PACLITAXEL KABI paclitaxel 300 mg/50 mL concentrated injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

paclitaxel, Quantity: 300 mg

Dostupné z:

Fresenius Kabi Australia Pty Ltd

INN (Medzinárodný Name):

Paclitaxel

Forma lieku:

Injection, concentrated

Zloženie:

Excipient Ingredients: ethanol; citric acid; PEG-35 castor oil

Spôsob podávania:

Intravenous

Počet v balení:

5 x 50 mL vials, 1 x 50 mL vial

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Primary treatment of ovarian cancer in combination with a platinum agent. Treatment of metastatic carcinoma of the ovary after failure of standard therapy. Treatment of metastatic carcinoma of the breast after failure of standard therapy. Adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide. Treatment of metastatic cancer of the breast, in combination with trastuzumab (Herceptin), in patients who have tumours that over-express HER-2 and who have not received previous chemotherapy for their metastatic disease. In combination with gemcitabine (Gemzar), the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Treatment of non-small cell lung cancer (NSCLC).

Prehľad produktov:

Visual Identification: Clear, slightly yellowish solution, free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2010-06-24

Príbalový leták

CMI for Paclitaxel Kabi
October 2016
Filename: PacCMI-20161007_clean
1
PACLITAXEL KABI
Paclitaxel (pak-li-TAX-el)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Paclitaxel Kabi. 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 taking Paclitaxel
Kabi against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PACLITAXEL KABI IS
USED FOR
This medicine is used to treat:

ovarian cancer

breast cancer

non-small cell lung cancer
(NSCLC).
This medicine belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
It works by killing cancer cells and
stopping cancer cells from growing
and multiplying.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed it for
another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this
medicine for children.
BEFORE YOU ARE GIVEN
PACLITAXEL KABI
_WHEN YOU MUST NOT BE _
_GIVEN IT_
_ _
You must not be given Paclitaxel
Kabi if you have an allergy to:

any medicine containing
paclitaxel

any of the ingredients listed at
the end of this leaflet

any medicines containing PEG
35 castor oil, such as
cyclosporin injection or
teniposide injection
Some of the 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; rash, itching or hives on
the skin.
You must not be given this
medicine if you have a very low
white blood cell (WBC) count.
Tell your doctor if you have an
infection or

Súhrn charakteristických

Filename: PacPI-20161007_clean
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PRODUCT INFORMATION
PACLITAXEL KABI
NAME OF THE MEDICINE
Paclitaxel is an anticancer agent from the taxane class of medicines.
Paclitaxel is described chemically as
5β,20-Epoxy-1,7β-dihydroxy-9-oxotax-11-ene-
2α,4,10β,13α-tetrayl-4,10-diacetate-2-benzoate-13-[(2_R_,3_S_)-3-(benzoylamino)-2-
hydroxy-3-phenylpropanoate] or (2_S_, 5_R_, 7_S_, 10_R_,
13_S_)-10,20-bis(acetoxy)-2-
benzoyloxy-1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-13-yl(3_S_)-3-benzoylamino-3-
phenyl-D-lactate.
The structural formula is represented as follows:
Empirical formula:
C
47
H
51
NO
14
Molecular weight:
853.9
CAS Number:
33069-62-4
DESCRIPTION
Paclitaxel is a white to off-white crystalline powder that is highly
lipophilic, insoluble in
water and melts at around 216–217°C.
Paclitaxel Kabi is a sterile solution containing 6 mg/mL paclitaxel,
530 mg/mL PEG-
35 castor oil and 393 mg/mL ethanol. It is a clear to slightly
yellowish solution free of
visible particles. It is supplied as a non-aqueous solution intended
for dilution with
0.9% Sodium Chloride Injection or 5% Glucose Injection prior to
intravenous infusion.
Paclitaxel Kabi must be diluted prior to intravenous infusion.
PHARMACOLOGY
Pharmacological Actions
Paclitaxel
is
an
antimicrotubule
antineoplastic
agent.
It
promotes
microtubule
assembly by enhancing the polymerisation of tubulin, the protein
subunit of spindle
microtubules, even in the absence of the mediators normally required
for microtubule
assembly (e.g. guanosine triphosphate), thereby inducing the formation
of stable,
nonfunctional microtubules. While the precise mechanism of action is
not completely
known, paclitaxel disrupts the dynamic equilibrium within the
microtubule system and
blocks cells in the late G2 phase and M phase of the cell cycle,
inhibiting cell
replication and impairing function of nervous tissue.
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Pharmacokinetics
After paclitaxel is administered intravenously, its plasma
concentration declines
biphasically.
The
fi