MaxLife Hyper Royal Jelly

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Navodilo za uporabo Navodilo za uporabo (PIL)
03-06-2021
Lastnosti izdelka Lastnosti izdelka (SPC)
02-06-2021
Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-05-2019

Aktivna sestavina:

Royal Jelly fresh

Dostopno od:

Astragrace Corp Pty Ltd

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Medicine Listed

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                                PRIMACOR INJECTION
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PRIMACOR?
Primacor contains the active ingredient Milrinone Lactate. Primacor is
used for the short term treatment of severe congestive heart
failure.
For more information, see Section 1. Why am I using Primacor? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PRIMACOR?
Do not use if you have ever had an allergic reaction to Primacor or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Primacor? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Primacor and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PRIMACOR?
Primacor is usually given to you in hospital. It is given to you as a
series of injections.
More instructions can be found in Section 4. How do I use Primacor? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PRIMACOR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Primacor.
THINGS YOU
SHOULD NOT DO
•
You should not use Primacor if you are allergic to milrinone, similar
medicines, or any of the ingredients
listed at the end of this leaflet.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Primacor affects you.
DRINKING
ALCOHOL
•
NA
LOOKING AFTER
YOUR MEDICINE
•
If you need to store Primacor make sure it is in a cool dry place
where the temperature does not exceed
30°C.
•
Do not refrigerate.
For more information, see Section 5. What should I know while using
Primacor? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
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                                primacor-ccdsv7-piv8-28may21
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – PRIMACOR
®
(MILRINONE LACTATE)
1
NAME OF THE MEDICINE
Milrinone lactate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
STERILE, SINGLE DOSE AMPOULES
Single-dose ampoules of 10 mL contain in each mL milrinone lactate
equivalent to 1 mg
milrinone, and 47 mg glucose monohydrate, in water for injections. 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 mg/mL and 1.29 mg/mL. These ampoules
require preparation of
dilutions prior to administration to patients intravenously.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Sterile aqueous solution of the lactate salt of milrinone for
injection or infusion intravenously.
Colourless to pale yellow in solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primacor Injection is indicated for the short term (48 hours)
intravenous therapy of severe
congestive heart failure patients in intensive care and coronary care
units not responding to
other therapy (eg. digoxin, diuretics, vasodilators, including ACE
inhibitors). The majority
of experience with intravenous Primacor has been in patients receiving
digoxin and diuretics.
Primacor is also indicated for low output states following cardiac
surgery, including weaning
from cardio-pulmonary bypass pump.
4.2
DOSE AND METHOD OF ADMINISTRATION
Primacor Injection should be administered with a loading dose followed
by a continuous
infusion (maintenance dose) according to the following guidelines:
primacor-ccdsv7-piv8-28may21
Page 2 of 12
TABLE 1
LOADING DOSE
50 ΜG/KG ADMINISTER SLOWLY OVER 10 MINUTES
MAINTENANCE DOSE
INFUSION RATE
TOTAL DAILY DOSE
(24 HOURS)
MINIMUM
0.375 µg/kg/min
0.60 mg/kg
STANDARD
0.50 µg/kg/min
0.77 mg/kg
MAXIMUM
0.75 µg/kg/min
1.13 mg/kg
Note: Administer as a continuous intravenous infusion.
The infusion rate should be adjusted according to haemodynamic and
clinical response.
Patients should be clo
                                
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