THALIDOMIDE BMS 50 MG HARD CAPSULES

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

THALIDOMIDE

Fáanlegur frá:

NEOPHARM LTD

ATC númer:

L04AX02

Lyfjaform:

HARD CAPSULE

Samsetning:

THALIDOMIDE 50 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

BRISTOL-MYERS SQUIBB PHARMA EEIG, IRELAND

Lækningarsvæði:

THALIDOMIDE

Ábendingar:

Multiple myeloma : * For the treatment of multiple myeloma after failure of standard therapies. * Thalidomide BMS 50 mg hard capsules in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. * Thalidomide BMS in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma > or = 65 years or ineligible for high dose chemotherapy. Erythema Nodosum Leprosum: For the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Thalidomide is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. It is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

Leyfisdagur:

2015-02-12

Upplýsingar fylgiseðill

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed only by a physician’s prescription
THALIDOMIDE BMS
® 50MG HARD CAPSULES
COMPOSITION:
NAME AND QUANTITY OF ACTIVE INGREDIENT:
EACH CAPSULE CONTAINS: Thalidomide 50mg
Inactive ingredients - See section “Additional information”.
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE AND
EVERY TIME THIS MEDICINE IS PRESCRIBED TO YOU, AS IT MAY CONTAIN NEWER
INFORMATION. IT IS RECOMMENDED TO READ THIS INSERT WITH ANOTHER FAMILY
MEMBER.
This leaflet contains summary information about this medicine. If you
have any
further questions, refer to the physician or the pharmacist.
This medicine has been prescribed for treating your illness. Do not
pass it on to
others. It may harm them, even if it seems to you that their medical
condition is
similar to yours.
DO NOT GIVE THIS MEDICINE TO A CHILD UNDER THE AGE OF 12 YEARS.
SAFETY AND EFFECTIVENESS IN CHILDREN YOUNGER THAN 12 YEARS HAVE NOT
BEEN
ESTABLISHED.
THALIDOMIDE HAS CAUSED SEVERE BIRTH DEFECTS WHEN TAKEN DURING
PREGNANCY.
THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO
COULD
BECOME PREGNANT WHILST TAKING THE MEDICINE OR COULD BECOME PREGNANT
WITHIN
4 WEEKS AFTER STOPPING THE MEDICINE. EVEN A SINGLE DOSE CAN CAUSE
BIRTH
DEFECTS.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is indicated for the treatment of multiple myeloma and
certain
symptoms of leprosy.
THERAPEUTIC GROUP: Immunosuppressive agent
2.
BEFORE USING THIS MEDICINE
2
DO NOT USE THIS MEDICINE IF:
Women:
! Do not use this medicine IF YOU ARE PREGNANT, THINK YOU MAY BE
PREGNANT OR
ARE PLANNING TO BECOME PREGNANT OR ARE BREASTFEEDING. If you take it
during
pregnancy, Thalidomide BMS 50mg Hard Capsules causes birth defects
(deformed babies) and death to an foetus and may affect your
developing foetus.
Thalidomide BMS 50mg Hard Capsules should never be used by women who
are
pregnant, and women of childbearing potential who are not using,

Vara einkenni

1
PRODUCT INFORMATION
I)
NAME OF THE
MEDICINAL PRODUCT
THALIDOMIDE BMS 50 MG HARD
®
CAPSULES
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains thalidomide 50mg
PHARMACEUTICAL FORM
Hard Capsule
TERATOGENIC EFFECTS:
THALIDOMIDE HAS CAUSED SEVERE BIRTH DEFECTS WHEN TAKEN DURING
PREGNANCY.
THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO
COULD
BECOME PREGNANT WHILST TAKING THE MEDICINE OR COULD BECOME PREGNANT
WITHIN
4 WEEKS AFTER STOPPING THE MEDICINE (SEE SECTION 2). EVEN A SINGLE
DOSE CAN CAUSE
BIRTH DEFECTS
.
PATIENT SAFETY INFORMATION CARD
THE MARKETING OF THALIDOMIDE IS SUBJECT TO A RISK MANAGEMENT PLAN
(RMP)
INCLUDING ' PATIENT SAFETY INFORMATION CARD '. THE ' PATIENT SAFETY
INFORMATION CARD ' EMPHASIZES IMPORTANT SAFETY INFORMATION THAT THE
PATIENT
SHOULD BE AWARE OF BEFORE AND DURING TREATMENT.
PLEASE EXPLAIN TO THE PATIENT THE NEED TO REVIEW THE CARD BEFORE
STATING
TREATMENT.
II)
THERAPEUTIC INDICATIONS MULTIPLE MYELOMA
•
For the treatment of multiple myeloma after failure of standard
therapies.
•
Thalidomide BMS 50mg Hard Capsules in combination with dexamethasone
is
indicated for the treatment of patients with newly diagnosed multiple
myeloma.
•
Thalidomide BMS in combination with melphalan and prednisone is
indicated
for the treatment of patients with untreated multiple myeloma > or =
65 years
or ineligible for high dose chemotherapy.
ERYTHEMA NODOSUM LEPROSUM (ENL)
•
For the acute treatment of the cutaneous manifestations of moderate to
severe
erythema
nodosum
leprosum
(ENL).
Thalidomide
is
not
indicated
as
monotherapy for such ENL treatment in the presence of moderate to
severe
neuritis.
It
is
also
indicated
as
maintenance
therapy
for
prevention
and
suppression of the cutaneous manifestations of ENL recurrence.
2
Thalidomide
BMS
50mg
Hard
Capsules
contain
thalidomide,
2-(2,6-dioxo-3-
piperidinyl)-1H-iso-indole-1,3(2H)-dione.
The
Chemical
Abstract
Service
(CAS)
registry number for thalidomide is 50-35-1 and the structural formula
is:
III) DESCRIPTION
Thalidomi