natgillin/translations-raw huggingface dataset:
ROUTE(S) OF ADMINISTRATION Intramuscular injection
NAČIN IN POT(I) UPORABE Intramuskularno injiciranje
In animals with hepatic and renal failure, the dosage regimen should be carefully evaluated.
Pri živalih z odpovedjo jeter in ledvic je treba način odmerjanja previdno določiti.
The safety of the product has not been assessed in pregnant and lactating targets species.
Varnost izdelka ni ocenjena pri ciljnih živalskih vrstah v obdobju brejosti in laktacije.
Suramox 15% LA and its associated name Stabox 15% LA is presented as an injectable suspension containing amoxicillin, which is a β-lactam antibiotic, belonging to the group of penicillins intended for the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Zdravilo Suramox 15 % LA in z njim povezano ime Stabox 15 % LA sta na voljo v obliki raztopine za injiciranje, ki vsebujeta amoksicilin, ki je beta-laktamski antibiotik iz skupine penicilinov, namenjenih zdravljenju okužb dihal, ki jih povzročata Pasteurella multocida in Mannheimia haemolytica pri govedu, ter za zdravljenje okužb dihal, ki jih povzroča Pasteurella multocida pri prašičih.
It is recommended that the maximum volume administered per site of injection should not exceed 20 ml in cattle and 5 ml in swine.
Priporočamo vam, da ne prekoračite največje količine, odmerjene na kraju injiciranja, ki pri govedu znaša 20 ml in pri prašičih 5 ml.
The use of heavier animals would have given extra assurance about residues levels at the injection site and would have made all studies homogenous.
Uporaba težjih živali pri teh študijah bi zagotovila večjo potrditev vrednosti ostankov na mestih injiciranja, študije pa bi tako bile tudi homogene.
50 days - Milk: 2.5 days BATCH NUMBER <Batch> <Lot> <BN> {number} EXPIRY DATE <EXP {month/year}> Shelf-life after first opening the container: 28 days.
2,5 dni ŠTEVILKA SERIJE <Serija> <lot> <številka serije> {številka} DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA <EXP {mesec/leto}> Rok uporabnosti po prvem odpiranju ovojnine: 28 dni.
Hypersensitity reactions unrelated to dose can be observed.
Ugotoviti je mogoče reakcije preobčutljivosti, kar ni povezano z odmerkom.
All samples were analysed for amoxicillin concentrations using a validated HPLC-MS/MS method with a limit of quantification of 25 µg/kg for all tissues.
Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC-MS/MS z mejo kvantifikacije 25 µg/kg za vsa tkiva.
Amoxicillin belongs to β-lactams antibiotic family.
Amoksicilin spada v skupino beta-laktamskih antibiotikov.
A withdrawal period of 88 days is therefore established for cattle.
Za govedo je tako bila določena 88-dnevna karenca.
The animals were slaughtered at 7, 14, 46 and 57 days after the final injection.
Živali so bile zaklane 7, 14, 46 in 57 dni po zadnjem odmerku.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Zdravilna(e) učinkovina(e):
With the exception of one animal after 36 days which had high residues (core sample 339.4 µg/kg), residue levels were below the MRL after 30, 38 and 46 days.
Z izjemo ene živali, pri katerih so bile 36 dni po zakolu vrednosti ostankov zelo visoke (osnovni vzorec 339,4 µg/kg), so bile pri vseh drugih vzorcih koncentracije ostankov po 30, 38 in 46 dneh pod mejno vrednostjo ostankov.
β-lactam antibiotics prevent the bacterial cell wall synthesis by interfering with the final stage of peptidoglycan synthesis.
Beta-laktamski antibiotiki preprečujejo sintezo bakterijske celične stene, pri čemer onemogočajo končno stopnjo sinteze peptidoglikana.
Shelf-life after first opening the container: 28 days.
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
In view of the weight of the animals only one injection site sample (core plus surrounding) was available for analysis unlike in the pivotal study where there were three samples per animal.
