Thalomid

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Thalidomide 50mg

Διαθέσιμο από:

Celgene Limited, a Bristol Myers Squibb company

INN (Διεθνής Όνομα):

Thalidomide 50 mg

Δοσολογία:

50 mg

Φαρμακοτεχνική μορφή:

Capsule

Σύνθεση:

Active: Thalidomide 50mg Excipient: Gelatin Magnesium stearate Pregelatinised maize starch

Μονάδες σε πακέτο:

Blister pack, PVC/PCTFE (Aclar)/Al, 28 capsules

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Celgene Chemicals GmbH

Θεραπευτικές ενδείξεις:

· Thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years or older, or ineligible for high dose chemotherapy. · Thalomid in combination with dexamethasone is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma. ·Thalomid, as monotherapy, is indicated for the treatment of multiple myeloma after failure of standard therapies.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE (Aclar)/Al - 28 capsules - 60 months from date of manufacture stored at or below 25°C

Ημερομηνία της άδειας:

2010-05-24

Φύλλο οδηγιών χρήσης

THALOMID
®
CAPSULES
1
THALOMID
® CAPSULES
_thalidomide _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Thalomid. It does not
contain all the available information.
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 Thalomid
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THALOMID IS
USED FOR
Thalomid contains an active
substance called thalidomide.
Thalomid belongs to a group of
medicines known as immuno-
modulating agents that work by
acting on the cells involved in the
body's immune system. The immune
system is part of the body's defence
which helps to fight illness and
infection.
_TREATMENT OF MULTIPLE _
_MYELOMA _
Thalomid is used to treat multiple
myeloma, a cancer of the bone
marrow.
It is used in combination with other
medicines, melphalan and
prednisone, for the treatment of
newly diagnosed multiple myeloma
in patients aged over 65 years or
patients who cannot receive high
dose chemotherapy. It is also used in
combination with dexamethasone at
the start of high dose chemotherapy
treatment or a bone marrow
transplant. To find out more about
these medicines, please ask your
doctor.
Thalomid may also be used for the
treatment of multiple myeloma after
other treatments have failed.
_TREATMENT OF SKIN _
_SYMPTOMS ASSOCIATED WITH _
_SEVERE ERYTHEMA NODOSUM _
_LEPROSUM (ENL) _
Thalomid is also used for the
treatment of the skin symptoms
associated with moderate to severe
erythema nodosum leprosum (ENL)
which can occur if you have leprosy.
Thalidomide can also help to stop the
skin symptoms returning.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW THALOMID
WORKS OR WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
T

Αρχείο Π.Χ.Π.

Thalomid
®
(thalidomide) capsules - New Zealand Data Sheet
Celgene V3.0 – 10 October 2023 (CCDS V11)
Page
1
of
24
NEW ZEALAND DATA SHEET
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.
EVEN A SINGLE DOSE CAN CAUSE BIRTH DEFECTS
.
1
PRODUCT NAME
Thalomid 50 mg capsules
Thalomid 100 mg capsules
Thalomid 150 mg capsules
*
Thalomid 200 mg capsules
*
* Not distributed in New Zealand.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg capsule contains 50 mg of thalidomide.
Each 100 mg capsule contains 100 mg of thalidomide.
Each 150 mg capsule contains 150 mg of thalidomide.
Each 200 mg capsule contains 200 mg of thalidomide.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Thalomid 50 mg capsules: White, opaque capsule shells imprinted with
“BMS” and “50 mg” on the
body, with a “Do not get pregnant” symbol in black ink
(SW-9008/SW-9009) on the cap. The capsule
shell contains gelatin and titanium dioxide (E171).
Thalomid 100 mg capsules: Tan, opaque capsule shells imprinted with
“BMS” and “100 mg” on the
body, with a “Do not get pregnant” symbol in black ink
(SW-9008/SW-9009) on the cap. The capsule
shell contains gelatin, titanium dioxide (E171) and colourants black
iron oxide and yellow iron oxide.
Thalomid 150 mg capsules: Tan, opaque body capsule shells imprinted
with “BMS” and “150 mg” on
the body in black ink (SW-9008/SW-9009), and a blue, opaque cap with a
“Do not get pregnant”
symbol in white ink (S-1-7085) on the cap. The capsule shell contains
gelatin, titanium dioxide
(E171) and colourants blue #2, black iron oxide and yellow iron oxide.
Thalomid 200 mg capsules: Blue, opaque capsule shells imprinted with
‘BMS” and “200 mg” on the
body, with a “Do not get pregnant” symbol in white ink (S-1-7085)
on the cap.