natgillin/translations-raw huggingface dataset:
In a later laboratory study involving 48 rabbits, 95% of Eravac vaccinated rabbits survived, compared to 65% of rabbits given placebo, following artificial infection with RHDV2 at 12 months after vaccination.
V poznejši laboratorijski študiji, v katero je bilo vključenih 48 kuncev, je preživelo 95 % kuncev, ki so bili cepljeni s cepivom Eravac, v primerjavi s 65 % kuncev, ki so prejemali placebo, potem ko so bili kunci 12 mesecev po cepljenju umetno okuženi z virusom RHDV 2.
In the third study all Eravac-vaccinated rabbits survived, compared with less than 70% of the rabbits in the control group, when rabbits were artificially infected with RHDV2 nine months after vaccination.
V tretji študiji so preživeli vsi kunci, cepljeni s cepivom Eravac, medtem ko je bila stopnja preživetja v kontrolni skupini manj kot 70-odstotna, potem ko so bili kunci devet mesecev po cepljenju umetno okuženi z virusom RHDV 2.
In the second study survival of Eravac-vaccinated rabbits was 93% compared with 50% for rabbits given placebo.
V drugi študiji je bilo preživetje kuncev, cepljenih s cepivom Eravac, 93-odstotno, v primerjavi s 50-odstotnim pri kuncih, cepljenih s placebom.
Eravac (rabbit haemorrhagic disease vaccine, inactivated)
Eravac (inaktivirano cepivo proti hemoragični bolezni kuncev)
In one study all Eravac-vaccinated rabbits survived, compared with a 37% survival rate in the group that received the placebo vaccine.
V eni izmed študij so preživeli vsi kunci, cepljeni s cepivom Eravac, v skupini, cepljeni s placebom, pa je bila stopnja preživetja 37-odstotna.
Eravac contains inactivated rabbit haemorrhagic disease type 2 virus, strain V-1037, as the active substance.
Učinkovina v cepivu Eravac je inaktivirani virus hemoragične bolezni kuncev tipa 2, sev V-1037.
How does Eravac work?
Kako zdravilo Eravac deluje?
The injection should not be repeated.
Injiciranje se ne sme ponoviti.
Further information on Forceris can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/forceris.
Nadaljnje informacije o zdravilu Forceris so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/forceris.
Excess iron is stored mainly in the liver.
Presežek železa se shranjuje predvsem v jetrih.
Hands should be washed after using the medicine.
Po uporabi zdravila si je treba umiti roke.
The European Medicines Agency decided that Forceris' benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Forceris večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Forceris may be harmful for the unborn child.
Zdravilo Forceris je lahko škodljivo za nerojene otroke.
In case of skin or eye contact the affected area should be rinsed immediately with water.
V primeru stika s kožo ali očmi je treba prizadeto področje nemudoma sprati z vodo.
Other information about Forceris
Druge informacije o zdravilu Forceris
It is given as a single injection into the muscle behind the ear of piglets between 24 and 96 hours old.
Daje se daje v obliki enkratne injekcije v mišico za ušesom pujskov, starih med 24 in 96 ur.
The withdrawal period for meat from pigs treated with Forceris is 70 days.
Karenca za meso prašičev, zdravljenih z zdravilom Forceris, je 70 dni.
Forceris received a marketing authorisation valid throughout the EU on 23 April 2019.
Zdravilo Forceris je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 23/04/2019.
As a result it is able to kill the parasites at all stages of their development and prevent the symptoms of coccidiosis and the spread of infection.
Posledično lahko zajedavce uniči na vseh razvojnih stopnjah ter prepreči simptome kokcidioze in širjenje okužbe.
What benefits of Forceris have been shown in studies?
Kakšne koristi je zdravilo Forceris izkazalo v študijah?
Pregnant women and women intending to conceive should avoid contact with the medicine, especially accidental self-injection.
Nosečnice in ženske, ki nameravajo zanositi, naj se izogibajo stiku z zdravilom, zlasti nenamernemu samoinjiciranju.
Forceris is a veterinary medicine.
Forceris je zdravilo za uporabo v veterinarski medicini.
What are the risks associated with Forceris?
Kakšna tveganja so povezana z zdravilom Forceris?
Why is Forceris authorised in the EU?
