natgillin/translations-raw huggingface dataset:
less than 1 per 10, but more than 1 per 100 treated people less than 1 per 100, but more than 1 per 1,000 treated people less than 1 per 1,000, but more than 1 per 10,000 treated people less than 1 per 10,000 treated people, incl. isolated cases
manj kot pri 1 od 10 zdravljenih oseb, vendar pogosti: več kot pri 1 od 100 zdravljenih oseb manj kot pri 1 od 100 zdravljenih oseb, vendar občasni več kot pri 1 od 1. 000 zdravljenih oseb manj kot pri 1 od 1. 000 zdravljenih oseb, vendar redki več kot pri 1 od 10. 000 zdravljenih oseb manj kot pri 1 od 10. 000 zdravljenih oseb, zelo redki vključno s posameznimi primeri
42 Uncommon:
Občasni:
muscle weakness, pins and needles (paraesthesia), headache, inflammation of the conjunctiva (conjunctivitis), dry mouth, skin rash, inflicted injury
mišična šibkost, mravljinčenje (parestezija), glavobol, vnetje veznice (konjunktivitis), suha usta, kožni izpuščaj, poškodbe
Uncommon:
43 Občasni:
facial paralysis, facial muscle weakness, inflammation of the cornea (keratitis), everted margin of the lid (ectropion), double vision (diplopia), inverted margin of the lid (entropion), visual disturbance, blurred vision, dizziness, inflammatory skin reaction (dermatitis), tiredness
ohromelost obraza, šibkost obraznih mišic, vnetje roženice (keratitis), obrnjenost roba veke navzven (aktropij), dvojni vid (diplopija), obrnjenost roba veke navznoter (entropij), motnje vida, zamegljen vid, omotica, vnetna reakcija na koži (dermatitis), utrujenost
Rare: swelling of eyelid
otekanje očesnih vek
disease of the vision nerve, usually associated with an increased pressure inside the eye (angle closure glaucoma), corneal ulceration
bolezen optičnega živca, po navadi povezana z zvišanim tlakom v notranjosti očesa (glavkom z zaprtim zakotjem), razjede na roženici
Twisted neck (spasmodic torticollis) The following side effects were reported with Xeomin:
Ukrivljen vrat (spastični tortikolis) Pri zdravljenju z zdravilom Xeomin so poročali o naslednjih neželenih učinkih:
speech disorders (dysphonia), weakness (asthenia), muscle pain (myalgia), headache, shaking (tremor), eye pain, diarrhoea, dry mouth, vomiting, inflammation of the colon (colitis), skin rash, skin redness (erythema), itching (pruritus), sweating increased, skeletal pain, injection site inflammation, injection site tenderness
motnje govora (disfonija), šibkost (astenija), bolečine v mišicah (nialgija), glavobol, tresenje (tremor), bolečina v očesu, driska, suha usta, bruhanje, vnetje debelega črevesa (kolitis), kožni izpuščaj, rdečica kože (eritem), srbenje (pruritus), povečano potenje, bolečine v kosteh, vnetje na mestu injiciranja, občutljivost na mestu injiciranja
Very common: pain, local weakness
bolečina, lokalna šibkost
breathing difficulties (dyspnoea), double vision (diplopia), drooping eyelid (ptosis), voice alteration, fever
težave pri dihanju (dispneja), dvojni vid (diplopija), povešene veke (ptoza), sprememba glasu, zvišana telesna temperatura
43 There are rare reports on side effects related to the cardiovascular system, such as irregular heartbeat (arrhythmia) and heart attack, some of them with fatal outcome.
Obstajajo redka poročila o neželenih učinkih, povezanih s srčno- žilnim sistemom, kot sta neredni srčni utrip (aritmija) in srčna kap, v nekaterih primerih s smrtnim izidom.
It remains unclear whether these deaths were induced by conventional preparations containing the Botulinum toxin type A complex or caused by a pre-existing cardiovascular disease.
Ni znano, ali so te smrti povzročili običajna zdravila s kompleksom botulinskega toksina tipa A ali pa obstoječa kardiovaskularna bolezen.
