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CARMUSTINE OBVIUS Powder and solvent for solution for infusion (2018)

Active ingredients: Carmustine

Product Name and Form

Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion.

Pharmaceutical form

Powder and solvent for concentrate for solution for infusion.

Powder: white to almost white powder or lyophilisate.

Solvent: colourless clear liquid.

The pH and osmolarity of ready-to-use solutions for infusion are:

pH 4.0 to 5.0 and 385-397mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection), and

pH 4.0 to 6.8 and 370-378mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).

Qualitative and Quantitative Composition

Each vial of powder for concentrate for solution for infusion contains 100 mg carmustine.

After reconstitution and dilution (se section 6.6), one mL of solution contains 3.3 mg carmustine.

Excipient with known effect: Each ampoule of solvent contains 3 ml ethanol anhydrous (that is equivalent to 2.37 g).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Carmustine

Carmustine is a cell-cycle phase nonspecific antineoplastic agent of the nitrosourea type. As an alkylating agent, it can alkylate reactive sites on nucleoproteins, thus interfering with DNA and RNA synthesis and DNA repair. In addition, carmustine is known to carbamoylate lysine residues on proteins causing irreversible inactivation of enzymes including glutathione reductase.

List of excipients

Powder: No excipients.

Solvent: Ethanol, anhydrous.

Pack sizes and Marketing

Powder: Brown type I hydrolytic glass vial (50 ml) with light grey 20 mm bromobutyl rubber stopper and sealed with a dark red aluminium flip-off cap.

Solvent: Clear type I glass ampoule (5 ml).

One pack contains one vial with 100 mg of powder for concentrate for solution for infusion and one ampoule with 3 ml of solvent.

Marketing authorization holder
Authorization dates

Obvius Investment B.V. De, Cuserstraat 93, 1081 CN, Amsterdam, The Netherlands

19.07.2018

Marketing authorization number:

EU/1/18/1278/001