Erymin-400 Tablet

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

ERYTHROMYCIN ETHYLSUCCINATE

Verfügbar ab:

ROYCE PHARMA MANUFACTURING SDN. BHD.

INN (Internationale Bezeichnung):

ERYTHROMYCIN ETHYLSUCCINATE

Einheiten im Paket:

500 Tablet Tablets; 100Tablet Tablets; 1000Tablet Tablets; 10Tablet Tablets

Hergestellt von:

ROYCE PHARMA MANUFACTURING SDN. BHD.

Gebrauchsinformation

1
RA Department
From:
Farmakovigilans (Unit Risk Communication (RiMUP))
Sent:
Thursday, 6 December, 2018 11:32 AM
To:
[e-mail]
Subject:
Erymin -400 Tablet Rimups
Attachments:
RiMUP-ErymT400 (ENG) 240918.pdf; RiMUP-ErymT400 (BM) 240918.pdf
Dear Ms Huda,
I have rejected the ERYMIN-400 TABLET RIMUPS
today as the approved PI was not updated with the directive issued on
12
Dec 2017.
Please refer to Directive Bil. (33) dlm. BPFK/PPP/07/25 Jld 1 in NPRA
website.
This is a TOTAL REJECTION for
ERYMIN-400 TABLET RIMUPS RiMUP as you need to proceed with variation
submission
to update the PI and relevant section A as soon as possible.
The evaluation will only resume after they are updated
accordingly.
For the following submission for this product after the variation is
approved, please submit the clean copy of RiMUPs with
cover letter hardcopy manually to us.
Do contact me if you have any further queries.
Thank you.
Regards,
Bavahrni
PHARMACOVIGILANCE SECTION |
CENTRE FOR POST REGISTRATION AND COSMETIC CONTROL |
NATIONAL PHARMACEUTICAL REGULATORY DIVISION (NPRA)
MINISTRY OF HEALTH MALAYSIA.
LOT. 36, JALAN UNIVERSITI, 46200 PETALING JAYA, SELANGOR, MALAYSIA.
TEL : [phone] | FAX : [phone]

Fachinformation

7
8
9
10
Revision date: 071019
Appropriate monitoring should be undertaken and dosage should be
a d j u s t e d
a s
n e c e s s a r y .
C a u t i o n
w h e n
t a k e n
w i t h
t e r f e n a d i n e
or
a s t e m i z o l e
b e c a u s e
i t
i s
l i k e l y
t o
r e s u l t
i n
a n
e n h a n c e d
r i s k
of
c a r d i o t o x i c i t y .
T h e
m e t a b o l i s m
o f
t e r f e n a d i n e
a n d
a s t e m i z o l e
is
s i g n i f i c a n t l y
a l t e r e d w h e n
e i t h e r
i s
t a k e n
c o n c o m i t a n t l y
with
erythromycin.
Rare
cases
of
serious
cardiovascular
events
have
been
observed,
including
Torsades
de
pointes,
other
ventricular
arrhythmias
and
c a r d i a c
a r r e s t .
D e a t h
h a s
b e e n
r e p o r t e d
w i t h
t h e
terfenadine/
erythromycin
combination.
Elevated
cisapride
levels
have
been
reported
in
patients
receiving
erythromycin
and
cisapride
concomitantly.
This
may
result
in
QT
prolongation
and
cardiac
arrhythmias including ventricular tachycardia, ventricular
fibrillation
and Torsades de pointes. Similar effects have been observed with
concomitant administration of pimozide and clarithromycin, another
macrolide antibiotic.
PREGNANCY AND LACTATION:
The
safety
of
erythromycin
for
use
during
pregnancy
has
not
been
e s t a b l i s h e d .
E r y t h r o m y c i n
c r o s s e s
t h e
p l a c e n t a l
barrier.
Erythromycin also appears in breast milk.
SIDE EFFECTS:
Skin and Subcutaneous Disorders
F r e q u e n c y
n o t
k n o w n :
s e v e r e
c u t a n e o u s
a d v e r s e
reactions
( S C A R s
i n c l u d i n g
S t e v e n s - J o h n s o n
s y n d r o m e
( S J S ,
toxic
e p i d e r m a l
n e c r o l y s i s
( T E N,
d r u g
r e a c t i o n
w i t h
e o s i n o p h i l i a
and
systemic
symptoms
(DRESS &
acute
generalised
exanthematous
pustulosis (AGEP.
The most frequent adverse effects of erythromycin preparations are
gastrointestinal,
e.g.
abdominal
cramping
and
discomfort,
and
are
d o s e - r e l a t e d .
N a u s e a ,
v o m i t i n g
a n d
d i a r r h o e a
o c c u r
infrequently
with