Ob upoštevanju mase živali je bil za analizo na voljo samo en vzorec tkiva na mestu injiciranja (mesto injiciranja in okolica), za razliko od glavne študije, pri kateri so bili pri vsaki živali analizirani trije vzorci tkiv.
The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold.
Odbor za zdravila za uporabo v veterinarski medicini je določil take mejne vrednosti ostankov, da vnos z vso hrano pri potrošniku ne preseže meje 30 µg.
Target tissue
Ciljna tkiva
The results from the study were used to design the pivotal residue study to include time points at 7, 14, 21 and 27 days after the last injection.
Na podlagi rezultatov študije je bila oblikovana glavna študija izločanja ostankov s časovnimi točkami 7, 14, 21 in 27 dni po zadnjem injiciranju.
2.1 Residue studies in cattle
2.1 Študije izločanja ostankov pri govedu
2.3 Residue studies in pigs
2.3 Študije izločanja ostankov pri prašičih
The first residue depletion study in cattle was performed to identify the time points to be used in the pivotal residue depletion study.
Prva študija izločanja ostankov pri govedu je bila izvedena za opredelitev časovnih točk za uporabo pri glavni študiji izločanja ostankov.
The statistical approach could not be used for the calculation of the withdrawal period as the test for log-linearity (F-test) was not met and therefore the ‘alternative approach' as set out in the CVMP guideline (EMEA/CVMP/036/95-Final) was used.
Statistični pristop se ni mogel uporabiti za izračun karence na mestu injiciranja, saj test logaritemske linearnosti (F-test) ni bil izpolnjen, tako da je bil uporabljen „alternativni pristop“ v skladu z navodili Odbora za zdravila za uporabo v veterinarski medicini (EMEA/CVMP/036/95-Končni).
Use during pregnancy or lactation
Uporaba med brejostjo ali laktacijo
• the new residue depletion studies in both cattle and pigs are of an acceptable standard and in large part in accordance with CVMP guideline on injection site residues (EMEA/CVMP/542/03);
• so nove študije o izločanju ostankov pri govedu in prašičih sprejemljive kakovosti in večinoma v skladu z Navodili Odbora za zdravila za uporabo v veterinarski medicini Pristop k usklajevanju karenc (EMEA/CVMP/542/03);
The pilot residue depletion study in pigs was performed to identify the time points to be used in the pivotal residue depletion study.
Pilotna študija izločanja ostankov pri prašičih je bila izvedena za določitev časovnih točk za uporabo pri glavni študiji izločanja ostankov.
In the pivotal residue study, heavy animals (body weight: 66 - 84.5 kg) were used (eight male and eight female).
Pri glavni študiji izločanja ostankov so bile uporabljene težke živali (telesna masa 66-84,5 kg) (8 samcev in 8 samic).
In the pivotal residue study, heavy animals (body weight: 600 to 692 kg) were used (eight males and eight females).
Pri glavni študiji izločanja ostankov so uporabili težke živali (telesna masa 600 do 692 kilogramov) (osem samcev in osem samic).
• A meat withdrawal period of 88 days for cattle and 50 days for pigs can now be established;
• se lahko za govedo tako določi karenca 88 dni, za prašiče pa karenca v trajanju 50 dni.
4.2 Indications for use, specifying the target species Cattle: Treatment of respiratory infections due to Pasteurella multocida and Mannheimia haemolytica.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Govedo: Zdravljenje infekcij dihal zaradi Pasteurella multocida in Mannheimia haemolytica.
Amoxicillin is susceptible to breakdown by ß-lactamases produced by some bacterial strains.
Amoksicilin je dovzeten na razdelitev beta-laktamaz, ki jih proizvajajo nekateri bakterijski sevi.
Pigs: Treatment of respiratory infections due to Pasteurella multocida.
Prašiči: Zdravljenje infekcij dihal zaradi Pasteurella multocida.
