Calcium Folinate Solution for Injection 10mg/ml (10mL)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM FOLINATE

Available from:

Hospira UK Limited

ATC code:

V03AF03

INN (International Name):

CALCIUM FOLINATE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CALCIUM FOLINATE 10 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2006-12-27

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

CALCIUM FOLINATE 10 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. 

Calcium Folinate Injection may also be used to increase the
effectiveness of the anti-
cancer medicine fluorouracil. 

2. BEFORE YOU USE CALCIUM FOLINATE INJECTION  

CALCIUM FOLINATE INJECTION MUST NOT BE INJECTED INTRATHECALLY (INTO
THE SPINE). 

DO NOT USE CALCIUM FOLINATE INJECTION 
•  if you have shown signs of hypersensitivity (severe allergy)
to calcium 
folinate in the past 
•  if you have a type of anaemia caused by too little vitamin B
12

Tell your doctor if either of the above applies to you before this
medicine is used. 

TAKE SPECIAL CARE WITH CALCIUM FOLINATE INJECTION 
If you are to receive calcium folinate and fluorouracil treatment at

Summary of Product characteristics

Page 1 of 10 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 

Calcium Folinate 10 mg/mL Injection 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each vial of 10 ml solution contains 10 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”; 
b) 
in combination with 5-fluorouracil in cytotoxic therapy. 

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