AMGEVITA adalimumab (rch) 20mg/0.4mL injection solution syringe

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

Adalimumab, Quantity: 20 mg

Mevcut itibaren:

Amgen Australia Pty Ltd

Farmasötik formu:

Injection, solution

Kompozisyon:

Excipient Ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide

Uygulama yolu:

Subcutaneous

Paketteki üniteler:

2, 1

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

Rheumatoid Arthritis,AMGEVITA is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. AMGEVITA can be used alone or in combination with methotrexate.,Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis AMGEVITA in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-Related Arthritis AMGEVITA is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,Psoriatic Arthritis AMGEVITA is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis AMGEVITA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn?s Disease in Adults and Children (6 years and old) AMGEVITA is indicated for the treatment of moderate to severe Crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant of infliximab.,Ulcerative colitis AMGEVITA is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,Psoriasis in Adults and Children AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,AMGEVITA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,Hidradenitis Suppurativa AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Ürün özeti:

Visual Identification: Liquid, practically free from particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2017-11-09

Bilgilendirme broşürü

AMGEVITA
®
A
M
G
E
V
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T
A
®
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 AMGEVITA?
AMGEVITA pre-filled syringes and pre-filled SureClick
®
pens contain the active ingredient adalimumab. AMGEVITA is used to
treat
various inflammatory conditions.
For more information, see Section 1. Why am I using AMGEVITA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AMGEVITA?
Read this leaflet carefully before you use AMGEVITA and keep it with
the medicine.
Check the list of ingredients at the end of the CMI. Do not use
AMGEVITA if you have ever had an allergic reaction to any of the
ingredients.
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
AMGEVITA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AMGEVITA and affect how it works.
AMGEVITA may interfere with other medicines and how
they work.
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 AMGEVITA?
AMGEVITA is injected under the skin (subcutaneous).
More instructions can be found in Section 4. How do I use AMGEVITA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AMGEVITA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
AMGEVITA.
•
Keep all your appointments, including those for blood tests.
•
Tell your doctor if you develop an infection or you notice new or
changed spots on your skin.
•
Talk to your doctor if you are scheduled for any vaccines.
THINGS YOU
SHOULD NOT DO
•
Do not stop using AMGEVITA suddenly or change the dose unless your
doctor tells you to.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines until you know how
AMGEVITA affects you.
•
The effe

Ürün özellikleri

PRODUCT INFORMATION – AMGEVITA
®
PAGE 1 OF 71
AUSTRALIAN PRODUCT INFORMATION – AMGEVITA
®
(ADALIMUMAB) SOLUTION FOR SUBCUTANEOUS INJECTION
1. NAME OF THE MEDICINE
Adalimumab.
AMGEVITA is a biosimilar medicine to the reference product Humira
®
(adalimumab). The
evidence for comparability supports the use of AMGEVITA for the listed
indications.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AMGEVITA 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Each pre-filled syringe contains adalimumab 20 mg in 0.4 mL solution
(50 mg/mL).
AMGEVITA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Each pre-filled syringe contains adalimumab 40 mg in 0.8 mL solution
(50 mg/mL).
AMGEVITA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
Each pre-filled pen contains adalimumab 40 mg in 0.8 mL solution (50
mg/mL).
EXCIPIENTS
AMGEVITA contains no antimicrobial agent. For the full list of
excipients, see section 6.1
List of excipients.
3. PHARMACEUTICAL FORM
AMGEVITA is a sterile, preservative free solution of adalimumab for
subcutaneous
administration. The solution of AMGEVITA is a clear liquid with a pH
of 5.2. AMGEVITA is
supplied as either a single use pre-filled glass syringe or as a
single use pre-filled
SureClick
®
pen. Enclosed within the pre-filled pen is a single use, pre-filled
glass syringe.
The presentation for paediatric use contains 20 mg adalimumab per 0.4
mL (50 mg/mL).
The adult presentations contain 40 mg adalimumab per 0.8 mL (50
mg/mL).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS (RA)
AMGEVITA is indicated for reducing signs and symptoms, as well as
inhibiting the
progression of structural damage in adult patients with moderate to
severely active RA.
This includes the treatment of patients with recently diagnosed
moderate to severely active
disease who have not received methotrexate (MTX).
AMGEVITA can be used alone or in combination with MTX.
PRODUCT INFORMATION – AMGEVITA
®
PAGE 2 OF 71
JUVENILE IDIOPATHIC ARTHRITIS (JIA)
_POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) _