ADALICIP adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled syringe

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

Adalimumab, Quantity: 40 mg

MAH:

Cipla Australia Pty Ltd

pharmaceutical_form:

Injection, solution

composition:

Excipient Ingredients: sodium chloride; sucrose; polysorbate 80; water for injections

administration_route:

Subcutaneous

units_in_package:

2 x pre-filled syringe, 6 x pre-filled syringe, 1 pre-filled syringe

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

Rheumatoid arthritis,Adalicip 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. Adalicip can be used alone or in combination with methotrexate.,Juvenile idiopathic arthritis,Polyarticular juvenile idiopathic arthritis,Adalicip 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 weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). Adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-related arthritis,Adalicip 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,Adalicip 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,Adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. Crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) Adalicip 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,Adalicip 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 section 5.1 Pharmacodynamic properties -clinical trials).,Psoriasis in adults and children,Adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,Adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg 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),Adalicip 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,Adalicip 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.

leaflet_short:

Visual Identification: AVT02 is a clear, colorless, sterile, preservative-free solution for subcutaneous injection; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

authorization_status:

Registered

authorization_date:

2022-09-06

PIL

Adalicip
1
ADALICIP
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 ADALICIP?
Adalicip contains the active ingredient adalimumab. Adalicip is used
to treat various inflammatory conditions.
For more information, see Section 1. Why am I using Adalicip?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADALICIP?
Check the list of ingredients at the end of the CMI. Do not use
Adalicip if you have ever had an allergic reaction to any of them.
TALK TO YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE IF HE/SHE IS 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
Adalicip?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with adalimumab and affect how it works,
or adalimumab 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 ADALICIP?
Adalicip is injected under the skin (subcutaneous).
More instructions can be found in Section 4. How do I use Adalicip?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ADALICIP?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist or pharmacist you visit that you are
using Adalicip.
•
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 until you know how
adalimumab affects you. The
effects on your ability to drive or use machines whilst taking
adalimumab are not known.
DRINKING
ALCOHOL

SPC

AUSTRALIAN PRODUCT INFORMATION
ADALICIP (ADALIMUMAB) SOLUTION FOR SUBCUTANEOUS INJECTION
1
NAME OF THE MEDICINE
Adalimumab
ADALICIP (adalimumab) is a biosimilar medicine to HUMIRA
®
.
The comparability of Adalicip with Humira has been demonstrated with
regard to physicochemical
characteristics and efficacy and safety outcomes (see Section 5
Pharmacological Properties, 5.1
Pharmacodynamic properties - Clinical trials and 4.8 Adverse Effects).
The evidence for
comparability supports the use of Adalicip for the listed indications.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adalimumab is a recombinant human immunoglobulin (IgG1) monoclonal
antibody containing
only human peptide sequences. Adalimumab was created using phage
display technology resulting
in fully human heavy and light chain variable regions, which confer
specificity to human tumour
necrosis factor (TNF), and human IgG1 heavy chain and kappa light
chain sequences. Adalimumab
binds with high affinity and specificity to soluble tumour necrosis
factor (TNF-alpha) but not
lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA
technology in a
mammalian cell expression system. It consists of 1330 amino acids and
has a molecular weight of
approximately 148 kilodaltons.
Adult presentations contain 80 mg adalimumab per 0.8 mL (100 mg/mL),
40 mg adalimumab per
0.4 mL (100 mg/mL).
For the full list of excipients, see
section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Adalicip is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous
administration. The solution of Adalicip is a clear and colorless
liquid solution and isotonic with a pH
of 5.0 to 5.6. The drug product is supplied as either a single-use
pre-filled glass syringe or as a single
use, pre-filled pen (Adalicip Pen). Enclosed within the pen is a
single-use, pre-filled glass syringe.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Adalicip is indicated for reducing signs and symptoms, as well as
inhibiting the progression of
structural damage