YUFLYMA adalimumab (rch) 40 mg/0.4 mL solution for injection pre-filled syringe in autoinjector

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Adalimumab, Quantity: 40 mg

Հասանելի է:

Celltrion Healthcare Australia Pty Ltd

Դեղագործական ձեւ:

Injection, solution

Կազմը:

Excipient Ingredients: acetic acid; polysorbate 80; sodium acetate trihydrate; glycine; water for injections

Կառավարման երթուղին:

Subcutaneous

Միավորները փաթեթում:

4, 2, 6, 1

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Rheumatoid Arthritis,Yuflyma 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. Yuflyma can be used alone or in combination with methotrexate.,Juvenile Idiopathic Arthritis,Polyarticular Juvenile Idiopathic Arthritis,Yuflyma 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). Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-Related Arthritis,Yuflyma 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,Yuflyma is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis,Yuflyma is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. Crohn?s Disease in Adults and Children (6 years and older),Yuflyma 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 to infliximab,Ulcerative colitis,Yuflyma 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. (see 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).,Psoriasis in Adults and Children,Yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,Yuflyma 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 in Adults and Adolescents (from 12 years of age),Yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis,Yuflyma 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.

Ապրանքի ամփոփագիր:

Visual Identification: Clear to slightly opalescent solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2022-03-25

Տեղեկատվական թերթիկ

Yuflyma ver03-0922
1
YUFLYMA®
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 TAKING YUFLYMA?
Yuflyma contains the active ingredient adalimumab. Yuflyma is used to
treat various inflammatory conditions. For
more information, see Section 1. Why am I using Yuflyma? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE YUFLYMA?
Check the list of ingredients at the end of the CMI. Do not use
Yuflyma if you have ever had an allergic reaction to
any of them.
TALK TO YOUR DOCTOR BEFORE TAKING THIS MEDICINE IF YOU ARE NOT AWARE
THAT 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
Yuflyma? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Yuflyma and affect how it works, or
Yuflyma may interfere with other medicines
and affect 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 YUFLYMA?
Yuflyma is injected under the skin (subcutaneous).
More instructions can be found in Section 4. How do I use Yuflyma? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING YUFLYMA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Yuflyma.
•
Keep all your appointments, including for blood tests.
•
Tell your doctor if you develop an infection or you notice new or
changed spots on your skin.
•
Tell your doctor if you are scheduled for any vaccines.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dose unless your doctor
tells you to.
DRIVING OR
USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Yuflyma affects
you. The effects on your ability to drive or use machines whilst
taking Yuflyma are not known.
DRINKING
ALCOHOL
•
Ther

Ապրանքի հատկությունները

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AUSTRALIAN PI – YUFLYMA
®
(ADALIMUMAB) – SOLUTION FOR SUBCUTANEOUS INJECTION
1.
NAME OF THE MEDICINE
Adalimumab (rch)
Yuflyma (adalimumab) is a biosimilar medicine to Humira
®
(adalimumab). The evidence for
comparability supports the use of Yuflyma for the listed indications.
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Yuflyma (adalimumab) is a recombinant human monoclonal antibody
produced in Chinese
Hamster Ovary cells.
Yuflyma presentation contains 40 mg adalimumab per 0.4 mL (100 mg/mL)
in a pre-filled
syringe in a pre-filled pen.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Yuflyma is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous
administration. The solution of Yuflyma is a clear to slightly
opalescent, colourless to pale
brown solution. The drug product is supplied as a single use,
pre-filled pen (Yuflyma Pen).
Enclosed within the pen is the single-use, pre-filled glass syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid Arthritis
Yuflyma 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.
Yuflyma can be used alone or in combination with methotrexate.
Juvenile Idiopathic Arthritis
_Polyarticular Juvenile Idiopathic Arthritis _
Yuflyma 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). Yuflyma can be given as monotherapy in case
of intolerance to
methotrexate or when continued treatment with methotrexate is
inappropriate.
_Enthesitis-Related Arthritis _
Yuflyma-AI v07