post-title portfolio-title Calcium Folinate Injection IP 10mg/ml Taj Pharma 2020-03-07 11:18:48 no no

Calcium Folinate Injection IP 10mg/ml Taj Pharma

Calcium Folinate Injection IP 10mg/ml Taj Pharma

Overview

INTRODUCTION

Calcium Folinate Injection is used to prevent the harmful effects of methotrexate (anticancer medicine). It is also used to treat overdose of methotrexate.

Calcium Folinate Injection is given as a slow injection into veins under the supervision of a doctor. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.

Injection site reactions (pain, swelling, redness) are common side effects of this medicine. If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them. Regular blood tests are required to check your blood cells and serum methotrexate concentration in blood.

Before taking it, tell your doctor if have seizures, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using, especially phenytoin for your seizures. This medicine is not recommended during pregnancy or while breastfeeding.

USES OF CALCIUM FOLINATE INJECTION

  • Harmful effects of methotrexate

SIDE EFFECTS OF CALCIUM FOLINATE INJECTION

Common

  • Injection site reactions (pain, swelling, redness)

HOW TO USE CALCIUM FOLINATE INJECTION

Your doctor or nurse will give you this medicine. Kindly do not self administer.

HOW CALCIUM FOLINATE INJECTION WORKS

Calcium Folinate Injection is a form of vitamin B. It works by protecting healthy cells from the toxic effects of methotrexate (anticancer medicine) while allowing it to enter and kill the cancer cells.

SAFETY ADVICE

warningsAlcohol

CONSULT YOUR DOCTOR

It is not known whether it is safe to consume alcohol with Calcium Folinate Injection. Please consult your doctor.

warningsPregnancy

CONSULT YOUR DOCTOR

Calcium Folinate Injection may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

warningsBreastfeeding

CONSULT YOUR DOCTOR

Information regarding the use of Calcium Folinate Injection during breastfeeding is not available. Please consult your doctor.

warningsDriving

SAFE

Calcium Folinate Injection does not usually affect your ability to drive.

warningsKidney

CONSULT YOUR DOCTOR

There is limited information available on the use of Calcium Folinate Injection in patients with kidney disease. Please consult your doctor.

warningsLiver

CONSULT YOUR DOCTOR

There is limited information available on the use of Calcium Folinate Injection in patients with liver disease. Please consult your doctor.

WHAT IF YOU FORGET TO TAKE CALCIUM FOLINATE INJECTION?

If you miss a dose of Calcium Folinate Injection, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Calcium Folinate Injection IP 10mg/ml Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Calcium Folinate Injection IP 10mg/ml Taj Pharma

2.QUALITATIVE AND QUANTITATIVE COMPOSITION??????????????????????????????

Each vial of 10ml solution contains:
10mg/ml of folinic acid provided as calcium folinate IP.

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 and children:

Calcium folinate rescue has to 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.

Calcium folinate rescue is necessary when methotrexate is given at doses exceeding 500 mg/m2?body surface and should be considered with doses of 100 mg ? 500 mg/m2?body surface.

Dosage and duration of calcium folinate rescue 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 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 prompt 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 through daily measurements of serum creatinine.

Forty-eight hours after the start of the methotrexate infusion, the residual methotrexate-level should be measured. If the residual methotrexate-level is >0.5 ?mol/l, calcium folinate dosages should be adapted according to the following table:

Residual methotrexate blood level 48 hours after the start of the methotrexate administration:Additional calcium folinate to be administered every 6 hours for 48 hours or until levels of methotrexate are lower than 0.05 ?mol/l:
> 0.5 ?mol/l15 mg/m2
> 1.0 ?mol/l100 mg/m2
> 2.0 ?mol/l200 mg/m2

In combination with 5-fluorouracil in cytotoxic therapy:

Different regimens and different dosages are used, without any dosage having been proven to be the optimal one.

The following regimens have been used in adults and elderly in the treatment of advanced or metastatic colorectal cancer and are given as examples. There are no data on the use of these combinations in children:

Bimonthly regimen: Calcium folinate 200 mg/m2?by intravenous infusion over two hours, followed by bolus 400 mg/m2?of 5-FU and 22-hour infusion of 5-FU (600 mg/m2) for 2 consecutive days, every 2 weeks on days 1 and 2.

Weekly 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 plus 500 mg/m2?5-fluorouracil as i.v. 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 i.v. bolus injection during five consecutive days.

For the combination therapy with 5-fluorouracil, modification of the 5-fluorouracil 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 by the intravenous route at a dose of 20 mg/m2for 5 to 10 minutes every 6 hours for a total daily dose of 80 mg/m2, or by oral route with four doses of 20 mg/m2administered at equal time intervals. Daily doses of calcium folinate should be adjusted depending on the haematological toxicity of trimetrexate.
  • Overdosage (possibly occurring with trimetrexate doses above 90 mg/m2without concomitant administration of calcium folinate): after stopping trimetrexate, calcium folinate 40 mg/m2IV every 6 hours for 3 days.

Trimethoprim toxicity:

  • After stopping trimethoprim, 3-10 mg/day calcium folinate until recovery of a normal blood count.

Pyrimethamine toxicity:

  • In case 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.

?4.3 Contraindications

  • Known hypersensitivity to calcium folinate, or to any of the excipients.
  • Pernicious anaemia or other anaemias due to vitamin B12 deficiency.

Regarding the use of calcium folinate with methotrexate or 5-fluorouracil during pregnancy and lactation, see section 4.6, ?Pregnancy and Lactation? and the summaries of product characteristics for methotrexate- and 5-fluorouracil- containing medicinal products.

?4.4 Special warnings and precautions for use

Calcium folinate should only be given by intramuscular or intravenous injection and must not be administered intrathecally.?When folinic acid has been administered intrathecally following intrathecal overdose of methotrexate death has been reported.

General

Calcium folinate should be used with methotrexate or 5-fluorouracil only under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Calcium folinate treatment may mask pernicious anaemia and other anaemias resulting from vitamin B12 deficiency.

Many cytotoxic medicinal products ? direct or indirect DNA synthesis inhibitors ? lead to macrocytosis (hydroxycarbamide, cytarabine, mecaptopurine, thioguanine). Such macrocytosis should not be treated with folinic acid.

In epileptic patients treated with phenobarbital, phenytoin, primidone, and succinimides there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drugs. Clinical monitoring, possibly monitoring of the plasma concentrations and, if necessary, dose adaptation of the anti-epileptic drug during calcium folinate administration and after discontinuation is recommended (see also section 4.5 Interactions).

Calcium folinate/5-fluorouracil

Calcium folinate may enhance the toxicity risk of 5-fluorouracil, particularly in elderly or debilitated patients. The most common manifestations are leucopenia, mucositis, stomatitis and/or diarrhoea, which may be dose limiting. When calcium folinate and 5-fluorouracil are used in combination, the 5- fluorouracil dosage has to be reduced more in cases of toxicity than when 5-fluorouracil is used alone.

Combined 5-fluorouracil/calcium folinate treatment should neither be initiated nor maintained in patients with symptoms of gastrointestinal toxicity, regardless of the severity, until all of these symptoms have completely disappeared.

Because diarrhoea may be a sign of gastrointestinal toxicity, patients presenting with diarrhoea must be carefully monitored until the symptoms have disappeared completely, since a rapid clinical deterioration leading to death can occur. If diarrhoea and/or stomatitis occur, it is advisable to reduce the dose of 5-FU until symptoms have fully disappeared. Especially the elderly and patients with a low physical performance due to their illness are prone to these toxicities. Therefore, particular care should be taken when treating these patients.

In elderly patients and patients who have undergone preliminary radiotherapy, it is recommended to begin with a reduced dosage of 5-fluorouracil.

Calcium folinate must not be mixed with 5-fluorouracil in the same IV injection or infusion.

Calcium levels should be monitored in patients receiving combined 5-fluorouracil/calcium folinate treatment and calcium supplementation should be provided if calcium levels are low.

Calcium folinate/methotrexate

For specific details on reduction of methotrexate toxicity refer to the SPC of methotrexate.

Calcium folinate has no effect on non-haematological toxicities of methotrexate such as the nephrotoxicity resulting from methotrexate and/or metabolite precipitation in the kidney. Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure and all toxicities associated with methotrexate (please refer to the SPC for methotrexate). The presence of pre-existing- or methotrexate-induced renal insufficiency is potentially associated with delayed excretion of methotrexate and may increase the need for higher doses or more prolonged use of calcium folinate.

