natgillin/translations-raw huggingface dataset:
tho being treated but others may need medical attention.
19 et bo morda potrebna zdravniška pomoč.
Tell your doctor or nurse immediately, if you notice any of the effects listed below.
rom obvestite svojega zdravnika ali medicinsko sestro.
au • difficulties in breathing (bronchospasm) • swelling of the tongue or throat • anaphylactic shock (a very severe type of allergic response)
p • otekanje jezika ali grla, • anafilaktični šok (zelo hud tip alergijske reakcije).
r ge Such allergic reactions have only been seen in a very few cases and the most extreme form, anaphylactic shock, is very rare.
za Takšne alergijske reakcije so se pojavile samo v nekaterih primerih, najekstremnejša oblika, anafilaktični šok, pa je izredno redka.
He will take the appropriate countermeasures.
Če pride do zgoraj opisanih učinkov, takoj obvestite svojega zdravnika, ki bo ustrezno ukrepal.
Approximately 10% of patients treated with salmon calcitonin suffer from nausea, sometimes with vomiting.
nja Približno 10% bolnikov, zdravljenih z lososovim kalcitoninom, muči občutek slabosti, ki ga včasih spremlja bruhanje.
The effect may also disappear if the dose is reduced. ol
Učinek lahko izgine tudi z zmanjšanjem odmerka.
Irritation at or around the injection site has been reported occasionally in patients treated with salmon calcitonin.
Pri bolnikih, zdravljenih z lososovim kalcitoninom, so poročali o občasnem vnetju kože na mestu
The effect disappears without the need for special treatment.
lje injiciranja ali okoli njega.
It is recommended that you do not inject your medicine at exactly the same site each time you use it in order to avoid discomfort. tn
Učinek je izginil, ne da bi ga bilo treba posebej zdraviti.
Flushing of the face and hands has been noted.
Da bi se izognili tej neprijetnosti, svetujemo, da zdravila ne injicirate vedno na istem mestu. vo Opažena je bila rdečica na obrazu in dlaneh.
Again, this effect disappears with time, usually during the first or second week of treatment. uc
Tudi ta učinek sčasoma izgine, ponavadi v prvem ali drugem tednu zdravljenja.
Other possible but less frequent undesirable effects are:
Drugi možni, vendar manj pogosti, neželeni učinki so: do
• skin rash rod
• kožni izpuščaj, • diureza (povečano izločanje urina), • diareja, eā
• diuresis (increase in urination) • diarrhoea • metallic taste in the mouth • dizziness lp
• kovinski okus v ustih, • omotičnost.
Most of the effects do not last long and disappear of their own accord.
dolgo in izgine sama od sebe.
The remaining effects can be treated by your doctor if they persist. ina
Preostale učinke, če ne izginejo, lahko zdravi vaš zdravnik.
If you notice any unwanted effects not mentioned in this leaflet or any change in your health while receiving this medicine, or afterwards, please inform your doctor, nurse or pharmacist (chemist). dic
med prejemanjem zdravila ali po njem, vas prosimo, da o tem obvestite svojega zdravnika, medicinsko sestro ali farmacevta (lekarnarja).
STORING FORCALTONIN
SHRANJEVANJE FORCALTONINA
Me
Zdravilo shranjujte zunaj dosega in pogleda otrok. ilo
20 ed Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2ºC - 8°C).
Do not freeze.
Ne zamrznite. rav
ris solution from freezing.
Priporočamo, da ampule shranjujete v spodnjem delu ali predalu na vratih hladilnika, da raztopina ne zamrzne.
Any unused product must be discarded.
Zd
tho Do not use after the expiry date stated on the ampoule and the packaging.
20 et Zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na ampuli in na škatli.
Do not use Forcaltonin if you notice the solution is not completely clear and colourless.
rom Forcaltonina ne smete uporabiti, če raztopina ni prozorna in brezbarvna.
r ge on ol tn uc rod lp ina dic Me
p za nja lje vo do eā av nim ilo rav Zd
Forsteo is a prefilled pen that contains a solution for injection.
Zdravilo Forsteo je predhodno napolnjeni injekcijski peresnik, ki vsebuje raztopino za injiciranje.
Forsteo contains the active substance teriparatide (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Zdravilo Forsteo vsebuje zdravilno učinkovino teriparatid (en 2, 4- mililitrski predhodno napolnjeni peresnik vsebuje 600 mikrogramov teriparatida).
Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:  women who have been through the menopause.
Zdravilo Forsteo se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri naslednjih skupinah:  ženskah po menopavzi.
In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;  men who are at an increased risk of fractures;  men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
Pri teh bolnicah je bilo dokazano, da zdravilo Forsteo znatno zmanjšuje pojavnost zlomov vretenc (hrbtenice) in nevretenčnih zlomov, ne pa tudi zlomov kolka;  moških s povečanim tveganjem za zlom;  moških in ženskah, ki imajo povečano tveganje za zlome zaradi dolgotrajnega zdravljenja z glukokortikoidi (vrsto steroida).
Forsteo must not be used in children or in young adults whose bones are not yet fully mature.
Zdravilo Forsteo se ne sme uporabljati pri otrocih ali mlajših odraslih, katerih kosti še niso popolnoma razvite.
Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Osteoporoza se lahko pri obeh spolih pojavi tudi kot stranski učinek zdravljenja z glukokortikoidi.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Deluje enako kot hormon in vzpodbuja tvorbo kosti tako, da deluje na osteoblaste (celice, ki tvorijo 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Poleg tega poveča absorpcijo kalcija iz hrane in preprečuje izgubo velike količine kalcija v urinu.
Teriparatide is produced by a method known as ‘ recombinant DNA technology’: the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce the hormone.
Teriparatid proizvajajo z metodo, znano kot “ tehnologija rekombinantne DNK ”, pri kateri hormon izdela bakterija, ki je prejela gen (DNK), s katerim lahko tvori hormon.
Forsteo replaces the natural hormone.
Zdravilo Forsteo je nadomestilo za naravni hormon.
The first study involved 1,637 women with osteoporosis who had been through the menopause (average age:
V prvo študijo, v kateri so zdravilo Forsteo v obdobju povprečno 19 mesecev primerjali s placebom (zdravilom brez zdravilne učinkovine), je bilo vključenih 1 637 žensk (povprečna starost:
69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months.
69, 5 leta) s pomenopavzalno osteoporozo.
The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
Druga študija se je ukvarjala z uporabo zdravila Forsteo pri 437 moških z osteoporozo in je primerjala njegov učinek na gostoto kosti v hrbtenici v primerjavi z učinkom placeba.
The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years.
V tretji študiji so v obdobju treh let primerjali učinke zdravila Forsteo in alendronata (drugega zdravila za zdravljenje osteoporoze) na gostoto kosti v hrbtenici.
Forsteo was more effective than placebo in reducing vertebral fractures:
Kakšne koristi je zdravilo Forsteo izkazalo med študijami?
5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
Zdravilo Forsteo je bilo pri zmanjševanju pojavnosti zloma vretenc učinkovitejše od placeba: pri 5% žensk, ki so prejemale zdravilo Forsteo, je med študijo prišlo do novega zloma vretenc v primerjavi s 14% bolnic v skupini, ki je prejemala placebo.
Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo.
Zdravilo Forsteo je v primerjavi s placebom za 65% zmanjšalo tveganje za pojav novega zloma vretenc v 19- mesečnem obdobju študije.
It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Hkrati je za 62% zmanjšalo tveganje za nevretenčne zlome, vendar ni zmanjšalo tveganja za zlome kolka.
In the study in men, Forsteo increased bone density in the spine by about 6% after an average of almost 12 months.
V študiji, v katero so bili vključeni moški, je zdravilo Forsteo v povprečju za okoli 6% povečalo gostoto kosti v hrbtenici v obdobju 12 mesecev.
In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
V študiji, v katero so bili vključeni bolniki, ki so jemali glukokortikoide, je bilo zdravilo Forsteo učinkovitejše od alendronata: po 18 mesecih se je pri bolnikih, ki so prejemali zdravilo Forsteo, gostota kosti v hrbtenici povečala za 7% v primerjavi s 3% pri bolnikih, ki so prejemali alendronat.
The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.
Študije so tudi pokazale, da so bile koristi zdravljenja z zdravilom Forsteo vedno večje v obdobju do dveh let s povečevanjem gostote kosti.
The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs.
Najpogostejši neželeni učinek zdravila Forsteo (opažen pri 1 bolniku izmed 10) je bolečina v rokah ali nogah.
For the full list of all side effects reported with Forsteo, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Forsteo, glejte navodilo za uporabo.
Forsteo should not be used in people who may be hypersensitive (allergic) to teriparatide or any of the other ingredients.
Zdravila Forsteo ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) teriparatid ali katero koli drugo sestavino zdravila.
It must not be used in patients who have other bone diseases such as Paget’ s disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Ne sme se uporabljati pri bolnikih, ki imajo druge bolezni kosti, kot so Pagetova bolezen, kostni rak ali metastaze v kosteh (rak, ki se je razširil na kosti), bolnikih, ki so bili na obsevanju okostja, ali bolnikih, ki imajo hiperkalciemijo (visoke ravni kalcija v krvi), z nepojasnjeno visokimi ravnmi alkalne fosfataze (vrste encima) ali s hudim obolenjem ledvic.
Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breast- feeding.
Zdravilo Forsteo se ne sme uporabljati pri otrocih ali mlajših odraslih, katerih kosti še niso popolnoma razvite, oziroma med nosečnostjo ali dojenjem.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Forsteo’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, and for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Forsteo za zdravljenje osteoporoze pri ženskah po menopavzi in pri moških, pri katerih obstaja veliko tveganje za zlome, ter za zdravljenje osteoporoze, povezane s trajno sistemsko terapijo z glukokortikoidi pri ženskah in moških s povečanim tveganjem za zlome, večje od z njim povezanih tveganj.
The Committee recommended that Forsteo be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Forsteo odobri dovoljenje za promet.
Other information about Forsteo:
Druge informacije o zdravilu Forsteo:
The European Commission granted a marketing authorisation valid throughout the European Union for Forsteo to Eli Lilly Nederland B. V. on 10 June 2003.
Evropska komisija je dovoljenje za promet z zdravilom Forsteo, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland B. V. dne 10. junija 2003.
The marketing authorisation was renewed on 10 June 2008.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 10. junija 2008.
2/ 3 The full EPAR for Forsteo is available here.
2/ 3 Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Forsteo je na voljo tukaj.
Pre-filled pen (glass)
napolnjen injekcijski peresnik (steklo)
FORSTEO 20 micrograms/ 80 microliters solution for injection in pre-filled pen
FORSTEO 20 mikrogramov/ 80 mikrolitrov raztopina za injiciranje v napolnjenem injekcijskem peresniku
Each dose contains 20 micrograms of teriparatide.
Vsak odmerek vsebuje 20 mikrogramov teriparatida.
One pre-filled pen of 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).
En napolnjeni injekcijski peresnik z 2, 4 ml vsebuje 600 mikrogramov teriparatida (kar ustreza 250 mikrogramom na ml).
Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.
Teriparatid, rhPTH( 1- 34), izdelan v E. coli z uporabo tehnologije rekombinantne DNA, je istoveten 34 N- terminalnemu aminokislinskemu zaporedju endogenega človeškega paratiroidnega hormona.
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1).
Zdravljenje osteoporoze pri ženskah po menopavzi in moških s povečanim tveganjem za zlom (glejte poglavje 5. 1).
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Zdravljenje osteoporoze povezane s podaljšanim sistemskim glukokortikoidnim zdravljenjem pri ženskah in moških s povečanim tveganjme za zlom (glejte poglavje 5. 1).
The recommended dose of FORSTEO is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen.
Priporočeni odmerek FORSTEA je 20 mikrogramov, injiciran subkutano enkrat dnevno v stegno ali trebuh.
Patients must be trained to use the proper injection techniques (see section 6.6).
Bolnike moramo usposobiti za uporabo pravilnih tehnik injiciranja (glejte poglavje 6. 6).
A User Manual is also available to instruct patients on the correct use of the pen.
Za navodila bolnikom o pravilni uporabi injekcijskega peresnika je na voljo tudi Priročnik za uporabo.
The maximum total duration of treatment with FORSTEO should be 24 months (see section 4.4).
Najdaljše skupno trajanje zdravljenja s FORSTEOM naj bo 24 mesecev (glejte poglavje 4. 4).
The 24-month course of FORSTEO should not be repeated over a patient’ s lifetime.
24 - mesečni postopek zdravljenja ne sme biti ponovljen v času bolnikovega življenja.
Patients should receive supplemental Calcium and vitamin D supplements if dietary intake is inadequate.
Če vnos s hrano ne zadošča, naj bolniki prejemajo dodatek kalcija in vitamina D.
Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies.
Po ukinitvi zdravljenja s FORSTEOM lahko bolniki naprej prejemajo druga zdravila za osteoporozo.
Use in renal impairment:
Uporaba pri okvarjenem delovanju ledvic:
FORSTEO should not be used in patients with severe renal impairment (see 4.3.).
FORSTEA pri bolnikih z resno okvarjenim delovanjem ledvic ne smemo uporabljati (glejte poglavje 4. 3).
In patients with moderate renal impairment, FORSTEO should be used with caution.
Pri bolnikih z zmerno okvarjenim delovanjem ledvic moramo FORSTEO uporabljati previdno.
2 Use in hepatic impairment: no data are available in patients with impaired hepatic function (see section 5.3).
Uporaba pri okvarjenem delovanju jeter: za bolnike z okvarjenim delovanjem jeter ni na voljo podatkov (glejte poglavje 5. 3).
Paediatric population and young adults with open epiphyses:
2 Pediatrična populacija in mladi odrasli z odprtimi epifizami:
There is no experience in paediatric patients (less than 18 years).
Izkušenj pri pediatrični populaciji (mlajših od 18 let) ni.
FORSTEO should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.
FORSTEA pri pediatrični populaciji (mlajših od 18 let) ali mladih odraslih z odprtimi epifizami ne smemo uporabljati.
Dosage adjustment based on age is not required (see section 5.2).
Prilagoditev odmerjanja glede na starost ni potrebna (glejte poglavje 5. 2).
• Hypersensitivity to the active substance or to any of the excipients. • Pregnancy and lactation (see section 4.4 and 4.6) • Pre-existing hypercalcemia • Severe renal impairment • Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget’ s disease of the bone) • Unexplained elevations of alkaline phosphatase • Prior external beam or implant radiation therapy to the skeleton • Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov • Nosečnost in dojenje (glejte poglavje 4. 4 in 4. 6) • Že obstoječa hiperkalciemija • Hudo okvarjeno delovanje ledvic • Presnovne bolezni kosti (vključujoč hiperparatiroidizem in Pagetovo bolezen kosti) z izjemo primarne osteoporoze • Nepojasnjene povišane vrednosti alkalne fosfataze • Teleradioterapija ali brahiradioterapija za zdravljenje okostja v preteklosti • Bolniki s skeletnimi malignostmi ali kostnimi metastazami morajo biti izključeni iz zdravljenja s teriparatidom
In normocalcemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection.
Pri normokalcemičnih bolnikih so po injiciranju teriparatida opažali rahla in prehodna povišanja serumskih koncentracij kalcija.
Therefore if any blood samples are taken from a patient, this should be done at least 16 hours after the most recent FORSTEO injection.
Torej, če bolnikom jemljemo vzorce krvi, je treba to storiti vsaj 16 ur po zadnji injekciji FORSTEA.
FORSTEO may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.
FORSTEO lahko povzroči majhna povečanja izločanja kalcija s sečem, vendar se incidenca hiperkalciurije ni razlikovala od incidence pri bolnikih, ki so v kliničnih preskušanjih prejemali placebo.
FORSTEO has not been studied in patients with active urolithiasis.
FORSTEA pri bolnikih z aktivno urolitiazo niso preučevali.
FORSTEO should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
FORSTEO je treba pri bolnikih z aktivno ali nedavno urolitiazo uporabljati previdno zaradi možnosti poslabšanja tega stanja.
In short-term clinical studies with FORSTEO, isolated episodes of transient orthostatic hypotension were observed.
V kratkotrajnih kliničnih študijah FORSTEA so opažali osamljene epizode prehodne ortostatske hipotenzije.
Experience in the younger adult population, including premenopausal women, is limited (see section 5.1).
Izkušnje pri populaciji mladih odraslih, vključno z ženskami pred menopavzo, so omejene (glejte poglavje 5. 1).
Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Ženske, ki bi lahko zanosile morajo med uporabo FORSTEA uporabljati učinkovito metodo kontracepcije.
If pregnancy occurs, FORSTEO should be discontinued.
Če zanosijo, mora biti FORSTEO ukinjen.
3 Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide (see section 5.3).
Študije pri podganah so pokazale povečano incidenco osteosarkoma po dolgotrajnem dajanju teriparatida (glejte poglavje 5. 3).
FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
3 FORSTEO so vrednotili v študijah farmakodinamičnega medsebojnega delovanja s hidroklorotiazidom.
Co-administration of raloxifene or hormone replacement therapy with FORSTEO did not alter the effects of FORSTEO on serum or urine calcium or on clinical adverse events.
Sočasno dajanje FORSTEA in raloksifena ali hormonske nadomestne terapije s FORSTEOM ni spremenilo učinkov FORSTEA na serumske koncentracije kalcija, koncentracije kalcija v seču ali na klinične neželene dogodke.
In a study of 15 healthy subjects administered digoxin daily to steady state, a single FORSTEO dose did not alter the cardiac effect of digoxin.
V študiji 15 zdravih oseb, ki so dnevno prejemali digoksin do stanja dinamičnega ravnovesja, enkratni odmerek FORSTEA ni spremenil učinka digoksina na srce.
However, sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity.
Vendar pa so sporadična poročila o primerih bolnikov nakazala, da hiperkalciemija lahko naredi bolnike bolj dovzetne za toksičnost digitalisa.
Because FORSTEO transiently increases serum calcium, FORSTEO should be used with caution in patients taking digitalis.
Ker FORSTEO prehodno zviša serumsko koncentracijo kalcija, ga moramo pri bolnikih, ki jemljejo digitalis, uporabljati previdno.
General recommendation
Splošna priporočila
Studies in rabbits have shown reproductive toxicity (see section 5.3).
Študije na kuncih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
It is not known whether teriparatide is excreted in human milk.
Ni znano ali se teriparatid izloča v materino mleko.
FORSTEO is contraindicated for use during pregnancy or breast-feeding.
FORSTEO je med nosečnostjo ali dojenjem kontraindiciran.
Women of childbearing potential / Contraception in females
Ženske, ki bi lahko zanosile/ Kontracepcija za ženske
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso naredili.
However, transient, orthostatic hypotension or dizziness was observed in some patients.
Kljub temu so pri nekaterih bolnikih opažali prehodno ortostatsko hipotenzijo ali omotico.
Of patients in the teriparatide trials, 82.8% of the FORSTEO patients and 84.5% of the placebo patients reported at least 1 adverse event.
Od bolnikov v preskušanjih teriparatida je o vsaj 1 neželenem dogodku poročalo 82, 8% bolnikov, ki so prejemali FORSTEO, in 84, 5% bolnikov, ki so prejemali placebo.
The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness.
Najpogosteje poročane neželene reakcije pri bolnikih, zdravljenih s FORSTEOM, so slabost, bolečine v okončinah, glavobol in omotica.
The undesirable reactions associated with the use of teriparatide in osteoporosis clinical trials are summarised in the table below.
Neželene reakcije, povezane z uporabo teriparatida pri bolnikih z osteoporozo v kliničnih preskušanjih, so povzete v spodnji preglednici.
The following convention has been used for the classification of the adverse reactions: 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), not known (cannot be estimated from the available data).
Za klasifikacijo neželenih reakcij smo uporabili naslednji dogovor: zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100 do < 1/ 10), občasno (≥ 1/ 1. 000 do < 1/ 100), redko (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redko (< 1/ 10. 000), ni znano (ocena ni možna iz znanih podatkov).
4 Investigations Uncommon:
4 Pogosto:
Tachycardia Blood and lymphatic system disorders Common:
Omotica, glavobol, išias Ušesne bolezni, vključno z motnjami labirinta Pogosto:
Vertigo Respiratory, thoracic and mediastinal disorders Common:
Vrtoglavica Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosto:
Dyspnoea Uncommon:
Dispneja Občasno:
Emphysema Gastrointestinal disorders Common:
Emfizem Bolezni prebavil Pogosto: