natgillin/translations-raw huggingface dataset:
The most common side effects with Ceplene (seen in more than 1 patient in 10) are eosinophilia (an increase in eosinophil levels, a type of white blood cell), thrombocytopenia (low blood platelet counts), headache, dizziness, dysgeusia (a bitter or unusual taste in the mouth), tachycardia (rapid heart beat), flushing (reddening), hypotension (low blood pressure), cough, dyspnoea (shortness of breath), nausea (feeling sick), dyspepsia (indigestion), diarrhoea, rash, arthralgia (pain in the joints), myalgia (muscle pain), pyrexia (fever), rigors (shaking chills), fatigue (tiredness), flu-like symptoms, feeling hot and injection site reaction (redness, bruising, pain and inflammation).
Najpogostejši neželeni učinki zdravila Ceplene (opaženi pri več kot 1 bolniku izmed 10) so eozinofilija (povečanje števila eozinofilcev, tj. ene od vrst belih krvničk), trombocitopenija (majhno število trombocitov), glavobol, vrtoglavica, disgevzija (trpek ali nenavaden okus v ustih), tahikardija (hitro utripanje srca), rdečica (zardevanje), hipotenzija (nizek krvni tlak), kašljanje, dispneja (oteženo dihanje), navzeja (občutek slabosti), dispepsija (slaba prebava), driska, izpuščaji, artralgija (bolečina v sklepih), mialgija (bolečina v mišicah), pireksija (povišana telesna temperatura), mrzlica (drgetanje), utrujenost, gripi podobni simptomi, občutek vročine na mestu vbrizganja (rdečina, modrice, bolečina in vnetje).
For the full list of all side effects reported with Ceplene, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ceplene, glejte navodilo za uporabo.
Ceplene should not be used in people who may be hypersensitive (allergic) to histamine dihydrochloride or any of the other ingredients.
Zdravila Ceplene ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) histamin dihidroklorid ali katero koli drugo sestavino zdravila.
It must not be used in patients who have severe heart problems or in women who are pregnant or breast-feeding.
Zdravila ne smejo uporabljati bolniki z resnimi težavami s srcem ali ženske, ki so noseče oziroma dojijo.
It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (used to reduce or prevent inflammation), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Zdravila prav tako ne smejo uporabljati bolniki, ki so jim presadili kostni mozeg ali jemljejo steroide (za zmanjšanje ali preprečevanje vnetja), klonidin (za zmanjšanje visokega krvnega tlaka) ali zaviralce histamina H2 (za zdravljenje želodčnih razjed, prebavnih motenj ali zgage).
The Committee for Medicinal Products for Human Use (CHMP) decided that Ceplene’ s benefits are greater than its risks as maintenance treatment in adults with AML when used in combination with interleukin-2.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ceplene kot vzdrževalno zdravljenje odraslih z AML v kombinaciji z interlevkinom- 2 večje od z njim povezanih tveganj.
The Committee recommended that Ceplene be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ceplene odobri dovoljenje za promet.
Ceplene has been authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu Ceplene.
Every year, the EMEA will review any new data that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.
The company will carry out further studies to look in more detail at the effectiveness of the combination of Ceplene and interleukin-2 and at how the combination works.
Družba bo izvedla nadaljnje študije, ki bodo podrobneje obravnavale učinkovitost kombinacije zdravila Ceplene in interlevkina- 2 ter delovanja kombinacije.
Other information about Ceplene:
Druge informacije o zdravilu Ceplene:
The European Commission granted a marketing authorisation valid throughout the European Union for Ceplene to EpiCept GmbH on 7 October 2008.
Evropska komisija je dovoljenje za promet z zdravilom Ceplene, veljavno po vsej Evropski uniji, odobrila družbi EpiCept GmbH dne 7. oktobra 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Ceplene is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Ceplene je na voljo tukaj.
The full EPAR for Ceplene can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ceplene je na voljo tukaj.
Subcutaneous use Vial (glass)
Subkutana uporaba Viala (steklena)
Ceplene 0.5 mg/ 0.5 ml solution for injection
Ceplene 0, 5 mg/ 0, 5 ml raztopina za injiciranje
One vial of 0.5 ml of solution contains 0.5 mg of histamine dihydrochloride.
Ena viala z 0, 5 ml raztopine vsebuje 0, 5 mg histaminijevega diklorida.
Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2).
Vzdrževalno zdravljenje z zdravilom Ceplene je indicirano pri odraslih bolnikih z akutno mieloično levkemijo ob prvi remisiji, ob sočasnem zdravljenju z interlevkinom- 2 (IL- 2).
Ceplene maintenance therapy should be administered following completion of consolidation therapy in patients concomitantly treated with IL-2 under the supervision of a physician experienced in the management of acute myeloid leukaemia.
Vzdrževalno zdravljenje z zdravilom Ceplene je namenjeno uporabi po zaključku utrditvene terapije pri bolnikih, sočasno zdravljenih z IL- 2 pod nadzorom zdravnika z izkušnjami na področju zdravljenja akutne mieloične levkemije.
For dosing instructions for Ceplene in combination with IL-2, see posology below.
Navodila za odmerjanje zdravila Ceplene v kombinaciji z IL- 2 so navedena v nadaljevanju tega poglavja.
Interleukin-2 (IL-2) IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of Ceplene; each dose of IL-2 is 16 400 IU/ kg.
Vsak odmerek IL- 2 je 16. 400 i. e. / kg.
Ceplene 0.5 ml solution is sufficient for a single dose (see section 6.6).
Zdravilo Ceplene 0, 5 ml raztopine zadostuje za enkraten odmerek (glejte poglavje 6. 6).
Ceplene is administered 1 to 3 minutes after each injection of IL-2.
Zdravilo Ceplene se daje 1 do 3 minute po vsaki injekciji IL- 2.
Each 0.5 ml Ceplene dose is injected slowly, over 5-15 minutes.
Vsak 0, 5 ml odmerek zdravila Ceplene se injicira počasi, in sicer v 5 – 15 minutah.
Treatment cycles Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a three-week or six-week treatment-free period.
Cikli zdravljenja Zdravili Ceplene in IL- 2 se uporabljata v 10 ciklih zdravljenja: vsak cikel predstavlja 21- dnevno obdobje zdravljenja (3 tedni), temu pa sledi obdobje treh ali šestih tednov brez zdravljenja.
For cycles 1-3, each cycle consists of 3 weeks of treatment, followed by a 3-week treatment free period.
Cikli 1– 3 so sestavljeni iz 3 tednov zdravljenja, čemur sledi 3 tedensko obdobje brez zdravljenja.
For cycles 4-10, each cycle consists of 3 weeks of treatment, followed by a 6-week treatment- free period.
Cikli 4– 10 so sestavljeni iz 3 tednov zdravljenja, čemur sledi 6 tedensko obdobje brez zdravljenja.
2 Table 1:
2 Prelednica 1:
For treatment cycles 1-3 with Ceplene and IL-2
Za cikle zdravljenja 1– 3 z zdravilom Ceplene in IL- 2.
Cycle 1
Zdravljenje *
Week
Cikel 1
number (w)* Cycle 2
Cikel 2
Cycle 3
3
Treatment*
7 do t.
w.1 to w.3
13 do t.
w.13 to w.15 IL-2 16 400 IU/ kg followed by 0.5 ml Ceplene.
15 IL- 2 16. 400 i. e/ kg, čemur sledi 0, 5 ml zdravila
(Days 1-21) Twice daily.
(dnevi 1– 21) (dnevi 1– 21) (dnevi 1– 21) Ceplene.
w.10 to w.12 w.16
Dvakrat na dan.
For treatment cycles 4-6 with Ceplene and IL-2, same as for Table 1 above, with the exception of number of cycles and duration of rest periods
Za zdravljenje z zdravilom Ceplene in IL- 2 v ciklih 4– 6 velja enako, kot je navedeno v zgornji preglednici 1, z izjemo števila ciklov in trajanja obdobja brez zdravljenja.
Week number (w)* Cycles
Številka tedna (t) * Cikli
Treatment*
Zdravljenje *
w.1 w.2 w.3 w.4 w.55 w.6 w.7 IL-2 16 400 IU/ kg followed by 0.5 ml
73 IL- 2 16. 400 i. e/ kg, čemur sledi 0, 5 ml do zdravila Ceplene.
9 to 8 to 7 to 6 to w.2 w.3 w.3 w.4 w.57 w.6 w.7
do do do do do
- to
do
4 to 3 to Ceplene.
30 t.
Twice daily
48 t.
1 0 9 8 w.2 w.3 w.4 w.4 w.58 w.6 w.7
do
6 5 Treatment-free (6 weeks)
do do t. do do d
2 to 1 to 0 to 9 to w.2 w.3 w.4 w.5 w.63 w.7 w.8
do do do t. do do do
7 to 6 to
27 t.
7 6 5 4
45
2 1
81
Dose modification Patients should be monitored for the expected symptomatic adverse reactions and laboratory changes associated with this treatment.
Prilagajanje odmerkov Bolnike je treba opazovati zaradi pričakovanih simptomatskih neželenih učinkov in laboratorijskih sprememb, povezanih s tem zdravljenjem.
Doses of Ceplene and IL-2 should be modified as necessary based on individual patient tolerance to treatment.
Odmerke zdravila Ceplene in IL- 2 po potrebi prilagodite toleranci na zdravljenje vsakega posameznega bolnika.
Should Ceplene related toxicities occur (such as hypotension, headache), the injection time can be increased from 5 minutes to a maximum of duration of 15 minutes.
V primeru pojava toksičnih dogodkov zaradi uporabe zdravila Ceplene (kot je na primer hipotenzija, glavobol) se lahko čas trajanja injiciranja zdravila podaljša od 5 minut na največ 15 minut.
For patients experiencing grade 1 toxicity events:
Za bolnike, pri katerih se pojavlja 1. stopnja toksičnih dogodkov:
For patients experiencing grade 1-4 neurologic toxicity -for grade 1 to 3 toxicity, treatment should be discontinued until grade 0 toxicity event has been achieved.
- pri 1. do 3. stopnji toksičnosti je treba zdravljenje prekiniti, dokler ni dosežena stopnja 0
Treatment should then be resumed at a 20% dose reduction for both Ceplene and IL-2. -for grade 4 toxicity, discontinuation of treatment should be considered.
Za bolnike, pri katerih se pojavlja 1. – 4. stopnja generaliziranega toksičnega dermatitisa
For patients experiencing grade 1-4 generalised toxic dermatitis -for grade 1 toxicity, the treatment should be delayed for 48 hours or until all symptoms have been resolved.
- pri 1. stopnji toksičnosti je treba zdravljenje prekiniti za 48 ur ali dokler simptomi ne
Treatment should then be resumed using the full dose of Ceplene, but reducing the IL-2 dose by 20%. -for grade 2 toxicity, the IL-2 dose should be reduced 50% and only increased to full dose if the symptoms do not reappear.
- pri 2. stopnji toksičnosti odmerek IL- 2 zmanjšajte za 50% in ponovno povečajte na poln
Ceplene and IL-2 doses should be separated by 60 minutes, which should be maintained throughout treatment. -for grade 3 and 4 toxicity, treatment should be discontinued and not resumed until events have been resolved.
pri 3. in 4. stopnji toksičnosti zdravljenje prekinite, dokler dogodki ne izzvenijo.
3 For patients experiencing grade 2 (including cardiac function, renal, hepatic) toxicity:
Za bolnike, pri katerih se pojavlja 2. stopnja toksičnosti (vključno s srčnimi, ledvičnimi, jetrnimi funkcijami):
- treatment should be discontinued until the event has returned to grade 1
- zdravljenje je treba prekiniti, dokler se dogodki ne povrnejo na 1. stopnjo,
- the time of injection of the dose of Ceplene should be extended to a maximum of 15
- čas injiciranja odmerka zdravila Ceplene podaljšajte na največ 15 minut,
- for cardiac, hepatic or renal toxicities the dose should be reduced by 20% for both Ceplene
- pri srčni, jetrni ali ledvični toksičnosti odmerka tako zdravila Ceplene kot IL- 2 zmanjšajte
and IL-2.
za 20%.
