natgillin/translations-raw huggingface dataset:
Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
intervala)*, nenormalno mednarodno umerjeno razmerje*, znižan pH v želodcu, zvečana agregacija trombocitov, zvišana koncentracija troponina I,
Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction Rare
Občasni krvavitev iz nožnice, bolečina v spolovilih*, erektilna disfunkcija
NAME OF THE MEDICINAL PRODUCT Bortezomib SUN 3.5 mg powder for solution for injection
Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje
Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Med zdravljenjem z bortezomibom se zelo pogosto pojavijo toksični učinki na prebavila, kot so navzea, driska, bruhanje in zaprtost.
If local injection site reactions occur following Bortezomib SUN subcutaneous injection, either a less concentrated Bortezomib SUN solution (bortezomib 3.5 mg to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Bortezomib SUN (1 mg/ml namesto 2,5 mg/ml) ali preidete na intravensko dajanje zdravila.
PR n (%) nCR n(%)
ORR (CR+PR) p-vrednosta CR n (%) PR n (%) nCR n(%)
GENERAL CLASSIFICATION FOR SUPPLY
Prilagoditev začetnega odmerka blaga
• different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
• Informacijo o različnem postopku rekonstitucije pri intravenskem (i.v.)
Common Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion#, Blepharitis#, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
Občasni krvavitve v očesu*, okužba veke*, halazij#, blefaritis#, vnetje očesa*, diplopija, suhe oči*, draženje očesa*, bolečina v očesu, povečano solzenje, izcedek iz očesa
Bortezomib SUN contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Kaj je zdravilo Bortezomib SUN in za kaj ga uporabljamo Zdravilo Bortezomib SUN vsebuje zdravilno učinkovino bortezomib, ki je zaviralec proteasomov.
breathing that becomes shallow, difficult or stops, wheezing - blood clots in your lungs - yellow discoloration of the eyes and skin (jaundice) - lump in the eyelid (chalazion), red and swollen eyelids.
Nekatere vključujejo oteženo dihanje, zasoplost, zasoplost brez telesnega napora, dihanje, ki postane plitvo, oteženo ali preneha, sopenje - krvni strdki v pljučih - rumeno obarvanje beločnic ali kože (zlatenica) - zatrdlina na veki (halazij), rdeče in otekle veke.
Name and address of the manufacturer responsible for batch release
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serije Sun Pharmaceutical Industries Europe B.V.
Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
sindrom možganskega debla, možgansko-žilne bolezni, lezija živčnih korenov, psihomotorna hiperaktivnost, kompresija hrbtenjače, kognitivna motnja n.d.n., motorične motnje, bolezni živčevja n.d.n., radikulitis, slinjenje, hipotonija
In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Pri vseh bolnikih, kot tudi pri bolnikih, ki so pred tem že prejeli eno vrsto terapije, je preskušanje zdravljenja z bortezomibom vodilo do statistično značilno daljšega časa do napredovanja bolezni, statistično značilno podaljšanega preživetja in statistično značilno boljšega odziva na zdravljenje v primerjavi z zdravljenjem z deksametazonom (glejte preglednico 14).
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Prilagajanje odmerkov med zdravljenjem pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic
Common Sleep disorders and disturbances* Nervous system disorders Very Common
Pogosti motnje razpoloženja*, anksiozne motnje*, motnje spanja*
Hypermagnesaemia*, Acidosis, Electrolyte imbalance*,
levkocitoza*, limfadenopatija, hemolitična anemija#
Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions.
Pri bolnikih z obstoječimi resnimi boleznimi, ki so bortezomib prejemali sočasno z drugimi zdravili, so poročali o redkih primerih odpovedi jeter.
What Bortezomib SUN is and what it is used for
Zdravilo Bortezomib SUN se uporablja za zdravljenje:
Common Dyspnoea*, Cough*, Hiccups Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Občasni sindrom akutne dihalne stiske, pljučna embolija, pnevmonitis, pljučna hipertenzija, pljučni edem (vključno z akutnim)
- When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle.
Bortezomib SUN injicirali v veno ali v podkožje v 21-dnevnem krogu zdravljenja.
Common Rash*, Pruritus*, Erythema, Dry skin Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis#, Stevens-Johnson syndrome#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer#, Acne*, Blister*, Pigmentation disorder*
Občasni multiformni eritem, urtikarija, akutna febrilna nevtrofilna dermatoza, toksični kožni izpuščaj, toksična epidermalna nekroliza#, Stevens-Johnsonov sindrom#, dermatitis*,
4.2 mo
4,2 meseca
• that Bortezomib SUN is to be given only by IV or SC injections; no other route of administration is allowed
• Zdravilo Bortezomib SUN se lahko injicira samo i.v.
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib SUN 21-day treatment cycle.
Bolnik jemlje 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan 21-dnevnega kroga zdravljenja z zdravilom Bortezomib SUN.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3.5 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
letargijo, zmedenostjo, slepoto in drugimi motnjami vida ter nevrološkimi motnjami.
Table 2: Recommended posology for Bortezomib SUN in combination with melphalan and prednisone Twice weekly Bortezomib SUN (cycles 1-4)
Bortezomib SUN v kombinaciji z deksametazonon in zdravilo Bortezomib SUN v kombinaciji z deksametazonom in talidomidom).
At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Po najmanj 6 mesecih po predhodnem zdravljenju so bortezomib uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1,3 mg/m2 (n=93) ali ≤ 1,0 mg/m2 (n=37).
in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.
Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in niso primerni za presaditev krvotvornih matičnih celic
Bortezomib SUN powder has to be dissolved before administration.
Zdravilo Bortezomib SUN je v obliki praška, ki ga je treba raztopiti pred injiciranjem.
Decreased appetite Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention Uncommon Tumour lysis syndrome
Zelo pogosti zmanjšan apetit Pogosti hipokaliemija*, nenormalne koncentracije glukoze v krvi*, hiponatriemija*, sladkorna bolezen*, zastajanje
One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression.
Bolnike, ki so predhodno imeli vsaj delni odziv na režim zdravljenja z bortezomibom, so ponovno zdravili po napredovanju bolezni.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzmbR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini
rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Macrophage activation
Redki aktivacija makrofagov n.d.n.
België/Belgique/Belgien/България/Česká republika/
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
Common Oedema (inc peripheral), Chills, Pain*, Malaise* Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain*
Občasni poslabšanje splošnega zdravstvenega stanja*, edem obraza*, reakcija na mestu injiciranja*, bolezni sluznice*, bolečina v prsih, motnje hoje, občutek mrazenja, ekstravazacija*, s katetrom povezani zapleti*,
Common Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence
Pogosti krvavitev v prebavilih (vključno s sluznico)*, dispepsija, stomatitis*, abdominalna distenzija, bolečina v žrelu in grlu*, bolečina v trebuhu (vključno z bolečino v prebavilih in vranici)*, bolezni ust*, flatulenca
However, the reconstituted solution is stable for 8 hours at 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration.
Rekonstituirana raztopina je stabilna 8 ur pri 25 °C, shranjena v originalni viali in/ali injekcijski brizgi.
Pregnancy
premor
*RR (Post-induction) CR+nCR
*CR+nCR CR+nCR+VGPR+PR
A hazard ratio less than 1 indicates an advantage for VMP c Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f CR=Complete Response; PR=Partial Response.
Razmerje tveganja, manjše kot 1, kaže prednost zdravljenja z VMP. c Nominalna p-vrednost na podlagi stratificiranega log-rank testa, prilagojena na podlagi stratifikacijskih dejavnikov: β2
- Non-haematological toxicities should have resolved to Grade 1 or baseline Table 3: Posology modifications during subsequent cycles of Bortezomib SUN therapy in combination with melphalan and prednisone
Preglednica 2: Priporočeno odmerjanje zdravila Bortezomib SUN v kombinaciji z melfalanom in prednizonom
c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
e Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja.
Dexamethasone 40 mg is given orally on days-1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib SUN 28-day treatment cycle.
Bolnik jemlje 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan kroga zdravljenja z zdravilom Bortezomib SUN.
Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Na voljo je malo podatkov o ponovnem zdravljenju z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma.
- swelling of body, to include eyes and other parts of the body - shivering - redness and pain at injection site - general ill feeling - weight loss - weight increase.
- srbenje kože - pordelost kože - izpuščaj - mišični krči - okužba sečil - bolečine v udih - otekanje telesa, vključno z očmi in drugimi deli telesa
Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
Glede na vaš odziv na zdravljenje, pojavnost določenih neželenih učinkov in morebitne druge bolezni
Bladder irritation
avtonomna nevropatija
Common Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Občasni duševne motnje*, halucinacije*, psihotične motnje*,
Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Za ugotavljanje učinkovitosti in varnosti ponovnega zdravljenja z bortezomibom so izvedli odprto, enokračno, študijo faze II MMY-2036 (RETRIEVE) pri stotridesetih bolnikih (starih ≥ 18 let) z diseminiranim plazmocitomom.
- In cycles 5 to 9, Bortezomib SUN is administered once weekly on days 1, 8, 22 and 29.
- V krogih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
Other medicines and Bortezomib SUN
Med zaporednimi odmerki zdravila Bortezomib
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m2) and prednisone (60 mg/m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
(60 mg/m2) pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom so izvedli prospektivno, mednarodno, randomizirano (1:1) odprto klinično študijo faze III (MMY-3002 VISTA) pri 682 bolnikih.
- If local injection site reactions occur following Bortezomib SUN injection subcutaneously, either a less concentrated Bortezomib SUN solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Če se po subkutanem injiciranju zdravila Bortezomib SUN na mestu injiciranja pojavijo lokalne reakcije, se priporoča, da subkutano injicirate manj koncentrirano raztopino zdravila Bortezomib SUN
Discontinue Bortezomib SUN
Izpostavljenost bortezomibu
> 1.0 x - 1.5 x ULN Any
> 1,0-1,5x ULN katera koli ni potrebna zmerna
Table 4: Posology for Bortezomib SUN combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Preglednica 4: Priporočeno odmerjanje zdravila Bortezomib SUN pri bolnikih, s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Zelo pogosti nevropatije*, periferna senzorična nevropatija,
Common Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache* Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Organski sistem Pogostnost Neželeni učinek encefalopatija*, posteriorni reverzibilni encefalopatični sindrom#, nevrotoksičnost, motnje s krči*, postherpetična nevralgija, motnje govora*, sindrom nemirnih nog,
VDDx (N=239)
(n=239)
in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
samostojno ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali deksametazonom pri bolnikih, pri katerih je bolezen napredovala po tem, ko so prejeli vsaj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev krvotvornih matičnih celic pri njih ni mogoča; v kombinaciji z melfalanom in prednizonom pri bolnikih, pri katerih bolezni še nismo zdravili in pri njih kemoterapija v velikih odmerkih pred presaditvijo krvotvornih matičnih celic ni mogoča;
Pyrexia*, Fatigue, Asthenia
zmedenost*, nemir
Common Oedema (inc peripheral), Chills, Injection site reaction*, Malaise*
Zelo pogosti zvišana telesna temperatura*, utrujenost, astenija Pogosti edem (vključno s perifernim), mrazenje, reakcija na mestu injiciranja*, splošno slabo počutje*
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
1 pre-filled pen
1 napolnjen injekcijsk peresnik
MA (EU) number (Invented) name
Številka postopka EMEA Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Pack size
30 tablet
Strength Pharmaceutical Form
30 tablets
and Citovirax.
in Citovirax.
The European Commission issued an EU-wide legally binding decision on this opinion on 28 April 2016.
Evropska komisija je o tem mnenju dne 28. aprila 2016 izdala pravno zavezujočo odločbo za vso EU.
The company that markets these medicines is F. Hoffmann - La Roche Ltd. and associated companies.
Ta zdravila tržijo družba F. Hofmann - La Roche Ltd. in povezane družbe.
Cymevene is marketed in all EU member states with the exception of Latvia, Malta and Slovenia.
Zdravilo Cymevene se trži v vseh državah članicah EU, razen v Latviji, na Malti in v Sloveniji.
It is also available in the EU under the names Cymevan, Cymeven i.v.
V EU je na voljo tudi pod imeni Cymevan, Cymeven i.v.
It can infect almost anyone but usually remains dormant in healthy people, rarely causing symptoms.
Okuži lahko skoraj vsakogar, vendar pri zdravih ljudeh običajno ostane mirujoč in le redko povzroči simptome.
Information on the safety and efficacy of Cymevene in children under 12 years of age is limited.
Podatki o varnosti in učinkovitosti zdravila Cymevene pri otrocih, mlajših od 12 let, so omejeni.
