Videx

עלון מידע

VIDEX
®
EC

_didanosine_
CONSUMER PRODUCT INFORMATION

WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking VIDEX EC capsules. This
leaflet answers some common
questions about VIDEX EC.
It does not contain all the available
information. Some of the information
contained in this leaflet may not
apply to you.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking VIDEX EC
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist. Always follow the
instructions that your doctor or
pharmacist give you about VIDEX
EC capsules.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT VIDEX EC IS
USED FOR
VIDEX is a trade name
(manufacturer's name) for the
medicine, didanosine. VIDEX
belongs to a group of medicines
called nucleoside (NUKE-lee-O-side)
analogues. You may also know
didanosine as "ddI".
VIDEX is used to treat adults and
children infected with the Human
Immunodeficiency Virus (HIV).
VIDEX EC capsules are a different
presentation of VIDEX. EC stands
for 'enteric coated'. The didanosine in
the capsules has a special coating
which prevents acid in the stomach
from destroying it. The enteric coat
protects the beads of didanosine in
the stomach, and then release the
didanosine in the small intestine
where there is no acid, and the
didanosine can be absorbed.
WHAT IS HIV
HIV is a virus that kills important
cells in the immune system over time
(eg. CD4 cells). When enough of the
immune cells have been killed by
HIV, the body can become prone to
certain types of infections. Some
infections are the cause of "AIDS-
defining" illnesses. This is when
someone is said to have developed
the Acquired Immunodeficiency
Syndrome or AIDS. AIDS is a
serious condition and can lead to
death.
HOW VIDEX EC WORKS
When HIV infects cells in the
immune system it takes over part of
the cell's internal workings and u

קרא את המסמך השלם

מאפייני מוצר

Version 5.0
PRODUCT INFORMATION

VIDEX

AND VIDEX

EC
(DIDANOSINE)
NAME OF THE MEDICINE

Didanosine

DESCRIPTION

Didanosine  is  a  synthetic,  purine  nucleoside  analogue  active  against  the  Human  Immuno-
deficiency Virus (HIV).  The chemical name for didanosine is 2', 3'-dideoxyinosine; it is also
called ddI. It has the following structural formula:

Didanosine  is  a  white,  crystalline,  non-hygroscopic  powder  with  the  molecular  formula
C
10
H
12
N
4
O
3
and a molecular weight of 236.2 daltons. The aqueous
solubility of didanosine at
25
o
C and pH of approximately 6 is 27.3mg/mL. CAS Registry Number:
69655-05-6

Videx Paediatric Powder for Oral Solution contains
only didanosine.

Videx  EC  capsules  contain  didanosine,  sodium  starch  glycollate,  carmellose  sodium,
methacrylic  acid  copolymer,  diethyl  phthalate,  talc,  sodium  hydroxide,  gelatin,  titanium
dioxide, silicon dioxide and sodium lauryl sulfate.  The capsules are imprinted with Tan Ink
SW-8010 ARTG No 4409 (125 mg capsules), Tekprint SB-4020 Green Ink ARTG No 2652
(200mg  capsules),  Tekprint  SB-6018  Blue  Ink  ARTG  No  2653  (250mg  capsules),  and
Opacode S-1-15034 Red ARTG No 2861 (400mg capsules).

PHARMACOLOGY

Pharmacokinetics
Didanosine  is  rapidly  degraded  at  acidic  pH.    The  paediatric  powder  must  be  administered
with a buffering agent.

Adult Absorption Information

Peak plasma concentrations and area under the plasma concentration versus time curves were
proportional  to  dose  over  the  range  of  0.4-16.5mg/kg  IV  and  0.8-10.2mg/kg  PO.    Plasma

Version 5.0
2

concentrations  in  excess  of  2400  ng/mL  (10

M)  were  achieved  at  in

קרא את המסמך השלם

Videx EC

מרכיב פעיל:

זמין מ:

סיווג:

עלון מידע

מאפייני מוצר

מוצרים דומים

מרכיב פעיל

יצרן או מחזיק ברשיון

חיפוש התראות הקשורות למוצר זה

התראות

צפו בהיסטוריית המסמכים

היסטוריית המסמכים