BLEOSOL (BLEOMYCIN POWDER FOR SOLUTION FOR INJECTION INFUSION 15 UNITS)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BLEOMYCIN SULFATE

Available from:

UNIMED SDN BHD

INN (International Name):

BLEOMYCIN SULFATE

Units in package:

15 units/ Vials

Manufactured by:

Venus Remedies Limited

Summary of Product characteristics

Manufactured by :
VENUS REMEDIES LIMITED
Hill Top Industrial Estate, Jharmajri, EPIP
Phase-I (Extn.), Bhatoli Kalan, Baddi,
Distt. Solan, Himachal Pradesh, 173205, India
Product Registration Holder:
Unimed Sdn Bhd
53, Jalan Tembaga SD 5/2B, Bandar Sri
Damansara, 52200, Kuala Lumpur, Malaysia
Date of revision of package insert: 10/08/2023
_To be sold by retail on the prescription of a cancer specialist /
cancer hospital / institution only_
increase the dose to the usual level).
With long-term administration of bleomycin, peplomycin or other
analogies of bleomycin,
toxicity is thought to be additive, thus administration must be
performed with care.
Attention should be paid to the appearance or exacerbation of
infection and any bleeding
tendency.
In adults or adolescents capable of reproduction, effects on the
sexual glands should be
considered.
INTRAVENOUS ADMINISTRATION:
Vascular pain may occur, therefore, it is important to pay due
attention to concentration of the injection and administration rate.
Give intravenously as slowly
as possible.
INTRAMUSCULAR ADMINISTRATION:
Avoid repeated injections at the same site and innervated
sites, particularly if administering to paediatrics. If insertion of
the injection needle evokes
intense pain or if blood flows back into the syringe, withdraw the
needle immediately and inject
at a different site.
INTERACTION WITH OTHER MEDICAMENTS:
When bleomycin is used as one of the drugs in multiple chemotherapy
regimes the toxicity of
bleomycin should be borne in mind in the selection and dosage of drugs
with similar toxic
potential.
The addition of other cytotoxic drugs can necessitate changes and dose
alterations. Increased
pulmonary toxicity has been noted when bleomycin is given with
cisplatin.
Previous or concurrent radiotherapy to the chest and/or administration
of anti-tumour agents
(e.g. cisplatin) are important factors in increasing the incidence and
severity of lung toxicity
such as interstitial pneumonia or pulmonary fibrosis.
Previous or concurrent radiotherapy to the head