natgillin/translations-raw huggingface dataset:
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, v področje uporabe
Diarrhoea has been observed rarely in post marketing safety experience.
Redko je bila po prihodu na trg v okviru spremljanja varnosti zdravila opažena driska.
Cattle from 3 months of age:
Govedo od 3 mesecev starosti: Osnovno cepljenje:
The reaction reduces and disappears without need for treatment.
Reakcija tkiva se zmanjšuje in izgine brez potrebe po zdravljenju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX for 40 ml or 100 ml plastic bottle
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla za 40 ml plastenko, 100 ml plastenko
Marketing authorisation holder: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Imetnik dovoljenja za promet z zdravilom: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje,
SC Read the package leaflet before use.
s.c. Pred uporabo preberite navodilo za uporabo.
Systemic signs as lethargy, malaise and/or anorexia have been observed uncommonly in post marketing safety experience.
Občasno so po prihodu na trg v okviru spremljanja varnosti zdravila opazili sistemske znake kot so letargija, slabo počutje in/ali anoreksija.
For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.
Koze Za aktivno zaščito koz pred zvrgom katerega vzrok je Coxiella burnetii in za zmanjšanje prenosa organizma preko mleka, nožnične mukoze, iztrebkov in placente.
PACKAGE LEAFLET: COXEVAC suspension for injection for cattle and goats
NAVODILO ZA UPORABO COXEVAC suspenzija za injiciranje za govedo in koze
Goats from 3 months of age:
Koze od 3 meseca starosti: Osnovno cepljenje:
It was very common to see in laboratory trials a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days.
V laboratorijskih preizkusih se je zelo pogosto pojavila otipljiva reakcija tkiva premera 3 do 4 cm na mestu vboda, ki lahko traja 6 dni.
Specific pharmacovigilance requirement(s): The MAH should provide an additional PSUR.
Imetnik dovoljenja za promet z zdravilom mora priskrbeti dodatni PSUR (periodično posodobljeno varnostno poročilo).
With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site, lasting for 4 days.
Pri dvojnem odmerku je bila opažena zmerna otipljiva reakcija tkiva premera 4 do 5 cm na mestu vboda, ki je trajala 4 dni.
Administer the vaccine as follows: Cattle: 4 ml in the neck region.
Govedo: 4 ml na področje vratu Koze: 2 ml na področje vratu
With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site, lasting for 16 days.
Pri dvojnem odmerku je bila opažena otipljiva reakcija tkiva premera največ 10 cm na mestu vboda, ki je trajala 16 dni.
No efficacy data are available concerning the use of COXEVAC in male animals.
Glede uporabe cepiva COXEVAC pri samcih ni na voljo podatkov o učinkovitosti cepiva.
Goats:
Koze
Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava izdelovati,uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati cepivo COXEVAC, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
Withdrawal period(s): zero days.
Karenca: 0 dni
Excipients:
Brejost:
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI)
The European Commission issued a decision on 29 May 2009.
Evropska komisija je odločbo izdala dne 29. maja 2009.
Dr Lechat (France)
dr. Lechat (Francija)
Ref. EMEA/CHMP/342694/2009 EMEA/H/A-29/1123
EMEA/CHMP/356668/2009 EMEA/H/A-29/1123
F) 500MBq per ml
F) 500 MBq na ml
Questions and answers on the referral for Gluscan 500 solution for injection containing fludeoxyglucose (
Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Gluscan 500 raztopina za injiciranje, ki vsebuje fludeoksiglukozo (
Dr Prieto Yerro (Spain)
dr. Prieto Yerro (Španija)
Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
1 Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi potencialnega resnega tveganja za javno zdravje.
The review was carried out under an ‘Article 29' referral1.
Pregled je bil izveden v skladu z napotitvenim postopkom1 iz „člena 29“.
This means that it will be absorbed differently by cells depending on their state.
To pomeni, da se bo glede na stanje celic različno absorbirala.
