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SPC: CELLCEPT Capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CellCept 250 mg capsules.

Qualitative and quantitative composition

Each capsule contains 250 mg mycophenolate mofetil. Excipient(s) with known effect: Sodium less than 1 mmol (23 mg) per dose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Capsules, hard. CellCept capsules: oblong, blue/brown, branded with black CellCept 250 on the capsule cap and Roche name on the capsule body.

Therapeutic indications

CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Posology and method of administration

Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists. Posology Use in renal transplant Adults Oral CellCept should be initiated within 72 hours following ...

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 1557 patients received CellCept during five 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

Absorption Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA. As evidenced by suppression of ...

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 capsules: Pregelatinised maize starch Croscarmellose sodium Polyvidone (K-90) Magnesium stearate Capsule shells: Gelatin Indigo carmine (E132) Yellow iron oxide (E172) Red iron oxide (E172) Titanium ...

Incompatibilities

Not applicable.

Shelf life

Shelf-life: 3 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.

Nature and contents of container

CellCept 250 mg capsules: 1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10) Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/96/005/001 CellCept (100 capsules) EU/1/96/005/003 CellCept (300 capsules)

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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