natgillin/translations-raw huggingface dataset:
On 9 March 2017, Viridian Pharma Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Blectifor, for the prevention of bronchopulmonary dysplasia.
Družba Viridian Pharma Ltd je 9. marca 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Blectifor, namenjenim preprečevanju bronhopulmonalne displazije.
The active substance in Blectifor, caffeine citrate, is a stimulant of the nervous system and is currently authorised in the EU as Peyona for the treatment of a breathing disorder called primary apnoea in
Zdravilna učinkovina zdravila Blectifor, kofeinijev citrat, je spodbujevalec živčnega sistema in je trenutno odobrena v EU kot zdravilo Peyona, namenjeno zdravljenju motnje dihanja, imenovane primarna apneja pri nedonošenčkih.
In addition, caffeine citrate may also have other effects in the lungs, such as reducing inflammation, which are expected to prevent the damage that leads to bronchopulmonary dysplasia.
Poleg tega ima kofeinijev citrat morda še druge učinke na pljuča, kot je na primer zmanjševanje vnetja, kar naj bi preprečilo poškodbe, ki privedejo do bronhopulmonalne displazije.
It was to be available as a solution for injection, which can also be given by mouth.
Na voljo naj bi bilo v obliki raztopine za injiciranje, ki se lahko daje tudi peroralno.
In these babies, the continuous high pressure and high concentration of the oxygen supplied through mechanical ventilation may cause inflammation and injury to the lungs and prevent normal development of the alveoli (air sacs in the lungs).
Pri teh dojenčkih lahko stalen visok tlak in visoka koncentracija kisika, ki se dovaja z mehanskim predihavanjem, povzročita vnetje in poškodbe pljuč ter preprečita normalen razvoj alveolov (pljučnih mešičkov).
Additionally, the facility designated to test the stability of Blectifor was not certified to comply with good manufacturing practices (GMP).
Poleg tega ustanova, kjer so preskušali stabilnost zdravila Blectifor, ni imela certifikata skladnosti z dobro proizvodno prakso.
The company presented data from the published scientific literature mainly on the use of caffeine citrate for the treatment of primary apnoea in premature babies; several articles also provided data on the development of bronchopulmonary dysplasia in these patients.
Družba je predložila podatke iz objavljene znanstvene literature, zlasti o uporabi kofeinijevega citrata za zdravljenje primarne apneje pri nedonošenčkih; podatki o razvoju bronhopulmonalne displazije pri teh bolnikih pa so na voljo v številnih člankih.
The Committee considered that the role of caffeine citrate in the prevention of the disease had not been sufficiently demonstrated, and no definite conclusion on the effect of caffeine citrate for the prevention of bronchopulmonary dysplasia could be drawn.
Odbor je ocenil, da vloga kofeinijevega citrata pri preprečevanju te bolezni ni bila dovolj dokazana in da ni mogoče podati dokončnih zaključkov o učinku kofeinijevega citrata na preprečevanje bronhopulmonalne displazije.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 March 2017 EMA/188385/2017 EMEA/H/C/004100
marec 2017 EMA/188385/2017 EMEA/H/C/004100
What was Blectifor expected to be used for?
Za kaj naj bi se zdravilo Blectifor uporabljalo?
Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Blectifor (kofeinijev citrat)
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Blectifor.
Zato je odbor CHMP ob umiku vloge menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Blectifor.
Blectifor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2014 for the prevention of bronchopulmonary dysplasia.
Zdravilo Blectifor je bilo dne 11. aprila 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za preprečevanje bronhopulmonalne displazije.
Blectifor was expected to be used to prevent bronchopulmonary dysplasia, a lung disease affecting premature babies who have been on prolonged mechanical ventilation (using a machine that supplies oxygen to support breathing).
Zdravilo Blectifor naj bi se uporabljalo za preprečevanje bronhopulmonalne displazije, tj. bolezni pljuč, ki prizadene nedonošenčke, ki so bili na dolgotrajnem mehanskem predihavanju (s pomočjo aparata, ki dovaja kisik in podpira dihanje).
Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that, based on the data submitted by the company, Blectifor could not have been approved for the prevention of bronchopulmonary dysplasia.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da na podlagi podatkov, ki jih je predložila družba, zdravila Blectifor ni mogoče odobriti za preprečevanje bronhopulmonalne displazije.
What is Blectifor?
Kaj je zdravilo Blectifor?
