Like all medicines, Busilvex can cause side effects, although not every body gets them.
Serious side effects:
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. Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Very common side effects (affects more than 1 user in 10):
Blood : decrease of blood circulating cells (red and white) and platelets. Nervous system: insomnia, anxiety, dizziness, and depression. Nutrition : loss of appetite, decrease in magnesium, calcium, potassium, phosphate in blood, and increase in blood sugar. Cardiac : increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots. Respiratory : shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds. Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain , diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen. Hepatic : enlarged liver, jaundice,. Skin: rash, itching, loss of hairs. Muscleand bone: back, muscle and joint pain. Renal: increase in creatinine elimination, discomfort in urination, and decrease in urine output. General:, fever, headache, , weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa. Investigations: elevated liver enzymes, weight increased
Common side effects (affects 1 to 10 users in 100 patients):
Nervous system: confusion. Nutrition : low blood sodium. Cardiac : changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output. Respiratory : increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung. Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.. Skin: 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.
Uncommon side effects (affects 1 to 10 users in 1,000 patients):
Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure. Cardiac : clotting offemoral artery, thrombosis, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels). Respiratory : decrease in blood oxygen. Gastro-intestinal: bleeding in the stomach and/or the gut.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. STORING BUSILVEX
Keep out of the reach and sight of children.
Do not use Busilvex after the expiry date which is stated on the carton.
- Store in a refrigerator (2°C ? 8°C). ? .
Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 8 hours (including infusion time) after dilution 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).
Do not freeze