natgillin/translations-raw huggingface dataset:
Approximately one-third of patients across the studies had at least 1 prior failure on a migraine prophylactic treatment for efficacy reasons and approximately 16 % of patients across the studies had at least 2 prior failure on a prophylactic treatment for efficacy reasons.
Približno ena tretjina bolnikov v študijah se je predhodno neuspešno zdravila z vsaj enim profilaktičnim zdravilom proti migreni zaradi pomanjkanja učinkovitosti, približno 16 % bolnikov v študijah pa se je predhodno neuspešno zdravilo z vsaj dvema profilaktičnima zdraviloma zaradi pomanjkanja učinkovitosti.
• Do not put the needle cap back on - you could damage the needle or injure yourself by accident.
• Pokrovčka igle ne nameščajte ponovno nazaj - lahko poškodujete iglo ali nenamerno poškodujete sebe.
When your injection is complete:
Ko je injiciranje končano:
Such signs are listed under “Serious side effects” in section 4.
Ti znaki so navedeni v poglavju 4 pod »Možni neželeni učinki«.
Based on a population PK analysis that included doses ranging from 5 - 300 mg, the rate of absorption, apparent clearance and apparent volume of distribution was independent of dose.
Na podlagi populacijske farmakokinetične analize, ki je vključevala odmerke v razponu od 5 do 300 mg, so bili stopnja absorpcije, navidezni očistek in navidezni volumen porazdelitve neodvisni od odmerka.
These findings were noted at no maternal toxicity and were considered to be related to galcanezumab but non-adverse.
Te izsledke so zabeležili pri odsotnosti toksičnosti za mater in so bili ocenjeni kot povezani z galkanezumabom, vendar neškodljivi.
You will also see the grey plunger at the top of the clear base.
Prav tako boste na vrhu prozornega podstavka videli siv bat.
For a more comfortable injection, leave the syringe at room temperature for 30 minutes before injecting.
Da bo injiciranje udobnejše, pustite injekcijski peresnik na sobni temperaturi 30 minut pred injiciranjem.
Choose your injection site
Izberite svoje mesto injiciranja
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
What you need to know before you use Emgality 3.
Kaj morate vedeti, preden boste uporabili zdravilo Emgality 3.
Serious hypersensitivity
Resna preobčutljivost
Frequency estimate: 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).
Ocena pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100),
• The pen contains glass parts.
• Injekcijski peresnik vsebuje steklene dele.
Galcanezumab binds to CGRP with high affinity (KD = 31 pM) and high specificity (> 10,000-fold vs related peptides adrenomedullin, amylin, calcitonin and intermedin).
Galkanezumab se veže na CGRP z visoko afiniteto (KD = 31 pM) in visoko specifičnostjo (> 10.000-krat večjo od sorodnih peptidov adrenomedulina, amilina, kalcitonina in intermedina).
Patients with recent acute cardiovascular events (including MI, unstable angina, CABG, stroke, DVT) and/or those deemed to be at serious cardiovascular risk were excluded from the galcanezumab clinical trials.
Bolniki z nedavnimi akutnimi srčno-žilnimi dogodki (vključno z miokardnim infarktom, nestabilno angino pektoris, CABG, možgansko kapjo, GVT) in/ali bolniki, za katere so presodili, da imajo resno srčnožilno tveganje, so bili izključeni iz kliničnih preskušanj z galkanezumabom.
Q. Do I need to hold the injection button down until the injection is complete?
V. Ali moram držati gumb za injiciranje, dokler injiciranje ni končano?
The needle included in the pack is only suitable for sub-cutaneous injection.
Igla, priložena v pakiranju, je primerna samo za subkutano injiciranje.
The majority of injection site reactions were reported within 1 day and on average resolved within 5 days.
Poročali so, da se je večina reakcij na mestu injiciranja pojavila v enem dnevu, minile pa so povprečno v petih dneh.
One percent of the patients exposed to galcanezumab during the phase 3 studies experienced severe pain at the injection site.
En odstotek bolnikov, izpostavljenih galkanezumabu v študijah 3. faze, je občutil hudo bolečino na mestu injiciranja.