A case of peripheral neuropathy has been reported in a male after receiving four sets of injections of a conventional preparation containing the Botulinum toxin type A complex (for neck and back spasm, and severe pain) over an 11 week period.
44 O enem primeru periferne nevropatije so poročali pri moškem, ki je v 11 tednih prejel štiri nize injekcij običajnega zdravila s kompleksom botulinskega toksina tipa A (za spazem hrbta in vratu ter hudo bolečino).
A female patient developed a nerve lesion affecting the arm (brachial plexopathy) two days after injection of a conventional preparation containing the Botulinum toxin type A complex for the treatment of twisted neck, with recovery after five months.
Bolnica je okrevala po petih mesecih.
Various forms of skin eruptions (erythema multiforme, urticaria, psoriasis-like rash), itching, and allergic reactions have been described with the use of conventional preparations containing the Botulinum toxin type A complex, but their causal relationship remains unclear.
Pri uporabi običajnih zdravil s kompleksom botulinskega toksina tipa A so poročali o različnih oblikah kožnih izbruhov (multiformnem eritemu), srbenju, izpuščaju, podobnem psoriazi, pruritusu in alergijskih reakcijah, vendar je vzročno- posledična povezava neznana.
Do not use Xeomin after the expiry date which is stated on the carton and vial label after “ EXP”.
Zdravila Xeomin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake "Uporabno do".
Do not store above 25°C Reconstituted solution:
Rekonstituirana raztopina:
Store in a refrigerator (2 - 8°C)
Shranjujte v hladilniku (2 °C– 8 °C).
Your doctor will reconstitute the medicine with physiological saline before use.
Zdravnik bo zdravilo pred uporabo rekonstituiral s fiziološko raztopino.
Your doctor should not use Xeomin if the vial reconstituted according to the instructions has a cloudy appearance or contains e. g. floccular or particulate matter.
Zdravnik ne sme uporabiti zdravila Xeomin, če je rekonstituirana raztopina, pripravljena po navodilih, videti motna ali če vsebuje kosmiče ali delce.
• The other ingredients are: human albumin, sucrose 44 What Xeomin looks like and contents of the pack
• Pomožni snovi sta humani albumin, saharoza.
When dissolved Xeomin is a clear and colourless solution which is free of particulate matter.
Raztopljeno zdravilo Xeomin je bistra brezbarvna raztopina brez delcev.
{Name and address }< {tel }> < {fax }> < {e-mail }>
45 Imetnik dovoljenja za promet z zdravilom Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main Nemčija Telefon: +49- 69/ 15 03- 1 Faks: +49- 69/ 15 03- 200
KGaA Eckenheimer Landstraße 100 60318 Frankfurt/ Main Germany Phone: +49-69/ 15 03-1 Fax: +49-69/ 15 03-200
KGaA Eckenheimer Landstraße 100 60318 Frankfurt/ Main Nemčija Telefon: +49- 69/ 15 03- 1 Faks: +49- 69/ 15 03- 200
Solvent added (sodium chloride 9 mg/ ml (0.9%) solution for injection)
Količina dodanega vehikla (natrijev klorid 9 mg/ ml (0, 9%) raztopino za injiciranje)
units per 0.1 ml
Končni odmerek v enotah na 0, 1 ml
20.0 U 10.0 U 5.0 U 2.5 U
10, 0 e.
45
5, 0 e.
8.0 ml
2, 5 e.
1.25 U
1, 25 e.
Special precautions for disposal Any solution for injection that has been stored for more than 24 hours as well as any unused solution for injection should be discarded.
Vso raztopino za injiciranje, ki je bila shranjena več kot 24 ur, in neuporabljeno raztopino za injiciranje je treba zavreči.
Any used vials, syringes, and spillage etc. should be sterilised under high pressure and any residual Xeomin inactivated using diluted sodium hydroxide solution (0.1 N NaOH).
Vse uporabljene viale, brizge, prelito tekočino itd. je treba sterilizirati pod visokim tlakom, preostalo zdravilo Xeomin pa inaktivirati z razredčeno raztopino natrijevega hidroksida (0, 1 N NaOH).
