DAUNORUBICIN Hydrochloride Injection

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

DAUNORUBICIN HYDROCHLORIDE (UNII: UD984I04LZ) (DAUNORUBICIN - UNII:ZS7284E0ZP)

Διαθέσιμο από:

Teva Parenteral Medicines, Inc.

INN (Διεθνής Όνομα):

DAUNORUBICIN HYDROCHLORIDE

Σύνθεση:

DAUNORUBICIN 5 mg in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults. Daunorubicin hydrochloride is contraindicated in patients who have shown a hypersensitivity to it.

Περίληψη προϊόντος:

Daunorubicin Hydrochloride Injection, 5 mg (base)/mL, is available as follows: The 20 mg base/4 mL vials are packaged in tens.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DAUNORUBICIN HYDROCHLORIDE- DAUNORUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
TEVA PARENTERAL MEDICINES, INC.
----------
DAUNORUBICIN
HYDROCHLORIDE INJECTION
PACKAGE INSERT
RX ONLY
WARNINGS
1. Daunorubicin hydrochloride injection must be given into a rapidly
flowing intravenous
infusion. It must never be given by the intramuscular or subcutaneous
route. Severe local
tissue necrosis will occur if there is extravasation during
administration.
2. Myocardial toxicity manifested in its most severe form by
potentially fatal congestive heart
failure may occur either during therapy or months to years after
termination of therapy. The
incidence of myocardial toxicity increases after a total cumulative
dose exceeding 400 to 550
mg/m in adults, 300 mg/m in children more than 2 years of age, or 10
mg/kg in children less
than 2 years of age.
3. Severe myelosuppression occurs when used in therapeutic doses; this
may lead to infection or
hemorrhage.
4. It is recommended that daunorubicin hydrochloride be administered
only by physicians who
are experienced in leukemia chemotherapy and in facilities with
laboratory and supportive
resources adequate to monitor drug tolerance and protect and maintain
a patient compromised
by drug toxicity. The physician and institution must be capable of
responding rapidly and
completely to severe hemorrhagic conditions and/or overwhelming
infection.
5. Dosage should be reduced in patients with impaired hepatic or renal
function.
DESCRIPTION
Daunorubicin Hydrochloride Injection consists of the hydrochloride
salt of an anthracycline cytotoxic
antibiotic produced by a strain of _Streptomyces coeruleorubidus_. It
is provided as a deep red sterile
liquid in vials for intravenous administration only. Each mL contains
daunorubicin hydrochloride, USP
equivalent to 5 mg of daunorubicin, 9 mg sodium chloride, hydrochloric
acid (to adjust pH), and water
for injection, q.s. It has the following structural formula which may
be described with the chemical
name of
(1_S_,3_S_)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-