Pharmacotherapeutic group: analgesics, other antimigraine preparations, ATC code: N02CX08
Farmakoterapevtska skupina: analgetiki, druga zdravila proti migreni, oznaka ATC: N02CX08
Emgality has not been studied in patients with serious cardiovascular diseases.
Zdravila Emgality pri bolnikih z resnimi srčno-žilnimi boleznimi niso preučevali.
If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated.
Če se pojavi resna preobčutljivostna reakcija, je treba dajanje galkanezumaba nemudoma prekiniti in uvesti ustrezno zdravljenje.
The efficacy and safety of galcanezumab has been studied in 3 phase 3, randomized, placebocontrolled, double-blind studies in adult patients (N = 2886).
Klinična učinkovitost in varnost Učinkovitost in varnost galkanezumaba so preučevali v treh randomiziranih, s placebom nadzorovanih, dvojno slepih študijah 3. faze pri odraslih bolnikih (n = 2.886).
The chronic migraine study (REGAIN) enrolled patients who met ICHD criteria for chronic migraine with ≥ 15 headache days per month, of which at least 8 had the features of migraine.
študijo kronične migrene (REGAIN) so vključili bolnike, ki so izpolnjevali merila ICHD za kronično migreno z ≥ 15 dnevi glavobola na mesec, od katerih jih je vsaj 8 imelo značilnosti migrene.
P-value
p-vrednost
Most of the reactions were mild or moderate in severity.
Večina učinkov je bila blagih do zmernih.
There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine.
Galkanezumab ni primeren za uporabo pri otrocih, mlajših od 6 let, za preprečevanje migrene.
The second click tells you that your injection is complete.
Drugi klik pomeni, da je injiciranje končano.
You should not stop using Emgality without speaking to your doctor first.
Zdravila Emgality ne smete prenehati uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
Do not inject within 5 centimeters of the belly button (navel).
Ne injicirajte si v predel 5 centimetrov okrog popka.
It is important not to try to inject yourself until you have been trained by your doctor or nurse.
Pomembno je, da si zdravila ne skušate injicirati sami, dokler vas zdravnik ali medicinska sestra primerno ne usposobi za to.
Doses up to 600 mg have been administered subcutaneously to humans without dose-limiting toxicity.
Ljudem so subkutano dajali odmerke do 600 mg brez toksičnosti, ki bi omejevala velikost odmerka.
Figure 1 Reduction in monthly migraine headache days over time in studies EVOLVE-1 and EVOLVE-2
Zmanjšanje števila dni z migrenskim glavobolom na mesec v časovnem intervalu v študijah EVOLVE-1 in EVOLVE-2
• Another person may give you the injection in the back of your upper arm or buttock.
• Druga oseba vam lahko da injekcijo v hrbtno stran nadlakti ali zadnjico.
96 cases describing hypersensitivity reactions, anaphylactic reactions or angioedema were identified (29 serious, 0 fatal outcomes); 18 cases (14 serious, 4 non-serious) qualified under the anaphylactic reaction SMQ, 40 cases qualified under the angioedema SMQ (narrow) and 36 cases described as rash.
Ugotovljenih je bilo 96 neželenih učinkov, pri katerih so opisovali preobčutljivostne reakcije, anafilaktične reakcije ali angioedem (29 resnih, 0 smrtnih izidov); 18 neželenih učinkov (14 resnih, 4 niso bili resni) je bilo po standardizirani poizvedbi MedDRA (SMQ) razvrščenih med anafilaktične reakcije, 40 neželenih učinkov med angioedem (iskanje po najbližjem izrazu), 36 pa je bilo opisanih kot izpuščaj.
3 Inject
3 Injicirajte
Nonclinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of galcanezumab.
Nekliničnih študij za ovrednotenje kancerogenega ali mutagenega potenciala galkanezumaba niso izvedli.
Some patients have had vertigo whilst using Emgality.
Nekateri bolniki so med uporabo zdravila Emgality imeli vrtoglavico.
