natgillin/translations-raw huggingface dataset:
Infusion related reaction c a Common = Reported in ≥ 1 patient receiving KANUMA b Reported at the same frequency in patients receiving KANUMA or placebo or more frequently in patients receiving placebo during the double-blind period of LAL-CL02
O njih so v dvojno slepem obdobju študije LAL-CL02 poročali z enako pogostnostjo pri bolnikih, ki so dobivali zdravilo KANUMA ali placebo, ali pogosteje pri bolnikih, ki so dobivali placebo c
a. The number of vials to be diluted for infusion should be determined based on the patient's weight and prescribed dose.
a. Na podlagi bolnikove telesne mase in predpisanega odmerka je treba določiti število vial, ki jih je treba razredčiti za infundiranje.
Non-interventional post-authorisation safety study (PASS): LAL Deficiency Registry: Non-interventional, multicentre, prospective disease and clinical outcome registry of patients with Lysosomal Acid Lipase Deficiency to further understand the disease, its progression and any associated complication, and to evaluate the long-term efficacy (normalisation of hepatic function) and safety
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Register o pomanjkanju LAL: Neintervencijski, multicentrični, bodoči register bolezni in kliničnih izidov pri bolnikih s pomanjkanjem lizozomalne kisle lipaze za nadaljnje razumevanje bolezni, njenega napredovanja in vseh morebitnih zapletov, ter za ocenjevanje dolgoročne učinkovitosti (normalizacija delovanja jeter) in varnosti zdravila Kanuma (zlasti glede preobčutljivostnih reakcij, vključno z anafilaksijo, in razvoja protiteles protui zdravilu, ki potencialno vplivajo na odziva na zdravilo) v skladno z dogovorjenim protokolom.
Sebelipase alfa catalyses the lysosomal hydrolysis of cholesteryl esters and triglycerides to free cholesterol, glycerol and free fatty acids.
Sebelipaza alfa katalizira lizosomsko hidrolizo holesterolnih estrov in trigliceridov v prosti holesterol, glicerol in proste maščobne kisline.
In LAL-CL02, 5 of 35 evaluable children and adults (14%) who were administered KANUMA during the 20-week double-blind period of the study developed ADA.
V študiji LAL-CL02 se je pri 5 od 35 otrok in odraslih, ki jih je bilo možno oceniti (14%) in so v 20-tedenskem dvojno slepem obdobju študije dobivali zdravilo KANUMA, razvila ADA.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity in rats and monkeys, or fertility, embryo-foetal and peri- and postnatal development in rats and rabbits.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih pri podganah in opicah ali plodnosti ter embrio-fetalnega in peri- in postnatalnega razvoja pri podganah in kuncih ne kažejo posebnega tveganja za človeka.
Other medicines and KANUMA Tell your doctor if you or your child are using, have recently used or might use any other medicines.
Obvestite zdravnika, če vi sami oziroma vaš otrok jemljeta, sta pred kratkim jemala ali pa bosta morda začela jemati katero koli drugo zdravilo.
Primary Endpoint Normalisation of ALT
Primarni opazovani dogodek Normalizacija vrednosti ALT
There is a lack of data in patients with renal impairment.
Podatki za bolnike z okvaro ledvic so pomanjkljivi.
For diluted solutions, immediate use is recommended.
Priporoča se, da razredčeno raztopino takoj uporabite.
Table 1: Adverse reactions reported in infants c receiving KANUMA
Preglednica 1: Neželeni učinki, o katerih so poročali pri dojenčkih c, ki so prejemali zdravilo
Three patients of 106 (3%) patients treated with KANUMA, including 1 of 14 (7%) infants and 2 of 92 (2%) children and adults, in clinical studies experienced signs and symptoms consistent with anaphylaxis.
Pri treh bolnikih od 106 (3%) bolnikov, zdravljenih z zdravilom KANUMA v kliničnih študijah, vključno pri 1 od 14 (7 %) dojenčkov in 2 od 92 (2 %) otrok ter odraslih, so se pojavili znaki in simptomi, skladni z anafilakso.
Two patients were determined to be positive for antibodies that inhibit in vitro enzyme activity and cellular uptake of the enzyme.
Pri dveh bolnikih se je ugotovilo, da sta pozitivna na protitelesa, ki in vitro zavirajo aktivnost encima in celični privzem encima.
Very common Diarrhoea, gastro-oesophageal reflux disease, retching, vomiting b
Bolezni prebavil zelo pogosti driska, gastro-ezofagealna refluksna bolezen, spahovanje, bruhanje b
Animal studies show no evidence of impaired fertility (see section 5.3).
