LITAK cladribine 10mg/5mL injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

cladribine, Quantity: 2 mg/mL

제공처:

Viatris Pty Ltd

INN (국제 이름):

Cladribine

약제 형태:

Injection, solution

구성:

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

관리 경로:

Intravenous, Subcutaneous

패키지 단위:

1 vial, 5 vials

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

LITAK is indicated for the treatment of hairy cell leukaemia and the second line treatment of lymphoplasmacytic lymphoma (Waldernstorm's Macroglobulinaemia), i.e. after failure of alkylating agents.

제품 요약:

Visual Identification: clear, colourless, odourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2004-07-01

환자 정보 전단

LITAK
_cladribine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LITAK. 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 LITAK
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 WITH THE MEDICINE.
You may need to read it again.
WHAT LITAK IS USED
FOR
This medicine is used to treat:
•
hairy cell leukaemia
•
lymphoplasmacytic lymphoma
(also known as Waldenström's
Macroglobulinemia)
This medicine belongs to a group of
medicines called antineoplastic
medicines (cytotoxic or
chemotherapy agents).
This medicine works by helping to
stop the uncontrolled increase and
abnormal growth of cancer cells.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN
LITAK
LITAK is only available on a doctor's
prescription.
_WHEN YOU MUST NOT USE IT_
DO NOT TAKE LITAK IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
cladribine
•
any of the ingredients listed at the
end of this leaflet
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
DO NOT TAKE THIS MEDICINE IF YOU
HAVE KIDNEY OR LIVER DISEASE.
DO NOT TAKE THIS MEDICINE IF YOU
ARE USING OTHER CHEMOTHERAPY
DRUGS.
DO NOT RECEIVE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
DO NOT GIVE THIS MEDICINE TO A CHILD
UNDER THE AGE OF 18 YEARS.
Safety and effectiveness in children
younger than 18 years have not been
established.
_BEFORE YOU START TO USE IT_
You must tell your doctor if
•
you are pregnant or planning to
become p

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
LITAK
_Cladribine _
1
NAME OF THE MEDICINE
Cladribine
2
& 3
QUALITATIVE AND QUANTITATIVE COMPOSITION
LITAK solution for injection is presented as clear, colourless,
sterile, preservative-free, isotonic solution.
LITAK is available in single-use vials containing 10 mg of cladribine
in 5 mL of solution, ready-to-use for
subcutaneous injection without dilution or can be diluted for
intravenous infusion. Each mL of the solution
contains 2 mg of cladribine and 9 mg of sodium chloride.
LITAK also contains water for injections to make the solution up to 5
mL. The product may also contain
sodium hydroxide or hydrochloric acid to adjust the pH. The pH range
of LITAK solution is 6.5 - 7.5.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LITAK
is
indicated
for
the
treatment
of
hairy
cell
leukaemia
and
the
second
line
treatment
of
lymphoplasmacytic lymphoma (Waldenström’s Macroglobulinaemia), i.e.
after failure of alkylating agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy with LITAK should be initiated by a qualified physician with
experience in cancer chemotherapy.
LITAK contains no antimicrobial agent. Product is for single use in
one patient only. Opened vials should be
used immediately to assure sterility. Discard any residue.
LITAK is supplied as ready-to-use solution for subcutaneous bolus
injection or can be diluted for intravenous
infusion. Aseptic technique and proper environment precautions must be
observed while handling LITAK
solution and preparing infusions.
_FOR SUBCUTANEOUS BOLUS INJECTION _
The recommended dose is directly withdrawn by a syringe and injected
without dilution. Allow LITAK to
warm up to room temperature prior to administration.
_FOR INTRAVENOUS INFUSION _
The fresh infusion should be prepared daily. The recommended dose is
diluted in 500 mL of 0.9% sodium
chloride. The ready-to-use solution should be used immediately; if
storage is necessary refrigerate between
2°C and 8°C for not more than 8 hours prior to administration.
Hairy cell leukaemia
_SUBCU