need to further evaluate the benefit/ risk balance of some non-selective NSAIDs including piroxicam was identified.
Ugotovljena pa je bila potreba po nadaljnji presoji razmerja med koristmi in tveganji za nekatera neselektivna nesteroidna protivnetna zdravila, vključno s piroksikamom.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
CHMP je menil, da ocena vzbuja pomisleke glede razmerja med koristmi in tveganji za piroksikam, ter je skladno s tem obvestil Evropsko komisijo.
On 2 August 2006, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC, as amended, for piroxicam containing medicinal products.
Dne 2. avgusta 2006 je Evropska komisija Evropski agenciji za zdravila v skladu s členom 31 Direktive 2001/ 83/ ES, kot je bila spremenjena, predložila napotitev za zdravila, ki vsebujejo piroksikam.
Based on the available data the CHMP considered that the benefit/ risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/ risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
Vseeno pa je ocenil, da je razmerje med koristmi in tveganji za piroksikam pri zdravljenju akutnih stanj negativno in da je treba te indikacije razveljaviti.
The scientific conclusions are provided in Annex II, together with the amended product information in Annex III and the conditions of the Marketing Authorisation in Annex IV.
Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenimi informacijami o izdelku v Dodatku III in Pogoji dovoljenja za promet v Dodatku IV.
(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 The final opinion was converted into a Decision by the European Commission on 7 September 2007.
(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 * Opombe:
∗ Notes: the information given in this document and annexes reflects only the CHMP Opinion dated 21 June 2007.
Informacije v tem dokumentu in dodatkih odražajo zgolj mnenje CHMP z dne 21 junija 2007.
London, 10 April 2006 EMEA/ 85997/ 2006
London, 10. aprila 2006 EMEA/ 85983/ 2006
SUMMARY INFORMATION ON REFERRAL OPINION
POVZETEK MNENJA IZ NAPOTITVENEGA POSTOPKA
Prograf and associated names (See Annex I)
Prograf in z njim povezana imena (glejte Dodatek I)
Tacrolimus
Mednarodno nelastniško ime (INN): takrolimus
On 23 march 2005, Fujisawa GmbH on behalf of all the Marketing Authorisation Holders (see Annex 1 of Opinion) presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the national SPCs of the medicinal product Prograf and associated names.
23. marca 2005 je podjetje Fujisawa GmbH v imenu vseh imetnikov dovoljenja za promet z zdravilom (glejte Dodatek I Mnenja) pri EMEA sprožilo napotitveni postopek za obravnavo v skladu s členom 30 Direktive 2001/ 83/ ES, kot je bila spremenjena, da bi tako uskladili nacionalne Povzetke glavnih značilnosti zdravila za zdravilo Prograf in z njim povezana imena.
The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/ risk ratio of Prograf and associated names is considered to be positive in the following indications:
Upoštevaje poročila o oceni poročevalca in soporočevalca, znanstveno razpravo v okviru Odbora ter pojasnila imetnika dovoljenja za promet z zdravilom je CHMP menil, da je razmerje med tveganji in koristmi za zdravilo Prograf in z njim povezana imena pozitivno za naslednje indikacije:
The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.
Znanstveni zaključki so podani v Dodatku II skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
A Decision was issued by the European Commission on 10/ 04/ 06.
Evropska komisija je odločbo izdala dne 10/ 04/ 2006.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, < PREDLAGATELJEV >, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH TER NORVEŠKA IN ISLANDIJA
Invented name
< Izmišljeno ime > < Ime >
Linzerstraße 221 – 227 1140 Vienna Austria
221- 227 A- 1140 Wien Avstrija
Concentrate for Solution for Infusion
Koncentrat za pripravo raztopine Intravenska uporaba za infundiranje
Oral use
Kapsula, trda Peroralna uporaba
61 81673 München Germany
61 D- 81673 München Nemčija
Box 25676 2003 Strovolos 1640 Nicosia
Box 25676 2003 Strovolos 1640 Nikosia Ciper
Meteor Office Centre Park Sokolovská 100/ 94 186 00 Praha 8 Czech Republic
Astellas Pharma s. r. o Meteor Office Centre Park Sokolovská 100/ 94 186 00 Praha 8 Češka
3 Germany
3 Nemčija
Astellas Pharma a/ s Naverland 4 2600 Glostrup Denmark
Astellas Pharma a/ s Naverland 4 2600 Glostrup Danska
4
4 Grčija
Tatoiou Street Lamia NationalRoad 14671 Nea Erythrea Greece
Tatoiou Street Lamia National Road 14671 Nea Erythrea Grčija
Intravenous use
Španija
Spain
Astellas Pharma S. A.