Študije na živalih niso pokazale vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca biološke zdravilne učinkovine (učinkovin)
P-values are from Fisher's exact test for normalisation endpoints and Wilcoxon rank-sum test for all other endpoints.
d Vrednosti P so iz Fisherjevega testa natančnosti za opazovane dogodke normalizacije in
How KANUMA works
Kako deluje zdravilo KANUMA
How KANUMA is given
Kako se daje zdravilo KANUMA
There is a lack of data in patients with severe hepatic impairment.
Podatki za bolnike s hudo okvaro jeter so pomanjkljivi.
Deficient LAL enzyme activity results in the lysosomal accumulation of cholesteryl esters and triglycerides.
Pomanjkanje encima LAL povzroči lizosomsko kopičenje holesterolnih estrov in trigliceridov.
LDL-cholesterol, mean % change from baseline non-HDL-cholesterol, mean % change from baseline Normalisation of AST
Sekundarni opazovani dogodki LDL-holesterol, povprečna sprememba v % od izhodišča ne-HDL-holesterol, povprečna sprememba v % od izhodišča
Common side effects reported in children and adolescents (4 to 18 years old) and adults are: severe allergic reaction (anaphylactic reaction)
Pogosti neželeni učinki, o katerih so poročali pri otrocih in mladostnikih (starih od 4 do 18 let) in odraslih, so:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KANUMA 2 mg/ml sterile concentrate sebelipase alfa
IME ZDRAVILA IN POT(I) UPORABE KANUMA 2 mg/ml sterilni koncentrat sebelipasum alfa i.v.
If you or your child gets any side effects, talk to your doctor.
Če pri sebi ali svojem otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
Infants presenting with LAL deficiency
Dojenčki s pomanjkanjem LAL
Therefore, appropriate medical support must be readily available when sebelipase alfa is administered.
Zato mora biti pri dajanju sebelipaze alfa takoj na voljo ustrezna zdravstvena oskrba.
Hyperaemia e, hypotension
Žilne bolezni pogosti hiperemija e, hipotenzija
It is a solution that is clear to slightly opalescent, and colourless to slightly coloured.
Raztopina je bistra do nekoliko motna in brezbarvna do nekoliko obarvana.
Trisodium citrate dihydrate Citric acid monohydrate Human serum albumin Water for injections
6.1 Seznam pomožnih snovi trinatrijev citrat dihidrat citronska kislina monohidrat humani serumski albumin voda za injekcije
There is limited information of sebelipase alfa pharmacokinetics in non-Caucasian ethnic groups.
Informacije o farmakokinetiki sebelipaze alfa so pri drugih etničnih skupinah, razen pri belcih, omejene.
ADA titres decreased to undetectable levels during continued treatment in all patients.
Pri vseh bolnikih so se titri ADA z nadaljevanjem zdravljenja zmanjšali do nezaznavnih ravni.
METHOD OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK UPORABE Pred uporabo preberite navodilo za uporabo!
Administration of KANUMA to infants with confirmed multiple-organ failure should be at the discretion of the treating physician.
Dajanje zdravila Kanuma dojenčkom (starim < 6 mesecev) s potrjeno odpovedjo več organov je dovoljeno po presoji lečečega zdravnika.
Signs and symptoms included chest discomfort, conjunctival injection, dyspnoea, generalised and itchy rash, hyperaemia, mild eyelid oedema, rhinorrhoea, severe respiratory distress, tachycardia, tachypnoea and urticaria.
Znaki in simptomi so vključevali nelagodje v prsnem košu, pordelost očesne veznice, dispnejo, generaliziran in srbeč izpuščaj, hiperemijo, blag edem veke, rinorejo, resno dihalno stisko, tahikardijo, tahipnejo in urtikarijo.
e. Up to 10 ml of solution should be slowly withdrawn from each vial and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion.
e. Iz vsake viale je treba počasi vsrkati do 10 ml raztopine in jo razredčiti z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za infundiranje.
Reported in ≥ 2 patients receiving KANUMA
O njih so poročali pri ≥ 2 bolnikih, ki sta dobivala zdravilo KANUMA
KANUMA contains the active substance sebelipase alfa.
Zdravilo KANUMA vsebuje zdravilno učinkovino sebelipaza alfa.
There is limited information on the impact of anti-drug antibodies on sebelipase alfa pharmacokinetics.
Informacije o vplivu protiteles proti zdravilu na farmakokinetiko sebelipaze so omejene.
d. Do not use if the solution is cloudy, or if foreign particulate matter is present.
d. Ne uporabite raztopine, ki je motna ali v kateri plavajo delci.
≥ 18 years old N=18 Week 0 Week 22* Week 0 Week 22* Week 0 Week 22* AUCss (ng∙hr/mL) 1133.8 941.6 1436.4 1453.6 1989.3 1861.0 Cmax (ng/mL) Tmax (hr) CL (L/hr) Vc (L) T1/2 (hr) * Week 22 for placebo patients reset to Week 0, i.e. first week of active treatment.
≥ 18 let starosti n=18 0. teden 22. teden* 0. teden 22. teden* 0. teden 22. teden*
Each vial contains 20 mg of sebelipase alfa in 10 ml (2 mg/ml).
Vsaka viala vsebuje 20 mg sebelipaze alfa (2 mg/ml).
KANUMA 2 mg/ml concentrate for solution for infusion sebelipase alfa
KANUMA 2 mg/ml koncentrat za raztopino za infundiranje sebelipaza alfa (sebelipasum alfa)
Very common Hypotonia
Bolezni živčevja zelo pogosti hipotonija
Diarrhoea b,e
Bolezni prebavil pogosti driska b,e
What KANUMA contains
Kaj vsebuje zdravilo KANUMA
Very common Hypertension, pallor b
Žilne bolezni zelo pogosti hipertenzija, bledica b
MedDRA System organ class
KANUMA Organski sistem po MedDRA
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih pogosti reakcije, povezane z infundiranjem c a
Very common Tachycardia b
Srčne bolezni zelo pogosti tahikardija b
No patients developed antibodies that inhibited in vitro enzyme activity and one patient developed antibodies that inhibited cellular uptake of the enzyme in vitro.
Pri nobenem bolniku se niso razvila protitelesa, ki in vitro zavirajo aktivnost encima.
A 1-hour infusion may be considered after patient tolerability is established.
Ko se ugotovi, da bolnik zdravilo prenaša, se lahko razmisli o 1-urni infuziji.
The recommended dose in children and adults who do not present with rapidly progressive LAL deficiency prior to 6 months of age is 1 mg/kg administered as an intravenous infusion once every other week.
Priporočeni odmerek za otroke in odrasle s pomanjkanjem LAL je 1 mg/kg dan v obliki intravenske infuzije enkrat vsak drugi teden.
Urticaria, rashc,e (including rash papular and rash pruritic), prurituse, eczema e
(vključno s papularnim in pruritičnim izpuščajem), pruritus e, ekcem e
KANUMA 2 mg/ml concentrate for solution for infusion
KANUMA 2 mg/ml koncentrat za raztopino za infundiranje
KANUMA contains sodium
Zdravilo KANUMA vsebuje natrij
Very common Respiratory distress, wheezing, cough, rhinitis, nasal congestion, sneezing
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti dihalna stiska, zasoplost, kašelj, rinitis, zamašen nos, kihanje
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg sebelipase alfa in 10 ml of solution (2 mg/ml)
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 20 mg sebelipaze alfa v 10 ml raztopine (2 mg/ml)
See Table 5 for recommended total infusion volumes by weight range.
Za priporočeno skupno količino za infundiranje glede na razpon telesne mase glejte preglednico 5.
Transient hypercholesterolaemia, transient hypertriglyceridaemia
Presnovne in prehranske motnje pogosti prehodna hiperholesterolemija, prehodna hipertrigliceridemija
Nervous system disorders
Bolezni živčevja pogosti omotica
No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of sebelipase alfa.
Na podlagi trenutnega znanja o farmakokinetiki in farmakodinamiki sebelipaze alfa prilagajanje odmerkov pri bolnikih z okvaro ledvic ali jeter ni potrebno.
Trisodium citrate dihydrate (see leaflet for further information) Citric acid monohydrate
Pomožne snovi: trinatrijev citrat dihidrat (glejte navodilo za uporabo za več informacij) citronska kislina monohidrat humani serumski albumin voda za injekcije
Menorrhagia
Imunogenost
Obligation to conduct post-authorisation measures The MAH shall complete, the measures described below:
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
How to store KANUMA
Shranjevanje zdravila KANUMA
Table 2: Adverse reactions reported in children and adultsd receiving KANUMA MedDRA System organ class
Starost ob prvem odmerku: 1 do 6 mesecev Preglednica 2: Neželeni učinki, o katerih so poročali pri otrocih in odraslih d, ki so prejemali zdravilo KANUMA Organski sistem po MedDRA
See Table 1 for recommended total infusion volumes by weight range.
Za priporočeno skupno količino za infundiranje glede na razpon telesne mase glejte preglednico 1.
Age at first dose: 4 to 58 years e
Starost ob prvem odmerku: 4 do 58 let e O njih so poročali pri ≥ 2 bolnikih, ki sta dobivala zdravilo KANUMA
Dose adjustments may be considered based on how well you or your child responds to treatment.
Glede na vaš oziroma otrokov odziv na zdravljenje se lahko razmisli o prilagoditvi odmerka.
Dose escalation to 3 mg/kg once weekly should be considered based on clinical response.
Na podlagi kliničnega odziva se lahko razmisli o povečevanju odmerka na 3 mg/kg enkrat na teden.
Skin and subcutaneous tissue disorders Very common Urticariab, rashb, eczemab, pruritis, rash maculo-papular
Bolezni kože in podkožja zelo pogosti urtikarija b, izpuščaj b, ekcem b, pruritus,
Reproductive system and breast disorders
Infekcijske in parazitske bolezni pogosti okužba sečil
Anxietyc, insomnia
Psihiatrične motnje pogosti tesnobnost c, nespečnost
Skin and subcutaneous tissue disorders Common
Srčne bolezni pogosti tahikardija
Laryngeal oedema e, dyspnoea b,c,e
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti laringealni edeme, dispnejab,c,e
Store in a refrigerator Do not freeze.
DRUGI PODATKI Shranjujte v hladilniku.
Each vial contains 33 mg sodium.
Pomožne snovi z znanim učinkom: ena viala vsebuje 33 mg natrija.
The medicine will be diluted before being given to you or your child.
Zdravilo je treba pred dajanjem razredčiti.
● Risk Management Plan (RMP)
● Načrt za obvladovanje tveganj (RMP)
Your doctor will decide how much medicine you will take and how often.
Vaš zdravnik se bo odločil, koliko zdravila boste uporabljali in kako pogosto.
• you have difficulty in breathing.
• imate težave z dihanjem.
It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Sprejemljivo je podaljšanje trajanja stimulacije v kateremkoli ciklusu do 5 tednov.
Children and adolescents This medicine is not indicated for use in children and adolescents less than 18 years of age.
Otroci in mladostniki To zdravilo ni indicirano za uporabo pri otrocih in mladostnikih, starih manj kot 18 let.
• This medicine is usually given every day.
• To zdravilo se običajno daje vsak dan.
Benzyl alcohol may cause allergic reactions.
Benzilalkohol lahko povzroči alergijske reakcije.
The doses described below are stated in International Units (IU).
Spodaj opisani odmerki so navedeni v mednarodnih enotah (i.e.).
All strengths listed above contain the other ingredients.
Vse jakosti, navedene zgoraj, vsebujejo druge sestavine.
Alternatively, IUI may be performed.
Alternativno se lahko izvede IUI.
Proper treatment of your condition, however, requires close and constant co-operation with your doctor.
Zaradi pravilnega zdravljenja vašega stanja morate tesno in stalno sodelovati s svojim zdravnikom.
This usually takes about 10 days but can take any time between 5 and 20 days.
To običajno traja približno 10 dni, vendar je razpon kadar koli med 5 in 20 dni.
• The dose may be increased, depending on your response.
• Odmerek se lahko zviša glede na vaš odziv.
The majority of multiple conceptions are twins.
Večino večplodnih zanositev predstavljajo dvojčki.
OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
Ker se lahko OHSS razvije hitro (v 24 urah) ali v nekaj dneh v resen zdravstven zaplet.
However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Vendar pa je treba upoštevati, da so razlike med rezultati meritev LH, ki so izvedene v različnih laboratorijih.
Following subcutaneous administration, the absolute bioavailability is about 70 %.
Po subkutani uporabi je absolutna biološka razpoložljivost 70 %.
Do not use this medicine if any of the above applies to you.
Ne uporabljajte tega zdravila, če kar koli od zgoraj naštetega velja za vas.
• Treatment is continued until your eggs have developed to a desired point.
• Zdravljenje se nadaljuje, dokler se jajčeca ne razvijejo do želene stopnje.
It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about 7 to 10 days following treatment.
Najpogosteje se pojavi po prekinitvi hormonskega zdravljenja in doseže maksimum približno 7 do 10 dni po zdravljenju.
What the recommended dose is
Priporočeni odmerek je
Multiple pregnancy may lead to medical complications for you and your babies.
Večplodne nosečnosti lahko vodijo v zdravstvene zaplete pri vas in vaših otrocih.
The pH of the solution is 6.8-7.2.
pH raztopine je 6,8-7,2.
Differences between the 2 groups were statistically significant (p < 0.05) for all criteria listed.
Razlike med obema skupinama so bile po vseh navedenih merilih statistično značilne (p < 0,05).
• if you are a man with: - testicular failure that is not treatable.
• če ste moški: - z odpovedjo testisov, ki je ni mogoče zdraviti.
• malformations of sexual organs incompatible with pregnancy;
• malformacije spolnih organov, ki niso združljive z nosečnostjo
• If you have not responded to treatment after 4 months, your doctor may suggest that you continue using these two medicines for at least 18 months.
• Če se po 4 mesecih ne odzovete na zdravljenje, vam bo zdravnik morda predlagal, da nadaljujete z uporabo teh dveh zdravil vsaj 18 mesecev.
• You will use these two medicines three times a week for at least 4 months.
• Ti dve zdravili boste uporabili trikrat na teden vsaj 4 mesece.
You may be told not to have sex or to use a barrier contraceptive method for at least 4 days.
Morda vam bo povedal, da ne smete imeti spolnih odnosov ali da morate uporabljati mehanska kontracepcijska sredstva najmanj 4 dni.
Self-administration should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Sami si jih lahko dajejo samo bolniki, ki so dobro motivirani, ustrezno poučeni in imajo dostop do strokovnega nasveta.
The first injection should be performed under direct medical supervision.
Injiciranje prve injekcije se mora izvesti pod neposrednim zdravniškim nadzorom.
Tell your doctor straight away if:
Svojemu zdravniku takoj povejte, če:
You can reduce the risk of multiple pregnancy by using the right dose of this medicine at the right times.
Tveganje večplodne nosečnosti lahko zmanjšate tako, da ob pravem času uporabite pravi odmerek tega zdravila.
If you are a man, having too much natural FSH in your blood can be a sign of damaged testicles.
Če ste moški in imate previsoko raven naravnega FSH v krvi, je morda to znak za poškodbo testisov.
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Celokupne izkušnje z IVF kažejo, da je na splošno uspeh zdravljenja v prvih štirih poskusih konstanten, nato pa se postopno zmanjšuje.
No teratogenic effect has been observed in animal studies (see section 5.3).
V študijah na živalih niso opazili nobenega teratogenega učinka (glejte poglavje 5.3).
• you get pain in the lower part of the abdomen (belly),
• imate bolečine v spodnjem delu abdomna (trebuha),
It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Vendar pa moramo upoštevati, da nosečnost sama kot tudi OHSS prinašata povečano tveganje za trombembolične dogodke.
The adverse reactions are ranked under heading of frequency using the following convention: 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) and not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po pogostnosti v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
FSH je gonadotropin, vrsta hormona, ki ima pomembno vlogo pri plodnosti in razmnoževanju ljudi.
You can also report side effects directly via the national reporting system listed in Appendix V.. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
This is a condition that may be passed on from parents to children which means that you have an inability to break down porphyrins (organic compounds).
To je stanje, ki se lahko prenaša s staršev na otroke, in pomeni nezmožnost razgradnje porfirinov (organskih spojin).
If you administer this medicine to yourself, please carefully read and follow the “Instructions for Use” of the pen.
Če si boste to zdravilo dajali sami, skrbno preberite in upoštevajte "Navodila za uporabo" peresnika.
Tell your doctor before you start treatment, if you or any member of your family have porphyria.
Pred začetkom zdravljenja povejte zdravniku, če imate vi ali kdo v družini porfirijo.
6.6 Special precautions for disposal and other handling No special requirements for disposal.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev za odstranjevanje.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
● Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
Za izboljšanje sledljivosti biološkega zdravila je treba tržno ime in številko serije uporabljenega zdravila jasno zabeležiti v bolnikovo kartoteko.
If you think you are having this type of reaction, you must stop your Ovaleap injection and get medical help immediately.
Če menite, da imate to vrsto reakcije, morate prenehati z injiciranjem zdravila Ovaleap in takoj poiskati zdravniško pomoč.
Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Ker so te bolnice amenoreične in imajo nizko sekrecijo endogenega estrogena, se lahko zdravljenje začne kadarkoli.
Talk to your doctor straight away if:
Takoj povejte svojemu zdravniku, če:
Ovaleap must not be used when an effective response cannot be obtained, such as:
Zdravila Ovaleap ne smete uporabljati, kadar ni mogoče doseči učinkovitega odziva, kot je npr.: