ICATIBANT LUPIN icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

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

Mevcut itibaren:

Generic Health Pty Ltd

Farmasötik formu:

Injection, solution

Kompozisyon:

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

Uygulama yolu:

Subcutaneous

Paketteki üniteler:

1 syringe with 1 x 25 G Luer lock needle

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

Icatibant Lupin 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.

Ürün özeti:

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

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2022-06-22

Bilgilendirme broşürü

Icatibant Lupin v1.0
1
ICATIBANT LUPIN
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.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING ICATIBANT LUPIN?
Icatibant Lupin contains the active ingredient Icatibant acetate.
Icatibant Lupin 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 Icatibant Lupin?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ICATIBANT LUPIN?
Do not use if you have ever had an allergic reaction to icatibant
acetate or any of the ingredients listed at the end of the CMI.
DO NOT GIVE ICATIBANT LUPIN TO A CHILD UNDER 2 YEARS OF AGE OR
WEIGHING LESS THAN 12 KG.
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
Icatibant Lupin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Icatibant Lupin 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 ICATIBANT LUPIN?
•
Your doctor will determine the exact dose of Icatibant Lupin and will
tell you how often it should be used.
•
The recommended dose of Icatibant Lupin for adults is one subcutaneous
(under the skin) injection of 30 mg.
More instructions can be found in Section 4. How do I use Icatibant
Lupin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ICATIBANT LUPIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
Icatibant Lupin or if you are
about to be started on any new medicine.
•
Tell your doctor immediately, if you notice that your symptoms o

Ürün özellikleri

▼
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 – ICATIBANT LUPIN
(ICATIBANT ACETATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Icatibant acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 3 mL contains 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.
Icatibant Lupin 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
Icatibant Lupin 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 Icatibant Lupin for adults is one subcutaneous
injection of 30 mg.
In the majority of cases a single injection of Icatibant Lupin is
sufficient to treat an attack. In case of
insufficient relief or recurrence of symptoms, a second injection of
Icatibant Lupin can be administered
after 6 hours. If the second injection produces insufficient relief or
a recurrence of symptoms is
observed, a third injection of Icatibant Lupin can be administered
after a further 6 hours. No more than
3 injections of Icatibant Lupin should be administered in a 24-hour
period.
Icatibant Lupin v1.0
Page 2 of 15
(icatibant acetate) solution for injection
In clinical trials, not more than 8 injections of Icatibant Lupin per
month have been administered.
Adolescents and Children (aged 2 to 17 years)
The recommended dose o