natgillin/translations-raw huggingface dataset:
Tevagrastim 30 MIU/ 0.5 ml solution for injection or infusion Tevagrastim 48 MIU/ 0.8 ml solution for injection or infusion
Tevagrastim 30 000 k. i. e. / 0, 5 ml raztopina za injiciranje ali infundiranje Tevagrastim 48 000 k. i. e. / 0, 8 ml raztopina za injiciranje ali infundiranje
What Tevagrastim is and what it is used for 2.
Kaj je zdravilo Tevagrastim in za kaj ga uporabljamo 2.
Before you use Tevagrastim 3.
Kaj morate vedeti, preden boste uporabili zdravilo Tevagrastim 3.
How to use Tevagrastim 4.
Kako uporabljati zdravilo Tevagrastim 4.
How to store Tevagrastim 6.
Shranjevanje zdravila Tevagrastim 6.
WHAT Tevagrastim IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO Tevagrastim IN ZA KAJ GA UPORABLJAMO
What Tevagrastim is Tevagrastim contains the active substance filgrastim.
Kaj je zdravilo Tevagrastim Tevagrastim vsebuje zdravilno učinkovino filgrastim.
What Tevagrastim is used for Your doctor has prescribed Tevagrastim for you to help your body make more white blood cells.
Za kaj se uporablja zdravilo Tevagrastim Zdravnik vam je predpisal zdravilo Tevagrastim zato, da bi vaše telo lahko proizvajalo več belih krvničk.
Tevagrastim is useful in several different conditions which are:
Zdravilo Tevagrastim pomaga pri več različnih stanjih, med katere spadajo:
BEFORE YOU USE Tevagrastim
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO Tevagrastim
Do not use Tevagrastim
Ne uporabljajte zdravila Tevagrastim
- if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of
- če ste alergični (preobčutljivi) na filgrastim ali katerokoli sestavino zdravila Tevagrastim.
Take special care with Tevagrastim
Bodite posebno pozorni pri uporabi zdravila Tevagrastim
You will need to have regular blood tests whilst being treated with Tevagrastim to count the number of neutrophils and other white blood cells in your blood.
54 Med zdravljenjem z zdravilom Tevagrastim vam bodo morali redno pregledovati kri, zato da naredijo analizo števila nevtrofilcev in drugih belih krvničk v vaši krvi.
Important information about some of the ingredients of Tevagrastim This medicine contains sorbitol (a type of sugar).
Pomembne informacije o nekaterih sestavinah zdravila Tevagrastim To zdravilo vsebuje sorbitol (vrsta sladkorja).
HOW TO USE Tevagrastim
KAKO UPORABLJATI ZDRAVILO Tevagrastim
Always use Tevagrastim exactly as your doctor has told you.
Pri uporabi zdravila Tevagrastim natančno upoštevajte zdravnikova navodila.
The amount of Tevagrastim you need will depend on the condition you are taking Tevagrastim for and on your bodyweight.
Količina zdravila Tevagrastim, ki jo potrebujete, je odvisna od stanja, zaradi katerega morate jemati zdravilo, in od vaše telesne teže.
Tevagrastim and chemotherapy The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Zdravilo Tevagrastim in kemoterapija Običajni odmerek na kilogram telesne teže je 0, 5 milijonov mednarodnih enot (i. e.) dnevno.
Tevagrastim and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Zdravilo Tevagrastim in presaditev kostnega mozga Običajni odmerek na kilogram telesne teže je 1 milijon mednarodnih enot (i. e.) dnevno.
You will normally receive your first dose of Tevagrastim at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Običajno boste prvi odmerek zdravila Tevagrastim prejeli šele 24 ur po kemoterapiji, v primeru presaditve kostnega mozga pa boste zdravili prejeli v roku 24- ih ur.
Tevagrastim and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
Zdravilo Tevagrastim in huda kronična nevtropenija Običajni odmerek na kilogram telesne teže je od 0, 5 do 1, 2 milijona mednarodnih enot (i. e.) dnevno, bodisi v enkratnem ali večkratnih odmerkih.
54 Tevagrastim and neutropenia in patients with HIV infection The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
55 Zdravilo Tevagrastim in nevtropenija pri bolnikih, okuženih s HIV Običajni odmerek na kilogram telesne teže je od 0, 1 do 0, 4 milijona mednarodnih enot (i. e.) dnevno.
Long term treatment with Tevagrastim may be required to maintain a normal number of white cells in your blood.
Zato da bi število belih krvničk v vaši krvi ostalo na običajni ravni, bo morda potrebno dolgotrajno zdravljenje z zdravilom Tevagrastim.
Tevagrastim and peripheral blood stem cell mobilisation If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day.
Zdravilo Tevagrastim in zbiranje matičnih celic iz periferne krvi Če darujete izvorne celice zase, potem je običajni odmerek na kilogram telesne teže 0, 5 milijonov mednarodnih enot (i. e.) dnevno.
If you use more Tevagrastim than you should If you use more Tevagrastim than you should, contact your doctor or pharmacist as soon as possible.
Če ste uporabili večji odmerek zdravila Tevagrastim, kot bi smeli Če ste uporabili večji odmerek zdravila Tevagrastim, kot bi smeli, se čimprej posvetujte z zdravnikom ali farmacevtom.
If you forget to use Tevagrastim Do not use a double dose to make up for a forgotten injection.
Če ste pozabili uporabiti zdravilo Tevagrastim Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
If you stop using Tevagrastim Before you stop using Tevagrastim, talk to your doctor.
Če ste prenehali uporabljati zdravilo Tevagrastim Preden prenehate uporabljati zdravilo Tevagrastim se pogovorite z vašim zdravnikom.
Like all medicines, Tevagrastim can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Tevagrastim neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you think you are having this type of reaction, stop your Tevagrastim injection and get medical help immediately.
Če menite, da se je pri vas pojavila takšna reakcija, prenehajte z odmerjanjem zdravila Tevagrastim in takoj poiščite zdravniško pomoč.
HOW TO STORE Tevagrastim
SHRANJEVANJE ZDRAVILA Tevagrastim
Do not use Tevagrastim after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Zdravila Tevagrastim ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in na napolnjeni injekcijski brizgi poleg oznake 'uporabno do'.
Do not use Tevagrastim if you notice it is cloudy or there are particles in it.
57 Ne uporabite zdravila Tevagrastim, če opazite, da je motno ali da so v njem delci.
What Tevagrastim contains
Kaj vsebuje zdravilo Tevagrastim
Tevagrastim 30 MIU/ 0.5 ml:
milijonov mednarodnih enot [i. e.] (600 mikrogramov) zdravila filigrastim Tevagrastim 30 000 k. i. e. / 0, 5 ml: ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i. e.] (300 mikrogramov) zdravila filgrastim v 0, 5 ml raztopine.
Tevagrastim 48 MIU/ 0.8 ml:
Tevagrastim 48 000 k. i. e. / 0, 8 ml: ena napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i. e.] (480 mikrogramov) zdravila filgrastim v 0, 8 ml raztopine.
You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “ Important information about some of the ingredients of Tevagrastim”.
Podrobne podatke o sorbitolu (vrsta sladkorja) boste našli v poglavju 2 pod “ Pomembne informacije o nekaterih sestavinah zdravila ratiogratsim ”.
What Tevagrastim looks like and contents of the pack Tevagrastim is a solution for injection or infusion in a pre-filled syringe.
Izgled zdravila Tevagrastim in vsebina pakiranja Zdravilo Tevagrastim je raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi.
Tevagrastim are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Zdravilo Tevagrastim je mogoče dobiti v pakiranjih po 1, 5 ali 10 napolnjenih injekcijskih brizg ali v obliki skupnih pakiranj po 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg.
