natgillin/translations-raw huggingface dataset:
50% of the
Izgled zdravila Liprolog Mix50 100 i. e. / ml KwikPen suspenzija za injiciranje in vsebina pakiranja Zdravilo Liprolog Mix50 100 i. e. / ml KwikPen suspenzija za injiciranje je bela, sterilna suspenzija in vsebuje 100 mednarodnih enot insulina lispro na mililiter (100 i. e. / ml) suspenzije za injiciranje.
267 insulin lispro in Liprolog Mix50 is dissolved in water.
50% insulina lispro v zdravilu Liprolog Mix50 je raztopljenega v vodi.
The Liprolog Mix50 KwikPen comes in a pack of 5 pre -filled pens or a multipack of 2 x 5 pre-filled pens.
Zdravilo Liprolog Mix50 KwikPen je na voljo v pakiranju po 5 injekcijskih peresnikov ali kot večje pakiranje 2 x 5 injekcijskih peresnikov.
The Liprolog Mix50 in your pre -filled pen is the same as the Liprolog Mix50, which comes in separate Liprolog Mix50 cartridges.
Zdravilo Liprolog Mix50 v vašem KwikPenu je enako zdravilu Liprolog Mix50, ki se dobavlja v posameznih vložkih zdravila Liprolog Mix50.
Marketing Authorisation Holder and Manufacturer Liprolog Mix50 100 U/ml KwikPen, suspension for injection is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Lilly Pharma Fertigung und Distribution GmbH & Co.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Zdravilo Liprolog Mix50 100 i. e. / ml KwikPen suspenzijo za injiciranje izdelujejo: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Francija, • Lilly Pharma Fertigung und Distribution GmbH & Co.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
279 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000
280 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000
INFORMATION FOR THE USER
281 NAVODILO ZA UPORABO
Liprolog Basal 100 U/ml KwikPen, suspension for injection (insulin lispro)
Liprolog Basal 100 i. e. / ml KwikPen suspenzija za injiciranje (insulin lispro)
What Liprolog Basal KwikPen is and what it is used for 2.
Kaj je zdravilo Liprolog Basal KwikPen in za kaj ga uporabljamo 2.
Before you use Liprolog Basal KwikPen 3.
Kaj morate vedeti, preden boste uporabili zdravilo Liprolog Basal KwikPen 3.
How to use Liprolog Basal KwikPen 4.
Kako uporabljati zdravilo Liprolog Basal KwikPen 4.
How to store Liprolog Basal KwikPen 6.
Shranjevanje zdravila Liprolog Basal KwikPen 6.
WHAT LIPROLOG Basal KWIKPEN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO LIPROLOG BASAL KWIKPEN IN ZA KAJ GA UPORABLJAMO
BEFORE YOU USE LIPROLOG Basal KWIKPEN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LIPROLOG BASAL KWIKPEN
Further in this leaflet it tells you
Ne uporabljajte zdravila Liprolog Basal KwikPen − če mislite, da se začenja hipoglikemija (nizek krvni sladkor).
- if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of Liprolog
V nadaljevanju teh navodil boste našli nasvete za odpravo blage hipoglikemije. − če ste alergični na (preobčutljivi za) insulin lispro ali katerokoli sestavino zdravila Liprolog Basal KwikPen.
Take special care with Liprolog Basal KwikPen • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
Bodite posebno pozorni pri uporabi zdravila Liprolog Basal KwikPen • Če ste z dosedanjim zdravljenjem z insulinom dobro uravnavali ravni sladkorja v krvi, morda pri čezmernem znižanju krvnega sladkorja ne boste začutili opozorilnih znakov.
270 • If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse
Če imate hipoglikemije pogosto, ali če jih le s težavo prepoznate, se o tem, prosimo, pogovorite s svojim zdravnikom. • Če je vaš odgovor na katerokoli od naslednjih vprašanj DA, morate o tem obvestiti svojega zdravnika, farmacevta ali medicinsko sestro v diabetološki ambulanti.
HOW TO USE LIPROLOG Basal KWIKPEN
KAKO UPORABLJATI ZDRAVILO LIPROLOG BASAL KWIKPEN
271 Preparing Liprolog Basal KwikPen • The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky.
Priprava zdravila Liprolog Basal KwikPen • KwikPen je treba tik pred uporabo desetkrat zavrteti med dlanmi rok in desetkrat obrniti za 180°, da ponovno suspendirate insulin, dokler ni enakomerno motnega ali mlečnega videza.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).
284 Če hipoglikemije (nizkega krvnega sladkorja) ali hiperglikemije (previsokega krvnega sladkorja) ne zdravimo, lahko postane ena ali druga zelo huda in povzroči glavobole, slabost, bruhanje, dehidracijo, nezavest, komo ali celo smrt (glejte točki A in B poglavja 4 „ Možni neželeni učinki “). • Vedno imejte pri roki rezervne injekcijske brizge in rezervno vialo zdravila Liprolog Basal ali rezervni injekcijski peresnik in vložke za primer, da vaš KwikPen izgubite ali je poškodovan. • Vedno nosite s seboj nekaj, kar bo pokazalo, da ste sladkorni bolnik. • S seboj imejte vedno tudi nekaj sladkorja.
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.
285 Če niste prepričani, da boste zagotovo prepoznali opozorilne simptome, se izogibajte okoliščinam, npr. vožnji avtomobila, v katerih bi zaradi hipoglikemije ogrozili sebe ali druge.
Hyperglycaemia can be brought about by: • not taking your Liprolog or other insulin; 273 • taking less insulin than your doctor tells you to; • eating a lot more than your diet allows; or • fever, infection or emotional stress.
Vzroki za hiperglikemijo so lahko naslednji: • niste vzeli zdravila Liprolog ali kakega drugega insulina; • vzeli ste manj insulina, kot vam je predpisal vaš zdravnik; • pojedli ste veliko več, kot predpisuje vaša dieta; ali • imate zvišano telesno temperaturo, okužbo ali čustvene obremenitve.
HOW TO STORE LIPROLOG Basal KWIKPEN
SHRANJEVANJE ZDRAVILA LIPROLOG BASAL KWIKPEN
Before the first use store your Liprolog Basal KwikPen in a refrigerator (2°C – 8°C).
Pred prvo uporabo shranjujte zdravilo Liprolog Basal KwikPen v hladilniku (2 °C - 8 °C).
Keep your Liprolog Basal KwikPen in use at room temperature (below 30°C) for up to 21 days.
Zdravilo Liprolog Basal KwikPen, ki ga trenutno uporabljate, shranjujte pri temperaturi do 30 °C do 21 dni.
What Liprolog Basal 100 U/ml KwikPen, suspension for injection contains
Kaj vsebuje zdravilo Liprolog Basal 100 i. e. / ml KwikPen suspenzija za injiciranje
What Liprolog Basal 100 U/ml KwikPen, suspension for injection looks like and contents of the pack Liprolog Basal 100 U/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 U/ml) suspension for injection.
286 Izgled zdravila Liprolog Basal 100 i. e. / ml KwikPen suspenzija za injiciranje in vsebina pakiranja Zdravilo Liprolog Basal 100 i. e. / ml KwikPen suspenzija za injiciranje je bela, sterilna suspenzija in vsebuje 100 mednarodnih enot insulina lispro na mililiter (100 i. e. / ml) suspenzije za injiciranje.
Each Liprolog Basal KwikPen contains 300 units (3 millilitres).
Vsako zdravilo Liprolog Basal KwikPen vsebuje 300 enot (3 mililitre).
The Liprolog Basal KwikPen comes in a pack of 5 pre-filled pens or a multipack of 2 x 5 pre-filled pens.
Zdravilo Liprolog Basal KwikPen je na voljo v pakiranju po 5 injekcijskih peresnikov ali kot večje pakiranje 2 x 5 injekcijskih peresnikov.
