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

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Cipla Australia Pty Ltd

Dawa fomu:

Injection, solution

Tungo:

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

Njia ya uendeshaji:

Subcutaneous

Vitengo katika mfuko:

1 syringe with 1 x 25 G Luer lock needle

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Cipla Icatibant 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.

Bidhaa muhtasari:

Visual Identification: Clear, colourless solution free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Registered

Idhini ya tarehe:

2020-05-04

Taarifa za kipeperushi

1
▼
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.
CIPLA ICATIBANT
_(Icatibant acetate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET BEFORE
YOU START USING CIPLA
ICATIBANT.
This leaflet answers some
common questions about Cipla
Icatibant. It does not contain all
the available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
Cipla Icatibant against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT CIPLA ICATIBANT IS USED
FOR
Cipla Icatibant is used for
treating the symptoms of an
acute attack of hereditary
angioedema (HAE) in
adults, adolescents and children
aged 2 years and older.
During attacks of HAE, levels of
a substance in your bloodstream
called bradykinin are increased
and this leads to symptoms like
swelling, pain, nausea, and
diarrhoea.
_HOW IT WORKS _
Cipla Icatibant contains the
active ingredient icatibant. It
blocks the activity of bradykinin
and therefore, helps reduce the
symptoms of an HAE attack.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is not addictive.
This medicine is available only
with a doctor's prescription.
BEFORE YOU USE CIPLA ICATIBANT
_WHEN YOU MUST NOT USE IT _
DO NOT USE CIPLA ICATIBANT IF
YOU HAVE AN ALLERGY
(HYPERSENSITIVITY) TO ICATIBANT,
OR ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips,
tongue or other parts of the
body, skin

Tabia za bidhaa

▼
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
CIPLA ICATIBANT (ICATIBANT ACETATE)
1.
NAME OF THE MEDICINE
Australian approved name: 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.
Excipient with known effect
Each pre-filled syringe of 3 mL contains 9.954 mg of sodium.
For the full list of excipients, see section 6.1.
Description
Icatibant is a selective competitive antagonist at the bradykinin type
2 (B2) receptor. It is a synthetic
decapeptide with a structure similar to bradykinin, but with 5
non-proteinogenic amino acids.
Bradykinin has been shown to be elevated during hereditary angioedema
attacks and is responsible for
oedema formation.
3.
PHARMACEUTICAL FORM
Solution for injection.
Cipla Icatibant (icatibant acetate) is supplied as sterile solution
for injection in single use pre-filled
syringes. The solution is a clear and colourless liquid. The pH of the
injection is approximately 5.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cipla Icatibant 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 Cipla Icatibant for adults is one subcutaneous
injection of 30 mg.
In the majority of cases a single injection of Cipla Icatibant is
sufficient to treat an attack. In case of
insufficient relief or recurrence of symptoms, a second injection of
Cipla Icatibant can be administered
after 6 hours. If the second injection produces insufficient relief or
a recurrence of symptoms is
observed, a third injection of Cipl