natgillin/translations-raw huggingface dataset:
- The recommended dose of vinflunine is 200 mg/m² given once every 3 weeks in patients with moderate liver impairment (Child-Pugh grade B) or in patients with a prothrombin time ≥ 50% NV and bilirubin > 3×ULN and transaminases > ULN and GGT > ULN.
- pri bolnikih z zmerno okvaro jeter (stopnja B po Child-Pugh-u) ali pri bolnikih s protrombinskim časom ≥ 50% NV in bilirubinom > 3×ZMNR in transaminazami > ZMNR in GGT > ZMNR, je priporočeni odmerek vinflunina 200 mg/m², enkrat na vsake tri tedne.
Unopened vials
OVOJNINAH NALEPKA NA VIALI
In case of any Grade ≥ 3 gastrointestinal toxicity (except vomiting or nausea) or of mucositis (Grade 2 for 5 days or more or Grade ≥ 3 of any duration) dose adjustment is required.
stopnje ≥3 ali mukozitisa (stopnje 2, ki traja 5 dni ali več oz. stopnje ≥3, ne glede na trajanje).
Decreased appetite Common Dehydration
Presnovne in prehranske motnje zelo pogosti hiponatremija Zmanjšan apetit pogosti dehidracija
For further cycles the dose should be adjusted in the event of toxicities (see section 4.2).
Ob pojavu toksičnosti morate v naslednjih ciklih zdravljenja odmerek zmanjšati (glejte poglavje 4.2).
One 10 mL vial contains 250 mg of vinflunine (as ditartrate).
Ena viala z 10 ml zdravila vsebuje 250 mg vinflunina (v obliki ditartrata).
The recommended dose should be reduced in patients with haematological toxicity (see section 4.2).
Pri bolnikih s hematološko toksičnostjo stopnje>3 je treba priporočeni odmerek zmanjšati (glejte poglavje 4.2).
Patients with renal impairment
Bolniki z največjo stopnjo po NCI
Initiation of vinflunine is contraindicated in subjects with baseline ANC < 1,500/mm3 or platelets < 100,000/mm3.
Vinflunina ne smete dajati bolnikom s številom AŠN <1.500/mm3 ali trombocitov <100.000/mm3 Nadaljevanje dajanja vinflunina je kontraindicirano pri bolnikih z izhodiščnim AŠN <1.000/mm3 ali s trombociti < 100.000//mm3.
One mL of concentrate contains 25 mg of vinflunine (as ditartrate).
En ml koncentrata vsebuje 25 mg vinflunina (v obliki ditartrata).
In the two multi-centre open-label, single-arm phase II clinical trials a total of 202 patients were treated with vinflunine.
faze brez kontrolne skupine so z vinfluninom zdravili 202 bolnika.
Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Javlor 25 mg/ml koncentrat za raztopino za infundiranje vinflunin
Javlor 25 mg/mL concentrate for solution for infusion
Javlor 25 mg/ml koncentrat za raztopino za infundiranje
vincristine, vindesine, vinorelbine), - if you have had (in the last 2 weeks) or currently have a severe infection, - if you are breast-feeding, - if your levels of white blood cells and/or platelets are too low
- če ste nedavno (v zadnjih 2 tednih) imeli hudo okužbo ali če takšna okužba še poteka, - če dojite,
Paediatric population There is no relevant use of Javlor in the paediatric population.
Uporaba zdravila za zdravljenje otrok - Ni relevantne indikacije za uporabo zdravila Javlor za zdravljenje otrok.
Your doctor will adjust the starting dose of Javlor based on your age and physical conditions and in specific situations: - if you had a previous irradiation of the pelvis - if you have moderate or severe kidney problems - if you have liver problems.
V specifičnih okoliščinah bo vaš zdravnik glede na vašo starost in telesno stanje prilagodil začetni odmerek zdravila Javlor:
See leaflet
Redčena raztopina
Common Dyspnoea Cough
Začetni odmerek vinflunina
In particular, you should tell your doctor if you are taking medicines containing any of the following active substances: - ketoconazole and itraconazole, used to treat fungal infection, - opioids, used to treat pain, - ritonavir, used to treat HIV infection, - doxorubicin and pegylated liposomal doxorubicin, used to treat some kinds of cancer, - rifampicin, used to treat tuberculosis or meningitis, - herbal preparation containing hypericum perforatum (St John's wort) used to treat minor to moderate depression.
