Pfizer (Australia) LEUCOVORIN CALCIUM folinic acid (as calcium folinate) 100mg/10mL injection USP ampoule

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

calcium folinate, Quantity: 10.8 mg/mL (Equivalent: folinic acid, Qty 10 mg/mL)

Disponibbli minn:

Pfizer Australia Pty Ltd

Għamla farmaċewtika:

Injection, solution

Kompożizzjoni:

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

Rotta amministrattiva:

Intravenous, Intramuscular

Unitajiet fil-pakkett:

10 x 10mL ampoules, 5x 10mL ampoules

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Leucovorin Calcium Injection USP is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). It is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

Sommarju tal-prodott:

Visual Identification: Clear yellowish solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

1997-11-12

Fuljett ta 'informazzjoni

LEUCOVORIN CALCIUM
INJECTION
_Calcium folinate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Leucovorin Calcium
Injection. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Leucovorin
Calcium Injection against the
benefits this medicine is expected to
have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases, this
leaflet may be given to you after the
medicine has been used.
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 LEUCOVORIN
CALCIUM INJECTION IS
USED FOR
Leucovorin Calcium Injection
contains calcium folinate. It belongs
to a group of vitamins used as an
antidote to the harmful effects of
methotrexate therapy. Calcium
folinate acts in the same way as folic
acid which may be low in these
patients.
Leucovorin Calcium Injection may
be used for the management of other
conditions that are not mentioned
above. Your doctor will be able to
tell you about the specific condition
for which you have been prescribed
Leucovorin Calcium Injection.
BEFORE YOU ARE GIVEN
LEUCOVORIN CALCIUM
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT HAVE LEUCOVORIN CALCIUM
INJECTION IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
leucovorin calcium (calcium
folinate or folinic acid)
•
any of the ingredients listed at the
end of this leaflet
•
any similar medicines.
YOU MUST NOT BE GIVEN LEUCOVORIN
CALCIUM IF YOU HAVE OR HAVE HAD
ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
pernicious anaemia
•
any other megaloblastic anaemias
which are due to a lack of
Vitamin B12.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF:
1.
YOU HAVE ANY ALLERGIES TO:
-
any other medicine
-
any other substances, such

Karatteristiċi tal-prodott

Version pfpleuci11219
Supersedes: pfpleuci10313
Page 1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
[LEUCOVORIN
CALCIUM
INJECTION
(CALCIUM FOLINATE)]
1.
NAME OF THE MEDICINE
Calcium folinate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium folinate as equivalent to folinic acid 50 mg/5 mL, 100 mg/10
mL, containing calcium
folinate 54 mg in 5 mL (equivalent to 50 mg folinic acid) and 108 mg
in 10 mL (equivalent to
100 mg folinic acid).
Calcium folinate potency is usually expressed in terms of equivalent
units of folinic acid.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Leucovorin Calcium Injection is a sterile, isotonic, clear, yellowish,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Leucovorin Calcium Injection is indicated following high dose
methotrexate therapy to reduce
toxicity (leucovorin rescue). It is also indicated after inadvertent
overdosage with methotrexate
and in impaired methotrexate elimination.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
LABORATORY TESTS
Patients treated with Leucovorin Calcium Injection following
methotrexate therapy, including
inadvertent overdose, or patients with impaired methotrexate
elimination, should have serum
creatinine and methotrexate concentrations determined at least once
daily.
Urine pH: in cases of methotrexate overdose or delayed excretion,
monitor as appropriate to
ensure maintenance of pH ≥ 7.0 Foods, drinks and drugs that may
increase urinary acidity
should be avoided during the therapy.
LEUCOVORIN CALCIUM RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY
The dose of Leucovorin Calcium Injection required depends on the
amount of methotrexate
administered and whether there is impaired methotrexate elimination.
Table 1 provides dosing
Version pfpleuci11219
Supersedes: pfpleuci10313
Page 2 of 11
guidelines for a methotrexate dose of 12 to 15 g/m
2
by intravenous infusion over 4 hours.
Leucovorin Calcium Injection is commenced 24 hours after the start of
the methotrexate
infusion.
TABLE