natgillin/translations-raw huggingface dataset:
- if you have type 1 diabetes.
(pogledajte dio 4.). - ako imate šećernu bolest tipa 1 koja se ponekad naziva šećernom bolešću ovisnom o inzulinu.
Hospitalization for heart failure
Oštećenje funkcije bubrega
This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Ristfor (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Ristfor, as you may experience low blood sugar levels (hypoglycaemia).
- ako imate ili ste imali alergijsku reakciju na sitagliptin, metformin ili Ristfor (pogledajte dio 4.).
tmax is between 3 and 8 hours.
Vrijednost Tmax je između 3 i 8 sati.
Your doctor will advise you.
Liječnik će Vas savjetovati.
Children and adolescents
Djeca i adolescent
- Do not take a double dose to make up for a forgotten dose.
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
The volume of distribution is around 10 l/kg.
Volumen distribucije je oko 10 l/kg.
When opened, use within 3 months.
Kada se otvori, upotrijebiti unutar 3 mjeseca.
Week 1, 2, 3, 4 Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
Tjedan 1, 2, 3, 4 Dan 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
To benefit from your medicine you should take it regularly every day at the same time of the day.
Kako bi imali korist od ovog lijeka, trebate ga uzimati redovito svaki dan, u isto doba dana.
Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur:
Zbog farmakoloških učinaka i mehanizma djelovanja memantina moguće su sljedeće interakcije:
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem netolerancije fruktoze ne bi trebali uzimati ovaj lijek.
The tablet can be divided into equal doses.
Tableta se može razdijeliti na jednake doze.
The clinical relevance of these findings is unknown.
Klinički značaj tih nalaza nije poznat.
Take one tablet once a day.
Uzmite jednu tabletu jednom dnevno.
Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Neki čimbenici koji mogu povisiti pH mokraće (vidjeti dio 5.2 “Eliminacija”) mogu zahtijevati pažljivo nadziranje bolesnika.
The effects of barbiturates and neuroleptics may be reduced.
Učinci barbiturata i neuroleptika mogu biti smanjeni.
There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Moguća je povezanost između tog nakupljanja i vakuolizacije opažene u plućima.
Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain.
Gubitak pamćenja u Alzheimerovoj bolesti pripisuje se poremećaju prijenosa signala u mozgu.
2 Isolated cases reported in post-marketing experience.
2 Izolirani slučajevi prijavljeni u postmarketinškom iskustvu.
About 45% of memantine is bound to plasma-proteins.
Oko 45% memantina veže se na proteine plazme.
In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
U prospektivno definiranoj primarnoj analizi nije postignuta statistička značajnost primarnih ishoda djelotvornosti u 24. tjednu.
The treatment scheme is also indicated on the treatment initiation pack.
Shema liječenja je također opisana u pakovanju za uvođenje liječenja.
Purified water
voda, pročišćena
Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
Umjerena do teška Alzheimerova bolest obično uzrokuje oštećenje sposobnosti upravljanja vozilima i kompromitira sposobnost rada sa strojevima.
No specific antidote for intoxication or overdose is available.
Ne postoji specifični antidot za intoksikaciju ili predoziranje.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Liječnik će Vam reći dopušta li Vam bolest sigurno upravljanje vozilima i rad sa strojevima.
In the event of overdose, treatment should be symptomatic.
U slučaju predoziranja liječenje treba biti simptomatsko.
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours.
Memantin se eliminira monoeksponencijalno s terminalnim t½ od 60 do 100 sati.
The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Brzina bubrežne eliminacije memantina u uvjetima alkalnog urina može biti smanjena za faktor od 7 do 9 (vidjeti dio 4.4).
- If you find you have forgotten to take your dose of Memantine Merz, wait and take your next dose at the usual time.
Ako ustanovite da ste zaboravili uzeti dozu Memantine Merza, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
Instruction for proper use of the pump
Upute za ispravnu uporabu pumpice
When used for the first time, the dosing pump does not dispense the correct amount of oral solution.
Kada se koristi prvi put, pumpica za doziranje ne raspršuje ispravnu količinu oralne otopine.
There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Objavljen je jedan slučaj o mogućem riziku za kombinaciju memantina i fenitoina.
It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
On modulira učinke patološki povišenih toničkih razina glutamata koje mogu dovesti do disfunkcije neurona.
The tablets should be swallowed with some water.
Tablete treba progutati s malo vode.
Memantine Merz with food and drink
Memantine Merz s hranom i, pićem
Always take Memantine Merz exactly as your doctor has told you.
Uvijek uzimajte Memantine Merz točno onako kako Vam je rekao Vaš liječnik.
If the pump does not function as described during intended use and according to instruction, the patient should consult the treating physician or a pharmacist.
