natgillin/translations-raw huggingface dataset:
Shake off excess water and leave the disassembled oral syringe to dry until reassemble for next dosing occasion.
Odvečno vodo otresite in pustite razstavljeno brizgo za peroralno dajanje, da se suši, dokler je spet ne sestavite za naslednji odmerek.
During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4).
Med rednim nadzorovanjem je treba spremljati sukcinilaceton v urinu, teste delovanja jeter in raven alfa-fetoproteina (glejte poglavje 4.4).
Precautions to be taken before handling or administering the medicinal product No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Na brizgo za peroralno dajanje ne smejo biti pritrjene igle, intravenski infuzijski sistemi ali katere koli druge naprave za parenteralno dajanje.
Sodium benzoate (E211) Citric acid monohydrate Sodium citrate
Natrijev benzoat (E211) Citronska kislina monohidrat Natrijev citrat
Place the open bottle upright on a table.
Postavite odprto steklenico v pokončnem položaju na mizo.
The oral syringe must be emptied slowly to allow swallowing; rapid squirting of the medicine may cause choking.
Brizgo za peroralno dajanje je treba izprazniti počasi, da se omogoči požiranje; hitro brizganje zdravila lahko povzroči davljenje.
Before shaking the bottle, it may look like a solid cake in the bottom and a slightly opalescent liquid.
Preden steklenico pretresete, je lahko videti kot trdna usedlina na dnu in rahlo motna tekočina.
Orfadin is for oral use only.
Zdravilo Orfadin je samo za peroralno uporabo.
The capsules are packaged in plastic bottles with tamper-proof closures.
Kapsule so pakirane v plastenkah z zaščitno zaporko.
If the levels are markedly higher than they should be, especially in prematures babies with risk factors as acidosis (too low pH in the blood) and low albumin level (a protein in the blood) treatment with Orfadin capsules will be considered instead of the oral suspension until the bilirubin plasma levels are normalised.
Če so ravni znatno višje, kot bi smele biti, zlasti pri nedonošenčkih z dejavniki tveganja, kot sta acidoza (prenizka vrednost pH v krvi) in nizko ravnijo albumina (beljakovina v krvi) bodo razmislili o zdravljenju z zdravilom Orfadin v obliki kapsul namesto s peroralno suspenzijo, dokler se ravni bilirubina v plazmi ne normalizirajo.
A dose of 20 ml oral suspension (10 g glycerol) or more may cause headache, stomach upset and diarrhoea.
Odmerek 20 ml peroralne suspenzije (10 g glicerola) ali več lahko povzroči glavobol, želodčne motnje in drisko.
In patients with HT-1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
Pri bolnikih s HT-1 se ta intermediata pretvorita v toksična presnovka sukcinilaceton in sukcinilacetoacetat.
Therefore, mothers receiving nitisinone must not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
Matere, ki jemljejo Orfadin, ne smejo dojiti, ker tveganja za dojenčka ni mogoče izključiti (glejte poglavji 4.3 in 5.3).
It is used for measuring doses of more than 3 ml.
Uporablja se za merjenje odmerkov, večjih od 3 ml.
Restriction of tyrosine and phenylalanine in the diet should limit the toxicity associated with this type of tyrosinemia by lowering tyrosine levels (see section 4.4).
Omejitev tirozina in fenilalanina v dieti bi morala omejiti toksičnost, ki je povezana s tem tipom tirozinemije z zniževanjem ravni tirozina (glejte poglavje 4.4).
It is recommended that the healthcare professional advises the patient or carer giver how to use the oral syringes to ensure that the correct volume is administered.
Priporoča se, da zdravstveni delavec svetuje bolniku ali negovalcu, kako uporabljati brizge za peroralno dajanje, da se zagotovi dajanje pravilne količine.
Push the plastic adapter firmly into the neck of the bottle as far as you can (figure C) and close the bottle with the child resistant screw cap.
Čvrsto potisnite plastični nastavek na vrat steklenice, kolikor se da (slika C) in zaprite steklenico z za otroke varno navojno zaporko.
