FrancophonIA/ELRC3.0 huggingface dataset:
English: VOD occurred only with the dose regimen of 14 g/m²/day treosulfan.
Slovenian: VOD se je pojavljala samo pri shemi odmerjanja treosulfana 14 g/m²/dan.
English: Treosulfan can impair fertility.
Slovenian: Plodnost Treosulfan lahko zmanjša plodnost.
English: • liver damage
Slovenian: bolečina v jetrih
English: About 25-40% of treosulfan is excreted in urine; however, an influence of renal function on renal clearance of treosulfan was not observed.
Slovenian: Okrog 25-40 % treosulfana se izloči v urinu;
English: • Thiotepa 5 mg/kg twice a day, given as two intravenous infusions over 2-4 hours on day -2 before stem cell infusion (day 0).
Slovenian: • Tiotepa 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).
English: Acute kidney injury, renal failure
Slovenian: Akutna okvara ledvic, odpoved ledvic
English: • high blood pressure, flushing
Slovenian: • zvišan krvni tlak, rdečica,
English: Hazard ratiob (95% CI)
Slovenian: (95 % IZ)
English: Conjunctival haemorrhage, dry eye
Slovenian: Konjunktivalne krvavitve, suho oko
English: How to store Trecondi
Slovenian: Kako dajemo zdravilo Trecondi
English: The volume of distribution in adult patients is about 20-30 litres.
Slovenian: Porazdelitveni volumen pri odraslih bolnikih je okrog
English: Not known Hypoxia
Slovenian: Neznana Hipoksija
English: Cardiac arrest, cardiac failure, myocardial infarction, pericardial effusion
Slovenian: Zastoj srca, miokardni infarkt
English: • fluid around the lung (pleural effusion), inflammation of throat, inflammation of or pain in voice box, cough, hiccups
Slovenian: • tekočina okrog pljuč (plevralni izliv), vnetje žrela, vnetje ali bolečina v grlu, kašelj, kolcanje,
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution.
Slovenian: Za intravensko uporabo po rekonstituciji.
English: Maculo-papular rash, purpura, erythema, palmar-plantar erythrodysaesthesia syndrome, pruritus, alopecia
Slovenian: eritem, sindrom palmarno-plantarne eritrodizestezije, pruritus, alopecija
English: 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.
Slovenian: Pri ravnanju s treosulfanom se izogibajte vdihavanju, stiku s kožo in stiku s sluznicami.
English: Infections (bacterial, viral, fungal)
Slovenian: Pogosti Infekcije (bakterijske, virusne,
English: Not known Treatment-related second malignancy
Slovenian: Druga maligna bolezen, povezana z zdravljenjem
English: Very common Stomatitis/mucositis, nausea
Slovenian: Zelo pogosti Stomatitis/mukozitis, navzea
English: • mouth pain, inflammation of the stomach, upset stomach, constipation, difficulty in swallowing
Slovenian: • bolečina v ustih, vnetje želodca, vznemirjen želodec, zaprtje, oteženo požiranje,
English: • kidney failure, inflammation of the urinary bladder (cystitis), pain on passing urine (dysuria)
Slovenian: • odpoved ledvic, vnetje sečnika (cistitis), bolečina pri odvajanju vode (dizurija),
English: • headache, sensation of tingling, pricking or numbness (paraesthesia), seizure
Slovenian: • glavobol, občutek mravljinčenja, zbadanja ali odrevenelosti (parestezije), epileptični napad,
English: Dyspnoea, pleural effusion, pharyngeal or laryngeal inflammation
Slovenian: Dispnea, plevralni izliv, faringitis ali laringitis
English: Not known Chills, fatigue, pain
Slovenian: Mrzlica, utrujenost, bolečina
English: • liver failure, enlarged liver, liver pain
Slovenian: • odpoved jeter, zvečana jetra, bolečina v jetrih,
English: 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
Slovenian: Obsežna kronična GvHDa; % (95 % IZ) 18,4 (12,0; 24,8) 26,1 (19,2; 33,1) 0,1099
English: Maculo-papular rash, purpura, erythema
Slovenian: Makulopapularni izpuščaj, purpura,
English: Pneumonitis, pleural effusion, pharyngeal or laryngeal inflammation, cough, laryngeal pain, hiccups
Slovenian: Pnevmonitis, plevralni izliv, faringitis ali laringitis, kašelj,
English: There was a significant association between age and respiratory toxicity in paediatric patients treated with treosulfan-based conditioning.
Slovenian: 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.
English: 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.
Slovenian: (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.
