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

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

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

Tersedia dari:

Pfizer Australia Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: sodium chloride; water for injections

Rute administrasi :

Intravenous, Intramuscular

Unit dalam paket:

10mL x 1

Jenis Resep:

(S3) Pharmacist Only Medicine

Indikasi Terapi:

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.

Ringkasan produk:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

1994-06-23

Karakteristik produk

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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
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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