For patients experiencing grade 3 and 4 (including hypotension, arrhythmia) toxicities:
Za bolnike, pri katerih se pojavlja 3. in 4. stopnja toksičnosti (vključno s hipotenzijo, aritmijo):
- treatment should be discontinued until the event is resolved.
- zdravljenje je treba prekiniti, dokler dogodki ne izzvenijo.
treatment cycle can be considered for the resolution of grade 3 and 4 events.
Za razrešitev dogodkov 3. in 4.
For persistent hypotension, headache, arrhythmia, cardiac, hepatic and renal toxicities:
Pri trdovratni hipotenziji, glavobolu, aritmiji, srčni, jetrni in ledvični toksičnosti:
- the time of injection of the dose of Ceplene should be extended to a maximum of 15
- čas injiciranja odmerka zdravila Ceplene podaljšajte na največ 15 minut;
- the dose amount of both Ceplene and IL-2 should be reduced by 20%.
- količini odmerkov tako zdravila Ceplene kot IL- 2 zmanjšajte za 20%.
- IL-2 can be discontinued for 24 hours and then restarted at a 20% dose reduction level.
- zdravljenje z IL- 2 prekinite za 24 ur, nato pa ponovno pričnite z 20- odstotno zmanjšanim
Abnormal WBC counts
odmerkom.
- the dose of IL-2 can be reduced by 20% for the remaining duration of the treatment course
- odmerek IL- 2 lahko za preostali čas zdravljenja zmanjšate za 20%, če pa se nenormalno
and if abnormal WBC counts re-occur during the following cycle a permanent IL-2 reduction is recommended.
število belih krvnih telesc med naslednjim ciklom zdravljenja ponovno pojavi, je priporočeno trajno zmanjšanje odmerka IL- 2.
Localised toxic dermatitis
Lokaliziran toksični dermatitis
- treatment should be discontinued until symptoms resolved.
- zdravljenje prekinite, dokler simptomi ne izginejo.
Treatment can be resumed by
Zdravljenje lahko nadaljujete z
administering Ceplene at the full dose and IL-2 at 50%.
dajanjem polnega odmerka zdravila Ceplene in 50% odmerka IL- 2.
Patients with renal impairment may be more sensitive to the blood pressure lowering effects of Ceplene.
Ledvična okvara Bolniki z ledvično okvaro so lahko bolj občutljivi na zniževanje krvnega tlaka, ki ga povzroči zdravilo Ceplene.
Ceplene should be used with caution in patients with moderate to severe hepatic impairment (see section 5.2).
Okvare jeter Pri bolnikih z zmernimi do hudimi jetrnimi okvarami je treba zdravilo Ceplene uporabljati previdno (glejte poglavje 5. 2).
Ceplene is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy in this age group (see section 5.1 and 5.2).
Pediatrična populacija Uporaba zdravila Ceplene pri otrocih, mlajših od 18 let, ni priporočljiva zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej starostni skupini (glejte poglavji 5. 1 in 5. 2).
4 One to 3 minutes after the subcutaneous administration of IL-2 has been completed, Ceplene should be administered by slow subcutaneous injection at a rate not to exceed 0.1 ml (0.1 mg histamine dihydrochloride) per minute.
Hitrost injiciranja ne sme preseči 0, 1 ml (0, 1 mg histaminijevega diklorida) na minuto.
The usual time for administering a 0.5 ml Ceplene dose is 5 minutes.
Običajni čas za injiciranje 0, 5 ml zdravila Ceplene je 5 minut.
The first dose of Ceplene and IL-2 on day 1 of the initiation of the first cycle of treatment should be administered in the clinic under direct supervision by a physician.
Prvo injiciranje odmerka zdravila Ceplene in IL- 2 na prvi dan prvega cikla zdravljenja naj poteka na kliniki pod neposrednim nadzorom zdravnika.
If the patient experiences a significant change in vital signs, the physician should evaluate the status of the patient and continue to monitor vital signs; these patients should be monitored during subsequent treatments.
Te bolnike je treba spremljati med nadaljnjim zdravljenjem.
Ceplene should not be injected into the same anatomic region as IL-2.
Zdravilo Ceplene ne sme biti injicirano na isto anatomsko mesto kot IL- 2.
The twice daily dosing of IL-2 and Ceplene should be separated by a minimum of 6 hours.
Med dvema dnevnima dajanjema IL- 2 in zdravila Ceplene naj preteče vsaj 6 ur.
• Hypersensitivity to the active substance or to any of the excipients. • Patients with significantly compromised cardiac function, e. g., NYHA Class III/ IV. • Patients receiving systemic steroid therapy, clonidine and H2 blocking agents. • Patients who have received an allogenic stem cell transplant. • During pregnancy. • During breast feeding.
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov. • Bolniki z izrazito kompromitirano srčno funkcijo, na primer stopnja III/ IV po NYHA klasifikaciji. • Bolniki, zdravljeni s sistemskimi steroidi, klonidinom ali zaviralci H2 receptorjev. • Bolniki, pri katerih je bila izvedena transplantacija alogenskih izvornih celic. • Med nosečnostjo. • Med dojenjem.
Ceplene should be administered 1 to 3 minutes after IL-2 administration, and not concomitantly. • Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia, or syncope.
Zdravilo Ceplene je treba injicirati 1 do 3 minute po injiciranju IL- 2 in ne takoj po injiciranju IL- 2. • Hitro subkutano injiciranje ali injiciranje v žilo lahko povzroči hudo hipotenzijo, tahikardijo ali sinkopo.
Treatment with Ceplene in conjunction with IL-2 should be used with caution in patients with poorly compensated cardiac function.
Previdnost je potrebna pri sočasnem zdravljenju z zdravilom Ceplene in IL- 2 pri bolnikih s slabšim delovanjem srca.
Patients with cardiac disease should be evaluated for ventricular ejection fraction and wall function by echocardiography or nuclear medicine stress test and then treated with caution. • Patients should be monitored during treatment for possible clinical complications due to hypotension or hypovolaemia.
Pri bolnikih s srčnimi boleznimi je treba ustrezno oceniti iztisni delež levega prekata in delovanje srčne stene z elektrokardiografom ali stresnim testom nuklearne medicine, pri zdravljenju pa je potrebna previdnost. • Bolnike je med zdravljenjem treba spremljati zaradi možnih kliničnih zapletov zaradi hipotenzije in hipovolemije.
Patient monitoring on day 1 should include vital signs, including pulse, blood pressure and respiratory rate. • Patient monitoring during subsequent treatment days or cycles should be performed as long as the patient continues to experience significant changes in vital signs during administration of Ceplene.
Nadzorovanje bolnika v prvem dnevu cikla naj vključuje spremljanje življenjskih znakov, vključno s srčnim utripom, krvnim tlakom in hitrostjo dihanja. • Spremljanje bolnikov med nadaljnjim zdravljenjem v ciklu ali med naslednjimi cikli naj poteka, dokler se pri bolniku pojavljajo bistvene spremembe v življenjskih znakih med uporabo zdravila Ceplene.
If significant hypotension or related symptoms are observed in subsequent treatment cycles, dose reduction should be initiated and if required, administered in hospital until responses to treatment allow for home administration.
Če se pri bolniku med zdravljenjem v naslednjih ciklih očitno pojavi hipotenzija ali povezani simptomi, je treba ustrezno zmanjšati odmerek zdravila in po potrebi
5 • Caution should be used for patients with any of the following: symptomatic peripheral arterial disease, past or present peptic or oesophageal ulcer disease with a history of bleeding, clinically significant renal disease and stroke within the last 12 months.
5 zdravilo injicirati v bolnišnici, dokler odziv na zdravljenje ne omogoči uporabe zdravila doma. • Posebna previdnost je potrebna pri bolnikih, pri katerih se pojavlja simptomatska periferna arterijska bolezen, ki so imeli ali imajo peptično razjedo ali razjede požiralnika s krvavitvami v anamnezi, klinično pomembne ledvične bolezni in kap v zadnjih 12 mesecih.
Where appropriate, consideration should be made to providing concomitant treatment with a proton pump inhibitor. • Patients with clinically significant infection requiring the use of antibiotics, antifungals, or antivirals, or who have completed prior anti-infectious therapy within 14 days of starting treatment should be treated with caution unless the use of antibiotics and antivirals were for prophylaxis purposes. • Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution. • Monitoring of laboratory test results is recommended including standard haematological and blood chemistry tests. • Patients receiving the following medicinal products should be treated with caution (see section 4.5) -Beta-blockers or other anti-hypertensive agents. -H1 blocking agents and neuroleptics (anti-psychotics) with H1 receptor blocking properties. -Tricyclic anti-depressants that may have H1 and H2 receptor blocking properties. -Monoamine oxidase inhibitors and anti-malarial and anti-trypanosomal agents. -Neuromuscular blocking agents, narcotic analgesics, and various contrast media.
Kadar je potrebno, lahko razmislite o sočasnem zdravljenju z zaviralci protonske črpalke. • Bolniki s klinično pomembnimi okužbami, ki zahtevajo zdravljenje z antibiotiki, antimikotiki ali protivirusnimi zdravili, ali ki so v obdobju 14 dni pred pričetkom zdravljenja z zdravilom Ceplene zaključili z antiinfektivno terapijo, naj bodo posebej nadzorovani, razen če so bili antibiotiki in protivirusna zdravila uporabljeni v preventivne namene. • Bolnike z avtoimunimi boleznimi v anamnezi (vključno s sistemskim lupusom, vnetno črevesno boleznijo, psoriazo in revmatoidnim artritisom) je treba zdraviti previdno. • Priporočljivo je spremljanje rezultatov laboratorijskih preiskav, vključno s standardnimi hematološkimi preiskavami in kemijskimi preiskavami krvi. • Posebna previdnost je potrebna pri bolnikih, ki prejemajo katero od naslednjih navedenih zdravil (glejte poglavje 4. 5):
4.5 Interaction with other medicinal products and other forms of interaction
- beta- zaviralce ali druga antihipertenzivna zdravila,
While posology differs, when Ceplene is used in conjunction with IL-2, physicians should also refer to the SmPC for IL-2 and observe the respective medical product interactions.
- zaviralce monoaminooksidaze ter antimalarike in zdravila za zdravljenje tripanosomoze,
H2 receptor antagonists with imidazole structures similar to histamine, e. g., cimetidine, systemic steroids and clonidine, must not be used during treatment with Ceplene (see section 4.3).
Zaviralcev H2 receptorjev z imidazolnimi strukturami, podobnimi histaminu, na primer cimetidina, sistemskih steroidov in klonidina, med zdravljenjem z zdravilom Ceplene ne smemo uporabljati (glejte poglavje 4. 3).
Beta-blockers and other anti-hypertensive agents should be used with caution during treatment with Ceplene.
Beta- zaviralce in druga antihipertenzivna zdravila je treba v času zdravljenja z zdravilom Ceplene uporabljati previdno.
H1 receptor blocking antihistamines or neuroleptics (anti-psychotics) with H1 receptor blocking properties that might decrease efficacy of Ceplene should be avoided.
Antihistaminski zaviralci H1 receptorjev ali nevroleptiki (antipsihotiki) z lastnostmi zaviralcev H1 receptorjev lahko zmanjšajo učinkovitost zdravila Ceplene in se jim je zato treba izogibati.
Tricyclic anti-depressants may have H1 and H2 receptor blocking properties and should be avoided.
Triciklični antidepresivi lahko imajo lastnosti zaviralcev H1 in H2 receptorjev in se jim je zato treba izogibati.
Monoamine oxidase inhibitors, anti-malarial, and anti-trypanosomal active substances may alter the metabolism of Ceplene and should be avoided (see section 4.4).
Zaviralci monoaminooksidaze, antimalariki in zdravila za zdravljenje tripanosomoze lahko spremenijo presnovo zdravila Ceplene in se jim je zato treba izogibati (glejte poglavje 4. 4).