English: b
Slovenian: Pb
English: • 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
Slovenian: • 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,
English: Infections and infestations* Very common Infections (bacterial, viral, fungal)
Slovenian: Zelo pogosti Infekcije (bakterijske, virusne,
English: Very common Myelosuppression, pancytopenia
Slovenian: Zelo pogosti Mielosupresija, pancitopenija
English: Sepsisa
Slovenian: Mukozitis
English: Cardiac disorders* Common Cardiac arrhythmias (e.g. atrial fibrillation, sinus arrhythmia)
Slovenian: Občasni Srčne aritmije (npr. atrijska fibrilacija, sinusna aritmija) Neznana
English: Hepatobiliary disorders
Slovenian: hepatotoksičnost
English: Common Dyspnoea, epistaxis
Slovenian: Pogosti Dispnea, epistaksa
English: • inflammation of the lining of various parts of the body, especially in the mouth (which can cause ulcers), diarrhoea, nausea, vomiting, belly (abdominal) pain
Slovenian: • vnetje sluznice v različnih delih telesa, posebno v ustih (kjer lahko povzroči razjede), driska,
English: • throat pain, nosebleeds
Slovenian: • bolečina v žrelu, krvavitve iz nosu,
English: Generalised erythema, dermatitis, skin necrosis or ulcer, skin hyperpigmentationd, dry skin
Slovenian: kožna nekroza ali razjeda, hiperpigmentacija kožed, suha koža
English: Uncommon Hypertension
Slovenian: Hipertenzija Neznana
English: Renal and urinary disorders Not known Acute kidney injury, renal failure, noninfective cystitis
Slovenian: Akutna okvara ledvic, odpoved ledvic, neinfektivni cistitis
English: • difficulty in swallowing, mouth pain
Slovenian: Disfagija, bolečina v ustih
English: • decrease of kidney function, kidney failure, inflammation of the urinary bladder (cystitis)
Slovenian: • zmanjšano delovanje ledvic, odpoved ledvic, vnetje sečnika (cistitis),
English: Five cases of a second malignancy (myelodysplastic syndrome, acute lymphoblastic leukaemia, Ewing's sarcoma) were reported by other investigators after treosulfan-based conditioning.
Slovenian: 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).
English: Cardiac disorders
Slovenian: Srčne bolezni*
English: * 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
Slovenian: 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.
English: Neutropenic colitis, anal inflammation, dyspepsia, proctitis, gastrointestinal pain, constipation
Slovenian: Nevtropenični kolitis, analno vnetje, dispepsija, proktitis,
English: Trecondi 1 g powder for solution for infusion Colourless type III glass vial, with rubber stopper and aluminium cap containing 1 g of treosulfan.
Slovenian: Viala iz neobarvanega stekla tipa III z gumijastim zamaškom in aluminijasto zaporko, ki vsebuje 1 g treosulfana.
English: Gastrointestinal haemorrhage, neutropenic colitis
Slovenian: Krvavitev v prebavila, nevtropenični kolitis
English: Pain in extremities, back pain, bone pain, arthralgia, myalgia Not known
Slovenian: Bolečine v udih, bolečina v križu, bolečine v kosteh, artralgija, mialgija
English: Trecondi 5 g powder for solution for infusion Colourless type III glass vial, with rubber stopper and aluminium cap containing 5 g of treosulfan.
Slovenian: Viala iz neobarvanega stekla tipa III z gumijastim zamaškom in aluminijasto zaporko, ki vsebuje 5 g treosulfana.
English: Very common Pyrexiac
Slovenian: Zelo pogosti Pireksijac
English: • 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).
Slovenian: • 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).
English: Uncommon Haematoma, hypotension
Slovenian: Hematom, hipotenzija Neznana
English: • headache, dizziness
Slovenian: • glavobol, omotica,
English: • 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
Slovenian: rdeče pege na koži (purpura), rdečina kože (eritem), sindrom dlani in stopal (dlani ali stopala srbijo, odrevenijo, boleče otečejo ali pordečijo), srbenje, izguba las,
English: • chills, tiredness, pain
Slovenian: • mrzlica, utrujenost, bolečina,
English: • increased liver enzymes, increased C-reactive protein (a marker of inflammation in the body),
Slovenian: • 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.
English: • 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).
Slovenian: • 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).
English: Fatigue
Slovenian: Agitacija
English: • pain in arms or legs, back pain, bone pain, joint pain, muscle pain
Slovenian: • bolečine v zgornjih ali spodnjih udih, bolečine v križu, kosteh, sklepih, mišicah,
English: • 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).
Slovenian: • 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).
English: Pain in extremities
Slovenian: Bolečine v udih
English: Very common Asthenic conditions (fatigue, asthenia, lethargy)
Slovenian: Astenična stanja (utrujenost, astenija,
English: Trecondi 5 g powder for solution for infusion One vial contains 5 g of treosulfan.
Slovenian: Trecondi 5 g prašek za raztopino za infundiranje Ena viala vsebuje 5 g treosulfana.
English: Trecondi 1 g powder for solution for infusion 1 vial contains 1 g of treosulfan.
Slovenian: Trecondi 1 g prašek za raztopino za infundiranje 1 viala vsebuje 1 g treosulfana.
English: • enlarged liver, liver damage
Slovenian: • zvečana jetra, okvara jeter,
English: • pain in arms or legs
Slovenian: • bolečina v zgornjih ali spodnjih udih,
English: • 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).
Slovenian: • 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).
English: 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).
Slovenian: Izgled zdravila Trecondi in vsebina pakiranja Bel kristalen prašek v stekleni viali z gumijastim zamaškom in aluminijasto zaporko.
English: Trecondi 5 g powder for solution for infusion 1 vial contains 5 g of treosulfan.
Slovenian: Trecondi 5 g prašek za raztopino za infundiranje 1 viala vsebuje 5 g treosulfana.
English: Number of patients Overall survivala; % (95% CI) 71.3 (63.6,
Slovenian: 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
English: Dermatitis exfoliative, maculo-papular rash, rash, erythema, pain of skin, skin hyperpigmentationb, alopecia
Slovenian: makulopapularni izpuščaj, izpuščaj, eritem, bolečina v koži, hiperpigmentiranost kožeb,
English: Trecondi 1 g powder for solution for infusion One vial contains 1 g of treosulfan.
Slovenian: Trecondi 1 g prašek za raztopino za infundiranje Ena viala vsebuje 1 g treosulfana.
English: 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):
Slovenian: Odmerek treosulfana moramo prilagoditi bolnikovi telesni površini kot sledi (glejte poglavje 5.2):
English: Gastrointestinal disorders* Very common Stomatitis/mucositis, diarrhoea, nausea, vomiting, abdominal pain
Slovenian: Bolezni prebavil* Zelo pogosti Stomatitis/mukozitis, driska, navzea,
English: • Thiotepa (intensified regimen5 mg/kg twice a day), given as two intravenous infusions over 2
Slovenian: • 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).
English: Not known Skin necrosis
Slovenian: Nekroza kože
English: • gastrointestinal bleeding, inflammation of the colon, inflammation of the gullet, inflammation of the anus, mouth ulcer
Slovenian: • krvavitev v prebavilih, vnetje debelega črevesa, vnetje požiralnika, vnetje zadnjika (anusa),
English: • 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).
Slovenian: • 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).
English: NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion treosulfan
Slovenian: Trecondi 1 g prašek za raztopino za infundiranje Trecondi 5 g prašek za raztopino za infundiranje treosulfan
English: Vascular disorders
Slovenian: Nevtropenični kolitis
English: A very low penetration of blood-brain-barrier by treosulfan was observed in rats.
Slovenian: Pri podganah so ugotovili, da treosulfan zelo slabo penetrira skozi krvno-možgansko pregrado.
English: Uncommon Confusional state
Slovenian: Stanje zmedenosti Neznana
English: Nervous system disorders* Not known Headache, paraesthesia, seizure
Slovenian: Neznana Glavobol, parestezije,
English: • difficulty breathing, nosebleeds
Slovenian: • oteženo dihanje, krvavitve iz nosu,
English: NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion
Slovenian: Trecondi 1 g prašek za raztopino za infundiranje Trecondi 5 g prašek za raztopino za infundiranje
English: Peripheral sensory neuropathy Not known
Slovenian: Občasni Periferna senzorična nevropatija
English: Oral pain, gastritis, dyspepsia, constipation, dysphagia
Slovenian: Bolečina v ustih, gastritis, dispepsija,
English: • tiredness
Slovenian: pireksijae
English: Oropharyngeal pain, hypoxia, dysphonia
Slovenian: Orofaringealna bolečina, hipoksija,
English: Vomiting, oral pain, dysphagia, mouth haemorrhage, oesophageal or gastrointestinal pain
Slovenian: Bruhanje, bolečina v ustih, disfagija, krvavitev v ustih, bolečina v požiralniku ali prebavilih
English: The lowest frequency of cardiac disorders was seen with the dose regimen of 10 g/m²/day, day -4 to -2 (2.7%).
Slovenian: 10 g/m²/dan od dneva -4 do -2 (2,7 %).
English: • inflammation of the colon, inflammation of anus, upset stomach, inflammation of the lining of the rectum, gastrointestinal pain, constipation
Slovenian: • vnetje debelega črevesa, vnetje zadnjika (anusa), vznemirjen želodec, vnetje sluznice danke,
English: abdominal pain
Slovenian: Orofaringealna bolečina,
English: Common Acute kidney injury, haematuria
Slovenian: Akutna okvara ledvic, hematurija
English: Common Bilirubin increased, transaminases
Slovenian: Zvišan bilirubin, zvišane transaminaze (ALT/AST), zvišana γGT Občasni
English: • chest pain, pain
Slovenian: • bolečina v prsih, bolečine.
English: Gastrointestinal haemorrhage, neutropenic colitis, oesophagitis, anal inflammation, mouth ulceration
Slovenian: Krvavitev v prebavila, nevtropenični kolitis, ezofagitis, analno vnetje, razjede v ustih
English: Veno-occlusive liver disease, hepatotoxicity
Slovenian: Venookluzivna bolezen jeter,
English: Nervous system disorders
Slovenian: Bolezni živčevja Pogosti
English: Not known Scrotal erythema
Slovenian: Neznana Generaliziran eritem, dermatitis,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 g treosulfan.
Slovenian: Ena viala vsebuje 1 g treosulfana.
English: Adequate care and precautions should be taken in the disposal of items (syringes, needles, etc.) used to reconstitute cytotoxic medicinal products.
Slovenian: (brizg, igel itn.), ki ste jih uporabili pri rekonstituciji citotoksičnih zdravil.
English: Breast-feeding
Slovenian: Hiperglikemija
English: 50 vials (suspension)
Slovenian: 50 vial (suspenzija)
English: suspension: 2.5 ml; emulsion: 2.5 ml
Slovenian: suspenzija: 2,5 ml; emulzija: 2,5 ml
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Slovenian: Adjuvans AS03, ki je sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
English: 2 x 25 vials (emulsion)
Slovenian: 2 x 25 vial (emulzija)
English: A/Indonesia/05/2005 (H5N1) 3.75 micrograms** * propagated in eggs ** haemagglutinin
Slovenian: A/Indonesia/05/2005 (H5N1) 3,75 mikrogramov** * namnožen v jajcih ** hemaglutinin
English: Invented name Strength Pharmaceutical Form
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: Split influenza virus inactivated, containing antigen* equivalent to:
Slovenian: Po premešanju, 1 odmerek (0,5 ml) vsebuje: inaktivirane delce virusa gripe, ki vsebujejo antigene*, ki ustrezajo:
English: Intramuscular use suspension (H5N1): vial (glass); emulsion (adjuvant): vial (glass)
Slovenian: EU/1/10/664/001 Pumarix suspenzija in emulzija za emulzijo za injiciranje intramuskularna uporaba suspenzija (H5N1): viala (steklo); emulzija (adjuvans): viala (steklo)
English: l t o r
Slovenian: o ā
English: 15 May 2019
Slovenian: 15. maj 2019
English: Adoption of CMDh position:
Slovenian: Sprejetje stališča skupine CMDh:
English: 16 March 2019
Slovenian: 16. marec 2019
English: 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.
Slovenian: 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.
English: The CMDh agrees with the scientific conclusions made by the PRAC.
Slovenian: Skupina CMDh se strinja z znanstvenimi zaključki odbora PRAC.
English: Timetable for the implementation of the position
Slovenian: Časovnica za uveljavitev tega stališča
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Slovenian: Posredovanje prevodov prilog k stališču pristojnim nacionalnim organom:
English: 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.
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo izvesti študijo o uporabi zdravil, namenjeno oceni učinkovitosti ukrepov za zmanjšanje tveganja in spremljanju nenamenske uporabe.
English: January 2019 CMDh meeting
Slovenian: Zasedanje skupine CMDh januarja 2019
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Slovenian: Uveljavitev stališča v državah članicah (predložitev spremembe s strani imetnika dovoljenja za promet z zdravilom):
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Slovenian: Imetnik (imetniki) dovoljenja za promet z zdravilom mora (morajo) izbrisati naslednji pogoj (naslednje pogoje) (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo prečrtano)
English: Annex II Conditions to the Marketing Authorisation(s)
Slovenian: Priloga II Pogoji dovoljenja (dovoljenj) za promet z zdravilom
English: 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.
Slovenian: 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.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Slovenian: Skupina CMDh je sprejela stališče, da je potrebna sprememba dovoljenja (dovoljenj) za promet z zdravili, ki so zajeta v to končno poročilo študije PASS.