Bleo-Kyowa 15,000unit powder for solution for injection vials

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Bleomycin sulfate

Διαθέσιμο από:

Kyowa Kirin Ltd

Φαρμακολογική κατηγορία (ATC):

L01DC01

INN (Διεθνής Όνομα):

Bleomycin sulfate

Δοσολογία:

15000unit

Φαρμακοτεχνική μορφή:

Powder for solution for injection

Οδός χορήγησης:

Intraperitoneal; Intrapleural; Intraarterial; Intravenous; Intramuscular

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 08010200; GTIN: 5702157107704

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BLEO-KYOWA
® POWDER FOR SOLUTION FOR INJECTION 15,000 IU
Bleomycin sulphate
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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bleo-Kyowa is and what it is used for
2.
What you need to know before you use Bleo-Kyowa
3.
How to use Bleo-Kyowa
4.
Possible side effects
5.
How to store Bleo-Kyowa
6.
Contents of the pack and other information
1.
WHAT BLEO-KYOWA IS AND WHAT IT IS USED FOR
Bleo-Kyowa is an anti-cancer medicine (chemotherapy) used for treating
certain types of cancer. Bleo-
Kyowa is used to treat cancer known as squamous cell carcinoma which
can affect the mouth, nose, throat,
skin, cervix or external genitalia.
It is also used to treat Hodgkin's disease and other types of cancer
of the blood, as well as to treat fluid
producing cancers in the cavity around the lungs or in the abdomen,
and to treat testicular teratoma.
Bleo-Kyowa is also of value in treating malignant melanoma (a type of
skin cancer) and thyroid, lung and
bladder cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BLEO-KYOWA
DO NOT USE BLEO-KYOWA:
-
if you are allergic to bleomycin or to any similar anti-cancer
medicine
-
if you have a chest infection
-
if you have scarring of the lungs
-
if you have greatly reduced lung function.
If any of these apply to you, tell your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Bleo-Kyowa if you have or have
recently had any of the following:
-
kidney problems
-
lung problems or you have been receiving oxygen
-
severe heart disease

Αρχείο Π.Χ.Π.

OBJECT 1
BLEO-KYOWA POWDER FOR SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 04-Dec-2017 | Kyowa Kirin
Ltd
1. Name of the medicinal product
Bleo-Kyowa
2. Qualitative and quantitative composition
Bleomycin Sulphate equivalent to 15,000 IU (15 x 10
3
IU)
3. Pharmaceutical form
Powder for solution for injection
White to light yellowish, freeze-dried substance
4. Clinical particulars
4.1 Therapeutic indications
a. Squamous cell carcinoma affecting the mouth, nasopharynx and
paranasal sinuses, larynx, oesophagus,
external genitalia, cervix or skin. Well differentiated tumours
usually respond better than anaplastic ones.
b. Hodgkin's disease and other malignant lymphomas, including mycosis
fungoides.
c. Testicular teratoma
d. Malignant effusions of serous cavities.
e. Secondary indications in which bleomycin has been shown to be of
some value (alone or in
combination with other drugs) include metastatic malignant melanoma,
carcinoma of the thyroid, lung
and bladder.
4.2 Posology and method of administration
_Adults _
_Routes of administration _
Bleomycin is usually administered intramuscularly but may be given
intravenously (bolus or drip), intra-
arterially, intrapleurally or intraperitoneally as a solution in
physiological saline.
Local injection directly into the tumour may occasionally be
indicated.
_RECOMMENDED DOSE AND DOSAGE SCHEDULES_
_Squamous cell carcinoma and testicular teratoma:_
Used alone the normal dosage is 15 x 10
3
IU (1 vial) three times a week or 30 x 10
3
IU (2 vials) twice a
week, either intramuscularly or intravenously. Treatment may continue
on consecutive weeks, or more
usually at intervals of 3-4 weeks, up to a lifetime cumulative dose of
360 x 10
3
IU. Continuous
intravenous infusion at a rate of 15 x 10
3
IU (1 vial) per 24 hours for up to 10 days, or 30 x 10
3
IU (2
vials) per 24 hours for up to 5 days may produce a therapeutic effect
more rapidly. The development of
stomatitis is the most useful guide to the determination of individual
tolerance of maximum therapeutic