Calcium Folinate Kabi

Leaflet accompanying the packaging: information for the user

Calcium Folinate Kabi, 10 mg/ml, solution for injection/infusion

Calcium folinate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Calcium Folinate Kabi and what is it used for
• 2. Important information before using Calcium Folinate Kabi
• 3. How to use Calcium Folinate Kabi
• 4. Possible side effects
• 5. How to store Calcium Folinate Kabi
• 6. Contents of the packaging and other information

1. What is Calcium Folinate Kabi and what is it used for

Calcium Folinate Kabi, 10 mg/ml, solution for injection or infusion, contains calcium folinate, which belongs to the group of medicines: antidotes used in cancer treatment. It is a calcium salt of folinic acid associated with a vitamin - folic acid.
Calcium Folinate Kabi is indicated for use:

• to reduce the toxicity and in cases of overdose of certain anticancer medicines, such as methotrexate and other folic acid antagonists, which is referred to as "protective folinate therapy";
• in combination with 5-fluorouracil (an anticancer medicine). 5-fluorouracil works better when given with calcium folinate.

2. Important information before using Calcium Folinate Kabi

When not to use Calcium Folinate Kabi:

• if the patient is allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has anemia (insufficient number of red blood cells) caused by a vitamin B12 deficiency, such as:
• pernicious anemia (the patient's immune system fights their red blood cells),
• megaloblastic anemia (red blood cells are larger than normal).

Calcium Folinate Kabi should not be administered simultaneously with certain anticancer medicines in pregnant or breastfeeding women. The doctor will know which medicines this applies to.

Warnings and precautions

Before starting treatment with Calcium Folinate Kabi, discuss it with your doctor or nurse.
Calcium Folinate Kabi should be administered only intramuscularly by injection, or intravenously by injection or infusion. It must not be administered intrathecally.

Tell your doctor if the patient has any of the following conditions:

• the patient is being treated with 5-fluorouracil, especially if the patient is elderly or in poor health, as Calcium Folinate Kabi may enhance the toxic effects of 5-fluorouracil. The patient may be more susceptible to infections (due to a low white blood cell count). Mouth ulcers or diarrhea may occur. Gastrointestinal disorders also occur frequently and can be severe or even life-threatening (see section 4, "Possible side effects"). The doctor may decide to discontinue 5-fluorouracil and Calcium Folinate Kabi.
• the patient has epilepsy and is taking antiepileptic medicines (such as phenobarbital, phenytoin, primidone, or barbiturates). Since there is a risk of increased frequency of epileptic seizures when using Calcium Folinate Kabi, the doctor may decide to change the dose of the antiepileptic medicine.
• the patient has macrocytosis (enlarged red blood cells) caused by the use of anticancer medicines (such as hydroxyurea, cytarabine, mercaptopurine, and thioguanine), as this condition should not be treated with Calcium Folinate Kabi.
• the patient has kidney function disorders, as the dose of Calcium Folinate Kabi may need to be changed.

Calcium Folinate Kabi and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Tell your doctor if the patient is currently taking or has recently taken:

• medicines that block the action of folic acid (folic acid antagonists), such as cotrimoxazole (an antibacterial medicine) or pyrimethamine (used to treat certain infections, such as malaria), as Calcium Folinate Kabi may reduce the effectiveness of these medicines.
• antiepileptic medicines, such as phenobarbital, phenytoin, primidone, or barbiturates. Calcium Folinate Kabi reduces the levels of these medicines in the body, which may increase the frequency of epileptic seizures. The doctor will order blood tests to check the levels of these medicines. The doctor will also decide whether to change the dosage of the antiepileptic medicines.
• 5-fluorouracil, as concurrent administration of calcium folinate with 5-fluorouracil increases its effectiveness but also enhances toxic effects. The doctor will decide whether to change the dosage of 5-fluorouracil.

Pregnancy and breastfeeding

Pregnancy

During pregnancy or breastfeeding, calcium folinate can be used to reduce the toxicity of methotrexate only if the doctor considers it necessary to treat with methotrexate.
However, methotrexate should not be used during pregnancy or breastfeeding as a rule.

Breastfeeding

There is no sufficient data on the use of calcium folinate and 5-fluorouracil or other anticancer medicines during pregnancy or breastfeeding. However, anticancer medicines should not be used during pregnancy or breastfeeding as a rule.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines

The effect of Calcium Folinate Kabi on the ability to drive and use machines has not been proven.

Calcium Folinate Kabi contains sodium

This medicine contains 3.14 mg/ml to 3.20 mg/ml (0.14 mmol/ml) of sodium. This should be taken into account for patients controlling their sodium intake.

3. How to use Calcium Folinate Kabi

Calcium Folinate Kabi should be administered with anticancer medicines (methotrexate or 5-fluorouracil) only under the strict control of an experienced doctor.
The doctor will decide on the dose of the medicine, depending on the patient's health condition.
The solution is prepared for the patient by medical personnel. The medicine is administered slowly into a vein (by injection or infusion) or by intramuscular injection. The doctor will decide how many injections or infusions the patient should receive and how often the medicine should be administered.

Using a higher dose of Calcium Folinate Kabi than recommended

There are no reports of the consequences of administering much higher doses than recommended of Calcium Folinate Kabi. However, excessive doses of the medicine may reduce the effectiveness of methotrexate.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Inform your doctor immediately if the patient experiences sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially all over the body). These may be symptoms of an allergic reaction to this medicine.

