Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indigo carmine
SERB
Indigo carmine
8mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5055956400089
OBJECT 1 INDIGO CARMINE 40 MG/5 ML, SOLUTION FOR INJECTION Summary of Product Characteristics Updated 13-Sep-2017 | SERB 1. Name of the medicinal product Indigo carmine 40 mg/5 mL solution for injection 2. Qualitative and quantitative composition Indigotin (indigo carmine) ………………………………………………………………………………. ……….40 mg For 5 mL of solution for injection. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. pH: 3,0 to 5,9 Osmolarity: 0,05 osmol/L. 4. Clinical particulars 4.1 Therapeutic indications This medicinal product is for diagnostic use only. Indigo carmine is indicated for the intra-operative detection of suspected ureteral injuries during abdominal and pelvic surgery. 4.2 Posology and method of administration Posology This medicinal product is to be injected by intravenous route. The recommended initial dosage is 1 ampoule of 5 mL by slow intravenous injection. A second ampoule may be injected 20 to 30 minutes after the first injection if necessary. _Paediatric population _ The efficacy and safety of Indigo carmine in children has not been established (see section 4.4). _Patients with renal impairement_ In patients with a clearance of creatinine ≥ 10 mL/min, Indigo carmine may be administered. In patients with a clearance of creatinine < 10 mL/min, Indigo carmine should not be used (see section 4.4). _Elderly_ No dosage adjustment is necessary. _Patients with liver impairement_ The excretion of Indigo carmine is mainly renal. There is no data in patients with liver impairement, however no dosage adjustment is necessary. Method of administration Slow intravenous injection under monitoring of arterial pressure and heart rate. _Precautions to be taken before administering the medicinal product_ Considering the dark blue colour of Indigo carmine, a filtration is recommended during the intravenous administration (for example a filter of 0.45 µm, with a filtering surface of at least 2.8 cm², composed of a Soma hati kamili