Calcium folinate 3mg/1ml solution for injection ampoules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Calcium folinate

Dostępny od:

Hospira UK Ltd

Kod ATC:

V03AF03

INN (International Nazwa):

Calcium folinate

Dawkowanie:

3mg/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Intravenous; Intramuscular

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 08010000; GTIN: 5015997896555

Ulotka dla pacjenta

Page 1 of 5
2016-0020386
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIUM FOLINATE 3 MG/ML INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Calcium Folinate Injection is and what it is used for
2.
Before you use Calcium Folinate Injection
3.
How to use Calcium Folinate Injection
4.
Possible side effects
5.
How to store Calcium Folinate Injection
6.
Further information
1. WHAT CALCIUM FOLINATE INJECTION IS AND WHAT IT IS USED
FOR
Calcium folinate
is one of the B group of vitamins.
Calcium Folinate Injection is used to reduce the side effects of other
medicines (a
group of medicines called folic acid antagonists). Examples of folic
acid antagonists
are:

methotrexate (a medicine often used to treat cancer)

trimetrexate (an antibiotic and anti-cancer medicine)

trimethoprim (an antibiotic)

pyrimethamine (a medicine often used to treat malaria)
It may also be used to treat an overdose of these medicines.
2. BEFORE YOU USE CALCIUM FOLINATE INJECTION
CALCIUM FOLINATE INJECTION MUST NOT BE INJECTED INTRATHECALLY (INTO
THE SPINE).
YOU SHOULD NOT BE GIVEN CALCIUM FOLINATE INJECTION IF

you have shown signs of hypersensitivity (severe allergy) to calcium
folinate
in the past

you have a particular type of anaemia (pernicious anaemia) caused by
too little
vitamin B
12
Tell your doctor if either of the above applies to you before this
medicine is used.
Page 2 of 5
2016-0020386
TAKING/USING OTHER MEDICINES
Special care is needed if you are taking/using other medicines as some
could interact
with Calcium Folinate Injection, for example:

folic acid antagonists (see section 1 ‘What Calcium Folinate
Injection is and
what it is used for’ for examples of these medicines) - the
effectiveness of
these medicine

Charakterystyka produktu

OBJECT 1
CALCIUM FOLINATE 3 MG/ML INJECTION
Summary of Product Characteristics Updated 29-Jan-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Calcium Folinate 3 mg/mL Injection
2. Qualitative and quantitative composition
Each vial of 1 ml solution contains 3 mg/ml of folinic acid provided
as calcium folinate.
For excipients, see 6.1_._
3. Pharmaceutical form
Solution for Injection
4. Clinical particulars
4.1 Therapeutic indications
Calcium folinate is indicated
a) 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”;
4.2 Posology and method of administration
For intravenous and intramuscular administration only. In the case of
intravenous administration, no more
than 160 mg of calcium folinate should be injected per minute due to
the calcium content of the solution.
For intravenous infusion, calcium folinate may be diluted with 0.9%
sodium chloride solution or 5%
glucose solution before use. Refer also to sections 6.3 and 6.6.
_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 dosage
regimen of calcium folinate rescue. Therefore, it is best to refer to
the applied intermediate or high dose
methotrexate protocol for posology and method of administration of
calcium folinate.
The following guidelines may serve as an illustration of regimens used
in adults, elderly and children:
_Calcium folinate rescue has to be performed by parenteral
administration in patients with malabsorption _
_syndromes or other gastrointestinal disorders where enteral
absorption is not assured. Dosages above _
_25-50 mg should be given parenterally due to saturable enteral
absorption of calcium folinate._
Calcium folinate rescue is necessary when methot