natgillin/translations-raw huggingface dataset:
Onset of immunity: 21 days after completion of the primary vaccination scheme Duration of immunity: 12 months after completion of the primary vaccination scheme 4.3 Contraindications
Trajanje imunosti: 12 mesecev po končanem osnovnem cepljenju.
Cardboard box with one type II glass vial of either 100 ml (containing 50 doses) or 240 ml (containing 120 doses) with a chlorobutyl rubber stopper and aluminium cap.
Kartonasta škatla z vialo iz stekla tipa tipa II s klorobutilnim zamaškom in aluminijasto zaporko, ki vsebuje 100 ml (50 odmerkov) ali 240 ml (120 odmerkov cepiva).
Lactation:
Laktacija :
Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap.
Kartonasta škatla z vialo iz stekla tipa I s klorobutilnim zamaškom in aluminijasto zaporko, ki vsebuje 20 ml (10 odmerkov cepiva).
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
RP* ≥ 1 * Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
Adjuvant:
Dodatka:
The entire content of the bottle should be used immediately after broaching and during the same procedure.
Takoj po odpiranju porabite naenkrat celotno vsebino viale.
STATEMENT OF ACTIVE SUBSTANCES Per dose of 2 ml
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2011
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
4 mg
4 mg saponin
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) Zoetis Manufacturing & Research Spain, S.L.
The use in lactating animals is therefore not recommended.
Uporaba cepiva ni priporočljiva v obdobju laktacije.
Adcetris 50 mg Powder for concentrate for solution for infusion
50 mg Prašek za koncentrat za raztopino za infundiranje
The European Commission granted a marketing authorisation valid throughout the European Union for Holoclar on 17 February 2015.
Evropska komisija je dovoljenje za promet z zdravilom Holoclar, veljavno po vsej Evropski uniji, izdala 17. februarja 2015.
Other information about Holoclar
Druge informacije o zdravilu Holoclar
What measures are being taken to ensure the safe and effective use of Holoclar?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Holoclar?
This is a summary of the European public assessment report (EPAR) for Holoclar.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Holoclar.
Holoclar is intended for a single treatment, although treatment can be repeated if the doctor considers it necessary.
Zdravilo Holoclar je namenjeno za enkratno zdravljenje, ki pa ga je mogoče ponoviti, če zdravnik presodi, da je to potrebno.
The company is to provide data on the benefits and risks of Holoclar from a prospective clinical study.
Družba mora zagotoviti podatke o koristih in tveganjih zdravila Holoclar iz prospektivne klinične študije.
In the first stage of treatment, a small part of healthy limbal tissue (1−2 mm2 in size) is taken from the patient in hospital and sent to the manufacturer on the same day.
V prvi fazi zdravljenja se bolniku v bolnišnici odvzame delček zdravega limbusnega tkiva (velikosti 1−2 mm2), ki se še isti dan pošlje proizvajalcu.
A risk management plan has been developed to ensure that Holoclar is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Holoclar je bil pripravljen načrt obvladovanja tveganj.
The summary of the opinion of the Committee for Orphan Medicinal Products for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Holoclar je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
As the side effects of Holoclar treatment are generally manageable, the CHMP concluded that Holoclar's benefits outweigh its risks and recommended that it be approved for use in the EU.
Ker so neželeni učinki zdravila Holoclar na splošno obvladljivi, je CHMP zaključil, da so koristi zdravila Holoclar večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
There were also reductions in patients' symptoms, such as pain and inflammation, and improvements in vision.
Poleg tega so pri bolnikih opazili ublažitev simptomov, kot sta bolečina in vnetje, ter izboljšanje vida.
What is Holoclar and what is it used for?
Kaj je zdravilo Holoclar in za kaj se uporablja?
Because the number of patients with limbal stem-cell deficiency due to burns to the eyes is low, the disease is considered ‘rare', and Holoclar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Ker je bolnikov s pomanjkanjem limbusnih matičnih celic zaradi opekline očesa malo, velja ta bolezen za redko, zato je bilo zdravilo Holoclar 7. novembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Next, the cells in the tissue are grown in a laboratory and frozen until the date of surgery is confirmed.
Celice v tkivu se nato vzgojijo v laboratoriju in zamrznejo do potrjenega datuma kirurškega posega.
The Committee noted that that moderate to severe forms of limbal stem-cell deficiency are serious conditions which, if untreated, can lead to severe reduction or complete loss of vision.
Odbor je opozoril, da so zmerne do hude oblike pomanjkanja limbusnih matičnih celic hude okvare, ki lahko, če se ne zdravijo, privedejo do hudega zmanjšanja ali popolne izgube vida.
What are the risks associated with Holoclar?
Kakšna tveganja so povezana z zdravilom Holoclar?
It is not intended to provide practical advice on how to use Holoclar.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Holoclar has therefore been given ‘conditional approval'.
Zdravilo Holoclar je zato pridobilo „pogojno dovoljenje za promet“.
What benefits of Holoclar have been shown in studies?
Kakšne koristi je zdravilo Holoclar izkazalo v študijah?
Why is Holoclar approved?
Zakaj je bilo zdravilo Holoclar odobreno?
The conclusion on the benefit-risk balance of Holoclar is based on results of two retrospective studies (using past medical records), and the company is to provide further data from a prospective study (that records outcomes during the course of the study).
Opredelitev razmerja med koristmi in tveganji pri zdravilu Holoclar temelji na rezultatih dveh retrospektivnih študij (ob uporabi zdravniških izvidov iz preteklosti), družba pa mora zagotoviti nadaljnje podatke iz prospektivne študije (pri kateri se beležijo rezultati tekom študije).
Patients with this condition do not have enough limbal stem cells which normally act as a regeneration system, replenishing the outer corneal cells when they get damaged and when they age.
Bolniki s to okvaro nimajo dovolj limbusnih matičnih celic, ki običajno delujejo kot regeneracijski sistem in nadomeščajo zunanje roženične celice, ko se te poškodujejo in ko se starajo.
Following the surgery, the patient should receive antibiotics and an appropriate antiinflammatory medicine.
Po kirurškem posegu je treba bolniku dajati antibiotike in ustrezno protivnetno zdravilo.
One year after Holoclar implantation, 75 out of 104 patients studied (72%) were judged to have had successful implants based on the presence of stable corneal surface with no surface defects and little or no ingrown blood vessels (a common feature of limbal stem-cell deficiency).
Eno leto po vsaditvi zdravila Holoclar se bili vsadki ocenjeni kot uspešni pri 75 od 104 (72 %) bolnikov, ki so bili obravnavani v študiji, merilo učinkovitosti pa je bil obstoj stabilne površine roženice brez okvar na površini in malo ali nič vraščenih krvnih žil (pogosta značilnost pomanjkanja limbusnih matičnih celic).
In addition, the company that makes Holoclar will provide healthcare professionals with educational material on the safe use of this treatment, including on the selection and follow-up of patients and on reporting side effects.
Poleg tega bo družba, ki izdeluje zdravilo Holoclar, zdravstvenim delavcem priskrbela izobraževalno gradivo o varni uporabi tega zdravila, ki bo vključevalo tudi informacije o izbiri in spremljanju bolnikov ter o poročanju o neželenih učinkih.
It consists of cells taken from the patient's limbus (at the edge of the cornea) and then grown in a laboratory so that they can be used to repair the damaged corneal surface.
Vsebuje celice, ki se odvzamejo iz bolnikovega limbusa (na robu roženice) in se nato vzgojijo v laboratoriju, da bi jih lahko uporabili za popravilo poškodovane površine roženice.
Holoclar is a type of advanced therapy product called a ‘tissue engineered product'.
Zdravilo Holoclar spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila, izdelana s tkivnim inženirstvom“.
The full EPAR and risk management plan summary for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Holoclar sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What information is still awaited for Holoclar?
Katere informacije o zdravilu Holoclar še pričakujemo?