The Liprolog Basal in your KwikPen is the same as the Liprolog Basal, which comes in separate Liprolog
Zdravilo Liprolog Basal v vašem KwikPenu je enako zdravilu Liprolog Basal, ki se dobavlja v posameznih vložkih zdravila Liprolog Basal.
Marketing Authorisation Holder and Manufacturer Liprolog Basal 100 U/ml KwikPen, suspension for injection is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France • Lilly Pharma Fertigung und Distribution GmbH & Co.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Zdravilo Liprolog Basal 100 i. e. / ml KwikPen suspenzijo za injiciranje izdelujejo: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Francija, • Lilly Pharma Fertigung und Distribution GmbH & Co.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
287 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000
288 Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000
276 USER MANUAL
289 PRIROČNIK ZA UPORABO
• Read and follow the directions provided in. the package leaflet for the insulin. • Check the label on your Pen before each injection for the expiration date and to make sure you are using the correct type of insulin. • Your healthcare professional has prescribed the most appropriate type of insulin for you.
• Preberite in sledite navodilom v Navodilu za uporabo za insulin. • Pred vsakim injiciranjem preglejte oznako na vašem Penu, da preverite datum izteka roka uporabnosti in da se prepričate, da uporabljate pravo vrsto insulina. • Vaš zdravnik vam je predpisal tisto vrsto insulina, ki je za vas najprimernejša.
277 Priming the KwikPen
290 Priprava KwikPena
278 • Why is insulin leaking from the needle after I finished my dose?
291 • Zakaj po končanem odmerjanju, insulin izteka iz igle?
If the needle is left on, insulin may leak from the Pen, insulin may dry inside the needle causing the needle to clog, or air bubbles may form in the cartridge. • Refer to the Information for the package leaflet for complete insulin storage instructions. • After first use the pen should not be used beyond the time specified in the insulin package leaflet Dispose of used needles in a puncture-resistant container or as directed by your healthcare professional. • Dispose of used Pens as instructed by your healthcare professional and without the needle attached. • Keep the Pen out of the reach of children.
Uporabljene igle zavrzite v vsebniku, ki je odporen proti vbodom ali kot vam je naročilo vaše zdravstveno osebje. • Uporabljene Pene zavrzite kot vam je priporočilo vaše zdravstveno osebje ter brez pritrjene igle. • Pen shranjujte nedosegljivo otrokom.
279 Getting Ready Make sure you have the following items:
292 Pripravite se Prepričajte se, da imate vse naslednje pripomočke:
280 2.
293 2.
D. • With needle pointed up, push Dose Knob in until it stops and 0 is seen in the Dose
iglo usmerjeno navzgor, pritisnite gumb za odmerjanje so konca, dokler
Pull off Outer Needle Shield.
Snemite zunanji pokrovček igle.
Dial 2 Units by
Z obračanjem
Point Pen up.
Ne zavrzite ga.
Window. • Hold Dose
gumba za
Do not throw away.
ne vidite 0.
Pull off Inner
• Držite gumb
turning the Dose Tap Cartridge Knob.
Snemite notranji nastavite na 2 pokrovček igle in enoti. ga zavrzite.
281 3.
294 3.
Unscrew the capped needle and throw away as directed by your healthcare professional.
osebje.
backwards.
osebje.
The odd numbers are shown as full lines between the even numbers.
Primer:
Place your thumb on the Dose Knob and push firmly until the Dose Knob stops moving.
Pen vam ne bo
Check to make sure you see 0 in the Dose Window to confirm you received the complete dose.
Za zagotovitev, da ste prejeli celotni odmerek, preverite, da se prepričate, da v okencu za odmerjanje vidite 0. omogočil
Remove the needle after each injection to keep air out of the cartridge.
Po vsakem injiciranju odstranite iglo, da preprečite vstop zraka v vložek.
You may use this function to determine the total amount of insulin remaining in the Pen when the cartridge has less than 60 units remaining.
število preostalih
If your dose is greater than the number of
To lastnost lahko uporabite enot. za določitev celotne količine insulina, ki je ostala v Penu potem, ko je v vložku ostalo manj kot 60 enot.
282
295
What is LITAK?
Kaj je zdravilo LITAK?
LITAK is a solution for injection that contains the active substance cladribine (2 mg/ ml).
Zdravilo LITAK je raztopina za injiciranje, ki vsebuje zdravilno učinkovino kladribin (2 mg/ ml).
What is LITAK used for?
Za kaj se zdravilo LITAK uporablja?
LITAK is used to treat patients over 16 years of age who have hairy cell leukaemia.
Zdravilo LITAK se uporablja za zdravljenje dlakavocelične levkemije pri bolnikih, starejših od 16 let.
This is a cancer of blood in which too many B-lymphocytes (a type of white blood cell) are produced.
To je vrsta krvnega raka, pri katerem nastaja preveč B- limfocitov (vrsta belih krvničk).
The term ‘ hairy cell’ refers to the hair-like projections that can be seen on the surface of the lymphocytes when they are examined under a microscope.
Izraz „ dlakavocelična ” se nanaša na lasaste izrastke na površini limfocitov, ki so vidni pod mikroskopom.
Because the number of patients with hairy cell leukaemia is low, the disease is considered ‘ rare’, and LITAK was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 18 September 2001.
Ker je število bolnikov z dlakavocelično levkemijo majhno, velja ta bolezen za „ redko ”, zato je bilo zdravilo LITAK dne 18. septembra 2001 določeno kot „ zdravilo sirota ” (zdravilo za zdravljenje redkih bolezni).
How is LITAK used?
Kako se zdravilo LITAK uporablja?
LITAK treatment should be initiated by a qualified doctor who has experience in the use of cancer treatments.
Zdravljenje z zdravilom LITAK mora uvesti usposobljen zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
LITAK is given as an injection under the skin.
Zdravilo LITAK se daje z injiciranjem pod kožo.
The recommended dose is 0.14 mg per kilogram body weight, once a day for five days.
Priporočeni odmerek je 0, 14 mg na kilogram telesne mase enkrat dnevno 5 zaporednih dni.
LITAK cannot be given to patients with moderate to severe liver or kidney disease.
Zdravilo LITAK se ne sme uporabiti pri bolnikih z zmerno do hudo okvarjenim delovanjem jeter ali ledvic.
How does LITAK work?
Kako zdravilo LITAK deluje?
The active substance in LITAK, cladribine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Zdravilna učinkovina zdravila LITAK, kladribin, je citotoksična, kar pomeni, da ubija celice, ki se delijo (npr. rakaste celice).
Cladribine is an analogue of purine, one of the fundamental chemicals that make up DNA.
Kladribin je analog purina, ene izmed temeljnih kemikalij, ki sestavljajo DNA.
In the body, it is converted within lymphocytes into a chemical called CdATP, which interferes with the production of new DNA.
V limfocitih v telesu se pretvori v kemikalijo, ki ji pravimo CdATP, ki moti nastajanje nove DNA.
This prevents the cells from dividing, slowing down the progression of leukaemia.
To prepreči podvojevanje celic in upočasni napredovanje levkemije.
Cladribine has been in use in anticancer medicines since the 1980s and it has been available as an intravenous infusion (drip into a vein) in some European Union (EU) Member States since 1993.
Kladribin se uporablja za zdravljenje raka od 1980- ih, od leta 1993 pa je na voljo kot intravenska infuzija (kapalna infuzija v veno) v določenih članicah Evropske unije.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zdravilo LITAK so preverili v eni glavni študiji, v katero je bilo vključenih 63 bolnikov z dlakavocelično 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
How has LITAK been studied?
Reproduction is authorised provided the source is acknowledged. levkemijo.
LITAK has been examined in one main study involving 63 patients with hairy cell leukaemia.
V tej študiji zdravila LITAK niso primerjali z nobeno drugo vrsto zdravljenja.
The main measures of effectiveness were the proportions of patients who had complete and partial remission following treatment.
Glavni merili učinkovitosti sta bila deleža bolnikov s popolno oz. delno remisijo po zdravljenju.
Complete remission was the disappearance of all evidence of disease, whereas partial remission was improved blood counts and the reduction in the number of cancerous cells.
Popolna remisija je bila opredeljena kot odsotnost vseh znakov bolezni, delna remisija pa je bila opredeljena kot izboljšanje krvne slike in zmanjšanje števila rakastih celic.
What benefit has LITAK shown during the studies?
Kakšne koristi je zdravilo LITAK izkazalo med raziskavami?
In the main study, 60 (97%) of 62 patients had either complete or partial remission, and 47 (76%) had complete remission.
V glavni študiji je 60 (97%) od 62 bolnikov doseglo bodisi popolno bodisi delno remisijo, od teh jih je 47 (76%) doseglo popolno remisijo.
These results were similar to those seen in other published studies using intravenous cladribine and were better than results seen with alternative treatments such as interferon alfa and pentostatin.
Ti rezultati so bili podobni rezultatom v drugih objavljenih študijah uporabe intravenskega kladribina ter boljši od rezultatov drugačnih oblik zdravljenja, kot sta interferon alfa in pentostatin.
What is the risk associated with LITAK?
Kakšna tveganja so povezana z zdravilom LITAK?
The most common side effects with LITAK (seen in more than 1 patient in 10) are infections, pancytopenia or myelosuppression (low blood cell counts), purpura (bruising), immunosuppression (a weakened immune system), decreased appetite, headache, dizziness, abnormal breath and chest sounds, cough, nausea (feeling sick), vomiting, constipation, diarrhoea, rash, diaphoresis (excessive sweating), injection site reactions (pain and inflammation at the site of injection), fever, fatigue (tiredness), chills and asthenia (weakness).
Najpogostejši neželeni učinki zdravila LITAK (opaženi pri več kot 1 bolniku od 10) so okužbe, pancitopenija ali mielosupresija (nizka raven krvnih celic), purpura (podplutbe), imunosupresija (oslabljen imunski sistem), zmanjšan apetit, glavobol, omotica, nenormalni dihalni zvoki in zvoki nad prsnim košem, kašelj, navzea (slabost), bruhanje, zaprtje, diareja, izpuščaj, diaforeza (čezmerno znojenje), reakcije na mestu injiciranja (bolečine in vnetje na mestu injiciranja), povišana telesna temperatura, utrujenost, mrazenje in astenija (šibkost).
For the full list of all side effects reported with LITAK, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila LITAK, glejte Navodilo za uporabo.
LITAK should not be used in people who may be hypersensitive (allergic) to cladribine or any of the other ingredients.
Zdravila LITAK ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) kladribin ali katero koli drugo sestavino zdravila.
LITAK should also not be used during pregnancy or breast-feeding, in patients less than 16 years of age, in patients with moderate to severe kidney or liver disease or in combination with other medicines that reduce the production of blood cells.
Zdravilo LITAK tudi ne smejo uporabljati nosečnice ali doječe matere, bolniki do 16 let starosti, bolniki z zmerno do hudo okvarjenim delovanjem ledvic ali jeter in bolniki, ki se zdravijo z drugimi zdravili, ki zavirajo nastajanje krvnih celic.
Why has LITAK been approved?
Zakaj je bilo zdravilo LITAK odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that LITAK’ s benefits are greater than its risks for the treatment of hairy cell leukaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila LITAK pri zdravljenje dlakavocelične levkemije večje od z njim povezanih tveganj.
The Committee recommended that LITAK be given marketing authorisation.
Odbor je priporočil, da se za zdravilo LITAK odobri dovoljenje za promet.
Other information about LITAK:
Druge informacije o zdravilu LITAK:
The European Commission granted a marketing authorisation valid throughout the EU for LITAK to Lipomed GmbH on 14 April 2004.
Evropska komisija je dovoljenje za promet z zdravilom LITAK, veljavno po vsej Evropski uniji, odobrila družbi Lipomed GmbH dne 14. aprila 2004.
The summary of opinion of the Committee for Orphan Medicinal Products for LITAK is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu LITAK je na voljo tukaj.
The full EPAR for LITAK can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo LITAK je na voljo tukaj.
LITAK 2 mg/ ml solution for injection
LITAK 2 mg/ ml raztopina za injiciranje
1 ml of solution for injection contains 2 mg of cladribine (2-CdA).
1 ml raztopine za injiciranje vsebuje 2 mg kladribina (2- CdA).
Each vial of LITAK contains 10 mg of cladribine in 5 ml of solution for injection.
Vsaka viala LITAKA vsebuje 10 mg kladribina v 5 ml raztopine za injiciranje.
For excipients, see 6.1.
Za pomožne snovi glejte 6. 1.
LITAK is indicated for the treatment of hairy cell leukaemia.
LITAK je indiciran za zdravljenje dlakavocelične levkemije.
Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy.
Zdravljenje z LITAKOM naj uvede usposobljeni zdravnik z izkušnjami pri kemoterapiji raka.
LITAK is supplied as a ready-to-use solution for injection.
LITAK je na voljo v obliki raztopine za injiciranje, pripravljene za uporabo.
The recommended dose is directly withdrawn by a syringe and injected without dilution.
Priporočeni odmerek neposredno odvzamemo z brizgo in injiciramo brez redčenja.
Allow LITAK to warm up to room temperature prior to administration.
Pred dajanjem naj bo LITAK ogret na sobno temperaturo.
The recommended treatment for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a dose of 0.14 mg/ kg body weight/ day for 5 consecutive days.
Priporočeno zdravljenje za dlakavocelično levkemijo je enkratni cikel LITAKA, dajanega s podkožnim bolusnim injiciranjem v odmerku 0, 14 mg/ kg telesne mase/ dan 5 zaporednih dni.
Deviations from the dosage regimen indicated above are not advised (see Section 4.9 Overdose).
Odstopanja od zgoraj navedenega režima odmerjanja niso priporočljiva (glej poglavje 4. 9 Preveliko odmerjanje).
Experience with patients older than 75 years is limited.
Izkušnje pri bolnikih, starejših od 75 let, so omejene.
The risk requires assessment on a case-by-case basis.
Tveganje zahteva oceno na podlagi posameznega primera.
There are no data on the use of LITAK in patients with renal or hepatic impairment.
Podatkov o uporabi LITAKA pri bolnikih z okvarjenim delovanjem ledvic ali jeter ni.
LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/ min) or with moderate to severe hepatic impairment (Child-Pugh score ≥ 4) (see Section 4.3 Contraindications, Section 4.4 Special warnings and special precautions for use and Section 5.2 Pharmacokinetic properties).
LITAK je pri bolnikih z zmerno do hudo okvarjenim delovanjem ledvic (očistek kreatinina ≤ 50 ml/ min) ali z zmerno do hudo okvarjenim delovanjem jeter (število točk po Child- Pughu ≥ 4) kontraindiciran (glej poglavje 4. 3 Kontraindikacije, poglavje 4. 4 Posebna opozorila in previdnostni ukrepi in poglavje 5. 2 Farmakokinetične lastnosti).
Paediatric use LITAK is contraindicated in patients less than 16 years of age.
Uporaba pri otrocih in mladostnikih LITAK je pri bolnikih, mlajših od 16 let, kontraindiciran.
2 During pregnancy and lactation.
2 V času nosečnosti in dojenja.
In patients less than 16 years of age.
Pri bolnikih, mlajših od 16 let.
In patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/ min) or with moderate to severe hepatic impairment (Child-Pugh score ≥ 4) (see also Section 4.4 Special warnings and special precautions for use).
Pri bolnikih z zmerno do hudo okvarjenim delovanjem ledvic (očistek kreatinina ≤ 50 ml/ min) ali z zmerno do hudo okvarjenim delovanjem jeter (število točk po Child- Pughu ≥ 4) (glej tudi poglavje 4. 4 Posebna opozorila in previdnostni ukrepi).