Table 1.

Pharmaceutical details of Carmustin Obvius (Medac GmbH) and Carmubris (Tillomed Pharma GmbH) according to the Summary of Product Characteristics^{1 2}

Product	Carmustin Obvius (Medac GmbH, Wedel, Germany)	Carmubris (Tillomed Pharma GmbH, Ahrensberg, Germany)
Active substance	Carmustine	Carmustine
Medicinal product	Carmustin 100 mg powder and solvent for concentrate for solution for infusion	Carmubris powder and solvent for preparing an infusion solution
Excipients	No	No
Powder	White to almost white powder or lyophilisate	Powder, lyophilisate
	Refrigerated storage and transport	Refrigerated storage
	Maximum temperature 30°C	Maximum temperature 27°C
Solvents	3.0 mL ethanol anhydrous 27.0 mL water for injection	3.0 mL ethanol absolute 27.0 mL water for injection
Stock solution	3.3 mg/mL carmustine	3.3 mg/mL carmustine
	Clear, colourless to light yellow	Clear, colourless to light yellow
	pH 4.0–5.0 (EPAR)9	pH 5.6–6.0
Diluent in glass containers	500 mL 5% glucose solution for injection 500 mL 0.9% sodium chloride solution for injection	500 mL 5% glucose solution for injection 500 mL 0.9% sodium chloride solution for injection
Concentration in diluted infusion solutions	0.2 mg/mL carmustine (0.5 mg/mL, 1.0 mg/mL in conditioning treatment)	0.2 mg/mL carmustine
pH and osmolarity of diluted (ready-to-administer) infusion solutions	pH 4.0–5.0 and 385–397 mOsm/L if stock solution is diluted in 5% glucose solution for injection; pH 4.0–6.8 and 370–378 mOsm/L if stock solution is diluted in 0.9% sodium chloride solution for injection	NA
Shelf life after reconstitution	Not declared	24 hours at 2–8°C
Shelf life of the ready-to-administer infusion solution	3 hours	8 hours at room temperature protected from light 24 hours at 2–8°C and further 6 hours at room temperature protected from light

EPAR, European Public Assessment Report; NA, not available.