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CALCIUM FOLINATE 10 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CALCIUM FOLINATE / CALCIUM FOLINATE PENTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIUM FOLINATE 10 MG/ML INJECTION BP
SOLUTION FOR INJECTION OR INFUSION
Calcium folinate

The name of your medicine is Calcium Folinate 10 mg/ml Injection BP, which will be called Calcium folinate
throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Calcium folinate is and what it is used for
2. Before you are given Calcium folinate
3. How you are given Calcium folinate
4. Possible side effects
5. How to store Calcium folinate
6. Further information
1. WHAT CALCIUM FOLINATE IS AND WHAT IT IS USED FOR
Calcium folinate is a solution containing the active ingredient Calcium folinate, which is one of a group of medicines
called detoxifying agents.
Calcium folinate is used to reduce the side effects of certain anticancer drugs or if too much has been given in adults
and children. Calcium folinate works by acting against drugs that work against folic acid such as methotrexate.
This is called “Calcium Folinate Rescue”.
Calcium folinate may also be used in combination with 5-fluorouracil (another anticancer drug).
2. BEFORE YOU ARE GIVEN CALCIUM FOLINATE
You should not be given Calcium folinate if you:
- are allergic (hypersensitive) to calcium folinate or any of the other ingredients of Calcium folinate (see list of
ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face,
lips, throat or tongue.
- have anaemia
You should not be given Calcium folinate together with certain anticancer drugs if you are pregnant or breastfeeding
(your doctor will know which these are).
Calcium folinate should only be given by intramuscular or intravenous injection and must not be administered
intrathecally.
Take special care with Calcium folinate and tell your doctor if you have any of the following conditions:
- epilepsy
- a kidney disorder
Tell your doctor if you develop any of the following conditions during treatment:
- diarrhoea
- inflammation of the mouth
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, e.g.:
- treatments for epilepsy
- 5-fluorouracil (an anticancer drug)
- co-trimoxazole (an antibiotic)
- pyrimethamine (a treatment for malaria)
Pregnancy and breast-feeding
You should not be given Calcium folinate together with 5-fluorouracil while pregnant or breast-feeding as it might
harm the baby.
You will only be given Calcium folinate together with methotrexate when pregnant or breast-feeding if your doctor
thinks it is necessary.
Driving and using machines
There is no evidence that Calcium folinate affects driving or using machines.
3. HOW YOU ARE GIVEN CALCIUM FOLINATE
Calcium folinate will only be given by a doctor or nurse under the supervision of a doctor who has experience in
the use of chemotherapy. Calcium folinate may be given by injection or infusion into a vein, or as an injection into
a muscle.
Adults, children and the elderly
The dose depends on your body surface area, the type of anticancer treatment used, and any other treatment you
may be receiving.

AASAA

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Calcium folinate can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight
away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body).
The following side effects have been reported:
Uncommon (between 1 in 1000 and 1 in 100)
• fever
Rare (between 1 in 1000 and 1 in 10,000)
• difficulty sleeping (insomnia)
• agitation
• depression
• digestive tract disorders (like vomiting, nausea, diarrhoea and dehydration)
• increased attacks in patients with epilepsy.
Very rare (less than 1 in 10000)
• allergic reactions, including severe allergic attacks and nettle rash.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. HOW TO STORE CALCIUM FOLINATE
Your doctor or pharmacist knows how to store Calcium folinate.
Calcium folinate should be kept out of the reach and sight of children.
Store at 2-8°C. Store in the original container to protect from light.
Do not use Calcium folinate after the expiry date which is stated on the label and the carton after EXP. The expiry
date refers to the last day of that month.