London, 25 October 2007 EMEA/ CHMP/ 350251/ 2007
London, 25. oktober 2007 EMEA/ CHMP/ 350251/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Xeomin International Non-Proprietary Name (INN):
Xeomin Mednarodno nelastniško ime (INN):
Clostridium botulinum neurotoxin type A
Nevrotoksin bakterije Clostridium botulinum tipa A
During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem od 16. do 19. julija 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Xeomin ugodno, pri čemer ugovori, ki so jih predstavile Finska, Francija in Italija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom, ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
London, 17 June 2008 EMEA/ 337156/ 2008
London, 17. junija 2008 EMEA/ CHMP/ 40502/ 2008
OPINION FOLLOWING AN ARTICLE 5(11) 1 REFERRAL FOR Yasminelle and associated names (see Annex I)
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 5( 11) 1 ZA zdravilo Yasminelle in z njim povezana imena (glejte Dodatek I)
Yasminelle and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Zdravilo Yasminelle in z njim povezana imena je kombinirano peroralno kontracepcijsko sredstvo, ki vsebuje 0, 02 mg etinilestradiola in 3 mg drospirenona.
During their December 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Med svojim zasedanjem decembra 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med koristmi in tveganji za zdravilo Yasminelle in z njim povezana imena ugodno, ter da ugovori, ki jih je podala Madžarska, ne bi smeli preprečiti odobritve vloge za spremembo in da naj bodo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice končne različice, dogovorjene med postopkom Skupine za usklajevanje.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
UCB Pharma GmbH (AT) Jacquingasse,16-18/ 3. OG 1030 Wien
UCB Pharma GmbH (AT) Jacquingasse, 16- 18/ 3. OG 1030 Dunaj
oral drops, solution
peroralne kapljice, raztopina
oral solution
peroralna raztopina
McNeil Roderveld 1 B – 2600 Berchem Belgium
McNeil Roderveld 1 B – 2600 Berchem Belgija
UCB Pharma SA (Brussels) Allée de la Recherche, 60 B-1070 Brussels
UCB Pharma SA (Bruselj) Allée de la Recherche, 60 B- 1070 Bruselj
Belgium
vsebina
ZYRTEC
zdravilom
1mg/ ml
oblika
oral use
zdravila
1mg/ ml
(koncentracija)
Box 22679 1523 Nicosia Cyprus
Box 22679 1523 Nicosia Ciper
UCB Pharma SA (BRAINE) Chemin du Foriest Braine-l'Alleud B-1420 Belgium
UCB Pharma SA (BRAINE) Chemin du Foriest Braine- l' Alleud B- 1420 Belgija
3 Member State
Danska
Marketing Authorisation Holder
McNeil Danska Aps Bregnerødvej 133 DK- 3460 Birkerød
Invented name
BENADAY
Route of administration
filmsko obložene tablete
Content (concentration)
peroralna uporaba
McNeil Denmark Aps Bregnerødvej 133 DK-3460 Birkerød
McNeil Danska Aps Bregnerødvej 133 DK- 3460 Birkerød
10mg
1mg/ ml
film-coated tablet
peroralna raztopina
oral use
1mg/ ml
Denmark
3 Država članica
McNeil Denmark Aps Bregnerødvej 133 DK-3460 Birkerød
Imetnik dovoljenja za promet z
BENADAY
Izmišljeno ime
1mg/ ml
Jakost
oral solution
Farmacevtska
oral use
vsebina
Denmark
zdravila
4 Member State
Finska
Pharmaceutical Form
peroralne kapljice, raztopina
oral drops, solution
peroralna raztopina
Finland
4 Država članica
UCB Pharma Oy Finland Malminkaari 5 FI-00700 HELSINKI
Imetnik dovoljenja za promet z
ZYRTEC
Jakost
1mg/ ml
vsebina
oral solution
zdravilom
oral use
oblika
1mg/ ml
zdravila
Strength
Francija
Pharmaceutical Form
UCB Pharma S. A.
film-coated tablet
5 Država članica
France
oblika
1 D-76139 Karlsruhe GERMANY
1 D- 76139 Karlsruhe NEMČIJA
film-coated tablet
6 Država članica
Greece
oblika
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary
UCB Magyarország Kft Árpád fejedelem útja 26- 28 1023 Budapest Madžarska
UCB Pharma Ireland Limited, United Drug House, Magna Drive City West Road Dublin 24 Ireland
UCB Pharma Irska Limited, United Drug House, Magna Drive City West Road Dublin 24 Irska
ZIRTEK ORAL SOLUTION 1MG/ ML
ZIRTEK PERORALNA RAZTOPINA 1MG/ ML
Ireland
vsebina
ZIRTEK TABLETS
zdravilom
10mg
oblika
film-coated tablet
zdravila
oral use
(koncentracija)
Istituto Lusofarmaco Via Walter Tobagi 8 20068 Peschiera Borromeo (MI) Italy
Istituto Lusofarmaco Via Walter Tobagi 8 20068 Peschiera Borromeo (MI) Italija
SS 156km 50 04010 Borgo San Michele (LT) Italy
SS 156km 50 04010 Borgo San Michele (LT) Italija
Marketing Authorisation Holder
filmsko obložene tablete
Invented name
peroralna uporaba
film-coated tablet
8 Država članica
Latvia
oblika
Pharmaceutical Form
peroralna uporaba
UCB Pharma SA (Brussels) Allée de la Recherche, 60 B-1070
UCB Pharma SA (Bruselj) Allée de la Recherche, 60 B- 1070
Luxemburg
zdravilom
Pfizer Consumer Healthcare BV Rivium Westlaan 142 NL-2909 LD Capelle a/ d IJsel Nederland
Pfizer Consumer Healthcare BV Rivium Westlaan 142 NL- 2909 LD Capelle ann/ den IJsel Nizozemska
Lage Mosten 33 NL-4822 NK Breda Nederland
Lage Mosten 33 NL- 4822 NK Breda Nizozemska
McNeil Sweden AB, Sollentuna Sweden
McNeil Švedska AB, Sollentuna Švedska
film-coated tablet
10 Država članica
Norway
oblika
Pfizer Consumer Healthcare (GB) Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Great Britain
Pfizer Consumer Healthcare (GB) Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Velika Britanija
Mogilska 80 31-546 Krakow Poland
Mogilska 80 31- 546 Krakow Poljska
Poland
oblika
Maria I Piso 1 A Quinta da Fonte 2770-229 Paco de Arcos Portugal
Maria I Piso 1 A Quinta da Fonte 2770- 229 Paco de Arcos Portugalska
Romania
vsebina
UCB GmbH Huttenstraße 205 D-50170 Kerpen Germany
UCB GmbH Huttenstraße 205 D- 50170 Kerpen Nemčija
UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine l´Alleud Belgium
UCB SA Pharma Secteur Chemin du Foriest, B- 1420 Braine- l´Alleud Belgija
(Slovenia) Brnciceva 1 SLO - 1001 Ljubljiana Slovenia
(Slovenija) Brnciceva 1 SLO - 1001 Ljubljiana Slovenija
Spain
oblika
Alfonso XII, 587 08918 Badalona (Barcelona) Spain
Alfonso XII, 587 08918 Badalona (Barcelona) Španija
Lacer SA Sardenya 346 - 350 E - 08025 Barcelona Spain
Lacer SA Sardenya 346 - 350 E - 08025 Barcelona Španija
film-coated tablet
14 Država članica
UCB Nordic A/ S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Denmark
UCB Nordic A/ S Arne Jacobsens Allé 15 DK- 2300 Kobenhavn S Danska
UCB Nordic A/ S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Denmark
15 Država članica
ZYRLEX
Jakost
United Kingdom
(koncentracija)
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, UK
UCB Nordic A/ S Arne Jacobsens Allé 15 DK- 2300 Kobenhavn S Danska
BENADRYL ALLERGY ORAL SYRUP
ZYRLEX
BENADRYL FOR CHILDREN ALLERGY SOLUTION
BENADRYL ALLERGY ORAL SYRUP
16 Member State
Velika Britanija
Marketing Authorisation Holder
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, Velika Britanija
Invented name
BENADRYL FOR CHILDREN ALLERGY SOLUTION
Pharmaceutical Form
peroralna raztopina
United Kingdom
16 Država članica
UCB PHARMA LIMITED 208 Bath Road SLOUGH Berkshire SL1 3WE
Imetnik dovoljenja za promet z
ZIRTEK ALLERGY SOLUTION
Izmišljeno ime
17 Member State
Velika Britanija
18 ANNEX II
18 ZNANSTVENI ZAKLJUČKI
In adults, all three indications are treated by a 10 mg daily dose of cetirizine.
