NIMODIPINE JUNO nimodipine 10 mg/50 mL concentrated intravenous infusion solution vial

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

nimodipine, Quantity: 10 mg

Dostupné s:

Juno Pharmaceuticals Pty Ltd

Léková forma:

Injection, intravenous infusion

Složení:

Excipient Ingredients: citric acid; sodium citrate dihydrate; water for injections; ethanol; macrogol 400

Podání:

Intravenous Infusion

Jednotky v balení:

Single

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus, e.g., Hunt and Hess Grades I-III (see section 5.1 Pharmacodynamic properties).

Přehled produktů:

Visual Identification: Clear and yellowish solution free from visible particles contained in a type II glass vial, rubber stopper and flip off top; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Registered

Datum autorizace:

2021-11-08

Informace pro uživatele

NIMODIPINE JUNO
1
NIMODIPINE JUNO
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 NIMODIPINE JUNO?
NIMODIPINE JUNO contains the active ingredient nimodipine. NIMODIPINE
JUNO is used to prevent or to treat a lack of blood
supply in the brain caused by narrowing of the blood vessels after a
haemorrhage (burst blood vessel in the brain).
For more information, see Section 1. Why am I using NIMODIPINE JUNO?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NIMODIPINE JUNO?
Do not use if you have ever had an allergic reaction to NIMODIPINE
JUNO or any of the ingredients listed at the end of the
CMI.
NIMODPINE JUNO contains alcohol. Tell your doctor if you suffer from
alcoholism or impaired alcohol metabolism.
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
NIMODIPINE JUNO?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NIMODIPINE JUNO 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 NIMODIPINE JUNO?
•
Your doctor will decide the appropriate dose for you.
•
A doctor or nurse will prepare and administer the infusion.
•
Follow all instructions given to you by your doctor and pharmacist.
More instructions can be found in Section 4. How do I use NIMODIPINE
JUNO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NIMODIPINE JUNO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NIMODIPINE JUNO.
•
Keep all of your doctor’s appointments so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly unless your doctor tells you
to.
DRIVING OR USING
MACHINES
•
NIMODIPINE JUNO contain

Charakteristika produktu

Juno Pharmaceuticals Pty Ltd
Nimodipine Juno
PI v 1.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
NIMODIPINE JUNO (_NIMODIPINE) _CONCENTRATED INTRAVENOUS INFUSION
SOLUTION
_ _
1
NAME OF THE MEDICINE
Nimodipine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nimodipine is a yellow crystalline substance, practically insoluble in
water.
Nimodipine is light sensitive but to a much lesser degree than
nifedipine.
Nimodipine Juno is available as a 0.2 mg/mL concentrated intravenous
infusion solution.
EXCIPIENTS WITH KNOWN EFFECT:
Ethanol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
NIMODIPINE JUNO CONCENTRATED INTRAVENOUS INFUSION SOLUTION is
presented
as
a
clear
slightly
yellowish
solution
containing
10
mg
nimodipine/50
mL
and
10 g alcohol/ 50 mL in a glass vial.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis and treatment of ischaemic neurological deficits caused by
cerebral vasospasm
after subarachnoid haemorrhage following ruptured intracranial
aneurysm, in patients who are
in good neurological condition post-ictus, e.g., Hunt and Hess Grades
I-III (see SECTION 5
Pharmacological properties).
4.2 DOSE AND METHOD OF ADMINISTRATION
_Nimodipine tablet is unavailable in this brand however is available
in other brands. Where _
_correct dosing requires nimodipine tablet formulation, refer to the
specific product information _
_for this formulation for its complete dosage and administration
instructions. _
DOSAGE: NIMODIPINE JUNO CONCENTRATED INTRAVENOUS INFUSION SOLUTION
For single use in one patient only. Discard any residue.
Continuous intravenous infusion:
Nimodipine Juno concentrated intravenous infusion solution must be
administered by co-
infusion via a three-way stopcock to the central catheter. The initial
dosage is 5 mL
Juno Pharmaceuticals Pty Ltd
Nimodipine Juno
PI v 1.0
Page | 2
Nimodipine Juno concentrated intravenous solution (= 1 mg nimodipine)
per hour infused
continuously for the first 2 hours (approximately 15 µg/kg body
weight/hr). Co- infusion
solu