Calcium folinate Sandoz

Package Leaflet: Information for the Patient

Calcium Folinate Sandoz, 10 mg/ml, Solution for Injection/Infusion

Folinic Acid

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

☑ Keep this Package Leaflet, You May Need to Read it Again.
☑ If You Have any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
☑ If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents:

• 1. What is Calcium Folinate Sandoz and What is it Used for
• 2. Important Information Before Using Calcium Folinate Sandoz
• 3. How to Use Calcium Folinate Sandoz
• 4. Possible Side Effects
• 5. How to Store Calcium Folinate Sandoz
• 6. Package Contents and Other Information

1. What is Calcium Folinate Sandoz and What is it Used for

Calcium Folinate Sandoz Solution Contains the Active Substance Calcium Folinate, Belonging to the Group of Antidote Medicines.
Calcium Folinate Sandoz is Used to Reduce the Side Effects of Certain Anticancer Medicines or in Case of Overdose in Adults and Children. The Medication Neutralizes the Toxic Effects of Folic Acid Antagonists, Such as Methotrexate (So-called Protective Effect of Calcium Folinate).
Calcium Folinate Sandoz can Also be Used in Combination with 5-Fluorouracil (Another Anticancer Medication).
Calcium Folinate Sandoz is Also Used to Reduce the Side Effects of Other Medicines (a Group of Medicines Called Folic Acid Antagonists). Examples of these Medicines are:

• Trimetrexate (an Antibiotic and Anticancer Medication),
• Trimethoprim (an Antibiotic),
• Pyrimethamine (a Medication Often Used to Treat Malaria).

It can Also be Used to Treat Overdose of these Medicines.

2. Important Information Before Using Calcium Folinate Sandoz

When Not to Use Calcium Folinate Sandoz

☑ if the Patient is Allergic to Calcium Folinate or any of the Other Ingredients of this Medication (Listed in Section 6);
☑ if the Patient has a Reduced Red Blood Cell Count (Anemia).
Calcium Folinate Sandoz Should Not be Used with Certain (Known to the Doctor) Anticancer Medicines in Pregnant or Breastfeeding Women.
Calcium Folinate Sandoz Should be Administered Only by Intramuscular or Intravenous Injection. It Should Not be Administered Directly into the Spine or Brain (Intrathecally).

Warnings and Precautions

Before Using Calcium Folinate Sandoz, the Patient Should Discuss with the Doctor if they Have:

• Epilepsy,
• Kidney Function Disorders.

The Patient Should Inform the Doctor if they Experience:

• Diarrhea,
• Mouth Ulcers.

Calcium Folinate Sandoz and Other Medicines

The Patient Should Tell the Doctor or Pharmacist About all Medicines they are Currently Taking or Have Recently Taken, as well as any Medicines they Plan to Take.
Examples Include:

• Antiepileptic Medicines,
• 5-Fluorouracil (an Anticancer Medication),
• Co-trimoxazole (an Antibiotic),
• Pyrimethamine (an Antimalarial Medication).

Pregnancy, Breastfeeding, and Fertility

Calcium Folinate Sandoz Should Not be Used with 5-Fluorouracil in Pregnant or Breastfeeding Women, as it May Harm the Child.
Pregnant or Breastfeeding Women may Receive Calcium Folinate Sandoz with Methotrexate Only if the Doctor Considers it Necessary.

Driving and Using Machines

There is no Evidence that Calcium Folinate Sandoz Affects the Ability to Drive and Use Machines.

Calcium Folinate Sandoz Contains Sodium

This Medication Contains 3.3 mg (0.14 mmol) of Sodium per ml.
Doses Less than 7 ml (70 mg)
The Medication Contains Less than 1 mmol (23 mg) of Sodium, i.e., the Medication is Considered "Sodium-Free".
For Maximum Single Doses of 500 mg/m2, i.e., 850 mg (for an Average Body Surface Area of 1.7 m2):
This Medication Contains 280.5 mg of Sodium (the Main Component of Table Salt) in Each Maximum Single Dose of 85 ml. This Corresponds to 14% of the Maximum Recommended Daily Sodium Intake in the Diet for Adults.

3. How to Use Calcium Folinate Sandoz

Calcium Folinate Sandoz is Administered by a Doctor or Nurse Under the Supervision of a Doctor Experienced in the Use of Chemotherapy. The Medication can be Administered by Injection or Infusion into a Vein, or by Intramuscular Injection.
The Dose Depends on the Patient's Body Surface Area, the Type of Anticancer Treatment, and Other Medicines or Therapies Used.
If the Patient has any Further Questions About the Use of this Medication, they Should Ask the Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicines, this Medication can Cause Side Effects, Although not Everybody Gets them.

Seek Immediate Medical Attention

• if the Patient Experiences a Severe Allergic Reaction with Symptoms such as Sudden Itching Rash (Hives), Swelling of the Hands, Feet, Ankles, Face, Lips, Mouth, or Throat (which may Cause Difficulty in Swallowing or Breathing) and a Feeling of Fainting. This is a Serious Side Effect. The Patient Should Seek Immediate Medical Attention.

This is a Very Rare Side Effect (may Occur Less than 1 in 10,000 People).
Other Side Effects
The Following Side Effects have been Reported:

• Fever

Uncommon(may Occur Less than 1 in 100 People)

• Insomnia
• Agitation
• Depression
• Gastrointestinal Disorders
• Increased Frequency of Seizures in Patients with Epilepsy

If the Patient is Taking Calcium Folinate Sandoz with a Fluoropyrimidine Anticancer Medication, there is a Higher Risk of the Following Side Effects of this Anticancer Medication:

• Nausea
• Vomiting
• Severe Diarrhea
• Dehydration (which may be Caused by Diarrhea)
• Mucositis (Inflammation of the Mucous Membranes) of the Intestine and Mouth (including Life-Threatening Cases)
• Decreased Blood Cell Count (including Life-Threatening Conditions)

Common(may Occur Less than 1 in 10 People)

• Redness and Swelling of the Palms or Soles, which may Cause Skin Peeling (Hand-Foot Syndrome)

Side Effects with Unknown Frequency(Frequency Cannot be Estimated from Available Data)

• Increased Blood Ammonia Levels

Reporting Side Effects

If the Patient Experiences any Side Effects, including those not Listed in this Package Leaflet, they Should Inform their Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301/Fax: +48 22 49 21 309/Website: https://smz.ezdrowie.gov.pl
Side Effects can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather More Information on the Safety of this Medication.

5. How to Store Calcium Folinate Sandoz

The Medication Should be Stored Out of Sight and Reach of Children.
Do not Use this Medication After the Expiration Date Stated on the Label and Carton After EXP. The Expiration Date Refers to the Last Day of the Specified Month.
Store in a Refrigerator (2°C - 8°C).
The Batch Number on the Packaging is Marked as "Lot".
Information on the Storage and Shelf Life of Calcium Folinate Sandoz After Dilution for Infusion is Provided in the Section for Healthcare Professionals at the End of this Package Leaflet.
Do not Use the Medication if the Solution is Cloudy or Contains Visible Particles.
Medicines Should not be Disposed of via Wastewater or Household Waste. Ask the Pharmacist How to Dispose of Medicines that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Calcium Folinate Sandoz Contains

• The Active Substance is Calcium Folinate. Each ml of Solution for Injection/Infusion Contains 10 mg of Folinic Acid in the Form of Calcium Folinate.
• The Other Ingredients are: Sodium Chloride, Water for Injections, Sodium Hydroxide, Diluted Hydrochloric Acid.

What Calcium Folinate Sandoz Looks Like and What the Package Contains

Calcium Folinate Sandoz is a Clear, Yellowish Solution.
The Vials are Made of Orange Glass and are Packaged in Cardboard Boxes.
The Vials are Closed with Bromobutyl Rubber Stoppers and Aluminum Seals.
Available Package Sizes
1, 5, 10 Vials of 3 ml
1, 5, 10 Vials of 5 ml
1 Vial of 10 ml
1 Vial of 20 ml
1 Vial of 35 ml
1 Vial of 50 ml
1 Vial of 100 ml
Not all Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestraße 11
4866 Unterach am Attersee, Austria
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Barleben, Sachsen-Anhalt, 39179
Germany

For More Information, Please Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Phone: 22 209 70 00
Date of Last Update of the Package Leaflet:12/2020
Logo of the Company
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Information Intended for Healthcare Professionals Only
Instructions for Preparation and Administration of the Medication
To Administer the Medication by Intravenous Infusion, Calcium Folinate Sandoz may be Diluted with Sodium Chloride 0.9% Solution or Glucose 5% Solution (see Storage and Shelf Life).
Before Administration, the Medication Should be Inspected. The Solution for Injection or Infusion Should be Clear and Yellowish. If the Solution is Cloudy or Contains Particles, it Should be Discarded.
Incompatibilities
There are Data on Incompatibilities Between Calcium Folinate for Injection and Droperidol, Fluorouracil, Foscarnet, and Methotrexate for Injection.

Administration of Calcium Folinate

Calcium Folinate Should be Administered Only by Intramuscular or Intravenous Injection.
It Should Not be Administered Intrathecally.

There have been Reports of Fatalities Due to Intrathecal Administration of Calcium Folinate After Overdose of Intrathecally Administered Methotrexate.
Intravenous Administration: the Medication Should Not be Administered at a Rate of More than 160 mg of Calcium Folinate per Minute, Due to the Calcium Content of the Solution.
Storage
Store in a Refrigerator (2°C - 8°C).
Shelf Life
Unopened Vial
2 Years
After Dilution for Infusion
Chemical and Physical Stability has been Demonstrated for 28 Days at a Temperature of 2°C - 8°C After Dilution with Sodium Chloride 0.9% Solution to a Concentration of 0.2 mg/ml and 4.0 mg/ml.
Chemical and Physical Stability has been Demonstrated for 4 Days at a Temperature of 2°C - 8°C After Dilution with Glucose 5% Solution to a Concentration of 0.2 mg/ml and for 28 Days at a Temperature of 2°C - 8°C After Dilution to a Concentration of 4.0 mg/ml.
From a Microbiological Point of View, the Product Should be Used Immediately. If not Used Immediately, the Responsibility for the Storage Conditions and Shelf Life of the Prepared Solution Lies with the User. Normally, this Storage Time Should not Exceed 24 Hours at 2°C - 8°C, Unless the Dilution has been Carried out in Controlled and Validated Aseptic Conditions.