Astellas Pharma S. A Paseo del Club Deportivo n°1, Bloque 14 28223 Pozuelo de Alarcón (Madrid) Spain
Paseo del Club Deportivo n° 1, Bloque 14 28223 Pozuelo de Alarcón (Madrid) Španija
Hard Capsules
Kapsula, trda Peroralna uporaba
Oral use
Španija
5 Finland
Finska
Finland
5 Finska
Intravenous use
Madžarska
61 81673 München Germany
61 81673 München Nemčija
6 Hungary
Madžarska
Hungary
6 Madžarska
25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Ireland
25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Irska
25, The Courtyard, Kilcarbery Business Park Clondalkin, Dublin 22 Ireland
25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Irska
Via delle Industrie 1 20061 Carugate (Milano) Italy
Astellas Pharma S. p. A Via delle Industrie 1 20061 Carugate (Milano) Italija
7 Italy
Italija
Postbus 108 2350 AC Leiderdorp The Netherlands
Postbus 108 2350 AC Leiderdorp Nizozemska
8 The Netherlands
Nizozemska
Norway
8 Norveška
9 Poland
Poljska
Astellas Farma Limitada Edifício Cinema Rua José Fontana, n° 1, 1° andar 2770-101 Paço de Arcos Portugal
Astellas Farma Limitada Edifício Cinema Rua José Fontana, n°1, 1° andar 2770- 101 Paço de Arcos Portugalska
10 Slovenia
Slovenija
Wolfova 1 1000 Ljubljana Slovenia
Wolfova 1 1000 Ljubljana Slovenija
United Kingdom
10 Združeno kraljestvo
Lovett House, Lovett Road Staines Middlesex TW18 3AZ United Kingdom
Lovett House, Lovett Road Staines Middlesex, TW18 3AZ Združeno kraljestvo
11 United Kingdom
Združeno kraljestvo
Intravenous use
11 DODATEK II
Fujisawa GmbH acting on behalf of all Marketing Authorisation holders (see Annex I) has applied for harmonisation according to Article 30 of Directive 2001/ 83/ EC, as amended, of their products Prograf and associated names 0.5, 1 and 5 mg hard capsules (oral use) and Prograf and associated names 5 mg/ ml concentrate for infusion (intravenous use).
Družba Fujisawa GmbH je v imenu vseh imetnikov dovoljenja za promet z zdravilom (glejte Dodatek I) vložila zahtevek za usklajevanje v skladu s členom 30 Direktive 2001/ 83/ ES, kot je bila spremenjena, za svoje proizvode Prograf in z njim povezana imena 0, 5, 1 in 5 mg trde kapsule (peroralna uporaba) ter Prograf in z njim povezana imena 5 mg/ ml koncentrat za raztopino za infundiranje (intravenska uporaba).
Kidney transplantation:
Presaditev ledvic:
One pitfall for the renal paediatric indication is, however, the lack of long- term data.
Pomanjkljivost v indikaciji za zdravljenje ledvic pri pediatričnih bolnikih pa je odsotnost dolgoročnih podatkov.
This has been done mainly by long time experience with the drug at different centres in Europe and the US.
Do tega je prišlo predvsem na podlagi dolgoletnih izkušenj z zdravilom v različnih centrih v Evropi in ZDA.
Data from “ The Registry of the International Society for Heart and Lung Transplantation” (ISHLT) confirm the findings of the MAH’ s pivotal study in primary heart transplantation as well as the results of an array of small, single centre, open, randomized/ non- randomized studies.
Podatki iz » Registra Mednarodnega združenja za presaditve srca in pljuč (ISHLT) « potrjujejo ugotovitve osrednje raziskave, ki jo je izvedel imetnik dovoljenja za promet z zdravilom v zvezi z primarno presaditvijo srca, kakor tudi rezultate iz nabora manjših, enocentričnih, odprtih randomiziranih/ nerandomiziranih raziskav.
In treatment of acute rejection the therapeutic regimen with tacrolimus has been proven to provide either a significantly improved histological endomyocardial biopsy grading of rejection or a resolution of rejection.
Dokazano je bilo, da shema zdravljenja s takrolimusom pri zdravljenju akutne zavrnitve bodisi bistveno zniža stopnjo zavrnitvene reakcije, ugotovljeno na podlagi histološke biopsije endomiokarda, bodisi odpravi zavrnitev.
Most of the data supporting this indication are as expected retrospective.
Večina podatkov, ki podpira to indikacijo, je v skladu s pričakovanji retrospektivna.
The ISHLT’ s annual report therefore adds important information to the use of heart transplantation in children.
Zato letno poročilo ISHLT nudi pomembne dodatne informacije o uporabi zdravila pri presaditvi srca pri otrocih.
As shown in both the published data and the ISHLT’ s annual report tacrolimus can substitute ciclosporin as primary immunosuppression therapy.
Kot kažejo objavljeni podatki in letno poročilo ISHLT, lahko takrolimus nadomesti ciklosporin v okviru primarnega imunosupresivnega zdravljenja.
In treatment of acute rejection the therapeutic regiment with tacrolimus has been proven to provide either a significantly improved histological endomyocardial biopsy grading of rejection or a resolution of rejection.
13 Dokazano je bilo, da shema zdravljenja s takrolimusom pri zdravljenju akutne zavrnitve bodisi bistveno zniža stopnjo zavrnitvene reakcije, ugotovljeno na podlagi histološke biopsije endomiokarda, bodisi odpravi zavrnitev.