This is a procedure when one Member State (the ‘reference Member State', in this instance France) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance are Germany, Poland, Portugal and Spain)2.
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Francija) oceni zdravilo z namenom pridobiti odobritev dovoljenja za promet z zdravilom, ki bo veljavno v tej državi in ostalih državah članicah (v „zadevnih državah članicah“, v tem primeru v Nemčiji, na Poljskem, Portugalskem in v Španiji)2.
Gluscan 500 can be used: - in cancer medicine to help detect the location of tumours, as cancer cells use a lot of energy and will absorb more fluodeoxyglucose than non-cancerous cells; - in cardiac medicine to help locate areas of the heart that are not taking up as much glucose as expected because of ischaemia (reduced blood supply); - in neurology to detect specific areas within the brain of epileptic patients before surgery; - and to locate areas of the body where there are abnormally high numbers of white blood cells (such as the sites of deep-seated infections or inflammation).
Zdravilo Gluscan 500 se lahko uporablja: - pri zdravljenju raka kot pomoč pri določanju položaja tumorjev, saj rakave celice porabijo veliko energije in absorbirajo več fluodeoksiglukoze kot nerakave celice; - pri zdravljenju srčnih bolezni kot pomoč pri določanju delov srca, ki zaradi ishemije (zmanjšane oskrbe s krvjo) ne sprejemajo toliko glukoze, kot bi pričakovali; - v nevrologiji za določanje specifičnih predelov v možganih epileptičnih bolnikov pred operacijo; - in za določanje delov telesa, kjer je neobičajno veliko število belih krvnih celic (kot so mesta globokih okužb ali vnetij).
Why was Gluscan 500 reviewed?
Zakaj je bilo zdravilo Gluscan 500 pregledano?
However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 30 January 2009.
Ker pa omenjene države članice niso dosegle soglasja, je francoska regulatorna agencija za zdravila zadevo 30. januarja 2009 napotila na CHMP v arbitražo.
What is Gluscan 500?
Kaj je zdravilo Gluscan 500?
Advanced Accelerator Applications submitted Gluscan 500 to the French medicines regulatory agency for a decentralised procedure.
Družba Advanced Accelerator Applications je predložila zdravilo Gluscan 500 francoski regulatorni agenciji za zdravila v decentralizirani postopek.
The grounds for the referral were concerns from the Spanish medicines regulatory agency that, while the use of fluodeoxyglucose (18F) with PET in the areas of cancer, cardiac and neurology medicine were well established, its use in the diagnosis of infectious and inflammatory conditions had not been shown to be sufficiently established in the European Union, and therefore the use of Gluscan 500 as a diagnostic radiopharmaceutical in the diagnosis of these conditions should not be authorised.
Razlogi za napotitveni postopek so bili zadržki španske regulatorne agencije za zdravila, in sicer glede tega, da je uporaba fluodeoksiglukoze (18F) s PET na področju zdravljenja raka in srčnih bolezni ter nevrologije dobro dokazana, njena uporaba pri diagnostiki infekcijskih in vnetnih stanj pa še ni pokazala zadovoljivih dokazov v Evropski uniji, zato se uporaba zdravila Gluscan 500 kot diagnostičnega radiofarmaka za diagnostiko teh stanj ne sme odobriti.
It contains a substance, fluodeoxyglucose, that has been labelled with 18F (fluoride-18), a radioactive form of the chemical element fluorine.
