Doxorubicin Rivopharm 2 mg/ml concentrate for solution for infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

DOXORUBICIN HYDROCHLORIDE

Disponible desde:

Rivopharm Limited

Código ATC:

L01DB; L01DB01

Designación común internacional (DCI):

DOXORUBICIN HYDROCHLORIDE

Dosis:

2 milligram(s)/millilitre

formulario farmacéutico:

Concentrate for solution for infusion

Área terapéutica:

Anthracyclines and related substances; doxorubicin

Estado de Autorización:

Marketed

Fecha de autorización:

2011-12-09

Información para el usuario

1
PACKAGE LEAFLET
Doxorubicin, SE/H/1757/001, 29.05.20
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXORUBICIN RIVOPHARM 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
doxorubicin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects , talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Doxorubicin Rivopharm is and what it is used for
2.
What you need to know before you receive Doxorubicin Rivopharm
3.
How Doxorubicin Rivopharm is administered
4.
Possible side effects
5.
How to store Doxorubicin Rivopharm
6.
Contents of the pack and other information
1.
WHAT DOXORUBICIN RIVOPHARM IS AND WHAT IT IS USED FOR
Doxorubicin Rivopharm belongs to a group of anti-cancer medicines
called antrhacyclines.
_Doxorubicin Rivopharm _
is used to treat the following types of cancer:
-
Small cell lung cancer
-
Bladder cancer
-
Bone cancer
-
Breast cancer
-
Cancer of the blood
-
Cancer in the lymph system (Hodgkin and Non-Hodgkin’s lymphoma)
-
Cancer of the bone marrow
-
Cancer in the thyroid gland
-
Cancer in soft tissue (in adult age)
-
Recurrent cancer in the ovaries or in the mucous membrane lining the
uterus
-
Certain type of kidney cancer that affects children (Wilm´s tumour)
-
Certain type of advanced cancer in nerve cells that affects children
(neuroblastoma)
Doxorubicin Rivopharm is also used in combination with other
anti-cancer drugs.
2.
WHAT YOU NEED TO KNOW BEFORE RECEIVING DOXORUBICIN RIVOPHARM
DO NOT RECEIVE DOXORUBICIN RIVOPHARM
-
if you are allergic to doxorubicin or any of the other ingredients of
this medicine (listed in section 6).
-
if you are allergic to drugs of the class anthracyclines or
anthracendiones;
-
if you are breastfeeding.
Please talk to your doctor in case any of the ab

Ficha técnica

Health Products Regulatory Authority
09 December 2021
CRN00CFVC
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxorubicin Rivopharm 2 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg doxorubicin hydrochloride.
Each 5 ml vial contains 10 mg doxorubicin hydrochloride.
Each 10 ml vial contains 20 mg doxorubicin hydrochloride.
Each 25 ml vial contains 50 mg doxorubicin hydrochloride.
Each 50 ml vial contains 100 mg doxorubicin hydrochloride.
Each 75 ml vial contains 150 mg doxorubicin hydrochloride.
Each 100 ml vial contains 200 mg doxorubicin hydrochloride.
Excipient with known effect: Each ml concentrate contains 3.54 mg
sodium (0.154 mmol/l)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear red solution, with pH 3 (2.8-3.2) and osmolarity 286 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxorubicin Rivopharm is indicated for the treatment of
- Small-cell lung cancer (SCLC)
- Breast cancer
- Recurrent ovarian carcinoma
- Intravesical prophylaxis of recurrences of superficial bladder
carcinoma following transurethral resection (TUR)
- Systemic treatment of local advanced or metastasized bladder
carcinoma
- Neoadjuvant and adjuvant therapy of osteosarcoma
- Advanced soft-tissue sarcoma in adult age
- Ewing’s sarcoma
- Hodgkin’s lymphoma
- Highly malignant Non-Hodgkin’s lymphoma
- Induction and consolidation treatment in acute lymphatic leukaemia
- Acute myeloblastic leukaemia
- Advanced multiple myeloma
- Advanced or recurrent endometrial carcinoma
- Wilms’ tumour (in stage II in highly malignant variants, in all
advanced stages [III – IV])
- Advanced papillary/follicular thyroid cancer
- Anaplastic thyroid cancer
- Advanced neuroblastoma
Doxorubicin is frequently used in combination chemotherapy regimens
with other cytostatic agents.
Health Products Regulatory Authority
09 December 2021
CRN00CFVC
Page 2 of 15
4.2 POSOLOGY AND METHOD OF