natgillin/translations-raw huggingface dataset:
Melosus should not be used following parenteral injection of meloxicam or any other NSAIDs as appropriate dosage regimens for such follow-up treatments have not been established in cats.
Melosus se ne sme uporabljati po parenteralnem injiciranju meloksikama ali katerega drugega nesteroidnega protivnetnega zdravila (NSAID), saj ustrezni režimi odmerjanja za tako nadaljnje zdravljenje za mačke niso bili določeni.
Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.
Ublažitev blage do zmerne pooperativne bolečine, povezane z operacijo mehkega tkiva, kot je kastracija pri samcih
EXPIRY DATE EXP {month/year} Use by …
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
To be administered orally either mixed with food or directly into the mouth.
Zdravilo dajemo peroralno, pomešano s hrano, ali neposredno v gobec.
The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.
Odmerjanje in pot uporabe Suspenzijo je mogoče dajati z uporabo standardne 1 ml brizge, ki ima ml lestvico in 0,01 ml porasta.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Zdravilna učinkovina:
4.2 Indications for use, specifying the target species
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Mačke:
OTHER INFORMATION 10, 25, 50 or 125 ml bottle.
DRUGE INFORMACIJE Plastenke po 10, 25, 50 ali 125 ml.
Polyethylene bottle containing 10 ml, 25 ml, 50 ml or 125 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Polietilenska plastenka po 10 ml, 25 ml, 50 ml ali 125 ml z varnostnim, za otroke varnim zapiralom in s polipropilensko merilno brizgo.
Polyethylene bottle containing 5 ml, 10 ml or 25 ml with a tamper proof child resistant closure and a polypropylene measuring syringe
Polietilenska plastenka po 5 ml, 10 ml ali 25 ml z varnostnim, za otroke varnim zapiralom in polipropilensko merilno brizgo.
Post-operative pain and inflammation following surgical procedures: After initial treatment with meloxicam solution for injection for cats, continue treatment 24 hours later with Melosus 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight.
Po začetnem zdravljenju z raztopino meloksikama za injiciranje za mačke nadaljujte zdravljenje 24 ur pozneje z zdravilom Melosus 0,5 mg/ml peroralna suspenzija za mačke v odmerku 0,05 mg meloksikama/kg telesne mase.
15 OTHER INFORMATION 5, 10 or 25 ml bottle.
DRUGE INFORMACIJE Plastenka po 5, 10 ali 25 ml.
Do not use the cat syringe with the kg-body weight scale for guinea pigs.
Brizge z lestvico telesne mase v kg za mačke ne uporabljajte za morske prašičke.
Marketing authorisation holder: CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Imetnik dovoljenja za promet z zdravilom: CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in plastenki po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
MARKETING AUTHORISATION NUMBER(S) EU/2/10/116/003 125 ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/116/003 125 ml
In cats, Melosus 0.5 mg/ml oral suspension for cats should be used.
Pri mačkah je treba uporabiti zdravilo Melosus 0,5 mg/ml peroralna suspenzija za mačke.
Do not use in pregnant or lactating animals.
Ne uporabite v obdobju brejosti in laktacije.
The suspension can be given using the Melosus measuring syringe provided in the package.
Odmerjanje in pot uporabe Suspenzijo lahko dajemo s priloženo merilno brizgo Melosus.
MARKETING AUTHORISATION NUMBERS EU/2/10/116/007 5 ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/116/007 5 ml
In cats, typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Pri mačkah so občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil (NSAID), kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in ledvična odpoved.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 0.5 mg/ml
KOLIČINA UČINKOVIN(E) Meloksikam 0,5 mg/ml
Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in ledvična odpoved.
ROUTE OF ADMINISTRATION Oral use.
POT UPORABE ZDRAVILA Peroralna uporaba.
NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 1,5 mg/ml peroralna suspenzija za pse
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 1.5 mg/ml
KOLIČINA UČINKOVIN(E) Meloksikam 1,5 mg/ml
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
PACKAGE LEAFLET: Melosus 1.5 mg/ml oral suspension for dogs
NAVODILO ZA UPORABO Melosus 1,5 mg/ml peroralna suspenzija za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 0.5 mg/ml oral suspension for cats and guinea pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 0,5 mg/ml peroralna suspenzija za mačke in morske prašičke
STATEMENT OF ACTIVE SUBSTANCES Meloxicam 1.5 mg/ml
NAVEDBA UČINKOVIN(E) Meloksikam 1,5 mg/ml
NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 1,5 mg/ml peroralna suspenzija za pse meloksikam
PACKAGE LEAFLET: Melosus 0.5 mg/ml oral suspension for cats and guinea pigs
NAVODILO ZA UPORABO Melosus 0,5 mg/ml peroralna suspenzija za mačke in morske prašičke
NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 0.5 mg/ml oral suspension for cats and guinea pigs Meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 0,5 mg/ml peroralna suspenzija za mačke in morske prašičke Meloksikam
Metabolism
Sukraloza
Meloxicam 0.5 mg
Meloksikam 0,5 mg Pomožna snov:
Dosage
KARENCA
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day.
Začetni peroralni odmerek prvi dan zdravljenja je 0,2 mg meloksikama na kilogram telesne mase.
Porcine influenza vaccine (inactivated)
cepivo proti prašičji influenci (inaktivirano)
It is given as two injections into the muscle three weeks apart.
Daje se v obliki dveh injekcij v mišico v razmiku treh tednov.
The vaccine starts to be effective one week after the second injection and protection lasts for three months.
Cepivo začne učinkovati en teden po drugi injekciji, zaščita pa traja tri mesece.
In case of accidental self-injection only a minor injection site reaction is expected.
V primeru nenamernega samo-injiciranja je pričakovati le manjšo reakcijo na mestu injiciranja.
The full EPAR for Respiporc FLUpan H1N1 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Respiporc FLUpan H1N1 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Signs can include fever, depression, coughing, sneezing, difficulty breathing and loss of appetite.
Njeni znaki lahko vključujejo povišano telesno temperaturo, izčrpanost, kašelj, kihanje, težave z dihanjem in izgubo teka.
This active immune response will help to protect the pig against the disease caused by this virus.
Aktivni imunski odziv bo pripomogel k zaščiti prašiča pred boleznijo, ki jo ta virus povzroča.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Respiporc FLUpan H1N1's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Respiporc FLUpan H1N1 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The effectiveness of Respiporc FLUpan H1N1 was shown in three laboratory studies and one combined field/laboratory study.
Učinkovitost cepiva Respiporc FLUpan H1N1 so dokazali v treh laboratorijskih študijah in eni kombinirani terensko-laboratorijski študiji.
The most common side effects with Respiporc FLUpan H1N1 (which may affect up to 1 in 10 animals) are a short-lived increase in rectal temperature, not exceeding 2 °C, which does not last for more than one day and a transient swelling up to 2 cm3 at the site of injection which usually resolves within
Najpogostejša neželena učinka cepiva Respiporc FLUpan H1N1 (ki se lahko pojavita pri največ 1 živali od 10) sta kratkotrajno povišanje rektalne temperature, ki ne presega 2°C in ne traja dlje kot en dan, ter prehodno otekanje do 2 cm3 na mestu injiciranja, ki običajno mine v 5 dneh.
When a pig is given the vaccine the pig's immune system recognises the virus as ‘foreign' and reacts by building up an active immune response.
Ko prašič prejme cepivo, njegov imunski sistem prepozna virus kot „tujek“ ter se nanj odzove tako, da sproži aktivni imunski odziv.
The vaccine contains inactivated (killed) influenza A virus/Jena/VI5258/2009(H1N1)pdm09, a strain of the virus that causes swine influenza.
Cepivo vsebuje inaktivirani (uničeni) virus influence A/Jena/VI5258/2009(H1N1)pdm09, sev virusa, ki povzroča prašičjo influenco.
This is a summary of the European public assessment report (EPAR) for Respiporc FLUpan H1N1.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Respiporc FLUpan H1N1.
Swine influenza or swine flu is a disease of the lungs and airways in pigs.
Prašičja influenca oziroma gripa je bolezen pljuč in dihalnih poti pri prašičih.
virus (Pan H1N1) which has been inactivated so it cannot cause the disease.
vsebuje virus influence A (Pan H1N1), ki je bilo inaktivirano, tako da ne more povzročiti bolezni.
The studies showed that pigs vaccinated with Respiporc FLUpan H1N1 had a reduction of virus in the lung and excreted from the nose.
Študije so pokazale, da je pri prašičih, cepljenih z zdravilom Respiporc FLUpan H1N1, prišlo do zmanjšanja količine virusa v pljučih in izcedku iz nosu.
In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus.
Ob ponovni izpostavitvi virusu v prihodnosti bo imunski sistem lahko hitreje reagiral proti virusu.
Respiporc FLUpan H1N1 is a vaccine used to protect pigs from eight weeks of age against swine influenza caused by pandemic subtype H1N1.
Zdravilo Respiporc FLUpan H1N1 je cepivo, ki se uporablja za zaščito prašičev, starih osem tednov ali več, pred prašičjo influenco, ki jo povzroča pandemični podtip H1N1.
The European Commission granted a marketing authorisation valid throughout the EU for Respiporc FLUpan H1N1 on 17 May 2017.
Evropska komisija je dovoljenje za promet z zdravilom Respiporc FLUpan H1N1, veljavno po vsej Evropski uniji, izdala 17/05/2017.
Respiporc FLUpan H1N1 contains an adjuvant (carbomer) to enhance the immune response.
Cepivo Respiporc FLUpan H1N1 vsebuje adjuvans (karbomer), ki spodbuja imunski odziv.
The withdrawal period for meat from pigs treated with Respiporc FLUpan H1N1 is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso prašičev, ki so prejeli cepivo Respiporc FLUpan H1N1, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Respiporc FLUpan H1N1 is available as a suspension for injection and can only be obtained with a prescription.
Zdravilo Respiporc FLUpan H1N1 je na voljo v obliki suspenzije za injiciranje, njegovo predpisovanje in izdaja pa je le na recept.
For more information about treatment with Respiporc FLUpan H1N1, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Respiporc FLUpan H1N1 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using Respiporc FLUpan H1N1, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Respiporc FLUpan H1N1 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
What is Respiporc FLUpan H1N1 and what is it used for?
Kaj je zdravilo Respiporc FLUpan H1N1 in za kaj se uporablja?
Other information about Respiporc FLUpan H1N1:
Druge informacije o zdravilu Respiporc FLUpan H1N1:
What are the risks associated with Respiporc FLUpan H1N1?
Kakšna tveganja so povezana z zdravilom Respiporc FLUpan H1N1?
Respiporc FLUpan H1N1 is a vaccine.
Zdravilo Respiporc FLUpan H1N1 je cepivo.
What benefits of Respiporc FLUpan H1N1 have been shown in studies?
Kakšne koristi je zdravilo Respiporc FLUpan H1N1 izkazalo v študijah?
Why is Respiporc FLUpan H1N1 approved?
Zakaj je bilo zdravilo Respiporc FLUpan H1N1 odobreno?
How is Respiporc FLUpan H1N1 used?
Kako se zdravilo Respiporc FLUpan H1N1 uporablja?
How does Respiporc FLUpan H1N1 work?
Kako zdravilo Respiporc FLUpan H1N1 deluje?
It is not intended to provide practical advice on how to use Respiporc FLUpan H1N1.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Date of first authorisation: 21 January 2013 Date of latest renewal: 21 September 2017
Datum prve odobritve: 21. januar 2013 Datum zadnjega podaljšanja: 21. september 2017
There were no statistically significant differences between the two treatment groups.
Med obema skupinama zdravljenja ni bilo statistično pomembnih razlik.
Ryzodeg which has been frozen must not be used.
Zdravila Ryzodeg, ki je bilo zamrznjeno, se ne sme uporabiti.
The European Medicines Agency has waived the obligation to submit the results of trials with Ryzodeg in:
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov preskušanj z zdravilom Ryzodeg za:
In general, patients are initiated on the same number of basal units.
Na splošno bolniki začnejo zdravljenje z enakim številom bazalnih enot.
Your doctor will decide with you:
Skupaj z zdravnikom se bosta odločila:
This medicinal product must not be mixed with other medicinal products.
Tega zdravila se ne sme mešati s katerim koli drugim zdravilom.
The duration of action of a single-dose of Ryzodeg is beyond 24 hours.
Trajanje delovanja posameznega odmerka zdravila Ryzodeg je več kot 24 ur.
This medicine contains two types of insulin:
To zdravilo vsebuje dve vrsti insulina:
EXP After first opening: Use within 4 weeks
Po prvem odprtju: porabite v 4 tednih.
This medicinal product has no or negligible influence on the ability to drive and use machines.
To zdravilo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
What Ryzodeg is and what it is used for
Kaj je zdravilo Ryzodeg in za kaj ga uporabljamo
• if you are allergic to insulin degludec, insulin aspart or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na insulin degludek, insulin aspart ali katero koli sestavino tega zdravila (navedene v poglavju 6).
What Ryzodeg is and what it is used for What you need to know before you use Ryzodeg How to use Ryzodeg
Kaj je zdravilo Ryzodeg in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ryzodeg Kako uporabljati zdravilo Ryzodeg
The study design included a standardised treatment schedule but allowed for certain adjustments to meet individual needs.
Zasnova študije je vključevala shemo standardiziranega zdravljenja, omogočala pa je tudi nekatere prilagoditve, da bi se zadovoljile potrebe posameznih bolnikov.
What you need to know before you use Ryzodeg Do not use Ryzodeg:
Kaj morate vedeti, preden boste uporabili zdravilo Ryzodeg Ne uporabljajte zdravila Ryzodeg:
Safety and efficacy have been demonstrated in a trial in children aged 2 to less than 18 years.
Varnost in učinkovitost sta bili dokazani v dolgoročnem preskušanju pri otrocih, starih od 2 let do 18 let.
• Test your urine for ketones.
• Določite ketone v urinu.
Pay special attention to these notes as they are important for correct use of the pen.
Upoštevajte te opombe, ker so pomembne za pravilno uporabo injekcijskega peresnika.
There is no difference in the pharmacodynamic effect of this medicinal product between elderly and younger patients.
Farmakodinamični učinek tega zdravila se pri starejših in mlajših bolnikih ne razlikuje.
Ryzodeg with alcohol
Zdravilo Ryzodeg skupaj z alkoholom
If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Ryzodeg, stop using this medicine and see a doctor straight away.
Če imate resno alergijsko reakcijo (pojavi se redko) na insulin ali katero koli sestavino zdravila Ryzodeg, prenehajte z uporabo tega zdravila in nemudoma obiščite zdravnika.
Adverse reactions listed below are based on clinical trial data and classified according to MedDRA System Organ Class.
Spodaj navedeni neželeni učinki temeljijo na podatkih iz kliničnih preskušanj in so razvrščeni po MedDRA organskih sistemih.
This medicinal product can be used in adolescents and children from the age of 2 years (see section 5.1).
To zdravilo se lahko uporablja pri mladostnikih in otrocih, starejših od 2 let (glejte poglavje 5.1).
Use in elderly (≥ 65 years old)
Uporaba pri starostnikih (≥ 65 let)
This should be kept in mind if treatment with the combination of pioglitazone and Ryzodeg is considered.
To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila Ryzodeg.
An updated RMP should be submitted: - At the request of the European Medicines Agency; - Whenever the risk management system is modfied, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
- na zahtevo Evropske agencije za zdravila; - ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Total exposure and peak concentration of insulin aspart were higher in children than in adults and were similar for adolescents and adults.
Celotna izpostavljenost in največja koncentracija insulina aspart sta bili pri otrocih večji kot pri odraslih, pri mladostnikih pa sta podobni kot pri odraslih.
The recommended starting dose of Ryzodeg is 60-70% of the total daily insulin requirements.
Priporočeni začetni odmerek zdravila Ryzodeg obsega 60-70 % celotne dnevne potrebe po insulinu.
If you forget to use Ryzodeg
Če ste pozabili uporabiti zdravilo Ryzodeg
Frequency categories are defined according to 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
Skupine pogostnosti so opredeljene po naslednjem dogovoru: 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) in neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
The potency of insulin analogues, including Ryzodeg, is expressed in units.
Moč insulinskih analogov, tudi zdravila Ryzodeg, izražamo v enotah.
Time since injection (hours) Treatment
Čas od injiciranja (v urah)
• Ryzodeg is given as an injection under the skin (subcutaneous injection).
• Zdravilo Ryzodeg je namenjeno injiciranju pod kožo (subkutano injiciranje).
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Ryzodeg must not be used if the solution does not appear clear and colourless.
Zdravila Ryzodeg se ne sme uporabiti, če raztopina ni bistra in brezbarvna.
Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin regimen) were aligned with the primary analysis.
Rezultati analiz podskupin (npr. spol, trajanje sladkorne bolezni, skupina s tveganjem za pojav srčnožilnih dogodkov in predhodni režim insulina) so bili skladni s primarno analizo.
Insulin degludec and insulin aspart bind specifically to the human insulin receptor and result in the same pharmacological effects as human insulin.
Insulin degludek in insulin aspart se specifično vežeta na človeški receptor za insulin in imata enake farmakološke učinke kot humani insulin.
Patients in the Ryzodeg arm included 40 exposed children aged 2-5 years, 61 children aged 6-11 years and 80 adolescents aged 12-17 years.
V skupini z zdravilom Ryzodeg se je zdravilo 40 otrok, starih od 2 do 5 let, 61 otrok, starih od 6 do 11 let, in 80 mladostnikov, starih od 12 do 17 let.
• Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
• Hude epizode hipoglikemije, pri katerih si bolnik sam ne more pomagati, je mogoče zdraviti z glukagonom (0,5 do 1 mg), ki ga intramuskularno ali subkutano aplicira ustrezno poučena oseba, ali z glukozo, ki jo intravensko aplicira zdravstveni delavec.
Ryzodeg should be used with special caution in children 2 to 5 years old because data from the clinical trial indicate that there may be a higher risk for severe hypoglycaemia in children in this age group (see sections 4.4, 4.8 and 5.1).
Pri otrocih, starih od 2 do 5 let, je treba zdravilo Ryzodeg uporabljati previdno, saj podatki iz kliničnih študij kažejo, da imajo otroci v tej starostni skupini morda povečano tveganje za pojav hude hipoglikemije (glejte poglavja 4.4, 4.8 in 5.1).
One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.
Ena (1) enota tega insulina ustreza 1 mednarodni enoti humanega insulina, 1 enoti insulina glargin, 1 enoti insulina detemir ali 1 enoti dvofaznega insulina aspart.
• if the pen is damaged or has not been stored correctly (see section 5 ‘How to store Ryzodeg').
• če je vložek poškodovan ali ni bil pravilno shranjen (glejte poglavje 5 »Shranjevanje zdravila
Patients switching from basal/bolus insulin therapy to Ryzodeg will need to convert their dose based on individual needs.
Bolniki, ki prehajajo z bazalno-bolusnega insulinskega zdravljenja na zdravilo Ryzodeg, bodo morali pretvoriti svoje odmerke glede na svoje potrebe.
• if the cartridge or the delivery system you are using is damaged.
• če je vložek ali sistem za dajanje insulina, ki ga uporabljate, poškodovan.
Other medicines and Ryzodeg
Druga zdravila in zdravilo Ryzodeg
This medicinal product must not be administered intravenously as it may result in severe hypoglycaemia.
Tega zdravila se ne sme aplicirati intravensko, ker lahko povzroči hudo hipoglikemijo.
It helps your body reduce your blood sugar level.
Telesu pomaga zniževati visok krvni sladkor.
Solution for injection (Penfill) 5 x 3 mL
raztopina za injiciranje (Penfill) 5 x 3 ml
Turn the dose selector until the dose counter stops.
Vrtite izbirnik odmerka, dokler se števec odmerka ne ustavi.
Insulin aspart has a low binding to plasma proteins (<10%), similar to that seen with regular human insulin.
Vezava insulina aspart na beljakovine v plazmi je majhna (< 10 %), podobna kot pri navadnem človeškem insulinu.