natgillin/translations-raw huggingface dataset:
3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
3Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
While overdose is less likely with parenteral than oral medicinal products, reference information for oral olanzapine overdose is presented below:
Medtem ko je preveliko odmerjanje manj verjetno pri parenteralnih kot peroralnih zdravilih,
After reconstitution each ml of suspension contains 150 mg olanzapine.
Po rekonstituciji 1 ml suspenzije vsebuje 150 mg olanzapina.
(≥ 2.26 mmol/l).
(≥ 4,39 mmol/l - < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Na podlagi izsledkov študij peroralnega olanzapina na miših in podganah je bilo zaključeno,
Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
AS THE SHEATH IS PRESSED (Fig. 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (Fig. 2).
KO JE ZAŠČITA PRITISNJENA (slika 1), JE IGLA POPOLNOMA NAMEŠČENA V
Injection site related adverse events
Neželeni učinki na mestu injiciranja
High creatine phosphokinase11 High Gamma Glutamyltransfera se 10
Visoka raven gamaglutamiltransferaze10
After reconstitution: 1ml suspension contains 150 mg/ml olanzapine.
Po rekonstituciji: 1 ml suspenzije vsebuje 150 mg/ml olanzapina.
What you need to know before you are given ZYPADHERA
Kaj morate vedeti, preden boste dobili zdravilo ZYPADHERA Zdravila ZYPADHERA ne uporabljajte:
Injection site pain
Bolečina na mestu injiciranja
- If you get any side effects, talk to your doctor or nurse.
− Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
What ZYPADHERA looks like and contents of the pack ZYPADHERA powder for prolonged release suspension for injection comes as a yellow powder in a clear glass vial.
ZYPADHERA prašek za suspenzijo za injiciranje s podaljšanim sproščanjem je na voljo kot rumen prašek v brezbarvni stekleni viali.
After repeated IM injections with 150 to 300 mg ZYPADHERA every two weeks, the 10th to 90th percentile of steady-state plasma concentrations of olanzapine were between 4.2 and 73.2 ng/ml.
Po ponovljenih i. m. injiciranjih z 150 mg do 300 mg zdravila ZYPADHERA vsaka dva tedna, sta bila 10-ti in 90-ti odstotek plazemskih koncentracij olanzapina v stanju dinamičnega ravnovesja med 4, 2 in 73, 2 ng/ ml. Plazemske koncentracije olanzapina, ki so jih opazovali v razponu odmerka od 150 mg vsake 4 tedne do 300 mg vsaka 2 tedna, kažejo na povišano sistemsko izpostavljenost olanzapinu pri zvišanih odmerkih zdravila
• A recent heart attack, heart disease, sick sinus syndrome, (abnormal heart rhythms),
• nedavni srčni napad, srčno obolenje, sindrom bolezni sinusnega vozla (motnje srčnega ritma), nestabilna angina pektoris ali nizek krvni tlak
13 Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15% of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), za ≥ 15 % pogosto (7,1 %) in za ≥ 25 % občasno (2,5 %).
Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12 mg dose).
Pri nekaj psih, ki so prejemali 8 ali 10 mg/kg/dan (celotno izpostavljanje olanzapinu [AUC] je 12- do 15-krat večje kot pri človeku, ki dobi 12-miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database.
ocenjeno na zgornjo mejo 95 % intervala zaupanja, določeno z uporabo integrirane baze podatkov za olanzapin.
The metabolism of olanzapine may be induced by smoking.
Kajenje lahko inducira presnavljanje olanzapina.
NAME OF THE MEDICINAL PRODUCT
Imetnik dovoljenja za promet z zdravilom
Thromboembolis m (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
(vključno s pljučno embolijo in globoko vensko trombozo) (glejte poglavje
ZYPADHERA should only be administered by deep intramuscular gluteal injection by a healthcare professional trained in the appropriate injection technique and in locations where post-injection observation and access to appropriate medical care in the case of overdose can be assured.
Uporablja se ga lahko le tam, kjer je možno opazovanje bolnika po injiciranju in kjer je možno zagotoviti ustrezne medicinske ukrepe v primeru prevelikega odmerjanja.
Olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Olanzapinijev pamoat monohidrat, ki ustreza 405 mg olanzapina.
However, the incidence of death was higher in oral olanzapine-treated than in placebo-treated patients independent of these risk factors.
neodvisno od omenjenih dejavnikov tveganja, večja pri bolnikih zdravljenih s peroralnim olanzapinom, kot pri bolnikih zdravljenih s placebom.
What ZYPADHERA contains
Kaj vsebuje zdravilo ZYPADHERA
Other common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and in early treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Drugi pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic in maščob v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno zvišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu, zvišanja v ravni sečne kisline in kreatin-fosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe (diskinezijo), zaprtje, suha usta, izpuščaj,
20 mg/day
20 mg/dan 300 mg/2 tedna
If this has happened to you, tell your nurse or doctor.
povejte svoji medicinski sestri ali zdravniku.
For obese patients, the 50 mm needle is recommended for injection: If the 50 mm needle is to be used for injection, attach the 38 mm safety needle to the syringe to withdraw the required suspension volume.
Če boste za injiciranje uporabili 50 mm iglo, pritrdite na injekcijsko brizgo 38 mm varnostno iglo, da izvlečete potrebni volumen suspenzije.
Olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Olanzapinijev pamoat monohidrat, ki ustreza 300 mg olanzapina.
• Diabetes
• sladkorna bolezen
One vial of powder for prolonged release suspension for injection.
Ena viala s praškom za suspenzijo za injiciranje s podaljšanim sproščanjem.
Dystonia (including oculogyration)11 Tardive dyskinesia11
(vključno z okulogiracijo)11
Other uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching; rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose: abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Drugi občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov) vključujejo preobčutljivost (npr. otekanje v ustih in grlu, srbenje, izpuščaj), sladkorno bolezen ali poslabšanje sladkorne bolezni, občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), sindrom nemirnih nog, težave pri govoru, jecljanje,
Attach the selected 50 mm or 38 mm safety needle to the syringe prior to injection.
Pred injiciranjem pritrdite na injekcijsko brizgo izbrano 50 mm ali 38 mm varnostno iglo.
ZYPADHERA 405 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Zdravilo ZYPADHERA 405 mg: Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 405 mg olanzapina.
• Weight gain has been seen in patients taking ZYPADHERA.
• Pri bolnikih, ki so jemali zdravilo ZYPADHERA, so opazili porast telesne mase.
In clinical trials with ZYPADHERA the incidence of injection site related adverse reactions was approximately 8%.
povezanih z mestom injiciranja, približno 8 %.
ZYPADHERA 300 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Zdravilo ZYPADHERA 300 mg: Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 300 mg olanzapina.
ZYPADHERA 210 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Zdravilo ZYPADHERA 210 mg: Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 210 mg olanzapina.
Olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Olanzapinijev pamoat monohidrat, ki ustreza 210 mg olanzapina.
ZYPADHERA 210 mg powder: Type I glass vial.
ZYPADHERA 210 mg prašek: Viala iz stekla tipa I. Brombutilna zaporka z obročkom rjaste barve.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥0.01% and <0.1%) when oral olanzapine is stopped abruptly.
Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja s peroralnim olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
Increased alkaline phosphatase10
Visoka raven kreatinfosfokinaze11
Solvent for ZYPADHERA
Vehikel za zdravilo ZYPADHERA
How to store ZYPADHERA
Kako uporabljati zdravilo ZYPADHERA
3 ml solvent: Type I glass vial.
3 ml vehikel: Viala iz stekla tipa I. Butilna zaporka s škrlatnim pečatom.
RECONSTITUTION AND ADMINISTRATION INSTRUCTIONS
OZNAČEVANJE IN NAVODILO ZA UPORABO
Supplementation
Dopolnjevanje
The mean increase in olanzapine AUC was 52 % and 108 % respectively.
52 % oziroma 108 %.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels (see sections 4.8 and 5.1).
spremembami v kazalcih presnove in zvišanjih ravni prolaktina (glejte poglavji 4.8 in 5.1).
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda.
Ime in naslov izdelovalca, odgovornega za sproščanje serije
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Klinične manifestacije NMS so zvišana telesna temperatura, okorelost mišic, motnje zavesti in znaki avtonomne nestabilnosti
Photosensitivity reaction
Fotosenzitivnost ne reakcije Alopecija
These reactions occurred in <0.1% of injections and approximately 2% of patients.
Med pre-marketinškimi kliničnimi študijami so se pri < 0,1 % injiciranj in približno 2 % bolnikov pojavili učinki, ki so vključevali znake in simptome, značilne za preveliko odmerjanje olanzapina.
ZYPADHERA 405 mg powder: Type I glass vial.
ZYPADHERA 405 mg prašek: Viala iz stekla tipa I. Brombutilna zaporka z obročkom jekleno modre barve.
Restless Legs Syndrome
Nevroleptični maligni sindrom
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.
≥ 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