natgillin/translations-raw huggingface dataset:
The Committee recommended that Nespo be given marketing authorisation.
Odbor je zato je priporočil, da se za zdravilo Nespo
The medicine can only be obtained with a prescription.
Zdravilo nima veā dovoljenja za promet
See the Package Leaflet for full details.
Za več informacij glejte Navodilo za
Bialfar - Produtos Farmacêuticos, Sociedade Anónima
Portugalska Bialfar - Produtos Farmacêuticos, Sociedade Anónima
Astrazeneca Produtos Farmacêuticos, Lda.
Portugalska Astrazeneca Produtos Farmacêuticos, Lda.
Astrazeneca Produtos Farmaceuticos Limitada
Portugalska Astrazeneca Produtos Farmaceuticos Limitada
Sandoz Hungária Kft
Madžarska Sandoz Hungária Kft
Glaxo Wellcome Farmacêutica, Limitada
Portugalska Glaxo Wellcome Farmacêutica, Limitada
Pentafarma - Sociedade TecnicoMedicinal S.A.
Portugalska Pentafarma - Sociedade TecnicoMedicinal S.A.
Sandoz Farmacêutica, Limitada
Portugalska Sandoz Farmacêutica, Limitada
Inhalation Powder, Hard Capsule
Prašek za inhaliranje, trda kapsula
Astrazeneca Kft.
Madžarska Astrazeneca Kft.
Montrose Kft
Madžarska Montrose Kft
Clenil Compositum Beclometasone Dipropionate 0.8mg/2 Ml, Salbutamol Sulfate 1.928mg/2 Ml
Clenil Compositum Beklometazon dipropionat 0,8 mg/2 ml, salbutamol sulfat 1,928 mg/2 ml
Pressurised Inhalation, Suspension
Inhalacijska suspenzija pod tlakom
Budesonide 0.8mg Capsule
Budezonid 0,8 mg kapsula
Salbutamol Sulfate 0.602mg Vial, Flunisolide 0.5mg Vial
Salbutamol sulfat 0,602 mg viala, flunizolid 0,5 mg viala
Glaxosmithkline - Produtos Farmacêuticos, Limitada
Portugalska Glaxosmithkline - Produtos Farmacêuticos, Limitada
Flunisolide 25mg Bottle, Salbutamol 10mg Bottle
Flunizolid 25 mg steklenička, salbutamol 10 mg steklenička
Glaxosmithkline Kft.
Madžarska Glaxosmithkline Kft.
Formoterol Fumarate Dihydrate 1,08 Mg, Beclometasone Dipropionate 18 Mg
Formoterol fumarat dihidrat 1,08 mg, beklometazon dipropionat 18 mg
Budezonid Lek-Am Budesonide 200µg Inhalation
Budezonid Lek-Am Budezonid 200 µg za inhaliranje
Samtoral Diskus Standard Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose
Samtoral Diskus Standard Flutikazon propionat, odmerek 250 µg, salmeterol, odmerek 50 µg
Beclometason Ratiopharm Beclometasone Dipropionate 0.25mg/18.7g
Beclometason Ratiopharm Beklometazon dipropionat 0,25 mg/18,7 g
Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg
Budozenid 320 mcg, formoterol fumarat dihidrat 9 mcg
Clenil Compositum Beclometasone Dipropionate 50µg Actuation, Salbutamol Sulfate 120µg Actuation
Clenil Compositum Beklometazon dipropionat 50 µg s sprožitvijo, salbutamol sulfat 120 µg s sprožitvijo
Budezonid Lek-Am Budesonide 400µg Inhalation
Budezonid Lek-Am Budezonid 400 µg za inhaliranje
Fluticasone Propionate 500 Microgram, Salmeterol Xinafoate 50 Microgram
Flutikazon propionat 500 mikrogramov, salmeterol ksinafoat 50 mikrogramov
Budosenide 160mcg, Formoterol Fumarate Dihydrate 4.5mcg
Budozenid 160 mcg, formoterol fumarat dihidrat 4,5 mcg
Belgium Orion Corporation
Portugalska Orion Corporation
Beclometasone Dipropionate 250µg/59.2 Mg
Beklometazon dipropionat 250 µg/59,2 mg
Fluticasone Propionate 0,5 Mg, Salmeterol Xinafoate 0,073 Mg
Flutikazon propionat 0,5 mg, salmeterol ksinafoat 0,073 mg
Fluticasone Propionate 0,25 Mg, Salmeterol Xinafoate 0,073 Mg
Flutikazon propionat 0,25 mg, salmeterol ksinafoat 0,073 mg
Salmeterol 25µg/Dose; Fluticasone Propionate 125µg/Dose
Salmeterol 25 µg/odmerek; flutikazon propionat 125 µg/odmerek
Fluticasone Propionate 125µg Capsule Inhalation Powder, Hard Capsule
Flutikazon propionat 125 µg kapsula Prašek za inhaliranje, trda kapsula
Netherlands Elpen Pharmaceutical Co. Inc.