Marketing Authorisation Holder Teva Generics GmbH Kandelstr.
Imetnik dovoljenja za promet z zdravilom Teva Generics GmbH Kandelstr.
Manufacturer Teva Pharma B. V.
Proizvajalec Teva Pharma B. V.
Italia Teva Pharma Italia S. r. l.
Suomi/ Finland Italia Teva Pharma Italia S. r. l.
58 INFORMATION FOR INJECTING YOURSELF
NAPOTKI ZA SAMOINJICIRANJE
This section contains information on how to give yourself an injection of Tevagrastim.
59 To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Tevagrastim.
- a pre-filled syringe of Tevagrastim,
- napolnjeno injekcijsko brizgo z zdravilom Tevagrastim,
59 2 2.
60 2 2.
Push the plunger up to the number (ml) on the syringe that matches the dose of Tevagrastim that your doctor prescribed.
Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Tevagrastim, ki vam ga je predpisal vaš zdravnik.
Dilution to a final concentration less than 0.2 MIU (2 μ g) per ml is not recommended at any time.
Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi končna koncentracija padla pod 0, 2 x 106 i. e.
Example:
(2 μg).
When diluted in glucose 50 mg/ ml (5%) solution for
Pred uporabo morate raztopino vizualno pregledati.
After dilution:
Uporabite lahko samo bistro
62
62 raztopine brez delcev.
1 The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
1 Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani v nadaljevanju:
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below. o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional’ s Kit containing the following:
Države članice se morajo z imetnikom dovoljenja za promet z zdravilom dogovoriti o podrobnostih za nadzorovani sistem distribucije v skladu z nacionalno ureditvijo in zdravstvenim sistemom in izvajati ta program na nacionalni ravni ter tako zagotoviti naslednje: o Pred uvedbo zdravila na trg morajo vsi zdravniki in farmacevti, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, prejeti Pismo za zdravstvene delavce, kot je opisano spodaj o Pred predpisovanjem vsi zdravstveni delavci, ki nameravajo predpisovati (in v skladu z dogovorom s pristojnimi nacionalnimi organi izdajati) zdravilo Thalidomide Celgene, prejmejo izobraževalni paket za zdravstvene delavce, ki vsebuje naslednje:
Healthcare professional booklet Patient booklets Patient cards Summary of Product Characteristics, Package Leaflet and Labelling
Brošura za zdravstvene delavce Brošure za paciente Kartice za bolnike Povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
Patients involved should be preferably naïve to the history of thalidomide.
Države članice bodo zagotovile, da bo imetnik dovoljenja za promet z zdravilom zagotovil izobraževalno gradivo za nacionalne organizacije za bolnike, ki jih pregledajo, oziroma če te ne obstajajo ali če ne morejo sodelovati, zadevnim skupinam bolnikov, ki še niso bili zdravljeni s talidomidom.
The Member States shall report to the EMEA the following information at 6 monthly intervals following the Commission Decision: o The status of implementation of the PPP within their MS o Estimates of usage in their MS
Država članica bo Evropsko agencijo za zdravila (EMEA) v 6- mesečnih časovnih presledkih po sklepu Komisije obveščala o naslednjem: o statusu izvajanja PPN v državi članici o ocenjeni rabi v državi članici
2 Dear Healthcare Professional letter The Dear Healthcare Professional letter will consist of two parts: • Core text as agreed by the CHMP • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
2 Pismo za zdravstvene delavce bo sestavljeno iz dveh delov: • osrednjega besedila, kot ga je odobril Odbor za zdravila za uporabo v humani medicini (CHMP), • posebnih zahtev posameznih držav po dogovoru s pristojnim nacionalnim organom glede: o distribucije zdravila o postopkov za zagotovitev izvedbe vseh ustreznih ukrepov pred začetkom izdajanja talidomida.
Educational healthcare professional’ s kit The Educational healthcare professional’ s kit shall contain the following elements: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “ Educational Healthcare Professional’ s Kit” (if applicable to a Member State)
Izobraževalni paket za zdravstvene delavce Izobraževalni paket za zdravstvene delavce naj vsebuje naslednje elemente: • Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobreno, o odmerjanje, o najdaljše obdobje predpisovanja 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o opozorilo o teratogenosti in da je treba preprečiti izpostavljenost ploda o obveznosti za zdravstvene delavce, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, kar vključuje: obveznost izčrpnega svetovanja in vodenja bolnika bolniki morajo biti sposobni izpolnjevati zahteve za varno rabo talidomida obveznost oskrbeti bolnike z zadevnim izobraževalnim gradivom poročanje o vsaki nosečnosti, nevropatiji ali drugih neželenih učinkih podjetju Celgene in lokalnim zdravstvenim organom na obrazcu v „ Izobraževalnem paketu za zdravstvene delavce “ (če je primerno za državo članico)
Safety Advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy Disposal of unwanted medicine Not to donate blood during treatment and for one week after treatment ends
Varnostne nasvete, pomembne za vse bolnike o opis in upravljanje trombembolitičnih in kardiovaskularnih dogodkov in periferna nevropatija napotke za odstranjevanje odvečnega zdravila opozorilo, da bolniki ne smejo darovati krvi med zdravljenjem in en teden po koncu zdravljenja
Algorithm for Pregnancy Prevention Plan implementation This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures.
Algoritem za izvajanje programa za preprečevanje nosečnosti o ta naj pomaga pri razvrstitvi bolnikov in določanju zahtevanega preprečevanja nosečnosti in merilih testiranja
Pregnancy Prevention Programme information Definition of women with childbearing potential (WCBP) and actions the prescriber should take if childbearing status is unclear Information on what is effective contraception Safety advice for WCBP • Need to avoid foetal exposure • Pregnancy prevention requirement, definition and need for adequate contraceptive methods • That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception • Pregnancy testing requirements o Advice on suitable tests
Podatke programa za preprečevanje nosečnosti o opredelitev žensk v rodni dobi (ŽRD) in ukrepov za zdravnika, ki zdravilo predpiše, če status rodnosti ni jasen informacije o učinkoviti kontracepciji varnostne nasvete za ŽRD • opozorilo, da je treba preprečiti izpostavljenost ploda • opredelitev zahteve preprečevanja nosečnosti in potrebe po ustreznih kontracepcijskih metodah • opozorilo, da mora v primeru spremembe ali prenehanja uporabe svoje kontracepcijske metode obvestiti:
3 o Frequency (before commencing, monthly during treatment and after finishing treatment) • Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy • Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not using effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse • That he should not donate semen during therapy and for one week following discontinuation of thalidomide
- zdravnika, ki je kontracepcijo predpisal, da jemlje talidomid
Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “ Educational Healthcare Professional’ s Kit” Local contact details for reporting of any suspected pregnancy
- zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali
• Pregnancy initial and outcome reporting forms • Post-marketing and compliance assessment (as applicable to a Member State) • Neuropathy and adverse reaction reporting forms
spremenila svojo kontracepcijsko metodo • zahteve testa nosečnosti o nasvete o ustreznih testih o pogostnost (pred pričetkom, mesečno med zdravljenjem in po končanem zdravljenju)
• Treatment initiation forms o There should be 3 types of treatment initiation forms:
3
All treatment initiation forms should contain the following elements:
opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene
Teratogenicity warning Date of counselling Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures.
• opozorilo, da je v primeru suma na nosečnost, o tem treba nemudoma obvestiti zdravnika, ki vodi zdravljenje varnostne nasvete za moške • Opozorilo, da je treba preprečiti izpostavljenost ploda • Opozorilo, da je talidomid prisoten v spermi in o potrebi zaščite s kondomom, če je spolna partnerica noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije • Opozorilo, da je treba v primeru zanositve partnerice nemudoma obvestiti zdravnika, ki vodi zdravljenje, in vedno med odnosom uporabljati kondom • Opozorilo, da ne sme darovati sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida
Patient details, signature and date Prescriber name, signature and date Aim of this document i. e. as stated in the PPP: “ The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
Zahteve poročanja nosečnosti o opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene napotitev k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji na svetovanje in oceno izpolnitev obrazca o poročanju nosečnosti, ki se nahaja v „ Izobraževalnem paketu za zdravstvene delavce “ lokalne kontaktne podrobnosti za poročanje kakršnegakoli suma na nosečnost
It is not a contract and does not absolve anybody from his/ her responsibilities with regard to the safe use of the product and prevention of foetal exposure .”
• obrazce za poročanje o začetku in izidu nosečnosti • ocenitev pomarketinških izkušenj in skladnosti (kot velja v državi članici) • nevropatija in obrazci za poročanje neželenih učinkov
o
• Obrazce za začetek zdravljenja o Obstajajo naj 3 vrste obrazcev za začetek zdravljenja: bolnica v rodni dobi bolnica, ki ne more zanositi moški bolnik
Treatment initiation forms for female patients with childbearing potential should also include:
Vsi obrazci za začetek zdravljenja naj vsebujejo naslednje elemente: o opozorilo o teratogenosti datum svetovanja potrdilo o bolnikovem razumevanju v zvezi s tveganjem talidomida in ukrepi PPN podatke bolnika, podpis in datum ime zdravnika, ki je zdravilo predpisal, podpis in datum namen dokumenta, tj. kot je zabeleženo v PPN:
Confirmation that the physician has discussed the following: • The need to avoid foetal exposure • That if she is pregnant or plans to be, she must not take Thalidomide Celgene • The need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment
To ni pogodba in nikogar ne odvezuje njegovih odgovornosti v zvezi z varno uporabo zdravila in preprečevanjem izpostavljenosti ploda temu zdravilu. ”
That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception
treba je preprečiti izpostavljenost ploda če je ženska noseča ali načrtuje nosečnost, ne sme jemati zdravila Thalidomide Celgene
The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment
potrebna je učinkovita kontracepcija brez prekinitev, 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter 4 tedne po koncu zdravljenja
The need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
če želi ženska spremeniti ali zamenjati svojo kontracepcijsko metodo, mora obvestiti - zdravnika, ki je kontracepcijo predpisal, da jemlje talidomid - zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali spremenila svojo kontracepcijsko metodo
The need to contact their doctor immediately upon suspicion of pregnancy
potrebno je izvesti teste nosečnosti pred zdravljenjem, vsake 4 tedne med zdravljenjem in po zdravljenju
That she sh ould not share the treatment with any other person That she should not donate blood during therapy and for one week following discontinuation of thalidomide
takoj po sumu na nosečnost mora prenehati uporabljati zdravilo Thalidomide Celgene
That she should return the capsules to the pharmacist at the end of treatment
če sumi, da je noseča, mora o tem takoj obvestiti svojega zdravnika svojega zdravila ne sme dajati nikomur drugemu ne sme darovati krvi med zdravljenjem in še en teden po prekinitvi jemanja talidomida
Treatment initiation forms for female patients with no childbearing potential should also include:
ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu
Confirmation that the physician has discussed the following: • That she should not share the treatment with any other person • That she should not donate blood during therapy and for one week following discontinuation of thalidomide • That she should return the capsules to the pharmacist at the end of treatment
Obrazci za začetek zdravljenja za ženske bolnice, ki ne morejo zanositi, morajo o vsebovati tudi: potrdilo, da se je zdravnik pogovoril o naslednjem: • svojega zdravila ne sme dajati nikomur drugemu • ne sme darovati krvi med zdravljenjem in še en teden po prekinitvi jemanja talidomida • ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu