Calcium folinate "EBEWE" solution for injection/infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

calcium folinate

Доступна с:

EBEWE Pharma Ges. m.b.H. Nfg. KG

код АТС:

V03AF03

ИНН (Международная Имя):

calcium folinate

дозировка:

10mg/ml

Фармацевтическая форма:

solution for injection/infusion

Штук в упаковке:

(1) and (5) glass vial 5ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2018-01-10

Характеристики продукта

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PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
CALCIUM FOLINATE EBEWE
®
SOLUTION FOR INJECTION AND INFUSION, 10 MG/ML
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains calcium folinate (on anhydrous basis),
corresponding to 10 mg folinic
acid.
One vial with 3 ml solution of calcium folinate contains 30 mg folinic
acid.
One vial with 5 ml solution of calcium folinate contains 50 mg folinic
acid.
One vial with 10 ml solution of calcium folinate contains 100 mg
folinic acid.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection and infusion
Appearance: clear, yellowish solution, practically free from turbidity
and foreign matter .
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

To reduce or counteract the toxicity and effects of folic acid
antagonists such as
methotrexate in cytotoxic therapy or in the case of an overdose in
adults and children.
This process is generally known as “calcium folinate rescue” in
cytotoxic therapy.

In combination with 5-fluorouracil in cytotoxic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous and intramuscular administration only.
INTRAVENOUS ADMINISTRATION:
If administered intravenously, the solution should not be injected at
more than 160 mg per
minute due to its calcium content.
For an intravenous infusion, calcium folinate can be diluted with 0.9%
sodium chloride
solution or 5% glucose solution prior to use!
See also sections 6.3 and 6.6.
CALCIUM FOLINATE RESCUE IN METHOTREXATE THERAPY:
The following guidelines serve to illustrate the protocols applied for
adults, the elderly (≥ 65
years), children and adolescents:
The parenteral administration of the calcium folinate rescue is
indicated for patients with
malabsorption syndromes or other gastrointestinal disorders in which
the enteral absorption
is not ensured. Dosages should exceed 25-50 mg in parenteral
administration due to the
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saturable enteral absorption of calcium folinate.