Pri odraslih se vse tri indikacije zdravijo z 10 - miligramskim dnevnim odmerkom cetirizina.
Due to the divergent national decisions taken by Member States concerning the authorisation of Zyrtec, a number of divergences exist in the product information and a referral was therefore triggered by the European Commission Article 30 of Directive 2001/ 83/ EC as amended in order to harmonise the divergent Product Information texts across the EU.
Ker so države članice sprejele različne odločitve glede dovoljenj za promet z zdravilom Zyrtec, obstajajo razhajanja v informacijah o zdravilu, zato je Evropska komisija v skladu s členom 30 Direktive 2001/ 83/ ES, kakor je bila spremenjena, sprožila napotitveni postopek za uskladitev različnih besedil v informacijah o zdravilu po vsej EU.
In adults, children, infants and toddlers 2 year and above: • Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis • Cetrizine is indicated for the relief of chronic idiopathic urticaria.
Pri odraslih, otrocih, dojenčkih in mlajših otrocih, starih 2 leti ali več: • je cetirizin indiciran za lajšanje nosnih in očesnih simptomov sezonskega ali trajnega alergijskega rinitisa; • je cetirizin indiciran za lajšanje kronične idiopatične urtikarije.
• Children aged from 2 to 6 years:
• Otroci, stari od 2 do 6 let:
2.5 mg twice daily (5 drops twice daily). • Children aged from 6 to 12 years:
2, 5 mg dvakrat dnevno (5 kapljic dvakrat dnevno); • Otroci, stari od 6 do 12 let:
5 mg twice daily (10 drops twice daily). • Adults and adolescents over 12 years of age:
5 mg dvakrat dnevno (10 kapljic dvakrat dnevno; • Odrasli in mladostniki, stari 12 let ali več:
10 mg once daily (20 drops).
10 mg enkrat na dan (20 kapljic). “
The posology proposed for children has been tested in clinical trials, but also results from dosing adaptations based on body weight and clearance that varies according to the maturation of the renal system.
19 Predlagano odmerjanje za otroke je bilo preverjeno v kliničnih preskušanjih, izhaja pa tudi iz prilagajanja odmerkov telesni masi in izločanju zdravila, kar je odvisno od zrelosti ledvičnega sistema.
This is why the harmonized wording does not propose a weight – based posology, as weight is clearly not the only factor to define the dose.
Zato usklajeno besedilo ne predlaga odmerjanja na podlagi telesne mase, saj ta ne more biti edini dejavnik pri določanju odmerka.
20 The MAH was also asked to provide data in support of the recommended dosing in patients with renal impairment and provide justifications for the benefit/ risk ratio of halving the dose.
Imetnik dovoljenja za promet z zdravilom je bil tudi naprošen, da zagotovi podatke v podporo predlaganim odmerkom pri bolnikih z ledvičnimi obolenji ter utemelji razmerje med koristmi in tveganji v primeru prepolovitve odmerka.
The MAH was also asked to justify the dosing in paediatric patients suffering from renal impairment and the dosing by weight in the 2-5 year age group and dosing by age groups 2-5, 6-11 and 12-18 as well as dosing for children less than 2 years old.
Imetnik dovoljenja za promet z zdravilom je bil tudi naprošen, da obrazloži odmerjanje pri pediatričnih bolnikih z ledvičnimi obolenji, pri odmerjanju zdravila na podlagi telesne mase pri starostni skupini od 2 do5 let ter odmerjanje pri starostnih skupinah od 2– 5, 6– 11 in 12– 18 let kakor tudi pri otrocih, mlajših od 2 let.
The MAH stated that the clinical benefit/ risk ratio of cetirizine has not been specifically evaluated in patients with renal impairment and that the dose is therefore based on pharmacokinetic calculations only.