But in a scenario
Večina podatkov, ki podpirajo to indikacijo, je v skladu s pričakovanji retrospektivna.
14 where re-transplantation or death is a likely outcome a more liberal attitude toward the indication is in place.
Vendar pa je pri scenariju, pri katerem je verjeten rezultat ponovna presaditev ali smrt, upravičeno bolj liberalno stališče v povezavi s to indikacijo.
Liver transplantation:
Presaditev jeter:
Dosage recommendations are provided for rejection therapy, concerning “ other allografts”.
Podana so priporočila za odmerjanje pri zdravljenju zavrnitve, ki zadevajo » druge alotransplantate «.
Several amendments to the SPC were introduced, in particular pertaining clinical indications (4.1) and the section on posology and method of administration (4.2).
V Povzetek glavnih značilnosti zdravila je bilo vključenih več dopolnitev, zlasti tistih, ki zadevajo klinične indikacije (4. 1) ter poglavje o odmerjanju in načinu uporabe (4. 2).
In addition, findings on clinical pharmacology were introduced in the sections on special warnings and precautions for use (4.4), interaction with other medicinal products and other forms of interaction (4.5) and the section on pharmacokinetic properties (5.2).
Poleg tega so bile v poglavja o posebnih opozorilih in previdnostnih ukrepih za uporabo (4. 4), medsebojnem delovanju z drugimi zdravili in drugih oblikah interakcij (4. 5) ter v poglavje o farmakokinetičnih lastnostih (5. 2) vključene ugotovitve o klinični farmakologiji.
Section on contraindications (4.3) remained unchanged.
Poglavje o kontraindikacijah (4. 3) je ostalo nespremenjeno.
A wording modification was introduced to section on pregnancy and lactation (4.6) in order to add clarity and to put it in line with the guideline on summary of product characteristics.
Sprememba je bila vključena v poglavje o nosečnosti in dojenju (4. 6), da bi tako povečali njegovo jasnost ter ga uskladili s smernico o povzetku glavnih značilnosti zdravila.
Inconsistencies between section 4.6 (Pregnancy and lactation) and section 5.3 (Preclinical safety data) have been corrected and more information has been included on male fertility.
Neskladnosti med poglavjema 4. 6 (Nosečnost in dojenje) ter 5. 3 (Predklinični podatki o varnosti) so bile odpravljene, vključenih je bilo tudi več podatkov o moški plodnosti.
Section on undesirable effects (4.8) was brought in line with the guideline on summary of product characteristics.
Poglavje o neželenih učinkih (4. 8) je bilo usklajeno s smernico o povzetku glavnih značilnosti zdravila.
Benefit/ Risk considerations
14 Razmerje med koristmi in tveganji
15 Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered that the benefit/ risk ratio of Prograf and associated names is favourable for use relating to:
Na podlagi dokumentacije, ki jo je predložil imetnik dovoljenja za promet z zdravilom, ter znanstvene razprave znotraj Odbora je CHMP menil, da je razmerje med tveganji in koristmi za zdravilo Prograf in z njim povezana imena ugodno za uporabo pri:
- Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.
- profilaksi zavrnitve presadka pri prejemnikih alotransplantata jeter, ledvic ali srca;
- Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal
- zdravljenju zavrnitve alotransplantata, odporne proti terapiji z drugimi imunosupresivi.
Whereas,
• •
• the scope of the referral was the harmonisation of the Summaries of Products Characteristics, • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
je bil namen napotitve uskladitev Povzetkov glavnih značilnosti zdravila, je so bili Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ocenjeni na podlagi posredovane dokumentacije in znanstvene razprave znotraj Odbora,
16 ANNEX III
15 DODATEK III
Prograf and associated names (see Annex I) 0.5 mg hard capsules Prograf and associated names (see Annex I) 1 mg hard capsules Prograf and associated names (see Annex I) 5 mg hard capsules
Prograf in povezana imena (glejte Dodatek I) 0, 5 mg trde kapsule Prograf in povezana imena (glejte Dodatek I) 1 mg trde kapsule Prograf in povezana imena (glejte Dodatek I) 5 mg trde kapsule
< Invented name > therapy requires careful monitoring by adequately qualified and equipped personnel.
Zdravljenje s < (Lastniško) ime zdravila > mora natančno nadzorovati ustrezno usposobljeno in opremljeno osebje.
General considerations The recommended initial dosages presented below are intended to act solely as a guideline .< Invented name > dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations).
Odmerjanje < (Lastniško) ime zdravila > mora temeljiti predvsem na klinični oceni zavrnitve in prenašanja pri vsakem bolniku posebej; v dodatno pomoč je spremljanje koncentracije v krvi (za priporočene ciljne najnižje koncentracije v polni krvi glejte v nadaljevanju).
If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered .< Invented name > can be administered intravenously or orally.
Če so opazni klinični znaki zavrnitve, je treba razmisliti o spremembi imunosupresivne sheme. < (Lastniško) ime zdravila > je mogoče uporabljati intravensko ali peroralno.