At the injection site residues above the muscle MRLs were found in at least one core sample at the last time point tested (27 days) and as a result three other residues studies measuring residue levels at 30, 36, 38 and 46 days were carried out.
Na mestih injiciranja so vsaj pri enem vzorcu mišičnega tkiva vrednosti koncentracije ostankov presegle mejne vrednosti ostankov pri živalih, zaklanih na zadnji časovni točki (27 dni), zato so posledično bile izvedene še tri študije izločanja ostankov, pri katerih so merili koncentracijo ostankov 30, 36, 38 in 46 dni po zakolu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX of 125, 250 or 500 ml
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 125, 250 ALI 500 ml
Further reassurance as to the adequacy of this withdrawal period is provided by the fact that at 46 days residues were below the LOQ in all injection site samples.
Dodatno potrditev tega obdobja karenca daje tudi dejstvo, da so bile pri 46 dnevni časovni točki vse vrednosti koncentracije ostankov na mestih injiciranja pod mejo določljivosti (LOQ).
Residues from the core injection site and its surrounding also remained below the limit of detection of muscle (2.1 µg/kg) in all samples after 80 days and three samples after 90 days with remaining one being below the limit of quantification (25 µg/kg).
Ostanki na mestu injiciranja in njegovi okolici so bili po 80 dneh pri vseh vzorcih pod ravnijo detekcije pri mišičnem tkivu (2,1 µg/kg), po 90 dneh pa pri treh vzorcih, z izjemo enega, pri katerem pa je bila vrednost ostanka pod določeno mejo kvantifikacije (25 µg/kg).
In order to obtain the lifting of the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA, the marketing authorisation holder performed four new residue studies in cattle and five new residue studies in pigs.
Za odpravo preklica dovoljenja za promet z zdravilom Suramox 15 % LA in z njim povezanega imena Stabox 15 % LA je imetnik dovoljenja za promet z zdravilom izvedel štiri nove študije izločanja ostankov pri govedu in pet novih študij izločanja ostankov pri prašičih.
Cattle: Treatment of respiratory infections due to Pasteurella multocida and Mannheimia haemolytica.
Govedo: Zdravljenje infekcij dihal zaradi Pasteurella multocida in Mannheimia haemolytica.
The statistical approach, although preferred, could not be used for the calculation of the withdrawal period at the injection site given the non homogeneous nature of the studies as shown by the weight differences as well as the way residue levels were determined (3 samples versus just one), and therefore the ‘alternative approach' as set out in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) was used.
Statistični pristop, ki je sicer zaželen, se tokrat ni mogel uporabiti za izračun karence na mestu injiciranja zaradi nehomogenosti študij, kot jih kažejo prevelike razlike v masi uporabljenih živali, ter načina določitve vrednosti ostankov (3 vzorci v primerjavi z enim), zato se je uporabil „alternativni pristop“ v skladu z Navodili Odbora za zdravila za uporabo v veterinarski medicini: „Pristop k usklajevanju karenc“ (EMEA/CVMP/036/95).
After a single intramuscular administration of the product at 15 mg/kg to pigs, mean amoxicillin plasma peak concentration of 3.78 µg/ml is reached 0.77 hours after dosing.
Po posameznem intramuskularnem dajanju zdravila v količini 15 mg/kg pri prašičih je povprečna največja koncentracija3,78 µg/ml amoksicilina v plazmi dosežena v 0,77 ure.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Vsako neuporabljeno zdravilo za uporabo v veterinarski medicini ali odpadni material tega zdravila odstranite v skladu z nacionalnimi predpisi.
(as trihydrate) Excipient:
(kot trihidrat)
In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA/10 kg bw) twice at 48 hours interval.
Pri obeh vrstah se zdravilo injicira intramuskularno z odmerkom 15 mg amoksicilina/kg telesne mase (enakovredno 1 ml zdravila Suramox 15 % LA/10 kg telesne mase) dvakrat v intervalu 48 ur.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RESIDUE DATA FOR SURAMOX 15% LA AND ITS ASSOCIATED NAME STABOX 15% LA, SUBMITTED TO THE CVMP AS A FOLLOW-UP OF AN ARTICLE 35 REFERRAL, FOR LIFTING THE SUSPENSION OF THE MARKETING AUTHORISATIONS
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA PODATKOV O IZLOČANJU OSTANKOV ZA ZDRAVILO SURAMAX 15 % IN Z NJIM POVEZANO IME STABOX 15 % LA, PREDLOŽENO ODBORU ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI KOT NADALJEVANJE POSTOPKA NAPOTITVE V SKLADU S ČLENOM 35 ZA UMIK PREKLICA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Pharmaceutical form
FARMACEVTSKA OBLIKA
Cattle and pigs: Administer 15 mg amoxicillin (as trihydrate) per kg bodyweight equivalent to 1 ml per 10 kg, twice at 48 hours interval.
Govedo in prašiči: Odmerite 15 mg amoksicilina (kot trihidrat) na kg telesne teže, enakovredno 1 ml na 10 kg, dvakrat v razmiku 48 ur.
Micronised amoxicillin
Mikronizirani amoksicilin
The results from the study were used to design the pivotal residue study to include time points at 7, 14, 46 and 57 days after the last injection.
Rezultati študije so bili uporabljeni pri določanju časovnih točk zakola 7, 14, 46 in 57 dni po zadnjem injiciranju.
Having considered the new residue depletion data provided for the lifting of the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA concerning the establishment of withdrawal periods for cattle and pigs, the CVMP concluded that:
Ob upoštevanju novih podatkov o izločanju ostankov, predloženih za umik preklica dovoljenja za promet z zdravilom Suramox 15 % LA in z njim povezanega imena Stabox 15 % LA v zvezi z določitvijo karence za govedo in prašiče je Odbor za zdravila za uporabo v veterinarski medicini zaključil, da:
Therefore, the Committee for Medicinal Products for Veterinary Use recommends to lift the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA and to vary the marketing authorisations in order to set the withdrawal periods as stated above.
Odbor za zdravila za uporabo v veterinarski medicini zato priporoča, da se preklic dovoljenja za promet za zdravilo Suramox 15 % LA in z njim povezano ime Stabox 15 % LA umakne in ter da se dovoljenje za promet z zdravilom spremeni v skladu z zgoraj navedenima obdobjema karence.
After a single intramuscular administration of the product at 15 mg/kg to cattle, mean amoxicillin plasma peak concentration of 2.93 µg/ml is reached 1.64 hours after dosing.
Po posameznem intramuskularnem dajanju zdravila v količini 15 mg/kg pri govedu povprečna največja koncentracija 2,93 µg/ml amoksicilina v plazmi doseženav 1,64 ure.
Using the ‘alternative approach' as stated in CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) a withdrawal period of 8 days is obtained after adding 10 % ‘uncertainty factor'.
Z uporabo „alternativnega pristopa“, določenega v skladu z „Navodili: Pristop k usklajevanju karenc“ (EMEA/CVMP/036/95), je dodana karenca v trajanju 8 dni zaradi dodanega 10 % „faktorja negotovosti“.
Using the ‘alternative approach' as stated in CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) a withdrawal period of 16 days is obtained after adding 10 % ‘uncertainty factor'.
Z uporabo „alternativnega pristopa“, določenega v skladu z „Navodili: Pristop k usklajevanju karenc“ (EMEA/CVMP/036/95), je dodana karenca v trajanju 16 dni zaradi dodanega 10 % „faktorja negotovosti“.
The first time point where residues fell below their respective MRLs was 38 days in all injection site samples.
Prva časovna točka, pri kateri so bile vse koncentracije ostankov pod mejnimi vrednostmi ostankov, je bila 38 dni pri vseh vzorcih, vzetih na mestu injiciranja.
