natgillin/translations-raw huggingface dataset:
Do not inject into a muscle.
Ne injicirajte v mišico.
22) Carefully choose where you want to inject Myalepta.
22) Previdno izberite mesto, kjer želite injicirati zdravilo Myalepta.
Signs of an allergic reaction can be seen in section 4 under “Allergic reactions”.
Znaki alergijske reakcije so našteti v 4. poglavju pod "Alergijske reakcije".
Always use a new syringe.
Vedno uporabite novo brizgo.
Take your time to carefully prepare and inject your medicine, which when including the period of the vial warming up after being taken out of the fridge, can be approximately 20 minutes in total.
Vzemite si čas in previdno pripravite in si injicirajte svoje zdravilo, kar lahko, vključno z obdobjem segrevanja viale po tem, ko jo vzamete iz hladilnika, traja približno 20 minut.
• Do not use the syringes more than once.
• Brizg ne uporabite več kot enkrat.
Discontinuation in patients at risk for pancreatitis
Prekinitev pri bolnikih s tveganjem za pankreatitis
• you are allergic to metreleptin or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na metreleptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Your doctor will decide if you should stop using this medicine.
Zdravnik se bo odločil, ali morate prenehati z jemanjem tega zdravila.
Most of these patients (13 of 16) were able to stop insulin use within the first year of metreleptin.
Večina teh bolnikov (13 od 16) je lahko prenehala uporabljati insulin v prvem letu jemanja metreleptina.
There are additional education training information and videos to help you understand how to use Myalepta correctly.
Na voljo so dodatne informacije za usposabljanje in video posnetki, ki vam pomagajo razumeti, kako pravilno uporabljati zdravilo Myalepta.
25) With the other hand, hold the syringe like a pencil.
25) Z drugo roko primite brizgo kot svinčnik.
• If you weigh 40 kg or less:
• Če tehtate 40 kg ali manj:
In general, dose selection and modification for an elderly patient should be cautious, although no specific dose adjustment is recommended.
Na splošno je treba biti pri izboru odmerka in prilagoditvi slednjega pri starejših bolnikih previden, čeprav posebna prilagoditev odmerka ni priporočena.
Influenza, Pneumonia
Gripa, pljučnica
In one post-marketing case, an infant was exposed to a 10-fold overdose of metreleptin for 8 months.
V enem primeru po prihodu zdravila na trg je bil dojenček 8 mesecev izpostavljen 10-kratnemu prevelikemu odmerku metreleptina.
• you have ever had problems with your blood (such as a low blood count)
• če ste kadar koli imeli težave s svojo krvjo (kot je nizko število krvnih celic);
Also some other medicines can affect the way this medicine works.
Prav tako lahko druga zdravila vplivajo na delovanje tega.
• very fast heartbeat
• zelo hiter srčni utrip
The most frequently occurring adverse reactions from the clinical studies were hypoglycaemia (14%) and weight decreased (17%).
Najpogostejša negativna učinka, ki sta se pojavila v kliničnih študijah, sta bila hipoglikemija (14 %) in izguba telesne teže (17 %).
• The glass ampoule should be at a 45 degree angle to the ground.
• Steklena ampula mora biti pod kotom 45 stopinj glede na tla.
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe:
Gradually reducing your dose, and following a reduced fat diet may help to prevent this.
Postopno zmanjšanje odmerka in upoštevanje diete z nizko vsebnostjo maščob pomaga to preprečiti.
Pack sizes of 1 or 30 vials.
Velikosti pakiranja 1 ali 30 vial.
It is used in adults, adolescents and children 2 years or over:
Uporablja se pri odraslih, mladostnikih in otrocih, starih 2 leti ali več:
• Women who could get pregnant should use effective contraception, including non-hormonal methods such as condoms, while using Myalepta.
• Ženske, ki bi lahko zanosile, morajo med jemanjem zdravila Myalepta uporabljati učinkovito kontracepcijo, vključno z nehormonskimi metodami, kot so kondomi.
The medicinal product was administered subcutaneously either once daily or twice daily (in two equal doses).
Zdravilo so dajali subkutano enkrat ali dvakrat dnevno (v dveh enakih odmerkih).
Hypoglycaemia, deemed as related to metreleptin treatment, occurred in 14.2% of patients studied.
Hipoglikemija, ki se smatra kot povezana z zdravljenjem z metreleptinom, se je pojavila pri 14,2 % bolnikov v študiji.
Mean change among the 5 patients < 6 years of age was 0.2%.
Povprečna sprememba pri 5 bolnikih < 6 let je bila 0,2 %.
• Do not try to prepare the medicine or inject yourself if you have not been trained.
• Zdravila ne poskušajte pripraviti ali injicirati sami, če niste bili ustrezno poučeni, kako to narediti.
The effect of metreleptin on CYP450 enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted.
Učinek metreleptina na encime CYP450 je lahko klinično relevanten za substrate CYP450 z ozkim terapevtskim indeksom, kjer se odmerek prilagaja individualno.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE Z ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
• feeling very thirsty or hungry
• močan občutek žeje ali lakote
You might feel dizzy or tired when using this medicine.
Med uporabo tega zdravila ste lahko omotični ali se počutite utrujeno.
• Inject all of the medicine.
• Injicirajte vso zdravilo.
28) Remove the syringe from the skin.
28) Odmaknite brizgo od kože.
Use new syringes each time.
Vsakič uporabite novo brizgo.
• Sometimes, large spaces of air (air pockets) get caught inside the syringe.
• Včasih se v brizgo ujame velik prostor zraka (zračni žep).
• feeling more hungry than normal
• večji občutek lakote kot običajno
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
24) To inject under the skin, pinch the skin with one hand where you are going to inject.
24) Da si zdravilo injicirate pod kožo, jo z eno roko nagubajte (uščipnite) na mestu, kjer želite injicirati.
Your doctor will also ask you to follow a reduced fat diet.
Zdravnik vam bo prav tako predpisal dieto z nizko vsebnostjo maščob.
Actual amount of solution*
Dejanski volumen raztopine*
What you need to know before you use Myalepta 3.
Kaj morate vedeti, preden boste uporabili zdravilo Myalepta 3.
23) Clean the area where you will inject yourself with a clean alcohol swab and let the skin dry.
23) Mesto injiciranja očistite s čistim alkoholnim robčkom in pustite, da se koža posuši.
Very common (may affect more than 1 in 10 people): • weight loss
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): • izguba telesne mase
Prolonged gestation resulted in the death of some females during parturition and lower survival of offspring within the immediate postnatal period.
Daljša gestacija je vodila do smrti nekaterih samic med porodom in manjše stopnje preživetja mladičev takoj po porodu.
Dose decreases based on weight loss may be made weekly.
Zmanjšanje odmerka zaradi izgube telesne teže je možno enkrat tedensko.
Your doctor will change your dose of insulin or other medicines if needed.
Po potrebi bo spremenil odmerek insulina ali drugih zdravil.
Never use remaining water for injection left over from a previous day's preparation of Myalepta solution.
Nikoli ne uporabite vode za injekcije, ki je ostala od priprave raztopine zdravila Myalepta iz preteklega dne.
If you want to use the same area of the body for each injection, do not use the same spot that you used for your last injection.
Če želite za vsako injekcije uporabiti isti del na telesu, pazite, da ne injicirate na isto točko kot prejšnjič.
• You must remove an air pocket and air bubbles from the syringe to make sure you get the correct amount of sterile water in the syringe.
• Odstraniti morate zračni žep in zračne mehurčke iz brizge, da dobite pravilno količino sterilne vode v brizgo.
Leptin is a cytokine and has the potential to alter the formation of cytochrome P450 (CYP450) enzymes.
Leptin je citokin in lahko spremeni tvorbo encimov citokroma P450 (CYP450).
o Your pharmacist will give you the correct syringe for injecting.
o Farmacevt vam bo dal pravilno brizgo za injiciranje.
13) Hold the vial at 45 degree angle to the table and slowly push the plunger all the way down with your thumb.
13) Vialo držite pod kotom 45 stopinj na mizo in bat s palcem počasi potisnite čisto navzdol.
Multiple dosing regimens were explored during the NIH study, which led to the posology recommended in section 4.2.
Med študijo NIH je bilo preizkušenih več režimov odmerjanja, kar je vodilo do odmerjanja, priporočenega v poglavju 4.2.
Draft protocol to be submitted 6 months after notification of the European Commission decision
Osnutek protokola je treba predložiti 6 mesecev po objavi sklepa Evropske komisije.
*Metreleptin is a recombinant human leptin analogue (produced in Escherichia coli cells by recombinant DNA technology to form recombinant methionyl-human leptin).
*Metreleptin je rekombinantni analog humanega leptina (proizvaja se v celicah Escherichia coli z tehnologijo rekombinantne DNK, pri čemer se tvori rekombinantni humani-metionil leptin).
26) Gently insert the needle into the skin at approximately a 45 degree angle to the body.
26) Nežno vstavite iglo v kožo pod kotom približno 45 stopinj na telo.
See steps 6-8 below on removal of air pockets and air bubbles from the syringe.
Glejte korake 6 do 8 spodaj za odstranitev zračnih žepov in zračnih mehurčkov iz brizge.
Since it cannot be excluded that metreleptin may reduce exposure to substrates of CYP3A through enzyme induction, the efficacy of hormonal contraceptives may be reduced if co-administered with metreleptin.
Ker ni mogoče izključiti, da lahko metreleptin zmanjša izpostavljenost substratom CYP3A z indukcijo encima, se lahko učinkovitost hormonskih kontraceptivov zmanjša, če se uporabljajo sočasno z metreleptinom.
Some medicines need to be monitored while you are using Myalepta since the dose of these medicines might need to be changed.
Nekatera zdravila je treba med uporabo zdravila Myalepta spremljati, saj je morda treba odmerek teh zdravil spremeniti.
Visually inspect the vial containing the medicinal product.
Vizualno preglejte vialo z zdravilom.
People with lipodystrophy can get a type of blood cancer called lymphoma, whether or not they are using Myalepta.
Ljudje z lipodistrofijo lahko zbolijo za vrsto krvnega raka, ki se imenuje limfom, ne glede na to, ali uporabljajo zdravilo Myalepta ali ne.
• If you see an air pocket or any air bubbles, follow the same instructions described in step 7 to remove the air from the syringe.
• Če vidite zračni žep ali zračne mehurčke, sledite istim navodilom, kot so opisana v 7. koraku,
Your doctor may decide that you inject yourself.
Zdravnik se lahko odloči, da si boste zdravilo injicirali sami.
Reductions in HbA1c and TG may not be seen in children as metabolic abnormalities may not be present at the start of treatment.
Zmanjšanja HbA1c in TG morda pri otrocih ne bodo opazna, saj presnovne nepravilnosti ob začetku zdravljenja morda še niso prisotne.
Injection site reactions were reported in 3.4% of patients with LD treated with metreleptin.
Reakcije na mestu injiciranja so bile poročane pri 3,4 % bolnikov, pri katerih so LD zdravili z metreleptinom.
• medicines which suppress the immune system (such as cyclosporine)
• zdravila, ki zavirajo imunski sistem (kot je ciklosporin);
8) Check the amount of water for injection
8) Preverite količino vode za injekcije.
Important: Myalepta must be injected under the skin (‘subcutaneous').
Pomembno: Zdravilo Myalepta je treba injicirati pod kožo ("subkutano").
Your dose of Myalepta may change over time depending on how this medicine works for you.
Vaš odmerek zdravila Myalepta se lahko s časom spremeni glede na to, kako to zdravilo pri vas deluje.
• or partial lipodystrophy has been caused by your body's response to something such as a viral illness (also called acquired lipodystrophy)
• ali s parcialno lipodistrofijo, nastalo zaradi odziva lastnega telesa na nekaj, npr. na virusno obolenje (imenovana tudi pridobljena lipodistrofija).
Myalepta is available in packs containing 1 or 30 vials.
Zdravilo Myalepta je na voljo v pakiranjih po 1 ali 30 vial.
• you have ever had inflammation of an organ called the pancreas (‘pancreatitis')
• če ste kadar koli imeli vnetje organa, ki se imenuje trebušna slinavka ("pankreatitis").
• Do not use a double dose to make up for a forgotten dose.
• Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
Clinical trials of metreleptin did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.
Pri kliničnih študijah metreleptina ni sodelovalo dovolj bolnikov, starejših od 65 let, da bi bilo mogoče določiti, ali se na učinkovino odzivajo drugače od mlajših.
All patients had a history of pancreatitis and hypertriglyceridaemia.
Vsi bolniki so imeli anamnezo pankreatitisa in hipertrigliceridemijo.
In order to avoid medication errors including overdose, dose calculation and dose adjustment guidelines below should be followed.
V izogib napakam pri dajanju zdravila, vključno s prekomernim odmerjanjem, je treba upoštevati spodnji izračun za odmerek ter smernice za prilagajanje odmerka.
• The needle is short in length, and all of the needle should go into the skin at a 45 degree angle.
• Igla je kratka in celotno iglo je treba vstaviti v kožo pod kotom 45 stopinj.
In clinical studies, hypoglycaemia has been managed with food/drink intake and by modifying the dose of anti-diabetic medicinal product.
V kliničnih študijah so hipoglikemijo obvladali z zaužitjem hrane/pijače in s prilagajanjem odmerka antidiabetikov.
Anaphylactic reactions may follow immediately after administration of the medicine.
Anafilaktične reakcije se lahko pojavijo takoj po uporabi zdravila.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Your doctor will monitor you for side effects.
Zdravnik vas bo spremljal glede neželenih učinkov.
Though not confirmed in clinical trials, neutralising antibodies could in theory affect the activity of endogenous leptin.
Četudi s kliničnimi študijami to ni bilo potrjeno, bi nevtralizirajoča protitelesa teoretično lahko vplivala na aktivnost endogenega leptina.
Inflamed pancreas (‘pancreatitis'):
Vnetje trebušne slinavke ("pankreatitis"):
Due to the number of patients with generalised and partial LD treated in clinical trials, it is not possible to detect with certainty, events which occur at a frequency of < 1%.
LD, ki so se zdravili v kliničnih študijah, ni mogoče z gotovostjo zaznati dogodkov, ki se pojavljajo s pogostostjo < 1 %.
These events included 1 episode in 1 patient of serious and severe appendicitis, 2 episodes in patients of serious and severe pneumonia, a single episode of serious and severe sepsis and non-serious severe gingivitis in 1 patient and 6 episodes of serious and severe sepsis or bacteraemia and 1 episode of non-serious severe ear infection in 1 patient.
Ti dogodki so vključevali 1 epizodo resnega in hudega vnetja slepiča pri 1 bolniku, 2 epizodi resne in hude pljučnice, eno epizodo resne in hude sepse in ne-resnega hudega gingivitisa pri 1 bolniku, 6 dogodkov resne in hude sepse ali bakteremije ter 1 dogodek ne-resnega hudega vnetja ušesa pri 1 bolniku.
Signs of high fat
Znaki visokih ravni maščob
When dividing doses due to volume, doses can be administered one after the other at different injection sites.
Kadar zaradi količine razdelite odmerke, ju lahko injicirate enega za drugim na različnih mestih injiciranja.
Generally the majority of events could be managed by food intake with only relatively few modifications of anti-diabetic medicinal product dose occurring.
Večino dogodkov je bilo mogoče obvladati z zaužitjem hrane, le v relativno malo primerih je prišlo do sprememb pri odmerjanju antidiabetikov.
High blood sugar and fat levels
Visok krvni sladkor in ravni maščob
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and supportive treatment initiated.
V primeru prevelikega odmerjanja je treba bolnike pozorno spremljati glede znakov ali simptomov neželenih učinkov ter uvesti podporno zdravljenje.
The injection should be administered at the same time every day.
Zdravilo je treba injicirati vsak dan ob isti uri.
Using the glass vial or plastic ampoule
Uporaba steklene viale ali plastične ampule
• with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above
• s potrjeno prirojeno generalizirano lipodistrofijo (LD) (Berardinelli-Seipov sindrom) ali pridobljeno generalizirano LD (Lawrenceov sindrom) pri odraslih in otrocih, starih 2 leti ali več;
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Myalepta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Myalepta , pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
This card will also include pictures of the relevant syringe sizes on which the doctor can draw a line to indicate on the volume of water for injection to use for reconstitution and the volume of reconstituted solution to inject.
Ta kartica vsebuje tudi slike brizg ustreznih velikosti, na katerih lahko zdravnik nariše črto, ki označuje prostornino vode za injiciranje, ki je potrebna za rekonstitucijo, in prostornino rekonstituirane raztopine, ki jo je treba injicirati.
Two-year carcinogenicity studies in rodents have not been conducted.
Dvoletnih študije kancerogenosti pri glodavcih niso izvedli.
The maximum tolerated dose may be less than the maximum daily dose, outlined in Table 1, as evidenced by excessive weight loss, even if metabolic response is incomplete.
Največji toleriran odmerek je lahko manjši od največjega dnevnega odmerka, navedenega v Preglednica 1, če prihaja do prekomerne izgube telesne teže, četudi metabolni odziv ni popoln.
• Metreleptin is similar to a human hormone called leptin.
• Metreleptin je podoben humanemu hormonu leptinu.
Based on clinical response (e.g. inadequate metabolic control) or other consideration (e.g. tolerability issues, excessive weight loss especially in paediatric patients), the dose may be decreased, or increased to the maximum dose listed in Table 1.
Na osnovi kliničnega odziva (npr. neustrezen nadzor presnove) ali drugih dejavnikov (npr. težave z intoleranco, prekomerna izguba telesne mase, predvsem pri pediatričnih bolnikih) je mogoče odmerek zmanjšati ali povečati do največjega odmerka, navedenega v Preglednica 1.
For instructions on administration, see section 4.2.
Za navodila o dajanju zdravila glejte poglavje 4.2.
• medicines for sleep or anxiety called ‘benzodiazepines'
• zdravila za spanje ali proti anksioznosti, imenovana "benzodiazepini".
Talk to a doctor straight away if you notice any allergic reactions, including:
Takoj se posvetujte z zdravnikom, če opazite katere koli alergijske reakcije, vključno z naslednjimi:
In clinical trials, antidrug antibodies (ADA) to metreleptin occurred very commonly (88%) in patients.
V kliničnih študijah so se protitelesa proti zdravilu (ADA - antidrug antibodies) na metreleptin pri bolnikih pojavila zelo pogosto (88 %).
The glass ampoule is a sealed container.
Steklena ampula je zatesnjen vsebnik.
Prior to launch of Myalepta in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila Myalepta na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in drugimi vidiki programa.
- HCPs should provide training to patients on the correct technique.
- Zdravstveni delavci morajo bolnike usposobiti za uporabo pravilne tehnike.
• with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
• s potrjeno familiarno parcialno LD ali pridobljeno parcialno LD (Barraquer-Simonsov sindrom)pri odraslih in otrocih, starih 12 let ali več, za katere standardno zdravljenje ni doseglo zadostne urejenosti presnove.
You and your doctor will decide whether or not to continue breast-feeding while using this medicine.
Skupaj z zdravnikom se boste odločili, ali boste med jemanjem tega zdravila nadaljevali z dojenjem ali ne.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Increasing abnormalities of TG and HbA1c may be seen which may require a dose increase.
Zaradi morebitnih opaženih nepravilnosti v TG in HBA1c bo morda treba povečati odmerek.
If clinical response is not seen after 6 months of treatment the physician should ensure that the patient is compliant with the administration technique, is receiving the correct dose and is adherent to diet.
Če po 6 mesecih zdravljenja klinični odziv ni opazen, se mora zdravnik prepričati, ali bolnik pravilno izvaja tehniko injiciranja in ali prejema pravilni odmerek ter upošteva dieto.
If you notice any of the symptoms referred to above and described further in section 4 of this leaflet, or you are not sure, talk to your doctor straight away.
Če opazite katere od simptomov, navedene zgoraj ali opisane v nadaljevanju v 4. poglavju tega navodila, oz. niste prepričani, se takoj posvetujte z zdravnikom.
The MAH shall ensure that in each Member State where Myalepta is marketed, all healthcare professionals and patients/carers who are expected to use Myalepta are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Myalepta trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo to zdravilo uporabljali, prejeli naslednji paket izobraževalnih gradiv:
• who have partial lipodystrophy which is inherited (also called congenital or familial lipodystrophy)
• s parcialno lipodistrofijo, ki je podedovana (imenovana tudi prirojena ali družinska lipodistrofija);
● Fasting TG concentration > 2.26 mmol/L or postprandially elevated triglycerides
● koncentracija TG na tešče > 2,26 mmol/L ali povišana raven trigliceridov po jedi
• your body producing antibodies to metreleptin which may increase the risk of developing serious or severe infections.
• vaše telo proizvaja protitelesa na metreleptin, zaradi česar lahko obstaja povečano tveganje pojava resnih ali hudih okužb.
In partial LD patients, assessment across age groups is limited, due to the small sample size.
Pri bolnikih s parcialno LD je zaradi majhne velikosti vzorca ocena po starostnih skupinah omejena.