Imetnik dovoljenja za promet z zdravilom je navedel, da klinično razmerje med koristmi in tveganji cetirizina ni bilo posebej ovrednoteno pri bolnikih z ledvičnimi obolenji in da so zato odmerki določeni samo na podlagi farmakokinetičnih izračunov.
No signal suggesting an unfavourable benefit/ risk ratio for Zyrtec compared to other anti- histamines was ever detected in pharmacovigilance during the 22 years on the market; however the MAH would like to retain the contraindication: “ Patients with severe renal impairment at less than 10 ml/ min creatinine clearance .”
„ Bolniki s hudimi ledvičnimi obolenji z manj kot 10 ml/ min izločanja kreatinina. “
The sentence will therefore be adapted to: “ In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age, and his body weight”
„ Pri pediatričnih bolnikih z ledvičnim obolenjem bo treba odmerek prilagoditi za vsakega posameznika posebej, ob upoštevanju bolnikovega ledvičnega izločanja, njegove starosti in telesne mase. “
The MAH also proposed harmonised Product Information texts for section 4.3 Contraindications reflecting the hypersensitivity to formulation constituents and addressing patients with severe renal impairment.
Kontraindikacije, ki odražajo preobčutljivost na posamezne sestavine pripravka in obravnavo bolnikov s hudimi ledvičnimi obolenji.
The MAH proposed a harmonised text for section 4.4 Special Warnings, as the section was extensively disharmonised and added some warnings regarding the suitability of the formulations for certain age ranges and reflecting the lack of appropriate data on the benefit- risk for children below one year old, restricting the use of film-coated tablets in children aged less than 6 years, the use of the oral solution children aged less than 2 years and the use of the drop formulation in infants and toddlers aged less than 1 year old.
Posebna opozorila, saj se je razdelek v tem delu precej razhajal, dodana pa so bila tudi posebna opozorila o primernosti oblik pripravkov za določene starostne skupine in, glede na pomanjkanje ustreznih podatkov o razmerju med koristmi in tveganji pri otrocih, mlajših od enega leta, omejevanju uporabe filmsko obloženih tablet pri otrocih, mlajših od 6 let, peroralne raztopine pri otrocih, mlajših od 2 let, ter
The MAH was asked to revise section 4.5 Interaction with other medicinal products, as no pharmacokinetic interactions are awaited with this substance, since it is not metabolised and two third of the ingested dose are eliminated unchanged in urine.
Imetnik dovoljenja za promet z zdravilom je bil naprošen tudi za preoblikovanje razdelka 4. 5 Medsebojno delovanje z drugimi zdravili, ker se ne pričakuje nobeno farmakokinetično medsebojno delovanje s to snovjo, saj se ta ne presnavlja, dve tretjini zaužitega odmerka pa se izločita nespremenjeni z urinom.
21 The MAH also reworded the entire section 4.8 Undesirable effects in accordance with current guidelines and with the QRD comments received.
Imetnik dovoljenja za promet z zdravilom je preoblikoval tudi celotni razdelek 4. 8 Neželeni učinki v skladu s trenutnimi smernicami in prejetimi pripombami po pregledu kakovosti dokumentacije.
The CHMP acknowledged the problem of translating from old to new formats and the MAH’ s division of events into frequencies observed in clinical trials and frequencies estimated from post marketing experience could be agreed upon.
CHMP je priznal težave s prevajanjem iz starih oblik v nove, soglašal pa bi lahko tudi o razdelitvi pojavov na pogostnosti, opažene v kliničnih preskušanjih, in pogostnosti, ocenjene na podlagi izkušenj po izdaji dovoljenja za promet, ki jo je opravil imetnik dovoljenja za promet z zdravilom.
Regarding section 5.1 Pharmacodynamic properties, the MAH was asked to reword section 5.1 and retain only the properties that are relevant with regards to the therapeutic effects.
V zvezi z razdelkom 5. 1 Farmakodinamične lastnosti je bil imetnik dovoljenja za promet z zdravilom zaprošen, da preoblikuje razdelek 5. 1 in obdrži le lastnosti, ki so pomembne v zvezi s terapevtskimi učinki.
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- da je bila podlaga napotitve uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodil
labelling and package leaflet,
za uporabo;