natgillin/translations-raw huggingface dataset:
Renal failure (including renal failure acute) 
Bolezni sečil zvišanje kreatinina v krvi odpoved ledvic (vključno z akutno odpovedjo ledvic)
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection/infusion or oral solution 1 powder vial and 1 solvent ampoule 5 powder vials and 5 solvent ampoules 10 powder vials and 10 solvent ampoules 25 powder vials and 25 solvent ampoules 
FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino 1 viala s praškom in 1 ampula z vehiklom
• community acquired pneumonia, 
• pljučnica, dobljena v domačem okolju,
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder [See Annex I - To be completed nationally] 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom [Glejte Prilogo I - Izpolni država članica]
Coagulase-negative staphylococci a 
Koagulaza-negativni stafilokoki a
• Starting dose (for the first three doses): 10 mg for every kilogram of body weight, given every 
• Začetni odmerek (za prve tri odmerke): 400 mg (to je enakovredno 6 mg na kilogram telesne mase)
• Rash, erythema, pruritus 
• izpuščaj, rdečina, srbenje
• in a Type I, colourless glass vial of useful volume of 8 mL for 100 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium red overseal. 
• v viali iz brezbarvnega stekla tipa I z uporabnim volumnom 8 ml za 100 mg, zaprti z zamaškom iz brombutilne gume in plastičnim snemnim pokrovčkom rdeče aluminijske prekrivne zapore.
Targocid and associated names (see Annex I) 400 mg powder for solution for injection/infusion or oral solution [See Annex I - To be completed nationally] 
Targocid in povezana imena (glejte Prilogo I) 400 mg prašek za raztopino za injiciranje ali infundiranje ali za peroralno raztopino [Glejte Prilogo I - Izpolni država članica]
How to store Targocid 
Kako se daje zdravilo Targocid
Peritonitis for patients on peritoneal dialysis 
Bolezni živčevja omotica, glavobol epileptični napadi
• in a Type I, colourless glass vial of useful volume of 22 mL for 400 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium green overseal. 
• v viali iz brezbarvnega stekla tipa I z uporabnim volumnom 22 ml za 400 mg, zaprti z zamaškom iz brombutilne gume in plastičnim snemnim pokrovčkom zelene aluminijske prekrivne zapore.
Targocid and associated names (see Annex I) 400 mg powder and solvent for solution for injection/infusion or oral solution [See Annex I - To be completed nationally] 
Targocid in povezana imena (glejte Prilogo I) 400 mg prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino [Glejte Prilogo I - Izpolni država članica]
Type I, colourless glass vial of useful volume of 22 mL for 400 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium green overseal. 
viali iz brezbarvnega stekla tipa I z uporabnim volumnom 22 ml za 400 mg, zaprti z zamaškom iz brombutilne gume in plastičnim snemnim pokrovčkom zelene aluminijske prekrivne zapore.
Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium yellow overseal. 
viali iz brezbarvnega stekla tipa I z uporabnim volumnom 10 ml za 200 mg, zaprti z zamaškom iz brombutilne gume in plastičnim snemnim pokrovčkom rumene aluminijske prekrivne zapore.
They will decide whether or not you are given this medicine while you are pregnant. 
Oni bodo presodili, ali naj med nosečnostjo dobite to zdravilo ali ne. Obstaja lahko tveganje za okvaro notranjega ušesa in za težave z ledvicami.
• in a Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium yellow overseal. 
• v viali iz brezbarvnega stekla tipa I z uporabnim volumnom 10 ml za 200 mg, zaprti z zamaškom iz brombutilne gume in plastičnim snemnim pokrovčkom rumene aluminijske prekrivne zapore.
Nervous system disorders 
Priprava raztopine
It is unlikely that they will not give you the medicine as prescribed. 
Ni verjetno, da vam ne bi dala predpisanega zdravila.
