natgillin/translations-raw huggingface dataset:
- The use of gloves and protective clothing is recommended.
- Priporočena je uporaba rokavic in zaščitnih oblačil.
- If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with
- Če Busilvex ali razredčena raztopina Busilvexa pride v stik s kožo ali sluznico, ju takoj temeljito sperite z
water immediately.
vodo.
Calculation of the quantity of Busilvex to be diluted and of the diluent
Izračun količine Busilvexa, ki ga morate razredčiti, in redčila Busilvex morate pred uporabo razredčiti z 0, 9% raztopino natrijevega klorida (9 mg/ ml) ali 5% raztopino glukoze za injiciranje).
Busilvex must be diluted prior to use with either sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose solution for injection 5%.
Količina redčila mora biti desetkratna prostornina Busilvexa.
The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ ml.
Tako bo končna koncentracija busulfana približno 0, 5 mg/ ml.
The amount of Busilvex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:
Količino Busilveksa in redčila lahko izračunamo na naslednji način: za bolnika, ki tehta Y kg:
•
• Količina Busilvexa:
Y (kg) x D (mg/kg) = A ml of Busilvex to be diluted
Y (kg) x D (mg/ kg) ———————— = A ml Busilvexa, ki ga morate redčiti 6 (mg/ ml)
Y: body weight of the patient in kg D: dose of Busilvex (see section 4.2)
Y: telesna masa bolnika v kilogramih D: odmerek zdravila Busilvex (glejte poglavje 4. 2)
• Quantity of diluent:
13 • Količina redčila:
(A ml Busilvex) x (10) = B ml of diluent
(A ml Busilvexa) x (10) = B ml redčila
To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)
Za pripravo končne raztopine za infuzijo dodajte (A) ml Busilvexa v (B) ml redčila (0, 9% raztopino natrijevega klorida (9 mg/ ml) za injiciranje ali 5% raztopino glukoze za injiciranje).
Preparation of the solution for infusion
Priprava raztopine za infundiranje • Zdravilo Busilvex mora pripraviti usposobljen zdravstveni delavec ali delavka v sterilnih pogojih.
• Busilvex must be prepared by a healthcare professional using sterile transfer techniques.Using a non polycarbonate syringe fitted with a needle:
• Z nepolikarbonatsko brizgo, na kateri je nameščena igla:
- the calculated volume of Busilvex must be removed from the vial.
izračunano prostornino Busilvexa morate odstraniti iz viale,
- the contents of the syringe must be dispensed into an intravenous bag (or syringe) which
-
already contains the calculated amount of the selected diluent.
vsebino brizge morate prestaviti v vrečko ali brizgo za intravensko uporabo, v katero ste že dali izračunano količino izbranega redčila.
Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Busilvexa ne smete dati v intravensko vrečko, v kateri ni 0, 9% raztopine natrijevega klorida (9 mg/ ml) za injiciranje ali 5% raztopina glukoze za injiciranje.
• The diluted solution must be mixed thoroughly by inverting several times
• Vrečko morate temeljito premešati z nekajkratnim obračanjem
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan
Po redčenju 1 ml raztopine za infundiranje vsebuje 0, 5 mg busulfana.
Diluted Busilvex is a clear colourless solution
Razredčeni Busilvex je prozorna, brezbarvna raztopina.
Instructions for use Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Navodila za uporabo Pred in po vsaki infuziji izperite katetrsko cev s približno 5 mililitri 0, 9% raztopine natrijevega klorida (9 mg/ ml) za injiciranje ali 5% raztopine glukoze za injiciranje.
The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
Preostalega zdravila ne smete izpirati v ceveh med uporabo, kajti hitre infuzije Busilvexa še niso preizkusili in je ne priporočamo.
The entire prescribed Busilvex dose should be delivered over two hours.
Infuzija celotnega predpisanega odmerka Busilvexa mora trajati dve uri.
In this case infusion sets with minimal priming space should be used (i.e 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
0, 3- 0, 6 ml), pri katerih je raztopina zdravila infundirana pred dejanskim infundiranjem Busilvexa in nato splaknjena z 0, 9 - odstotno raztopino natrijevega klorida (9 mg/ ml) za injiciranje ali 5- odstotno raztopino glukoze za injiciranje.
Polycarbonate syringes must not be used with Busilvex.
