Ceptava 180mg gastro-resistant tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Mycophenolate sodium

から入手可能:

Sandoz Ltd

ATCコード:

L04AA06

INN（国際名）:

Mycophenolate sodium

投薬量:

180mg

医薬品形態:

Gastro-resistant tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 08020100; GTIN: 5050650072037

製品の特徴

OBJECT 1
CEPTAVA 180 MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 25-Apr-2022 | Sandoz
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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).
Excipients with known effect
Each gastro-resistant tablet contains 12.93 mg of sodium (as
mycophenolate sodium) and 45 mg of lactose
(anhydrous).
For the full list of excipients, see section 6.1.
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 x 4.2 mm
4. Clinical particulars
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 met