• Ringer-lactate solution 
• Ringerjeva raztopina
What Targocid looks like and contents of the pack Targocid is a powder and solvent for solution for injection/infusion or oral solution. 
Izgled zdravila Targocid in vsebina pakiranja Zdravilo Targocid je prašek za raztopino za injiciranje ali infundiranje ali za peroralno raztopino Prašek je gobasta, homogena masa slonokoščene barve.
Type I, colourless glass vial of useful volume of 8 mL for 100 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium red overseal. 
Liofilizirano zdravilo je pakirano v: viali iz brezbarvnega stekla tipa I z uporabnim volumnom 8 ml za 100 mg, zaprti z zamaškom iz brombutilne gume in plastičnim snemnim pokrovčkom rdeče aluminijske prekrivne zapore.
Targocid and associated names (see Annex I) 400 mg powder for solution for injection/infusion or oral solution 
Targocid in povezana imena (glejte Prilogo I) 400 mg prašek za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
Targocid and associated names (see Annex I) 200 mg powder for solution for injection/infusion or oral solution 
Targocid in povezana imena (glejte Prilogo I) 200 mg prašek za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
Targocid and associated names (see Annex I) 100 mg powder for solution for injection/infusion or oral solution 
Targocid in povezana imena (glejte Prilogo I) 100 mg prašek za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
For Targocid, powder and solvent for solution for injection/ infusion or oral solution What Targocid contains 
Za zdravilo Targocid prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
Targocid and associated names (see Annex I) 200 mg powder and solvent for solution for injection/infusion or oral solution 
Targocid in povezana imena (glejte Prilogo I) 200 mg prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
Targocid and associated names (see Annex I) 400 mg powder and solvent for solution for injection/infusion or oral solution 
Targocid in povezana imena (glejte Prilogo I) 400 mg prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
Loading dose 
Polnilni odmerek
Targocid and associated names (see Annex I) 100 mg powder and solvent for solution for injection/infusion or oral solution 
Targocid in povezana imena (glejte Prilogo I) 100 mg prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
There may be a potential risk of inner ear and kidney problems. 
povzročijo lahko težave s sluhom, težave z ledvicami ali oboje.
Blood and the lymphatic system disorders 
Bolezni krvi in limfatičnega sistema levkopenija, trombocitopenija, eozinofilija agranulocitoza, nevtropenija
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Prilogo I - Izpolni država članica]
If symptoms or signs of SJS or TEN 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Shelf life of diluted medicinal product: 
Rok uporabnosti redčenega zdravila:
3 (3 x 1) cartridges + 3 (3 x 1) automated minidosers (multipack) 
3 (3 x 1) vložki + 3 (3 x 1) avtomatski odmerniki (skupno pakiranje)
1 cartridge + 1 automated minidoser 
1 vložek + 1 avtomatski odmernik
6 (3 x 2) pre-filled pens (multipack) 
6 (3x2) napolnjenih injekcijskih peresnikov (skupno pakiranje)
Content (concentration) 
Številka (EU) dovoljenja za promet
Pre-filled syringe (glass) 
Pot uporabe Stična ovojnina Vsebina Velikost pakiranja napolnjena injekcijska brizga (steklena)
*** International units. 
*** mednarodne enote.
ATC vet code: QI07AJ. 
Oznaka ATC vet: QI07AJ.
Such reactions may evolve to a more severe condition which may be life-threatening. 
Take reakcije se lahko razvijejo v težja stanja, ki lahko ogrožajo življenje.
Active immunisation of dogs from 8-9 weeks of age: 
Aktivna imunizacija psov, starejših od 8-9 tednov:
Suspension: pink colour with fine sediment. 
Suspenzija: rožnate barve s finim sedimentom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31/07/2014. 
Datum pridobitve dovoljenja za promet: 31/07/2014.
Store and transport refrigerated (2°C-8°C). 
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
In case of need, dogs younger than 8 weeks can be vaccinated as safety of this product has been demonstrated in 6-week old dogs. 