In the prevention of bronchopulmonary dysplasia, caffeine citrate is expected to act mainly by stimulating the part of the brain that controls breathing, which is thought to help babies breathe on their own and reduce the time spent on mechanical ventilation.
citrat deloval predvsem tako, da naj bi spodbudil del možganov, ki nadzoruje dihanje, kar naj bi dojenčkom pomagalo pri samostojnem dihanju in skrajšalo čas mehanskega predihavanja.
How does Blectifor work?
Kako zdravilo Blectifor deluje?
170 mg Nebuliser solution Inhalation use ampoule (LDPE)
170 mg inhalacijska raztopina za nebulator za inhaliranje ampula (PE) 1,7 ml
56 ampoules + 1 administration device
56 ampul x 1 pripomoček za aplikacijo
After opening: 3 hours.
Po odpiranju: 3 ure.
Thereby the following instructions should be used:
Upoštevati je treba naslednja navodila:
Member State/EEA
Država članica/EEA
This was regarded as the worst case scenario using the most susceptible animals.
To je najslabši možni scenarij, ki vključuje najbolj občutljive živali.
The inactivated vaccine is a suspension for injection.
Inaktivirano cepivo je suspenzija za injiciranje.
The marketing authorisation holder has complied with these requirements with the design of this study.
Imetnik dovoljenja za promet z zdravilom je te zahteve izpolnil z zasnovo te študije.
1210 Wien Austria
1210 Dunaj Avstrija
3) the minimum efficacious titre is 4.0 TCID50
3) najmanjši učinkovit titer je 4,0 TCID50
The animals return to normal the next day.
Pri vseh živalih se naslednji dan zniža na normalno vrednost.
Agualva-Cacém Portugal
Agualva-Cacém Portugalska
The specific claims for finishing pigs to improve the rearing results have not been demonstrated.
Specifične zahteve za prašiče, ki se redijo za zakol, glede izboljšanja rezultata pri vzreji niso bile dokazane.
ADVERSE REACTIONS
NEŽELENE REAKCIJE
2) the apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
2) očitno zmanjšanje po 1 uri iz titra ob sprostitvi (6,4/6,2 TCID50) je 0,12/-0,02
2.3 Potential impact on the efficacy parameter of duration of immunity due to an interference caused by mixing of the two products.
2.3 Potencialni vpliv na parameter učinkovitosti „trajanje imunosti“ zaradi interference, ki jo povzroči mešanje obeh zdravil.
Given that a lack of interference has been demonstrated a specific time point the duration of immunity remains the same as originally proven.
Ker je bilo dokazano pomanjkanje medsebojnih vplivov, ostaja specifična časovna točka trajanja imunosti enaka, kot je bila dokazana na začetku.
The general claim to reduce viraemia has only been demonstrated in laboratory studies.
Splošna zahteva (zmanjšanje viremije) je bila dokazana le v laboratorijskih študijah.
In isolated cases hypersensitivity reactions may occur.
Možni so posamični primeri preobčutljivostnih reakcij.
1) the claimed in-use shelf life for the “mixed” product is one hour;
1) predlagani rok uporabnosti „mešanega“ zdravila je ena ura;
Following the absence of agreement between the Reference Member State (the United Kingdom acted on behalf of France as the Reference Member State in a work-sharing arrangement) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Ker ni bilo strinjanja med referenčno državo članico (Združeno kraljestvo je delovalo v imenu Francije kot referenčna država članica v dogovoru o delitvi dela) in eno od zadevnih držav članic (Španija) na 90. dan postopka, ki ga je pripravila Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini, je bila zadeva dne 2. oktobra 2009 napotena na CVMP.
Koerverstraat 35 5831 AN Boxmeer The Netherlands
5831 AN Boxmeer Nizozemska
Before using the vaccine allow it to reach room temperature (15-25C) and shake well before use.
Cepivo pred uporabo ogrejemo na sobno temperaturo (15-25 °C) in ga dobro pretresemo.
and EU guidelines require safety studies to use animals which are seronegative for the antigens of the vaccine components.
Evropska farmakopeja in smernice EU zahtevajo, da se študije varnosti izvedejo z živalmi, ki so seronegativne za antigene komponent cepiva.
The marketing authorisation holder has demonstrated that there is no immunological interference when the vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Imetnik dovoljenja za promet z zdravilom je dokazal, da ni imunološkega medsebojnega vpliva ob mešanju cepiv, kar pomeni, da se ohrani ista raven učinkovitosti ob preučevanju enega parametra učinkovitosti „zmanjšanje viremije“ (zmanjšanje za 70-75 % po sočasni uporabi in zmanjšanje za 72-75 % po samostojni uporabi zdravila Porcilis PRRS).
After mixing with Porcilis PRRS: 1 hour (at room temperature)
Po mešanju s Porcilisom PRRS: 1 uro (pri sobni temperaturi)
CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) (Smernica CVMP glede podatkov za podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini med njihovo uporabo)http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
The first injection can be given from an age of 1 week onwards.
Prvi odmerek lahko dajemo od starosti 1 tedna naprej.
For simultaneous use with Porcilis PRRS in finishing pigs from 4 weeks of age (3 weeks after priming) the vaccine may be used for reconstitution shortly before vaccination.
Pri sočasni uporabi s Porcilisom PRRS pri prašičih pitancih po starosti 4 tednov (3 tedne po prvem cepljenju), lahko cepivo uporabimo za rekonstitucijo tik pred cepljenjem.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS M HYO (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PORCILIS M HYO (GLEJTE DODATEK I)
The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis M Hyo in the framework of Article 6 of Commission Regulation (EC) No 1084/2003.
Imetnik dovoljenja za promet z zdravilom Intervet International BV je predložil vlogo za spremembo tipa II, ki jo ureja postopek z medsebojnim priznavanjem za dovoljenja za promet z zdravilom Porcilis M Hyo za uporabo v veterinarski medicini v okviru člena 6 Uredbe Komisije (ES) št. 1084/2003.
A transient swelling/redness (max. diameter 5 cm) may occur at the injection site diminishing over a period of maximally 14 days.
Na mestu injiciranja se lahko pojavi prehodna oteklina ali rdečina (premera največ 5 cm), ki se po največ 14 dneh zmanjša.
However the argumentation provided by the marketing authorisation holder to date raises some concerns that by mixing the products some of the efficacy claims for the monovalent products would not be achieved.
Vendar pa utemeljitev, ki jo je doslej predložil imetnik dovoljenja za promet z zdravilom, zbuja določene pomisleke, da z mešanjem zdravil nekatere zahteve učinkovitosti monovalentnih zdravil ne bi bile izpolnjene.
The proposed vaccination scheme for the mixed product is:
Predlagana shema cepljenja za mešano zdravilo:
The National Competent Authority of Spain was concerned that some aspects regarding the quality, safety and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified.
Nacionalni pristojni organ Španije je izrazil zaskrbljenost, da nekateri vidiki kakovosti, varnosti in učinkovitosti po mešanju obeh zdravil (Porcilis PRRS in Porcilis M Hyo) niso bili ustrezno utemeljeni.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
O varnosti in učinkovitosti sočasne uporabe tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini, razen z zgoraj navedenim, ni podatkov.
The guideline on data requirements to support in-use stability claims for veterinary vaccines*, states that “For inactivated vaccines, if the proposed in-use shelf-life is within one working day (maximum 10 hours) it is acceptable to omit the potency testing from the in-use shelf-life stability study.”
Smernica o zahtevah glede podatkov v podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini med njihovo uporabo*, navaja, da je „pri inaktiviranih cepivih v primeru, da je predlagan rok uporabnosti krajši od enega delovnega dne (največ 10 ur), sprejemljivo, da se v študiji stabilnosti roka uporabnosti test jakosti izpusti“.
The marketing authorisation holder examined the repeated administration of a single dose of each vaccine administered simultaneously at an interval of 14 days in animals of 4 weeks of age.
Imetnik dovoljenja za promet z zdravilom je proučeval ponovitve enkratnih odmerkov posameznega cepiva, dajanega sočasno v intervalu 14 dneh pri živalih, starih 4 tedne.
4.6 Adverse reactions (frequency and seriousness) A mean transient temperature increase in body temperature of about 0.3C, in individual pigs up to 2.0C, may occur on the first 1 to 2 days after vaccination.
4.6 Neželeni učinki (pogostost in resnost) Dan ali dva po cepljenju se lahko prehodno poveča telesna temperatura, povprečno za približno 0,3 °C, pri nekaterih prašičih do 2,0 °C.
It is indicated for finishing pigs from 1 week of age.
Indicirano je za prašiče, ki se redijo za zakol, stare od 1 tedna dalje.
2.2 Justification regarding the approach followed to demonstrate the safety of the individual vaccination schemes when the two products are administered together.
2.2 Utemeljitev pristopa, ki je služil za dokaz varnosti posameznih shem cepljenja pri sočasni uporabi obeh zdravil.
It should be administered intramuscularly (2 ml in the neck).
Zdravilo je treba dajati v mišico (2 ml v vrat).
Intervet PortugalSaúde Animal, Lda
Portugalska Intervet PortugalSaúde Animal, Lda Rua Agualva dos
While it was suggested that the provided data was not adequate because the animals had not received a single M Hyo vaccination at 1 week of age within the design of this study and therefore the safety of the overall schedule was unproven, the marketing authorisation holder has proven the worst case scenario of a repeated dose of simultaneous vaccination with the two vaccines in susceptible animals (seronegative) of the minimum age.
Medtem ko je veljalo prepričanje, da predlagani podatki niso ustrezni, saj živali niso prejele enkratnega odmerka cepiva Porcilis M Hyo v starosti 1 tedna v skladu z zasnovo te študije, zaradi česar je ostala varnost celotne sheme odmerjanja nedokazana, je imetnik dovoljenja za promet z zdravilom dokazal najslabši možni scenarij ponovitev odmerkov pri sočasni uporabi obeh cepiv pri občutljivih (seronegativnih) živalih minimalne starosti.
Nevertheless absence of immunological interference has not been inferred but has been clearly demonstrated by providing laboratory challenge data which showed that there is not significant difference in protection between animals vaccinated with the mixed products and those vaccinated with single products.
Odsotnost imunološkega medsebojnega vpliva ni bila rezultat sklepanja, temveč je bila jasno dokazana s predloženimi podatki iz dodatne laboratorijske študije, ki so pokazali, da ni bistvene razlike med zaščito živali, ki so bile cepljene z mešanim zdravilom, in živali, ki so prejele samo eno cepivo.
Pigs should be vaccinated twice with a 3 week interval.
Prašiče je treba cepiti dvakrat v intervalu 3 tednov.
Safety and efficacy data are available in pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis PRRS.
Na voljo so podatki o varnosti in učinkovitosti pri prašičih od 4 tednov starosti, ki dokazujejo, da lahko cepivo mešamo s cepivom Porcilis PRRS.
In addition, it is considered that potency of the Porcilis M Hyo component after mixing should have been analysed in order to the exclude a quality interference right after mixing (at t=0) and after the proposed in-use shelf life.
Poleg tega velja, da bi bilo treba analizirati jakost komponente Porcilis M Hyo po mešanju, da bi bilo mogoče izključiti vpliv na kakovost neposredno po mešanju (pri času t=0) in po izteku predlaganega roka uporabnosti mešanice.
Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae and dl--tocopherol acetate as adjuvant.
Porcilis M Hyo je imunološko zdravilo za uporabo v veterinarski medicini, ki vsebuje Mycoplasma hyopneumoniae in dl-α-tokoferolacetat kot adjuvans.
Since the protective immunity against lung lesion score is not altered by the mixed administration, the marketing authorisation holder considered that all the other efficacy parameters will also not be altered, and therefore, no more data are required in support of the duration of immunity for the mixed administration.
Ker dajanje mešanega cepiva ne spremeni zaščitne imunosti proti izidu lezije pljuč, je imetnik dovoljenja za promet z zdravilom menil, da tudi noben drug parameter učinkovitosti ne bo spremenjen, zato niso potrebni nadaljnji podatki za podporo trajanja imunosti ob dajanju mešanega cepiva.
6.2 Incompatibilities Do not mix with any other veterinary medicinal product except with Porcilis PRRS.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s Porcilisom PRRS.
GROUNDS FOR THE GRANTING OF THE VARIATION OF THE MARKETING AUTHORISATIONS
PODLAGA ZA ODOBRITEV SPREMEMBE DOVOLJENJ ZA PROMET
The marketing authorisation holder considered that, based on the “Guideline on requirements for concurrent administration of immunological veterinary medicinal products*, the efficacy data of the individual products, including duration of immunity, can be applied for the concurrent use of them if absence of immunological interference is demonstrated.
Imetnik dovoljenja za promet z zdravilom je menil, da je na podlagi „Smernice glede zahtev za sočasno uporabo imunoloških zdravil za uporabo v veterinarski medicini“* podatke o učinkovitosti posameznih zdravil, vključno s trajanjem imunosti, mogoče uporabiti za sočasno uporabo teh zdravil, če je dokazana odsotnost imunološkega medsebojnega vpliva.
The efficacy studies using appropriate challenges for Porcilis M Hyo and Porcilis PRRS have shown that there is no affect of simultaneous administration on the efficacy parameters of reduced viraemia and a reduction in lung lesions.
Študije učinkovitosti, ki so vključevale ustrezne izzive za zdravili Porcilis M Hyo in Porcilis PRRS, so pokazale, da sočasna uporaba ne vpliva na parametra učinkovitosti „zmanjšanje viremije“ in „zmanjšanje lezij pljuč“.
This is at three weeks after the first injection with Porcilis M Hyo which is to be given from one week of age onwards.
To je tri tedne po prvi injekciji zdravila Porcilis M Hyo, ki se daje od starosti enega tedna dalje.
Data on laboratory efficacy studies and on one field study were provided showing that the reduction of lung lesion score of pigs vaccinated with the mixed product is similar to the reduction of lung lesion score of pigs vaccinated with Porcilis M Hyo alone.
Predloženi so bili podatki iz študij laboratorijske učinkovitosti in ene terenske študije, ki so pokazali, da je zmanjšanje izida pri leziji pljuč pri prašičih, ki so prejeli mešano cepivo, podobno zmanjšanju izida pri leziji pljuč pri prašičih, ki so prejeli samo cepivo Porcilis M Hyo.
The youngest age for the two products to be used simultaneously is thus four weeks of age.
Sočasna uporaba obeh zdravil je tako mogoča od starosti štirih tednov dalje.
List of the names, pharmaceutical forms, strengths of the Veterinary medicinal product, animal species, routes of administration, withdrawal period, marketing authorisation holders in the Member states
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV
The marketing authorisation holder has presented data on safety studies (single dose, overdose, repeated dose) starting at 4 weeks of age with Porcilis PRRS mixed with Porcilis M Hyo, considering that 4 weeks is the youngest age recommended for the administration of the mixed product.
Imetnik dovoljenja za promet z zdravilom je predložil podatke iz študij varnosti (posamezen odmerek, preveliko odmerjanje, ponavljanje odmerkov) od starosti 4 tednov dalje za mešanico zdravil Porcilis PRRS in Porcilis M Hyo ob upoštevanju, da je starost 4 tednov najmanjša priporočljiva starost za dajanje mešanega zdravila.
A single dose (2 ml) of Porcilis M Hyo mixed with Porcilis PRRS is given intramuscularly in the neck.
Enkratni odmerek (2 ml) Porcilisa M Hyo, pomešanega s Porcilisom PRRS, damo intramuskularno na vratu.
Vaccinate pigs twice with a three week interval.
Prašiče cepimo dvakrat v presledku treh tednov.
Porcillis M.Hyo
PORCILIS M. HYO
- First vaccination: Porcilis M Hyo at 1 week of age.
- prvo cepljenje: Porcilis M Hyo pri starosti 1 tedna.
Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl--tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Za zdravilo Porcilis M Hyo je imetnik dovoljenja za promet z zdravilom predložil podatke o vsebini adjuvansa (dl-α-tokoferolacetat), vrednosti pH in sterilnosti mešanice po rekonstituciji dveh serij zdravila Porcilis PRRS v dveh serijah zdravila Porcilis M Hyo po 3 urah hranjenja pri sobni temperaturi.
4.9 Amounts to be administered and administration route Intramuscular injection in pigs of 2 ml per animal in the neck in the area behind the ear.
Intramuskularno prašičem po 2 ml za eno žival v vrat v predel za ušesom.
The marketing authorisation holder was requested to justify why the proposed vaccination scheme (Porcilis M Hyo at 1 week of age and Porcilis M Hyo mixed with Porcilis PRRS at 4 weeks of age) was not followed to show the safety of the mixed administration.
Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj utemelji, zakaj ni upošteval predlagane sheme cepljenja (Porcilis M Hyo pri starosti 1 tedna ter mešanica zdravil Porcilis M Hyo in Porcilis PRRS pri starosti 4 tednov), da bi bilo mogoče pokazati varnost mešanega zdravila.