Zakaj je zdravilo Forceris odobreno v EU?
An overview of Forceris and why it is authorised in the EU
Pregled zdravila Forceris in zakaj je odobreno v EU
What is Forceris and what is it used for?
Kaj je zdravilo Forceris in za kaj se uporablja?
Care should be taken to avoid accidental self-injection, which may cause local reactions such as irritation, granulomas, or severe anaphylactic (allergic) reactions in sensitive people.
Pazite, da ne pride do nenamernega samoinjiciranja, saj lahko pri občutljivih osebah povzroči lokalne reakcije, kot so draženje, granulomi ali hude anafilaktične (alergijske) reakcije.
Forceris must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Zdravilo Forceris se ne sme dajati pujskom, pri katerih obstaja sum pomanjkanja vitamina E ali selena.
Following injection into the muscle, gleptoferron is absorbed and broken down to release iron for use and/or storage depending on the nutritional need of the piglet.
Gleptoferon se po injiciranju v mišico absorbira in presnavlja z namenom, da sprosti železo za uporabo in/ali shranjevanje glede na prehranske potrebe pujska.
Iron is an essential nutrient needed to make haemoglobin to transport oxygen in the blood, as well as certain key enzymes, and may be lacking in the diet of piglets raised under intensive farming conditions.
Železo je pomembno hranilo, ki je potrebno za prenos kisika v krvi in nekaterih ključnih encimov, ki jih morda primanjkuje v prehrani pujskov, vzrejenih v pogojih intenzivnega kmetovanja.
Forceris (toltrazuril/gleptoferron) EMA/146411/2019
Forceris (toltrazuril/gleptoferon) EMA/265640/2019
People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Forceris.
Ljudje, ki so preobčutljivi za (alergični na) železove spojine ali toltrazuril, se morajo izogibati stiku z zdravilom Forceris.
For more information about using Forceris, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Forceris glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy.
Toltrazuril je antiparazitik, ki vpliva na encime, ki jih zajedavci kokcidije potrebujejo za tvorbo energije.
It is used in young piglets on farms which have been affected by the parasitic infection coccidiosis in the past to prevent diarrhoea caused by a new coccidiosis infection, to reduce spread of the infection through passage of oocysts (disease spores) in faeces, and at the same time to prevent iron deficiency anaemia due to lack of iron in the piglets' diet.
Uporablja se pri pujskih na prašičjih farmah, na katerih se je v preteklosti že pojavila parazitska okužba s kokcidiozo, za preprečevanje diareje, ki jo povzroči nova okužba s kokcidiozo, za zmanjšanje širjenja okužbe prek oocist (bolezenskih spor) v iztrebkih in sočasno za preprečevanje anemije zaradi pomanjkanja železa v prehrani pujskov.
Forceris is available as an injection and can only be obtained with a prescription.
Zdravilo Forceris je na voljo v obliki injekcije, njegovo predpisovanje in izdaja pa je le na recept.
For the full list of side effects and restrictions of Forceris, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Forceris glejte navodilo za uporabo.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
V primeru nenamernega samoinjiciranja nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
In a field study performed in 3 EU countries and involving over 1,500 piglets, a single intramuscular injection of Forceris given at 24 to 96 hours of age was effective in preventing iron deficiency anaemia,
V terenski študiji, ki so jo izvedli v treh državah članicah EU in v kateri je sodelovalo več kot 1 500 pujskov, se je izkazalo, da je enkratna intramuskularna injekcija zdravila Forceris, ki se daje v starosti
The other active substance in Forceris, gleptoferron, is an iron-containing compound.
Druga učinkovina v zdravilu Forceris, gleptoferon, je spojina, ki vsebuje železo.
How is Forceris used?
Kako se zdravilo Forceris uporablja?
Forceris contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Zdravilo Forceris vsebuje učinkovini toltrazuril in gleptoferon (spojina, ki vsebuje železo).
reducing oocyst excretion and preventing diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) on the first day after birth.
med 24 in 96 ur, učinkovita pri preprečevanju anemije zaradi pomanjkanja železa, zmanjšanju števila oocist v iztrebkih in preprečevanju diareje, povezane s kokcidiozo, ki jo povzroča zajedavec Cystoisospora suis, v primerjavi z dajanjem samo železa (v obliki gleptoferona) prvi dan po kotitvi.
