DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
18-08-2017

Viambatanisho vya kazi:

DOXORUBICIN HYDROCHLORIDE

Inapatikana kutoka:

PANDA PHARMACEUTICALS INC.

ATC kanuni:

L01DB01

INN (Jina la Kimataifa):

DOXORUBICIN

Kipimo:

50MG

Dawa fomu:

POWDER FOR SOLUTION

Tungo:

DOXORUBICIN HYDROCHLORIDE 50MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0110825003; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2017-08-16

Tabia za bidhaa

                                _Doxorubicin Hydrochloride for Injection USP _
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PRODUCT MONOGRAPH
PR DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP 50 MG / VIAL
Sterile Powder for Solution - Intravenous
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
PANDA PHARMACEUTICALS INC.
35 Nixon Road Unit 10
Caledon, ON
L7E 1K1
Control # 195868
Date of Preparation: August 11, 2017
_Doxorubicin Hydrochloride for Injection USP _
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_ of 43_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...............................................................................................
10
DRUG INTERACTIONS
................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
12
OVERDOSAGE
............................................................................................................
16
STORAGE AND STABILITY
.........................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 18
PART II: SCIENTIFIC INFORMATION
...........................................................................
18
PHARMACEUTICAL INFORMATION
...........................................................................
18
CLINICAL TRIALS
.........................
                                
                                Soma hati kamili
                                
                            

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Tabia za bidhaa Tabia za bidhaa Kifaransa 17-08-2017

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