Ako pumpica ne radi kako je opisano tijekom namijenjene uporabe i prema uputama, bolesnik se treba obratiti nadležnom liječniku ili ljekarniku.
This effect was only observed at high doses in rodents.
Taj je učinak primijećen samo pri primjeni visokih doza kod glodavaca.
As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Posljedično tome, dostupni su samo ograničeni podaci, te bolesnike s navedenim stanjima treba pažljivo nadzirati.
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Your doctor should assess your treatment on a regular basis.
Vaš liječnik treba redovito procjenjivati Vaše liječenje.
• Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
• Potrebno je izbjegavati istodobnu primjenu memantina i amantadina zbog rizika od farmakotoksične psihoze.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet.
The same may be true for ketamine and dextromethorphan (see also section 4.4).
Isto bi moglo vrijediti za ketamin i dekstrometorfan (vidjeti također dio 4.4).
Pharmacotherapeutic group: Other Anti-dementia drugs, ATC code: N06DX01.
Farmakoterapijska skupina: ostali lijekovi protiv demencije, ATK oznaka: N06DX01.
This effect is known from other active substances with cationic amphiphilic properties.
Taj je učinak poznat i kod drugih djelatnih tvari s kationskim amfifilnim svojstvima.
The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment.
Podnošljivost i doziranje memantina treba redovito ponovno procjenjivati, po mogućnosti unutar tri mjeseca od početka liječenja.
Memantine has an absolute bioavailability of approximately 100%.
Apsorpcija Memantin ima apsolutnu bioraspoloživost od približno 100%.
The dosing pump should be locked after use.
Pumpicu za doziranje treba zaključati nakon uporabe.
Once opened, the contents of the bottle should be used within 3 months.
Jednom kad se otvori, sadržaj boce treba upotrijebiti unutar 3 mjeseca.
None of these metabolites exhibit NMDA-antagonistic activity.
Nijedan od navedenih metabolita ne pokazuje NMDA-antagonističku aktivnost.
It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs.
Nije poznato izlučuje li se memantin u majčino mlijeko ljudi, no, uzimajući u obzir lipofilnost tvari, do toga vjerojatno dolazi.
Once daily
Jedanput dnevno
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Sve je više dokaza da slabo funkcioniranje glutamatergične neurotransmisije, posebice na NMDA-receptorima, doprinosi izraženosti simptoma i progresiji bolesti kod neurodegenerativne demencije.
Memantine should not be used during pregnancy unless clearly necessary.
Memantin se ne smije primjenjivati tijekom trudnoće, osim ako to nije izričito potrebno.
1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
1 Halucinacije su opažene uglavnom kod bolesnika s teškom Alzheimerovom bolešću.
Both compounds are chemically related NMDA-antagonists.
Oba spoja su kemijski srodni NMDA-antagonisti.
Psychotic reactions2
Nepoznato psihotične reakcije2
As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
Budući da učinci nisu bili primijećeni u dugoročnim ispitivanjima na glodavcima i neglodavcima, klinički značaj ovih nalaza nije poznat.
For detailed instructions on the preparation and handling of the product see end of this leaflet.
Za detaljne upute o pripremi i postupanju s lijekom, vidjeti kraj ove upute.
In particular, Memantine Merz may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Posebice, Memantine Merz može promijeniti učinak sljedećih lijekova, te će liječnik možda morati prilagoditi njihovu dozu:
Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient.
Terapiju treba započeti samo ako je dostupan njegovatelj koji će redovito nadzirati bolesnikovo uzimanje lijeka.
This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
Ova doza će se povećavati za 5 mg tjedno dok se ne postigne preporučena doza (doza održavanja).
In short term studies in rats memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
U kratkoročnim ispitivanjima na štakorima, memantin je, kao i drugi NMDA-antagonisti, uzrokovao neuronsku vakuolizaciju i nekrozu (Olney lezije) samo nakon doza koje su dovodile do vrlo visokih vršnih serumskih koncentracija.
If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme.
Ako se lijek dobro podnosi tijekom razdoblja liječenja od najmanje 7 dana, doza se može povećati do 20 mg/dan prema standardnoj shemi titriranja.
Diagnosis should be made according to current guidelines.
Dijagnozu treba postaviti prema važećim smjernicama.
Week 2 (day 8-14):
2. tjedan (8. - 14. dan):
Date of first authorisation: 22 Nov 2012 Date of latest renewal: {DD month YYYY}
Datum prvog odobrenja: 22 studeni 2012.
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Ako imate oštećenu funkciju bubrega, liječnik će odlučiti o dozi koja odgovara Vašem stanju.
Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Također, pH mokraće može biti povišen stanjima renalne tubularne acidoze (RTA) ili teških infekcija mokraćnog trakta uzrokovanih bakterijama vrste Proteus.
