Mycept-S 180 Tablets

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Mycophenolate Sodium

Available from:

Panacea Biotec Pharma Limited, INDIA

ATC code:

Immunosuppressants drugs

INN (International Name):

Mycophenolate Sodium

Dosage:

180

Pharmaceutical form:

Tablets

Manufactured by:

Panacea Biotec Pharma Limited, INDIA

Product summary:

Physical description: Reddish brown coloured , round shaped , coated tablets, plain on both sides; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)

Authorization status:

Registered/Compliant

Authorization date:

2021-10-09

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
MYCEPT - S 180/ 360
MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS USP 180MG/
360 MG
1.
TRADE NAME OF THE MEDICINAL PRODUCT
MYCEPT-S 180 (Mycophenolic Acid Delayed-Release tablets USP 180 mg).
MYCEPT-S 360 (Mycophenolic Acid Delayed-Release tablets USP 360 mg).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delayed release tablet contains:
Mycophenolate Sodium USP
Eq. to Mycophenolic Acid ….180mg
Colours: Ferric oxide (Red) and Titanium dioxide
Each delayed release tablet contains:
Mycophenolate Sodium USP
Eq. to Mycophenolic Acid ….360mg
Colours: Ferric oxide (Red) and Titanium dioxide
3.
PHARMACEUTICAL FORM
•
PHARMACEUTICAL FORM: Delayed-Release tablets.
•
PRODUCT DESCRIPTION (MYCEPT-S 180): Reddish brown coloured, round
shaped, coated tablets & plain on both side.
•
PRODUCT DESCRIPTION (MYCEPT-S 360): Reddish brown coloured, oblong
shaped, coated tablets, plain on both side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycophenolic Acid is indicated in combination with ciclosporin and
corticosteroids
for the prophylaxis of acute transplant rejection in adult patients
receiving allogeneic
renal transplants.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
Treatment with Mycophenolic Acid 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
dose of mycophenolate sodium corresponds to 1 g mycophenolate mofetil
administered
twice daily (2 g daily dose) in terms of mycophenolic acid (MPA)
content.
For additional information about the corresponding therapeutic doses
of mycophenolate
sodium and mycophenolate mofetil.
In _ de novo_ patients, Mycophenolic Acid should be initiated within
72 hours following
transplantation.
Special population
_Paediatric population _
Insufficient data are available to support the efficacy and safety of
Mycophenolic Acid in
children and adolescents. Limited pharmacokinetic data are available
for