Milrinone-Baxter

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Milrinone lactate 1.43 mg/mL equivalent to Milrinone 1 mg/mL

थमां उपलब्ध:

Baxter Healthcare Ltd

INN (इंटरनेशनल नाम):

Milrinone lactate 1.43 mg/mL (equivalent to Milrinone 1 mg/mL)

डोज़:

1 mg/mL

फार्मास्यूटिकल फॉर्म:

Concentrate for injection

रचना:

Active: Milrinone lactate 1.43 mg/mL equivalent to Milrinone 1 mg/mL Excipient: Glucose Lactic acid Sodium hydroxide Water for injection

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Huzhou Zhan Wang Pharmaceutical Co., Ltd.

चिकित्सीय संकेत:

Milrinone-Baxter is indicated for the short term intravenous therapy of severe congestive heart failure. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Ampoule, glass, Type I, 10 mL - 5 dose units - 24 months from date of manufacture stored at or below 30°C. Do not freeze. - Ampoule, glass, Type I, 10 mL - 10 dose units - 24 months from date of manufacture stored at or below 30°C. Do not freeze.

प्राधिकरण की तारीख:

2015-05-27

उत्पाद विशेषताएं

NEW ZEALAND DATA SHEET
MILRINONE‐BAXTER Data Sheet 15 October 2019
Page 1 of 10
Baxter Healthcare Ltd
1 MILRINONE‐BAXTER (1mg/mL, concentrate for injection)
MILRINONE‐BAXTER (as lactate) 10mg/10mL concentrate for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient _
Each single‐dose ampoule of MILRINONE‐BAXTER contains milrinone
lactate equivalent to milrinone
10mg/10mL with anhydrous glucose (47mg/mL) in water for injections.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for injection.
MILRINONE‐BAXTER is a sterile, clear, colourless to pale yellow
aqueous solution, practically free from
visible particles.
The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium
hydroxide.
The total concentration of lactic acid can vary between 0.95 and
1.29mg/mL.
MILRINONE‐BAXTER requires dilution prior to administration to
patients intravenously.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
MILRINONE‐BAXTER is indicated for the short‐term intravenous
therapy of severe congestive heart
failure. The majority of experience with intravenous milrinone has
been in patients receiving digoxin
and diuretics.
MILRINONE‐BAXTER is also indicated for low output states following
cardiac surgery, including
weaning from cardio‐pulmonary bypass pump.
4.2
Dose and method of administration
MILRINONE‐BAXTER should be administered with a loading dose followed
by a continuous infusion
(maintenance dose) according to the following guidelines:
Loading Dose
50µg/kg administer slowly over 10 minutes
Maintenance Dose
Infusion Rate
Total Daily Dose (24 hours)
Minimum
0.375µg/kg/min
0.60mg/kg
Standard
0.50µg/kg/min
0.77mg/kg
Maximum
0.75µg/kg/min
1.13mg/kg
Note: Administer as a continuous intravenous infusion.
The infusion rate should be adjusted according to haemodynamic and
clinical response. Patients
should be closely monitored. Most patients show an improvement in
haemodynamic status as
evidenced by increases in cardiac output and reductions in pulm