CEPTAVA Gastro-resistant tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Ceptava 180 mg Gastro-resistant Tablets.
2. Qualitative and quantitative composition
Each gastro-resistant tablet contains 180 mg of mycophenolic acid (as mycophenolate sodium). <u>Excipients with known effect:</u> Each gastro-resistant tablet contains 12.93 mg of sodium (as mycophenolate ...
3. Pharmaceutical form
Gastro-resistant tablet. Lime green film-coated round tablets with bevelled edges and the imprint (debossing) C on one side. Dimensions: approximately 10.4 4.2 mm.
4.1. Therapeutic indications
Ceptava is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.
4.2. Posology and method of administration
Treatment with Ceptava should be initiated and maintained by appropriately qualified transplant specialists. The recommended dose is 720 mg administered twice daily (1,440 mg daily dose). This dose of ...
4.3. Contraindications
Hypersensitivity to mycophenolate sodium, mycophenolic acid or mycophenolate mofetil or to any of the excipients listed in section 6.1. Ceptava must not be used in women of child bearing potential (WOCBP) ...
4.4. Special warnings and precautions for use
Patients receiving immunosuppressive regimens involving combinations of drugs, including Ceptava, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section ...
4.5. 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 mycophenolate sodium and ...
4.6. 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) before ...
4.7. 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 ...
4.8. 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 ...
4.9. Overdose
There have been reports of intentional or accidental overdoses with mycophenolate sodium, whereas not all patients experienced related adverse events. In those overdose cases in which adverse events were ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> immunosuppressant, selective immunosuppressants <b>ATC code:</b> L04AA06 MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, ...
5.2. 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 ...
5.3. Preclinical safety data
The hematopoietic and lymphoid systems were the primary organs affected in repeated-dose toxicity studies conducted with mycophenolate sodium in rats and mice. Aplastic, regenerative anemia was identified ...
6.1. List of excipients
<u>Core:</u> Lactose, anhydrous Crospovidone (Type A) Povidone K30 Maize starch/Corn starch Silica, colloidal anhydrous/Colloidal silicon dioxide Magnesium stearate <u>Coating:</u> Hypromellose phthalate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
30 months.
6.4. 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.
6.5. Nature and contents of container
PA/AL/PVC-aluminium blister packs. <u>Pack sizes:</u> 20, 50, 100, 120, 250 gastro-resistant tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
In order to retain the integrity of the enteric coating, this medicine should not be crushed (see section 4.2). Mycophenolic acid has demonstrated teratogenic effects (see section 4.6). Where crushing ...
7. Marketing authorization holder
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
8. Marketing authorization number(s)
PL 04416/1467
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 15 December 2016
10. Date of revision of the text
29 October 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
