natgillin/translations-raw huggingface dataset:
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol/l) to high 
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 5,17 mmol/l - < 6,2 mmol/l) na visoke (≥ 6,2 mmol/l).
Engage the needle safety device. 
Namestite varnostni pripomoček za iglo.
• disorientation 
• neorientiranost
NAME OF THE MEDICINAL PRODUCT ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Olanzapine 
IME ZDRAVILA ZYPADHERA 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem olanzapin
ZYPADHERA 300 mg powder: Type I glass vial. 
ZYPADHERA 300 mg prašek: Viala iz stekla tipa I. Brombutilna zaporka z obročkom olivne barve.
NAME OF THE MEDICINAL PRODUCT ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Olanzapine 
IME ZDRAVILA ZYPADHERA 300 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem olanzapin
Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment. 
Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, ALT, AST,
Amenorrhea Breast enlargement Galactorrhea in females 
Galaktoreja pri ženskah
NAME OF THE MEDICINAL PRODUCT ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Olanzapine 
IME ZDRAVILA ZYPADHERA 210 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem olanzapin
It is recommended that gloves are used as ZYPADHERA may irritate the skin. 
Ker zdravilo ZYPADHERA lahko draži kožo, priporočamo uporabo rokavic.
Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25% of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 
(vsaj 48 tednov) pojavljalo zelo pogosto (v 64,4 %, 31,7 % in 12,3 %).
PHARMACEUTICAL FORM AND CONTENTS One vial of powder for prolonged release suspension for injection. 
Prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection 
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla ZYPADHERA 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Protect the surface to cushion impact. 
Površino zaščitite za omilitev stika.
MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/08/479/001
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection 
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla ZYPADHERA 210 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/002 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/08/479/002
Other adverse reactions observed in patients treated with ZYPADHERA were similar to those seen with oral olanzapine. 
Drugi neželeni učinki, ki so jih opazovali pri bolnikih, zdravljenih z zdravilom ZYPADHERA
Do not administer intravenously or subcutaneously. 
NE DAJAJTE INTRAVENSKO ALI SUBKUTANO.
Other very common side effects (may affect more than 1 in 10 people) include weight gain; and increases in levels of prolactin in the blood. 
Drugi zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov)
Injection site abscess 
Abces na mestu injiciranja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection 
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla ZYPADHERA 300 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
• anxiety 
• strah
ZYPADHERA olanzapine powder and solvent for prolonged release suspension for injection 
NAVODILA ZA REKONSTITUCIJO IN DAJANJE ZYPADHERA olanzapin prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/003 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/08/479/003
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest. 
konvulzije, komo, možen nevroleptični maligni sindrom, depresijo dihanja, aspiracijo,
1) Description of post injection syndrome - Education about the 2 intramuscular formulations of olanzapine, including packaging differences - Description of reconstitution and proper administration technique - Recommendation for a 3-hour on-site observation period post injection - Recommendation that, immediately prior to a patient leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs or symptoms of overdose - Recommendation that the 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose - Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed - Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur 
- Opis rekonstitucije in pravilnih tehnik injiciranja - Priporočilo za 3-urno opazovanje na mestu po injiciranju - Priporočilo, da se nemudoma pred odhodom iz zdravstvene ustanove potrdi, da je bolnik buden, orientiran in da nima znakov in simptomov prevelikega odmerjanja
• dizziness 
• krči
The 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose. 
- Priporočilo, da se pri bolnikih, ki kažejo kakršenkoli znak ali simptom, značilen za preveliko odmerjanje olanzapina, 3-urno obdobje opazovanja klinično ustrezno podaljša
5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high 
5Opazovano pri osnovnih normalnih ravneh na tešče (< 1,69 mmol/l), ki so se povišale na visoke (≥ 2,26 mmol/l).
Elderly 
Amenoreja
Signs and symptoms 
Opozorila in previdnostni ukrepi
- Keep this leaflet. 
Iglo držite v višini oči
• Patient Information Leaflet 
Študije pri bolnikih,
Neutropenia10 
fosfataza10
Warnings and precautions Talk to your doctor or nurse before you are given ZYPADHERA 
Pred začetkom uporabe zdravila ZYPADHERA se posvetujte s svojim zdravnikom ali s farmacevtom.
ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection 
ZYPADHERA 210 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
DO NOT ADMINISTER INTRAVENOUSLY OR SUBCUTANEOUSLY 
Ne injicirajte intravensko ali subkutano.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHERA 300 mg powder for prolonged release suspension for injection 
OVOJNINAH Nalepka viale ZYPADHERA 300 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
In particular, tell your doctor if you are taking: • medicines for Parkinson's disease. 
Še zlasti pa povejte svojemu zdravniku, če jemljete:
Mutagenicity 
Manitol
The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, 
Najpogosteje poročani (opaženi pri ≥ 1 % bolnikov) neželeni učinki, povezani z uporabo olanzapina v kliničnih preskušanjih, so bili zaspanost, povečanje telesne mase, eozinofilija,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHER 405 mg powder for prolonged release suspension for injection 
OVOJNINAH Nalepka viale ZYPADHERA 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
You do not need to do anything about it. 
Glede tega vam ni treba storiti ničesar.
Other warming methods should not be used. 
Drugačni načini segrevanja se ne smejo uporabljati.
(months) 
(meseci)
≥ 75 to < 100* 
od ≥ 75 do < 100*
There may be new information. 
Morda bodo na voljo nove informacije.
Wash your hands with soap and water. 
Umijte si roke z vodo in milom.
9/L prior to treatment. 
9/l pred zdravljenjem
Treatment should be discontinued. 
Zdravljenje je treba prekiniti.
Non-V30 
Ne-V30
It is important that you tell your doctor if you are already being treated with any of the following: 
Pomembno je, da svojemu zdravniku poveste, če se že zdravite s čimer koli od naslednjega:
Definitive assessments were limited in some cases as covariates were limited by the overall low numbers. 
Dokončne ocene so bile v nekaterih primerih omejene, ker so bili kovariati omejeni s skupnimi nizkimi števili.
9/L; one of these patients experienced a fatal intracranial haemorrhage. 
9/l; eden od teh bolnikov je doživel smrtno intrakranialno krvavitev.
A risk to the breastfed newborn/infant cannot be excluded. 
Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
Do not inject through clothing. 
Ne injicirajte skozi oblačila.
Week 66 
66. teden
Wait seconds 
Počakajte sekund
This reaction typically resolves spontaneously after a few days of treatment. 
Ta reakcija navadno spontano mine po nekaj dneh zdravljenja.
LSM Difference (SE) 
Razlika LSM (SE)
Safety Spring (inside body) 
Varnostna vzmet (znotraj telesa)
Every week 
Vsak teden
This can lead to bruising as well as other more serious problems such as excessive bleeding and internal bleeding. 
To lahko povzroči nastajanje podplutb in druge resnejše težave, kot so pretirana krvavitev in notranje krvavitve.
* If the subsequent test confirms the initial test result, then monitoring frequency and dosing should be adjusted as recommended in the table. 
* Če poznejši test potrdi začetni rezultat testa, je treba pogostnost spremljanja in odmerjanje prilagoditi, kot je priporočeno v preglednici.
These events are usually either self-limiting or can be managed using symptomatic treatment. 
Ti učinki navadno minejo sami od sebe ali pa jih je mogoče obvladati s simptomatskim zdravljenjem.
It should be removed from refrigerated storage at least 30 minutes before use. 
Iz hladilnika jo je treba vzeti najmanj 30 minut pred uporabo.
For example, do not warm in a microwave or hot water, or near other heat sources. 
Ne smete je na primer segreti v mikrovalovni pečici, vroči vodi ali v bližini drugih virov toplote.
• To undergo all blood or urine tests as arranged by their doctor; 
• da morajo opraviti vse preiskave krvi in urina, na katere jih napoti njihov zdravnik;
Weekly dosing should be continued. 
Tedensko odmerjanje je treba nadaljevati.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 July 2018 
Datum prve odobritve: 6. julij 2018
INJECTION 6. 
INJICIRANJE 6.
Do not let the needle touch any surface. 
Pazite, da se igla ne dotakne nobene površine.
Then weekly monitoring until stable. 
Nato tedensko spremljanje, dokler vrednosti niso stabilne.
The safety and efficacy of inotersen in children and adolescents below 18 years of age have not been established. 
Varnost in učinkovitost inotersena pri otrocih in mladostnikih, starih manj kot 18 let, nista dokazani.
Symptoms of low vitamin A include: 
Simptomi nizkih ravni vitamina A vključujejo:
Corticosteroids recommended. 
Priporočeni so kortikosteroidi.
Precautions prior to initiation of inotersen 
Previdnostni ukrepi pred začetkom zdravljenja z inotersenom
List of adverse reactions in clinical studies 
Seznam neželenih učinkov v kliničnih študijah
Statistical significance in favour of inotersen was demonstrated at all thresholds beyond a 0-point change. 
Statistična pomembnost v korist inotersena je bila dokazana pri vseh pragovih, ki presegajo spremembo za 0 točk.
Genotoxicity/ carcinogenicity 
Genotoksičnost/karcinogenost
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines. 
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
In addition to a prompt to include the contact details of the patient's physician and a call for reporting, the patient card should also: 
Poleg poziva, da se vnesejo podatki za stik z bolnikovim zdravnikom, in poziva za poročanje, mora kartica za bolnika:
The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional. 
Prvo injiciranje, ki ga opravi bolnik ali negovalec, mora potekati pod vodstvom ustrezno usposobljenega zdravstvenega delavca.
Let the skin air dry. 
Počakajte, da se koža posuši na zraku.
In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient. 
V primeru prevelikega odmerjanja je treba zagotoviti podporno medicinsko oskrbo, vključno s posvetovanjem z zdravstvenim delavcem in natančnim spremljanjem kliničnega stanja bolnika.
Every 2 weeks 
Vsaka 2 tedna
Patients were randomised 2:1 to receive either inotersen or placebo. 
Bolniki so bili randomizirani v razmerju 2 : 1 za prejemanje bodisi inotersena ali placeba.
Children and adolescents Tegsedi should not be used in children and adolescents under 18 years old. 
Otroci in mladostniki Zdravila Tegsedi se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
The disease hATTR-PN is classified into 3 stages such that i) Stage 1 patients do not require assistance with ambulation, ii) Stage 2 patients do require assistance with ambulation, and iii) Stage 3 patients are bound to wheelchair. 
Bolezen hATTR-PN je razvrščena v tri stadije, pri čemer i) bolniki v 1. stadiju ne potrebujejo pomoči pri gibanju, ii) bolniki v 2. stadiju potrebujejo pomoč pri gibanju in iii) so bolniki v 3. stadiju vezani na invalidski voziček.
Inotersen did not exhibit genotoxic potential in in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice. 
Inotersen ni pokazal genotoksičnega potenciala in vitro in vivo ter ni bil kancerogen pri transgenskih miših rasH2.
For consistency of dosing, patients should be instructed to receive the injection on the same day every week. 
Za zagotavljanje doslednosti odmerjanja morajo bolniki vsak teden dobiti injekcijo na isti dan.
During the first 60 days of pregnancy, both too high and too low vitamin A levels may be associated with an increased risk of foetal malformation. 
V prvih 60 dneh nosečnosti so lahko prevelike in premajhne ravni vitamina A povezane s povečanim tveganjem malformacij ploda.
Dosing should be paused until 3 successive values > 100. 
Odmerjanje je treba prekiniti, dokler niso 3 zaporedne vrednosti > 100.
• Remove the plastic tray from the carton and check the expiry date. 
• Vzemite plastični podstavek iz škatle in preverite rok uporabnosti.
In addition, the corresponding frequency category for each ADR is based on 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 < 1/1,000); very rare (< 1/10,000). 
Ustrezna kategorija pogostnosti za vsak neželeni učinek temelji na naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (od ≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
UPCR and eGFR should be monitored every 3 months or more frequently, as clinically indicated, based on history of chronic kidney disease and/or renal amyloidosis. 
UPCR in eGFR je treba spremljati na vsake 3 mesece ali pogosteje, kot je klinično indicirano glede na zgodovino kronične bolezni ledvic in/ali ledvične amiloidoze.
The most frequently observed adverse reactions during treatment with inotersen were events associated with injection site reactions (50.9%). 
Najpogosteje opaženi neželeni učinki med zdravljenjem z inotersenom so bili dogodki, povezani z reakcijami na mestu injiciranja (50,9 %).
In the placebo group, mean serum TTR concentration decreased by 8.50% at Week 3 and then remained fairly constant throughout the treatment period. 
V skupini, ki je prejemala placebo, se je povprečna koncentracija TTR v serumu v 3. tednu znižala za 8,50 % in nato ostala dokaj konstantna skozi celotno obdobje zdravljenja.
Pharmacotherapeutic group: Other Nervous System Drugs, ATC code: N07XX15 
Farmakoterapevtska skupina: Druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX15
Baseline demographic and disease characteristics are shown in Table 3. 
Demografske značilnosti in značilnosti bolezni ob izhodišču so prikazane v preglednici 3.
Hold the pre-filled syringe in 1 hand. 
Napolnjeno injekcijsko brizgo držite v eni roki.
Before using your pre-filled syringe, your doctor should show you or your caregiver how to use it the right way. 
Preden uporabite napolnjeno injekcijsko brizgo, mora zdravnik vam ali vašemu negovalcu pokazati, kako se brizgo pravilno uporablja.
What you need to know before you use Tegsedi 3. 
Kaj morate vedeti, preden boste uporabili zdravilo Tegsedi 3.
If not used within 6 weeks, it should be discarded. 
Če se ne uporabi v 6 tednih, ga je treba zavreči.
See Section 4.8 for how to report adverse reactions 
Glejte poglavje 4.8, kako poročati o neželenih učinkih.
Subjects that terminate the treatment early irrespective of the reason or have missing week 66 data are considered as non-responders. 
Bolniki, ki so prezgodaj prekinil zdravljenje ne glede na vzrok, ali bolniki, za katere ni podatkov za 66. teden, se štejejo kot bolniki, ki se niso odzvali.
UPCR and eGFR should be monitored for 8 weeks following discontinuation of treatment. 
UPCR in eGFR je treba spremljati še 8 tednov po prekinitvi zdravljenja.
Due to the long half-life of inotersen (see section 5.2), a vitamin A deficit may even develop after cessation of treatment. 
Zaradi dolgega razpolovnega časa izločanja inotersena (glejte poglavje 5.2), se pomanjkanje vitamina A lahko pojavi tudi po prekinitvi zdravljenja.
Due to the potential teratogenic risk arising from unbalanced vitamin A levels, inotersen should not be used during pregnancy, unless the clinical condition of the woman requires treatment with inotersen. 
Zaradi morebitnega teratogenega tveganja, ki je posledica neuravnovešenih ravni vitamina A, se inotersena med nosečnostjo ne sme uporabljati, razen če je zaradi kliničnega stanja ženske potrebno zdravljenje z inotersenom.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
You will only be treated with Tegsedi if these are all at acceptable levels and your doctor will repeat these checks regularly during treatment. 
Z zdravilom Tegsedi se boste zdravili samo, če je vse našteto na sprejemljivi ravni, in vaš zdravnik bo med zdravljenjem redno ponavljal te preiskave.
Lift here and pull to open 
Tukaj dvignite in s potegom odprite
TTR is a carrier protein for retinol binding protein 4 (RBP4) which is the principal carrier of vitamin A (retinol). 
TTR je prenašalna beljakovina za beljakovino 4, ki veže retinol (RBP4), ki je glavni prenašalec vitamina A (retinola).
Yes No hATTR-CM2, n (%) hATTR-PN Disease Duration3 (months) 
Da Ne hATTR-CM2, n (%) Trajanje bolezni hATTR-PN3 (meseci)
Lift the whole pre-filled syringe straight up. 
Celotno napolnjeno injekcijsko brizgo dvignite naravnost navzgor.
6.6 Special precautions for disposal and other handling Tegsedi should be inspected visually prior to administration. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Tegsedi je treba pred uporabo vizualno pregledati.
This suggests an immunologically related mechanism. 
To kaže mehanizem z imunološko povezavo.
• Alert HCPs that the patient is taking Tegsedi, its indication and the key safety concerns; 
• opozoriti zdravstvene delavce, da bolnik jemlje zdravilo Tegsedi, vsebovati njegove indikacije in ključne skrbi glede varnosti;
Hold the plunger fully down and wait for 5 seconds. 
Držite ga pritisnjenega do konca navzdol in počakajte 5 sekund.
• dry eyes, poor vision, decrease in night vision, hazy or cloudy vision 
• suhe oči, slab vid, poslabšanje nočnega vida, meglen oz. nejasen vid.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Akcea Therapeutics Ireland Ltd 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Akcea Therapeutics Ireland Ltd
When you do not have enough platelets, like in thrombocytopenia, your blood may not clot quickly enough to stop bleeding. 
Če nimate dovolj trombocitov (kot je značilno za trombocitopenijo), se vaša kri morda ne bo strjevala dovolj hitro, da bi ustavila krvavitve.
If you or your caregiver have any questions, ask your doctor. 
Če imate vi ali vaš negovalec dodatna vprašanja, se posvetujte z zdravnikom.
Therefore, reduction in plasma TTR is expected to result in reduction of plasma retinol levels to below the lower limit of normal. 
Zato se pričakuje, da bo znižanje ravni TTR v plazmi znižalo ravni retinola v plazmi pod spodnjo normalno mejo.
In the case of UPCR ≥ 2 g/g (226 mg/mmol), which is confirmed on repeat testing, dosing of inotersen should be paused while further evaluation for acute glomerulonephritis is performed. 
Če je UPCR ≥ 2 g/g (226 mg/mmol) in se vrednost potrdi s ponovnim testiranjem, je treba odmerjanje inotersena prekiniti, medtem ko se opravlja nadaljnja ocena glede akutnega glomerulonefritisa.
Do not inject into tattoos, scars or damaged skin. 
Ne injicirajte v tetovaže, brazgotine ali poškodovano kožo.
Look in the inspection area to check that the solution is clear and colourless or pale yellow. 
V območju za preverjanje vsebine preverite, ali je raztopina bistra in brezbarvna ali bledo rumena.
Slowly insert the needle into the chosen injection site at a 90° angle until it is fully inserted. 
Iglo počasi zabodite na izbrano mesto injiciranja pod kotom 90°, dokler ni vstavljena v celoti.
Patients with UPCR more than or equal to twice the upper limit of normal, or eGFR < 60 ml/min, which is confirmed on repeat testing and in the absence of an alternative explanation, should be monitored every 4 weeks. 
Bolnike z vrednostjo UPCR, ki ustreza najmanj dvakratni zgornji normalni vrednosti, ali z vrednostjo eGFR < 60 ml/min, ki se potrdi s ponovnim testiranjem ali če ni drugačnega pojasnila, je treba spremljati na vsake 4 tedne.
Prior to the launch of Tegsedi in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA). 
Pred prihodom zdravila Tegsedi na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnih gradiv, vključno z mediji za komunikacijo, načini distribucije in vsemi drugimi vidiki programa.
After use, the safety spring is automatically activated and retracts the needle. 
Po uporabi se varnostna vzmet samodejno aktivira in potisne iglo navznoter.
Your doctor may refer you to an eye specialist for a check-up if it is necessary. 
Zdravnik vas bo po potrebi napotil na pregled pri specialistu za oči.
Tegsedi is used when the disease is causing symptoms of polyneuropathy (nerve damage). 
Zdravilo Tegsedi se uporablja, kadar bolezen povzroča simptome polinevropatije (poškodbe živcev).