natgillin/translations-raw huggingface dataset:
In order to allow proper dosing, the dog should be weighed on day 1 and on day 35 (i.e. at the start of each treatment period).
NASVET O PRAVILNI UPORABI ZDRAVILA Da bi omogočili ustrezno odmerjanje, je treba psa stehtati prvi dan in 35. dan (tj. na začetku vsakega obdobja zdravljenja).
Do not use in dogs with impaired liver function.
Ne uporabite pri psih s poslabšanim delovanjem jeter.
No drug interactions were observed in studies where Yarvitan was administered concomitantly with NSAIDs (carprofen, meloxicam) or ACE inhibitors (enalapril, benazepril).
V študijah, v katerih so zdravilo Yarvitan uporabili sočasno z nesteroidnimi protivnetnimi zdravili (karprofen, meloksikam) ali zaviralci ACE (enalapril, benazepril), niso opazili nobenih interakcij.
The usual dose is once daily 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg).
Navadni odmerek je 0,63 mg mitratapida/kg telesne teže (1 ml zdravila na 8 kg) enkrat dnevno.
Use the dosing pipette as provided with the product.
Uporabite pipeto za odmerjanje, kot je navedeno v navodilih zdravila.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
NAČIN IN POT(I) UPORABE Peroralno.
The following adverse reactions were observed during the clinical trials (pooled data*):
Med kliničnimi preskušanji (skupni podatki*) so ugotovili naslednje neželene učinke:
Yarvitan is a colourless to slightly yellow solution.
Yarvitan je brezbarvna do rahlo rumena raztopina.
• if overweight or obesity in your dog is caused by a concomitant systemic disease such as hypothyroidism (this is due to a malfunction of the thyroid gland) or hyperadrenocorticism.
• čezmerno težo ali adipoznost povzroča sočasna sistemska bolezen, kot je hipotiroidizem (ki je posledica okvarjenega delovanja ščitnice) ali hiperadrenokorticizem (ki je posledica okvarjenega delovanja nadledvične žleze).
After each dose, the pipette should be washed and dried and the bottle cap screwed back on tightly.
Po vsakem odmerjanju je treba pipeto oprati in posušiti ter spet tesno priviti pokrovček.
Administer orally once daily at 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg) given for 2 periods of 21 days with 14 days without treatment in between.
Odmerjajte enkrat dnevno 0,63 mg mitratapida/kg telesne teže peroralno (1 ml zdravila na 8 kg) v dveh obdobjih po 21 dni, z vmesnim presledkom brez zdravljenja, ki traja 14 dni.
• up to 36 kg for the 55 ml bottle
• do 36 kg za 55-mililitrsko stekleničko;
The dosing pipette has a gradation in body weight:
Pipeta za odmerjanje ima lestvico, prilagojeno telesni teži:
Once opened, use within 3 months.
Odprto zdravilo uporabite v 3 mesecih.
At the end of a three week dosing period, mitratapide attains average steady-state concentrations of 0.0068 g/ml, the sulphoxide metabolites 0.0089 g/ml and 0.0167 g/ml, respectively, the sulphone 0.0471 g/ml.
Na koncu tritedenskega odmerjanja mitratapid doseže povprečne koncentracije dinamičnega ravnovesja 0,0068 µg/ml, presnovka sulfoksida 0,0089 µg/ml in 0,0167 µg/ml ter presnovek sulfona 0,0471 µg/ml.
Thereafter, your dog should follow a nutrition programme.
Potem se mora pes držati diete.
Vomiting, diarrhoea or softened stools may occur during treatment.
Med zdravljenjem se lahko pojavijo bruhanje, driska ali zmehčano blato.
Pack sizes - amber glass bottles containing : 55ml:  10 kg bodyweight, 120ml:  22 kg bodyweight, 210ml:  40 kg bodyweight.
Velikosti pakiranja - rumenorjave stekleničke, ki vsebujejo: 55 ml: ≤ 10 kg telesne teže, 120 ml: ≤ 22 kg telesne teže, 210 ml: ≤ 40 kg telesne teže.
To be used as part of an overall weight management programme which also includes appropriate dietary changes.
Uporablja se kot del skupne obravnave telesne teže, ki vključuje tudi spremembe prehrane.
Always administer Yarvitan exactly as your veterinary surgeon has instructed you.
Zdravilo Yarvitan vedno uporabljajte skladno z navodili veterinarja.
The treatment is part of an overall weight management programme which also includes a nutrition programme.
Zdravljenje je del skupne obravnave telesne teže, ki vključuje tudi spremembe prehrane.
MANUFACTURER'S BATCH NUMBER Lot:
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija:
The following clinical signs were observed after 3 or 5 times overdosing in dogs: softened or liquid faeces, vomiting, salivation, anorexia, severe weight loss, emaciated appearance, dehydration and pale mucosae.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pri psih so po 3- do 5-kratnem prevelikem odmerjanju opazili naslednje klinične znake: zmehčano ali tekoče blato, bruhanje, slinjenje, anoreksija, huda izguba telesne teže, videz izčrpanosti, dehidracija in blede sluznice.
• up to 36 kg for the 120 ml bottle
• do 36 kg za 120-mililitrsko stekleničko;
INDICATION(S) As an aid in the management of overweight and obesity in adult dogs.
INDIKACIJA(E) Kot pripomoček pri obravnavi čezmerne teže in adipoznosti pri odraslih psih.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega za sprostitev serije
Excipient(s):
Pomožna(e) snov(i):
• up to 48 kg for the 210 ml bottle
• do 48 kg za 210-mililitrsko stekleničko.
6.5 Nature and composition of immediate packaging 55, 120 or 210 ml amber glass bottle (type III) with a child resistant polypropylene closure and dosing pipette.
55-, 120- ali 210-mililitrska rumenorjava steklenička (tipa III) s propilensko zaporko, varno za otroke, in pipeto za odmerjanje.
Yarvitan is indicated as an aid in the management of overweight and obesity in adult dogs.
Yarvitan je indiciran kot pripomoček pri obravnavi čezmerne teže in adipoznosti pri odraslih psih.
If vomiting, significantly reduced appetite or diarrhoea repeatedly occurs, treatment should be interrupted and the advice of a veterinarian should be sought.
Če se ponavljajo bruhanje, opazno zmanjšan tek ali driska, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
In order to avoid rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Da bi se izognili ponovnemu pridobivanju telesne teže, je pomembno, da psa po koncu zdravljenja hranite po vzdrževalnem režimu.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
BESEDILO "SAMO ZA ŽIVALI" Samo za živali.
• softened stools
• zmehčano blato.
Loss of appetite may occur during treatment.
Med zdravljenjem se lahko pojavi izguba teka.
Read all of this leaflet carefully before you start administering the medicine to your dog:
Preden svojemu psu daste to zdravilo, natančno preberite navodilo:
In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
V laboratorijskih študijah so po uporabi zdravila pri priporočenem odmerku opazili zmanjšanje vrednosti albumina, globulina, skupnih beljakovin, kalcija in alkalne fosfataze v serumu ter povečanje vrednosti ALT in AST.
A decreased appetite may occur during treatment.
Med zdravljenjem se lahko pojavi zmanjšanje teka.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Mitratapide 5 mg/ml
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Mitratapid 5 mg/ml
MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/0/00/000/001
The dosing pipettes provided with the product show graduations corresponding to the correct body weight of the dog.
Pipete za odmerjanje, priložene zdravilu, imajo lestvico, prilagojeno ustrezni telesni teži psa.
You should check with your veterinary surgeon if you are unsure.
Če ste negotovi, se posvetujte z veterinarjem.
NAME OF THE VETERINARY MEDICINAL PRODUCT Yarvitan 5 mg/ml oral solution for dogs Mitratapide
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Yarvitan 5 mg/ml peroralna raztopina za pse Mitratapid
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Posebni previdnostni ukrepi za uporabo pri živalih Varnost zdravila med brejostjo in laktacijo ni bila dokazana.
In case an adverse reaction repeatedly occurs or in case the dog stops eating for two consecutive days, treatment should be interrupted and the advice of a veterinarian should be sought.
Če se neželeni učinek ponavlja ali če pes dva zaporedna dneva odklanja hrano, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
• vomiting
• bruhanje;
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Mitratapide 5 mg/ml
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E) Mitratapid 5 mg/ml
QUANTITY OF THE ACTIVE SUBSTANCE(S) Mitratapide 5 mg/ml
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Mitratapid 5 mg/ml
NAME OF THE VETERINARY MEDICINAL PRODUCT Yarvitan 5 mg/ml oral solution for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Yarvitan 5 mg/ml peroralna raztopina za pse
Do not administer Yarvitan:
Zdravila Yarvitan pri psu ne uporabljajte, če:
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
PACKAGE SIZE 55 ml:  10 kg BW 120 ml:  22 kg BW 210 ml:  40 kg BW
120 ml: ≤ 22 kg telesne teže; 210 ml: ≤ 40 kg telesne teže.
• diarrhoea
• driska;
In case vomiting, diarrhoea, softening stools repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
Če se bruhanje, driska, zmehčano blato ponavljajo ali če pes v dveh zaporednih dneh odklanja hrano, je treba zdravljenje psa z zdravilom Yarvitan prekiniti in se čim prej posvetovati z veterinarjem.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO "ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM"
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 3 months 6.4 Special precautions for storage
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti.
• if your dog has impaired liver function.
• ima poslabšano delovanje jeter;
ROUTE(S) OF ADMINISTRATION Oral use.
POT(I) UPORABE ZDRAVILA Peroralno.
After multiple dosing, the highest concentrations are present in the adrenal glands, liver, jejunum and kidney, but there is no exposure in the brain, excluding any central effect of the product.
Po večkratnem odmerjanju so največje koncentracije v nadledvični žlezi, jetrih, jejunumu in ledvicah.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
BESEDILO "ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM" Zdravilo shranjujte nedosegljivo otrokom.
EU field trial
Terensko preskušanje v ZDA
MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/002
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVILA EU/0/00/000/002
In case a side effect repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
Če se neželeni učinki ponavljajo ali če pes dva zaporedna dneva odklanja hrano, je treba zdravljenje psa z zdravilom Yarvitan prekiniti in se čim prej posvetovati z veterinarjem.
Tell your veterinary surgeon if you notice any of the following:
Če opazite katerega od spodnjih neželenih učinkov, obvestite svojega veterinarja:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
PACKAGE LEAFLET Yarvitan 5 mg/ml oral solution for dogs
NAVODILO ZA UPORABO Yarvitan 5 mg/ml peroralna raztopina za pse
This is called ‘myeloablation'.
To se imenuje „mieloablacija“.
This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Tovrstna presaditev se uporablja pri bolnikih, ki potrebujejo zamenjavo krvotvornih celic, ker imajo krvno bolezen (na primer redko vrsto anemije) ali krvnega raka.
The company provided data from the published literature on busulfan.
Družba je predstavila podatke o busulfanu iz objavljene literature.
This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (‘stem') cells (cells that make other types of cell).
To pomeni, da uničujejo celice, še zlasti pa hitro razvijajoče se celice, kot so na primer rakave ali progenitorske („matične“) celice (celice, ki tvorijo druge vrste celic).
The full EPAR and risk management plan summary for Busulfan Fresenius Kabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Busulfan Fresenius Kabi sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Busulfan Fresenius Kabi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Busulfan Fresenius Kabi.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Busulfan Fresenius Kabi has been shown to be comparable to Busilvex.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da je zdravilo Busulfan Fresenius Kabi primerljivo z zdravilom Busilvex.
It is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Uporablja se pri odraslih in otrocih kot del pripravljalnega zdravljenja pred presaditvijo krvotvornih matičnih celic (celic, ki tvorijo krvne celice).
The medicine is available as a concentrate to be made up into a solution for central intravenous infusion (drip into a central vein in the chest).
Zdravilo je na voljo v obliki koncentrata za pripravo raztopine za infundiranje skozi osrednji venski kateter (kapalne infuzije v osrednjo veno v prsnem košu).
Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Nato se za zaviranje delovanja imunskega sistema uporabijo ciklofosfamid, melfalan ali fludarabin, s čimer se zmanjša naravna obramba telesa.
Before receiving Busulfan Fresenius Kabi, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Preden bolniki prejmejo zdravilo Busulfan Fresenius Kabi, dobijo zdravila proti konvulzijam (za preprečevanje epileptičnih napadov) in antiemetike (za preprečevanje bruhanja).
The European Commission granted a marketing authorisation valid throughout the European Union for Busulfan Fresenius Kabi on 22 September 2014.
Evropska komisija je dovoljenje za promet z zdravilom Busulfan Fresenius Kabi, veljavno po vsej Evropski uniji, izdala 22. septembra 2014.
Because Busulfan Fresenius Kabi is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker se zdravilo Busulfan Fresenius Kabi daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Busulfan is used before transplantation to destroy abnormal cells and the patient's existing bloodmaking cells.
Zdravilo Busulfan Fresenius Kabi se uporablja pred presaditvijo, da se uničijo nenormalne celice in obstoječe bolnikove krvotvorne celice.
The Committee recommended that Busulfan Fresenius Kabi be approved for use in the EU.
Priporočil je, da se zdravilo Busulfan Fresenius Kabi odobri za uporabo v EU.
Busulfan Fresenius Kabi can only be obtained with a prescription and should only be used by a doctor who has experience in treatments given before transplantation.
Izdaja zdravila Busulfan Fresenius Kabi je le na recept, uporabljajo pa ga lahko samo zdravniki, ki imajo izkušnje z zdravili, ki se dajejo pred presaditvijo.
What measures are being taken to ensure the safe and effective use of Busulfan Fresenius Kabi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Busulfan Fresenius Kabi?
This means that Busulfan Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Busilvex.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Busilvex.
In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busulfan Fresenius Kabi is given right after treatment with another medicine, fludarabine.
Pri odraslih bolnikih, ki so primerni za pripravljalni režim zdravljenja z zmanjšano jakostjo zdravila, se zdravilo Busulfan Fresenius Kabi daje neposredno po zdravljenju z drugim zdravilom, fludarabinom.
For more information about treatment with Busulfan Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Busulfan Fresenius Kabi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
When used in combination with fludarabine, the recommended dose of Busulfan Fresenius Kabi is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Kadar se zdravilo Busulfan Fresenius Kabi uporablja v kombinaciji s fludarabinom, znaša priporočeni odmerek 3,2 mg/kg in se daje enkrat na dan kot triurna infuzija dva ali tri dni zapored neposredno po uporabi fludarabina.
Busulfan Fresenius Kabi is a ‘generic medicine'.
Zdravilo Busulfan Fresenius Kabi je „generično zdravilo“.
For a conventional conditioning treatment, Busulfan Fresenius Kabi is given before treatment with a second medicine, cyclophosphamide in adults, and either cyclophosphamide or melphalan in children.
V okviru konvencionalnega pripravljalnega zdravljenja se zdravilo Busulfan Fresenius Kabi uporablja pred začetkom zdravljenja z drugim zdravilom, in sicer pri odraslih pred ciklofosfamidom, pri otrocih pa bodisi pred ciklofosfamidom ali melfalanom.
What are the benefits and risks of Busulfan Fresenius Kabi?
Kakšne so koristi in tveganja, povezani z zdravilom Busulfan Fresenius Kabi?
A risk management plan has been developed to ensure that Busulfan Fresenius Kabi is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Busulfan Fresenius Kabi je bil pripravljen načrt obvladovanja tveganj.
For practical information about using Busulfan Fresenius Kabi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Busulfan Fresenius Kabi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about Busulfan Fresenius Kabi
Druge informacije o zdravilu Busulfan Fresenius Kabi
Busulfan Fresenius Kabi is a medicine that contains the active substance busulfan.
Busulfan Fresenius Kabi je zdravilo, ki vsebuje zdravilno učinkovino busulfan.
The active substance in Busulfan Fresenius Kabi, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Zdravilna učinkovina v zdravilu Busulfan Fresenius Kabi, busulfan, spada v skupino zdravil, ki se imenujejo „alkilirajoči citostatiki“.
When used in combination with cyclophosphamide or melphalan the recommended dose of Busulfan Fresenius Kabi in adults is 0.8 mg per kilogram body weight.
Kadar se zdravilo Busulfan Fresenius Kabi uporablja v kombinaciji s ciklofosfamidom ali melfalanom, znaša njegov priporočeni odmerek pri odraslih 0,8 mg na kilogram telesne mase.
What is Busulfan Fresenius Kabi and what is it used for?
Kaj je zdravilo Busulfan Fresenius Kabi in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Busulfan Fresenius Kabi, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Therefore, the CHMP's view was that, as for Busilvex, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Busilvex odtehtajo znana tveganja.
Why is Busulfan Fresenius Kabi approved?
Zakaj je bilo zdravilo Busulfan Fresenius Kabi odobreno?
How has Busulfan Fresenius Kabi been studied?
Kako je bilo zdravilo Busulfan Fresenius Kabi raziskano?
How is Busulfan Fresenius Kabi used?
Kako se zdravilo Busulfan Fresenius Kabi uporablja?
No additional studies were needed as Busulfan Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Busilvex.
Ker je zdravilo Busulfan Fresenius Kabi generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo, Busilvex, dodatne študije niso bile potrebne.
In children up to 17 years of age, the recommended dose of Busulfan Fresenius Kabi varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Vsaka infuzija traja dve uri, bolnik pa jo prejme vsakih šest ur štiri dni zapored pred zdravljenjem s ciklofosfamidom ali melfalanom in presaditvijo.
How does Busulfan Fresenius Kabi work?
Kako zdravilo Busulfan Fresenius Kabi deluje?
In addition, H2 receptor antagonists have a more immediate effect.
Poleg tega imajo antagonisti receptorjev H2 hitrejši učinek.
Regarding Section 4.1, the CHMP adopted the following harmonised indication:
V zvezi s poglavjem 4.1 je CHMP sprejel naslednjo usklajeno indikacijo:
The mention of erosions was therefore deleted from the indication.
Omembo erozije so zato izbrisali iz indikacije.
Further information on recommended antibiotic combinations is stated in Section 4.2.
Dodatni podatki o priporočenih kombinacijah antibiotikov so navedeni v poglavju 4.2.
In line with the indication, this product should not be used in children.
V skladu z indikacijo se to zdravilo ne sme uporabljati za otroke.
The intravenous indications were largely harmonised already.
Indikacije za intravensko uporabo so bile že v večji meri usklajene.
In children over 1 year of age and ≥ 10 kg
Otroci, starejši od 1 leta in s telesno maso ≥10 kg
For the elderly (>65 years old), no dose adjustment is needed.
Pri starostnikih (>65 let) prilagajanje odmerka ni potrebno.
Special populations: all formulations
Posebne skupine bolnikov: vse formulacije
Patients are also told not to take omeprazole as a preventive medication.
Bolnike se tudi pouči, da ne smejo jemati omeprazola kot preventivno zdravilo.
The conditions of the Marketing Authorisations are described in Annex IV.
Pogoji dovoljenja za promet so navedeni v Dodatku IV.
Alternatively, patients can suck the capsule and swallow the pellets with water.
Drugače pa lahko bolniki kapsulo sesajo in pelete pogoltnejo z vodo.
While literature data strongly indicates that there is no cross-reactivity between the various substituted benzimidazoles, there is data indicating suspected cross-reactivity.
Čeprav podatki iz literature jasno kažejo, da ni navzkrižne reaktivnosti med raznimi substituiranimi benzimidazoli, obstajajo tudi podatki, ki kažejo sum navzkrižne reaktivnosti.
The CHMP considered that this indication is similar to chemical pneumonia (among others caused by gastric acid aspiration).
CHMP je menil, da je ta indikacija podobna kemijski pljučnici (ki jo med drugim povzroči aspiracija želodčne kisline).
When the dose exceeds 80 mg daily, it should be divided and given twice daily.
Če odmerek preseže 80 mg na dan, ga je treba razdeliti in vzeti dvakrat na dan.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LOSEC AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LOSEC IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)