natgillin/translations-raw huggingface dataset:
Figure Q
Slika Q
• If there are remaining doses in the pen and the “Discard On” date has not passed (see Medicine Tracker), place the pen in the refrigerator (see “How to Store your Medicine” (Section D) below).
• Ako u brizgalici ostalo još doza lijeka, a datum naveden pored „Baciti“ (pogledajte Dnevnik zamjene brizgalice) još nije prošao, brizgalicu spremite u hladnjak (pogledajte „Kako čuvati lijek“ (dio D) u nastavku).
Natpar is produced in E. coli using recombinant DNA technology, and is identical to the 84 amino acid sequence of endogenous human parathyroid hormone.
Natpar je proizveden u bakteriji E. coli tehnologijom rekombinantne DNK, a istovjetan je slijedu 84 aminokiseline endogenog humanog paratiroidnog hormona.
• Discard all pens on the “Discard On” date, 14 days after mixing (see Medicine Tracker).
• Bacite sve brizgalice na datum naveden pored „Baciti“, a to je 14 dana poslije miješanja lijeka
How to store Natpar
Kako čuvati Natpar
19 How to discard your empty pens
Kako baciti prazne brizgalice
• Write today's date in the space next to “Date Mixed”.
• pored „Datum miješanja“ upišite današnji datum
Initiating Natpar
Prijavljivanje nuspojava
No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 mL/min).
Nije potrebno prilagođavanje doze u bolesnika s blago do umjereno oštećenom funkcijom bubrega (klirens kreatinina 30 do 80 ml/min).
9 • With the needle cap still pointing straight up, tap the cartridge with the tip of your fingernail 3 to 5 times, or until any large air bubbles move to the top (See Figure J).
9. • Držeći kapicu igle i dalje usmjerenu ravno prema gore, vrhom prsta kucnite po ulošku 3 do 5 puta ili koliko je potrebno da se veliki mjehurići zraka podignu prema vrhu (pogledajte sliku J).
It is not known if Natpar has any effects on fertility.
Nije poznato utječe li Natpar na plodnost.
abdominal pain upper*
bol u gornjem dijelu abdomena*
• If the pen is empty (there is no liquid remaining, or the dose counter shows “0”) or today is the “Discard On” date noted on your Medicine Tracker, discard the pen and follow the instructions in “Getting Started” (Section A) with a new pen.
• Ako je brizgalica prazna (nema više tekućine ili brojač doza pokazuje „0“), ili je u Vašem Dnevniku zamjene brizgalice pored „Baciti“ naveden današnji datum, bacite ovu brizgalicu i uzmite novu te slijedite upute opisane pod „Kako početi“ (dio A).
Use pen needles (31Gx5 mm, 31Gx8 mm, or 32Gx4 mm).
Koristite igle za brizgalicu (31G x 5 mm, 31G x 8 mm ili 32G x 4 mm).
15 • Carefully put the needle cap back on the pen needle by scooping the back of the needle using only one hand (See Figure V).
15. • Pažljivo vratite kapicu natrag na iglu brizgalice tako što ćete, držeći brizgalicu samo jednom rukom, iglu umetnuti u kapicu bez dodirivanja kapice (pogledajte sliku V).
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Figure A
Slika A
14 • Slowly pull the needle straight out of your thigh (See Figure U).
14. • Polako izvucite iglu iz bedra ravnim pokretom (pogledajte sliku U).
What should I do if the clear medicine cartridge is difficult to screw down?
Što ako je prozirni uložak za lijek teško spojiti?
8 • Use an alcohol wipe to clean the injection site area of the thigh (See Figure O).
8. • Pomoću alkoholne maramice očistite područje na bedru u koje ćete injicirati lijek (pogledajte sliku O).
There are no data in patients with severe hepatic impairment.
Nema podataka vezanih uz bolesnike s teškim oštećenjem funkcije bubrega.
Cases of hypocalcaemia resulting in seizures have been reported post-marketing (see section 4.4).
U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi hipokalcemije koji su doveli do napadaja (vidjeti dio 4.4).
