natgillin/translations-raw huggingface dataset:
Acute kidney injury, renal failure 
Akutna okvara ledvic, odpoved ledvic
• high blood pressure, flushing 
• zvišan krvni tlak, rdečica,
Hazard ratiob (95% CI) 
(95 % IZ)
Conjunctival haemorrhage, dry eye 
Konjunktivalne krvavitve, suho oko
How to store Trecondi 
Kako dajemo zdravilo Trecondi
The volume of distribution in adult patients is about 20-30 litres. 
Porazdelitveni volumen pri odraslih bolnikih je okrog
Not known Hypoxia 
Neznana Hipoksija
Cardiac arrest, cardiac failure, myocardial infarction, pericardial effusion 
Zastoj srca, miokardni infarkt
• fluid around the lung (pleural effusion), inflammation of throat, inflammation of or pain in voice box, cough, hiccups 
• tekočina okrog pljuč (plevralni izliv), vnetje žrela, vnetje ali bolečina v grlu, kašelj, kolcanje,
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution. 
Za intravensko uporabo po rekonstituciji.
Maculo-papular rash, purpura, erythema, palmar-plantar erythrodysaesthesia syndrome, pruritus, alopecia 
eritem, sindrom palmarno-plantarne eritrodizestezije, pruritus, alopecija
Precautions to be taken before handling or administering the medicinal product When handling treosulfan, inhalation, skin contact or contact with mucous membranes should be avoided. 
Pri ravnanju s treosulfanom se izogibajte vdihavanju, stiku s kožo in stiku s sluznicami.
Infections (bacterial, viral, fungal) 
Pogosti Infekcije (bakterijske, virusne,
Not known Treatment-related second malignancy 
Druga maligna bolezen, povezana z zdravljenjem
Very common Stomatitis/mucositis, nausea 
Zelo pogosti Stomatitis/mukozitis, navzea
• mouth pain, inflammation of the stomach, upset stomach, constipation, difficulty in swallowing 
• bolečina v ustih, vnetje želodca, vznemirjen želodec, zaprtje, oteženo požiranje,
• kidney failure, inflammation of the urinary bladder (cystitis), pain on passing urine (dysuria) 
• odpoved ledvic, vnetje sečnika (cistitis), bolečina pri odvajanju vode (dizurija),
• headache, sensation of tingling, pricking or numbness (paraesthesia), seizure 
• glavobol, občutek mravljinčenja, zbadanja ali odrevenelosti (parestezije), epileptični napad,
Dyspnoea, pleural effusion, pharyngeal or laryngeal inflammation 
Dispnea, plevralni izliv, faringitis ali laringitis
Not known Chills, fatigue, pain 
Mrzlica, utrujenost, bolečina
• liver failure, enlarged liver, liver pain 
• odpoved jeter, zvečana jetra, bolečina v jetrih,
Extensive chronic GvHDa; % (95% CI) 18.4 (12.0, 24.8) 26.1 (19.2, 33.1) 0.1099 a Up to 2 years after alloHSCT 
Obsežna kronična GvHDa; % (95 % IZ) 18,4 (12,0; 24,8) 26,1 (19,2; 33,1) 0,1099
Maculo-papular rash, purpura, erythema 
Makulopapularni izpuščaj, purpura,
Pneumonitis, pleural effusion, pharyngeal or laryngeal inflammation, cough, laryngeal pain, hiccups 
Pnevmonitis, plevralni izliv, faringitis ali laringitis, kašelj,
There was a significant association between age and respiratory toxicity in paediatric patients treated with treosulfan-based conditioning. 
Bolezni dihal, prsnega koša in mediastinalnega prostora Pri pediatričnih bolnikih, zdravljenih s kondicioniranjem na podlagi treosulfana, obstaja značilna povezava med starostjo in toksičnostjo za dihala.
The frequencies of adverse reactions reported in the table below are derived from 5 clinical trials (including a total of 564 patients) where treosulfan combined with fludarabine was investigated as conditioning treatment prior to alloHSCT in adult patients. 
(v katera je bilo vključenih skupaj 564 bolnikov), v katerih so raziskovali treosulfan v kombinaciji s fludarabinom kot pripravljalno zdravljenje pred alloHSCT pri odraslih bolnikih.
b 
Pb
• skin ulcer, a type of rash with red spots and sometimes with purple or blistered areas in the centre (erythema multiforme), hives, skin condition with fluid-filled blisters (dermatitis bullous), acne, hand and foot syndrome (palms of the hands or soles of the feet tingle, become numb, painfully swollen, or red), nappy rash with ulceration in the area surrounding the anus 
• razjeda kože, vrsta izpuščaja z rdečimi pegami in včasih s škrlatnimi ali mehurjastimi predeli v sredini (multiformni eritem), koprivnica (urtikarija), bolezen kože z mehurji, napolnjenimi s tekočino (bulozni dermatitis), akne, sindrom dlani in stopal (dlani ali stopala srbijo, odrevenijo,
Infections and infestations* Very common Infections (bacterial, viral, fungal) 
Zelo pogosti Infekcije (bakterijske, virusne,
Very common Myelosuppression, pancytopenia 
Zelo pogosti Mielosupresija, pancitopenija
Sepsisa 
Mukozitis
Cardiac disorders* Common Cardiac arrhythmias (e.g. atrial fibrillation, sinus arrhythmia) 
Občasni Srčne aritmije (npr. atrijska fibrilacija, sinusna aritmija) Neznana
Hepatobiliary disorders 
hepatotoksičnost
Common Dyspnoea, epistaxis 
Pogosti Dispnea, epistaksa
• inflammation of the lining of various parts of the body, especially in the mouth (which can cause ulcers), diarrhoea, nausea, vomiting, belly (abdominal) pain 
• vnetje sluznice v različnih delih telesa, posebno v ustih (kjer lahko povzroči razjede), driska,
• throat pain, nosebleeds 
• bolečina v žrelu, krvavitve iz nosu,
Generalised erythema, dermatitis, skin necrosis or ulcer, skin hyperpigmentationd, dry skin 
kožna nekroza ali razjeda, hiperpigmentacija kožed, suha koža
Uncommon Hypertension 
Hipertenzija Neznana
Renal and urinary disorders Not known Acute kidney injury, renal failure, noninfective cystitis 
Akutna okvara ledvic, odpoved ledvic, neinfektivni cistitis
• difficulty in swallowing, mouth pain 
Disfagija, bolečina v ustih
• decrease of kidney function, kidney failure, inflammation of the urinary bladder (cystitis) 
• zmanjšano delovanje ledvic, odpoved ledvic, vnetje sečnika (cistitis),
Five cases of a second malignancy (myelodysplastic syndrome, acute lymphoblastic leukaemia, Ewing's sarcoma) were reported by other investigators after treosulfan-based conditioning. 
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Drugi raziskovalci so po kondicioniranju na podlagi treosulfana poročali o petih primerih druge maligne bolezni (mielodisplastični sindrom, akutna limfoblastna levkemija, Ewingov sarkom).
Cardiac disorders 
Srčne bolezni*
* See detailed sections below a Clinically or microbiologically documented infection with grade 3 or 4 neutropenia (absolute neutrophil count [ANC] < 1.0 x 109/L) and sepsis b Acidosis might be a consequence of the release of methanesulfonic acid through treosulfan activation/cleavage in the plasma c Case reports (> 2) after treosulfan-based conditioning obtained from other sources d Bronze pigmentation e Fever in the absence of neutropenia where neutropenia is defined as ANC < 1.0 x 109/L 
a Klinično ali mikrobiološko dokumentirana infekcija z nevtropenijo stopnje 3 ali 4 (absolutno število nevtrofilcev [absolute neutrophil count - ANC] < 1,0 x 109/l) in sepsa.
Neutropenic colitis, anal inflammation, dyspepsia, proctitis, gastrointestinal pain, constipation 
Nevtropenični kolitis, analno vnetje, dispepsija, proktitis,
Trecondi 1 g powder for solution for infusion Colourless type III glass vial, with rubber stopper and aluminium cap containing 1 g of treosulfan. 
Viala iz neobarvanega stekla tipa III z gumijastim zamaškom in aluminijasto zaporko, ki vsebuje 1 g treosulfana.
Gastrointestinal haemorrhage, neutropenic colitis 
Krvavitev v prebavila, nevtropenični kolitis
Pain in extremities, back pain, bone pain, arthralgia, myalgia Not known 
Bolečine v udih, bolečina v križu, bolečine v kosteh, artralgija, mialgija
Trecondi 5 g powder for solution for infusion Colourless type III glass vial, with rubber stopper and aluminium cap containing 5 g of treosulfan. 
Viala iz neobarvanega stekla tipa III z gumijastim zamaškom in aluminijasto zaporko, ki vsebuje 5 g treosulfana.
Very common Pyrexiac 
Zelo pogosti Pireksijac
• Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0). 
• Fludarabin 30 mg/m² BSA na dan v obliki polurne intravenske infuzije, ki jo dajemo pet zaporednih dni (dnevi -6, -5, -4, -3, -2) pred infuzijo matičnih celic (dan 0).
Uncommon Haematoma, hypotension 
Hematom, hipotenzija Neznana
• headache, dizziness 
• glavobol, omotica,
• a type of rash with flat or raised red bumps on the skin (maculopapular rash), red spots on the skin (purpura), redness of skin (erythema), hand and foot syndrome (palms of the hands or soles of the feet tingle, become numb, painfully swollen, or red), itching, hair loss 
rdeče pege na koži (purpura), rdečina kože (eritem), sindrom dlani in stopal (dlani ali stopala srbijo, odrevenijo, boleče otečejo ali pordečijo), srbenje, izguba las,
• chills, tiredness, pain 
• mrzlica, utrujenost, bolečina,
• increased liver enzymes, increased C-reactive protein (a marker of inflammation in the body), 
• zastajanje tekočine v telesu, ki povzroči otekline (edeme), zvišana telesna temperatura, mrzlica, • zvišani jetrni encimi, zvišan C-reaktivni protein (označevalec vnetja v telesu), zvečanje telesne mase, zmanjšanje telesne mase.
• Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -4, -3, -2) before stem cell infusion (day 0). 
• Treosulfan 10 g/m² telesne površine (body surface area - BSA) na dan v obliki dveurne intravenske infuzije, ki jo dajemo tri zaporedne dni (dnevi -4, -3, -2) pred infuzijo matičnih celic (dan 0).
• pain in arms or legs, back pain, bone pain, joint pain, muscle pain 
• bolečine v zgornjih ali spodnjih udih, bolečine v križu, kosteh, sklepih, mišicah,
• Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -7, -6, -5, -4, -3) before stem cell infusion (day 0). 
• Fludarabin 30 mg/m² telesne površine na dan v obliki polurne intravenske infuzije, ki jo dajemo pet zaporednih dni (dnevi -7, -6, -5, -4, -3) pred infuzijo matičnih celic (dan 0).
Pain in extremities 
Bolečine v udih
Very common Asthenic conditions (fatigue, asthenia, lethargy) 
Astenična stanja (utrujenost, astenija,
Trecondi 5 g powder for solution for infusion One vial contains 5 g of treosulfan. 
Trecondi 5 g prašek za raztopino za infundiranje Ena viala vsebuje 5 g treosulfana.
Trecondi 1 g powder for solution for infusion 1 vial contains 1 g of treosulfan. 
Trecondi 1 g prašek za raztopino za infundiranje 1 viala vsebuje 1 g treosulfana.
• enlarged liver, liver damage 
• zvečana jetra, okvara jeter,
• pain in arms or legs 
• bolečina v zgornjih ali spodnjih udih,
• Treosulfan 10-14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0). 
• Treosulfan 10-14 g/m² telesne površine (body surface area - BSA) na dan v obliki dveurne intravenske infuzije, ki jo dajemo tri zaporedne dni (dnevi -6, -5, -4) pred infuzijo matičnih celic (dan 0).
What Trecondi looks like and contents of the pack White crystalline powder in a glass vial with a rubber stopper and aluminium cap. Trecondi is available in packs containing 1 or 5 vials (type III glass). 
Izgled zdravila Trecondi in vsebina pakiranja Bel kristalen prašek v stekleni viali z gumijastim zamaškom in aluminijasto zaporko.
Trecondi 5 g powder for solution for infusion 1 vial contains 5 g of treosulfan. 
Trecondi 5 g prašek za raztopino za infundiranje 1 viala vsebuje 5 g treosulfana.
Number of patients Overall survivala; % (95% CI) 71.3 (63.6, 
Število bolnikov Celotno preživetjea; % (95 % IZ) 71,3 (63,6; 77,6) 56,4 (48,4; 63,6) 0,61 (0,42; 0,88) 0,0082
Dermatitis exfoliative, maculo-papular rash, rash, erythema, pain of skin, skin hyperpigmentationb, alopecia 
makulopapularni izpuščaj, izpuščaj, eritem, bolečina v koži, hiperpigmentiranost kožeb,
Trecondi 1 g powder for solution for infusion One vial contains 1 g of treosulfan. 
Trecondi 1 g prašek za raztopino za infundiranje Ena viala vsebuje 1 g treosulfana.
The total treosulfan dose is 30-42 g/m²; The dose of treosulfan should be adapted to the patient's BSA as follows (see section 5.2): 
Odmerek treosulfana moramo prilagoditi bolnikovi telesni površini kot sledi (glejte poglavje 5.2):
Gastrointestinal disorders* Very common Stomatitis/mucositis, diarrhoea, nausea, vomiting, abdominal pain 
Bolezni prebavil* Zelo pogosti Stomatitis/mukozitis, driska, navzea,
• Thiotepa (intensified regimen5 mg/kg twice a day), given as two intravenous infusions over 2 
• Tiotepa (intenzivirana shema 5 mg/kg dvakrat na dan) v obliki dveh intravenskih infuzij v času 2-4 ur na dan -2 pred infuzijo matičnih celic (dan 0).
Not known Skin necrosis 
Nekroza kože
• gastrointestinal bleeding, inflammation of the colon, inflammation of the gullet, inflammation of the anus, mouth ulcer 
• krvavitev v prebavilih, vnetje debelega črevesa, vnetje požiralnika, vnetje zadnjika (anusa),
• Treosulfan 14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0). 
• Treosulfan 14 g/m² telesne površine (body surface area - BSA) na dan v obliki dveurne intravenske infuzije, ki jo dajemo tri zaporedne dni (dnevi -6, -5, -4) pred infuzijo matičnih celic (dan 0).
NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion treosulfan 
Trecondi 1 g prašek za raztopino za infundiranje Trecondi 5 g prašek za raztopino za infundiranje treosulfan
Vascular disorders 
Nevtropenični kolitis
A very low penetration of blood-brain-barrier by treosulfan was observed in rats. 
Pri podganah so ugotovili, da treosulfan zelo slabo penetrira skozi krvno-možgansko pregrado.
Uncommon Confusional state 
Stanje zmedenosti Neznana
Nervous system disorders* Not known Headache, paraesthesia, seizure 
Neznana Glavobol, parestezije,
• difficulty breathing, nosebleeds 
• oteženo dihanje, krvavitve iz nosu,
NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion 
Trecondi 1 g prašek za raztopino za infundiranje Trecondi 5 g prašek za raztopino za infundiranje
Peripheral sensory neuropathy Not known 
Občasni Periferna senzorična nevropatija
Oral pain, gastritis, dyspepsia, constipation, dysphagia 
Bolečina v ustih, gastritis, dispepsija,
• tiredness 
pireksijae
Oropharyngeal pain, hypoxia, dysphonia 
Orofaringealna bolečina, hipoksija,
Vomiting, oral pain, dysphagia, mouth haemorrhage, oesophageal or gastrointestinal pain 
Bruhanje, bolečina v ustih, disfagija, krvavitev v ustih, bolečina v požiralniku ali prebavilih
The lowest frequency of cardiac disorders was seen with the dose regimen of 10 g/m²/day, day -4 to -2 (2.7%). 
10 g/m²/dan od dneva -4 do -2 (2,7 %).
• inflammation of the colon, inflammation of anus, upset stomach, inflammation of the lining of the rectum, gastrointestinal pain, constipation 
• vnetje debelega črevesa, vnetje zadnjika (anusa), vznemirjen želodec, vnetje sluznice danke,
abdominal pain 
Orofaringealna bolečina,
Common Acute kidney injury, haematuria 
Akutna okvara ledvic, hematurija
Common Bilirubin increased, transaminases 
Zvišan bilirubin, zvišane transaminaze (ALT/AST), zvišana γGT Občasni
• chest pain, pain 
• bolečina v prsih, bolečine.
Gastrointestinal haemorrhage, neutropenic colitis, oesophagitis, anal inflammation, mouth ulceration 
Krvavitev v prebavila, nevtropenični kolitis, ezofagitis, analno vnetje, razjede v ustih
Veno-occlusive liver disease, hepatotoxicity 
Venookluzivna bolezen jeter,
Nervous system disorders 
Bolezni živčevja Pogosti
Not known Scrotal erythema 
Neznana Generaliziran eritem, dermatitis,
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 g treosulfan. 
Ena viala vsebuje 1 g treosulfana.
Adequate care and precautions should be taken in the disposal of items (syringes, needles, etc.) used to reconstitute cytotoxic medicinal products. 
(brizg, igel itn.), ki ste jih uporabili pri rekonstituciji citotoksičnih zdravil.
50 vials (suspension) 
50 vial (suspenzija)
suspension: 2.5 ml; emulsion: 2.5 ml 
suspenzija: 2,5 ml; emulzija: 2,5 ml
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams) 
Adjuvans AS03, ki je sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
2 x 25 vials (emulsion) 
2 x 25 vial (emulzija)
A/Indonesia/05/2005 (H5N1) 3.75 micrograms** * propagated in eggs ** haemagglutinin 
A/Indonesia/05/2005 (H5N1) 3,75 mikrogramov** * namnožen v jajcih ** hemaglutinin
Invented name Strength Pharmaceutical Form 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
Split influenza virus inactivated, containing antigen* equivalent to: 
Po premešanju, 1 odmerek (0,5 ml) vsebuje: inaktivirane delce virusa gripe, ki vsebujejo antigene*, ki ustrezajo:
Intramuscular use suspension (H5N1): vial (glass); emulsion (adjuvant): vial (glass) 
EU/1/10/664/001 Pumarix suspenzija in emulzija za emulzijo za injiciranje intramuskularna uporaba suspenzija (H5N1): viala (steklo); emulzija (adjuvans): viala (steklo)
l t o r 
o ā
15 May 2019 
15. maj 2019
Adoption of CMDh position: 
Sprejetje stališča skupine CMDh:
The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure. 
Študijo je treba izvesti v več kot eni državi članici, protokol pa je treba predložiti odboru PRAC v treh mesecih od izdaje sklepa Komisije v zvezi s tem postopkom.
The CMDh agrees with the scientific conclusions made by the PRAC. 
Skupina CMDh se strinja z znanstvenimi zaključki odbora PRAC.
Timetable for the implementation of the position 
Časovnica za uveljavitev tega stališča
Transmission to National Competent Authorities of the translations of the annexes to the position: 
Posredovanje prevodov prilog k stališču pristojnim nacionalnim organom:
The Marketing Authorisation Holders shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor off-label use. 
Imetniki dovoljenj za promet z zdravilom morajo izvesti študijo o uporabi zdravil, namenjeno oceni učinkovitosti ukrepov za zmanjšanje tveganja in spremljanju nenamenske uporabe.
January 2019 CMDh meeting 
Zasedanje skupine CMDh januarja 2019
Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder): 
Uveljavitev stališča v državah članicah (predložitev spremembe s strani imetnika dovoljenja za promet z zdravilom):
The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through) 
Imetnik (imetniki) dovoljenja za promet z zdravilom mora (morajo) izbrisati naslednji pogoj (naslednje pogoje) (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo prečrtano)
Annex II Conditions to the Marketing Authorisation(s) 
Priloga II Pogoji dovoljenja (dovoljenj) za promet z zdravilom
The joint database drug utilisation final study report submitted by the MAHs, together with the joint PASS (physician survey) final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0010), comply with their obligation to conduct a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor the off-label use of the drug as imposed during the referral under Article 31 of Directive 2001/83/EC for domperidone containing products. 
Končno poročilo študije skupne zbirke podatkov o uporabi zdravila, ki so ga skupaj s skupnim končnim poročilom študije varnosti zdravila po pridobitvi dovoljenja za promet (PASS) (raziskava zdravnikov) predložili imetniki dovoljenj za promet v ločenem postopku (EMEA/H/N/PSR/J/0010), je v skladu z obveznostjo izvajanja študije o uporabi zdravila za oceno učinkovitosti ukrepov za zmanjšanje tveganja in spremljanje nenamenske uporabe zdravila, kot je naložena med napotitvijo na podlagi člena 31 Direktive 2001/83/ES za zdravila, ki vsebujejo domperidon.
The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied. 
Skupina CMDh je sprejela stališče, da je potrebna sprememba dovoljenja (dovoljenj) za promet z zdravili, ki so zajeta v to končno poročilo študije PASS.
On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance domperidone 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 vsebuje(jo) zdravilno učinkovino domperidon, ter ob izraženi zaskrbljenosti zaradi končnega poročila študije PASS skupina CMDh meni, da je razmerje med koristjo in tveganjem zgoraj navedenega zdravila (zdravil) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance domperidone concerned by the noninterventional imposed PASS final report 
Spremembe pogoja (pogojev) za promet z zdravili, ki vsebujejo zdravilno učinkovino domperidon, ki jih je treba vnesti in ki jih zadeva končno poročilo odrejene neintervencijske študije PASS
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
Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the scientific conclusions are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o končnem poročilu odrejene neintervencijske študije varnosti zdravila po pridobitvi dovoljenja za promet (PASS) za zdravilo (zdravila), ki vsebujejo zdravilno učinkovino domperidon, in ob izraženi zaskrbljenosti zaradi končnega poročila te študije so bili sprejeti naslednji znanstveni zaključki:
Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint PASS (physician survey) final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0010), the PRAC considered that changes to the conditions of the marketing authorisation were warranted. 
Odbor PRAC je glede na razpoložljive podatke o končnem poročilu študije skupne zbirke podatkov o uporabi zdravila, skupaj s skupnim končnim poročilom študije varnosti zdravila po pridobitvi dovoljenja za promet (PASS) (raziskava zdravnikov), predloženim v ločenem postopku (EMEA/H/N/PSR/J/0010), menil, da so spremembe dovoljenja za promet z zdravilom upravičene.
Grounds for the variation to the terms of the Marketing Authorisation(s) 
Podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
Annex III Timetable for the implementation of this position 
Priloga III
EU Number Tradename Strength 
EU številka Izmišljeno ime
ContentPackage size Withdrawal period 
Vsebina Velikost pakiranja
Live attenuated Aujeszky's Disease Virus, strain NIA3783: ≥ 105.2 CCID50* 
1 viala z 10 odmerki in 1 stekleničko za rekonstitucijo
EU Number Invented name 
Številka EU Izmišljeno ime
Page 1 of 1 
Stran 1 od 1
1.2 Application Form - Annex A 
1.2 Obrazec za prijavo - Priloga A
Strength Pharmaceutical Form Route of Administration 
Farmacevtska oblika Pot uporabe
Confidential 
Zaupno
- Tell your doctor: 
- Povejte svojemu zdravniku:
Some patients have committed suicide. 
Nekateri bolniki so storili samomor.
As of week 144: 
Od 144. tedna naprej:
- if you are over 65. 
če ste starejši od 65 let.
Keep the bottle tightly closed. 
Steklenico shranjujte tesno zaprto.
A risk to the infants cannot be excluded. 
Tveganja za otroke ni mogoče izključiti.
• disturbances of coordination and balance 
• motnje koordinacije in ravnotežja;
** based on historical comparison. 
**glede na predhodno primerjavo.
The virus may then become harder to treat. 
Virus bo potem morda težje zdraviti.