FYZANT Icatibant (as acetate) 30mg/3mL solution for injection pre-filled syringe

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

icatibant acetate, Quantity: 31.38 mg (Equivalent: icatibant, Qty 30 mg)

Dostupné z:

Juno Pharmaceuticals Pty Ltd

Forma lieku:

Injection, solution

Zloženie:

Excipient Ingredients: glacial acetic acid; sodium chloride; water for injections; sodium hydroxide

Spôsob podávania:

Subcutaneous

Počet v balení:

1 pre-filled syringe with 1 25G luer lock needle

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

FYZANT is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase-inhibitor deficiency.

Prehľad produktov:

Visual Identification: Clear colourless solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2022-03-18

Príbalový leták

Fyzant
1
FYZANT
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.
In Australia, this medicine is subject to additional monitoring. This
will allow quick identification of new safety information.
You can help by reporting any side effects you may get. You can report
side effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
1.
WHY AM I USING FYZANT?
FYZANT contains the active ingredient icatibant. FYZANT is used for
treating the symptoms of an acute attack of hereditary
angioedema (HAE) in adults, adolescents and children aged 2 years and
older.
For more information, see Section 1. Why am I using Fyzant?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FYZANT?
Do not use if you have ever had an allergic reaction to icatibant 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
FYZANT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FYZANT 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 FYZANT?
Your doctor will determine the exact dose of FYZANT and will tell you
how often it should be used. Please see step-by-step
instructions for injecting FYZANT in children and adolescents.
More instructions can be found in Section 4. How do I use FYZANT?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FYZANT?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if you notice that your symptoms of the
attack get worse after you use
FYZANT.
•
Remind any doctor, dentist or pharmacist you visit that you are using
FYZANT.
•
Tell your doctor immediately If you become pregnant while using this
medicine
THINGS YOU
SHOULD NOT DO
•

Súhrn charakteristických

FYZANT PI
1
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
FYZANT (ICATIBANT ACETATE)
1
NAME OF THE MEDICINE
Icatibant acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe delivers 3 mL containing icatibant acetate
equivalent to 30 mg icatibant.
Each mL of the solution contains 10 mg of icatibant.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
FYZANT is supplied as a sterile solution for injection in single use
pre-filled syringes. The solution
should be clear and colourless and free from visible particles. The pH
of the injection is
approximately 5.5.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FYZANT is indicated for symptomatic treatment of acute attacks of
hereditary angioedema (HAE)
in adults, adolescents and children aged 2 years and older with
C1-esterase-inhibitor deficiency.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Adults
The recommended dose of FYZANT for adults is one subcutaneous
injection of 30 mg.
In the majority of cases a single injection of FYZANT is sufficient to
treat an attack. In case of
insufficient relief or recurrence of symptoms, a second injection of
FYZANT can be administered
after 6 hours. If the second injection produces insufficient relief or
a recurrence of symptoms is
observed, a third injection of FYZANT can be administered after a
further 6 hours. No more than
3 injections of FYZANT should be administered in a 24-hour period.
FYZANT PI
2
In clinical trials, not more than 8 injections of icatibant acetate
per month have been administered.
Adolescents and children (aged 2 to 17 years)
The recommended dose of FYZANT based on body weight in children and
adolescents (aged
2 to 17 years) is provided in Table 1 below. Studies in children aged
less than 3.