Če je potrebno, lahko cepimo pse, mlajše od 8 tednov, saj je bila varnost tega cepiva dokazana pri psih, starih 6 tednov.
Pharmacotherapeutic group: Immunologicals for canidae, live and inactivated viral and inactivated bacterial vaccines. 
Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae), živa in inaktivirana virusna in inaktivirana bakterijska cepiva.
* Tissue culture infectious dose 50 %. 
* 50% infektivnega odmerka za tkivno kulturo.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus. 
Ne cepite živali, ki kažejo znake stekline ali se sumi, da so okužene z virusom stekline.
However, due to the low pathogenicity of the strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs. 
Zaradi nizke patogenosti teh sevov ločevanje cepljenih psov od necepljenih ni potrebno.
Reconstituted vaccine: pink/red, or yellowish colour with slight opalescence. 
Rekonstituirano cepivo: rožnato/rdeče ali rumenkaste barve, rahlo opalescentno.
** Antibody micro agglutination-lytic reaction. 
** reakcija mikroaglutinacije-lize protiteles.
≥ 2.0 IU*** 
≥ 2,0 i.e.***
The second dose should not be given before 12 weeks of age. 
Drugega odmerka ne smete dati pred starostjo 12 tednov.
A transient swelling (up to 5 cm) may commonly be observed at the injection site following subcutaneous administration in dogs. 
Prehodna oteklina (do 5 cm) se lahko pogosto pojavi na mestu injiciranjapo subkutani aplikaciji pri psih.
Shake well and administer immediately the entire content (1 ml) of the reconstituted product. 
Pred uporabo dobro pretresite in takoj injicirajte živali celotno rekonstituirano vsebino (1 ml).
Systemic reactions such as lethargy, hyperthermia and general malaise may occur very rarely. 
Sistemske reakcije kot so letargija, hipotermija in splošno slabo počutje se pojavljajo zelo redko.
Dose and route of administration: 
Odmerjanje in pot uporabe:
Duration of immunity for rabies was demonstrated after one vaccination at 12 weeks of age. 
Trajanje imunosti proti steklini je bilo dokazano po enkratnem cepljenju pri starosti 12 tednov.
In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml). 
V primeru potovanja na območja z večjim tveganjem ali izven EU se lahko veterinarji odločijo za dodatna cepljenja proti steklini po 12. tednu starosti, da zagotovijo titer protiteles v višini ≥ 0,5 i.e./ml, ki na splošno velja za učinkovito zaščito in obenem izpolnjuje zahteve za potovanje živali (titer protiteles ≥ 0,5 i.e./ml).
Aseptically reconstitute the lyophilisate with the suspension. 
Aseptično rekonstituirajte liofilizat s suspenzijo.
BATCH NUMBER Lot {number} 
Lot{številka}
EXP {month/year} Once reconstituted, use immediately. 
EXP {mesec/leto} Rekonstituirano zdravilo uporabite uporabite takoj.
Rabies virus 
Virus stekline
≥ 2.0 IU 
≥ 2,0 i.e.
Two doses of Versican Plus Pi/L4R 3-4 weeks apart from 8-9 weeks of age. 
Dva odmerka cepiva Versican Plus Pi/L4R v razmaku 3-4 tednov od starosti 8-9 tednov naprej.
Canine parainfluenza virus Type 2 
Virus pasje parainfluence tipa 2
CLINICAL PARTICULARS 4.1 Target species Dogs 
KLINIČNI PODATKI 4.1 Ciljne živalske vrste
However, in field studies 10% of sero-negative dogs did not show seroconversion (> 0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies. 
Študije na terenu so pokazale, da pri 10 % serološko negativnih psov ne pride do serološke konverzije (> 0,1 i.e./ml) 3-4 tedne po enkratnem osnovnem cepljenju proti steklini.
MANUFACTURER'S BATCH NUMBER Lot {number} 
PROIZVAJALČEVA ŠTEVILKA SERIJE
Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases. 
Klinični znaki imunsko pogojenih bolezni kot so hemolitična anemija, trombocitopenija, ali poliartritis so bili opaženi v zelo redkih primerih.
At least three years following the primary vaccination course for rabies. 
Vsaj tri leta po osnovnem cepljenju proti stekline.
Primary vaccination scheme: 
Osnovno cepljenje:
− to prevent mortality, clinical signs and infection caused by rabies virus. 
− za preprečevanje smrtnosti, kliničnih znakov in okužb, ki jih povzroča virus stekline.
A single dose of Versican Plus Pi/L4R should be given every 3 years. 
Enkratni odmerek Versican Plus Pi/L4R je potrebno dati vsaka 3 leta.
Re-vaccination scheme: 
Ponovno cepljenje:
The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals following vaccination. 
Cepljene živali lahko po cepljenju izločajo žive atenuirane vakcinalne seve CPiV.
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated): 
Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15 103,1 TCID50* 105,1 TCID50
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus. 
Cepivo je namenjeno aktivni imunizaciji pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo virus pasje parainfluence, Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae in virus stekline.
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. 
Učinkovitost komponente za steklino po enkratnem odmerku v starosti od 12 tednov je dokazana v laboratorijskih študijah.
Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of suspension. 
Plastična škatla s 25 vialami (s po 1 odmerkom) liofilizata in 25 vialami (po 1 ml) suspenzije.
Lyophilisate: spongy matter of white colour. 
Liofilizat: gobasta snov bele barve.
Type 1 glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap. 
Viala iz stekla tipa I, ki vsebuje 1 ml v suspenzije, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of suspension. 
Plastična škatla s 50 vialami (s po 1 odmerkom) liofilizata in 50 vialami (po 1 ml) suspenzije.
Name and address of the manufacturer of the biological active substances 
Ime in naslov proizvajalca (proizvajalcev)biološke (bioloških) učinkovine (učinkovin)
Manufacturer responsible for batch release: 
Proizvajalec, odgovoren za sproščanje serij:
− to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus, 
− za preprečevanje kliničnih znakov (izcedek iz smrčka in oči) in zmanjšanje izločanja virusa, ki jih povzroča virus pasje parainfluence,
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
(European Medicines Agency) (http://www.ema.europa.eu/).
Adjuvant: 
Videz:
At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components. 
Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence in komponentov Leptospire.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila
Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 
Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
Lyophilisate (live attenuated): 
Učinkovina(e): Liofilizat (živ, atenuiran):
Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70 
Liofilizat: trometamol edetna kislina saharoza dekstran 70
ALR** titre ≥ 1:40 
titer ALR** ≥ 1:40
Active substances: 
Pomožna (pomožne) snovi:
VIAL (1 ML SUSPENSION) 
VIALA (1 ML SUSPENZIJA) IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required. 
Vsako leto je treba ponoviti cepljenje proti virusu parainfluence in komponentam Leptospire, za kar se lahko letno uporabi enkratni odmerek kompatibilnega cepiva Versican Plus Pi/L4 vsakoletno, če je potrebno.
In this case the second vaccination with Versican Plus Pi/L4R should not be given before 12 weeks. 
Za prvo cepljenje se lahko uporabiti cepivo Versican Plus Pi/L4, vendar pa v tem primeru cepiva Versican plus Pi/L4R za drugo cepljenje ne smete uporabiti pred 12 tednom starosti.
ALR** titre ≥ 1:51 
titer ALR** ≥ 1:51
ALR titre ≥ 1:51 
titer ALR ≥ 1:51
6.5 Nature and composition of immediate packaging Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap. 
Viala iz stekla tipa I, ki vsebuje 1 odmerek liofilizata, zaprta z zamaškom iz brombutilne gume in aluminijasto zaporko.
