natgillin/translations-raw huggingface dataset:
HOW TO USE KINERET
KAKO UPORABLJATI ZDRAVILO KINERET
Always use Kineret exactly as your doctor has told you.
Pri jemanju zdravila Kineret natančno upoštevajte zdravnikova navodila.
Kineret must be injected under your skin (subcutaneous) once daily.
Kineret je treba enkrat na dan injicirati pod kožo (subkutano).
Injecting Kineret yourself
Samoinjiciranje Kinereta
Your doctor may decide that it would be more convenient for you to inject Kineret yourself.
Vaš zdravnik bo morda odločil, da bo za vas prikladneje, če si boste Kineret injicirali sami.
32 For instructions on how to inject yourself with Kineret, please read the section at the end of this leaflet.
Navodila za samoinjiciranje zdravila Kineret si preberite v poglavju na koncu tega navodila za uporabo.
If you use more Kineret than you should
30 Če ste uporabili večji odmerek zdravila Kineret, kot bi smeli
Like all medicines, Kineret may cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Kineret neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common side effects (seen in more than 1 in 10 people who take Kineret) are:
Zelo pogosti neželeni učinki (zabeleženi pri več kot 1 na 10 bolnikov, ki so dobivali Kineret) so:
• Redness, swelling, bruising or itching at the injection site.
rdečina, otekanje, modrica ali srbenje na mestu injiciranja.
This is generally mild to moderate and is more common at the start of your treatment.
Ti učinki so v splošnem blagi do • zmerni in pogostejši na začetku zdravljenja;
• Headaches.
glavoboli. •
Common side effects (seen in more than 1, but less than 10 in 100 people taking Kineret) are:
Pogosti neželeni učinki (zabeleženi pri več kot 1, a manj kot 10 od 100 bolnikov, ki so dobivali Kineret) so:
• Neutropenia (low white blood cell count) determined after a blood test.
nevtropenija (nizko število belih krvnih celic), ugotovljena po preiskavi krvi.
This might increase the risk of you getting an infection.
To utegne zvečati • nevarnost, da boste dobili okužbo.
Symptoms of infection might include a fever or a sore throat.
Simptomi okužbe utegnejo obsegati vročino ali vneto žrelo;
• Serious infections such as pneumonia (a chest infection) or infections of the skin.
resne okužbe, na primer pljučnica (okužba v prsnem košu) ali okužbe kože.
Symptoms might include a fever, a cough or redness and tenderness of the skin.
Simptomi lahko • obsegajo vročino, kašelj ali rdečino in občutljivost kože.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Če katerikoli od teh simptomov traja dalj časa ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
HOW TO STORE KINERET
SHRANJEVANJE ZDRAVILA KINERET
Do not use Kineret after the expiry date which is stated on the label and carton after EXP.
Zdravila Kineret ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki za oznako "Upor. do".
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 12 hours or disposed of.
Ko injekcijsko brizgo vzamete iz hladilnika in le- ta doseže sobno temperaturo (do 25 ºC), jo morate bodisi v 12 urah porabiti ali zavreči.
What Kineret contains
Kaj vsebuje zdravilo Kineret
The other ingredients are:
31 Pomožne snovi so:
• sodium citrate, sodium chloride, disodium edetate, polysorbate 80 and sodium hydroxide and water for injections.
• natrijev citrat, natrijev klorid, dinatrijev edetat, polisorbat 80, natrijev hidroksid in voda za injekcije.
Kineret is a clear, colourless-to-white solution for injection and is supplied ready for use in a pre-filled syringe.
Kineret je bistra, brezbarvna do bela raztopina za injiciranje, opremljena v napolnjenih injekcijskih brizgah, pripravljenih za uporabo.
Pack sizes of 1, 7 or 28 pre-filled syringes.
Pakiranja po 1, 7 ali 28 napolnjenih injekcijskih brizg.
This leaflet was last approved in Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/ __________________________________________________________________________________
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /
How do you or the person injecting you, use the Kineret pre-filled syringe?
Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo Kineret?
Kineret is injected just under the skin.
Kineret se injicira tik pod kožo.
• a new pre-filled syringe of Kineret; and
• novo napolnjeno injekcijsko brizgo zdravila Kineret in
34 What should you do before you give yourself a subcutaneous injection of Kineret?
Kaj morate narediti, preden si daste podkožno injekcijo zdravila Kineret?