However, the actual withdrawal period for the product is to be based on the injection site residues.
Kljub temu pa se dejanska karenca določi na podlagi vrednosti ostankov na mestu injiciranja.
A withdrawal period of 50 days is therefore established for pigs.
Za prašičje meso je tako določena karenca 50 dni.
Allergic reactions, skin reactions, anaphylaxis) may occur.
Pojavijo se lahko alergične reakcije, reakcije kože, anafilakse.
Micronised amoxicillin (as trihydrate) 150.0 mg/ml Excipient: Benzyl alcohol 35.0 mg/ml
Pomožna snov: benzil alkohol 35,0 mg/ml
Liver Kidney Milk
Ledvica Mleko
Spain
FRANCIJA
Suramox 15% LA, suspension for injection Amoxicillin
Suramox 15% LA, suspenzija za injiciranje Amoksicilin
NAME OF THE VETERINARY MEDICINAL PRODUCT Suramox 15% LA, suspension for injection
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suramox 15% LA, suspenzija za injiciranje
A safety span of 30% was considered necessary in this case because at the previous time point, which was only 2 days earlier, one sample contained residues of nearly 7 times the MRL.
V tem primeru je bil zaradi enega vzorca, pri katerem je pri predhodni časovni točki, ki je bila le dva dni prej, izmerjena vrednost koncentracije ostankov presegla mejno vrednost ostankov za kar sedemkrat, določen 30 % varnostni razpon.
The first time point where residues fell below their respective MRLs was 80 days in all injection site samples.
Prva časovna točka, pri kateri so bile vse koncentracije ostankov pod mejno vrednostjo ostankov, je bila na vseh mestih injiciranja 80 dni.
6.5 Nature and composition of immediate packaging Polyethylene terephtalate (PET) bottles with rubber closures and aluminium capsules Product presentations:
Steklenice iz polietilen tereftalata (PET) z gumijastim pokrovom in aluminijevimi kapsulami.
• time points where residues at the injection sites were below the muscle MRL were identified for both cattle and pigs;
• se lahko določijo časovne točke za govedo in prašiče, pri katerih je koncentracija ostankov v mišicah na mestu injiciranja pod mejno vrednostjo ostankov;
Residue levels in kidney, fat, liver and non-injection site muscle were below their respective MRLs from the first time point (7 days) tested.
Vrednosti ostankov v ledvicah, maščobnem tkivu, jetrih in mišičnem tkivu, v katera niso bili injicirani odmerki, so bile pri prvi časovni točki (7 dni) pod mejno vrednostjo ostankov.
The animals were given 15 mg amoxicillin/kg bw corresponding to 1ml/10 kg bw which required 4 injections, three of which were the maximum volumes (20 ml) and the remaining given in the fourth injection.
raztopine/10 kg telesne mase; za to so bile potrebne štiri injekcije, tri od teh so bile največje možne količine (20 ml), preostala količina pa je bila injicirana s četrtim odmerkom.
Residue levels in fat, liver, kidney and non-injection site muscle were below the limit of quantification from the first time point (7 days) with the exception of one kidney sample that contained residues at the level of the limit of quantification (25 µg/kg).
Vrednosti koncentracije ostankov v maščobnih tkivih, jetrih, ledvicah in mišicah, v katere raztopine niso bile injicirane direktno, so bile pri prvi časovni točki (7 dni) pod mejno vrednostjo koncentracije ostankov, z izjemo enega vzorca ledvic, ki je vseboval mejno vrednost 25 µg/kg.
The animals were given 15 mg amoxicillin/kg bw corresponding to 1ml/10 kg/bw which required 2 injections, one of which was the maximum volume (5 ml) and the remaining given in the second injection.
raztopine /10 kg telesne mase; za to sta bili potrebni dve injekciji, ena od njiju največje možne količine (5 ml), preostala količina pa je bila injicirana z drugim odmerkom.