PACKAGE LEAFLET: Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs 
Versican Plus Pi/L4R liofilizat in suspenzija za suspenzijo za injiciranje za pse
L. kirschneri serovar Grippotyphosa 
L. kirschneri, serološka skupina Grippotyphosa, serovar Grippotyphosa in
Disodium phosphate dodecahydrate 
Suspenzija: natrijev klorid kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat voda za injekcije
Special warnings for each target species 
POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako ciljno živalsko vrsto:
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs 
NAVODILO ZA UPORABO Versican Plus Pi/L4R liofilizat in v suspenzija za suspenzijo za injiciranje za pse
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju 10-krat prevelikega odmerka cepiva ni bilo opaziti neželenih učinkov, razen tistih, navedenih v poglavju 4.6.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae 
L. interrogans serovar Icterohaemorrhagiae,
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, 
L.interrogans, serološka skupina Canicola,serovar Canicola ter L. interrogans, serološka skupina Icterohaemorrhagiae, serovar Icterohaemorrhagiae,
STATEMENT OF THE MRLs Not applicable. 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
L. interrogans serovar Bratislava 
interrogans serološka skupina Australis, serovar Bratislava,
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
Onset of immunity: - 2 weeks after a single vaccination from 12 weeks of age for rabies, - 3 weeks after completion of the primary course for CPiV and - 4 weeks after the completion of primary course for Leptospira components. 
− 2 tedna po enkratnem cepljenju od 12 tedna starosti dalje proti steklini,
Annual re-vaccination is required for canine parainfluenza and Leptospira components. 
Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence in komponentam Leptospire.
− to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava, 
− za preprečevanje kliničnih znakov, okužbe in izločanja virusa z urinom, ki jih povzroča L.
The procedure started in November 2010. 
Postopek se je začel novembra 2010.
Suppositories containing terpenic derivatives have been authorised through national procedures in Europe since the 1950s and are currently authorised and marketed in seven EU member states. 
Svečke, ki vsebujejo derivate terpena, so bile v Evropi odobrene z nacionalnimi postopki v petdesetih letih prejšnjega stoletja, trenutno pa so odobrene in se tržijo v sedmih državah članicah EU.
Risk minimisation measures 
Ukrepi za zmanjševanje tveganja
In most cases, medication errors involved the use of a child formulation instead of the infant formulation. 
V večini primerov so napake pri uporabi zdravil vključevale uporabo formulacije za otroke namesto formulacije za dojenčke.
Limited clinically relevant efficacy has been demonstrated in the paediatric population. 
Dokazana je bila omejena klinično pomembna učinkovitost pri pediatrični populaciji.
In children less than 30 months, no data on efficacy is available. 
Za otroke, mlajše od 30 mesecev, podatki o učinkovitosti niso na voljo.
In particular, the minimum age recommendations varied from the neonatal period for some products, to 1 or even 6 months of age for others. 
Razlikovala so se zlasti priporočila glede najnižje starosti, in sicer od neonatalnega obdobja za nekatera zdravila, do enega ali celo šest mesecev starosti za druga.
The main data was obtained from spontaneous reports, the literature and pre-clinical data. 
Glavni podatki so bili pridobljeni iz spontanih poročil, literature in predkliničnih podatkov.
Changes to the product information (PI) 
Spremembe informacij o zdravilu
Rectal lesions, including rectal burning, are of particular concern because of their severity and because they represent a limiting factor for treatment duration. 
Rektalne lezije, vključno s pekočo bolečino v danki, so še posebej zaskrbljujoče zaradi svoje resnosti, in ker predstavljajo dejavnik, ki omejuje trajanje zdravljenja.
Overall conclusion 
Splošni zaključki
The CHMP also took into account the 2010 safety review conducted by the French National Agency. 
CHMP je upošteval tudi varnostni pregled, ki ga je leta 2010 izvedla francoska nacionalna agencija.