BORTEZOMIB EVER PHARMA bortezomib 3.5 mg/1.4 mL solution for injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

bortezomib, Quantity: 3.5 mg

Dostupno od:

Interpharma Pty Ltd

Farmaceutski oblik:

Injection, solution

Sastav:

Excipient Ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol

Administracija rute:

Intravenous, Subcutaneous

Jedinice u paketu:

1 vial, 5 vials

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

BORTEZOMIB EVER PHARMA, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. BORTEZOMIB EVER PHARMA, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. BORTEZOMIB EVER PHARMA is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. BORTEZOMIB EVER PHARMA in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Proizvod sažetak:

Visual Identification: Clear to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

2021-09-13

Uputa o lijeku

BORTEZOMIB EVER PHARMA CMI V1.0
1
BORTEZOMIB EVER PHARMA
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 BORTEZOMIB EVER PHARMA?
BORTEZOMIB EVER PHARMA contains the active ingredient bortezomib.
BORTEZOMIB EVER PHARMA is used to
treat adults with multiple myeloma (cancer of the bone marrow). It is
prescribed for patients who have not been previously
treated for multiple myeloma. It is also prescribed for patients who
have received one or more prior treatments and whose
cancer is still progressing. It is also used for the treatment of
mantle cell lymphoma (a type of cancer affecting the lymph
nodes) in adults in combination with the medicines rituximab,
cyclophosphamide, doxorubicin and prednisone, for patients
whose disease has not been previously treated. For more information,
see Section
1. Why am I using BORTEZOMIB EVER
PHARMA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB EVER PHARMA?
Do not use if you have ever had an allergic reaction to bortezomib or
any of the ingredients listed at the end of the CMI.
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 BORTEZOMIB EVER
PHARMA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BORTEZOMIB EVER PHARMA 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 BORTEZOMIB EVER PHARMA?
Overall treatment with BORTEZOMIB EVER PHARMA must be done under the
supervision of a doctor. Your treatment with
BORTEZOMIB EVER PHARMA may be given by a healthcare professional (eg
doctor or nurse) experienced in the
adminis

Svojstava lijeka

BORTEZOMIB EVERPHARMA PI V1.3 (Sep 2021)
InterPharma Pty Ltd
A
USTRALIAN
P
RODUCT
I
NFORMATION
BORTEZOMIB EVER PHARMA
®
(BORTEZOMIB) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Bortezomib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BORTEZOMIB EVER PHARMA (bortezomib) is an antineoplastic agent for
intravenous injection (IV) or
subcutaneous (SC) use only. Each 1 mL vial contains 1.0 mL solution
for injection which contains 2.5
mg bortezomib (as a mannitol boronic ester).Also contains 25 mg
mannitol_ _
Each 1.4 mL vial contains 1.4 mL solution for injection which contains
3.5 mg bortezomib (as a
mannitol boronic ester) Also contains 35 mg mannitol.
_ _
For subcutaneous injection, no dilution is necessary._ _
1 mL of solution for subcutaneous injection contains 2.5 mg
bortezomib._ _
_ _
For intravenous injection, dilution is necessary._ _
1 mL of diluted solution for intravenous injection contains 1 mg
bortezomib. _ _
Excipient with known effect:
Each mL of concentrate contains less than 1 mmol (approximately 3.5
mg) sodium.
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for injection. Colourless to light yellow solution with a
pH-value of 4.0 – 5.5._ _
Bortezomib is a modified dipeptidyl boronic acid. The product is
provided as a mannitol boronic
ester which, consists of the mannitol ester in equilibrium with its
hydrolysis product, the
monomeric boronic acid. The drug substance exists in its cyclic
anhydride form as a trimeric
boroxine.
The chemical name for bortezomib, the monomeric boronic acid, is
[(1R)-3-methyl-1-[[(2S)- 1-
oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl] boronic
acid.
BORTEZOMIB EVERPHARMA PI V1.3 (Sep 2021)
InterPharma Pty Ltd
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
BORTEZOMIB EVER PHARMA, in combination with melphalan and prednisone
is indicated for
the treatment of patients with previously untreated multiple myeloma
who are not candidates for
high dose chemotherapy.
BORTEZOMIB EVER PHARMA, as part of combina