natgillin/translations-raw huggingface dataset:
6.5 Nature and composition of immediate packaging Sterile aqueous solution in 10 ml polyethylene intramammary syringes, packaged as 8 x 10 ml, 24 x 10 ml in an outer cardboard box.
Injektorji so v kartonski škatli in sicer: 8x10 ml ali 24x10 ml injektorjev.
Muscle Fat
Pirlimicin govedo
PHARMACEUTICAL FORM Intramammary solution
FARMACEVTSKA OBLIKA
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Proizvajalec, odgovoren za sproščanje serij: Norbrook Laboratories Limited
To be supplied only on veterinary prescription.
Nalepka na injektorju IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Tablet
Pakiranje
EU/2/98/007/001 Clomicalm 5 mg
EU (MA) številka Izmišljeno ime Jakost Farmacevtska oblika
--1 Porcine circovirus type 2 ORF2 protein RP 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
--1 beljakovina ORF2 prašičjega cirkovirusa tipa 2 1,0 - 3,75 RP * relativna učinkovitost (preskus ELISA) v primerjavi z referenčnim cepivom
Suspension for
Karenca
The replacement acts in same way as naturally produced G-CSF.
Nadomestek deluje na enak način kot naravno proizvedeni G-CSF.
Patients can inject themselves if they have been trained appropriately.
Bolniki si lahko zdravilo vbrizgajo sami, če so bili ustrezno usposobljeni.
The marketing authorisation was renewed on 22 August
Dovoljenje za promet je bilo podaljšano 22. avgusta 2007.
Other information about Neupopeg:
Druge informacije o zdravilu Neupopeg:
Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Filgrastim je v Evropski uniji (EU) na voljo kot sestavina v drugih zdravilih že precej let.
Neupopeg treatment should be initiated and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Zdravljenje z zdravilom Neupopeg mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka ali boleznimi krvi.
What is the risk associated with Neupopeg?
Kakšna tveganja so povezana z zdravilom Neupopeg?
Neupopeg has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Zdravilo Neupopeg so raziskovali v dveh glavnih študijah, v katerih je sodelovalo 467 bolnikov z rakom na prsih, ki so bili zdravljeni s citotoksično kemoterapijo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEUPOPEG EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NEUPOPEG Povzetek EPAR za javnost
Neupopeg is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Zdravilo Neupopeg se daje kot enkratna 6 mg injekcija pod kožo približno 24 ur ob koncu vsakega cikla kemoterapije.
The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Glavno merilo učinkovitosti je bilo trajanje hude nevtropenije med prvim ciklom kemoterapije.
What benefit has Neupopeg shown during the studies?
Kakšne koristi je zdravilo Neupopeg izkazalo med študijami?
The filgrastim in Neupopeg is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Filgrastim v zdravilu Neupopeg se proizvaja po metodi, imenovani „tehnologija rekombinantne DNK“: encim proizvede bakterija, ki je prejela gen (DNK) s pomočjo katerega postane sposobna tvoriti filgrastim.
Neupopeg should not be used in people who may be hypersensitive (allergic) to pegfilgrastim or any of the other ingredients.
Zdravila Neupopeg ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pegfilgrastim ali katero koli drugo sestavino zdravila .
The most common side effects with Neupopeg (seen in more than 1 in 10 patients) are bone pain and raised levels of lactate dehydrogenase (a marker of red blood cell breakdown).
Najpogostejši neželeni učinki pri jemanju zdravila Neupopeg (opaženi pri več kot enem izmed 10 bolnikov) so bolečine v kosteh in povišane ravni laktatdehidrogenaze (označevalec razgradnje rdečih krvničk).
In both studies, the effectiveness of a single injection of Neupopeg was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
V obeh študijah so primerjali učinkovitost enkratne injekcije zdravila Neupopeg z večkratnimi dnevnimi injekcijami filgrastima med vsakim od štirih ciklov kemoterapije.
It consists of filgrastim, a copy of a human protein called granulocyte colony stimulating factor (G-CSF), which has been ‘pegylated' (coated with a chemical called polyethylene glycol).
Sestavlja ga filgrastim, kopija človeške beljakovine, imenovane granulocitne kolonije spodbujajoči faktor (G-CSF), ki je bil „pegiliran“ (prevlečen s kemično spojino polietilenglikol).
Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
V obliki pegfilgrastim je pegiliran, kar pomeni, da je izločanje iz telesa upočasnjeno in se zato zdravilo lahko daje manj pogosto.
It also cannot be used in patients with myelodysplastic syndromes, a disease in which too many white blood cells are produced, and which can develop into leukaemia.
Zdravila prav tako ne smejo prejemati osebe z mielodisplastičnim sindromom, boleznijo, pri kateri nastaja preveč belih krvničk in ki se lahko razvije v levkemijo.
In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle.
V obeh študijah je huda nevtropenija pri bolnikih trajala 1,7 dneva med prvim ciklom kemoterapije.
Neupopeg is used in cancer patients to help with some of the side effects of their treatment.
Zdravilo Neupopeg se uporablja pri rakavih bolnikih za pomoč pri nekaterih neželenih učinkih njihovega zdravljenja.
The active substance in Neupopeg, pegfilgrastim, is an immunostimulant that belongs to the group ‘colony stimulating factors'.
Zdravilna učinkovina v zdravilu Neupopeg, pegfilgrastim, je imunostimulant, ki spada v skupino „kolonije spodbujajočih faktorjev“.
Most of the side effects seen in patients taking Neupopeg in studies are due to their underlying disease or chemotherapy.
Večino neželenih učinkov, opaženih pri bolnikih, ki so jemali zdravilo Neupopeg, je treba pripisati njihovim osnovnim boleznim ali kemoterapiji.
Chemotherapy (cancer treatment) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low white blood cell counts) and the development of infections.
Kemoterapija (zdravljenje raka), ki je citotoksična (torej taka, ki ubija celice) ubija tudi bele krvničke, kar lahko povzroči nevtropenijo (zmanjšano število belih krvničk) ter razvoj vnetij.
Neupopeg can be used for many types of cancer, except for chronic myeloid leukaemia (a cancer of the white blood cells).
Zdravilo Neupopeg se lahko uporablja pri mnogih vrstah raka, razen pri kronični mieloidni levkemiji (raku belih krvničk).
The Committee recommended that Neupopeg be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Neupopeg odobri dovoljenje za promet.
The Committee for Medicinal Products for Human Use (CHMP) decided that Neupopeg's benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Neupopeg pri skrajšanju trajanja nevtropenije in zmanjševanju pojavljanja febrilne nevtropenije pri bolnikih z malignimi obolenji, ki se zdravijo s citotoksično kemoterapijo, večje od z njim povezanih tveganj.
Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.
Filgrastim deluje tako, da kostni mozeg spodbuja k izdelavi več belih krvničk, s čimer se njihovo število poveča in zdravi nevtropenija.
It is available in a pre-filled syringe and a pre-filled pen (SureClick), each containing 6 mg pegfilgrastim.
Na voljo je kot napolnjena injekcijska brizga in napolnjeno injekcijsko pero (Sure Click), ki vsak vsebuje 6 mg pegfilgrastima.
Neupopeg was as effective as filgrastim in reducing the duration of severe neutropenia.
Zdravilo Neupopeg je bilo pri skrajšanju trajanja hude nevtropenije enako učinkovito kot filgrastim.
Neupopeg is a solution for injection that contains the active ingredient pegfilgrastim.
Zdravilo Neupopeg je raztopina za injiciranje, ki vsebuje zdravilno učinkovino pegfilgrastim.
The European Commission granted a marketing authorisation valid throughout the EU for Neupopeg to Dompé Biotec S.p.A. on 22 August 2002.
Evropska komisija je dovoljenje za promet z zdravilom Neupopeg, veljavno po vsej Evropski uniji, odobrila družbi Amgen Europe B.V.
Neupopeg is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Zdravilo Neupopeg se uporablja za skrajšanje trajanja nevtropenije ter zmanjševanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperature).
Why has Neupopeg been approved?
Zakaj je bilo zdravilo Neupopeg odobreno?
For the full list of all side effects reported with Neupopeg, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Neupopeg, glejte Navodilo za uporabo.
How has Neupopeg been studied?
Kako je bilo zdravilo Neupopeg raziskano?
Neupopeg is not recommended for use in children, due to a lack of information on its safety and effectiveness in this group.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti, zdravilo Neupopeg ni priporočeno za otroke.
What is Neupopeg used for?
Za kaj se zdravilo Neupopeg uporablja?
The full EPAR for Neupopeg can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Neupopeg je na voljo tukaj.
What is Neupopeg?
Kaj je zdravilo Neupopeg?
How is Neupopeg used?
Kako se zdravilo Neupopeg uporablja?
How does Neupopeg work?
Kako zdravilo Neupopeg deluje?
Target Species
Ciljne živalske vrste
Pharmaceutical Form
Farmace vtska oblika
This summary was last updated: March 2012.
Ta povzetek je bil nazadnje posodobljen: marcu 2012.
These side effects occur usually within the first week of treatment and are generally transient (temporary).
Običajno se pojavijo v prvem tednu zdravljenja in so ponavadi prehodni (začasni).
It can be used for both acute disorders, such as those seen after an injury, and chronic (long term) disorders.
Lahko se ga uporablja tako za akutna obolenja, do katerih pride ob poškodbi, kot tudi za kronična (dolgotrajna) obolenja.
If the product is swallowed by a person, the advice of a doctor should be sought immediately.
V primeru, da človek zdravilo nenamerno zaužije, se je treba nemudoma posvetovati z zdravnikom.
Other information about Meloxivet:
Druge informacije o zdravilu Meloxivet:
Meloxivet is given to the dog once a day, with food, at the dose of 0.2 mg/kg on the first day, then as 0.1 mg/kg afterwards.
Zdravilo Meloxivet se psu daje enkrat dnevno s hrano v odmerku 0,2 mg/kg na prvi dan, zatem pa v odmerku 0,1 mg/kg.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxivet.
Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Meloxivet.
The amount of suspension to be used is measured using a special dosing syringe (provided in the package), and poured on the food.
Količino suspenzije, ki jo želimo uporabiti, odmerimo s posebno merilno brizgo (priloženo zdravilu) in nato izbrizgamo v hrano.
Meloxivet contains meloxicam, which belongs to a class of medicines called nonsteroidal antiinflammatory drugs (NSAIDs).
Zdravilo Meloxivet vsebuje meloksikam, ki spada v skupino zdravil, ki jim pravimo nesteroidna protivnetna zdravila (NSAID).
The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxivet on 14 November 2007 Information on the prescription status of this product may be found on the label of the carton.
Evropska komisija je dovoljenje za promet z zdravilom Meloxivet, veljavno po vsej Evropski uniji, odobrila dne 14. novembra 2007.
Meloxivet is used in dogs to relieve inflammation and pain in musculo-skeletal disorders.
Zdravilo Meloxivet se uporablja pri psih za lajšanje vnetja in bolečin pri mišično-kostnih obolenjih.
Occasional side effects of Meloxivet are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Občasni neželeni učinki zdravila Meloxivet so enaki kot pri drugih nesteroidnih protivnetnih zdravilih in obsegajo izgubo apetita, bruhanje, drisko, kri v blatu in apatijo (pomanjkanje vitalnosti).
Therefore the CVMP's view was that, as for Metacam 1.5 mg/ml oral suspension, Meloxivet's benefits are greater than its risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Meloxivet should be given a marketing authorisation.
Zato je CVMP menil, da so koristi zdravila Meloxivet enako kot pri zdravilu Metacam 1,5 mg/ml peroralna suspenzija večje od z njim povezanih tveganj pri zdravljenju vnetja ali bolečine v mišicah ali sklepih pri psih, ter je priporočil odobritev dovoljenja za promet z zdravilom Meloxivet.
Why has Meloxivet been approved?
Zakaj je bilo zdravilo Meloxivet odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxivet has been shown to be bioequivalent to Metacam 1.5 mg/ml oral suspension.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da se je zdravilo Meloxivet v skladu z zahtevami Evropske unije izkazalo kot bioekvivalentno zdravilu Metacam 1,5 mg/ml peroralna suspenzija.
Meloxivet contains the active substance meloxicam and exists in 2 different strengths (0.5 and 1.5 mg/ml, respectively).
Zdravilo Meloxivet vsebuje zdravilno učinkovino meloksikam in je na voljo v 2 različnih jakostih (0,5 in 1,5 mg/ml).
Meloxivet is a ‘generic': this means that Meloxivet is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam 1.5 mg/ml oral suspension).
Zdravilo Meloxivet je „generično“ zdravilo, to pomeni, da je podobno „referenčnemu veterinarskemu zdravilu“, ki je že bilo odobreno v EU (zdravilu Metacam 1,5 mg/ml peroralna suspenzija).
A study looked at how Meloxivet was absorbed and its effects in the body, in comparison with Metacam 1.5 mg/ml oral suspension.
V študiji so preučevali absorbiranje zdravila Meloxivet ter njegove učinke na telo v primerjavi z zdravilom Metacam 1,5 mg/ml peroralna suspenzija.
Meloxivet is a white to yellowish opaque oral suspension which is to be given mixed with food.
Zdravilo Meloxivet je bela do rumenkasta motna peroralna suspenzija, ki se jo daje pomešano med hrano.
How has the effectiveness of Meloxivet been studied?
Kako je bila raziskana učinkovitost zdravila Meloxivet?
As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Prostaglandini sprožajo vnetje, bolečino, izločanje tekočine in zvišano telesno temperaturo, meloksikam pa zmanjša obseg teh odzivov.
Studies have been carried out to prove that Meloxivet is ‘bioequivalent' to the reference veterinary medicine: this means that Meloxivet is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.
Študije so pokazale, da je zdravilo Meloxivet „bioekvivalentno“ referenčnemu veterinarskemu zdravilu, to pomeni, da je zdravilo Meloxivet enako zdravilu Metacam 1,5 mg/ml peroralna suspenzija glede načina, kako ga telo absorbira in uporabi.
What is Meloxivet used for?
Za kaj se zdravilo Meloxivet uporablja?
How does Meloxivet work?
Kako zdravilo Meloxivet deluje?
What are the side-effects of Meloxivet?
Kakšni so neželeni učinki zdravila Meloxivet?
What is Meloxivet?
Kaj je zdravilo Meloxivet?
Invented name Strength Pharmaceutical Form Route of administration
Farmacevtska oblika Pot uporabe
EU/1/16/1102/001 Bortezomib SUN 3.5 mg Powder for solution for injection Intravenous use, Subcutaneous use vial (glass)
Bortezomib SUN 3,5 mg Prašek za raztopino za injiciranje
Intravenous use vial (glass) concentrate: 1.2 ml; solvent: 1.8 ml
koncentrat: 1,2 ml; vehikel: 1,8 ml
30 mg Concentrate and solvent for solution for infusion
30 mg koncentrat in vehikel za raztopino za infundiranje intravenska uporaba viala (steklo)
3 January 2019
3. januar 2019
The applicant will submit a draft study protocol within 3 months after approval, in Q2 2013 in order to be ready at the time of product launch in 2014.
Vlagatelj bo predložil osnutek protokola študije v treh mesecih po odobritvi, tj. v drugem četrtletju leta 2013, da bi tako bil pripravljen pred dajanjem zdravila na trg leta 2014.
The results showed that among the study population compliance is very satisfactory; no firm conclusion could be drawn in special populations.
Rezultati so pokazali, da je upoštevanje navodil za jemanje zdravil v populaciji, ki je sodelovala v študiji, zelo zadovoljivo, medtem ko pri posebnih skupinah bolnikov ni bilo mogoče priti do trdnih zaključkov.
November 2018 CMDh meeting
Zasedanje skupine CMDh novembra 2018
The Applicant commits to perform a post authorisation safety study (PASS) to assess drug utilisation in real life setting in a representative sample of the European target population.
Predlagatelj se zavezuje, da bo izvedel študijo o varnosti zdravila po pridobitvi dovoljenja za promet (PASS) za oceno uporabe zdravila v stvarnem življenjskem okolju na reprezentativnem vzorcu evropske ciljne populacije.
The final study report has been endorsed by the PRAC, and the related condition of the marketing authorisation has been fulfilled.
Odbor PRAC je odobril končno poročilo študije, s tem je bil izpolnjen zadevni pogoj dovoljenja za promet.
As part of the initial MA procedure (FR/H/511/01/DC), the MAH Ipsen Pharma committed to conduct a DUS to assess drug utilisation in the real life setting in a representative sample of the European target population.
Kot del prvotnega postopka za pridobitev dovoljenja za promet z zdravilom (FR/H/511/01/DC), se je imetnik dovoljenja za promet Ipsen Pharma zavezal, da bo izvedel študijo o uporabi zdravila (DUS) za oceno uporabe zdravil v stvarnem življenjskem okolju na reprezentativnem vzorcu evropske ciljne populacije.
Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Zato je odbor PRAC ob upoštevanju vseh razpoložljivih podatkov v povezavi s končnim poročilom študije PASS menil, da so potrebne spremembe pogojev dovoljenja za promet.
On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov o rezultatih študije za zdravilo (zdravila), ki vsebujejo učinkovine magnezijev sulfat heptahidrat, brezvodni natrijev sulfat in kalijev sulfat, ter ob izraženi zaskrbljenosti zaradi končnega poročila študije PASS skupina CMDh meni, da je razmerje med koristmi in tveganji zgoraj navedenih zdravil nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the scientific conclusions are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni končnega poročila odrejene neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet (PASS) za zdravila, ki vsebujejo učinkovine magnezijev sulfat heptahidrat, brezvodni natrijev sulfat in kalijev sulfat, in jih zadeva končno poročilo te študije, so bili sprejeti naslednji znanstveni zaključki:
Annex II Conditions of Marketing Authorisation
Pogoji dovoljenja (dovoljenj) za promet z zdravilom
Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate concerned by the non-interventional imposed PASS final report
Spremembe pogojev dovoljenja (dovoljenj) za promet z zdravili, ki vsebujejo učinkovine magnezijev sulfat heptahidrat, brezvodni natrijev sulfat in kalijev sulfat, in jih zadeva končno poročilo odrejene neintervencijske študije PASS Imetnik (imetniki) dovoljenja za promet z zdravilom mora (morajo) izbrisati naslednji pogoj (naslednje pogoje) (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo prečrtano):
• if you have any type of cancer.
• če imate katerokoli vrsto raka.
Prevention or treatment of graft-versus-host disease (GVHD).
Preprečevanje ali zdravljenje reakcije presadka proti prejemniku (angl. graft-versus-host disease, GVHD).
In a small percentage of patients these changes are more marked and may be of clinical significance.
Pri majhnem odstotku bolnikov so te spremembe bolj izrazite in so lahko klinično pomembne.
Paediatric population Interaction studies have only been performed in adults.
Pediatrična populacija Interakcijske študije so izvajali samo pri odraslih.
This will get rid of any large air bubbles.
S tem boste odstranili večje mehurčke zraka.
For severe rash, the treatment usually lasts for 8 weeks.
Za zdravljenje hude oblike izpuščaja traja zdravljenje običajno 8 tednov.
• if you have epilepsy.
• če imate epilepsijo,
PHARMACEUTICAL FORM AND CONTENTS Capsule, soft [To be completed nationally]
FARMACEVTSKA OBLIKA IN VSEBINA kapsula, mehka [izpolni država članica]
Increases in temperatures up to 30°C for a total maximum of 3 months do not affect the quality of the product.
Shranjevanje pri višji temperaturi do 30 °C največ 3 mesece ne vpliva na kakovost zdravila.
However, other drinks, such as soft drinks, can be used accordingly to individual taste.
Mogoče je uporabiti tudi druge brezalkoholne pijače po okusu posameznika.
Stir and drink the whole contents of the glass straight away.
Premešajte in takoj spijte celotno vsebino kozarca.
• if you need to have a vaccination.
• če morate prejeti cepivo.
Two, 4 and 8 weeks after the switch, renal function and blood pressure should be monitored.
2, 4 in 8 tednov po prehodu je treba preveriti ledvično funkcijo in krvni tlak.
Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Previdnostni ukrepi potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Za navodila glede redčenja zdravila pred dajanjem, glejte poglavje 6.6.
In addition the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Ustrezna kategorija pogostnosti pri posameznem neželenem učinku temelji na naslednjem dogovoru (CIOMS III): zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1.000, < 1/100); redki (≥ 1/10.000, < 1/1.000); zelo redki (< 1/10.000); pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
If the renal function (except for proteinuria) is normal, the recommended daily dose is the following: - adults: 5 mg/kg - children: 6 mg/kg
Če je ledvična funkcija normalna (razen proteinurije), je priporočen naslednji dnevni odmerek: - odrasli: 5 mg/kg - otroci: 6 mg/kg
Sandimmun Neoral with food and drink
Sandimmun Neoral skupaj s hrano in pijačo