MYFORTIC 360 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

MYCOPHENOLIC ACID

Fáanlegur frá:

NOVARTIS ISRAEL LTD

ATC númer:

L04AA06

Lyfjaform:

GASTRO RESISTANT TABLETS

Samsetning:

MYCOPHENOLIC ACID 360 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

NOVARTIS PHARMA PRODUKTIONS GMBH

Lækningarsvæði:

MYCOPHENOLIC ACID

Ábendingar:

Myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.

Leyfisdagur:

2023-05-31

Upplýsingar fylgiseðill

Novartis Israel Ltd.
6 Tozeret Haaretz street, P.O.Box 7126, Tel Aviv
Tel: [phone], Fax: [phone]
עב לארשי סיטרבונ
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03-9201111
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03-9229230
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2023
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תופוצמ תוילבט קיטרופימ
mg
mg, 360
coated Tablets 180
-
ilm
F
®
Myfortic
[128-30-30715, 128-33-30716]
ונא
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סראמ
2023
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רישכתה
לארשיב הוותמ
ל
היוותה
:ןמקלדכ
Myfortic is indicated in combination with ciclosporin and
corticosteroids for the prophylaxis of acute
transplant rejection in adult patients receiving allogeneic renal
transplants.
ביכרמ
ליעפ
:
mycophenolate sodium :ןונימ תרוצ
Film-coated Tablets
דומעב
בקועה
ןייעל שי ,ףסונ עדימל .יתועמשמ יוניש וא
הרמחה הווהמ רשא יוניש השענ םהב םיפיעס
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https://data.health.gov.il/drugs/index.html#!/byDrug
ןתינ
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,מ"עב לארשי סיטרבונ
ץראה תרצות
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7126
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:לט
03-9201111
:סקפ ,
03-9229230
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ילאירבג ךורב
הנוממ חקור
מ"עב לארשי סיטרבונ
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:
ןולעב
אפורל
:
4.4
Special warnings and precautions for use
...
Patients treated with immunosuppressants, including Myfortic, are at
increased risk for opportunistic infections
(bacterial, fungal, viral and proto

Vara einkenni

MYF API Dec23 V4
1.
NAME OF THE MEDICINAL PRODUCT
Myfortic
®
180 mg gastro-resistant tablets
Myfortic
®
360 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 192.4 and 384.8
mycophenolate sodium equivalent to
180 mg or 360 mg mycophenolic acid.
Excipients:
Each Myfortic 180 mg tablet contains 45 mg lactose anhydrous and 13 mg
sodium.
Each Myfortic 360 mg tablet contains 90 mg lactose anhydrous and 26 mg
sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant Tablets
Myfortic
180mg is a lime green, gastro-resistant film-coated round tablet, with
bevelled edges
and the imprint (debossing) “C” on one side.
Myfortic 360mg is a pale orange-red, gastro-resistant film-coated,
ovaloid tablet with imprint
(debossing) “CT” on one side.
4.
CLINICAL PARTICULARS
4.1
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.
4.2
Posology and method of administration
Posology
Treatment with Myfortic should be initiated and maintained by
appropriately qualified
transplant specialists.
The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic
gastro-resistant
tablets) administered twice daily (1,440 mg daily dose). In patients
receiving mycophenolate
mofetil (MMF) 2 g, treatment can be replaced by 720 mg administered
twice daily (1,440 mg
daily dose) of Myfortic.
For additional information about the corresponding therapeutic doses
of mycophenolate
sodium and mycophenolate mofetil, see sections 4.4 and 5.2.
In
_de novo_
patients, Myfortic should be initiated within 48 hours following
transplantation.
2
MYF API Dec23 V4
Special population
_Paediatric population_
Insufficient data are available to support the efficacy and safety of
Myfortic in children and
adolescents.
_ _
Limited pharmacokinetic data are available for paediatric renal
transplant
patients (see section 5.2