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FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Ask a doctor about a prescription for FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

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Doctor

Tarek Agami

General medicine10 years of experience

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Calcium Folinate Hikma 10 mg/ml Solution for Injection/Infusion

Folinic Acid

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor, pharmacist, or nurse.

  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Calcium Folinate Hikma and what is it used for
  2. What you need to know before you use Calcium Folinate Hikma
  3. How to use Calcium Folinate Hikma
  4. Possible side effects
  5. Storage of Calcium Folinate Hikma
  6. Contents of the pack and other information

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

Calcium Folinate Hikma contains calcium folinate, which belongs to a group of medicines called detoxifying agents. It is the calcium salt of folinic acid, which is related to folic acid vitamin.

Calcium Folinate Hikma is used to:

  • reduce the harmful effects and to treat overdose of certain cancer medicines, such as methotrexate and other folic acid antagonists. This process is known as "calcium folinate rescue".
  • treat cancer in combination with 5-fluorouracil (a cancer medicine). 5-fluorouracil works better when given with Calcium Folinate Hikma.

2. What you need to know before you use Calcium Folinate Hikma

Calcium Folinate Hikma must not be administered intrathecally (in the spine).

Do not use Calcium Folinate Hikma:

  • if you are allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6).
  • if you have a type of anemia caused by having very low vitamin B12.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Calcium Folinate Hikma.

If you are receiving treatment with calcium folinate and fluorouracil at the same time, be particularly careful if:

  • you have had radiotherapy
  • you have stomach or intestine problems

Special care is also needed if you are over 65 years old and are going to receive treatment with calcium folinate and fluorouracil at the same time.

Using Calcium Folinate Hikma with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines.

Special care is needed if you are taking/using other medicines as they may interact with Calcium Folinate Hikma, for example:

  • folic acid antagonists (see section 1) - the effectiveness of these medicines will be reduced by calcium folinate;
  • fluorouracil (cancer medicine) - the effectiveness and side effects of this medicine will be increased with calcium folinate;
  • medicines used to treat epilepsy (phenobarbital, phenytoin, primidone, or succinimides) - the effectiveness of these medicines may be reduced with calcium folinate. Your doctor may monitor the blood levels of these medicines and change the dose to prevent an increase in seizures (epilepsy).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is unlikely that your doctor will ask you to take/use a folic acid antagonist or fluorouracil during pregnancy or breastfeeding. However, if you have taken/used a folic acid antagonist while pregnant or breastfeeding, this medicine (calcium folinate) may be used to reduce side effects.

Calcium Folinate Hikma contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per vial, and is therefore essentially "sodium-free".

3. How to use Calcium Folinate Hikma

This medicine can be administered by injection (using a syringe) into the muscle. Alternatively, it can also be administered by injection or infusion (drip) into a vein. If administered by infusion, Calcium Folinate Hikma must be diluted first.

Your doctor will decide the correct dose of Calcium Folinate Hikma for you and how often you should receive it. The decision will depend on the medical condition being treated.

If you use more Calcium Folinate Hikma than you should

This medicine is administered in a hospital, under the supervision of a doctor.

It is unlikely that you will be given too much or too little, but talk to your doctor or nurse if you have any questions.

4. Possible side effects

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

Very rare: may affect up to 1 in 10,000 people

  • severe allergic reaction - you may feel a sudden itchy rash (urticaria), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty in swallowing or breathing) and you may feel weak. This is a serious side effect. You may need medical attention.

Uncommon: may affect up to 1 in 100 people

  • fever

Rare: may affect up to 1 in 1,000 people

  • an increase in seizures (epilepsy) in patients with epilepsy
  • depression
  • agitation
  • gastrointestinal disorders
  • difficulty sleeping (insomnia)

Combination therapy with 5-fluorouracil:

If you receive calcium folinate in combination with a cancer medicine that contains fluoropyrimidines, you are more likely to have the following side effects of the other medicine:

Very common: may affect more than 1 in 10 people

  • nausea
  • vomiting
  • severe diarrhea
  • dehydration that may be due to diarrhea
  • inflammation of the intestinal and oral mucosa (life-threatening situations have occurred)
  • reduction in the number of blood cells (including life-threatening situations)

Common: may affect up to 1 in 10 people

  • redness and swelling of the palms of the hands and soles of the feet, which can cause skin peeling (hand-foot syndrome)

Frequency not known: cannot be estimated from the available data

  • high levels of ammonia in the blood

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcium Folinate Hikma

Keep in the refrigerator (2°C – 8°C).

