natgillin/translations-raw huggingface dataset:
Do not blow into the 
Ne pihajte v ustnik.
For the 1 mg product, the spine of the blister card has one raised ridge with the individual blisters embossed with one raised dot each. 
Pri jakosti 1 mg ima hrbtišče ploščice s pretisnimi omoti eno podolgovato izboklino, vsak od posamičnih pretisnih omotov pa po eno izbočeno točko.
Caution: please remember that artificial sweeteners and foods with artificial sweeteners (e.g. diet drinks) are of no help in hypoglycaemia. 
(Enkrat si stehtajte polno žlico ali sladkorne kocke ali glukozne tablete, da boste videli, koliko je to.) Opozorilo: ne pozabite, da umetna sladila in jedi z umetnimi sladili (npr. dietne pijače) pri hipoglikemiji čisto nič ne pomagajo.
Hold your insulin inhaler in your hand. 
Insulinski inhalator razstavite Držite insulinski inhalator v roki.
Store your insulin inhaler in a dry place at room 
Insulinski inhalator shranjujte na suhem pri sobni
Taking three separate 1 mg blisters delivers more insulin to your lungs than a single 3 mg blister does. 
Uporaba treh ločenih 1-mg pretisnih omotov prinese v pljuča več insulina kot uporaba enega samega 3-mg pretisnega omota.
Put your insulin inhaler together Line the top of the base with the open end of the chamber. 
Poravnajte vrh podnožja z odprtim koncem komore.
Alcohol may intensify and prolong 
Alkohol lahko okrepi in podaljša hipoglikemični učinek insulina.
Always make sure you have the correct blisters available before using your insulin inhaler. 
Pred uporabo insulinskega inhalatorja vedno preverite, ali imate pripravljene pravilne pretisne omote.
In subjects with type 1 diabetes mellitus, inhaled human insulin had a comparable intrasubject variability of AUC to subcutaneously administered fast-acting human insulin. 
Pri preiskovancih z diabetesom mellitusom tipa 1 je bila intraindividualna variabilnost AUC humanega insulina za inhaliranje primerljiva kot pri subkutano apliciranem hitrodelujočem humanem insulinu.
You should avoid taking EXUBERA in moist conditions e.g. a bathroom following a steamy shower as this will usually give you a lower insulin dose than you need (see package leaflet 
Zdravila EXUBERA ne smete uporabljati v vlažnem okolju, npr. v kopalnici po prhi, ki povzroči veliko pare, saj boste zaradi tega v telo najverjetneje vnesli manjši odmerek insulina, kot ga potrebujete (za nasvet glejte ločeno navodilo za uporabo pretisnih omotov).
Approximate guidelines for initial, pre-meal EXUBERA doses, based on patient body weight, are 
Okvirne smernice za začetne odmerke zdravila EXUBERA, aplicirane pred obroki, na podlagi bolnikove telesne mase, kaže preglednica 1:
Small treatment group differences (favouring comparator) in change from baseline of 0.034L in type 1 and 0.039L in type 2 occurred after 2 years of therapy. 
Po 2 letih zdravljenja so se pojavile majhne razlike med skupinami, zdravljenimi z različnimi zdravili (v korist primerjalnega zdravila), sprememba od izhodišča je bila 0,034 L pri tipu 1 in 0,039 L pri tipu 2.
Push the base back into the chamber to store. 
Potisnite podnožje nazaj v komoro in inhalator shranite.
EXUBERA 1 mg inhalation powder pre-dispensed EXUBERA 3 mg inhalation powder pre-dispensed 
EXUBERA 1 mg prašek za inhaliranje, odmerjen EXUBERA 3 mg prašek za inhaliranje, odmerjen humani insulin
Dose adjustments may be required based on meal size and nutrient composition, time of day (higher insulin requirements in the morning), pre-meal blood glucose concentration, recent or planned 
Glede na velikost obrokov in sestavo hranil, dnevni čas (večja potreba po insulinu zjutraj), koncentracijo glukoze pred obroki ter nedavno ali načrtovano telesno dejavnost utegnejo biti potrebne prilagoditve odmerka.
In obese subjects with type 2 diabetes, intrasubject variability was comparable to or less than that of subcutaneously administered fast-acting human insulin for Cmax and AUC. 
Pri debelih preiskovancih z diabetesom tipa 2 je bila intraindividualna variabilnost Cmax in AUC primerljiva ali manjša kot subkutano apliciranega hitrodelujočega humanega insulina.
Fasting plasma glucose levels were significantly lower in patients treated with regimens including EXUBERA compared with those treated with subcutaneously administered fast-acting human insulin only regimens. 
Koncentracije plazemske glukoze na tešče so bile pomembno nižje pri bolnikih, zdravljenih s shemami z zdravilom EXUBERA, kot pri bolnikih, zdravljenih s shemami, ki so obsegale samo subkutano injicirani hitrodelujoči humani insulin.
While holding the IRU with one hand, turn the top counter-clockwise as 
Z eno roko držite nastavek za sproščanje insulina in zasukajte vrh v smeri, nasprotni od smeri urnega kazalca, kolikor
Please see the end of section 4 for important information about hypoglycaemia and hyperglycaemia 
Za pomembne nadaljnje informacije o hipoglikemji in hiperglikemiji ter njunem zdravljenju glejte zadnji del poglavja 4.
Therefore three 1 mg unit dose blisters should not be substituted for one 3 mg unit dose blister (see sections 2, 4.2 and 5.2). 
Zato se enega 3mg pretisnega omota za enkratni odmerek ne sme nadomestiti s tremi 1-mg (glejte poglavja 2, 4.2 in
Allow to air dry. 
Pustite komoro in ustnik, da se posušita na zraku.
There is very little experience with EXUBERA in patients with congestive heart failure. 
Pri bolnikih s kongestivnim srčnim popuščanjem imamo zelo malo izkušenj z zdravilom EXUBERA.
Your blood sugar level may either fall or rise if you take beta-blockers or drink alcohol. 
Če jemljete zaviralce adrenergičnih receptorjev beta ali pijete alkohol, se lahko koncentracija vašega krvnega sladkorja bodisi zniža bodisi zviša.
a) The need for consistent and standard inhalation technique to ensure both optimal and consistent b) Special precaution with the insulin inhaler d) 1 mg and 3 mg dose inequivalence e) Magnitude of titration steps and resulting precautions f) The change in pulmonary function and the need for pulmonary function monitoring g) Smoking in relation to induced alteration in pharmacokinetics i) Increased insulin antibody levels j) Recommendation for special populations; underlying lung diseases such as asthma and COPD, 
e) velikosti titracijskih korakov in posledičnih previdnostnih ukrepih, f) spremembah delovanja pljuč in potrebi po nadziranju pljučnega delovanja, g) kajenju v zvezi s povzročenimi spremembami farmakokinetike,
Therefore, EXUBERA should not be used during pregnancy. 
Zato zdravila EXUBERA v nosečnosti ni dovoljeno uporabljati.
Check with your doctor, nurse or pharmacist if you have any questions regarding EXUBERA or the insulin inhaler. 
Če imate kakšna vprašanja glede zdravila EXUBERA ali glede insulinskega inhalatorja, se obrnite na svojega zdravnika, medicinsko sestro ali farmacevta.
In clinical trials in type 1 diabetes, patients using a regimen of EXUBERA in combination with longor intermediate-acting insulin had similar reductions in HbA1c compared with patients taking subcutaneous insulin alone. 
Pri kliničnih preskušanjih pri diabetesu tipa 1 je bilo znižanje HbA1c podobno pri bolnikih, ki so se zdravili s shemo z zdravilom EXUBERA v kombinaciji z dolgo- ali srednjedolgo- delujočim insulinom, in pri bolnikih, ki so se zdravili samo s subkutanim insulinom.
Inhaled human insulin has a duration of glucose lowering activity comparable to subcutaneously administered fast-acting human insulin and longer than fast-acting insulin analogues (see Figure 1). 
Trajanje aktivnosti zniževanja glukoze pri humanem insulinu za inhaliranje je primerljivo kot pri subkutano injiciranem hitrodelujočem humanem insulinu in daljše kot pri hitrodelujočih analogih insulina (glejte
Store below 30°C. 
površine podnožja.
Inhaled human insulin has a faster onset of activity than subcutaneously administered fast-acting human insulin. 
Humani insulin za inhaliranje začne hitreje delovati kot subkutano apliciran hitrodelujoč humani insulin.
An approximately 40% higher bioavailability of three 1 mg unit dose blisters compared to one 3 mg unit dose blister was observed in healthy subjects. 
Pri zdravih preiskovancih je bila biološka uporabnost treh 1-mg pretisnih omotov za enkratni odmerek približno 40 % večja kot enega 3-mg pretisnega omota za enkratni odmerek.
Do not refrigerate or freeze. 
Zdravila ne shranjujte v hladilniku in ga ne zamrzujte.
It is important to follow your doctor's instructions exactly. 
Pomembno je, da zdravnikova
The 1 mg blister is printed with green ink and has one raised dot on the protruding end of each The 3 mg blister is printed with blue ink and has three raised dots on the protruding end of each 
3 mg pretisni omot ima oznako, natisnjeno z modro barvo, in po tri izbočene točke na vrhu
Insulin Release Unit Chamber Release Button (not visible) 
in modra ročica črni obroč napis Exubera sivi gumb gumb za sprostitev komore (ni viden)
The effect of hepatic impairment on the absorption of inhaled human insulin has not been studied (see section 4.2). 
Učinka okvar jeter na absorpcijo humanega insulina za inhaliranje niso proučevali (glejte poglavje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (60, 90, 270) 
PODATKI NA ZUNANJI OVOJNINI Škatla / enoodmerni pretisni omoti (60, 90, 270)
A 3 mg blister of inhaled insulin is approximately equivalent to 8 IU of subcutaneously injected fast-acting human insulin. 
3-mg pretisni omot inhaliranega insulina ustreza približno 8 i.e. subkutano injiciranega hitrodelujočega humanega insulina.
Close monitoring of blood glucose concentrations and dose titration as appropriate are recommended when inhaled human insulin is used in these patients. 
Pri uporabi humanega insulina za inhaliranje pri teh bolnikih priporočajo natančno spremljanje koncentracij glukoze v krvi in titriranje odmerka.
Thoroughly rinse the soap out of the chamber and mouthpiece with warm water. 
Komoro in ustnik temeljito splaknite s toplo
EXUBERA should only be breathed in through your mouth and should only be taken with your 
Zdravilo EXUBERA smete vdihniti samo skozi usta in samo z insulinskim inhalatorjem.
Inhaled human insulin is absorbed as rapidly as fast-acting insulin analogues and more rapidly than subcutaneously administered fast-acting human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4). 
Pri zdravih preiskovancih in preiskovancih z diabetesom tipa 1 ali 2 se humani insulin za inhaliranje absorbira enako hitro kot hitrodelujoči insulinski analogi in hitreje kot subkutano aplicirani hitrodelujoči humani insulin (glejte sliko 4).
Once you start treatment, your doctor will check your lung function again after 6 months and at other times to see how well you are tolerating 
Nato bo čez 6 mesecev in pozneje še večkrat znova preveril delovanje pljuč, da oceni, kako dobro prenašate zdravilo EXUBERA.
BEFORE YOU TAKE EXUBERA 
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EXUBERA
Refraction abnormalities of the eye may occur upon initiation of insulin therapy. 
Po uvedbi zdravljenja z insulinom se lahko pojavijo refrakcijske očesne nenormalnosti.
Bioavailability of inhaled human insulin relative to subcutaneously administered fast-acting human insulin was comparable to those in younger 
Biološka uporabnost humanega insulina za inhaliranje glede na subkutano injicirani hitrodelujoči humani insulin je bila primerljiva s tisto pri mlajših odraslih bolnikih z diabetesom tipa 2.
Push the IRU gently into the base. 
Nežno potisnite nastavek za sproščanje insulina v podnožje.
please tell your doctor or pharmacist. 
Če ste glede česarkoli negotovi, se obrnite na svojega zdravnika, medicinsko sestro ali farmacevta.
A 1 mg blister of EXUBERA gives you about the same insulin dose as 3 IU of subcutaneously injected fast-acting insulin human. 
Z 1-mg pretisnim omotom zdravila EXUBERA dobite približno toliko insulina kot s podkožnim injiciranjem 3 i.e. hitrodelujočega humanega insulina.
If your blood sugar is too high (hyperglycaemia) Your blood sugar level may be too high, if for example: - you have not taken enough insulin, or if it has become less effective, e.g. through incorrect storage, - you are doing less physical exercise, you are under stress (emotional distress, excitement), or if you have an injury, operation, feverish illness or certain other diseases, - you are taking or have taken certain other medicines (see section 2, “Taking other medicines”). 
- ste telesno manj aktivni, ste pod stresom (čustvena stiska, razburjenje) ali če imate poškodbo, operacijo, vročinsko bolezen ali katero od določenih drugih bolezni, - jemljete ali ste jemali nekatera druga zdravila (glejte poglavje 2 “Jemanje drugih zdravil”).
Please also read the “Instructions for Use” of the inhaler at the end of the package leaflet carefully before taking EXUBERA. 
Preden začnete jemati zdravilo EXUBERA, tudi natančno preberite “Navodilo za uporabo insulinskega inhalatorja”, ki je na koncu tega navodila.
NAME OF THE MEDICINAL PRODUCT EXUBERA 3 mg inhalation powder pre-dispensed Insulin human 
IME ZDRAVILA EXUBERA 3 mg prašek za inhaliranje, odmerjen
A 1 mg blister of inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected fastacting human insulin. 
1-mg pretisni omot inhaliranega insulina ustreza približno 3 i.e. subkutano injiciranega hitrodelujočega humanega insulina.
• A pack containing 180 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin Release Units (IRU) 
• pakiranje, ki vsebuje 180 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (6 vrečk) in 2 rezervna nastavka za sproščanje insulina (Insulin release unitIRU)
Reattach the chamber to the base. 
Komoro potisnite nazaj na
What EXUBERA is and what it is used for 
Kaj je zdravilo EXUBERA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo EXUBERA
A 3 mg blister of EXUBERA gives you about the same insulin dose as 8 IU of subcutaneously injected fast-acting insulin human. 
Z 3-mg pretisnim omotom zdravila EXUBERA dobite približno toliko insulina kot s podkožnim injiciranjem 8 i.e. hitrodelujočega humanega insulina.
NAME OF THE MEDICINAL PRODUCT EXUBERA 1 mg inhalation powder pre-dispensed. 
IME ZDRAVILA EXUBERA 1 mg prašek za inhaliranje, odmerjen
Please talk to your doctor if you have problems administering EXUBERA or controlling your blood glucose. 
Če imate težave z uporabo zdravila EXUBERA ali z obvladovanjem krvnega sladkorja, se posvetujte z zdravnikom.
Intrasubject variability of time to peak insulin concentrations was less for inhaled human insulin than for subcutaneous fast-acting human insulin in subjects with type 1 or 2 diabetes. 
Pri preiskovancih z diabetesom tipa 1 in 2 je bila intraindividualna variabilnost časa do največje koncentracije insulina ob uporabi insulina za inhaliranje manjša kot ob subkutani uporabi hitrodelujočega humanega insulina.
Hold the black ring at the bottom of the base and use it to pull the base out of the chamber. 
Vtaknite kazalec v črni obroč na spodnjem delu inhalatorja in ga povlecite, s čimer boste
An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters since with less powder in the blister the inhaler is more efficient in breaking up or de-agglomerating the powder leading to a larger proportion of smaller aerodynamic particle sizes for the 1 mg blister 
Razlaga različne biološke uporabnosti je verjetno različno razmerje med energijo in maso pri 1-mg in 3-mg pretisnih omotih za enkratni odmerek.
Dyspnoea Productive Cough Throat Irritation Dry Throat 
Infekcijske in parazitske bolezni faringitis dispneja produktivni kašelj, vnetje žrela suho žrelo,
Read all of this leaflet carefully before starting to use your insulin inhaler 
Navodilo za uporabo insulinskega inhalatorja Preden začnete uporabljati insulinski inhalator, natančno preberite navodilo!
• A pack containing 270 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU) 
• pakiranje, ki vsebuje 270 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (9 vrečk) in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit
• A pack containing 270 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU) 
• pakiranje, ki vsebuje 270 x 1 1-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (9 vrečk) in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit
• A pack containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches) and 2 spare Insulin Release Units (IRU) 
• pakiranje, ki vsebuje 90 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke) in 2 rezervna nastavka za sproščanje insulina (Insulin release unitIRU)
Do not get the inside of the IRU wet. 
Notranjosti nastavka za sproščanje insulina ne smete zmočiti.
• A pack containing 60 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU) 
• pakiranje, ki vsebuje 60 x 1 1-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (2 vrečki) in 2 rezervna nastavka za sproščanje insulina (Insulin release unit
Use within 3 months of opening. 
Delovanje traja približno 6 ur.
(Seen in less than 1 in 10 but more than 1 in 100 patients) Commonly reported side effects are mild to moderate shortness of breath (dyspnoea), productive cough, throat irritation and dry throat. 
Neželeni učinki, o katerih bolniki pogosto poročajo, so blaga do zmerna kratka sapa (dispneja), kašelj z izkašljevanjem izmečka, vnetje žrela in suho žrelo.
Number of 1 mg Blisters per Dose 
število 1-mg pretisnih omotov na odmerek število 3-mg pretisnih omotov na odmerek
QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose blister contains 1 mg insulin human. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En enoodmerni pretisni omot vsebuje 1 mg humanega insulina.
• If you feel hypoglycaemia (low blood sugar) coming on. See the information at the end of section 4 “Possible side effects” of this leaflet for further advice. 
Za nadaljnje nasvete glejte informacije na koncu poglavja 4 “Možni neželeni učinki” tega navodila.
• A pack containing 60 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU) 
• pakiranje, ki vsebuje 60 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (2 vrečki) in 2 rezervna nastavka za sproščanje insulina (Insulin release unitIRU)
• A kit containing 90 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) 
• Komplet, ki vsebuje 90 x 1 perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke), 1 insulinski inhalator, 1 rezervno komoro in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit - IRU)
Your ability to concentrate or react may be reduced if you have too low blood sugar (hypoglycaemia). 
Pri prenizkem krvnem sladkorju (hipoglikemiji) bosta vaša sposobnost koncentracije ali vaša odzivnost morda zmanjšani.
There is no experience with EXUBERA in patients with infection of 
Z uporabo zdravila EXUBERA ni izkušenj pri bolnikih, ki imajo okužbo globoko v pljučih (pljučnico).
• A kit containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) 
• komplet, ki vsebuje 90 x 1 3-mg perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke), 1 insulinski inhalator, 1 rezervno komoro in 6 rezervnih nastavkov za sproščanje
Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs. 
Če hipoglikemije ne morete obvladati ali če se ponavlja, se nemudoma pogovorite z zdravnikom.
In patients with type 2 diabetes sufficiently controlled with oral agents the glycaemic control was not further improved by inhaled insulin. 
Insulin za inhaliranje ni dodatno izboljšal urejenosti glikemije pri bolnikih z diabetesom tipa 2, ki so imeli bolezen zadostno urejeno s
• A kit containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) Additional insulin inhaler, insulin release units and chamber packages are available. 
90 x 1 perforiran pretisni omot za enkratni odmerek iz PVC/aluminija (3 vrečke), 1 insulinski inhalator, 1 rezervna komora in 6 rezervnih nastavkov za sproščanje insulina (Insulin release unit
If your blood sugar is too low (hypoglycaemia) 
- če čutite, da se bliža hipoglikemija (nizek krvni sladkor).
oC and use within 3 months of opening. 
Po odprtju prekrivne folije: shranjujte pri temperaturi do 25o C in porabite najpozneje v 3 mesecih po odprtju.
• Cardboard box containing 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches) 
• Kartonska škatla, ki vsebuje 270 x 1 perforiran pretisni omot za enkratni odmerek iz
• Cardboard box containing 30 x 1 PVC/Aluminium perforated unit dose blisters (1 pouch) 
• Kartonska škatla, ki vsebuje 30 x 1 perforiran pretisni omot za enkratni odmerek iz
Respiratory, 
Varnost za dihala
4 vials Zero days 
4 viale Nič dni
* not attenuated ** CFU - colony forming units 
* neatenuirana ** CFU - enota, ki tvori kolonijo
Packaging Content Package size 
Način uporabe Pakiranje Vsebina Velikost pakiranj a
EU (MA) Number Invented name 
Izmišljen o ime
Packaging Content (concentration) 
izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
0.6 ml (20 mg/ml) 1 vial 
0,6 ml (20 mg/ml) 1 viala
Powder: 100 mg Solvent: 3 ml 
Prašek: 100 mg Vehikel: 3 ml
Intravenous use Powder: vial (glass) Solvent: ampoule (glass) 
Vehikel: ampula (steklo)
MA (EU) number (Invented) name Strength Pharmaceutical Form 
(Izmišljeno) ime
- 3 years. 
- 3 leta.
Warnings and precautions: 
Opozorila in previdnostni ukrepi:
Your doctor will not prescribe OSSEOR for you if you are at particular risk. 
Zdravnik vam ne bo predpisal zdravila OSSEOR, če pri vas obstaja posebno tveganje.
OSSEOR with food and drink: 
Zdravilo OSSEOR skupaj s hrano in pijačo:
What OSSEOR is and what it is used for 
Kaj je zdravilo OSSEOR in za kaj ga uporabljamo
However, these effects were mild and short-lived and usually did not cause the patients to stop taking their treatment. 
Ti učinki so bili blagi ter prehodni in bolniki zaradi njih običajno niso prekinjali zdravljenja.
You can take OSSEOR again when you have finished taking these antibiotics. 
Zdravilo OSSEOR lahko ponovno začnete jemati, ko prenehate z jemanjem tovrstnih antibiotikov.
Children and adolescents OSSEOR is not intended for use in children and adolescents (below the age of 18). 
Otroci in mladostniki Zdravilo OSSEOR ni namenjen otrokom in mladostnikom (mlajšim od 18 let).
The safety and efficacy of OSSEOR in children aged below 18 years have not been established. 
Varnost in učinkovitost zdravila OSSEOR pri otrocih, mlajših od 18 let, nista bili dokazani.
OSSEOR has been studied in clinical trials involving nearly 8,000 participants. 
Zdravilo OSSEOR so proučevali v kliničnih študijah, ki so zajele skoraj 8000 bolnikov.
Adverse reactions are listed below using the following convention : very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
Neželeni učinki so našteti po naslednjem pravilu: zelo pogosti (≥ 1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Heart attack may occur commonly in patients at high risk for heart disease. 
Srčni infarkt se običajno lahko pojavi pri bolnikih z velikim tveganjem za nastanek srčne bolezni.
If tests are positive for one or both alleles, OSSEOR should not be started. 
Če so testi pozitivni za enega ali oba alela, se zdravila OSSEOR ne sme uvesti.
However, absence of these alleles upon genotyping does not exclude that SJS/TEN can still occur. 
Vendar pa odsotnost obeh alelov pri genotipizaciji ne izključuje možnosti za pojav SJS/TEN.