LENALIDOMIDE-TEVA lenalidomide (as hydrochloride monohydrate) 20 mg capsule blister pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

lenalidomide hydrochloride monohydrate, Quantity: 24.2 mg

Disponibbli minn:

Teva Pharma Australia Pty Ltd

Għamla farmaċewtika:

Capsule

Kompożizzjoni:

Excipient Ingredients: croscarmellose sodium; indigo blue; colloidal anhydrous silica; microcrystalline cellulose; Gelatin; titanium dioxide; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

14, 21, 28

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Multiple Myeloma (MM),Lenalidomide-Teva is indicated for the treatment of multiple myeloma.,Myelodysplastic Syndromes (MDS),Lenalidomide-Teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Sommarju tal-prodott:

Visual Identification: Lenalidomide capsules, 20 mg are hard, non-transparent capsules with black mark 20 on blue body and with green cap.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2021-06-16

Karatteristiċi tal-prodott

1
Lenalidomide-Teva
(lenalidomide) capsules version 3.0
AUSTRALIAN PRODUCT INFORMATION
LENALIDOMIDE-TEVA
(LENALIDOMIDE) CAPSULES
1.
NAME OF THE MEDICINE
Lenalidomide (as lenalidomide hydrochloride monohydrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg capsule contains 2.5 mg of lenalidomide (as hydrochloride
monohydrate).
Each 5 mg capsule contains 5 mg of lenalidomide (as hydrochloride
monohydrate).
Each 7.5 mg capsule contains 7.5 mg of lenalidomide (as hydrochloride
monohydrate).
Each 10 mg capsule contains 10 mg of lenalidomide (as hydrochloride
monohydrate).
Each 15 mg capsule contains 15 mg of lenalidomide (as hydrochloride
monohydrate).
Each 20 mg capsule contains 20 mg of lenalidomide (as hydrochloride
monohydrate).
Each 25 mg capsule contains 25 mg of lenalidomide (as hydrochloride
monohydrate)
.
For the full list of excipients, see Section 6.1 (List of excipients).
3.
PHARMACEUTICAL FORM
Lenalidomide 2.5 mg capsules: hard, non-transparent capsules with
black mark 2.5 on white body
and with green cap.
Lenalidomide 5 mg capsules: hard, non-transparent capsules with black
mark 5 on white body and
with white cap.
Lenalidomide 7.5 mg capsules: hard, non-transparent capsules with
black mark 7.5 on white body
and with ivory cap.
Lenalidomide 10 mg capsules: hard, non-transparent capsules with black
mark 10 on ivory body
and with green cap.
Lenalidomide 15 mg capsules: hard, non-transparent capsules with black
mark 15 on white body
and with blue cap.
Lenalidomide 20 mg capsules: hard, non-transparent capsules with black
mark 20 on blue body and with
green cap.
Lenalidomide 25 mg capsules: hard, non-transparent capsules with black
mark 25 on white body and
with white cap.
DO NOT USE LENALIDOMIDE DURING PREGNANCY.
TERATOGENIC EFFECTS: LENALIDOMIDE IS STRUCTURALLY RELATED TO
THALIDOMIDE. THALIDOMIDE IS A KNOWN
HUMAN TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH
DEFECTS. IF LENALIDOMIDE IS TAKEN
DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN
BABY. WOMEN SHOULD BE
ADVISE