HOLOXAN FOR INJECTION 1 g25 ml

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

IFOSFAMIDE

Verfügbar ab:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC-Code:

L01AA06

Dosierung:

1 g/25 ml

Darreichungsform:

INJECTION, POWDER, FOR SOLUTION

Zusammensetzung:

IFOSFAMIDE 1 g/25 ml

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

Prescription Only

Hergestellt von:

BAXTER ONCOLOGY GMBH

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

1988-06-08

Gebrauchsinformation

PATIENT INFORMATION LEAFLET
PLEASE READ CAREFULLY! 
HOLOXAN
®
Active substance: Ifosfamide
COMPOSITION:
1 vial
Holoxan
Holoxan
Holoxan
Holoxan
200 mg
500 mg
1 g
2 g
contains:
Ifosfamide
200 mg
500 mg
1 g
2 g
as dry substance for preparing an injectable solution.
INDICATIONS:
Holoxan is to be administered exclusively by physicians with
experience in oncology. It is indicated in
inoperable malignant tumours that are sensitive to ifosfamide, e.g.
bronchial carcinoma, ovarian
carcinoma, testicular tumours, soft-tissue sarcoma, breast cancer,
pancreatic carcinoma, hyper-
nephroma, endometrial carcinoma, malignant lymphomas.
Special remark:
Should during treatment with Holoxan a cystitis in connection with
macro- or microhaematuria appear,
Holoxan therapy has to be interrupted until normalization.
CONTRAINDICATIONS:
Holoxan is contraindicated in cases of
– known hypersensitivity to ifosfamide
– severely depressed bone-marrow function (especially in patients
previously treated  with cytotoxic
agents or radiotherapy)
– active infections
– impaired renal function  and/or obstructions of the urine flow
– cystitis
– pregnancy (see special comments)
– lactation
REMARKS:
Before starting treatment, it is necessary to exclude or correct any
obstruction of the efferent urinary
tract, cystitis, infections and electrolyte imbalances. In general,
Holoxan®, like other cytostatics, should
be used with care in weakened or elderly patients and in patients who
have had previous radio-
therapy. Patients with a weakened immune system, e.g. those with
diabetes mellitus, chronic hepatic
and renal impairments, also require special care. Patients with brain
metastases, cerebral sym-
ptoms  and /or deteriorated renal function must be kept under close
observation.
Use during pregnancy and lactation
In a vital indication during the first trimester of pregnancy a
medical consultation regarding abortion
is absolutely necessary.
After the 1st trimester of pregnancy, if therapy cannot be delayed and
the patient wishes

Fachinformation

HA-30-02-137
MAL
C 411
Patient Information Leaflet Please read carefully!
Holoxan
®
Active substance: Ifosfamide
Composition:
1 vial
Holoxan
Holoxan
Holoxan
Holoxan
200 mg
500 mg
1 g
2 g
contains:
Ifosfamide
200 mg
500 mg
1 g
2 g
as dry substance for preparing an injectable solution. White powder
for solution for injection or infusion.
Indications:
Holoxan is to be administered exclusively by physicians with
experience in oncology. It is indicated in inoperable malignant
tumours that are sensitive to
ifosfamide, e.g. bronchial carcinoma, ovarian carcinoma, testicular
tumours, soft-tissue sarcoma, breast cancer, pancreatic carcinoma,
hyper- nephroma,
endometrial carcinoma, malignant lymphomas.
Special remark:
Should during treatment with Holoxan a cystitis in connection with
macro- or microhaematuria appear, Holoxan therapy has to be
interrupted until normalization.
Contraindications:
Holoxan is contraindicated in cases of
–
known hypersensitivity to ifosfamide
–
severely depressed bone-marrow function (especially in patients
previously treated with cytotoxic agents or radiotherapy)
–
active infections
–
impaired renal function and/or obstructions of the urine flow
–
cystitis
–
pregnancy (see special comments)
–
lactation
Adverse Reactions:
The adverse reactions and frequencies below are based on publications
describing clinical experience with fractionated administration of
ifosfamide as monotherapy with a total dose of 4 to 12 g/m2 per
course.
ADR frequency is based upon the following scale: Very common (>1/10);
Common (>1/100 - <1/10), Uncommon (>1/1,000 - <1/100), Rare
(>1/10,000 - <1/1,000), Very rare (<1/10,000), Not known (adverse
reactions reported in the post-marketing experience).
System Organ Class (SOC)
Adverse Reaction
Frequency Category
INFECTIONS AND INFESTATIONS
Infections (including reactivation of latent infections)
Sepsis (septic shock)*
Common
Not known
NEOPLASMS BENIGN, MALIGNANT AND
UNSPECIFIED (INCL CYCTS AND POLYPS)
Secondary tumors*
(including Urinary tract carcinoma, Myelod