- doksorubicin in pegelirani liposomski doksorubicin, ki se uporablja za zdravljenje določenih vrst raka, - rifampicin, ki se uporablja za zdravljenje tuberkuloze in meningitisa,
The recommended dose should be reduced in patients with moderate or severe renal impairment (see section 4.2).
Pri bolnikih z zmerno ali hudo okvaro ledvic morate zmanjšati priporočeni odmerek (glejte poglavje 4.2).
One 2 mL vial contains 50 mg of vinflunine (as ditartrate).
Ena viala z 2 ml zdravila vsebuje 50 mg vinflunina (v obliki ditartrata).
Very common Weight decreased Uncommon Transaminases increased Weight increased aadverse reactions reported from post-marketing experience bfrequency calculated on the basis of non-TCCU clinical trial
Preiskave zelo pogosti zmanjšanje telesne mase občasni zvišana vrednost transaminaz povečanje telesne mase aNeželeni učinki poročani v obdobju trženja.
The veins of the hand dorsum and those close to joints should be avoided.
• Če je možno, ne uporabite ven hrbtišča dlani ali ven v bližini sklepov.
Discontinuation of vinflunine should be considered in patients who develop cardiac ischaemia.
Če se pri bolniku pojavi srčna ishemija, morate preučiti možnost prekinitve zdravljenja z zdravilom Javlor.
- Discontinuation
Izločanje
Adequate monitoring of complete blood counts should be conducted to verify the ANC, platelet and haemoglobin values before each vinflunine infusion (see section 4.3).
Pred vsakim infundiranjem vinflunina je treba opraviti zadostno preverjanje popolne krvne slike s kontrolo vrednosti AŠN, trombocitov in hemoglobina.
- abdominal pain, nausea, vomiting - constipation, diarrhoea - inflammation of the mucosa of the mouth - tiredness, muscle pain - lack of sense of touch - weight decrease, decrease of appetite - loss of hair - reactions at injection site (pain, redness, swelling) - fever - low levels of white blood cells, red blood cells and/or platelets (seen in blood test) - low levels of blood sodium (hyponatraemia).
- zmanjšanje telesne mase, zmanjšan apetit, - izpadanje las, - reakcije na mestu injiciranja (bolečina, pordelost, otekanje), - zvišana telesna temperatura,
• After the infusion is completed, the remaining 250 mL from the sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion bag should be run at a flowing rate of 300 mL/h.
9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze 50 mg/ml (5 %) za infundiranje s pretokom 300 ml/h.
Neutropenia, leucopenia, anaemia and thrombocytopenia are frequent adverse reactions of vinflunine.
Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija levkopenija anemija trombocitopenija pogosti febrilna nevtropenija
Javlor MUST ONLY be administered intravenously.
Zdravilo Javlor MORATE uporabiti intravensko.
Patients with hepatic impairment
Psihiatrične motnje pogosti nespečnost
• A venous access should be established for a 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for infusion, on a large vein preferably in the upper part of the forearm or using a central venous line.
• Na veliki veni, najbolje na zgornjem delu podlakti, ali s centralnim venskim katetrom pripravite venski dostop za 500-mililitrsko vrečo raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali raztopine glukoze 50 mg/ml (5 %) za infundiranje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA
Very common Asthenia/Fatigue Injection site reaction Pyrexia
Splošne težave in spremembe na mestu aplikacije zelo pogosti astenija/utrujenost reakcija na mestu injiciranja pireksija pogosti bolečine v prsnem košu mrazenje bolečine edem občasni ekstravazacija
Neoplasm benign, malignant and unspecified
Benigne, maligne in neopredeljene novotvorbe občasni tumorska bolečina
Gastrointestinal disorders Very common Constipation
Bolezni imunskega sistema pogosti preobčutljivost
The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine should be mixed in a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion.
V 100-mililitrsko vrečo raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje vmešajte količino zdravila Javlor (koncentrata), ki ustreza izračunanemu odmerku vinflunina.
Cardiovascular disorders
Bolezni srca in ožilja
Recommended co-medication
NAČIN IZDAJANJA ZDRAVILA
Package Leaflet: Information for the user Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Navodilo za uporabo Javlor 25 mg/ml koncentrat za raztopino za infundiranje vinflunin
Bronchospam was reported in one patient treated with vinflunine for a different setting from the indication.
Pri bolniku, ki je prejemal vinflunin, vendar ne zaradi indikacije zdravila Javlor, se je pojavil bronhospazem.
For subsequent administrations, vinflunine is contraindicated in subjects with baseline ANC < 1,000/mm3 or platelets < 100,000/mm3.
V študijah reprodukcije so ugotovili, da ima vinflunin embrioletalne in teratogene učinke, zlasti pri kuncih v odmerkih nad 1,3 mg/kg (14,3 mg/m²).
Uncommon Tumour pain
občasni nevtropenična sepsa
Doctors and patients must be aware of this possibility.
Zdravniki in bolniki se morajo te možnosti zavedati.
This medicine is the same as Puregon, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Puregon, ki je že odobreno v Evropski uniji (EU).
The European Commission granted a marketing authorisation valid throughout the European Union for Fertavid on 19 March 2009.
Evropska komisija je dovoljenje za promet z zdravilom Fertavid, veljavno po vsej Evropski uniji, odobrila dne 19. marca 2009.
The full EPAR for Fertavid 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) za zdravilo Fertavid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Fertavid
Druge informacije o zdravilu Fertavid
This is a summary of the European public assessment report (EPAR) for Fertavid.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fertavid.
The patient or their partner may carry out the injections.
Injiciranje lahko izvedejo bolniki sami ali njihovi partnerji.
It must not be used in men with testicular failure.
Ne smejo ga uporabljati moški z odpovedjo testisov.
Fertavid is given as an injection under the skin or into a muscle.
Zdravilo Fertavid se daje z injekcijo pod kožo ali v mišico.
The dose and frequency of administration of Fertavid depend on its use (see above) and the patient's response to treatment.
Odmerjanje in pogostnost dajanja zdravila Fertavid sta odvisna od načina uporabe (glejte zgoraj) in bolnikovega odziva na zdravljenje.
• women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation);
• pri ženskah z anovulacijo (ki ne proizvajajo jajčec) in ženskah, ki se niso odzvale na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja ovulacijo);
The number of eggs recovered and the ongoing pregnancy rate were the main measures of effectiveness.
Glavni merili učinkovitosti sta bili število nastalih jajčec ter število doseženih in potekajočih nosečnosti.
For more information about treatment with Fertavid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Fertavid preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Fertavid's use in women undergoing fertility treatment has been studied in 981 patients.
Uporaba zdravila Fertavid pri ženskah, ki se zdravijo zaradi neplodnosti, je bila raziskana pri 981 bolnicah.
Fertavid can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Zdravilo Fertavid se prav tako lahko uporablja za spodbujanje proizvajanja semenčic pri moških, ki imajo hipogonadotropni hipogonadizem (redka bolezen pomanjkanja hormonov).
Fertavid was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Zdravilo Fertavid so proučevali pri 172 ženskah brez ovulacije, merili pa so, koliko ciklov zdravljenja so potrebovale, da je prišlo do ovulacije.
What benefit has Fertavid shown during the studies?
Kakšne koristi je zdravilo Fertavid izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fertavid.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Fertavid, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Treatment with Fertavid should be carried out by a doctor who has experience in the treatment of fertility problems.
Zdravljenje z zdravilom Fertavid mora izvajati zdravnik z izkušnjami na področju zdravljenja neplodnosti.
In the body, FSH regulates reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
V telesu FSH uravnava funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec, pri moških pa nastajanje semenčic v modih.
Fertavid should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients.
Zdravila Fertavid ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) na folitropin beta ali katero koli drugo sestavino zdravila.
Fertavid can only be obtained with a prescription.
Zdravilo Fertavid se dobi samo na recept.
Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Sindrom hiperstimulacije jajčnikov se pojavi, če je odziv jajčnikov na zdravljenje pretiran.
The CHMP decided that Fertavid's benefits are greater than its risks and recommended that Fertavid be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Fertavid večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
• women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation).
• pri ženskah, ki se zdravijo zaradi neplodnosti (postopki asistirane reprodukcije, kot je oploditev in vitro).
In all of the studies, Fertavid was compared with the natural FSH hormone that was extracted from urine.
Pri vseh študijah so zdravilo Fertavid primerjali z naravnim hormonom FSH, pridobljenim iz urina.
Fertavid is administered to stimulate the ovaries to produce more than one egg at a time.
Zdravilo Fertavid se daje za spodbujanje delovanja jajčnikov, da bi v njih nastalo več kot eno jajčece hkrati.
In 4% of the women treated with Fertavid in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported.
Pri štirih odstotkih žensk, ki so v kliničnih študijah prejemale zdravilo Fertavid, so poročali o znakih in simptomih, podobnih sindromu hiperstimulacije jajčnikov (kot so občutek slabosti, povečanje telesne mase, driska).
Fertavid must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Zdravila Fertavid ne smejo uporabljati bolniki s tumorjem jajčnikov, dojk, maternice, testisov, hipofize ali hipotalamusa.
What is the risk associated with Fertavid?
Kakšna tveganja so povezana z zdravilom Fertavid?
Previously, the FSH used as a medicine was extracted from urine.
V preteklosti so v medicini uporabljali FSH, pridobljen iz urina.
In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding.
Pri ženskah se ne sme uporabljati pri odpovedi jajčnikov, povečanju jajčnikov ali prisotnosti cist, ki niso posledica policističnega obolenja jajčnikov, ali pri krvavitvi iz nožnice.
In men, Fertavid was studied to see its effect on sperm production in 49 patients.
Pri moških so vpliv zdravila Fertavid na proizvajanje sperme proučevali pri 49 bolnikih.
Fertavid is used to treat infertility in women in the following situations:
Zdravilo Fertavid se uporablja za zdravljenje neplodnosti v naslednjih primerih:
Fertavid should only be administered by people who have been trained by the doctor and have access to expert advice.
Zdravilo Fertavid lahko dajejo samo osebe, ki jih je za to usposobil zdravnik in ki imajo možnost posvetovati se s strokovnjakom.
The most common side effects with Fertavid are a reaction and pain at the injection site.
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Fertavid, so reakcije in bolečine na mestu injiciranja.
Fertavid is a solution for injection that contains the active substance follitropin beta.
Zdravilo Fertavid je raztopina za injiciranje, ki vsebuje zdravilno učinkovino folitropin beta.
The company that makes Puregon has agreed that its scientific data can be used for Fertavid.
Družba, ki izdeluje zdravilo Puregon, je privolila, da se znanstveni podatki tega zdravila uporabljajo tudi za zdravilo Fertavid.
For a full list of all side effects reported with Fertavid, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fertavid, glejte navodilo za uporabo.
Why has Fertavid been approved?
Zakaj je bilo zdravilo Fertavid odobreno?
Fertavid was as effective as the comparator in all of the studies.
V vseh študijah je bilo zdravilo Fertavid enako učinkovito kot primerjalno zdravilo.
EPAR summary for the public follitropin beta
folitropin beta
The active substance in Fertavid, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Zdravilna učinkovina zdravila Fertavid, folitropin beta, je posnetek naravnega hormona FSH (folikle stimulirajočega hormona).
Fertavid was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Zdravilo Fertavid je bilo pri zdravljenju neplodnosti, spodbujanju ovulacije in nastajanju sperme enako učinkovito kot FSH, pridobljen iz urina.
How has Fertavid been studied?
Kako je bilo zdravilo Fertavid raziskano?
For a full description of the doses, see the package leaflet.
Za celoten opis odmerjanja glejte navodilo za uporabo.
What is Fertavid used for?
Za kaj se zdravilo Fertavid uporablja?
The follitropin beta in Fertavid is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Folitropin beta, ki ga vsebuje zdravilo Fertavid, je pridobljen z metodo, imenovano „tehnologija rekombinantne DNK“,.
How is Fertavid used?
Kako se zdravilo Fertavid uporablja?
How does Fertavid work?
Kako zdravilo Fertavid deluje?
What is Fertavid?
Kaj je zdravilo Fertavid?
What you need to know before you take [x]
Kaj morate vedeti, preden boste vzeli zdravilo [x]
• Oral contraception
• Peroralna kontracepcija
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu bodo morda pristojni organi držav članic v sodelovanju z referenčno državo članico kasneje posodobili v skladu s postopki, določenimi v poglavju 4 naslova III Direktive 2001/83/ES.
The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Obstoječe informacije o zdravilu je treba spremeniti (vstaviti, nadomestiti ali izbrisati besedilo, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj.
The decision to prescribe [x] should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [x] compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Pri odločitvi za predpisovanje zdravila [x] je treba upoštevati že obstoječe dejavnike tveganja pri posamezni ženski, predvsem dejavnike tveganja za vensko trombembolijo (VTE - venous thromboembolism), in kakšno je tveganje za VTE z zdravilom [x] v primerjavi s tveganjem pri drugih kombiniranih hormonskih kontraceptivih (CHC - combined hormonal contraceptives) (glejte poglavji 4.3 in 4.4).
What [x] is and what it is used for
Kaj je zdravilo [x] in za kaj ga uporabljamo
Annex III Amendments to relevant sections of the Product Information
Priloga III Dopolnitev ustreznih poglavij v informacijah o zdravilu
C. Package Leaflet This wording regarding the acne indication should be revised to read as follows:
C. Navodilo za uporabo To besedilo glede indikacije za akne je treba spremeniti tako, da se glasi:
Women should be assessed 3-6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
3 - 6 mesecev po začetku zdravljenja in nato ponovno v rednih časovnih presledkih je treba oceniti, če ženska potrebuje nadaljnje zdravljenje.
These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Ta dopolnitev ustreznih poglavij informacij o zdravilu je bila dogovorjena v postopku napotitve.
Amendments to relevant sections of the Product Information
Dopolnitev ustreznih poglavij v informacijah o zdravilu
o For treatment of women with moderate acne who agree to receive a contraceptive pill after failure of suitable local or oral antibiotic treatments.
• Zdravljenje zmerno hudih aken pri ženskah, ki so se odločile za uporabo peroralnega kontraceptiva in pri katerih ustrezno lokalno zdravljenje ali peroralno zdravljenje z antibiotiki ni bilo uspešno.
You should discuss with your doctor the need to continue your treatment three to six months after the start and regularly thereafter.
Tri do šest mesecev po začetku zdravljenja se posvetujte z zdravnikom, če je potrebno zdravljenje nadaljevati in nato se z njim ponovno posvetujte v rednih časovnih presledkih.
Your acne will usually improve between three and six months of treatment, and could continue to improve even after six months.
Do izboljšanja aken običajno pride v treh do šestih mesecih zdravljenja.
Section 4.1 Therapeutic indications The acne indication should be revised to read as follows:
Poglavje 4.1 Terapevtske indikacije
Apparent improvement of acne usually takes at least three months and further improvement has been reported after six months of treatment.
V zvezi z indikacijo za akne je treba spremeniti odmerjanje tako, da se doda naslednje besedilo: Do očitnega izboljšanja aken običajno pride po treh mesecih.
[x] is a medicinal product o to prevent pregnancy (contraceptive “pill”).
[x] je zdravilo o za preprečevanje nosečnosti (“kontracepcijske tablete”), o za zdravljenje žensk z zmerno hudimi aknami, ki so se odločile za uporabo kontracepcijskih tablet in pri katerih ustrezno lokalno ali peroralno zdravljenje z antibiotiki ni bilo uspešno.
The applicant was requested to provide the following information:
Odbor je od predlagatelja zahteval naslednje podatke:
Ireland considers that, due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Irska meni, da zaradi pomanjkanja dokumentacije o učinkovitosti ni možno domnevati, da je zdravilo učinkovito in zaradi tega predstavlja možno resno tveganje za zdravje živali.
The applicant submitted written responses to the List of Questions on 10 January 2008 and the clock was re-started.
Predlagatelj je 10. januarja 2008 predložil pisne odgovore na seznam vprašanj in ura se je ponastavila.
A List of Questions was adopted by CVMP and sent to the applicant on 12 December 2007.
CVMP je sprejel seznam vprašanj ter jih predlagatelju poslal 12. decembra 2007.