Check the expiry date on the pre-filled syringe label (EXP).
Preverite datum izteka roka uporabnosti na nalepki napolnjene injekcijske brizge (» Upor. do: «).
The solution should not be used if it is discoloured or cloudy, or if any particles other than translucent-to-white particles are present.
Raztopine ne smete uporabiti, če je obarvana ali motna, ali če vsebuje kakšne druge delce razen prosojnih do belih
Hold the syringe barrel and gently take the cover from the needle without twisting.
Primite telo brizge in previdno snemite pokrovček z igle, ne da bi ga sukali.
Change the place that you inject each time so you don’t become sore in one area.
Če vam
If someone else is injecting for you, they can also use the back of your arms.
zdravilo injicira kdo drug, vam ga lahko da tudi v zadnjo stran nadlakta.
Disinfect your skin by using the alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Nato kožo primite med palec in kazalec, ne da bi jo stiskali.
If you see blood in the syringe, remove the needle and re-insert it in another place.
Če se v brizgi pokaže kri, izvlecite iglo in jo še enkrat zabodite na drugo mesto.
• Keep used syringes out of reach and sight of children
• Uporabljene injekcijske brizge shranjujte nedosegljive otrokom!
• Never put the pre-filled syringes that you have used into your normal household rubbish bin.
• Uporabljenih injekcijskih brizg ne smete nikdar odvreči med običajne gospodinjske odpadke.
• The used pre-filled syringe should be disposed of in accordance with local requirements.
• Neuporabljene injekcijske brizge zavrzite v skladu z lokalnimi predpisi.
INFORMATION FOR THE USER
34 NAVODILO ZA UPORABO
Kineret 100 mg solution for injection in a vial Anakinra
Kineret 100 mg raztopina za injiciranje v viali Anakinra
Further information
Informacije za samoinjiciranje
The active substance of Kineret is anakinra produced by DNA technology using the micro-organism E coli and works in the same way as your natural blocking protein.
Zdravilna učinkovina v zdravilu Kineret je anakinra, izdelana s tehnologijo DNA z uporabo mikroorganizma E. coli, in deluje na enak način kot vaša naravna blokirajoča beljakovina.
• if you are allergic to other products that are produced by DNA technology using the micro- organism E coli;
če ste alergični na druge produkte, izdelane s tehnologijo DNA z uporabo mikroorganizma • E. coli;
37 Contact your doctor immediately:
35 Nemudoma se obrnite na svojega zdravnika:
• if you know you are allergic to latex.
• če veste, da ste alergični na lateks.
The vial stopper contains a derivative of latex.
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje snov, pridobljeno iz lateksa.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e. essentially ‘sodium-free’.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg, kar v bistvu pomeni "brez natrija".
Your doctor may decide that it would be m ore convenient for you to inject Kineret yourself.
Vaš zdravnik bo morda odločil, da bo za vas prikladneje, če si boste Kineret injicirali sami.
38 For instructions on how to inject yourself with Kineret, please read the section at the end of this leaflet.
Navodila za samoinjiciranje zdravila Kineret si preberite v poglavju na koncu tega navodila za uporabo.
If you use more Kineret than you should
36 Če ste uporabili večji odmerek zdravila Kineret, kot bi smeli
If you forget to use Kineret
Če ste pozabili vzeti Kineret
• redness, swelling, bruising or itching at the injection site.
rdečina, otekanje, modrica ali srbenje na mestu injiciranja.
• headaches.
glavoboli. •
• neutropenia (low white blood cell count) determined after a blood test.
nevtropenija (nizko število belih krvnih celic), ugotovljena po preiskavi krvi.
• serious infections such as pneumonia (a chest infection) or infections of the skin.
resne okužbe, na primer pljučnica (okužba v prsnem košu) ali okužbe kože.
Do not use Kineret after the expiry date which is stated on the label and carton after EXP.
Zdravila Kineret ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki za oznako "Upor. do:".
Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (med 2°C in 8°C).
Once a vial has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 12 hours or disposed of.
Ko vialo vzamete iz hladilnika in le- ta doseže sobno temperaturo (do 25 ºC), jo morate bodisi v 12 urah porabiti ali zavreči.
FURTHER INFORMATION
INFORMACIJE ZA SAMOINJICIRANJE
Each vial contains 100 mg of anakinra.
Vsaka viala vsebuje 100 mg anakinre.
The other ingredients are:
37 Pomožne snovi so:
Kineret is a clear, colourless-to-white solution for injection in a vial.
Kineret je bistra, brezbarvna do bela raztopina za injiciranje v viali.
It may contain some translucent- to-white particles of protein.
Vsebuje lahko nekaj prosojnih do belih beljakovinskih delcev.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ __________________________________________________________________________________
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /
This section contains information on how to give yourself an injection of Kineret.
To poglavje obsega informacije o tem, kako si sami injicirate zdravilo Kineret.
How do you or the person injecting you, use the Kineret vial?
Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite vialo Kineret?
• a new vial of Kineret;
• novo napolnjeno injekcijsko brizgo zdravila Kineret;
• a sterile syringe and needles; and
• sterilno injekcijsko brizgo in iglo; in
40 • alcohol wipes or similar.
• alkoholne lističe ali podobno.
Take your Kineret vial out of the refrigerator.
Vzemite vialo zdravila Kineret iz hladilnika.
Check the expiry date on the vial label (EXP).
Preverite datum izteka roka uporabnosti na nalepki viale (» Upor. do: «).
For a more comfortable injection, leave at room temperature for approximately 30 minutes.
Da injiciranje ne bo neprijetno, pustite vialo približno 30 minut na sobni temperaturi ali jo previdno nekaj minut držite v roki.
Remove the plastic top from the vial by pushing upwards to expose the rubber stopper.
Odstranite plastični pokrovček z viale, tako da ga potisnete navzgor in se pokaže gumijasti zamašek.
Clean the stopper with a fresh alcohol wipe.
Očistite zamašek s svežo alkoholno krpico.
Remove the syringe and needles from their packaging.
Vzemite injekcijsko brizgo in igle iz njihove ovojnine.
Attach the longer needle to the syringe and remove the cover.
Nataknite daljšo iglo na injekcijsko brizgo in snemite pokrovček.
Do not touch the needle.
Ne dotaknite se igle.
Pull the syringe plunger out, filling the syringe with air to the amount prescribed by your doctor.
Izvlecite bat injekcijske brizge, napolnite injekcijsko brizgo z zrakom do količine, ki vam jo je predpisal zdravnik.
Push the needle through the rubber stopper and introduce the air into the vial by pushing the plunger.
Potisnite iglo skozi gumijasti zamašek in s potiskanjem bata vbrizgajte zrak v vialo.
Turn the vial upside down, pull on the plunger and fill the syringe with the correct amount of liquid.
Zasukajte vialo z zgornjim delom navzdol, povlecite bat in napolnite injekcijsko brizgo s pravilno količino tekočine.
It is important that the needle is always in the liquid in order to prevent air bubbles forming in the syringe.
Pazite, da bo igla ves čas v tekočini, ker boste tako preprečili nastajanje zračnih mehurčkov v injekcijski brizgi.
Remove the needle from the vial.
Izvlecite iglo iz viale.
Remove the needle from the syringe.
Snemite iglo z injekcijske brizge.
Put the short needle on the syringe and remove the cover.
Nataknite kratko iglo na injekcijsko brizgo in odstranite pokrovček.
Hold the syringe with the needle pointing up to see if it has any air bubbles inside.
Držite injekcijsko brizgo z iglo navzgor, da preverite ali je v njej kaj zračnih mehurčkov.
If there are, gently press the plunger until all the air (but none of the liquid) has been removed.
Če so, nežno pritisnite na bat, dokler ne boste odstranili vsega zraka (ne pa tekočine).
The syringe is ready for you to use.
Sedaj lahko uporabite napolnjeno injekcijsko brizgo.
the top of your thighs; and
zgornji del stegen in trebuh (razen predela okrog popka).
41 • the abdomen, except for the area around the navel.
Mesto
You must not use any Kineret that is left in the vial.
Ne uporabite zdravila Kineret, ki ostane v viali.
Disposing of used needles, syringes and vials
Odlaganje uporabljenih igel, brizg in vial
• Keep used needles and syringes out of reach and sight of children
• Uporabljene injekcijske igle in brizge shranjujte nedosegljive otrokom!
• Never put the syringes and vials that you have used into your normal household rubbish bin.
• Uporabljenih injekcijskih brizg in vial ne smete nikdar odvreči med običajne gospodinjske odpadke.
• The used syringes and vials should be disposed of in accordance with local requirements.
• Uporabljene injekcijske brizge in viale zavrzite v skladu z lokalnimi predpisi.
It is available as oval tablets (red and white:
Na voljo je v obliki ovalnih tablet (rdeče in bele:
40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; yellow and white:
40 mg ali 80 mg telimisartana in 12, 5 mg hidroklorotiazida; rumene in bele:
80 mg telmisartan and 25 mg hydrochlorothiazide).
80 mg telmisartana in 25 mg hidroklorotiazida).
Kinzalkomb is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
„ Esencialna “ pomeni, da ni posledica nobenega drugega bolezenskega stanja.
The safety and effectiveness of Kinzalkomb have not been established in patients below 18 years of age.
Varnost in učinkovitost zdravila Kinzalkomb nista bili ugotovljenih pri bolnikih, mlajših od 18 let.
Kinzalkomb is taken by mouth once a day with liquid, with or without food.
Zdravilo Kinzalkomb se jemlje peroralno enkrat na dan s tekočino, s hrano ali brez nje.
The dose of Kinzalkomb to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/ 12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/ 12.5 mg tablets.
Odmerek zdravila Kinzalkomb je odvisen od odmerka telmisartana, ki ga je bolnik jemal do takrat: bolniki, ki so prejemali 40 mg telmisartana, morajo jemati tablete po 40/ 12, 5 mg, tisti, ki pa so prejemali 80 mg telmisartana, pa morajo jemati tablete po 80/ 12, 5 mg.
The 80/ 25 mg tablets are used in patients whose blood pressure is not controlled using the 80/ 12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Kinzalkomb.
Tablete po 80/ 25 mg se dajejo bolnikom, pri katerih se krvni tlak ne uravna z jemanjem tablet po 80/ 12, 5 mg ali pri katerih se je krvni tlak stabiliziral z uporabo dveh zdravilnih učinkovin, ki so ju jemali ločeno, preden so prešli na zdravilo Kinzalkomb.
Telmisartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Telmisartan je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu prepreči delovanje hormona, imenovanega angiotenzin II.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Ker telmisartan zavira receptorje, na katere se angiotenzin običajno veže, hormonu prepreči delovanje, zaradi česar se krvne žile lahko razširijo.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Kombinacija obeh zdravilnih učinkovin ima aditiven učinek, saj zniža krvni tlak bolj kot vsako posamezno zdravilo posebej.
By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Z znižanjem krvnega tlaka se zmanjša tveganje za poškodbe, ki jih povzroča visok krvni tlak, kot je na primer kap.
Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Zdravilo Kinzalkomb so proučevali v petih glavnih študijah, v katerih je sodelovalo skupno 2985 bolnikov z blago do zmerno hipertenzijo.
In four of these studies (2,272 patients), Kinzalkomb was compared with placebo (a dummy treatment) and with telmisartan taken alone.
V štirih študijah (2272 bolnikov) so zdravilo Kinzalkomb primerjali s placebom (zdravilom brez zdravilne učinkovine) in telmisartanom kot samostojnim zdravilom.
The fifth study compared the effects of remaining on the 80/ 12.5 mg tablet with switching to the 80/ 25 mg tablet in 713 patients who had not responded to the 80/ 12.5 mg tablet.
V peti študiji so pri 713 bolnikih, ki se niso odzvali na tablete po 80/ 12, 5 mg, primerjali učinke nadaljevanja jemanja tablet po 80/ 12, 5 mg s prehodom na jemanje tablet po 80/ 25 mg.
Kinzalkomb was more effective than placebo and than telmisartan taken alone in reducing diastolic blood pressure.
Zdravilo Kinzalkomb je bilo učinkovitejše od placeba in telmisartana, uporabljenega samostojno, pri zniževanju diastoličnega krvnega tlaka.
In patients who were not controlled on the 80/ 12.5 mg tablet, switching to the 80/ 25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.
Pri bolnikih, pri katerih se tlak ni uravnal s tabletami po 80/ 12, 5 mg, je bil prehod na tablete po 80/ 25 mg učinkovitejši pri znižanju diastoličnega krvnega tlaka kot nadaljevanje jemanja nižjega odmerka.
The most common side effects with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness.
Najpogostejši neželeni učinek zdravila Kinzalkomb (opažen pri 1 do 10 bolnikih od 100) je omotica.
Kinzalkomb should not be used in people who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients (including sorbitol).
Zdravila Kinzalkomb ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telmisartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila (vključno s sorbitolom).
It must not be used in women who are more than three months pregnant or who are breast-feeding.
Uporabljati se ne sme pri ženskah, ki so noseče več kot tri mesece ali ki dojijo.
Kinzalkomb must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Zdravilo Kinzalkomb se prav tako ne sme uporabljati pri osebah, ki imajo huda obolenja jeter, ledvic ali žolčnika, ter osebe s prenizkimi ravnmi kalija v krvi ali previsokimi ravnmi kalcija v krvi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Kinzalkomb’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Kinzalkomb pri zdravljenju esencialne hipertenzije pri bolnikih, katerih krvni tlak ni zadostno nadzorovan s telmisartanom, uporabljenim samostojno, večje od z njim povezanih tveganj.
The Committee recommended that Kinzalkomb be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Kinzalkomb odobri dovoljenje za promet.
Other information about Kinzalkomb:
Druge informacije o zdravilu Kinzalkomb:
The marketing authorisation holder is Bayer Healthcare AG.
Evropska komisija je dovoljenje za promet z zdravilom Kinzalkomb, veljavno po vsej Evropski uniji, odobrila družbi Bayer AG dne 19. aprila 2002.
The marketing authorisation was renewed on 19 April 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 19. aprila 2007.
The full EPAR for Kinzalkomb is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kinzalkomb je na voljo tukaj.
Kinzalkomb 40 mg/ 12.5 mg tablets
Kinzalkomb 40 mg/ 12, 5 mg tablete
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
1 tableta vsebuje 40 mg telmisartana in 12, 5 mg hidroklorotiazida.
Red and white oval shaped two layer tablet engraved with the code number'H4 '.
Tableta Rdeča in bela ovalna, dvoslojna tableta z vtisnjeno kodno številko 'H4'.
Kinzalkomb fixed dose combination (40 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
Kinzalkomb, fiksna kombinacija (40 mg telmisartana in 12, 5 mg hidroklorotiazida), je indicirana za bolnike, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom.
Adults Kinzalkomb should be taken once daily with liquid, with or without food in patients whose blood pressure is not adequately controlled by telmisartan alone.
Odrasli Bolniki, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom, jemljejo Kinzalkomb enkrat na dan s tekočino, s hrano ali brez nje.
• Kinzalkomb 40 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Kinzalmono 40 mg • Kinzalkomb 80 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Kinzalmono 80 mg
• Kinzalkomb po 40 mg/ 12, 5 mg lahko dajemo bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati s Pritorjem po 40 mg • Kinzalkomb po 80 mg/ 12, 5 mg lahko dajemo bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati s Pritorjem po 80 mg
Periodic monitoring of renal function is advised (see section 4.4).
Ledvična okvara Priporočamo periodične kontrolne preglede ledvičnega delovanja (glejte poglavje 4. 4).
In patients with mild to moderate hepatic impairment the posology should not exceed Kinzalkomb 40 mg/ 12.5 mg once daily.
Odmerek za bolnike z blago do zmerno zmanjšanim jetrnim delovanjem ne sme prekoračiti odmerka Kinzalkomba po 40 mg/ 12, 5 mg 1- krat na dan.
Kinzalkomb is not indicated in patients with severe hepatic impairment.
Kinzalkomb ni indiciran za bolnike s hudim jetrnim odpovedovanjem.
Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).
Tiazide moramo previdno dajati bolnikom z zmanjšanim jetrnim delovanjem (glejte poglavje 4. 4).
No dosage adjustment is necessary.
Odmerka ni potrebno prilagajati.
Kinzalkomb is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba Kinzalkomba pri otrocih pod 18 let ni priporočljiva.