No dose adjustment is needed on the basis of age (18 to 65 years), sex, weight, race or ethnicity as there was no clinically meaningful effect of these factors on the apparent clearance or apparent volume of distribution of galcanezumab.
Starost, spol, telesna masa, rasna in etnična pripadnost Na podlagi starosti (od 18 do 65 let), spola, telesne mase in rasne ali etnične pripadnosti ni potrebno prilagajanje odmerka, saj ni bilo klinično pomembnega učinka teh dejavnikov na navidezni očistek ali navidezni volumen porazdelitve galkanezumaba.
However, the presence of anti-drug antibodies did not affect the pharmacokinetics, efficacy, or safety of galcanezumab.
Prisotnost protiteles proti zdravilu ni vplivala na farmakokinetiko, učinkovitost ali varnost galkanezumaba.
Otherwise, you may give or get an infection.
Sicer lahko okužite druge ali pa se okužite sami.
• Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected.
• Počasi potiskajte ploščico za palec, da do konca potisnete bat, in injicirate vse zdravilo.
Galcanezumab may have a minor influence on the ability to drive and use machines.
Galkanezumab ima lahko manjši vpliv na sposobnost vožnje ali upravljanja strojev.
The 2 episodic migraine studies (EVOLVE-1 and EVOLVE-2) enrolled patients who met International Classification of Headache Disorders (ICHD) criteria for a diagnosis of migraine with or without aura with 4-14 migraine headache days per month.
V dve študiji epizodne migrene (EVOLVE-1 in EVOLVE-2) so bili vključeni bolniki, ki so izpolnjevali merila po mednarodni klasifikaciji glavobolov (ICHD - International Classification of Headache Disorders) za diagnozo migrene z avro ali brez nje ter z od 4 do 14 dnevi migrenskega glavobola na mesec.
The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection site pain (10.1 %/11.6 %), injection site reactions (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), constipation (1.0 %/1.5 %), pruritus (0.7 %/1.2 %) and urticaria (0.3 %/0.1 %).
Neželeni učinki zdravila v odmerku 120 mg in 240 mg, o katerih so poročali v kliničnih preskušanjih migrene, so bili bolečina na mestu injiciranja (10,1 %/11,6 %), reakcije na mestu injiciranja (9,9 %/14,5 %), vrtoglavica (0,7 %/1,2 %), obstipacija (1,0 %/1,5 %), pruritus (0,7 %/1,2 %) in urtikarija (0,3 %/0,1 %).
A. After you press the teal injection button, you will hear 2 loud clicks.
O. Po pritisku modro zelenega gumba za injiciranje boste slišali dva glasna klika.
What you need to know before you use Emgality Do not use Emgality:
Kaj morate vedeti, preden boste uporabili zdravilo Emgality Ne uporabljajte zdravila Emgality:
List of adverse reactions in clinical studies and post-marketing reports
Seznam neželenih učinkov v kliničnih študijah in v obdobju po uvedbi zdravila na trg
On the basis of the scientific conclusions for galcanezumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing galcanezumab is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za galkanezumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) galkanezumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
If you have injected more Emgality than you should, e.g. if after the first dose of 240 mg, you have injected it twice in a single month, or if anyone else has accidentally used Emgality, contact your doctor immediately.
Če ste uporabili večji odmerek zdravila Emgality, kot bi smeli Če ste si injicirali večji odmerek zdravila Emgality, kot bi smeli, npr. če ste si ga po prvem odmerku 240 mg injicirali dvakrat v enem mesecu ali če je kdo drug nenamerno uporabil zdravilo Emgality, o tem takoj obvestite zdravnika.
Vertigo may occur following the administration of galcanezumab (see section 4.8).
Po dajanju galkanezumaba se lahko pojavi vrtoglavica (glejte poglavje 4.8).
There are limited data from the use of galcanezumab in pregnant women.
Podatki o uporabi galkanezumaba pri nosečnicah so omejeni.
Similarly, IgG monoclonal antibodies are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence the clearance of galcanezumab.
Podobno velja, da se monoklonska protitelesa IgG večinoma izločajo z znotrajceličnim katabolizmom, zato ni pričakovati, da bi okvara jeter vplivala na očistek galkanezumaba.