Excessive calcium folinate doses must be avoided since this might impair the antitumour activity of methotrexate, especially in CNS tumours where calcium folinate accumulates after repeated courses.

Resistance to methotrexate as a result of decreased membrane transport implies also resistance to folinic acid rescue as both medicinal products share the same transport system.

An accidental overdose with a folate antagonist, such as methotrexate, should be treated as a medical emergency. As the time interval between methotrexate administration and calcium folinate rescue increases, calcium folinate effectiveness in counteracting toxicity decreases.

The possibility that the patient is taking other medications that interact with methotrexate (e.g., medications which may interfere with methotrexate elimination or binding to serum albumin) should always be considered when laboratory abnormalities or clinical toxicities are observed.

4.5 Interaction with other medicinal products and other forms of interaction

When calcium folinate is given in conjunction with a folic acid antagonist (e.g. cotrimoxazole, pyrimethamine) the efficacy of the folic acid antagonist may either be reduced or completely neutralised.

Calcium folinate may diminish the effect of anti-epileptic substances: phenobarbital, primidone, phenytoin and succinimides, and may increase the frequency of seizures (a decrease of plasma levels of enzymatic inductor anticonvulsant drugs may be observed because the hepatic metabolism is increased as folates are one of the cofactors) (see also sections 4.4 and 4.8).

Concomitant administration of calcium folinate with 5-fluorouracil has been shown to enhance the efficacy and toxicity of 5-fluorouracil (see sections 4.2, 4.4 and 4.8).

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate and well-controlled clinical studies conducted in pregnant or breast-feeding women. No formal animal reproductive toxicity studies with calcium folinate have been conducted. There are no indications that folic acid induces harmful effects if administered during pregnancy. During pregnancy, methotrexate should only be administered on strict indications, where the benefits of the drug to the mother should be weighed against possible hazards to the foetus. Should treatment with methotrexate or other folate antagonists take place despite pregnancy or lactation, there are no limitations as to the use of calcium folinate to diminish toxicity or counteract the effects.

5-fluorouracil use is generally contraindicated during pregnancy and contraindicated during breastfeeding; this applies also to the combined use of calcium folinate with 5-fluorouracil.

Please refer also to the summaries of product characteristics for methotrexate-, other folate antagonists and 5-fluorouracil- containing medicinal products.

Lactation

It is not known whether calcium folinate is excreted into human breast milk. Calcium folinate can be used during breast feeding when considered necessary according to the therapeutic indications.

4.7 Effects on ability to drive and use machines

There is no evidence that calcium folinate has an effect on the ability to drive or use machines.

?4.8 Undesirable effects

Frequencies are defined using the following convention:

Very common (?1/10);

common (?1/100 to <1/10);

uncommon (?1/1,000 to <1/100);

rare (?1/10,000 to <1/1,000);

very rare (<1/10,000);

not known (cannot be estimated from the available data).

Immune system disorders

Very rare (<0.01%): allergic reactions, including anaphylactoid/ anaphylactic reactions and urticaria.

Psychiatric disorders

Rare (0.01-0.1%): insomnia, agitation and depression after high doses.

Gastrointestinal disorders

Rare (0.01-0.1%): gastrointestinal disorders after high doses.

Neurological disorders

Rare (0.01-0.1%): increase in the frequency of attacks in epileptics (see also section 4.5 Interactions…).

General disorders and administration site conditions

Uncommon (0.1-1%): fever has been observed after administration of calcium folinate as solution for injection.

Combination therapy with 5-fluorouracil only:

Generally, the safety profile depends on the applied regimen of 5-fluorouracil due to enhancement of the 5-fluorouracil induced toxicities:

Metabolism and Nutritional Disorder:

Not known: Hyperammonaemia

Blood and lymphatic system disorders:

Very common: bone marrow failure, including fatal cases

General disorders and administration site conditions

Very common (>10%): mucositis, including stomatitis and chelitis. Fatalities have occurred as a result of mucositis

Skin and subcutaneous tissue disorders:

Common: Palmar-Plantar Erythrodysaesthesia

Monthly regimen:

Gastrointestinal disorders

Very common (>10%): vomiting and nausea

No enhancement of other 5-fluorouracil induced toxicities (e.g. neurotoxicity).

