Indigo carmine 40mg/5ml solution for injection ampoules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Indigo carmine

Disponibil de la:

SERB

INN (nume internaţional):

Indigo carmine

Dozare:

8mg/1ml

Forma farmaceutică:

Solution for injection

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: ; GTIN: 5055956400089

Caracteristicilor produsului

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