Study REGAIN had a 3 month, double-blind, placebo-controlled treatment period followed by a 9 month open-label extension.
Študija REGAIN je obsegala 3-mesečno, dvojno slepo, s placebom nadzorovano obdobje zdravljenja, ki mu je sledilo 9-mesečno odprto podaljšanje.
A patient may self-inject galcanezumab by following the Instructions for Use.
Bolnik si lahko sam injicira galkanezumab po navodilih za uporabo.
Other medicines and Emgality
Druga zdravila in zdravilo Emgality
What Emgality looks like and contents of the pack
Izgled zdravila Emgality in vsebina pakiranja
Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) thus preventing its biological activity.
Galkanezumab je humanizirano monoklonsko protitelo IgG4, ki se veže na peptid, povezan z genom za kalcitonin (CGRP - calcitonin gene-related peptide), s čimer preprečuje njegovo biološko aktivnost.
It is unknown whether galcanezumab is excreted in human milk.
Ni znano, ali se galkanezumab izloča v materino mleko.
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Zdravilo Emgality je indicirano za profilakso migrene pri odraslih, ki imajo vsaj 4 migrenske dni na mesec.
N = number of patients; CI95 % = 95 % confidence interval.
>0,05e n = število bolnikov; IZ95 % = 95-odstotni interval zaupanja aIzide učinkovitosti so vrednotili v času med 1. in 3. mesecem.
• the medicine is cloudy, is discolored, or has small particles
• je zdravilo motno, spremeni barvo ali vsebuje majhne delce;
• Your doctor, pharmacist or nurse can help you decide where on your body to inject your dose.
• Zdravnik, farmacevt ali medicinska sestra vam lahko pomaga pri odločitvi, na katero mesto na vašem telesu si boste injicirali svoj odmerek.
• Do not put the base cap back on - this could damage the needle.
• Pokrovčka podnožja ne nameščajte ponovno nazaj, saj bi s tem lahko poškodovali iglo.
• When you are ready to inject, pull the needle cap off and throw it away in the bin.
• Ko ste pripravljeni za injiciranje, odvijte pokrovček podnožja in ga vrzite v koš za smeti.
Fertility studies in animals do not indicate harmful effects with respect to male and female fertility (see section 5.3).
Študije na živalih ne kažejo škodljivih učinkov na plodnost pri moških in ženskah (glejte poglavje 5.3).
As a precautionary measure, it is preferable to avoid the use of galcanezumab during pregnancy.
Iz previdnosti se je med nosečnostjo bolje izogibati uporabi galkanezumaba.
2 Place and Unlock
2 Namestite in odklenite
Injection site location (abdomen, thigh, buttocks and arm) did not significantly influence the absorption of galcanezumab.
Mesto injiciranja (trebuh, stegno, zadnjica in roka) ni bistveno vplivalo na absorpcijo galkanezumaba.
Based on a population PK analysis, bilirubin concentration or Cockcroft-Gault creatinine clearance (range: 24 to 308 mL/min) did not significantly influence the apparent clearance of galcanezumab.
Na podlagi populacijske farmakokinetične analize koncentracija bilirubina ali očistek kreatinina po CockcroftGaultovi formuli (razpon od 24 do 308 ml/min) nista bistveno vplivala na navidezni očistek galkanezumaba.
The baseline scores of the MIDAS reflected severe migraine related disability of patients in EVOLVE-1 and EVOLVE-2 (mean of 33.1) and a very severely disabled population (mean of 67.2) in REGAIN.
Izhodiščni rezultati vprašalnika MIDAS so pokazali močno z migreno povezano zmanjšano opravilno sposobnost pri bolnikih v študijah EVOLVE-1 in EVOLVE-2 (povprečje 33,1) ter zelo močno zmanjšano opravilno sposobnost populacije (povprečje 67,2) v študiji REGAIN.
How can I tell if my injection is complete?
Kako ugotovim, ali je injiciranje končano?
In all 3 studies, the overall mean change from baseline in number of monthly Migraine Headache Days (MHDs) was the primary efficacy measure.
V vseh treh študijah je bilo primarno merilo učinkovitosti celokupna povprečna sprememba v številu dni migrenskega glavobola (MHD - Migraine Headache Days) na mesec od izhodišča.
• Remove the needle from your skin
• Odstranite iglo s kože.
Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.
Zdravnik, farmacevt ali medicinska sestra vam lahko pomaga izbrati mesto injiciranja, ki je najbolj ustrezno za vas.
After You Inject Your Medicine
Po injiciranju zdravila
Human immunoglobulin (IgG) is known to cross the placental barrier.
Znano je, da humani imunoglobulin (IgG) prehaja skozi placento.
You and your doctor or nurse should decide if you can inject Emgality yourself.
Skupaj z zdravnikom ali medicinsko sestro se boste odločili, ali si lahko zdravilo Emgality injicirate sami.
• If you have vision or hearing problems, do not use the pen without help from a caregiver.
• Če imate težave z vidom ali sluhom, ne uporabljajte injekcijskega peresnika brez pomoči negovalca.
• Remove the needle from your skin and gently let go of your skin.
• Iglo izvlecite iz kože in kožo nežno spustite.
For the MIDAS, higher scores indicate more disability.
Pri vprašalniku MIDAS višji rezultat pomeni bolj zmanjšano opravilno sposobnost.
N = 208 N = 425 N = 226
120 mg 240 mg n = 210 n = 208 n = 425 n=226 n=220 n=450
Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported.
Poročali so resnih preobčutljivostnih reakcijah, vključno s primeri anafilaksije, angioedema in urtikarije.
• Clean and dry the injection site before you inject.
• Pred injiciranjem očistite in osušite injekcijsko mesto.
Figure 2 Reduction in monthly migraine headache days over time in study REGAIN
Zmanjšanje števila dni z migrenskim glavobolom na mesec v časovnem intervalu v študiji REGAIN
In pooled data from studies EVOLVE-1 and EVOLVE-2, more than 19 % of the patients treated with galcanezumab maintained a ≥ 50 % response from Month 1 to Month 6 versus 8 % of the patients on placebo (p < 0.001).
V združenih podatkih iz študij EVOLVE-1 in EVOLVE-2 je več kot 19 % bolnikov, zdravljenih z galkanezumabom, ohranilo ≥ 50odstotni odziv med 1. in 6. mesecem, v primerjavi z 8 % bolnikov, ki so prejemali placebo (p < 0,001).
Studies EVOLVE-1 and EVOLVE-2 had a 6 month, double-blind, placebo-controlled treatment period.
Študiji EVOLVE-1 in EVOLVE-2 sta imeli 6-mesečno, dvojno slepo, s placebom nadzorovano obdobje zdravljenja.
Emgality is given by injection under your skin (subcutaneous injection).
Zdravilo Emgality se daje z injekcijo pod kožo (subkutano injekcijo).
Monthly doses of 120 mg or 240 mg achieved a steady-state Cmax (Cmax, ss) of approximately 28 μg/mL (35 % CV) or 54 μg/mL (31 % CV), respectively.
Po mesečnih odmerkih 120 mg oziroma 240 mg je bila koncentracija Cmax v stanju dinamičnega ravnovesja (Cmax, ss) približno 28 μg/ml (35 % KV) oziroma 54 μg/ml (31 % KV).
Put the original package with any unused syringes back in the refrigerator.
Originalno pakiranje z nerabljenimi injekcijskimi brizgami vrnite v hladilnik.
The active substance is galcanezumab.
Učinkovina je galkanezumab.
Over 72 % of patients completing the study reported a 50 % reduction in MHDs at month 12.
12. mesecu poročalo o 50-odstotnem zmanjšanju števila MHD.
Based on a population pharmacokinetic (PK) analysis, following a loading dose of 240 mg the maximum serum concentration (Cmax) of galcanezumab was approximately 30 μg/mL (27 % coefficient of variation, (CV)) and the time to Cmax was 5 days postdose.
Na podlagi populacijske farmakokinetične analize je bila po polnilnem odmerku 240 mg najvišja koncentracija galkanezumaba v serumu (Cmax) približno 30 μg/ml (27 % koeficient variacije (KV)), čas do Cmax pa je bil 5 dni po odmerku.
Before using your pre-filled syringe:
Pred uporabo napolnjene injekcijske brizge:
Do not take a double dose to make up for forgotten injection If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then inject the next dose after a month from that date.
Če ste si pozabili injicirati odmerek zdravila Emgality, si pozabljeni odmerek injicirajte takoj, kot je mogoče, nato pa si naslednji odmerek injicirajte en mesec od tega datuma.
No dose adjustment is required in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
Pri bolnikih z blago ali zmerno ledvično okvaro ali jetrno okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
- After the first dose, you will use one syringe (120 mg) every month.
- Po prvem odmerku boste vsak mesec uporabili eno injekcijsko brizgo (120 mg).
It may be colourless to slightly yellow.
Raztopina je lahko brezbarvna do rahlo rumena.
Emgality should not be used if the solution is cloudy, discoloured or contains particles, or if any part of the device appears to be damaged.
Zdravila Emgality ne smete uporabiti, če je raztopina motna, obarvana ali vsebuje delce ali če je kateri koli del pripomočka videti poškodovan.
Do not rub the injection site.
Injekcijskega mesta ne drgnite.
Based on a population PK analysis, the apparent volume of distribution of galcanezumab was 7.3 L. Biotransformation
Na podlagi populacijske farmakokinetične analize je bil navidezni volumen porazdelitve galkanezumaba 7,3 l. Biotransformacija
Galcanezumab is to be injected subcutaneously in the abdomen, thigh, back of the upper arm, or in the gluteal region.
Galkanezumab je treba injicirati subkutano v trebuh, stegno, hrbtni del nadlakti ali v glutealni predel.
Lock/Unlock Symbols
Simbola za zaklepanje/ odklepanje
As a humanised IgG4 monoclonal antibody, galcanezumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Ker je galkanezumab humanizirano monoklonsko protitelo IgG4, je pričakovati, da se bo po katabolnih poteh enako kot endogeni IgG razgradil v majhne peptide in aminokisline.
If you forget to use Emgality
Če ste pozabili uporabiti zdravilo Emgality
Q. What if the needle did not retract after my injection?
V. Kaj naj storim, če se igla po injiciranju ne umakne?
If these conditions are exceeded, the pre-filled syringe must be discarded.
Če te pogoje presežete, morate napolnjeno injekcijsko brizgo zavreči.
How to store Emgality 6.
Shranjevanje zdravila Emgality 6.
Completion rate of the double-blind treatment phase for patients who received galcanezumab ranged from 82.8 % to 87.7 %.
Dvojno slepo fazo zdravljenja je zaključilo od 82,8 % do 87,7 % bolnikov, ki so prejemali galkanezumab.
Make sure a sharps disposal container is close by.
Prepričajte se, da imate vsebnik za ostre odpadke v bližini.
What if I see air bubbles in my Emgality syringe?
Kaj moram narediti, če v svoji injekcijski brizgi Emgality opazim zračne mehurčke?
Q. How can I tell if my injection is complete?
V. Kako ugotovim, ali je injiciranje končano?
• Each syringe is for ONE-TIME USE ONLY.
• Vsaka injekcijska brizga je namenjena LE ZA ENKRATNO UPORABO.
The cumulative review of the data, taking into account pharmacological plausibility, temporal association to treatment and a general lack of confounding factors, concluded that anaphylaxis, angioedema, and rash should be added as new adverse drug reactions in the SmPC and package leaflet of galcanezumab.
Z upoštevanjem farmakološke verjetnosti, časovne povezave z zdravljenjem in splošne odsotnosti drugih možnih vzročnih dejavnikov je bil po kumulativnem pregledu podatkov sprejet zaključek, da je treba anafilaksijo, angioedem in izpuščaj dodati v povzetek glavnih značilnosti zdravila in navodilo za uporabo galkanezumaba kot nove neželene učinke.
Make sure the pen is locked.
Prepričajte se, da je injekcijski peresnik zaklenjen.