Vsebuje snov, fluodeoksiglukozo, označeno z 18F (fluorid-18), ki je radioaktivna oblika kemijskega elementa fluora.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Gluscan 500 outweigh its risks, and the marketing authorisation can be granted in France and in the following Member States of the European Union Germany, Poland, Portugal and Spain.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da koristi zdravila Gluscan 500 odtehtajo z njim povezana tveganja in da se dovoljenje za promet z zdravilom lahko odobri v Franciji in naslednjih državah članicah Evropske unije: Nemčiji, Poljski, Portugalski in Španiji.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Gluscan 500 outweigh its risks, and therefore the marketing authorisation for Gluscan 500 should be granted in all concerned Member States.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvenih zaključkov znotraj Odbora je CHMP zaključil, da koristi zdravila Gluscan 500 odtehtajo z njim povezana tveganja in da je treba zato dovoljenje za promet z zdravilom Gluscan 500 odobriti v vseh zadevnih državah članicah.
Once in the cell, the radioactivity remains trapped, and can be seen on scans such as those obtained using a ‘PET' (positron emission tomography) scanner.
Ko je fluodeoksiglukoza enkrat v celici, ostane radioaktivnost ujeta in jo lahko opazujemo na slikah, kot denimo na tistih, pridobljenih s „PET“ (pozitronsko emisijsko tomografijo).
London, 2 June 2009
London, 2. junija 2009 Sklic na dok.
When Gluscan 500 is injected in the body, the radiolabelled fluodeoxyglucose is absorbed in the same way as glucose, the main source of energy for the cells.
Ob injiciranju zdravila Gluscan 500 v telo se radioaktivno označena fluodeoksiglukoza absorbira na enak način kot glukoza, ki je glavni vir energije za celice.
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Gluscan 500.
Evropska agencija za zdravila (EMEA) je po nesoglasju med državami članicami Evropske unije glede dovoljenja za promet z zdravilom Gluscan 500 zaključila arbitražni postopek.
The active substance in Gluscan 500, fluodeoxyglucose (18F), is a diagnostic radiopharmaceutical.
Zdravilna učinkovina zdravila Gluscan 500, fluodeoksiglukoza (18F), je diagnostični radiofarmak.
F) is already authorised via national procedures in the Czech Republic, Ireland and the
2 Fluodeoksiglukozo (18F) so z nacionalnimi postopki že odobrile Češka republika, Irska in Združeno kraljestvo.
1 vial + 1 filter
1 viala + 1 filter
4 mg Powder for concentrate for dispersion for infusion
4 mg Prašek za koncentrat za disperzijo za infundiranje
Strength Pharmaceutical Form
Številka postopka EMA (Izmišljeno) ime Jakost Farmacevtska oblika
MA (EU) Numbers (Invented) name Strength
<Številka postopka EMA> <Številka (EU) dovoljenja za promet>
Intravenous use, Subcutaneous use vial (glass)
3,5 mg prašek za raztopino za injiciranje intravenska uporaba viala (steklena)
1 vial
1 viala subkutana uporaba
Pharmaceutical Form
(Izmišljeno) ime Jakost Farmacevtska oblika
20 July 2011
20. julij 2011
A European Commission issued a decision on 20 July 2011.
Evropska komisija je odločbo izdala dne 20. julija 2011.
The amended information to doctors and patients is available here.
Dopolnjeni podatki za zdravnike in bolnike so na voljo tukaj.
When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Kadar se 5HT veže na te receptorje, običajno povzroči slabost in bruhanje.
Why was Kytril reviewed?
Zakaj je bilo zdravilo Kytril pregledano?
Kytril tablets should be swallowed whole with water.
Tablete Kytril je treba pogoltniti cele, z vodo.
The European Medicines Agency has completed a review of Kytril.
Evropska agencija za zdravila je zaključila pregled zdravila Kytril.
This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the in the brain and the gut.
To pomeni, da kemični snovi v telesu, imenovani 5-hidroksitriptamin (5HT, znana tudi kot serotonin), prepreči vezavo na receptorje 5HT3 v možganih in v črevesju.
Kytril is authorised in the EU via national procedures.
Zdravilo Kytril je v EU odobreno z nacionalnimi postopki.
The active substance in Kytril, granisetron, is a ‘5HT3 antagonist'.
Zdravilna učinkovina v zdravilu Kytril, granisetron, je „antagonist 5HT3“.