Skin and eye contact with Forceris can cause irritation and should be avoided.
Izogibajte se stiku zdravila Forceris s kožo in očmi, saj lahko povzroči draženje.
12 August 2013
12. avgust 2013
The Czech Republic is the reference Member State and Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom are concerned Member States.
Referenčna država članica je Češka republika, zadevne države članice pa so Avstrija, Danska, Francija, Nemčija, Irska, Italija, Nizozemska, Portugalska, Španija in Združeno kraljestvo.
The Committee appointed Mr J. Schefferlie as rapporteur and Dr J. Bureš as co-rapporteur.
Odbor je imenoval g. J. Schefferlieja za poročevalca in dr. J. Bureša za soporočevalca.
The opinion was converted into a Decision by the European Commission on 12 August 2013.
Mnenje je bilo spremenjeno v sklep Evropske komisije dne 12. avgusta 2013.
The decentralised procedure started on 29 November 2010.
Decentralizirani postopek se je začel 29. novembra 2010.
International non-proprietary name (INN): amoxicillin and clavulanic acid
Mednarodno nelastniško ime (INN): amoksicilin in klavulanska kislina
Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding the environmental safety of the product.
Med postopkom sta Nizozemska in Združeno kraljestvo opozorila na morebitna resna tveganja, povezana z varnostjo zdravila za okolje.
Written explanations were provided by the applicant on 11 September 2012 and 6 February 2013.
Predlagatelj je 11. septembra 2012 in 6. februarja 2013 predložil pisna pojasnila ter 9. aprila 2013 podal še ustna pojasnila.
On 11 July 2012, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Referenčna država članica, Češka republika, je 11. julija 2012 obvestila Evropsko agencijo za zdravila, da skupina CMD(v) ni dosegla soglasja v zvezi z zdravilom, in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Ker ta vprašanja na 210. dan še vedno niso bila rešena, je bila zadeva 2. maja 2012 v skladu s členom 33(1) Direktive 2001/82/ES napotena na usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
This is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water authorised in the Czech Republic (MA No. 96/069/98-C).
Gre za vlogo za generično zdravilo v skladu s členom 13(1) Direktive 2001/82/ES, kakor je bila spremenjena, ki se sklicuje na referenčno zdravilo Amoksiklav 500/125 mg/g prašek za dajanje v vodo za pitje, ki je odobreno v Češki republiki (št. dovoljenja za promet: 96/069/98-C).
Day 60 of the CMD(v) procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Ker na 60. dan postopka, 29. junija 2012, zadevne države članice še vedno niso dosegle soglasja v zvezi z zdravilom, je bil postopek napoten na CVMP.
STRENZEN 500/125 mg/g powder for use in drinking water for pigs contains amoxicillin and clavulanic acid as active ingredients and is intended for use in pigs for the treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp.
Zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče vsebuje zdravilni učinkovini amoksicilin in klavulansko kislino in je namenjeno za uporabo pri prašičih za zdravljenje okužb dihal, ki jih povzročajo mikroorganizmi Actinobacillus pleuropneumoniae, Pasteurella spp.
Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of STRENZEN 500/125 mg/g powder for use in drinking water for pigs is positive.
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da je razmerje med tveganji in koristmi za zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče pozitivno.
The applicant, Novartis Animal Health Inc., submitted an application for a decentralised procedure for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names.
Predlagatelj, družba Novartis Animal Health Inc., je predložil vlogo za decentralizirani postopek za zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče in povezana imena.
Therefore, the Committee adopted by consensus a positive opinion on 10 April 2013 recommending the granting of a marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names.
Odbor je zato 10. aprila 2013 soglasno sprejel pozitivno mnenje, v katerem je priporočil odobritev dovoljenja za promet z zdravilom STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče ter povezanimi imeni.
Opinion following an Article 33(4)1 referral for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)0F za zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče in povezana imena
Do not use external heat.
Ne uporabljajte zunanjih virov vročine.
These differences should be taken into account when dosing.
Te razlike je treba upoštevati pri odmerjanju.
Do not reuse equipment.
Opreme ne uporabljajte ponovno.
5000 Davis Drive Research Triangle Park, NC 27709 USA
5000 Davis Drive Research Triangle Park, NC 27709 Združene države Amerike
Take your dose as soon as you remember and then resume your normal dosing schedule.
Svoj odmerek vzemite takoj, ko se spomnite, nato pa nadaljujte z običajnim urnikom odmerjanja.
Turn the leaflet over for section 7.
Obrnite list na poglavje 7.
How often you need an injection will depend on how well ELOCTA is working for you.
Kako pogosto boste potrebovali injekcijo bo odvisno od tega, kako dobro zdravilo ELOCTA deluje pri vas.
EXP Use within 6 hours after reconstitution.
EXP Uporabite v 6 urah po rekonstituciji.
Wash your hands before opening the pack
Preden odprete pakiranje, si umijte roke.
Your doctor may change your recommended injection rate to make it more comfortable for you.
Vaš zdravnik lahko spremeni priporočeno hitrost injiciranja tako, da vam bo bolj udobno.
This is of importance particularly when changing the laboratory and/or reagent used in the assay.
To je pomembno zlasti pri menjavi laboratorija in/ali reagenta, uporabljenega za preiskavo.
Date removed from refrigerator:
Datum odvzema iz hladilnika:
Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Zato se lahko faktor VIII uporablja med nosečnostjo in dojenjem le, če je jasno indiciran.
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Če se taki zaviralci pojavijo, se stanje kaže kot nezadosten klinični odziv.
1 In some patients and circumstances the dosing interval can be prolonged up to 36 hours.
1 Pri nekaterih bolnikih in v nekaterih okoliščinah se lahko interval odmerjanja podaljša za do 36 ur.
Check the name and strength of the package, to make sure it contains the correct medicine.
Preverite ime in jakost na pakiranju in zagotovite, da vsebuje pravilno zdravilo.
Frequency of doses (hours)/ Duration of therapy (days)
Pogostnost odmerkov (ure)/trajanje zdravljenja (dnevi)
Study I*
Študija I*
Pack size of 1.
Velikost pakiranja je 1.
79.2 % of first injections were rated as excellent or good by the patients.
79,2 % prvih injekcij so bolniki ocenili kot izvrstne ali dobre.
Do not stop using ELOCTA without consulting your doctor.
Zdravila ELOCTA ne prenehajte uporabljati, ne da bi se posvetovali s svojim zdravnikom.
QR code to be included+ http://www.elocta-instructions.com
Vključena bo koda QR + http://www.elocta-instructions.com
Administration (Intravenous injection):
Dajanje (intravensko injiciranje):
No symptoms of overdose have been reported.
Ni poročil o simptomih prevelikega odmerjanja.
• There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ELOCTA.
• Obstaja majhna možnost, da boste doživeli anafilaktično reakcijo (huda, nenadna alergijska reakcija) na zdravilo ELOCTA.
The rate of administration should be determined by the patient's comfort level and should not exceed 10 mL/min.
Hitrost dajanja se določi glede na raven bolnikovega udobja in ne sme preseči 10 ml/min.
After reconstitution, chemical and physical stability has been demonstrated for 6 hours when stored at room temperature (up to 30°C).
Po rekonstituciji sta bili kemična in fizikalna stabilnost dokazani za 6 ur za zdravilo, shranjeno pri sobni temperaturi (do 30 °C).
See section 5.2 for pharmacokinetic data.
Glejte poglavje 5.2 za farmakokinetske podatke.
If severe, sudden allergic reactions (anaphylactic reaction) occur, the injection must be stopped immediately.
Če se pojavijo hude, nenadne alergijske reakcije (anafilaktična reakcija), morate z injiciranjem takoj prenehati.
• if you are allergic to efmoroctocog alfa or any other ingredients of this medicine (listed in section 6).
• če ste alergični na efmoroktokog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Posamezni bolniki se lahko med seboj razlikujejo pri svojem odzivu na faktor VIII ter kažejo različne razpolovne čase in okrevanja.
If you stop using ELOCTA you may no longer be protected against bleeding or a current bleed may not stop.
Če boste prenehali uporabljati zdravilo ELOCTA, morda več ne boste zaščiteni pred krvavitvami ali pa se trenutna krvavitev ne bo ustavila.
90.2 % of first injections were rated as excellent or good by the patients and their caregivers.
90,2 % prvih injekcij so bolniki ali njihovi negovalci ocenili kot odlične ali dobre.
Do not use this medicine if it has been stored at room temperature for longer than 6 months.
Zdravila ne uporabite, če je bilo pri sobni temperaturi shranjeno dlje kot 6 mesecev.
Fertility There are no fertility data available.
Plodnost Podatkov o plodnosti ni na voljo.
The specific activity of ELOCTA is 4000-10200 IU/mg protein.
Specifična aktivnost zdravila ELOCTA je 4.000-10.200 i.e./mg beljakovine.
In case of anaphylactic shock, standard medical treatment for shock should be implemented.
V primeru anafilaktičnega šoka je treba uvesti standardno zdravljenje šoka.
(pre- and postoperative)
(pred operacijo in po njej)
Do not touch the top of the vial or allow it to touch anything else once wiped.
Zgornjega dela viale se ne dotikajte in ne dovolite, da se dotakne česa drugega, potem ko jo obrišete.
Do not use beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, whichever is earlier.
Ne uporabljajte po izteku roka uporabnosti, ki je natisnjen na viali, ali šest mesecev po odstranitvi škatle iz hladilnika; kar nastopi prej.
In comparison with adolescents and adults, children less than 12 years of age may have a higher clearance and a shorter half-life which is consistent with observations of other coagulation factors.
V primerjavi z mladostniki in odraslimi je pri otrocih, starih manj kot 12 let, očistek večji in razpolovni čas krajši, kar je v skladu z opažanji pri drugih koagulacijskih faktorjih.
12 to <18 years
12 do < 18 let
For adolescents of 12 years of age and above, the dose recommendations are the same as for adults.
Za mladostnike, stare 12 let ali več, so priporočila za odmerjanje enaka kot za odrasle.
If you are on a controlled sodium diet see section 2.
Če ste na dieti z nadzorovanim vnosom natrija, glejte poglavje 2.
Study II
Študija II
Out of 153 subjects who completed Study I, 150 were enrolled onto Study III (extension study).
Med 153 osebami, ki so zaključile študijo I, jih je bilo 150 vključenih v študijo III (podaljšek študije).
Elderly There is limited experience in patients ≥65 years.
Izkušnje pri bolnikih, starih ≥ 65 let, so omejene.
12 adolescent subjects age 12 up to 18 years were included in the adult study population on prophylactic treatment.
12 mladostnikov, starih od 12 do 18 let, je bilo vključenih v odraslo študijsko populacijo za profilaktično zdravljenje.
ELOCTA can be used in children and adolescents of all ages.
Zdravilo ELOCTA se lahko uporablja pri otrocih in mladostnikih vseh starosti.
Do not use this medicine after the expiry date which is stated on the carton and the vial label after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki škatle in viale poleg oznake "EXP".
Paediatric population No age-specific differences in adverse reactions were observed between paediatric and adult subjects.
Pediatrična populacija Starostno specifičnih razlik v neželenih učinkih med pediatričnimi in odraslimi osebami niso opazili.
The Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Spodaj predstavljena preglednica 2 je v skladu s klasifikacijo organskih sistemov MedDRA (klasifikacija organskih sistemov in raven prednostnega izraza).
The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 20 exposure days.
Tveganje za nastanek inhibitorjev je odvisno od resnosti bolezni in izpostavljenosti faktorju VIII, in je največje v prvih 20 dneh izpostavljenosti.
Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels in your blood.
Zdravnik bo z ustreznimi laboratorijskimi preiskavami zagotovil, da bodo ravni faktorja VIII v vaši krvi ustrezne.
ELOCTA is used to replace the missing or deficient factor VIII.
Zdravilo ELOCTA se uporablja za nadomeščanje manjkajočega ali pomanjkljivo delujočega faktorja VIII.
In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Na splošno je treba vse bolnike, zdravljene s koagulacijskim faktorjem VIII, skrbno spremljati glede nastanka zaviralcev z ustreznimi kliničnimi opazovanji in laboratorijskimi preiskavami.
For children below the age of 12, more frequent or higher doses may be required (see section 5.1).
Za otroke, stare manj kot 12 let, bodo morda potrebni pogostejši ali večji odmerki (glejte poglavje 5.1).