The following information is intended for medical and healthcare professionals only:
Instructions for use/handling
For single use only.
For intravenous infusion, calcium folinate may be diluted with 0.9% sodium chloride solution or 5% glucose solution
before use (see storage and shelf-life).
Prior to administration, calcium folinate should be inspected visually. The solution for injection or infusion should
be a clear yellowish solution. If cloudy in appearance or particles are observed, the solution should be discarded.
Calcium folinate solution for injection or infusion is intended for single use only. Any unused portion of the solution
should be disposed of in accordance with the local requirements.
Incompatibilities
Incompatibilities have been reported between injectable forms of calcium folinate and injectable forms of droperidol,
fluorouracil, foscarnet and methotrexate.
Droperidol
1. Droperidol 1.25 mg/0.5 ml with calcium folinate 5 mg/0.5 ml; immediate precipitation was observed after direct
admixture in a syringe for 5 minutes at 25°C followed by 8 minutes of centrifugation.
2. Droperidol 2.5 mg/0.5 ml with calcium folinate 10 mg/0.5 ml; immediate precipitation was observed when the
drugs were injected sequentially into a Y-connector without flushing the Y-side arm between injections.

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Fluorouracil
Calcium folinate must not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. Fluorouracil
50 mg/ml with calcium folinate 20 mg/ml, with or without dextrose 5% in water, has been shown to be incompatible
when mixed in different amounts and stored at 4°C, 23°C, or 32°C in polyvinyl chloride containers.
Foscarnet
The formation of a cloudy yellow solution has been reported when Foscarnet 24 mg/ml is mixed with with calcium
folinate 20 mg/ml.
Administration
For intravenous and intramuscular use only. Fatal if given by other routes.
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.
Calcium Folinate Rescue in methotrexate therapy:
Refer to the applied intermediate- or high-dose methotrexate protocol for posology and method of administration
of calcium folinate. The methotrexate protocol will dictate the dosage regimen of Calcium Folinate Rescue because
it depends heavily on the posology and method of the intermediate- or high-dose methotrexate administration.
The following guidelines may serve as an illustration of regimens used in adults, elderly and children:
Calcium Folinate Rescue is necessary when methotrexate is given at doses exceeding 500 mg/m2 body surface
and has to be considered with doses of 100 mg – 500 mg/m2 body surface. Calcium Folinate Rescue should 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.
Dosage and duration of use of Calcium folinate primarily depend on the type and dosage of methotrexate therapy,
the occurrence of toxicity symptoms, and the individual excretion capacity for methotrexate. As a rule, the first
dose of Calcium folinate is 15 mg (6-12 mg/m²) to be given 12-24 hours (24 hours at the latest) after the beginning
of the methotrexate infusion. The same dose is given every 6 hours throughout a period of 72 hours. After several
parenteral doses treatment can be switched over to the oral form.
In addition to calcium folinate administration, measures to ensure the rapid excretion of methotrexate (maintenance
of high urine output and alkalinisation of urine) are integral parts of the Calcium Folinate Rescue treatment. Renal
function should be monitored by measuring serum creatinine levels daily.
The residual methotrexate-level, in the blood, should be measured, forty-eight hours after the start of the
methotrexate-infusion. If the residual methotrexate-level is > 0.5 μmol/l, then the dosage of calcium folinate dosages
should be adapted according to the following table:
Residual methotrexate level in the blood 48 hours after the Additional Calcium folinate to be administered every 6 hours for 48 hours
start of the methotrexate administration:
or until levels of methotrexate are lower than 0.05 μmol/l:
> 0.5 μmol/l