Pri uporabi Busilvexa ne smete uporabljati polikarbonatnih brizg.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila.
14 7 MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex France
Pierre Fabre Médicament 45, Place Abel Gance F- 92654 Boulogne Billancourt Cedex 14 Francija
8 MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
09 July, 2003 Date of latest renewal:
09. julij 2003 Datum zadnjega podaljšanja dovoljenja za promet:
08 July, 2008
08. julij 2008
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN ZA SPROŠČANJE SERIJ
CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI ZA PRIDOBITEV DOVOLJENJA ZA PROMET
16 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN ZA SPROŠČANJE SERIJ
Pierre Fabre Médicament Production Site Aquitaine Pharm International Avenue du Béarn -Idron F-64320 France
Pierre Fabre Médicament Production Site Aquitaine Pharm International Avenue du Béarn- Idron F- 64320 Francija
B CONDITIONS OF THE MARKETING AUTH ORISATION
POGOJI ZA PRIDOBITEV DOVOLJENJA ZA PROMET
Medicinal product subject to restricted medical prescription (See Annex I:
Zdravstveni proizvod se izdaja le na zdravniški recept (glejte Dodatek I:
Summary of Product Characteristics, 4.2)
Povzetek temeljnih značilnosti proizvoda, 4. 2).
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Box containing 8 vials of 10ml)
19 PODATKI NA ZUNANJI OVOJNINI
Busilvex 6 mg/ml concentrate for solution for infusion busulfan
Busilvex 6 mg/ ml koncentrat za raztopino za infundiranje busulfan
One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
1 ml koncentrata vsebuje 6 mg busulfana in po redčenju je koncentracija busulfana 0, 5 mg/ ml.
Concentrate for solution for infusion Box of 8 single use vials of 10 ml 60 mg per vial
60 mg v vsaki viali.
Intravenous use (IV) Must be diluted before use Read the package leaflet before use
Pred uporabo preberite navodilo za uporabo.
Cytotoxic agent, special handling instructions
Citotoksična učinkovina, posebna navodila za ravnanje.
Store in a refrigerator (2°C – 8°C)
Shranjujte v hladilniku (2 °C - 8 °C).
Any unused product or waste material should be disposed of in accordance with local requirements
Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne Billancourt cedex France
Pierre Fabre Médicament 45, place Abel Gance F- 92654 Boulogne Billancourt cedex Francija
MARKETING AUTHORISATION NUMBERS
ŠTEVILKA( E) DOVOLJENJA ZA PROMET
Medicinal product subject to restricted medical prescription.
Izdaja zdravila je le na recept.
21 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
21 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA VMESNI OVOJNINI
{box containing 4 vials of 10ml)
Škatla s 4 vialami po 10 ml
Concentrate 10 ml
Koncentrat 10 ml
Intravenous use (IV) Must be diluted before use
Pred uporabo razredčite.
Read the leaflet before use
Pred uporabo preberite navodilo za uporabo.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
GENERAL CLASSIFICATION FOR SUPPLY
NAČINIZDAJANJA ZDRAVILA
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Busilvex 6 mg/ml sterile concentrate IV
Busilvex 6 mg/ ml sterilen koncentrat i. v.
25 PACKAGE LEAFLET:INFORMATION FOR THE USER
25 NAVODILO ZA UPORABO
Busilvex 6 mg/ml concentrate for solution for infusion. busulfan.
Busilvex 6 mg/ ml koncentrat za raztopino za infundiranje busulfan
- If you have further questions, ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
What Busilvex is and what it is used for 2.
Kaj je zdravilo Busilvex in za kaj ga uporabljamo 2.
Before you use Busilvex 3.
Kaj morate vedeti, preden boste uporabili zdravilo Busilvex 3.
How to use Busilvex 4.
Kako uporabljati zdravilo Busilvex 4.
Further information
Možni neželeni učinki 5 Shranjevanje zdravila Busilvex 6 Dodatne informacije
WHAT BUSILVEX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO BUSILVEX IN ZA KAJ GA UPORABLJAMO
Busilvex contains the substance busulfan, which belongs to a group of medicines called alkylating agents.
Zdravilo Busilvex vsebuje učinkovino busulfan, ki spada v skupino zdravil, ki jim pravimo alkilirajoče učinkovine.
Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Busilvex se pri odraslih, novorojencih, otrocih in mladostnikih uporablja kot terapija pred transplantacijo.
In adults Busilvex is used in combination with cyclophosphamide.
Busilvex se pri odraslih uporablja v kombinaciji s ciklofosfamidom.
In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan.
Busilvex se pri novorojencih, otrocih in mladostnikih uporablja v kombinaciji s ciklofosfamidom ali melfalanom.
You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell.
To pripravljalno zdravilo boste prejeli pred transplantacijo kostnega mozga ali progenskih hematopoetskih celic.
BEFORE YOU USE BUSILVEX
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO BUSILVEX
Do not use Busilvex: − if you are allergic (hypersensitive) to busulfan or any of the other ingredients of Busilvex − if you are pregnant, or think you may be pregnant.
– če ste alergični na (preobčutljivi za) busulfan ali katerokoli drugo sestavino zdravila Busilvex, – če ste noseči ali mislite, da bi lahko bili noseči.
Take special care with Busilvex:
Bodite posebno pozorni pri uporabi zdravila Busilvex:
Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells.
Busilvex je močno citotoksično zdravilo, ki zelo zmanjša število krvnih celic.
It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future.
Možno je, da bo uporaba Busilvexa povečala tveganje za nastanek drugega malignega obolenja v prihodnosti.
You should tell your doctor if: − you have a liver, kidney, heart or lung problem − you have a history of seizures, − you are currently taking other medicines.
Morate povedati zdravniku, če: – imate težave z jetri, srcem ali pljuči, – ste kdaj imeli epileptične napade, – trenutno jemljete druga zdravila.
It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with busulfan.
26 Po zdravljenju z busulfanom se lahko zgodi, da ne boste mogli več zanositi (da boste neplodni).
Busilvex can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Busilvex lahko izzove tudi znake menopavze in pri deklicah lahko prepreči začetek pubertete.
Men treated with Busilvex are advised not to father child during and up to 6 months after treatment.
Moškim, ki prejemajo Busilvex, ne priporočamo, da spočnejo otroka vsaj 6 mesecev po zdravljenju.
26 Taking other medicines:
Uporaba drugih zdravil:
Busilvex may interact with other medicines.
Busilvex lahko medsebojno učinkuje z drugimi zdravili.
Particular caution should be taken if you use itraconazol (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Sočasna uporaba s temi zdravili lahko poveča neželene učinke.
The use of paracetamol during the 72 hours prior to or with Busilvex administration should be used with caution.
Bodite zelo previdni pri uporabi paracetamola 72 ur pred uporabo ali sočasno z uporabo Busilvexa.
Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding, before you receive treatment with Busilvex.
Nosečnost in dojenje Preden začnete zdravljenje z Busilvexom, povejte zdravniku, če ste noseči, če mislite, da bi lahko bili noseči ali če dojite.
Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
Ženske, ki prejemajo Busilvex, ne smejo zanositi do 6 mesecev po zdravljenju.
Women must stopbreast-feeding before starting their treatment with Busilvex.
Ženske morajo prekiniti dojenje pred začetkom zdravljenja z Busilvexom.
Adequate contraceptive precautions should be used when either partner is receiving Busilvex.
Če katerikoli od partnerjev prejema Busilvex, morate poskrbeti za ustrezno kontracepcijo.
HOW TO USE BUSILVEX
KAKO UPORABLJATI ZDRAVILO BUSILVEX
The dose will be calculated according to your body weight.
Odmerek vam bodo izračunali na osnovi telesne mase.
The recommended dose of Busilvex is 0.8 mg per kg of body weight, in combination with cyclophosphamide.
Priporočeni odmerek Busilvexa je 0, 8 mg na kilogram telesne mase, v kombinaciji s ciklofosfamidom.
The recommended dose of Busilvex in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg.
Priporočeni odmerek zdravila Busilvex v kombinaciji s ciklofosfamidom ali melfalanom je odvisen od vaše telesne mase in sega od 0, 8 do 1, 2 mg/ kg.
Administration: − Busilvex is administered by a qualified healthcare professional as a central intravenous infusion, after dilution of the individual vial.
Uporaba – Busilvex vam bo po razredčenju vsebine posamezne viale kot osrednjo intravensko infuzijo dal usposobljen zdravstveni delavec ali delavka.
Each infusion will last 2 hours. − Busilvex will be administered every 6 hours during 4 consecutive days prior to transplant.
Vsaka infuzija bo trajala 2 uri. – Busilvex boste 4 zaporedne dneve pred transplantacijo prejemali vsakih 6 ur.
Medicines before you receive Busilvex:
Zdravila, ki jih boste prejemali pred uporabo Busilvexa:
Before receiving Busilvex, you will be medicated with − anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and − antiemetic medicines to prevent vomiting.
Preden boste prejeli Busilvex, boste prejeli: – protikonvulzivna zdravila, ki preprečujejo epileptične napade (fenitoin ali benzodiazepini), in – antiemetična zdravila, ki preprečuje bruhanje.
Like all medicines, Busilvex can cause side effects, although not every body gets them.
Kot vsa zdravila ima lahko tudi zdravilo Busilvex neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most serious side effects of Busilvex therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
Med najresnejše neželene učinke zdravljenja z Busilvexom in postopka transplantacije sodijo zmanjšanje števila krvnih celic v obtoku (nameravani učinek zdravila, ki vas pripravi na transplantacijsko infuzijo), okužba, motnje delovanja jeter, vključno z blokiranjem jetrne vene, reakcija
Very common side effects (affects more than 1 user in 10):
Zelo pogosti neželeni učinki (ki se pojavijo pri več kot 1 od 10 bolnikov):
Blood: decrease of blood circulating cells (red and white) and platelets.
Kri: zmanjšanje števila krvnih celic (rdečih in belih) in trombocitov v obtoku.
Nervous system: insomnia, anxiety, dizziness, and depression.
Živčni sistem: nespečnost, tesnoba, vrtoglavica in depresija.
Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate in blood, and increase in blood sugar.
Prehrana: izguba teka, zmanjšanje količine magnezija, kalcija, kalija in fosfata v krvi ter povečanje krvnega sladkorja.
Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Srce: povečanje hitrosti srčnega utripa, povečanje ali zmanjšanje krvnega pritiska, vazodilatacija (širjenje krvnih žil) in krvni strdki.
Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Dihala: težave pri dihanju, izločanje iz nosu (rinitis), vneto grlo, kašelj, kolcanje, krvavenje iz nosu, neobičajni zvoki pri dihanju.
Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Prebavila: slabost, vnetje ustne sluznice, bruhanje, bolečine v trebuhu, diareja, zaprtje, zgaga, bolečine v zadnjiku, tekočina v trebuhu.
Hepatic: enlarged liver, jaundice,.
Jetra: povečana jetra, zlatenica.
Skin: rash, itching, loss of hairs.
Koža: izpuščaji, srbenje, izguba las.
Renal: increase in creatinine elimination, discomfort in urination, and decrease in urine output.
Ledvica: povečanje kreatininskega očistka, bolečine pri uriniranju in zmanjšanje količine urina.
General:, fever, headache,, weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa.
Splošno: povišana telesna temperatura, glavobol, oslabelost, mrzlica, bolečine, alergijske reakcije, edem, bolečina ali vnetje na mestu vboda, bolečine v prsih, vnetje sluznice.
Investigations: elevated liver enzymes, weight increased
Preiskave: povečane vrednosti jetrnih encimov, povečana telesna teža.
Common side effects (affects 1 to 10 users in 100 patients):
Pogosti neželeni učinki (ki se pojavijo pri 1- 10 od 100 bolnikov):
Nervous system: confusion.
Živčni sistem: zmedenost.
Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood..
Prebavila: vnetje sluznice v požiralniku, paraliza črevesa, bruhanje krvi.
Skin colour disorder, redness of the skin, skin desquamation Renal: increase in the amount of nitrogen components in the blood stream, blood in urines, moderate renal insufficiency.
Ledvica: povečanje količine dušikovih spojin v krvnem obtoku, kri v urinu, zmerno zmanjšano delovanje ledvic.
Uncommon side effects (affects 1 to 10 users in 1,000 patients):
Občasni neželeni učinki (ki se pojavijo pri 1- 10 od 1. 000 bolnikov):
Cardiac: clotting of femoral artery, thrombosis, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Srce: zamašitev femoralne arterije, tromboza, dodatni utripi srca, zmanjšanje hitrosti srčnega utripa, difuzno prepuščanje tekočine iz kapilar (majhnih krvnih žil).