Nizozemska Elpen Pharmaceutical Co. Inc.
Budesonide 800µg Units
Budezonid, enote po 800 µg
Beclometasone Dipropionate 50µg/59 Mg
Beklometazon dipropionat 50 µg/59 mg
Fluticasone Propionate 100µg
Flutikazon propionat 100 µg
Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose, Lactose Monohydrate 24.677mg Dose
Flutikazon propionat, odmerek 250 µg, salmeterol, odmerek 50 µg, laktoza monohidrat, odmerek 24,677 mg
Fluticasone Propionate 250µg Capsule Inhalation Powder, Hard Capsule
Flutikazon propionat 250µg kapsula Prašek za inhaliranje, trda kapsula
Budesonide 100µg Units
Budezonid, enote po 100 µg
Beclometasone Dipropionate 250g/78mg
Beklometazon dipropionat 250 g/78 mg
Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose, Lactose Monohydrate 24.677mg Dose
Flutikazon propionat, odmerek 500 µg, salmeterol, odmerek 50 µg, laktoza monohidrat, odmerek 24,677 mg
Fluticasonpropionat „allen“ Fluticasone Propionate 250µg Dose Inhalation Powder
Fluticasonpropionat „allen“ Flutikazon propionat, odmerek 250 µg Prašek za inhaliranje
Cyclocaps Beclometason Beclometasone Dipropionate 200µg Units
Cyclocaps Beclometason Beklometazon dipropionat, enote po 200 µg
Fluticasone Propionate 125µg
Flutikazon propionat 125 µg
Symbicort Mite Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose
Symbicort Mite Turbuhaler Budezonid, odmerek 160 µg, formoterol fumarat dihidrat, odmerek 4,5 µg
Cyclocaps Beclometason Beclometasone Dipropionate 400µg Units
Cyclocaps Beclometason Beklometazon dipropionat, enote po 400 µg
Fluticasone Propionate 500µg Inhalation, Salmeterol 50µg Inhalation
Flutikazon propionat 500 µg za inhaliranje, salmeterol 50 µg za inhaliranje
Cyclocaps Beclometason Beclometasone Dipropionate 100µg Units
Cyclocaps Beclometason Beklometazon dipropionat, enote po 100 µg
Fluticasone Propionate 250µg Inhalation, Salmeterol Xinafoate 25µg Inhalation
Flutikazon propionat 250 µg za inhaliranje, salmeterol ksinafoat 25 µg za inhaliranje
Fluticasone Propionate 250µg
Flutikazon propionat 250 µg
Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation
Budezonid 320 µg za inhaliranje, formoterol fumarat dihidrat 9 µg za inhaliranje
Symbicort Forte Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose
Symbicort Forte Turbohaler Budezonid, odmerek 320 µg, formoterol fumarat dihidrat, odmerek 9 µg
Fluticasone Propionate 50µg
Flutikazon propionat 50 µg
Beclometasone Dipropionate 0,1 Mg Pressurised Inhalation, Solution
Beklometazon dipropionat 0,1 mg Inhalacijska raztopina pod tlakom
Fluticasone Propionate 50µg Inhalation
Flutikazon propionat 50 µg za inhaliranje
Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation
Budezonid 160 µg za inhaliranje, formoterol fumarat dihidrat 4,5 µg za inhaliranje
Symbicort Forte Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose
Symbicort Forte Turbuhaler Budezonid, odmerek 320 µg, formoterol fumarat dihidrat, odmerek 9 µg
Fluticasonpropionat „allen“ Fluticasone Propionate 125µg Dose Pressurised Inhalation,
Fluticasonpropionat „allen“ Flutikazon propionat, odmerek 125 µg Inhalacijska suspenzija pod tlakom
Budesonide, Micronised 0.4mg Actuation
Budezonid, mikroniziran, 0,4 mg s sprožitvijo
Belgium Elpen Pharmaceutical Co. Inc.
Madžarska Elpen Pharmaceutical Co. Inc.
Beclometasone Dipropionate 100g/18.7g
Beklometazon dipropionat 100 g/18,7 g
Beclometasone Dipropionate 100µg Inhalation, Formoterol Fumarate 6µg Inhalation
Beklometazon dipropionat 100 µg za inhaliranje, formoterol fumarat dihidrat 6 µg za inhaliranje
Fluticasone Propionate 100µg Dose Inhalation Powder
Flutikazon propionat, odmerek 100 µg Prašek za inhaliranje
Fluticasone Propionate 250µg Inhalation
Flutikazon propionat 250 µg za inhaliranje
Beclometasone Dipropionate 0.2mg Dose
Beklometazon dipropionat, odmerek 0,2 mg
Fluticasonpropionat „allen“ Fluticasone Propionate 250µg Dose Pressurised Inhalation,
Fluticasonpropionat „allen“ Flutikazon propionat, odmerek 250 µg Inhalacijska suspenzija pod tlakom
Fluticasone Propionate 125µg Inhalation
Flutikazon propionat 125 µg za inhaliranje
Fluticasone Propionate 125µg Dose Aerosol
Flutikazon propionat, odmerek 125 µg Aerosol
Beclometasone Dipropionate 0,2 Mg Pressurised Inhalation, Solution
Beklometazon dipropionat 0,2 mg Inhalacijska raztopina pod tlakom
Fluticasone Propionate 250µg Dose Aerosol
Flutikazon propionat, odmerek 250 µg Aerosol
Fluticasone Propionate 500µg Inhalation
Flutikazon propionat 500 µg za inhaliranje
Budesonide 320µg Dose, Formoterol Fumarate Dihydrate Ph.Eur.
Budezonid, odmerek 320 µg, formoterol fumarat dihidrat Ph.Eur., odmerek 9 µg
Budesonide, Micronised 200µg Dose Inhalation Powder
Budezonid, mikroniziran, odmerek 200 µg
Fluticasone Propionate 250µg Dose Inhalation Powder
Flutikazon propionat, odmerek 250 µg Prašek za inhaliranje
Budesonide 400µg Inhalation
Budezonid 400 µg za inhaliranje
Budesonide, Micronised 0.2mg Actuation
Budezonid, mikroniziran, 0,2 mg s sprožitvijo
Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Dose
Beklometazon dipropionat 100 µg s sprožitvijo, formoterol fumarat dihidrat, odmerek 6 µg
Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose
Salmeterol ksinafoat, odmerek 50 µg, flutikazon, odmerek 250 µg
Budesonide 0.2mg Dose
Budezonid, odmerek 0,2 mg
Formoterol Fumarate Dihydrate 6µg Dose, Beclometasone Dipropionate Anhydrous 100µg Dose
Formoterol fumarat dihidrat 6 µg s sprožitvijo, brezvodni beklometazon dipropionat 100 µg s sprožitvijo
Budesonide, Micronised 400µg Dose Inhalation Powder
Budezonid, mikroniziran, odmerek 400 µg
Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation
Beklometazon dipropionat 100 µg s sprožitvijo, formoterol fumarat dihidrat 6 µg s sprožitvijo
Salmeterol Xinafoate 50µg Dose, Fluticasone Propionate 250µg Dose
Salmeterol ksinafoat, odmerek 50 µg, flutikazon propionat, odmerek 250 µg
Budesonide 200µg Puff
Budezonid 200 µg pršilo
Beclometasone Dipropionate 250g/18.7g
Beklometazon dipropionat 250 g/18,7 g
Fluticasone Propionate 125µg Dose Pressurised Inhalation
Flutikazon propionat, odmerek 125 µg Inhalacijska raztopina pod tlakom
Fluticasone Propionate 500µg
Flutikazon propionat 500 µg
Fluticasone Propionate 250µg Dose Pressurised Inhalation
Flutikazon propionat, odmerek 250 µg Inhalacijska raztopina pod tlakom
Fluticasone Propionate 250mcg/Dose Inhalation Powder
Flutikazon propionat, 250 mcg/odmerek
Budesonide 160µg Dose, Formoterol Fumarate Dihydrate Ph.Eur.
Budezonid, odmerek 160 µg, formoterol fumarat dihidrat Ph.Eur., odmerek 4,5 µg
Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed
Flutikazon propionat, odmerek 250 µg Prašek za inhaliranje, odmerjeni
Fluticasone Propionate 500µg Dose Inhalation Powder
Flutikazon propionat, odmerek 500 µg Prašek za inhaliranje
Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed
Flutikazon propionat, odmerek 500 µg Prašek za inhaliranje, odmerjeni
Salmeterol Xinafoate 50µg Dose, Fluticasone Propionate 500µg Dose
Salmeterol ksinafoat, odmerek 50 µg, flutikazon propionat, odmerek 500 µg
Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose
Salmeterol ksinafoat, odmerek 50 µg, flutikazon, odmerek 500 µg
Fluticasone Propionate 250mcg/Dose Pressurised Inhalation,
Flutikazon propionat, 250 µg/odmerek Inhalacijska suspenzija pod tlakom
Salmeterol 50µg Dose, Fluticasone Propionate 500µg Dose
Salmeterol, odmerek 50 µg; flutikazon propionat, odmerek 500 µg
This may take 5-10 minutes.
To lahko traja 5-10 minut.
Below is a list of examples of these types of medicines:
Spodaj je seznam primerov tovrstnih zdravil:
• Additional monitoring
• Dodatno spremljanje
You may be more closely monitored by your doctor if you are below the age of 18 or over the age of 65.
Zdravnik vas bo morda skrbneje spremljal, če ste mlajši od 18 let ali starejši od 65 let.
This medicine should not be taken by those under 15 years of age.
Tega zdravila ne smejo jemati tisti, ki so mlajši od 15 let.
• seeing or hearing things that are not there (hallucinations).
• če slišite ali vidite stvari, ki jih ni (halucinacije).
Similar to control
Podobno kot kontrola
When a hepatic event is suspected, further biological and etiological evaluation is required.
Če sumite na jetrni dogodek, je potrebno nadaljnje biološko in etiološko ovrednotenje.
The patient should be transferred to an environment within which full resuscitation facilities are available.
Bolnika je treba prenesti v okolje, kjer so na voljo vsi pripomočki za oživljanje.
Email: PatientSafetyRoW@indivior.com
E-pošta: PatientSafetyRoW@indivior.com
• recently suffered a head injury or brain disease
• nedavnih poškodb glave ali bolezni možganov,
Important things to be aware of:
Pomembne informacije, ki jih morate poznati:
• Take the dose once a day by placing the tablets under the tongue.
• Odmerek vzemite enkrat dnevno, tako da tablete namestite pod jezik.
Date of latest renewal: 26 September 2011
Datum prve odobritve: 26. september 2006 Datum zadnjega podaljšanja: 26. september 2011
Due to the lack of data in adolescents (age 15-<18), patients in this age group should be more closely monitored during treatment.
Zaradi pomanjkanja podatkov o uporabi pri mladostnikih (starost 15 do <18) je treba bolnike v tej skupini med zdravljenjem spremljati bolj natančno.
• Dependence This product can cause dependence.
• Odvisnost To zdravilo lahko povzroča odvisnost.
• some medicines may decrease the effect of Suboxone.
• Nekatera zdravila lahko zmanjšajo učinek zdravila Suboxone.
You may be unable to think clearly, and may breathe much slower than is normal for you.
Morda ne boste mogli trezno razmišljati, vaše dihanje pa bo morda veliko počasnejše, kot je za vas normalno.
Use in adolescents (Age 15-<18)
Uporaba pri mladostnikih (starost 15 do <18)
• Misuse and abuse
• Napačna uporaba in zloraba
No synergistic enhancement of toxicity has been observed.
Sinergijske okrepitve toksičnosti niso opazili.
They may also cause central nervous system depression, which is very serious.
Povzročajo tudi depresijo osrednjega živčnega sistema, ki je zelo nevarna.
In some patients, after a satisfactory stabilisation has been achieved, the frequency of dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday).
Pri nekaterih bolnikih lahko po zadovoljivi stabilizaciji zmanjšate pogostnost odmerjanja na 3-krat tedensko (na primer ponedeljek, sreda in petek).
These may be signs of a life-threatening allergic reaction.
To so lahko znaki življenjsko nevarnih alergijskih reakcij.
Your doctor will decide if your treatment should be continued with an alternative medicine.
Vaš zdravnik se bo odločil, ali naj se zdravljenje nadaljuje z nadomestnim zdravilom.
The maximum daily dose is 24 mg.
Največji dnevni odmerek je 24 mg.
General supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient.
Uvesti je treba splošne podporne ukrepe, ki vključujejo pozorno spremljanje stanja dihanja in srčnega utripa bolnika.
Undesirable effects were based on the known pharmacological activity of opioid agonistic and/or antagonistic substances.
Neželeni učinki so temeljili na znani farmakološki aktivnosti opioidnih agonističnih in/ali antagonističnih snoveh.
A patent airway and assisted or controlled ventilation must be assured.
Zagotoviti morate prehodne dihalne poti in asistirano ali nadzorovano ventilacijo.
• Diagnosis of unrelated medical conditions This medicine may mask pain symptoms that could assist in the diagnosis of some diseases.
• Diagnoza ali nepovezana zdravstvena stanja To zdravilo lahko zakrije simptome bolečine, ki lahko pomagajo pri diagnozi nekaterih bolezni.
Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Zaradi tega je treba odmerke prilagoditi, in se izogniti tej kombinaciji, ko obstaja tveganje za napačno uporabo.
Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit.
Buprenorfin se lahko uporablja napačno ali zlorablja podobno kot druge opioide, zakonite ali nezakonite.
Patients with rare hereditary problems of galactose intolerance, should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo tega zdravila ne smejo jemati.
o benzodiazepines: This combination may result in death due to respiratory depression of central origin.
o Benzodiazepini: ta kombinacija lahko povzroči smrt zaradi respiratorne depresije centralnega izvora.
Depending on your condition, the dose of Suboxone may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Glede na vaše stanje lahko odmerek zdravila Suboxone še naprej zmanjšujete pod skrbnim zdravniškim nadzorom, dokler ga na koncu ne prenehate jemati.
These may be symptoms of liver damage.
To so lahko simptomi poškodb jeter.
The absorption of buprenorphine is followed by a rapid distribution phase (distribution half-life of 2 to 5 hours).
Porazdelitev Absorpciji buprenorfina sledi faza hitre porazdelitve (porazdelitveni razpolovni čas 2 do 5 ur).
However, Suboxone can be a target for people who abuse prescription medicine.
Vendar je lahko zdravilo Suboxone tarča ljudi, ki zlorabljajo zdravila na recept.
However, the dose given on any one day should not exceed 24 mg buprenorphine.
Vendar odmerek na kateri koli posamezen dan ne sme presegati 24 mg buprenorfina.
• alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7).
• alkoholnimi pijačami ali zdravili, ki vsebujejo alkohol, ker alkohol okrepi sedativni učinek buprenorfina (glejte poglavje 4.7).
• Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms.
• Tablet ne žvečite ali pogoltnite, ker zdravilo ne bo delovalo, lahko pa se pojavijo odtegnitveni simptomi.
A doctor's assessment of your readiness for treatment will guide the timing of your first Suboxone dose.
Zdravnikova ocena vaše primernosti za zdravljenje bo narekovala čas za vaš prvi odmerek zdravila Suboxone.
This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Suboxone.
To se lahko pogosteje zgodi v prvih nekaj tednih zdravljenja, ko se vaš odmerek spreminja, lahko pa se tudi med uživanjem alkohola ali jemanjem drugih pomirjeval sočasno z zdravilom Suboxone.
Suboxone is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Zdravilo Suboxone se uporablja pri odraslih ali mladostnikih, starih 15 let ali več, ki prejemajo tudi medicinsko, socialno in psihološko podporo.
Indivior Europe Limited
Slovenija Indivior Europe Limited
Pharmacotherapeutic group: Other nervous system drugs, drugs used in addictive disorders, ATC code: N07BC51.
Farmakoterapevtska skupina: druga zdravila za živčni sistem, zdravila, ki se uporabljajo pri motnjah odvisnosti, oznaka ATC: N07BC51.
Your doctor will determine the best dose for you.
Vaš zdravnik bo določil najprimernejši odmerek za vas.
• asthma or other breathing problems
• astme ali drugih težav z dihanjem,
Keep this medicine in a safe place to protect it from theft.
Zdravilo shranjujte na varnem mestu, zaščitenega pred krajo.
Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
Buprenorfin so prilagodili na vzdrževalni odmerek do 3. dne; aktivne kontrolne odmerke so titrirali bolj postopoma.
The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
Učinkovitost buprenorfina, 8 mg na dan, je bil podoben učinku zmernega aktivnega kontrolnega učinka, vendar enakovrednosti niso dokazali.
Do not take Suboxone together with alcohol.
Zdravila Suboxone ne smete vzeti skupaj z alkoholom.
28 sublingual tablets
28 podjezičnih tablet
PHARMACEUTICAL FORM AND CONTENTS 7 sublingual tablets
FARMACEVTSKA OBLIKA IN VSEBINA 7 podjezičnih tablet
Renal elimination plays a relatively small role (~30 %) in the overall clearance of buprenorphine/naloxone.
Renalna eliminacija ima relativno majhno vlogo (~30 %) pri celotnem očistku buprenorfina/naloksona.
PK Parameter
FK parameter
Some medicines may increase the side effects of Suboxone and may sometimes cause very serious reactions.
Nekatera zdravila lahko povečajo neželene učinke zdravila Suboxone in imajo lahko včasih zelo hude neželene učinke.
Content of the pack and other Information
Vsebina pakiranja in dodatne informacije
Also tell your doctor immediately if you experience side effects such as:
Svojemu zdravniku tudi takoj povejte, če izkusite neželene učinke, kot so:
Subjects were seen daily in the clinic (Monday through Friday) for dosing and efficacy assessments.
Osebe so bili vsak dan pregledani na kliniki (od ponedeljka do petka), kjer so jim odmerjali zdravilo in ocenili njegovo učinkovitost.
This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft.
To zdravilo je lahko tarča ljudi, ki zlorabljajo zdravila na recept, zato ga je treba hraniti na varnem mestu, zaščitenega pred krajo.
The risks of using Suboxone in pregnant women are not known.
Tveganja uporabe zdravila Suboxone pri nosečnicah niso znana.
Therefore, breastfeeding should be discontinued during treatment with Suboxone.
Zato je treba med zdravljenjem z zdravilom Suboxone prenehati z dojenjem.
What Suboxone is and what it is used for
Kaj je zdravilo Suboxone in za kaj ga uporabljamo
• This medicine has been prescribed for you Do not pass it on to others.
• Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Poročali so o številnih primerih smrti zaradi respiratorne depresije, še zlasti pri uporabi buprenorfina v kombinaciji z benzodiazepini (glejte poglavje 4.5) ali kadar se buprenorfina ni uporabljalo v skladu z navodili za predpisovanje.
Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist e.g. morphine.
Študije na živalih kot tudi klinične izkušnje so dokazale, da buprenorfin lahko povzroči odvisnost, ki pa ni tako močna kot pri popolnih agonistih, npr. morfiju.
Initial naloxone doses may range up to 2 mg and be repeated every 2-3 minutes until a satisfactory response is achieved, but should not exceed a 10 mg starting dose.
Začetni odmerki naloksona lahko znašajo do 2 mg in jih je treba ponavljati vsake 2-3 minute, dokler se ne doseže zadosten odziv, vendar začetni odmerek ne sme preseči 10 mg.
These underlying factors must be taken into consideration before prescribing buprenorphine/naloxone and during treatment.
Te osnovne dejavnike je treba upoštevati pred predpisovanjem buprenorfina/naloksona in med zdravljenjem.
Following intravenous administration, naloxone is rapidly distributed (distribution halflife ~ 4 minutes).
Po intravenski administraciji se nalokson hitro porazdeli (porazdelitveni razpolovni čas ~ 4 minute).
Initiation therapy (induction)
Začetek zdravljenja (indukcija)
Naloxone has a mean half-life from plasma of 1.2 hours.
Nalokson ima povprečni razpolovni čas v plazmi 1,2 ure.
How to remove the tablet from the blister 1 - Do not push the tablet through the foil.
Kako vzeti tableto iz pretisnega omota 1 - Tablete ne potiskajte skozi folijo.
Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Zdravljenje je namenjeno odraslim in mladostnikom nad 15 leti starosti, ki so privolili v zdravljenje svoje odvisnosti.
1 - Do not push the tablet through the foil.
1 - Tablete ne potiskajte skozi folijo.
During the days after you start treatment, your doctor may increase the dose of Suboxone you take according to your needs.
V dneh po začetku zdravljenja bo vaš zdravnik morda povečal odmerek zdravila Suboxone glede na vaše potrebe.
Both Cmax and AUC of buprenorphine increased with the increase in dose (in the range of 4-16 mg), although the increase was less than dose-proportional.
Vrednosti Cmax in AUC buprenorfina sta se povečali s povečanjem odmerka (v razponu od 4-16 mg), čeprav povečanje ni bilo odvisno od odmerka.