In the post-marketing setting, cases of symptomatic hypocalcaemia, including cases that resulted in seizures, have been reported in patients being treated with Natpar.
Tijekom praćenja nakon stavljanja lijeka u promet u bolesnika liječenih lijekom Natpar prijavljeni su slučajevi simptomatske hipokalcemije, uključujući slučajeve koji su doveli do napadaja.
3 • Remove the pen cap from your pen (See Figure M).
3. • Skinite poklopac s brizgalice (pogledajte sliku M).
Metacresol Water for injections
Voda za injekcije
D. How to store your medicine
Kako čuvati lijek
Temporary or permanent discontinuation of Natpar must be accompanied by monitoring of serum calcium levels and increase of exogenous calcium and/or active vitamin D sources as necessary.
Privremeni ili trajni prekid liječenja lijekom Natpar mora biti proveden uz praćenje razina kalcija u serumu i, po potrebi, povećanje egzogenog kalcija i/ili aktivnog vitamina D.
Use with pen needles (31Gx5 mm, 31Gx8 mm, or 32Gx4 mm)
Uporaba s iglama za brizgalicu (31G x 5 mm, 31G x 8 mm ili 32G x 4 mm).
There are no data available in patients with severe hepatic impairment (see section 4.4).
Nema dostupnih podataka vezanih uz bolesnike s teškim oštećenjem funkcije jetre (vidjeti dio 4.4).
What Natpar looks like and contents of the pack Each pre-filled pen of Natpar contains a cartridge with medicine as a powder together with a solvent to make a solution for injection.
Jedna napunjena brizgalica lijeka Natpar sadrži uložak s lijekom u obliku praška zajedno s otapalom za pripremu otopine za injekciju.
8 • Press the yellow button until the blue button pops out (See Figure I).
8. • Pritisnite žuti gumb tako da iskoči plavi gumb (pogledajte sliku I).
Do not use the pen if the solution is cloudy or coloured or if it contains visible particles.
Nemojte koristiti brizgalicu ako je otopina mutna, obojena ili ako sadrži vidljive čestice.
Figure N
Slika N
Keep the reconstituted pre-filled pen tightly closed in order to protect from light.
Napunjenu brizgalicu s rekonstituiranim lijekom čuvati čvrsto zatvorenu radi zaštite od svjetlosti.
No studies were conducted in patients on renal dialysis.
Nije provedeno nijedno ispitivanje u kojem su sudjelovali bolesnici na dijalizi.
Figure B
Slika B
Vascular disorders hypertension*
Krvožilni poremećaji hipertenzija*
Figure R
Slika R
• sodium chloride
• natrijev klorid
Save the cap for later use (See Figure D).
Spremite ga jer će Vam trebati kasnije (pogledajte sliku D).
See Figure X
Pogledajte sliku X.
18 • Put the pen cap back on your pen by pushing the cap until it clicks.
18. • Vratite poklopac na brizgalicu i pritisnite ga tako da začujete „klik“.
The glass dual-chamber cartridge inside the pen is made from type I glass with 2 bromobutyl rubber stoppers and a crimp cap (aluminium) with a bromobutyl rubber seal.
I s 2 čepa od bromobutilne gume i zatvaračem (aluminij) s brtvom od bromobutilne gume.
• In the Medicine Tracker below (See Figure C):
• U Dnevniku zamjene brizgalice (pogledajte sliku C):
No dose adjustment for Natpar is recommended in patients with mild to moderate hepatic impairment.
Ne preporučuje se prilagođavanje doze lijeka Natpar u bolesnika s blago do umjereno oštećenom funkcijom jetre.
Urolithiasis
Urolitijaza
• Do NOT freeze your pen.
• NEMOJTE zamrzavati brizgalicu.
Urinary calcium excretion
Izlučivanje kalcija u urinu
Natpar 75 micrograms
Natpar 75 mikrograma
Figure F
Slika F
• Keep the mixed pen tightly closed in order to protect from light.
• Brizgalicu s izmiješanim lijekom čuvati čvrsto zatvorenu radi zaštite od svjetlosti.
The inotropic effects of cardiac glycosides are affected by serum calcium levels.
Razine kalcija u serumu utječu na inotropne učinke kardioaktivnih glikozida
• Keep the pre-filled pen in the outer carton in order to protect from light.
• Napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Keep the pre-filled pen in the outer carton in order to protect from light.
Napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Figure H
Slika H
In the liver, parathyroid hormone is cleaved by cathepsins.
U jetri, katepsini cijepaju paratiroidni hormon.
• metacresol
• metakrezol
Special populations Elderly
Starije osobe
Figure S
Slika S
• If you are using the pen for the first time, continue to “New Pen Setup &
• Ako brizgalicu upotrebljavate prvi put, nastavite na dio „Priprema nove brizgalice i miješanje lijeka” (dio B).
• Remove the pen cap from your pen.
• Skinite poklopac s brizgalice.
If Natpar is to be discontinued, monitoring for hypocalcaemia is necessary (see section 4.2).
Prilikom prekida liječenja lijekom Natpar, bolesnike je potrebno pratiti na moguću pojavu hipokalcemije (vidjeti dio 4.2).
Natpar 25 micrograms
Natpar 25 mikrograma
10 • Pull the needle cap straight off and set it aside (See Figure Q).
10. • Jednim potezom povucite kapicu igle ravno prema dolje i odložite je sa strane (pogledajte sliku Q).
In this trial, patients with chronic hypoparathyroidism receiving calcium and active forms of vitamin D (vitamin D metabolite or analogues) were randomised to Natpar (n=84) or placebo (n=40).
D ili analoge) randomizirani za primanje lijeka Natpar (n=84) ili placeba (n=40).
• Do not use your medicine if it is cloudy, if it is coloured, or if it contains visible particles.
• Nemojte primijeniti lijek ako je mutan, obojen ili ako sadrži vidljive čestice.
Figure D
Slika D
Figure T
Slika T
What should I do if the medicine is cloudy, coloured, or contains particles?
Što ako je lijek mutan, obojen ili sadrži vidljive čestice?
• Call Shire at +44 (0)800 055 6614.
• nazovite tvrtku Shire na broj +44 (0)800 055 6614,
Natpar 75 micrograms/dose
Natpar 75 mikrograma/doza
Breast-feeding It is unknown whether Natpar is excreted in human milk.
Dojenje Nije poznato izlučuje li se Natpar u majčino mlijeko.
Natpar 50 micrograms
Natpar 50 mikrograma
Figure M
Slika M
Grey pen label.
Siva naljepnica na brizgalici.
6 • Remove the paper tab back from the needle cap (See Figure N).
6. • Skinite papirni jezičak s kapice igle (pogledajte sliku N).
Decrease
Smanjite
How to use Natpar
Kako primjenjivati Natpar
Tachyphylaxis
Tahifilaksija
Figure J
Slika J
Hypercalcaemia
Hiperkalcemija
Figure G
Slika G
You must use a new pen needle for each injection.
Za svaku primjenu lijeka morate upotrijebiti novu iglu.
Natpar 50 micrograms/dose
Natpar 50 mikrograma/doza
What you need to know before you use Natpar Do not use Natpar - if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed in section 6)
Što morate znati prije nego počnete primjenjivati Natpar Nemojte primjenjivati Natpar - ako ste alergični na paratiroidni hormon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako primate ili ste primali terapiju zračenja kostiju - ako imate rak kostiju ili druge vrste raka koje su se proširile u kosti
Natpar contains sodium
Natpar sadrži natrij
Figure P
Slika P
See section 5.2.
Posebne populacije Starije osobe Vidjeti dio 5.2.
Renal and urinary disorders hypercalciuria pollakiuria
Poremećaji bubrega i mokraćnog sustava hiperkalciurija*, polakizurija
Tabulated list of adverse reactions
Tablični prikaz popisa nuspojava
Figure O
Slika O
Increase
Povećajte
There have been post-marketing reports of hypersensitivity reactions in patients taking Natpar.
Nakon stavljanja lijeka u promet u bolesnika koji su uzimali Natpar prijavljene su reakcije preosjetljivosti.
If you have questions at any time, see the “Frequently Asked Questions” in Section E, contact your doctor or nurse, call Shire at +44 (0)800 055 6614, or email at medinfoEMEA@shire.com for help.
Također možete kontaktirati tvrtku Shire na broj +44 (0)800 055 6614, ili poslati svoja pitanja putem e-pošte na adresu medinfoEMEA@shire.com.
Try again to slowly screw down the cartridge.
Pokušajte ponovno polaganim zakretanjem spojiti uložak.
• diarrhoea*
• proljev*
Purple pen label.
Ljubičasta naljepnica na brizgalici.
3 • Pick up the needle and peel the paper tab back from the needle cap (See Figure F).
3. • Uzmite iglu i skinite papirni jezičak s kapice igle (pogledajte sliku F).
You should save the pen and call Shire at +44 (0)800 055 6614 to discuss getting a replacement.
Spremite brizgalicu i nazovite tvrtku Shire na broj +44 (0)800 055 6614 radi dogovora o zamjeni.
• stomach pain*
• bol u želucu*
Calcium supplement
Nadomjestak kalcija
The carton/pen label colour shows the strength of your Natpar medicine:
Boja naljepnice na kutiji/brizgalici pokazuje jačinu
Pre-dose and in some cases post-dose serum calcium levels must be monitored during treatment with Natpar (see section 4.2).
Razine kalcija u serumu moraju se pratiti prije primjene doze i, u određenim slučajevima, nakon primjene doze tijekom liječenja lijekom Natpar (vidjeti dio 4.2).
Figure C Medicine Tracker
PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
Figure Z
Slika Z
13 • Gently insert the needle fully into your thigh (See Figure T).
13 • Nježno i do kraja ubodite iglu u bedro (pogledajte sliku T).
Each pre-filled pen contains 1050 micrograms parathyroid hormone (rDNA).
Jedna napunjena brizgalica sadrži 1050 mikrograma paratiroidnog hormona (rDNK).
Figure W
Slika W
The objective of this trial was to maintain serum calcium with Natpar while reducing or replacing oral calcium and active vitamin D. The study was a 24-week, randomised, double-blind, placebo-controlled, multicentre trial.
Ispitivanje je bilo 24-tjedno, randomizirano, dvostruko slijepo, placebom kontrolirano i multicentrično.
Each pre-filled pen contains 350 micrograms parathyroid hormone (rDNA).
Jedna napunjena brizgalica sadrži 350 mikrograma paratiroidnog hormona (rDNK).
C. Daily Injection
Svakodnevna primjena
The reconstituted pre-filled pen should be discarded after the 14-day period.
Nakon tog 14-dnevnog razdoblja, napunjenu brizgalicu s rekonstituiranim lijekom treba baciti.
Investigations anti-PTH antibody positive, blood 25-hydroxycholecalcif erol decreased vitamin D decreased
Pretrage pozitivna antitijela anti-PTH, smanjena razina
Natpar 25 mcg/dose powder for solution for injection Natpar 50 mcg/dose powder for solution for injection Natpar 75 mcg/dose powder for solution for injection Natpar 100 mcg/dose powder for solution for injection Parathyroid hormone (rDNA) Subcutaneous use
Natpar 25 µg/doza, prašak za otopinu za injekciju Natpar 50 µg/doza, prašak za otopinu za injekciju Natpar 75 µg/doza, prašak za otopinu za injekciju Natpar 100 µg/doza, prašak za otopinu za injekciju paratiroidni hormon (rDNK) Za supkutanu primjenu
• Write the date 14 days from today in the space next to “Discard On”.
• pored „Baciti“ upišite datum koji je 14 dana udaljen od današnjeg datuma.
Pre-dose serum calcium
Kalcij u serumu prije primjene doze
Figure K
Slika K
Each pre-filled pen contains 700 micrograms parathyroid hormone (rDNA).
Jedna napunjena brizgalica sadrži 700 mikrograma paratiroidnog hormona (rDNK).
16 • Squeeze the needle cap and unscrew the needle (See Figure W).
16. • Stisnite kapicu igle i odvijte ju zajedno s iglom (pogledajte sliku W).
Natpar 25 micrograms/dose powder and solvent for solution for injection in pre-filled pen Natpar 50 micrograms/dose powder and solvent for solution for injection in pre-filled pen Natpar 75 micrograms/dose powder and solvent for solution for injection in pre-filled pen Natpar 100 micrograms/dose powder and solvent for solution for injection in pre-filled pen
Natpar 75 mikrograma/doza, prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici Natpar 100 mikrograma/doza, prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici
Each pre-filled pen contains 1400 micrograms parathyroid hormone (rDNA).
Jedna napunjena brizgalica sadrži 1400 mikrograma paratiroidnog hormona (rDNK).
Common (may affect up to 1 in 10 people):
Česte (mogu se javiti u do 1 na 10 osoba): • osjećaj nervoze ili tjeskobe
Natpar 25 microgram/dose powder and solvent for solution for injection in pre-filled pen Natpar 50 microgram/dose powder and solvent for solution for injection in pre-filled pen Natpar 75 microgram/dose powder and solvent for solution for injection in pre-filled pen Natpar 100 microgram/dose powder and solvent for solution for injection in pre-filled pen Parathyroid hormone (rDNA)
Natpar 75 mikrograma/doza, prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici Natpar 100 mikrograma/doza, prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici paratiroidni hormon (rDNK)
You may have screwed down the clear medicine cartridge too quickly, wait 5 minutes for the foaming to subside.
Možda ste prilikom spajanja prebrzo zakretali proziran uložak za lijek.
All adverse reactions identified in post-marketing experience are italicised.
Sve nuspojave prepoznate u razdoblju nakon stavljanja lijeka u promet navedene su u kurzivu.
At Week 24, for patients who completed the study, 34/79 (43%) Natpar patients were independent of active vitamin D treatment and were receiving no more than 500 mg of calcium citrate, compared with 2/33 (6.1%) placebo patients (p<0.001).
D te je primalo ne više od 500 mg kalcijevog citrata, u usporedbi s 2/33 (6,1%) bolesnika koji su primali placebo (p<0,001).
If you are concerned, call Shire at +44 (0)800 055 6614 for help.
Ako Vas to brine, za pomoć nazovite tvrtku Shire na broj +44 (0)800 055 6614.
• feeling nervous or anxious
• trzanje ili grčenje mišića
Call Shire at +44 (0)800 055 6614 for help.
Za pomoć nazovite tvrtku Shire na broj +44 (0)800 055 6614.
Posology
Slika
Each dose contains 100 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 100 mikrograma paratiroidnog hormona (rDNK) u 71,4 mikrolitre otopine nakon rekonstitucije.
• Store your pen with the pen cap on.
• Brizgalicu čuvajte s poklopcem na brizgalici.
Each dose contains 100 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 100 mikrograma paratiroidnog hormona u 71,4 mikrolitre otopine nakon rekonstitucije.
• Save the cap for later use.
• Spremite ga jer će Vam trebati kasnije.
Each pre-filled pen contains 1050 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Jedna napunjena brizgalica sadrži u prvoj komori 1050 mikrograma paratiroidnog hormona (rDNK) u obliku praška, a u drugoj komori 1000 mikrolitara otapala (što odgovara 14 doza).
Figure I
Slika E
Each pre-filled pen contains 700 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Jedna napunjena brizgalica sadrži u prvoj komori 700 mikrograma paratiroidnog hormona (rDNK) u obliku praška, a u drugoj komori 1000 mikrolitara otapala (što odgovara 14 doza).
Each pre-filled pen contains 350 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Jedna napunjena brizgalica sadrži u prvoj komori 350 mikrograma paratiroidnog hormona (rDNK) u obliku praška, a u drugoj komori 1000 mikrolitara otapala (što odgovara 14 doza).
Read and understand these Instructions for Use before you start using the Natpar Pre-filled Pen.
Prije nego što počnete upotrebljavati Natpar napunjenu brizgalicu morate pročitati i razumjeti ove upute za uporabu.
Each pre-filled pen contains 1400 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Jedna napunjena brizgalica sadrži u prvoj komori 1400 mikrograma paratiroidnog hormona (rDNK) u obliku praška, a u drugoj komori 1000 mikrolitara otapala (što odgovara 14 doza).
Each dose contains 25 micrograms parathyroid hormone (rDNA)* in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 25 mikrograma paratiroidnog hormona (rDNK)* u 71,4 mikrolitre otopine nakon rekonstitucije.
Read the package leaflet in full before using Natpar.
Prije upotrebe lijeka Natpar pročitajte u cijelosti uputu o lijeku.
General disorders and administration site conditions asthenia*, chest pain fatigue, injection site reactions, thirst*
Opći poremećaji i reakcije na mjestu primjene astenija*, bol u prsištu
Each dose contains 75 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 75 mikrograma paratiroidnog hormona u 71,4 mikrolitre otopine nakon rekonstitucije.
Each dose contains 25 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 25 mikrograma paratiroidnog hormona u 71,4 mikrolitre otopine nakon rekonstitucije.
Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 75 mikrograma paratiroidnog hormona (rDNK) u 71,4 mikrolitre otopine nakon rekonstitucije.
Each dose contains 50 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 50 mikrograma paratiroidnog hormona u 71,4 mikrolitre otopine nakon rekonstitucije.
Natpar 25 micrograms/dose
Vašeg lijeka Natpar: Natpar 25 mikrograma/doza
Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 50 mikrograma paratiroidnog hormona (rDNK) u 71,4 mikrolitre otopine nakon rekonstitucije.
Each dose contains 25 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Jedna doza sadrži 25 mikrograma paratiroidnog hormona (rDNK) u otopini od 71,4 mikrolitre nakon rekonstitucije.
Figure V
Slika V
For any drug that affects serum calcium levels (e.g., lithium, thiazides), patients' serum calcium levels should be monitored.
Potrebno je pratiti razine kalcija u serumu bolesnika u slučaju primjene bilo kojeg lijeka koji utječe na razine kalcija u serumu (npr. litij, tiazidi).
This overview was last updated in May 2018.
Ovaj sažetak posljednji je put ažuriran u svibnju 2018.
It should be used after careful evaluation of alternative treatment options;
Treba ga primjenjivati nakon pažljive ocjene alternativnih opcija liječenja;
This may also help in controlling seizures.
To također može pomoći u kontroli napadaja.
The dose is calculated according to the dog's weight.
Doza se izračunava na temelju težine psa.
These side effects are mild and generally short-lived.
Te su nuspojave blage i obično kratkoročne.
Further information on Pexion can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Više informacija o VMP-u Pexion nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Epilepsy is caused by excessive electrical activity in the brain.
Epilepsiju uzrokuje pretjerana električna aktivnost u mozgu.
Imepitoin also has a weak blocking effect on calcium channels.
Imepitoin također ima slabi učinak blokiranja kalcijevih kanala.
Imepitoin's effect on GABA receptors also reduces fear and anxiety.
Učinak imepitoina na GABA receptore također smanjuje strah i tjeskobu.
• reduce the frequency of generalised seizures (fits affecting most or all of the brain) due to epilepsy of unknown causes (idiopathic).
• smanjivanje učestalosti generaliziranih napadaja (napadaja koji utječu na veći dio mozga ili cijeli mozak) zbog epilepsije nepoznatih uzroka (idiopatska).
This compared with a reduction of 2.4 seizures to 1.1 per month with phenobarbital (another anti-epileptic medicine).
To je uspoređeno sa smanjenjem broja napadaja s 2,4 na 1,1 mjesečno fenobarbitalom (drugi antiepileptik).
Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Neurotransmiteri kao što je GABA jesu kemikalije koje omogućuju međusobnu komunikaciju živčanih stanica.
• reduce anxiety and fear associated with noise phobia.
• smanjenje tjeskobe i straha povezanog s akustikofobijom.
To prevent accidental ingestion, the bottle cap should be replaced immediately after withdrawing the required number of tablets for one dose.
Kako bi se spriječilo nehotično gutanje, zatvarač boce treba zatvoriti čim se izvadi broj tableta potreban za jednu dozu.