2.4 Determination of meat withdrawal periods for pigs
2.4 Izračun karence za prašičje meso
Box of 125 ml bottle
Škatla s steklenico 125 ml
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6.6 Posebni varnosti ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Box of 250 ml bottle
Škatla s steklenico z250 ml
Residue levels in fat+skin, liver and non injection site muscle were all below the limit of quantification from the first time point (7 days) with the exception of one kidney sample which had residues above the MRL at the first time point and another one above the Limit of quantification.
raztopine niso bile injicirane, so bile pri prvi časovni točki (7 dni) pod mejno vrednostjo kvantifikacije, z izjemo enega vzorca ledvic, pri katerem je bila pri prvi časovni točki koncentracija ostankov nad mejno vrednostjo ostankov, ter drugega vzorca ledvic, ki je vseboval ostanke nad mejo kvantifikacije.
PACKAGE LEAFLET Suramox 15% LA, suspension for injection
NAVODILO ZA UPORABO Suramox 15% LA, suspenzija za injiciranje
Box of 500 ml bottle
Škatla s steklenico 500 ml
Aluminium stearate Propylene glycol dicaprylate/dicaprate
Propilen glikol dikaprilat/dikaprat 6.2 Inkompatibilnosti
This veterinary medicinal product does not require any special storage conditions required.
POSEBNA NAVODILA ZA SHRANJEVANJE Za shranjevanje ni posebnih navodil.
MRLs
Jetra
2.2 Determination of meat withdrawal periods for cattle
2.2 Izračun karence za meso govedi
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
At the injection site, residues above the muscle MRLs were found in all three core samples at the last time point tested (57 days) and as a result two other residues studies measuring residue levels at 80 and 90 days were carried out.
57 dniZato sta bili izvedeni še dve študiji izločanja ostankov, pri katerih so merili koncentracijo 80 in 90 dni po zakolu.
• A meat withdrawal period can be set in both cattle and pigs using the ‘Alternative approach' as stated in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95);
• se lahko z uporabo „alternativnega pristopa“ v skladu z Navodili Odbora za zdravila za uporabo v veterinarski medicini Pristop k usklajevanju karenc (EMEA/CVMP/542/03) določi karenca za govedo in za prašiče;
Benzyl alcohol
Aluminijev stearat
Muscle Fat
Maščobna tkiva
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 125, 250 or 500 ml
Steklenica 125, 250 ali 500 ml
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 25 October 2005
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 25. oktober 2005
Unopened container: 2 years
Neodprt vsebnik: 2 leti
After first opening the container: 4 weeks.
Po prvem odprtju vsebnika: 4 tedne.
These findings are not necessarily indicative of a potential for functional changes in humans.
Ti izsledki pa ne kažejo nujno na možnost funkcionalnih sprememb pri človeku.
See Table 5 and 6 for results from both studies.
Za izsledke obeh študij glejte Preglednici 5 in 6.
However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
Ker pa to ni bila prospektvina, randomizirana in kontrolirana študija, morate vse primerjave z zunanjo kontrolno skupino pazljivo vrednotiti.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/
Fixed-time period c
Določeno časovno obdobje c
Use in paediatric patients
Uporaba pri pediatričnih bolnikih
Dose adjustment of calcium channel blockers may be required.
Lahko bo potrebna prilagoditev odmerka zaviralcev kalcijevih kanalov.
• Existing symptomatic arrhythmias
• obstoječe simptomatične aritmije,
If you have any suspension left in a bottle more than four weeks after it was first opened, you should not use this medicine.
Če vam v steklenički še ostane nekaj suspenzije več kot štiri tedne po prvem odprtju, tega zdravila ne smete več uporabljati.
Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery such as sleepiness or blurred vision.
Obvestite svojega zdravnika, če imate kakršnekoli učinke, zaradi katerih bi lahko imeli težave pri vožnji ali upravljanju drugih strojev, na primer zaspanost ali zamegljen vid.