The safety profile is mainly based on the paediatric population since nitisinone treatment should be started as soon as the diagnosis of hereditary tyrosinemia type 1 (HT-1) has been established.
Varnostni profil v glavnem temelji na pediatričnih bolnikih, ker je treba zdravljenje z nitizinonom začeti takoj, ko je ugotovljena diagnoza dedne tirozinemije tipa 1 (HT-1).
Strawberry aroma (artificial) Purified water
Jagodna aroma (umetna)
Orfadin is also available in 2 mg, 5 mg, 10 mg and 20 mg capsules, if considered more suitable for the patient.
Zdravilo Orfadin je na voljo tudi v obliki 2 mg, 5 mg, 10 mg in 20 mg kapsul, če je to za bolnika bolj ustrezno.
The bottle should be removed from the refrigerator, and the date when the bottle is removed from the refrigerator should be noted on the bottle label.
Steklenico je treba vzeti iz hladilnika in datum, ko je bila steklenica vzeta iz hladilnika, zabeležiti na nalepko na steklenici.
Bilirubin levels should be measured before start of treatment: in case of markedly elevated plasma levels of bilirubin, especially in premature patients with risk factors as acidosis and low albumin level, treatment with an appropriately weighed portion of an Orfadin capsule should be considered instead of the oral suspension until the unconjugated bilirubin plasma levels are normalised.
Ravni bilirubina je treba izmeriti pred začetkom zdravljenja: pri znatno povečanih ravneh bilirubina v plazmi, zlasti pri bolnikih nedonošenčkih z dejavniki tveganja, kot sta acidoza in nizka raven albumina, je treba razmisliti o zdravljenju z ustrezno odmerjenim delom kapsule zdravila Orfadin namesto peroralne suspenzije, dokler se ravni nekonjugiranega bilirubina v plazmi ne normalizirajo.
Based on in vitro studies, nitisinone is not expected to inhibit CYP1A2, 2C19 or 3A4-mediated metabolism or to induce CYP1A2, 2B6 or 3A4/5.
Študije in vitro so pokazale, da nitizonon ne bi smel zavirati presnove, ki deluje preko encimov CYP 1A2, 2C19 ali 3A4, ali inducirati encimov CYP 1A2, 2B6 ali 3A4/5.
Each ml contains 500 mg. A dose of 20 ml oral suspension (10 g glycerol) or more may cause headache, stomach upset and diarrhoea.
En ml vsebuje 500 mg. Odmerek 20 ml peroralne suspenzije (10 g glicerola) ali več lahko povzroči glavobol, želodčne motnje in drisko.
For subsequent dosing see the instructions below ‘How to prepare a dose of medicine'
Za nadaljnje odmerjanje glejte navodila spodaj: "Kako pripraviti odmerek zdravila"
A 1 ml, 3 ml and 5 ml oral syringes are included in the pack to measure the dose in ml in accordance with the prescribed posology.
V pakiranju so priložene 1 ml, 3 ml in 5 ml brizge za peroralno dajanje za merjenje odmerka v ml v skladu s predpisanim odmerjanjem.
If your prescription is in mg, contact your pharmacist or doctor for advice.
Če je vaš recept v mg, se posvetujte s farmacevtom ali zdravnikom.
Orfadin has minor influence on the ability to drive and use machines.
Zdravilo Orfadin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
It is recommended that the healthcare professional advises the patient or care giver how to use the oral syringes to ensure that the correct volume is administered and that the prescription is given in ml.
Priporoča se, da zdravstveni delavec svetuje bolniku ali negovalcu, kako uporabljati brizge za peroralno dajanje, da se zagotovi dajanje pravilne količine, in da je recept v mililitrih.
Probability of no HCC (95% confidence interval) at start
Verjetnost za nepojav HCK (95 % interval zaupanja) po na začetku po 2 letih po 4 letih po 6 letih
What Orfadin looks like and contents of the pack
Izgled zdravila Orfadin in vsebina pakiranja
Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients.
Zdravljenje z nitizinonom mora začeti in nadzorovati zdravnik, usposobljen za zdravljenje bolnikov s HT-1.
Hydroxypropylmethylcellulose Glycerol
Hidroksipropil metilceluloza Glicerol
The active ingredient of Orfadin is nitisinone.
Zdravilna učinkovina v zdravilu Orfadin je nitizinon.
100 ml brown glass bottle (type III) with a white child-resistant HDPE screw cap with sealing and tamper evidence.
100 ml rjava steklenica (tip III) z belo za otroke varno navojno zaporko iz HDPE in varnostnim zapiralom.
Orfadin contains sodium, glycerol and sodium benzoate
Zdravilo Orfadin vsebuje natrij, glicerol in natrijev benzoat
Excipients with known effect: Each ml contains: sodium 0.7 mg (0.03 mmol) glycerol 500 mg sodium benzoate 1 mg
En ml vsebuje: natrij 0,7 mg (0,03 mmol) glicerol 500 mg natrijev benzoat 1 mg
How to take Orfadin
Kako jemati zdravilo Orfadin
Dose Orfadin mg ml
Odmerek zdravila Orfadin mg ml
Clean the oral syringe immediately with water.
Brizgo za peroralno dajanje je treba takoj očistiti z vodo.
Before you take the first dose, shake the bottle vigorously since during long-term storage the particles will form a solid cake at the bottom of the bottle.
Preden vzamete prvi odmerek, steklenico močno pretresite, ker med dolgotrajnim shranjevanjem iz delcev nastane trdna usedlina na dnu steklenice.
The bottle should be shaken vigourously for at least 5 seconds (Figure D).
Steklenico je treba močno stresati najmanj 5 sekund (slika D).
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Therefore, it is recommended that the oral suspension is taken with food, see section 4.2.
Zato se priporoča jemanje peroralne suspenzije s hrano, glejte poglavje 4.2.
A patient displaying visual disorders during treatment with nitisinone should without delay be examined by an ophthalmologist.
Če se pri bolniku med zdravljenjem z nitizinonom pojavijo motnje vida, mora nemudoma na okulistični pregled.
If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.
Če ste vzeli večji odmerek zdravila Orfadin, kot bi smeli Če ste vzeli prevelik odmerek tega zdravila, se čim prej posvetujte z zdravnikom ali farmacevtom.
Separate barrel and plunger and rinse both with water.
Ločite telo in bat in oba splaknite z vodo.
2 mg, 5 mg, 10 mg and 20 mg hard capsules:
2 mg, 5 mg, 10 mg in 20 mg trde kapsule:
Read the package leaflet carefully before use.
Pred uporabo natančno preberite priloženo navodilo!
It is recommended that the oral suspension is taken with food, see section 4.5.
Priporočljivo je, da se peroralna suspenzija jemlje s hrano, glejte poglavje 4.5.
Do not forget to mark the date on the bottle, when removed from the refrigerator.
Ne pozabite na vsebniku označiti datuma, ko ste zdravilo vzeli iz hladilnika.
A pre- and postnatal development study in the mouse showed statistically significantly reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, respectively, than the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day.
Študije o pre- in postnatalnem razvoju pri miših so pokazale statistično značilno zmanjšano preživetje mladičev, izpostavljenih 125-krat večjim odmerkom, in zmanjšanje rasti mladičev po odstavitvi pri 25-krat večjih odmerkih v primerjavi z največjim priporočenim odmerkom za človeka.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in pre-term and full-term jaundiced neonates and develop into kernicterus (brain damage due to deposits of bilirubin in the brain).
Natrijev benzoat lahko okrepi zlatenico (porumenelost kože in oči) pri nedonošenčkih in pri donošenih novorojenčkih z zlatenico in se razvije v kernikterus (poškodba možganov zaradi usedlin bilirubina v možganih).
White, slightly viscous opaque suspension.
peroralna suspenzija Bela, rahlo viskozna motna suspenzija.
This medicinal product contains 0.7 mg (0.03 mmol) sodium per ml.
To zdravilo vsebuje 0,7 mg (0,03 mmol) natrija na ml.
Nitisinone plasma concentration reached in clinical setting is not expected to inhibit OATP1B1, OATP1B3 mediated transport.
Ni pričakovati, da bi koncentracija nitizinona v plazmi, dosežena v kliničnem okolju, zavirala transport, ki deluje preko OATP1B1,
Always use one of the oral syringes provided to take the medicine.
Za jemanje zdravila vedno uporabite eno od priloženih brizg za peroralno dajanje.
The open bottle should be placed upright on a table, and the plastic adapter pushed firmly into the neck of the bottle as far as possible (Figure C).
Odprto steklenico je treba pokonci postaviti na mizo in plastični nastavek čvrsto potisniti v vrat steklenice, kolikor se da (slika C).
Each pack contains one bottle, one bottle adapter and three oral syringes.
Eno pakiranje vsebuje eno steklenico, en nastavek za steklenico in tri brizge za peroralno dajanje.
Before re-dispersion, the medicinal product may appear as a solid cake with a slightly opalescent supernatant.
Pred redisperzijo ima lahko zdravilo obliko trdne pogače z blago motnim supernatantom.
The oral suspension is taken with a oral syringe directly in the mouth without dilution.
Peroralna suspenzija se jemlje z brizgo za peroralno dajanje neposredno v usta brez redčenja.
Shake the bottle vigorously for at least 5 seconds (figure D).
Močno stresajte steklenico najmanj 5 sekund (slika D).
There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Posebne skupine bolnikov Za starejše bolnike ali bolnike z ledvično ali jetrno okvaro ni posebnih priporočil glede odmerjanja.
Before taking the first dose, the bottle should be shaken vigorously since during long-term storage the particles will form a solid cake at the bottom of the bottle.
Pred prvim odmerkom je treba steklenico močno pretresti, ker med dolgotrajnim shranjevanjem iz delcev nastane trdna pogača na dnu steklenice.
The bottle should be turned to an upright position again, and the oral syringe disconnected by gently twisting it out of the bottle.
Steklenico je treba obrniti nazaj v pokončen položaj, nato pa se brizga za peroralno dajanje izvleče tako, da se jo nežno zasuče iz steklenice.
Disconnect the oral syringe by gently twisting it out of the bottle.
Izvlecite brizgo tako, da jo nežno zasučete iz steklenice.
Note the date when the bottle is removed from the refrigerator on the bottle label.
Zabeležite datum, ko je bila steklenica vzeta iz hladilnika, na nalepko na steklenici.
Oral use only.
Samo za peroralno uporabo.
4 mg/ml oral suspension:
4 mg/ml peroralna suspenzija:
Shake the bottle vigorously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (figure A).
Močno stresajte steklenico najmanj 20 sekund, dokler se trdna usedlina na dnu steklenice povsem ne razpusti (slika A).
If any air bubbles are observed inside the filled oral syringe, the plunger should be pushed back up until the air bubbles are expelled.
Če so znotraj napolnjene brizge za peroralno dajanje opazni mehurčki, je treba bat potisniti nazaj navzgor, dokler se mehurčki ne iztisnejo.
The oral suspension is a white, slightly thicker opaque suspension.
Peroralna suspenzija je bela, nekoliko gostejša motna suspenzija.
Capsule shell gelatin titanium dioxide (E 171)
Vsebina kapsule predgeliran (koruzni) škrob Ovojnica kapsule želatina titanov dioksid (E 171)
Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Orfadin Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
It is important to carefully follow the instructions given below for preparation and administration of the dose, in order to ensure the dosing accuracy.
Pomembno je, da se točno upošteva navodila, dana spodaj, za pripravo in dajanje odmerka, da se zagotovi natančnost odmerjanja.
The medicine can be stored for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which it must be discarded.
Zdravilo lahko shranjujete zunaj hladilnika največ 2 meseca (2 mg kapsule) ali 3 mesece (5 mg, 10 mg in 20 mg kapsule) pri temperaturi do 25 °C, potem ga je treba zavreči.
Each ml contains 1 mg. Increase in bilirubin following its displacement from albumin, caused by benzoic acid and its salts, may increase jaundice in pre-term and full-term jaundiced neonates and develop into kernicterus (unconjugated bilirubin deposits in the brain tissue).
Povečanje bilirubina po spodrinjenju iz albumina, ki ga povzročijo benzojska kislina in njene soli, lahko poveča zlatenico pri nedonošenčkih in donošenih novorojenčkih z zlatenico in se razvije v kernikterus (nekonjugirane usedline bilirubina v možganskem tkivu).
Oral suspension 1 bottle of 90 ml, 1 bottle adaptor, 3 oral syringes (1 ml, 3 ml, 5 ml).
1 steklenica z 90 ml suspenzije, 1 nastavek za steklenico, 3 brizge za peroralno dajanje (1 ml, 3 ml, 5 ml).
• The 5 ml oral syringe (the largest oral syringe), is marked from 1 ml to 5 ml with minor 0.2-ml graduations.
• 5-ml brizga za peroralno dajanje (največja brizga za peroralno dajanje) ima oznake od 1 ml do 5 ml z najmanjšimi razdelki 0,2 ml.
In order to withdraw the prescribed dose (ml), pull the plunger slowly down until the top edge of the black ring is exactly level with the line marking the dose (Figure F).
Da bi dobili predpisani odmerek (ml), potegnite bat počasi navzdol dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek (slika F).
Printing ink: iron oxide (E 172) shellac propylene glycol ammonium hydroxide
železov oksid (E 172) šelak propilenglikol amonijev hidroksid
The suspension is administered in the patient's mouth with an oral syringe without dilution.
Način uporabe Suspenzija se daje bolniku v usta z brizgo za peroralno dajanje brez redčenja.
In order to withdraw the prescribed dose (ml), the plunger should be pulled down slowly until the top edge of the black ring is exactly level with the line marking the dose (Figure F).
Da bi izvlekli predpisani odmerek (ml) je treba bat počasi povleči navzdol, dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek (slika F).
How to prepare the dose to be administered
Kako pripraviti odmerek za dajanje
During the shelf life, the patient may store the capsules for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which the medicinal product must be discarded.
2 leti Med rokom uporabnosti lahko bolnik shranjuje kapsule pri temperaturi do 25 °C le 2 meseca (2 mg kapsule) ali 3 mesece (5 mg, 10 mg in 20 mg kapsule), potem pa jih mora zavreči.
CONTENTS BY UNIT
VSEBINA, IZRAŽENA S ŠTEVILOM ENOT
Dose conversion tables respectively for the three oral syringe sizes:
Preglednice za pretvorbo odmerka za tri velikosti brizg za peroralno dajanje:
Each pack contains one bottle, one LDPE bottle adapter and 3 polypropylene (PP) oral syringes (1 ml, 3 ml and 5 ml).
Eno pakiranje vsebuje eno steklenico, en nastavek iz LDPE za steklenico in 3 polipropilenske (PP) brizge za peroralno dajanje (1 ml, 3 ml in 5 ml).
Sodium Each ml contains 0.7 mg (0.03 mmol).
En ml vsebuje 0,7 mg (0,03 mmol).
Figure F.
Slika F
It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year.
Nadziranje ravni tirozina v plazmi Pred začetkom zdravljenja z nitizinonom in nato redno, a vsaj enkrat na leto, je priporočljivo opraviti pregled oči s špranjsko svetilko.
Keep the bottle in an upright position and insert the oral syringe firmly into the hole at the top of the bottle (figure E).
Držite steklenico v pokončnem položaju in čvrsto vstavite brizgo za peroralno dajanje v odprtino na nastavku na vrhu steklenice (slika E).
If any air bubbles are observed inside the filled oral syringe, push the plunger back up until the air bubbles are expelled.
Če opazite znotraj napolnjene brizge za peroralno dajanje mehurčke, potisnite bat nazaj navzgor, dokler ne iztisnete mehurčkov.
It is provided in a 100 ml brown glass bottle with a white, child resistant screw cap. Each bottle contains 90 ml supension.
Na voljo je v 100 ml rjavi steklenici z belo za otroke varno navojno zaporko.
Orfadin 4 mg/ml oral suspension Nitisinone
Orfadin 4 mg/ml peroralna suspenzija nitizinon
Immediately thereafter, open the bottle by removing the child resistant screw cap. 3.
Takoj potem odprite steklenico tako, da odstranite za otroke varno navojno zaporko.
It is used for measuring doses of more than 1 ml and up to 3 ml.
Uporablja se za merjenje odmerkov do največ 3 ml.
How to store Orfadin
Shranjevanje zdravila Orfadin
• The 3 ml oral syringe (the middle sized oral syringe), is marked from 1 ml to 3 ml with minor 0.1-ml graduations.
• 3-ml brizga za peroralno dajanje (srednje velika brizga za peroralno dajanje) ima oznake od 1 ml do 3 ml z najmanjšimi razdelki 0,1 ml.
Remove the child resistant screw cap by pushing it down firmly and turning it anti-clockwise (figure B).
Odstranite za otroke varno navojno zaporko tako, da jo močno pritisnete navzdol in obrnete v nasprotni smeri urnega kazalca (slika B).
The child-resistant screw cap should be removed by pushing it down firmly and turning it anticlockwise (Figure B).
Za otroke varno navojno zaporko je treba odstraniti tako, da se jo močno pritisne navzdol in obrne v nasprotni smeri urnega kazalca (slika B).
Figure B.
Slika B
The pack contains a bottle of medicine with a cap, a bottle adaptor and three oral syringes (1 ml, 3 ml and 5 ml).
Pakiranje vsebuje steklenico zdravila z zaporko, nastavek za steklenico in tri brizge za peroralno dajanje (1 ml, 3 ml in 5 ml).
Immediately thereafter, the bottle should be opened by removing the child-resistant screw cap. 3.
Takoj potem je treba steklenico odpreti tako, da se odstrani za otroke varna navojna zaporka.
By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
HT-1, nitizinon prepreči akumulacijo toksičnih intermediatov, kot sta maleilacetoacetat in fumarilacetoacetat.
Then pull the plunger down again until the top edge of the black ring is exactly level with the line marking the dose.
Nato potegnite bat spet navzdol, dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek.
5 mg, 10 mg, 20 mg: Store in a refrigerator.
Datum odvzema zdravila iz hladilnika: 5 mg, 10 mg in 20 mg: Shranjujte v hladilniku.
Contents of the pack and other information
Shranjevanje zdravila Orfadin Vsebina pakiranja in dodatne informacije
Carefully turn the bottle upside down with the oral syringe in place (Figure F).
Previdno obrnite steklenico z nameščeno brizgo za peroralno dajanje z vrhom navzdol (slika F).
Orfadin 4 mg/ml oral suspension
Orfadin 4 mg/ml peroralna suspenzija
Then the plunger should be pulled down again until the top edge of the black ring is exactly level with the line marking the dose.
Nato je treba bat spet povleči navzdol, dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek.
The bottle should be closed with the child resistant screw cap.
Steklenico je treba zapreti z za otroke varno navojno zaporko.
Follow the instructions given below for dose preparation and administration carefully, in order to ensure that the correct dose is administered.
Točno upoštevajte navodila, dana spodaj, za pripravo in dajanje odmerka, da se zagotovi dajanje pravega odmerka.
Push the plunger inside the oral syringe fully down.
Pritisnite bat do konca navzdol v brizgo za peroralno dajanje.
The bottle should be shaken vigourously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (Figure A).
Steklenico je treba najmanj 20 sekund močno stresati (slika A), dokler se trdna pogača na dnu steklenice povsem ne razpusti.
5-ml oral syringe (0.2 ml graduation)
5-ml brizga za peroralno dajanje (graduira na po 0,2 ml)