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Store the vials in the outer packaging to protect them from light.

Unopened vials: 18 months.

After opening: 28 days at room temperature or at 2-8°C.

After dilution: the chemical and physical stability during use after dilution between 0.5 mg/ml and 4 mg/ml in 0.9% sodium chloride or 5% glucose has been demonstrated for 28 days at both room temperature and 2-8°C.

From a microbiological point of view, the product should be used immediately.

If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not be longer than 24 hours at 2 to 8°C, unless the dilution has been carried out in a controlled and validated aseptic environment.

6. Contents of the pack and other information

Composition of Calcium Folinate Hikma

  • The active substance is calcium folinate. Each ml contains 10 mg of folinic acid as calcium folinate.
  • Each 5, 10, 30, and 50 ml of solution contains 50, 100, 300, and 500 mg of folinic acid, respectively (as calcium folinate).
  • The other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection.

Appearance and packaging of the product

Calcium Folinate Hikma is a clear, pale yellow solution, which comes in glass containers called vials.

It is available in packs containing:

1 or 5 vials of 10 ml with 5 ml of calcium folinate

1 or 5 vials of 10 ml with 10 ml of calcium folinate

1 or 5 vials of 50 ml with 30 ml of calcium folinate

1 or 5 vials of 50 ml with 50 ml of calcium folinate

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, nº8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Italia S.p.A

Viale Certosa, 10

27100 - Pavia

Italy

You can ask for more information about this medicine from the local representative of the Marketing Authorisation Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany Calciumfolinat Hikma 10 mg/ml Injektions-/Infusionslösung

Spain Folinato Cálcico Hikma 10 mg/ml Solución inyectable y para perfusión

France Folinate de Calcium Hikma 10 mg/ml solution injectable/pour perfusion

United Kingdom Calcium Folinate 10 mg/ml Solution for injection/infusion

Date of last revision of this leaflet: February 2024

------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

In addition to the information included in section 3, practical information on the preparation/handling of this product is available here.

Incompatibilities

Incompatibilities have been observed between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet, and methotrexate.

Droperidol

Droperidol 1.25 mg/0.5 ml with calcium folinate 5 mg/0.5 ml, immediate precipitation after direct mixing in a syringe for 5 minutes at 25°C followed by 8 minutes of centrifugation.

Droperidol 2.5 mg/0.5 ml with calcium folinate 10 mg/0.5 ml, immediate precipitation when the medicines are injected sequentially into a Y-piece without flushing one arm of the equipment between injections.

Fluorouracil

Calcium folinate must not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. 50 mg/ml of fluorouracil with 20 mg/ml of calcium folinate, with or without 5% dextrose in water, have 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

24 mg/ml of Foscarnet with 20 mg/ml of calcium folinate: the formation of a yellowish turbid solution has been reported.

Special precautions for disposal and other handling

Calcium Folinate Hikma is intended for single use. Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

Before administration, calcium folinate should be visually inspected. The solution for injection or infusion should be clear and pale yellow in color. If it is cloudy in appearance or particles are observed, the solution should be discarded.

Alternatives to FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION in Polónia

Dosage form: Solução, 10 mg/ml
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Alternative to FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION in Ukraine

Dosage form: solução, 10 mg/ml; 5 ml
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Dosage form: solução, 10 mg/ml, 5 ml ou 10 ml em um frasco
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Active substance: calcium folinate
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Dosage form: solução, 10 mg/ml em 5 ml (50 mg)
Active substance: calcium folinate
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION – subject to medical assessment and local rules.

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Doctor

Tarek Agami

General medicine10 years of experience

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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  • Hypertension control and cardiovascular disease prevention
  • Interpretation of ECG, blood tests, and Holter monitor results
  • Management of heart failure and coronary artery disease
  • General medical issues: infections, fever, fatigue, gastrointestinal symptoms
  • Guidance on diagnostics, treatment plans, and medication adjustments
Dr. Alhasan’s approach is based on thorough assessment, clear communication, and personalised care – helping patients understand their health and make informed decisions about their treatment.
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Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

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  • sudden changes in how a child or adult feels
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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.

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Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

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Experience and qualifications:

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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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  • General and urgent care: fever, fatigue, infections, digestive issues, respiratory symptoms, and other common concerns
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  • Preventive care: health check-ups, lifestyle advice, second opinions

Dr. Correa combines medical knowledge with an aesthetic and holistic approach to help patients improve both health and quality of life.

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