Sodiofolin 900mg/18ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Disodium folinate

Available from:

medac UK

ATC code:

V03AF06

INN (International Name):

Disodium folinate

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010000

Summary of Product characteristics

OBJECT 1
SODIOFOLIN 50 MG/ML, SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 12-Jul-2017 | medac GmbH
1. Name of the medicinal product
Sodiofolin 50 mg/ml, solution for injection/infusion
2. Qualitative and quantitative composition
Sodiofolin contains 54.65 mg/ml disodium folinate equivalent to 50
mg/ml folinic acid.
2 ml of solution contains 109.3 mg disodium folinate equivalent to 100
mg folinic acid.
4 ml of solution contains 218.6 mg disodium folinate equivalent to 200
mg folinic acid.
6 ml of solution contains 327.9 mg disodium folinate equivalent to 300
mg folinic acid.
7 ml of solution contains 382.55 mg disodium folinate equivalent to
350 mg folinic acid.
8 ml of solution contains 437.2 mg disodium folinate equivalent to 400
mg folinic acid.
10 ml of solution contains 546.5 mg disodium folinate equivalent to
500 mg folinic acid.
18 ml of solution contains 983.7 mg disodium folinate equivalent to
900 mg folinic acid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection/infusion
Slightly yellow, clear solution.
4. Clinical particulars
4.1 Therapeutic indications
Disodium folinate is indicated
- to diminish the toxicity and counteract the action of folic acid
antagonists such as methotrexate in
cytotoxic therapy and overdose in adults and children. In cytotoxic
therapy, the procedure is commonly
known as “Folinate Rescue”;
- - in combination with 5-fluorouracil in cytotoxic therapy.
_Note:_
Persistently high serum methotrexate levels may also be expected in
low-dose methotrexate therapy
particularly in pleural effusions, ascites, renal insufficiency and
inadequate fluid intake during
methotrexate therapy.
4.2 Posology and method of administration
Posology
DISODIUM FOLINATE IN COMBINATION WITH 5-FLUOROURACIL IN CYTOTOXIC
THERAPY
The combined use of disodium folinate and 5-fluorouracil is reserved
for physicians experienced in the
combination of folinates with 5-fluorouracil in cytotoxic therapy.
Different regimes and different doses are used, w