Gastro-intestinal: bleeding in the stomach and/or the gut.
Prebavila: krvavitev v želodcu in/ ali črevesu.
STORING BUSILVEX
SHRANJEVANJE ZDRAVILA BUSILVEX
Keep out of the reach and sight of children.
Shranjujte nedosegljivo otrokom!
Do not use Busilvex after the expiry date which is stated on the carton.
Zdravila Busilvex ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
− Store in a refrigerator (2°C – 8°C). −.
Shranjujte v hladilniku (2 °C - 8 °C). –
28 when stored at 20 °C ± 5 °C or 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C ± 5 °C (including infusion time).
Razredčena raztopina: Kemijsko in fizikalno stabilnost za uporabo po redčenju v 5- odstotni raztopini glukoze ali 0, 9- odstotni raztopini natrijevega klorida (9 mg/ ml) za injiciranje so pokazali v 8 urah (vključno s časom infuzije) po redčenju, če je bila raztopina shranjena pri temperaturi 20 °C ± 5 °C, ali v 12 urah po redčenju, če je bila raztopina shranjena pri temperaturi med 2 °C in 8 °C in nato 3 ure pri temperaturi 20 °C ± 5 °C (vključno s časom infuzije).
One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
DODATNE INFORMACIJE
After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Po redčenju: en mililiter raztopine vsebuje približno 0, 5 mg busulfana.
- The other ingredients are dimethylacetamide and macrogol 400
- Pomožni snovi sta dimetilacetamid in makrogol 400.
What Busilvex looks like and contents of the pack Busilvex consists of a concentrate for solution for infusion and is supplied in colourless glass vials, each vial containing 60 mg of busulfan.
Vsaka viala vsebuje 60 mg busulfana.
When diluted Busilvex is a clear colourless solution.
Razredčeni Busilvex je prozorna, brezbarvna raztopina.
Busilvex is available in a box containing 8 vials.
Busilvex je na voljo v škatlah, ki vsebujejo po 8 vial.
Marketing Authorisation Holder Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne-Billancourt cedex France
Imetnik dovoljenja za promet z zdravilom Pierre Fabre Médicament 45, place Abel Gance F- 92654 Boulogne- Billancourt cedex Francija
Manufacturer Pierre Fabre Médicament Production, site Aquitaine Pharm International Avenue du béarn F-64320 Idron France
Izdelovalec Pierre Fabre Médicament Production, site Aquitaine Pharm International Avenue du béarn F- 64320 Idron Francija
This leaflet was last approved on:
Navodilo je bilo odobreno
Busilvex 6 mg/ml concentrate for solution for infusion Busulfan
Busilvex 6 mg/ ml koncentrat za raztopino za infundiranje Busulfan
Read this guide prior to the preparation and administration of Busilvex.
Pred pripravo in uporabo Busilvexa preberite to navodilo.
Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Busilvex je pakiran v obliki bistre, brezbarvne raztopine v prozornih steklenih vialah (tipa I) s prostornino 10 ml.
Busilvex must be diluted prior to administration.
Busilvex morate razredčiti pred uporabo.
RECOMMENDATION FOR SAFE HANDLING
PRIPOROČILO ZA VARNO RAVNANJE
29 All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood
Vsi postopki prenašanja zahtevajo strogo upoštevanje aseptičnih pogojev, po možnosti uporabo laminarija.
As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution:
Priporočena je uporaba rokavic in zaščitnih oblačil.
- The use of gloves and protective clothing is recommended.
-
- If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with
Če Busilvex ali razredčena raztopina Busilvexa pride v stik s kožo ali sluznico, ju takoj temeljito sperite z
Calculation of the quantity of Busilvex to be diluted and of the diluent Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
29 Busilvex morate pred uporabo razredčiti z 0, 9% raztopino natrijevega klorida (9 mg/ ml) za injiciranje ali 5% raztopino glukoze za injiciranje.
The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml.
Tako bo končna koncentracija busulfana približno 0, 5 mg/ ml.
Y (kg) x D (mg/kg) = A ml of Busilvex to be diluted 6 (mg/ml)
Y (kg) x D (mg/ kg) ———————— = A ml Busilvexa, ki ga morate redčiti 6 (mg/ ml)