Why was Cymevene reviewed?
Zakaj je bilo zdravilo Cymevene pregledano?
The CHMP was unable to make recommendations on such use based on currently available data and further assessment should be carried out.
Odbor CHMP na osnovi trenutno razpoložljivih podatkov ni mogel sprejeti priporočil, zato je treba izvesti dodatno ocenjevanje.
The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions) and 4.8 (side effects).
Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (Posebna opozorila in previdnostni ukrepi), 4.5 (Medsebojno delovanje) in 4.8 (Neželeni učinki).
Cymevene has been authorised in the EU via national procedures.
Zdravilo Cymevene je bilo v EU odobreno po nacionalnih postopkih.
On 25 February 2016, the European Medicines Agency completed a review of Cymevene.
Evropska agencija za zdravila je 25. februarja 2016 zaključila pregled zdravila Cymevene.
Questions and answers on Cymevene and associated names (ganciclovir, 500 mg powder for concentrate for solution for infusion, intravenous)
Vprašanja in odgovori v zvezi z zdravilom Cymevene in povezanimi imeni (ganciklovir, 500-mg prašek za koncentrat za raztopino za infundiranje, intravensko)
The medicine can be used in adults and adolescents from 12 years of age.
Zdravilo Cymevene se lahko uporablja pri odraslih in mladostnikih od 12. leta naprej.
In these patients, CMV can result in severe or life-threatening infections that attack various organs including the lungs, brain and eyes.
Pri teh bolnikih lahko CMV povzroči hudo oz. življenjsko nevarno okužbo različnih organov, vključno s pljuči, možgani in očmi.
CMV is a common virus that belongs to the herpes virus family.
CMV je pogost virus, ki spada v družino herpesvirusov.
This has led to divergences across member states in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je med državami članicami povzročilo razlike v načinu, kako se zdravilo lahko uporablja, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, kjer se zdravilo trži.
Patients with reduced kidney function should receive lower doses of Cymevene.
Bolniki z oslabljenim delovanjem ledvic morajo prejemati nižje odmerke zdravila Cymevene.
The recommended dose of Cymevene and duration of treatment depend on the weight of the patient and on whether the medicine is used to prevent or treat CMV disease.
Priporočeni odmerek zdravila Cymevene in trajanje zdravljenja sta odvisna od telesne mase bolnika in od tega, ali se zdravilo uporablja za preprečevanje ali za zdravljenje bolezni zaradi CMV.
Different treatment schedules should be followed during initial and maintenance treatment, in accordance with treatment guidelines.
Shemi zdravljenja pri začetnem in pri vzdrževalnem zdravljenju se morata razlikovati glede na smernice zdravljenja.
What is Cymevene?
Kaj je zdravilo Cymevene?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Cymevene in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Cymevene v Evropski uniji (EU).
When prescribing Cymevene, consideration should be given to official guidance on the appropriate use of antiviral agents.
Pri predpisovanju zdravila Cymevene je treba upoštevati uradne smernice za ustrezno uporabo protivirusnih zdravil.
For this reason, the CHMP agreed that Cymevene should not be used in pregnant women unless the potential benefit to the mother outweighs the potential risk to the unborn child.
Odbor CHMP je zato soglašal, da se pri nosečnicah zdravilo Cymevene ne sme uporabljati, razen če je morebitna korist za mater večja od morebitnega tveganja za nerojenega otroka.
Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Cymevene.
Po uskladitvi indikacij je odbor CHMP uskladil tudi priporočila o načinu uporabe zdravila Cymevene.
Since the use of highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with HIV infection, preventive treatment with Cymevene is no longer considered necessary.
Ker je uporaba visokoaktivne protiretrovirusne terapije (HAART) pri bolnikih, okuženih z virusom HIV, zmanjšala tveganje za bolezni zaradi CMV, preventivno zdravljenje z zdravilom Cymevene ni več potrebno.
Cymevene must not be used in patients allergic to its active substance ganciclovir, to a related antiviral medicine, valganciclovir, or to any other ingredients of the medicine.
Zdravilo Cymevene se ne sme uporabljati pri bolnikih, ki so alergični na zdravilno učinkovino ganciklovir, na sorodno protivirusno zdravilo, valganciklovir, ali na katero koli drugo sestavino zdravila.