MYFORTIC Gastro-resistant tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Myfortic 180 mg gastro-resistant tablets. Myfortic 360 mg gastro-resistant tablets.
Qualitative and quantitative composition
Each gastro-resistant tablet contains 180 mg or 360 mg mycophenolic acid (as mycophenolate sodium). Excipient with known effect: Lactose, anhydrous: 45 mg or 90 mg per tablet. For the full list of excipients, ...
Pharmaceutical form
Gastro-resistant tablet. 180mg: Lime green, film-coated round tablet, with bevelled edges and the imprint (debossing) C on one side. 360mg: Pale orange red film-coated ovaloid tablet, with imprint (debossing) ...
Therapeutic indications
Myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.
Posology and method of administration
Treatment with Myfortic should be initiated and maintained by appropriately qualified transplant specialists. Posology The recommended dose is 720 mg administered twice daily (1,440 mg daily dose). This ...
Contraindications
Myfortic should not be used in patients with hypersensitivity to mycophenolate sodium, mycophenolic acid or mycophenolate mofetil or to any of the excipients (see section 6.1). Myfortic should not be used ...
Special warnings and precautions for use
Patients receiving immunosuppressive regimens involving combinations of drugs, including Myfortic, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section ...
Interaction with other medicinal products and other forms of interaction
The following interactions have been reported between MPA and other medicinal products. Aciclovir and ganciclovir The potential for myelosuppression in patients receiving both Myfortic and aciclovir or ...
Fertility, pregnancy and lactation
Women of child-bearing potential Pregnancy whilst taking mycophenolate must be avoided. Therefore women of childbearing potential must use at least one form of reliable contraception (section 4.3) before ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. The mechanism of action and pharmacodynamic profile and the reported adverse reactions indicate that an effect is ...
Undesirable effects
The following undesirable effects cover adverse drug reactions from clinical trials: Malignancies Patients receiving immunosuppressive regimens involving combinations of drugs, including MPA, are at increased ...
Overdose
There have been reports of intentional or accidental overdoses with Myfortic, whereas not all patients experienced related adverse events. In those overdose cases in which adverse events were reported, ...
Pharmacodynamic properties
Pharmacotherapeutic group: immunosuppressant ATC code: L04AA06 MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo ...
Pharmacokinetic properties
Absorption Following oral administration, mycophenolate sodium is extensively absorbed. Consistent with its enteric coated design, the time to maximal concentration (T<sub>max</sub>) of MPA was approximately ...
Preclinical safety data
The haematopoetic and lymphoid system were the primary organs affected in repeated-dose toxicity studies conducted with mycophenolate sodium in rats and mice. Aplastic, regenerative anemia was identified ...
List of excipients
Core: Maize starch Povidone Crospovidone Lactose, anhydrous Silica, colloidal anhydrous Magnesium stearate Coating: Hypromellose phthalate Titanium dioxide (E171) Iron oxide yellow (E172) Indigo Carmine ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Nature and contents of container
The tablets are packed in polyamide/aluminium/PVC/aluminium blister packs of 10 tablets per blister in quantities of 20, (180mg only), 50, 100, 120 or 250 tablets per carton. Not all pack sizes may be ...
Special precautions for disposal and other handling
In order to retain the integrity of the enteric coating, Myfortic tablets should not be crushed (see section 4.2). Mycophenolic acid has demonstrated teratogenic effects (see section 4.6). Where crushing ...
Marketing authorization holder
Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
Marketing authorization number(s)
Myfortic 180mg gastro-resistant tablets: PL 00101/0664 Myfortic 360mg gastro-resistant tablets: PL 00101/0665
Date of first authorization / renewal of the authorization
Date of first authorisation: 5 July 2004 Date of latest renewal: 10 October 2008
Date of revision of the text
16 January 2020
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