15 mg/m²

> 1.0 μmol/l

100 mg/m²

> 2.0 μmol/l

200 mg/m²

In combination with 5-fluorouracil in cytotoxic therapy:
Different regimens and different dosages are used, however, no optimal dosage or regimen have been
determined.
The following regimens have been used in adults and the elderly in the treatment of advanced or metastatic
colorectal cancer and are given as examples. There are no data on the use of calcium folinate in combination with
5-fluorouracil in children:
Bimonthly regimen: Calcium folinate 200 mg/m² by intravenous infusion over two hours, followed by an intravenous
bolus of 400 mg/m² of 5-Fluorouracil and a 22-hour intravenous infusion of 5-Fluorouracil (600 mg/m²) for 2
consecutive days, every 2 weeks on days 1 and 2.
Weekly regimen: Calcium folinate 20 mg/m² by intravenous bolus injection or 200 to 500 mg/m² intravenous infusion
over a period of 2 hours, plus 500 mg/m² 5-fluorouracil as an intravenous bolus injection in the middle, or at the
end, of the calcium folinate infusion.
Monthly regimen: Calcium folinate 20 mg/m² by bolus i.v. injection or 200 to 500 mg/m² as i.v. infusion over a
period of 2 hours immediately followed by 425 or 370 mg/m² 5-fluorouracil as an intravenous bolus injection over
five consecutive days.
For the use of calcium folinate in combination with 5-fluorouracil, modification of the 5-fluorouacil
dosage and the treatment-free interval may be necessary depending on patient condition, clinical response and
dose limiting toxicity as stated in the product information of 5-fluorouracil. A reduction of calcium folinate dosage
is not required.
The number of repeat cycles used is at the discretion of the clinician.
Antidote to the folic acid antagonists trimetrexate, trimethoprim, and pyrimethamine:
Trimetrexate toxicity:
• Prevention: Calcium folinate should be administered every day during treatment with trimetrexate and for 72
hours after the last dose of trimetrexate. Calcium folinate can be administered either intravenously at a dose of
20 mg/m² for 5 to 10 minutes every 6 hours (total daily dose of 80 mg/m²), or orally with four doses of 20 mg/m²
administered at equal time intervals. Daily doses of calcium or calcium folinate should be adjusted depending
on the haematological toxicity of trimetrexate.
• Over dosage (possibly occurring with trimetrexate doses above 90 mg/m² without concomitant administration
of calcium folinate): Calcium folinate should be administered intravenously at a dose of 40 mg/m² every 6 hours
for 3 days, following cessation of treatment with trimetrexate.
Trimethoprim toxicity:
• Following cessation of treatment with trimethoprim, calcium folinate should be administered intravenously at a
dose of 3-10 mg/day calcium folinate until recovery of a normal blood count.
Pyrimethamine toxicity:
In cases of high dose pyrimethamine or prolonged treatment with low doses, calcium folinate 5 to 50 mg/day should
be simultaneously administered, based on the results of the peripheral blood counts.
Storage and shelf-life
782838–Reg

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6. FURTHER INFORMATION
What Calcium folinate contain:
The active substance is Calcium folinate 10 mg/ml.
The other ingredients are: sodium chloride and water for injection
What Calcium folinate looks like and contents of the pack
Amber glass vials packed in a carton.
Vials are closed with a rubber stopper with an aluminium cap.
1 vial containing 100 mg/10 ml of Calcium folinate.
1 vial containing 200 mg/20 ml of Calcium folinate.
1 vial containing 300 mg/30 ml of Calcium folinate.
1 vial containing 350 mg/35 ml of Calcium folinate.
1 vial containing 800 mg/80 ml of Calcium folinate.
Also amber glass ampoules packed in a carton.
5 ampoules each containing 30 mg/3 ml of Calcium folinate.
5 ampoules each containing 50 mg/5 ml of Calcium folinate.
5 ampoules each containing 100 mg/10 ml of Calcium folinate.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg. KG
Mondseestraße 11
4866 Unterach
Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
Folinezuur Sandoz 10 mg/ml, oplossing voor injectie
NL:
BE: Folinate de calcium “Ebewe” 10 mg/ml, solution injectable

Calciumfolinaat “Ebewe” 10 mg/ml oplossing voor injectie

Calciumfolinat “Ebewe” 10 mg/ml Injektionslösung
DK:
Calciumfolinat “Ebewe”
ES:
Folinato Cálcico Ferrer Farma 10 mg/ml, solución inyectable o para perfusión EFG
IE:
Folinic acid (as calcium folinate) 10 mg/ml, Solution for Injection or infusion
PT:
Folinato de Cálcio Generis
UK:
Calcium Folinate 10 mg/ml Injection BP
This leaflet was last revised in
05/2011 (To be amended after approval)

AASAA



Unopened - 24 months.
The chemical and physical in-use stability of the solution diluted with Sodium Chloride 0.9 % or Glucose 5 % for
intravenous infusion has been demonstrated for 24 hours at a temperature not exceeding 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use
storage times and conditions prior to use are the responsibility of the user and would normally not be longer than
24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Special precautions for storage
Store at 2-8°C (in a refrigerator).
Store in original container to protect from light.
A copy of the full SPC can be requested from the Marketing Authorisation Holder.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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