Kytril is also available in the EU under the trade name Kevatril.
Zdravilo Kytril je v EU na voljo tudi pod tržnim imenom Kevatril.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je v državah članicah povzročilo razhajanja glede uporabe zdravila, kar je razvidno iz razlik med povzetki glavnih značilnosti zdravila, označevanjem in navodili za uporabo v državah, kjer se zdravilo trži.
The company that markets these medicines is Roche.
Družba, ki trži ti zdravili, je Roche.
Other sections harmonised by the CHMP include sections on special warnings, side effects and the medicines pharmacological properties.
Druga poglavja, ki jih je CHMP uskladil, vključujejo poglavje s posebnimi opozorili, o neželenih učinkih in farmakoloških lastnostih zdravila.
For the prevention of nausea and vomiting, the recommended dose is 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy.
Priporočeni odmerek za preprečevanje slabosti in bruhanja je 1 mg dvakrat na dan ali 2 mg enkrat na dan v obdobju enega tedna po radioterapiji ali kemoterapiji.
When used for treatment, further doses of the solution may be given at least 10 minutes apart, up to a maximum of 9 mg per 24 hours.
Kadar se zdravilo Kytril uporablja za zdravljenje, se lahko dajejo tudi nadaljnji odmerki raztopine v 10-minutnih časovnih presledkih, do največ 9 mg na 24 ur.
What is Kytril?
Kaj je zdravilo Kytril?
Kytril solution for injection is given into a vein at a dose of 1-3 mg (10-40 g/kg) for the prevention and treatment of nausea and vomiting in adults.
Raztopina za injiciranje Kytril se daje v veno z odmerkom 1-3 mg (10-40 g/kg) za preprečevanje in zdravljenje slabosti in bruhanja pri odraslih.
Kytril must not be used in patients who are hypersensitive (allergic) to the active substance or to any of the excipients.
Zdravila Kytril ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
It is used to prevent nausea and vomiting following treatments for cancer such as chemotherapy and radiotherapy.
Uporablja se za preprečevanje slabosti in bruhanja po zdravljenju raka, kot sta kemoterapija in radioterapija.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v Odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v celotni EU.
Kytril is an anti-emetic (a medicine that prevents nausea and vomiting).
Zdravilo Kytril je antiemetik (zdravilo, ki preprečuje slabost in bruhanje).
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Kytril in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Kytril.
Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection)
Vprašanja in odgovori v zvezi z zdravilom Kytril in povezanimi imeni (granisetron, 1 in 2 mg tablete, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml raztopina za injiciranje)
Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection) EMA/585560/2011
Vprašanja in odgovori v zvezi z zdravilom Kytril in povezanimi imeni (granisetron, 1 in 2 mg tablete, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml raztopina za injiciranje) EMA/660555/2011
The CHMP recommended that Kytril tablets and solution for injection can be used in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy, and also for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
CHMP je priporočil, da se lahko tablete in raztopina za injiciranje Kytril uporabljajo pri odraslih za preprečevanje in zdravljenje akutne slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo, ter tudi za preprečevanje zakasnele slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.
On 3 June 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Kytril in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Kytril v EU, je dne 3. junija 2010 zadevo napotila na CHMP.
The solution for injection can also be used in children aged two years above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.
Raztopina za injiciranje se lahko uporablja tudi pri otrocih, starih 2 leti in več, za preprečevanje in zdravljenje akutne slabosti in bruhanja, povezanih s kemoterapijo.
In addition, the solution for injection can be used in adults for the prevention and treatment of nausea and vomiting following surgery.
Raztopina za injiciranje se lahko pri odraslih uporablja tudi za preprečevanje in zdravljenje slabosti in bruhanja po operaciji.
Granisetron prevents the nausea and vomiting by blocking these receptors.
Granisetron zavira te receptorje ter tako preprečuje slabost in bruhanje.
Kytril was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Kytril potrebno usklajevanje.
5 (5 x 1) vials (multipack)
5 (5 x 1) vial (skupno pakiranje)
10 (2 x 5) prefilled pens (multipack)
10 (2 x 5) napolnjenih injekcijskih peresnikov (skupno pakiranje)
25 (5 x 5) cartridges (multipack)
25 (5 x 5) injekcijskih vložkov (skupno pakiranje)
The patient safety card should contain:
Varnostna kartica za bolnike mora vsebovati:
• All patients must be monitored for signs of meningitidis
• vse bolnike je treba spremljati za znake meningitisa,
Eculizumab should be given to a pregnant woman only if clearly needed.
Ekulizumab dajemo nosečnicam samo v primeru nujne potrebe.
• Warning to seek immediate medical care if above are present
• opozorilo, naj nemudoma poišče zdravniško pomoč, če se zgoraj našteto pojavi,
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih morajo upoštevati države članice
• No clinical data on exposed pregnancies is available.
• za ekulizumab ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
• Signs and symptoms of severe infection and the need to obtain urgent medical care
• znaki in simptomi resne okužbe in potreba po urgentni medicinski pomoči,
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented
Države članice morajo zagotoviti, da bodo pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, ki so opisane spodaj, upoštevane.
The educational material should be agreed with the National Competent Authority and should contain the following:
Izobraževalno gradivo mora biti skladno z dogovorom s pristojnim nacionalnim organom in mora vsebovati naslednje:
All healthcare practitioners who may prescribe eculizumab receive the appropriate educational material.
1. bodo vsi tisti zdravstveni delavci, ki smejo predpisovati ekulizumab, prejeli ustrezno izobraževalno gradivo;
• Contact details where a health care practitioner can receive further information
• kontaktne podatke, kamor se lahko zdravstveni delavec obrne za dodatne informacije.
• Details of the PNH and aHUS registries and how to enter patients
• podrobnosti registrov bolnikov s PNH in aHUS in kako vanje vključiti bolnike.
• Patient safety card
• varnostno kartico za bolnike.
• Statement that the patient is receiving eculizumab
• izjavo, da bolnik prejema ekulizumab,
All patients being treated with eculizumab receive a patient safety card
2. bodo vsi bolniki, ki se zdravijo z ekulizumabom, prejeli varnostno kartico za bolnike;
• Summary of product characteristics
• povzetek glavnih značilnosti zdravila,
The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National CompetentAuthority and must implement such programmes nationally to ensure that:
Imetnik dovoljenja za promet z zdravilom mora s pristojnimi nacionalnimi organi uskladiti podrobnosti nadzorovanega distribucijskega sistema zdravila in izobraževalnega gradiva, vključno z varnostnimi karticami za bolnike, ter na nacionalni ravni izvesti programe, ki bodo zagotovili, da:
The patient's/carer's guides should be indication specific and contain the following key messages:
Smernice za bolnike/negovalce morajo biti specifične za indikacije in morajo vsebovati naslednja ključna sporočila:
• The patient safety card and the need to carry it on their person and tell any treating healthcare professional that they are being treated with eculizumab
• varnostno kartico za bolnike in potrebo po tem, da jo bolnik ves čas nosi pri sebi ter opozori vsakega zdravstvenega delavca, s katerim pride v stik, da prejema zdravljenje z ekulizumabom;
Drug distribution will only be possible after written confirmation that the patient has effectively received meningococcal vaccination and/or antibiotic prophylaxis.
3. bo distribucija zdravila možna samo po pisnem zagotovilu, da je bil bolnik uspešno cepljen proti meningokoku in/ali je prejel antibiotično zaščito;
The physician's guides to prescribing should be indication specific and contain the following key messages:
Smernice za predpisovanje za zdravnike morajo biti specifične za indikacije in morajo vsebovati naslednja ključna sporočila: