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SPC: CELLCEPT Powder for concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CellCept 500 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt). Excipient(s) with known effect: Sodium less than 1 mmol (23 mg) per dose. For the full list of excipients, see ...

Pharmaceutical form

Powder for concentrate for solution for infusion. CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to ...

Therapeutic indications

CellCept 500 mg powder for concentrate for solution for infusion is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving ...

Posology and method of administration

Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists. CAUTION: CELLCEPT I.V. SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION. ...

Contraindications

CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1. Hypersensitivity reactions to CellCept have ...

Special warnings and precautions for use

Neoplasms Patients receiving immunosuppressive regimens involving combinations of medicinal products, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly ...

Interaction with other medicinal products and other forms of interaction

Aciclovir Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone. The changes in MPAG (the ...

Fertility, pregnancy and lactation

Women of childbearing potential Pregnancy whilst taking mycophenolate must be avoided. Therefore, women of childbearing potential must use at least one form of reliable contraception (see section 4.3) ...

Effects on ability to drive and use machines

CellCept has a moderate influence on the ability to drive and use machines. Cellcept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients are advised to use caution ...

Undesirable effects

Summary of safety profile An estimated total of 1268 patients received CellCept during four clinical trials in the prevention of acute organ rejection. Of these, 991 were included in the three renal studies ...

Overdose

Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience. In many of these cases, no adverse events were reported. In those overdose ...

Pharmacodynamic properties

Pharmacotherapeutic group: immunosuppressive agents ATC code: L04AA06 Mechanism of action Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent, selective, uncompetitive and reversible ...

Pharmacokinetic properties

Distribution Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA. The parent substance mycophenolate mofetil can be measured ...

Preclinical safety data

In experimental models, mycophenolate mofetil was not tumourigenic. The highest dose tested in the animal carcinogenicity studies resulted in approximately 2-3 times the systemic exposure (AUC or C<sub> ...

List of excipients

CellCept 500 mg powder for concentrate for solution for infusion: Polysorbate 80 Citric acid Hydrochloric acid Sodium chloride

Incompatibilities

CellCept 500 mg powder for concentrate for solution for infusion solution should not be mixed or administered concurrently via the same catheter with other intravenous medicinal products or infusion admixtures. ...

Shelf life

Shelf-life Powder for concentrate for solution for infusion: 3 years. Reconstituted solution and infusion solution: If the infusion solution is not prepared immediately prior to administration, the commencement ...

Special precautions for storage

Powder for concentrate for solution for infusion: Do not store above 30°C. Reconstituted solution and infusion solution: Store at 15–30°C.

Nature and contents of container

20 mL type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps. CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing ...

Special precautions for disposal and other handling

Preparation of Infusion Solution (6 mg/mL) CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the ...

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization number(s)

EU/1/96/005/005 CellCept (4 vials)

Date of first authorization / renewal of the authorization

Date of first authorisation: 14 February 1996 Date of latest renewal: 13 March 2006

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