Uncommon side effects (less common than 1 in 100 patients):

• fever.

Rare side effects (less common than 1 in 1000 patients):

• sleep disorders (after administration of high doses);
• restlessness (inability to remain still after administration of high doses);
• depression (after administration of high doses);
• gastrointestinal disorders (after administration of high doses), such as vomiting, nausea, diarrhea, and dehydration;
• increased frequency of epileptic seizures in patients with epilepsy.

Very rare side effects (less common than 1 in 10,000 patients):

• allergic reactions, including severe allergic reactions with difficulty breathing or dizziness and urticaria.

Side effects after concurrent administration of Calcium Folinate Kabi and 5-fluorouracil may vary. They depend on the frequency of administration (once a week or once a month). Elderly patients and those in poor health are more susceptible to side effects. Possible side effects:
Weekly schedule:
Very common side effects (more common than 1 in 10 patients):

• severe diarrhea and dehydration.

Inform your doctor immediately if the patient experiences any of the above side effects. They can be life-threatening and may require hospital treatment. The doctor will decide whether to discontinue 5-fluorouracil until the symptoms subside.
Monthly schedule:
Very common side effects (more common than 1 in 10 patients):

• vomiting;
• nausea (nausea);
• severe mouth ulcers, redness, and swelling.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Calcium Folinate Kabi

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after: EXP.
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C-8°C).
Store the vial in the outer packaging to protect it from light.
Shelf life after first opening
For single use only. Any unused solution should be discarded immediately.
Shelf life after dilution
After dilution with 0.9% sodium chloride solution or 5% glucose solution, the calcium folinate solution shows chemical and physical stability during use, protected from light.
After dilution with 0.9% sodium chloride solution or 5% glucose solution to a concentration of 1.5 mg/ml, the calcium folinate solution shows chemical and physical stability during use for 24 hours at both 25°C and 2°C-8°C, protected from light.
After dilution with 0.9% sodium chloride solution to a concentration of 0.2 mg/ml, the calcium folinate solution shows chemical and physical stability during use for 24 hours at 2°C-8°C, protected from light.
From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions before use, and the storage time should not normally exceed 24 hours at 2°C-8°C, unless the dilution was performed under controlled and validated aseptic conditions.
In case of a change in color or presence of solid particles, the solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Calcium Folinate Kabi contains

• The active substance of the medicine is calcium folinate. Each ml contains 10 mg of folinic acid in the form of calcium folinate.

Each vial of 5 ml, 10 ml, 20 ml, 35 ml, 50 ml, 100 ml contains 50 mg, 100 mg, 200 mg, 350 mg, 500 mg, and 1000 mg of folinic acid, in the form of calcium folinate.

• The other ingredients are: sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections.

What Calcium Folinate Kabi looks like and what the packaging contains

This medicine is a solution for injection or infusion. It is a clear, yellowish solution, free from visible solid particles.
Calcium Folinate Kabi is available in vials made of orange glass type I containing 5 ml, 10 ml, 20 ml, 35 ml, 50 ml, or 100 ml of solution for injection/infusion, with a rubber stopper and an aluminum flip-off seal.
Pack sizes:
1, 5, or 10 vials of 5 ml, 10 ml, 20 ml, 35 ml, 50 ml, or 100 ml solution.
Not all pack sizes may be marketed.

Marketing authorization holder

FreseniusKabi Deutschland GmbH
Else-Kroener Strasse 1
Bad Homburg v.d.H. 61352
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: + 48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Authorization dates:

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Information intended for healthcare professionals only:

Incompatibilities

Do not mix Calcium Folinate Kabi with other medicines except those listed in the "Method of administration" section. Incompatibilities have been observed between calcium folinate in the form of injections and droperidol, 5-fluorouracil, foscarnet, and methotrexate in the form of injections.

Method of administration

Administer only intramuscularly by injection or intravenously by injection or infusion.

Administration by any other route may be fatal. Do not administer intrathecally.
Before administration in intravenous infusion, Calcium Folinate Kabi should be diluted with 0.9% sodium chloride solution or 5% glucose solution.
For single use only. Any unused solution should be discarded.
Before administration, the calcium folinate solution should be inspected. Only clear solutions without visible solid particles should be used.
In intravenous infusion of calcium folinate, the administration rate should not exceed 160 mg per minute due to the calcium ion content.

Shelf life

Shelf life after first opening
For single use only. Any unused solution should be discarded immediately.
Shelf life after dilution
After dilution with 0.9% sodium chloride solution or 5% glucose solution, the calcium folinate solution shows chemical and physical stability during use, protected from light.
After dilution with 0.9% sodium chloride solution or 5% glucose solution to a concentration of 1.5 mg/ml, the calcium folinate solution shows chemical and physical stability during use for 24 hours at both 25°C and 2°C-8°C, protected from light.
After dilution with 0.9% sodium chloride solution to a concentration of 0.2 mg/ml, the calcium folinate solution shows chemical and physical stability during use for 24 hours at 2°C-8°C, protected from light.
From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions before use, and the storage time should not normally exceed 24 hours at 2°C-8°C, unless the dilution was performed under controlled and validated aseptic conditions.

Disposal

Any unused medicine or waste material should be disposed of in accordance with local regulations.