natgillin/translations-raw huggingface dataset:
A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥8.0% after the first six months of therapy).
Za oceno časa do neuspeha zdravljenja (definirano kot pojav HbA1c ≥ 8,0% po prvih šest mesecih zdravljenja) so klinično preskušanje pioglitazona v primerjavi z gliklazidom kot monoterapiji podaljšali na dve leti.
Glubrava should be used every day to work properly.
Za pravilno delovanje morate zdravilo Glubrava jemati vsak dan.
Thu. 1
1 Sre.
Localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in patients taking Glubrava in combination with insulin.
Pri bolnikih, ki so jemali zdravilo Glubrava v kombinaciji z insulinom, so pogosto (pri največ 1 od 10 bolnikov) poročali o pojavu lokaliziranega otekanja (edem).
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Zato je potrebno pri sočasnem jemanju kationskih zdravil, ki se izločajo z ledvično tubulno sekrecijo, skrbno spremljati koncentracijo glukoze v krvi, prilagoditev odmerka znotraj priporočljivega odmerjanja in spremembe pri zdravljenju sladkorne bolezni.
60-89 Maximum daily dose is 3,000 mg Dose reduction may be considered in relation to declining renal function.
60 do 89 Največji dnevni odmerek je 3.000 mg.
Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
V obsežnem naboru genotoksičnih raziskav in vivo ter in vitro pioglitazon ni imel genotoksičnega potenciala.
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Glubrava and have also been reported in male patients (frequency cannot be estimated from the available data) taking Glubrava.
O zlomih so poročali tudi pri bolnikih, ki so se zdravili z zdravilom Glubrava (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Nervous system disorders hypo-aesthesia common common insomnia uncommon uncommon headache common taste disturbance common common
Bolezni živčevja hipestezija pogosti pogosti insomnija občasni občasni glavobol pogosti motnje okušanja pogosti pogosti
Thu. 2
Tor. 1 Tor. 2
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Pri sočasnem dajanju z zaviralci (npr. gemfibrozil) ali induktorji (npr. rifampicin) citokroma P450 2C8 je potrebna previdnost.
Foetal growth restriction was apparent in animal studies with pioglitazone.
Pri študijah pioglitazona na živalih so opažali zastoj rasti plodu.
Food had no effect on the AUC and Cmax of pioglitazone when Glubrava was administered to healthy volunteers.
Pri zdravih prostovoljcih, ki so dobivali zdravilo Glubrava hrana ni vplivala na AUC in Cmax pioglitazona.
No dose adjustment.
- Navodilo shranite.
An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Pri podganah, ki so prejemale pioglitazon do 2 leti, so opažali povišano incidenco hiperplazije (samci in samice) ter tumorjev (samci) povrhnjice sečnega mehurja.
Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida) in 850 mg metforminijevega klorida.
At the initiation of the treatment abdominal pain, diarrhoea, loss of appetite, nausea and vomiting may occur, these reactions are very common but usually disappear spontaneously in most cases.
Na začetku zdravljenja se lahko pojavijo bolečine v trebuhu, driska, izguba teka, slabost in bruhanje.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Če se telesna masa poveča, o tem obvestite svojega zdravnika.
If you stop using Glubrava, your blood sugar may go up.
Če zdravilo Glubrava prenehate jemati, se lahko raven krvnega sladkorja zviša, zato se pred prekinitvijo zdravljenja najprej posvetujte z zdravnikom.
Inve stigations weight increased8
Preiskave povečanje telesne mase8
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Cardiac failure or history of cardiac failure (NYHA stages I to IV) Current bladder cancer or a history of bladder cancer Uninvestigated macroscopic haematuria
Zdravilo Glubrava je kontraindicirano pri: - preobčutljivosti na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1; - srčnemu popuščanju ali anamnezi srčnega popuščanja (klasifikacija NYHA, stadiji I do IV); - raku sečnega mehurja ali raku sečnega mehurja v anamnezi; - neraziskani makroskopski hematuriji; - akutnih ali kroničnih boleznih, ki so lahko vzrok hipoksije tkiv, npr. srčno ali respiratorno popuščanje, nedaven miokardni infarkt, šok; - oslabljenem delovanju jeter; - akutni zastrupitvi z alkoholom, alkoholizmu; - vse vrste akutne metabolične acidoze (kot sta laktacidoza, diabetična ketoacidoza); - diabetični komi; - huda ledvična odpoved (GFR < 30 ml/min); - akutnih stanjih, ki lahko spremenijo delovanje ledvic:
Fri. 1
1 Ned.
The RMP has been updated in accordance.
V skladu s tem je bil posodobljen načrt o obvladovanju tveganja.
The following side effects have been experienced by some patients taking Glubrava
Pri nekaterih bolnikih, ki so jemali zdravilo Glubrava, so se pojavili naslednji neželeni učinki:
CARTON
Alkohol
1 bottle + 2 syringes
1 steklenica + 2 brizgi
Strength Pharmaceutical Form
Jakost farmacevtska oblika Pot uporabe Ovojnina
Oral suspension bottle (PET)
Steklenica (PET)
EU/1/06/378/017 Inovelon 40 mg/ml
40 mg/ml Peroralna suspenzija Peroralna uporaba
Box of 1 vial
1 odmerek Škatla z 1 stekleničko
Strength Pharmaceutical Form
Način uporabe zdravila
EU Number
Karenca
This summary was last updated in 08-2014.
Povzetek je bil nazadnje posodobljen 08-2014.
It is available as tablets (25, 50 and 100 mg).
Na voljo je v obliki tablet (25, 50 in 100 mg).
The maximum recommended dosing frequency is one tablet per day.
Največja priporočena pogostost odmerjanja je ena tableta na dan.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom severe kidney problems should start treatment with the 25 mg dose.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom začnejo zdravljenje s 25-miligramskim odmerkom.
The full EPAR for Sildenafil Actavis 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) za zdravilo Sildenafil Actavis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose of Sildenafil Actavis is 50 mg taken as needed about one hour before sexual activity.
Priporočeni odmerek zdravila Sildenafil Actavis je 50 mg, ki se vzame po potrebi eno uro pred spolno dejavnostjo.
The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Actavis on 10 December 2009.
Evropska komisija je dovoljenje za promet z zdravilom Sildenafil Actavis, veljavno po vsej Evropski uniji, izdala 10. decembra 2009.
For more information about treatment with Sildenafil Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Sildenafil Actavis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Sildenafil Actavis is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Zdravilo Sildenafil Actavis se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, kadar ne zmorejo doseči ali ohraniti take erekcije penisa, ki omogoča zadovoljivo spolno dejavnost.
This is a summary of the European public assessment report (EPAR) for Sildenafil Actavis.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sildenafil Actavis.
This means that Sildenafil Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Viagra.
Because Sildenafil Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Sildenafil Actavis generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sildenafil Actavis.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
This allows blood to flow into the corpora, producing the erection.
To omogoči večji dotok krvi vanj, kar povzroči erekcijo.
The CHMP concluded that, in accordance with EU requirements, Sildenafil Actavis has been shown to have comparable quality and to be bioequivalent to Viagra.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Sildenafil Actavis primerljivo raven kakovosti kot zdravilo Viagra ter da mu je biološko enakovredno.
By blocking the breakdown of cGMP, Sildenafil Actavis restores erectile function.
Z zaviranjem razgradnje cGMP zdravilo Sildenafil Actavis ponovno vzpostavi erektilno funkcijo.
What are the benefits and risks of Sildenafil Actavis?
Kakšne so koristi in tveganja, povezani z zdravilom Sildenafil Actavis?
Sexual stimulation is still needed to produce an erection.
Za erekcijo pa je vseeno potrebno spolno vzburjenje.
The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Odmerek zdravila se lahko glede na učinkovitost in neželene učinke poveča na 100 mg ali zmanjša na 25 mg. Bolniki z jetrnimi obolenji ali resnimi motnjami v delovanju ledvic naj
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Med normalnim spolnim vzburjenjem se cGMP tvori v penisu, v katerem povzroči, da se gobasto tkivo (corpora cavernosa) sprosti.
It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Deluje tako, da zavira encim fosfodiesteraze, ki običajno razgrajuje snov, imenovano ciklični gvanozinmonofosfat (cGMP).
The active ingredient in Sildenafil Actavis, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Zdravilna učinkovina v zdravilu Sildenafil Actavis, sildenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
Because Sildenafil Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Ker je zdravilo Sildenafil Actavis generično zdravilo, so bile študije na ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Viagra.
The Committee recommended that Sildenafil Actavis be given marketing authorisation.
Priporočil je, da se za zdravilo Sildenafil Actavis izda dovoljenje za promet.
Sildenafil Actavis is a ‘generic medicine'.
Zdravilo Sildenafil Actavis je „generično zdravilo“.
Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk.
Zato je menil, da koristi zdravila tako kot pri zdravilu Viagra odtehtajo znana tveganja.
Other information about Sildenafil Actavis
Druge informacije o zdravilu Sildenafil Actavis
Sildenafil Actavis is a medicine that contains the active substance sildenafil.
Sildenafil Actavis je zdravilo, ki vsebuje zdravilno učinkovino sildenafil.
If Sildenafil Actavis is taken with food, the onset of activity may be delayed compared with taking Sildenafil Actavis without food.
Če se zdravilo Sildenafil Actavis zaužije s hrano, lahko začne delovati pozneje, kot če se zaužije brez nje.
Why has Sildenafil Actavis been approved?
Zakaj je bilo zdravilo Sildenafil Actavis odobreno?
For Sildenafil Actavis to be effective, sexual stimulation is required.
Zdravilo Sildenafil Actavis je učinkovito le ob spolnem vzburjenju.
What is Sildenafil Actavis used for?
Za kaj se zdravilo Sildenafil Actavis uporablja?
How has Sildenafil Actavis been studied?
Kako je bilo zdravilo Sildenafil Actavis raziskano?
What is Sildenafil Actavis?
Kaj je zdravilo Sildenafil Actavis?
How does Sildenafil Actavis work?
Kako zdravilo Sildenafil Actavis deluje?
How is Sildenafil Actavis used?
Kako se zdravilo Sildenafil Actavis uporablja?
United Kingdom B.Braun Melsungen Ag
Združeno kraljestvo B.Braun Melsungen Ag
United Kingdom Fresenius Kabi Limited
Združeno kraljestvo Fresenius Kabi Limited
Haes-Steril Hes Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 200/0.5
Haes-Steril Hes Natrijev klorid 9 g/1 000 ml, hidroksietil škrob 200/0,5
Hes Hipertónico Sodium Chloride 72g/1000ml, Hydroxyethyl Starch 200/0.5
Hes Hipertónico Natrijev klorid 72 g/1 000 ml, hidroksietil škrob 200/0,5
Sodium Chloride 9g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
Natrijev klorid 9 g/1 000 ml, poli (O-2-hidroksietil) škrob 130/0,4 (Ph.
3.27g/1000ml, L-Malic Acid 0.67g/1000ml
3,27 g/1 000 ml, L-jabolčna kislina 0,67 g/1 000 ml
Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml
Natrijev klorid 9 g/1 000 ml, hetaškrob 60 g/1 000 ml
Sodium Chloride 4.5g/500ml, Hydroxyethyl Starch 130/0.4 30g/500ml
Natrijev klorid 4,5 g/500 ml, hidroksietil škrob 130/0,4 30 g/500 ml
Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 100gl
Natrijev klorid 9 gl, poli (0 2 hidroksietil) škrob 100 gl
Sodium Chloride 9g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml
Natrijev klorid 9 g/1 000 ml, poli (0 2 hidroksietil) škrob 60 g/1 000 ml
Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl
Magnezijev klorid heksahidrat 0,3 gl, kalijev klorid 0,3 gl, natrijev klorid 6,02 gl, natrijev acetat trihidrat 4,63 gl, hidroksietil škrob 130/0,4 60 gl
Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 200/0.5 100g/1000ml
Natrijev klorid 9 g/1 000 ml, hidroksietil škrob 200/0,5 100 g/1 000 ml
Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0.4 100g/1000ml
Natrijev klorid 9 g/1 000 ml, hidroksietil škrob 130/0,4 100 g/1 000 ml
Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Natrijev klorid 9 g/1 000 ml, hidroksietil škrob 130/0,4 60 g/1 000 ml
Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 60gl
Natrijev klorid 9 gl, poli (0 2 hidroksietil) škrob 600 gl
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.4g/1000ml, Sodium Chloride 6g/1000ml, Calcium Chloride Dihydrate 0.134g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3.7g/1000ml
Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,4 g/1 000 ml, natrijev klorid 6 g/1 000 ml, kalcijev klorid dihidrat 0,134 g/1 000 ml, hetaškrob 60 g/1 000 ml, natrijev acetat trihidrat 3,7 g/1 000 ml
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.4g/1000ml, Sodium Chloride 6g/1000ml, Calcium Chloride Dihydrate 0.134g/1000ml, Sodium Acetate Trihydrate 3.7g/1000ml, Poly (0 2
Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,4 g/1 000 ml, natrijev klorid 6 g/1 000 ml, kalcijev klorid dihidrat 0,134 g/1 000 ml, natrijev acetat trihidrat 3,7 g/1 000 ml, poli (0 2 hidroksietil) škrob 100 g/1 000 ml
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3gl, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (O-2Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
Magnezijev klorid heksahidrat 0,3 g/1 000 ml, kalijev klorid 0,3 gl, natrijev klorid 6,02 g/1 000 ml, natrijev acetat trihidrat 4,63 g/1 000 ml, poli (O-2-hidroksietil) škrob 130/0,4 (Ph.
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Magnezijev klorid heksahidrat 0,3 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,02 g/1 000 ml, natrijev acetat trihidrat 4,63 g/1 000 ml, hidroksietil škrob 130/0,4
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
Magnezijev klorid heksahidrat 0,3 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,02 g/1 000 ml, natrijev acetat trihidrat 4,63 g/1 000 ml, poli (O-2-hidroksietil) škrob 130/0,4 (Ph.
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000μl
Magnezijev klorid heksahidrat 0,3 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,02 g/1 000 ml, natrijev acetat trihidrat 4,63 g/1 000 ml, poli (0 2 hidroksietil) škrob 60 g/1 000 μl
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml
Magnezijev klorid heksahidrat 0,3 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,02 g/1 000 ml, natrijev acetat trihidrat 4,63 g/1 000 ml, poli (0 2 hidroksietil) škrob 60 g/1 000 ml
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml
Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,25 g/1 000 ml, kalcijev klorid dihidrat 0,37 g/1 000 ml, hetaškrob 100 g/1 000 ml, natrijev acetat trihidrat 3,27 g/1 000 ml
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,25 g/1 000 ml, kalcijev klorid dihidrat 0,37 g/1 000 ml, natrijev acetat trihidrat 3,27 g/1 000 ml, L-jabolčna kislina 0,67 g/1 000 ml
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Malic Acid 0.67g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, Poly (0 2
Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,25 g/1 000 ml, kalcijev klorid dihidrat 0,37 g/1 000 ml, natrijev acetat trihidrat 3,27 g/1 000 ml, poli (0 2 hidroksietil) škrob 60 g/1 000 ml, L-jabolčna kislina 0,67 g/1 000 ml
Study 1 - REPLACE
Študija 1 - REPLACE
Do not clean it with any other liquids, such as alcohol.
Ne čistite ga z nobeno drugo tekočino, na primer z alkoholom.
Study 2 - RACE
Študija 2 - RACE
30 June 2023
30. junija 2023
Here are 4 ways to get your questions answered:
Odgovore na svoja vprašanja lahko dobite na 4 načine:
This will be the same day of the week, 2 weeks later (See Figure B).
To bo isti dan v tednu, 2 tedna kasneje (glejte sliko B).
A total of 49 patients were enrolled in the study.
V študiji je sodelovalo skupaj 49 bolnikov.
• sleep problems (feeling sleepy during the day or having trouble sleeping at night)*
• težave s spanjem (zaspanost podnevi ali težave s spanjem ponoči)*
E. Frequently Asked Questions
E. Pogosta vprašanja
Important - Read this information before getting started:
Pomembno - pred začetkom uporabe preberite te informacije:
The mean age was 47.3 years (range 19 to 74 years); 79% were females.
Povprečna starost je bila 47,3 leta (razpon od 19 do 74 let); 79 % je bilo žensk.
Patients had hypoparathyroidism for an average of 13.6 years.
Bolniki so imeli hipoparatiroidizem v povprečju 13,6 leta.
Why won't the blue button go all the way down?
Zakaj modri gumb ne gre do konca navzdol?
• Do not use this medicine if it has not been stored correctly.
• Zdravila ne uporabljajte, če ni bilo pravilno shranjeno.
Who should I contact if I am concerned about not having received a full dose or if I have symptoms of any kind?
Na koga naj se obrnem, če me skrbi, da nisem prejel/-a celotnega odmerka ali imam kakršne koli simptome?
• Get 1 alcohol pad.
• Priskrbite 1 alkoholno blazinico.
- After 2 to 4 weeks, your doctor may adjust the dose.
- Po 2 do 4 tednih vam bo zdravnik morda prilagodil odmerek.
The needle may not be attached correctly.
Morda igla ni pravilno pritrjena.
Monitoring of patients during treatment
Spremljanje bolnikov med zdravljenjem
I'm trying to push it, but I can only partially push it down.
Ko nanj pritiskam, gre le delno navzdol.
For example, if you give your first injection on a Tuesday, you will need to discard your pen 2 weeks later on a Tuesday.
Če si na primer daste prvo injekcijo v torek, boste morali peresnik zavreči 2 tedna kasneje v torek.
Interruption or discontinuation of treatment
Prekinitev ali opustitev zdravljenja
This leaflet was last revised in 07/2019.
Navodilo je bilo nazadnje revidirano dne 07/2019.
If your symptoms are severe, your doctor may give you additional medical treatment.
Če so vaši simptomi hudi, vam bo zdravnik morda predpisal dodatno zdravljenje.
You will need the following supplies for your injection:
Za svojo injekcijo boste potrebovali naslednje potrebščine:
• Otherwise, go to “Daily Injection” (Section C).
• Sicer pojdite na »Dnevno injiciranje« (poglavje C).
• Prepare a new pen every 14 days.
• Vsakih 14 dni pripravite nov peresnik.
Call your doctor.
Pokličite zdravnika.
SPECIAL STORAGE CONDITIONS Store in a refrigerator.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is unknown.
Zaradi razlik v fiziologiji kosti pri podganah in ljudeh klinična pomembnost teh ugotovitev ni znana.
This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Te informacije ne nadomestijo pogovora z zdravnikom ali medicinsko sestro glede vašega zdravstvenega stanja ali vašega zdravljenja.
No change, or decrease if active vitamin D was already discontinued before this titration step
Ne spremenite ali zmanjšajte, če je bil aktivni vitamin D že ukinjen pred tem korakom titriranja.
This medicinal product must not be mixed with other medicinal products.
Zdravila ne smemo mešati z drugimi zdravili.
19 How to discard your empty pens
19 Kako odstraniti prazne peresnike
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 April 2017
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 24. april 2017
• Call your doctor or nurse.
• Pokličite zdravnika ali medicinsko sestro.
Your doctor will check how you respond to the treatment: - during the first 7 days of starting treatment and - if your dose is changed.
Zdravnik bo preveril, kako se odzivate na zdravljenje: - v prvih 7 dneh po začetku zdravljenja in - ob morebitnih spremembah odmerka.
Call your doctor for advice.
Za nasvet pokličite zdravnika.
A. Getting Started
A. Kako začeti
This may mean that you did not hold the needle in your thigh for the full 10 seconds.
To lahko pomeni, da igle niste držali v stegnu polnih 10 sekund.
Use in young adults
Uporaba pri mladih odraslih