The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Mozak sadržava takozvane N-metil-D-aspartat (NMDA) receptore koji su uključeni u prijenos živčanih signala važnih u učenju i pamćenju.
Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially potassium-free.
Nadalje, ovaj lijek sadržava kalij, manje od 1 mmol (39 mg) po dozi, tj. u osnovi ne sadržava kalij.
Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Preporučuje se oprez kod bolesnika s epilepsijom, konvulzijama u anamnezi ili bolesnicima s predisponirajućim čimbenicima za pojavu epilepsije.
In case of signs and symptoms of general Central Nervous System (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
U slučaju znakova i simptoma opće pretjerane stimulacije središnjeg živčanog sustava (SŽS), treba razmotriti pažljivo simptomatsko kliničko liječenje.
There is no indication that food influences the absorption of memantine.
Nema pokazatelja da hrana utječe na apsorpciju memantina.
One tablet daily
Jedna tableta dnevno
The patient received symptomatic treatment and plasmapheresis.
Bolesnik je liječen simptomatski i plazmaferezom.
The patient recovered without permanent sequelae.
Bolesnik se oporavio bez trajnih sekvela.
- In general, taking too much Memantine Merz should not result in any harm to you.
- Općenito, uzimanje previše Memantine Merza ne bi Vam trebalo naškoditi.
This medicinal product contains sorbitol.
Ovaj lijek sadržava sorbitol.
Thereafter, the clinical benefit of memantine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines.
Nakon toga, klinička korist memantina i podnošljivost liječenja trebaju biti redovito ponovno procjenjivane u skladu s kliničkim smjernicama.
Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
Ispitivanja na životinjama upućuju na postojanje mogućnosti smanjenja intrauterinog rasta pri izloženosti dozama istim ili nešto višim nego kod ljudi (vidjeti dio 5.3).
50 ml (and 10 x 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III).
50 ml (i 10 x 50 ml) u smeđim staklenim bočicama (hidrolitička skupina II) i 100 ml u smeđim staklenim bočicama (hidrolitička skupina III).
Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
Očne promjene su nedosljedno zabilježene u ispitivanjima toksičnosti ponovljenih doza kod glodavaca i pasa, ali ne i kod majmuna.
There was no evidence of any carcinogenicity in life long studies in mice and rats.
Nije bilo dokaza ni o kakvoj kancerogenosti u ispitivanjima tijekom životnih ciklusa miševa i štakora.
Push down the dosing pump head in a firm but calm and steady manner - not too slowly (fig. 7, fig. 8).
Pritisnite vrh pumpice za doziranje snažno, ali smireno i mirno - ne presporo (sl. 7, sl. 8).
Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on fertility.
Memantin nije bio teratogen kod štakora i kunića, čak ni kod maternalno toksičnih doza, a nisu zamijećeni niti štetni učinci memantina na plodnost.
Slide the plastic dip tube carefully into the bottle.
Pažljivo umetnite plastičnu tubu u bocu.
Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Alzheimerova bolest povezuje se s depresijom, samoubilačkim mislima i samoubojstvom.
• In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
• U postmarketinškom iskustvu zabilježeni su izolirani slučajevi povišenja međunarodno ujednačenog omjera (INR-a) kod bolesnika koji su istodobno liječeni varfarinom.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip.
Pakiranja s blisterima sadržavaju 14 filmom obloženih tableta po PVDC/PE/PVC/Al-blisteru ili PP/Al-blisteru.
The solution must not be poured or pumped directly into the mouth from the bottle or pump.
Otopina se ne smije uliti ili uštrcati izravno u usta iz boce ili pumpice.
Memantine Merz is not recommended for children and adolescents under the age of 18 years.
Merz se ne preporučuje za djecu i adolescente mlađe od 18 godina.
Specific ophthalmoscopic examinations in clinical studies with memantine did not disclose any ocular changes.
Specifični oftalmoskopski pregledi u kliničkim ispitivanjima memantina nisu otkrili nikakve promjene na očima.
In another case of a large overdose, the patient also survived and recovered.
U drugom slučaju predoziranja velikom dozom, bolesnik je također preživio te se oporavio.
Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
Relativno velika predoziranja (200 mg, odnosno, 105 mg/dan tijekom 3 dana) povezana su ili samo sa simptomima umora, slabosti i/ili proljeva, ili su bez simptoma.
Ataxia and other preclinical signs have preceded the vacuolisation and necrosis.
Ataksija i drugi neklinički znakovi prethodili su vakuolizaciji i nekrozi.
For detailed instructions on the preparation and handling of the product see section 6.6.
Za detaljne upute o pripremi i rukovanju lijekom, vidjeti dio 6.6.
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine Merz dose during the first 3 weeks of treatment.
Preporučena doza za liječenje od 20 mg dnevno postiže se postupnim povećanjem doze Memantine Merza tijekom prva 3 tjedna liječenja.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Liječenje treba započeti i nadzirati liječnik koji ima iskustva u dijagnosticiranju i liječenju
Continue to take Memantine Merz as long as it is of benefit to you.
Nastavite uzimati Memantine Merz onoliko dugo koliko od nje imate koristi.
You may experience increased symptoms as described in section 4.
Mogli bi Vam se javiti izraženiji simptomi opisani u dijelu 4. «Moguće nuspojave».
Multipack 500 ml, comprising 10 packs, each containing 1 bottle with 50 ml oral solution.
Višestruko pakiranje od 500 ml koje uključuje 10 pakiranja od kojih svako sadrži 1 bocu s 50 ml oralne otopine.
• Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
• Ostale djelatne tvari poput cimetidina, ranitidina, prokainamida, kinidina, kinina i nikotina koje koriste isti sustav bubrežnog kationskog transporta kao i amantadin, mogle bi također stupiti u interakciju s memantinom i dovesti do potencijalnog rizika povišenja njegove koncentracije u plazmi.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
Memantine Merz oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Memantine Merz oralna otopina dostupna je u bocama od 50 ml, 100 ml ili višestruko pakiranje od 500 ml (10 x 50 ml).
Talk to your doctor or pharmacist before taking Memantine Merz - if you have a history of epileptic seizures - if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
Obratite se svom liječniku ili ljekarniku prije nego uzmete Memantine Merz - ako u anamnezi imate epileptičke napadaje - ako ste nedavno imali infarkt miokarda (srčani udar), ili ako bolujete od kongestivnog zatajenja srca ili nekontrolirane hipertenzije (povišeni krvni tlak).
Prior to first use the dosing pump has to be screwed on the bottle.
Prije prve uporabe pumpicu za doziranje treba pričvrstiti zavrtanjem na bocu.
EU/1/12/799/028 500 ml (10 bottles of 50 ml)
EU/1/12/799/028 500 ml (10 boca od 50 ml)
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Iz većine kliničkih ispitivanja bili su isključeni bolesnici koji su nedavno imali infarkt miokarda, bolesnici s nekompenziranim kongestivnim zatajenjem srca (NYHA III-IV) ili nekontroliranom hipertenzijom.
For continuation of the treatment please consult your doctor.
Za nastavak liječenja posavjetujte se sa svojim liječnikom.
Content of the pack and other information What Memantine Merz contains
SADRŽAJ PAKIRANJA I DRUGE INFORMACIJE Što Memantine Merz sadrži
If you go into hospital, let your doctor know that you are taking Memantine Merz.
Ako dođete u bolnicu, obavijestite svog liječnika da uzimate Memantine Merz.
A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Metaanaliza bolesnika s umjerenom do teškom Alzheimerovom bolešću (ukupni MMSE <20) iz šest faza III placebom kontroliranih ispitivanja u trajanju od 6 mjeseci (uključujući monoterapijska ispitivanja i ispitivanja s bolesnicima na stabilnoj dozi inhibitora acetilkolinesteraze) pokazala je da postoji statistički značajan učinak u korist liječenja memantinom u kognitivnom, globalnom i funkcionalnom području.
The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Preporučena doza održavanja je 20 mg jednom dnevno, te se postiže na početku 4. tjedna.
- If you take a large overdose of Memantine Merz, contact your doctor or get medical advice, as you may need medical attention.
Ako ste uzeli preveliku dozu Memantine Merza, javite se Vašem liječniku za savjet, jer bi Vam mogla zatrebati medicinska pomoć.
CARTON AND LABEL FOR BOTTLE
KUTIJA I NAJEPNICA ZA BOCU
Hold a glass with a little water or a spoon below the nozzle.
Ispod mlaznice stavite čašu s malo vode ili žlicu.
Take the dosing pump out of the plastic bag (fig. 2) and place it on top of the bottle.
Izvadite pumpicu za doziranje iz plastične vrećice (sl. 2) i postavite ju na vrh boce.
The film-coated tablets can be taken with or without food.
Filmom obložene tablete mogu se uzimati sa ili bez hrane.
The dosing pump is then ready for use.
Pumpica za doziranje tada je spremna za uporabu.
In general, the observed side effects are mild to moderate.
Općenito, opažene nuspojave su blage do umjerene.
For up-titration other tablet strengths are available.
Za povećanje doze lijeka dostupne su i tablete drugih jačina.
Dosage in patients with impaired kidney function
Doziranje kod bolesnika s oštećenom funkcijom bubrega
Memantine Merz is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Primjena Memantine Merza kod djece mlađe od 18 godina se ne preporučuje zbog nedostatka podataka o sigurnosti i djelotvornosti.