Holoclar ex vivo expanded autologous human corneal epithelial cells containing stem cells
Holoclar ex vivo ekspandiran avtologen humani roženični epitelij, ki vsebuje matične celice
The most common side effect with Holoclar (seen in more than 1 patient in 10) is blepharitis (inflammation of the eye lid).
Najpogostejši neželeni učinek zdravila Holoclar (ki lahko prizadene več kot 1 osebo od 10) je blefaritis (vnetje očesne veke).
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo zdravilo Holoclar učinkovito pri ponovni vzpostavitvi zdrave površine roženice pri bolnikih z zmernim ali hudim pomanjkanjem limbusnih matičnih celic zaradi opekline ter pri izboljšanju njihovih simptomov in vida.
Holoclar must only be used by an appropriately trained and qualified eye surgeon in a hospital, and must only be given to the patient whose limbal cells were used to manufacture the medicine.
Zdravilo Holoclar lahko uporablja le ustrezno izšolan in usposobljen očesni kirurg v bolnišnici, daje pa se lahko le tistemu bolniku, katerega limbusne celice so bile uporabljene za izdelavo zdravila.
Holoclar, comprising the cells and the membrane, is then sent back to the hospital, where it is immediately surgically implanted in the patient's eye.
Zdravilo Holoclar, ki je sestavljeno iz celic in membrane, se nato pošlje nazaj v bolnišnico, kjer se nemudoma kirurško vsadi v bolnikovo oko.
It is used in adult patients with moderate to severe limbal stem-cell deficiency caused by burns, including chemical burns, to the eyes.
Uporablja se pri odraslih bolnikih z zmernim do hudim pomanjkanjem limbusnih matičnih celic zaradi opekline očesa, vključno s kemično opeklino.
Educational material will also be provided to patients undergoing treatment.
Izobraževalno gradivo bodo prejeli tudi bolniki, ki bodo zdravljeni z zdravilom Holoclar.
Once implanted in the eye, the corneal cells of Holoclar help to replace the corneal surface, while the limbal stem cells serve as a reservoir of new cells that continuously replenish the cornea.
Ko se vsadijo v oko, roženične celice v zdravilu Holoclar pomagajo nadomestiti površino roženice, medtem ko limbusne matične celice služijo kot rezervoar za nove celice, ki nenehno obnavljajo roženico.
For more information about treatment with Holoclar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Holoclar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Holoclar, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Holoclar in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For practical information about using Holoclar, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Holoclar naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Before Holoclar is used, the damaged corneal surface tissue of the affected eye is removed.
Pred uporabo zdravila Holoclar se iz očesa odstrani poškodovano tkivo na površini roženice.
Thawed cells are used to make Holoclar by growing them on a membrane made of a protein called fibrin.
Odtaljene celice se uporabijo za izdelavo zdravila Holoclar, tako da se vzgojijo na membrani iz beljakovine, imenovane fibrin.
How does Holoclar work?
Kako zdravilo Holoclar deluje?
Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar.
Ker je zdravilo Holoclar pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila nadaljnje podatke o tem zdravilu.
The active substance in Holoclar is the patient's own limbal cells, which include cells from the surface of the cornea and limbal stem cells grown in a laboratory.
Zdravilna učinkovina zdravila Holoclar so bolnikove lastne limbusne celice, ki vključujejo celice s površine roženice in limbusne matične celice, vzgojene v laboratoriju.
Holoclar is a stem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part).
Zdravilo Holoclar vsebuje matične celice in se uporablja v očesu za nadomestitev poškodovanih celic na površini (epiteliju) roženice, tj. prozorne plasti v sprednjem delu očesa, ki prekriva šarenico (obarvani del).
How is Holoclar used?
Kako se zdravilo Holoclar uporablja?
Antibiotics to prevent eye infection should be given to patients after limbal tissue has been taken from them.
Po odstranitvi limbusnega tkiva je treba bolniku dajati antibiotike, da se prepreči okužba očesa.
Holoclar was shown to be effective in restoring a stable corneal surface in patients with moderate or severe limbal stem-cell deficiency caused by burns in a retrospective study using patients' past medical records.
Zdravilo Holoclar se je v retrospektivni študiji, v kateri so uporabili zdravniške izvide bolnikov iz preteklosti, izkazalo za učinkovito pri ponovnem vzpostavljanju stabilne površine roženice pri bolnikih z zmernim ali hudim pomanjkanjem limbusnih matičnih celic zaradi opekline.
International Non-proprietary Name (INN): cytarabine
Mednarodno nelastniško ime (INN): citarabin
The evaluation was finished and the CHMP would have given a negative opinion.
Ocenjevanje je bilo takrat končano, CHMP pa bi podal negativno mnenje.
They had concerns with the way the data were analysed.
Zadržki so se nanašali na način analize podatkov.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preizkušanje ali program sočutne uporabe ter potrebujete več podatkov o vašem zdravljenju, se obrnite na zdravnika, ki vam je zdravljenje predpisal.
The letter from the Company notifying the EMEA of the withdrawal of DepoCyte is available here.
Dopis, s katerim je podjetje obvestilo EMEA o umiku zdravila DepoCyte, je na voljo tukaj.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF APPLICATION FOR A VARIATION OF MARKETING AUTHORISATION for DEPOCYTE
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET za zdravilo DEPOCYTE
Cytarabine has been used as an anti-cancer medicine since the 1970s.
Citarabin je v uporabi kot zdravilo proti raku že od 1970-ih dalje.
There are no consequences for DepoCyte's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.
Omenjeno nima posledic za uporabo zdravila DepoCyte za indikacije, za katere je bilo zdravilo že odobreno in pri katerih ostajajo koristi in tveganja nespremenjeni.
DepoCyte helps control the symptoms of the disease.
Zdravilo DepoCyte pomaga obvladovati simptome bolezni.
The studies measured how long it would take before the disease would progress.
Raziskavi sta merili čas do napredovanja bolezni.
Following CHMP opinion, it usually takes around 6 weeks for the European Commission to update the licence.
Ko CHMP poda mnenje, Evropska komisija v približno 6 tednih posodobi dovoljenje.
The company has informed the CHMP that the decision has no consequences for patients enrolled in clinical trials or compassionate use programmes.
Podjetje je obvestilo CHMP, da odločitev nima posledic za bolnike, ki so vključeni v klinična preizkušanja ali programe sočutne uporabe.
The company presented the results of two studies, involving 164 patients with solid tumour neoplastic meningitis.
Podjetje je predstavilo izsledke dveh raziskav, ki sta zajemali 164 bolnikov z neoplastičnim meningitisom zaradi trdnega tumorja.
On 28 June 2006, SkyePharma PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for DepoCyte 50 mg suspension for injection, in the intrathecal treatment of solid tumour neoplastic meningitis.
Podjetje SkyePharma PLC je 28. junija 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo DepoCyte 50 mg suspenzijo za injiciranje, ki se uporablja pri intratekalnem zdravljenju neoplastičnega meningitisa zaradi trdnega tumorja.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DepoCyte?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila DepoCyte?
DepoCyte was to be injected intrathecally.
Zdravilo DepoCyte naj bi se vbrizgavalo intratekalno.
The CHMP had concerns that the studies presented by the Company had not sufficiently shown that Depocyte was as effective as, or more effective than intrathecal methotrexate.
CHMP je imel zadržke, da raziskave, ki jih je predstavilo podjetje, niso v zadostni meri dokazale, da je zdravilo DepoCyte enako ali bolj učinkovito kot intratekalni metotreksat.
DepoCyte is a suspension for injection that contains 50 mg of the active substance cytarabine.
Zdravilo DepoCyte je suspenzija za injiciranje, ki vsebuje 50 mg zdravilne učinkovine citarabin.
What is happening for DepoCyte for the treatment of lymphomatous meningitis?
Kaj to pomeni za nadaljnjo uporabo zdravila DepoCyte za zdravljenje limfomatoznega meningitisa?
The application was at Day 90 when the Company withdrew.
Podjetje je umaknilo vlogo na 90. dan postopka.
DepoCyte is injected directly into the nervous system, in the space between the lining of the spinal cord and brain (intrathecal injection).
Zdravilo DepoCyte se vbrizga naravnost v živčni sistem, v prostor med ovojnice hrbtenjače in možganov (intratekalno vbrizgavanje).
Therefore, at the time of the withdrawal, the CHMP's view was that it had not been shown that the benefits of DepoCyte in the treatment of solid tumour neoplastic meningitis were greater that its risks.
Zato je bil v času umika vloge CHMP mnenja, da ni bilo dokazano, da so koristni učinki zdravila DepoCyte pri zdravljenju neoplastičnega meningitisa zaradi trdnega tumorja večji od z njim povezanih tveganj.
DepoCyte was compared with methotrexate (another anti-cancer medicine), both medicines being administered intrathecally.
V njih so zdravilo DepoCyte primerjali z zdravilom metotreksat (prav tako zdravilo proti raku), obe zdravili pa sta bili dajani intratekalno.
Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that DepoCyte could not be approved for the intrathecal treatment of solid tumour neoplastic meningitis.
Na podlagi podatkov na razpolago v času umika je imel CHMP zadržke in bil začasnega mnenja, da zdravilo DepoCyte ne more biti odobreno za intratekalno zdravljenje neoplastičnega meningitisa zaradi trdnega tumorja.
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group of anti-metabolites.
Zdravilo je citotoksin (zdravilo, ki ubija deleče se celice, kakršne so rakaste celice), ki spada v skupino antimetabolitov.
What was DepoCyte expected to be used for?
Za kaj naj bi se zdravilo DepoCyte uporabljalo?
DepoCyte contains cytarabine in a special formulation: the active substance is contained in liposomes (small fatty particles) from which it is slowly released.
Zdravilo DepoCyte vsebuje citarabin v posebni formulaciji: zdravilna učinkovina se nahaja v liposomih (majhnih maščobnih delcih), iz katerih se počasi sprošča.
DepoCyte was to be used in the treatment of solid tumour neoplastic meningitis: this is a disease where cancer cells, originally from a solid tumour (such as lung or breast cancer), spread to the membranes of the nervous system.
Zdravilo DepoCyte je bilo namenjeno za uporabo pri zdravljenju neoplastičnega meningitisa zaradi trdnega tumorja: pri tej bolezni se rakaste celice, ki izvirajo iz trdnega tumorja (kot npr. rak pljuč ali dojke), razširijo na membrane živčnega sistema.
London, 29 June 2006 Doc.Ref.
London, 29.06.06 Sklic dok.
The active substance in DepoCyte, cytarabine, is an anti-cancer agent.
Zdravilna učinkovina v zdravilu DepoCyte, citarabin, je učinkovina proti raku.
How is DepoCyte expected to work?
Kako naj bi zdravilo DepoCyte delovalo?
DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the membranes that surround the nervous system (meninges).
Zdravilo DepoCyte se uporablja za zdravljenje limfomatoznega meningitisa: to je stanje, v katerem so se tumorske celice limfoma razširile na membrane, ki obdajajo živčni sistem (meninge).
06 August 2014
6. avgust 2014
The European Commission issued a decision on 06 August 2014.
Evropska komisija je izdala odločbo dne 6. avgusta 2014.
This is a procedure where one European country (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the ‘concerned Member States', in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden).
To je postopek, v katerem ena evropska država („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih evropskih državah („zadevnih državah članicah“, v tem primeru na Danskem, Finskem, Irskem, v Luksemburgu, na Nizozemskem, Norveškem, v Španiji in na Švedskem).
On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate).
Evropska agencija za zdravila je dne 22. maja 2014 zaključila arbitražni postopek po nestrinjanju med državami članicami Evropske unije (EU) glede odobritve zdravila Dexamed (deksamfetaminijev sulfat).
Why was Dexamed reviewed?
Zakaj je bilo zdravilo Dexamed pregledano?