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

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

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

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 ...

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 ...

Therapeutic indications

Carmustine is effective in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): Brain tumours ...

Posology and method of administration

Carmustine Obvius must be administered only by specialists experienced in the field of chemotherapy and under appropriate medical supervision Posology Initial doses The recommended dose of Carmustine Obvius ...

Contraindications

Hypersensitivity to the active substance, to other nitrosoureas or to any of the excipients listed in section 6.1. Severe bone marrow depression. Severe (end-stage) renal impairment. Children and adolescents. ...

Special warnings and precautions for use

Pulmonary toxicity characterised by pulmonary infiltrates and/or fibrosis has been reported to occur with a frequency ranging up to 30%. This may occur within 3 years of therapy and appears to be dose ...

Interaction with other medicinal products and other forms of interaction

Phenytoin and dexamethasone In combination with chemotherapeutic medicinal products reduced activity of antiepileptic medicinal products must be anticipated. Cimetidine Concomitant use with cimetidine ...

Fertility, pregnancy and lactation

Women of childbearing potential / contraception in males and females Women should use effective contraception to avoid becoming pregnant while on treatment and for at least 6 months after treatment. Male ...

Effects on ability to drive and use machines

Carmustine Obvius has no or negligible influence on the ability to drive and use machines. However, the possibility will have to be taken into consideration, that the alcohol quantity in these pharmaceutical ...

Undesirable effects

Summary of the safety profile The table includes adverse reactions that were presented during treatment with this medicinal product but may not necessarily have a causal relationship with the medicinal ...

Overdose

The main symptom of intoxication is myelosuppression. In addition, the following serious adverse reactions may occur: liver necrosis, interstitial pneumonitis, encephalomyelitis. A specialized antidote ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, nitrosoureas ATC code: L01AD01 Mechanism of action Carmustine is a cell-cycle phase nonspecific antineoplastic agent of the nitrosourea ...

Pharmacokinetic properties

Distribution Intravenously administered carmustine is rapidly degraded, with no substance intact detectable after 15 minutes. Because of the good lipid solubility and the lack of ionisation at the physiological ...

Preclinical safety data

Carmustine was embryotoxic and teratogenic in rats and embryotoxic in rabbits at dose levels equivalent to the human dose. Carmustine affected the fertility of male rats at doses higher than the human ...

List of excipients

Powder: No excipients. Solvent: Ethanol, anhydrous.

Incompatibilities

The intravenous solution is unstable in polyvinyl chloride containers. All plastic coming into contact with the carmustine solution for infusion (e.g. infusion set, etc.) should be PVC-free polyethylene ...

Shelf life

Unopened vial: 2 years. After reconstitution and dilution: After reconstitution and dilution, the solution should be administered within 3 hours after reconstitution and dilution of the product. The solution ...

Special precautions for storage

Store and transport refrigerated (2°C-8°C). Keep the vial and ampoule in the outer carton in order to protect from light. For storage conditions after reconstitution and further dilution of the medicinal ...

Nature and contents of container

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 ...

Special precautions for disposal and other handling

The carmustine powder for concentrate for solution for infusion contains no preservative and is not intended as a multiple dose vial. Reconstitution and further dilutions should be carried out under aseptic ...

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/18/1278/001

Date of first authorization / renewal of the authorization

19.07.2018

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