Folinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Calcium folinate

Mevcut itibaren:

AS Kalceks

ATC kodu:

V03AF03

INN (International Adı):

Calcium folinate

Farmasötik formu:

Solution for injection/infusion

Terapötik alanı:

calcium folinate

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2023-12-07

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLINIC ACID (AS CALCIUM FOLINATE) 10 MG/ML SOLUTION FOR
INJECTION/INFUSION
folinic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or nurse.
−
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Folinic acid (as calcium folinate) is and what it is used for
2.
What you need to know before you are given Folinic acid (as calcium
folinate)
3.
How Folinic acid (as calcium folinate) is given
4.
Possible side effects
5.
How to store Folinic acid (as calcium folinate)
6.
Contents of the pack and other information
1.
WHAT FOLINIC ACID (AS CALCIUM FOLINATE) IS AND WHAT IT IS USED FOR
Folinic acid (as calcium folinate) 10 mg/ml solution for
injection/infusion
contains the active
substance folinic acid as calcium folinate hydrate (further referred
to as calcium folinate). Calcium
folinate is a calcium salt of folinic acid. It belongs to a group of
medicines called ‘detoxifying agents’.
This medicine is used to:

reduce the harmful effects and treat overdose of certain anticancer
medicines such as
methotrexate and other folic acid antagonists in adults and children.
This procedure is known as
“calcium folinate rescue”;

treat cancer in combination with fluorouracil (an anticancer
medicine). Fluorouracil works
better when given with calcium folinate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FOLINIC ACID (AS CALCIUM
FOLINATE)
YOU SHOULD NOT BE GIVEN FOLINIC ACID (AS CALCIUM FOLINATE)
−
if you are allergic to calcium folinate or any of the other
ingredients of this medicine (listed in
section 6);
−
if you have a type of anaemia (not enough red blood cells) caused by
lack of vitamin B
12
.
If you are not sure if any of the above applies to you, talk to your
d

Ürün özellikleri

Health Products Regulatory Authority
11 December 2023
CRN00DDN1
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folinic acid (as calcium folinate) 10 mg/ml solution for
injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains calcium folinate hydrate equivalent to 10
mg folinic acid.
Each ml of solution contains calcium folinate hydrate equivalent to 10
mg folinic acid.
Each vial with 5 ml solution contains calcium folinate hydrate
equivalent to 50 mg folinic acid.
Each vial with 10 ml solution contains calcium folinate hydrate
equivalent to 100 mg folinic acid.
Each vial with 20 ml solution contains calcium folinate hydrate
equivalent to 200 mg folinic acid.
Each vial with 30 ml solution contains calcium folinate hydrate
equivalent to 300 mg folinic acid.
Each vial with 50 ml solution contains calcium folinate hydrate
equivalent to 500 mg folinic acid.
Each vial with 100 ml solution contains calcium folinate hydrate
equivalent to 1000 mg folinic acid.
Excipient with known effect
Each ml of solution contains 3.15 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion (injection/infusion).
Clear, colourless or yellowish solution free from visible particles.
pH between 6.5 and 8.5
Osmolality 260‑310 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcium 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,
this procedure is commonly known as "calcium
folinate rescue";

in combination with 5‑fluorouracil in cytotoxic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CALCIUM FOLINATE RESCUE IN METHOTREXATE THERAPY
Since the calcium folinate rescue dosage regimen depends heavily on
the posology and method of the intermediate‑ or
high‑dose methotrexate administration, the methotrexate protocol
will dictate the do