Weekly regimen:

Gastrointestinal disorders

Very common (>10%): diarrhoea with higher grades of toxicity, and dehydration, resulting in hospital admission for treatment and even death.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

There have been no reported sequelae in patients who have received significantly more calcium folinate than the recommended dosage. However, excessive amounts of calcium folinate may nullify the chemotherapeutic effect of folic acid antagonists.

Should overdosage of the combination of 5-fluorouracil and calcium folinate occur, the overdosage instructions for 5-FU should be followed.

?5.PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment

Calcium folinate is the calcium salt of 5-formyl tetrahydrofolic acid. It is an active metabolite of folinic acid and an essential coenzyme for nucleic acid synthesis in cytotoxic therapy.

Calcium folinate is frequently used to diminish the toxicity and counteract the action of folate antagonists, such as methotrexate. Calcium folinate and folate antagonists share the same membrane transport carrier and compete for transport into cells, stimulating folate antagonist efflux. It also protects cells from the effects of folate antagonist by repletion of the reduce folate pool. Calcium folinate serves as a pre-reduced source of H4 folate; it can therefore bypass folate antagonist blockage and provide a source for the various coenzyme forms of folic acid.

Calcium folinate is also frequently used in the biochemical modulation of fluoropyridine (5-FU) to enhance its cytotoxic activity. 5-FU inhibits thymidylate synthase (TS), a key enzyme involved in pyrimidine biosynthesis, and calcium folinate enhances TS inhibition by increasing the intracellular folate pool, thus stabilising the 5FU-TS complex and increasing activity.

Finally intravenous calcium folinate can be administered for the prevention and treatment of folate deficiency when it cannot be prevented or corrected by the administration of folic acid by the oral route. This may be the case during total parenteral nutrition and severe malabsorption disorders. It is also indicated for the treatment of megaloblastic anaemia due to folic acid deficiency, when oral administration is not feasible.

?5.2 Pharmacokinetic properties

Absorption

Following intramuscular administration of the aqueous solution, systemic availability is comparable to an intravenous administration. However, lower peak serum levels (Cmax) are achieved.

Metabolism

Calcium folinate is a racemate where the L-form (L-5-formyl-tetrahydrofolate, L-5-formyl-THF), is the active enantiomer. The major metabolic product of folinic acid is 5-methyl-tetrahydrofolic acid (5-methyl-THF) which is predominantly produced in the liver and intestinal mucosa.

Distribution

The distribution volume of folinic acid is not known.

Peak serum levels of the parent substance (D/L-5-formyl-tetrahydrofolic acid, folinic acid) are reached 10 minutes after i.v. administration.

AUC for L-5-formyl-THF and 5-methylTHF were 28.4?3.5 mg.min/l and 129?112 mg.min/l after a dose of 25 mg. The inactive D-isomer is present in higher concentration than L-5-formyltetrahydrofolate.

Elimination

The elimination half-life is 32 – 35 minutes for the active L-form and 352 – 485 minutes for the inactive D-form, respectively.

The total terminal half-life of the active metabolites is about 6 hours (after intravenous and intramuscular administration).

Excretion

80-90 % with the urine (5- and 10-formyl-tetrahydrofolates inactive metabolites), 5-8 % with the faeces.

5.3 Preclinical safety data

There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.

6.PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Chloride
Water for Injections

6.2 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 in direct admixture in 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 when the drugs were injected sequentially into a Y-site without flushing the Y-side arm between injections.

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

Foscarnet 24 mg/ml with calcium folinate 20 mg/ml formation of a cloudy yellow solution reported.

?6.3 Shelf life

Product as packaged for sale: 24 months.

In use: From a microbial 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 mot be longer than 24 hours at 2 to 8?C.

?6.4 Special precautions for storage

Store in a refrigerator (+2?C to +8?C)

Keep vial in the outer carton in order to protect from light.

6.5 Nature and contents of container

5 mL Type I glass vials (50 mg/5 mL)

10 mL Type I glass vials (100 mg/10 mL)

30 mL Type I glass vials (300 mg/30 mL)

Not all pack sizes may be marketed.

?6.6 Special precautions for disposal and other handling

Prior to administration, calcium folinate should be inspected visually. The solution for injection or infusion should be a clear and yellowish solution. If cloudy in appearance or particles are observed, the solution should be discarded. Calcium folinate solution for injection or infusion is intended only for single use. Any unused portion of the solution should be disposed of in accordance with the local requirements.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
Survey No.188/1 to 189/1,190/1 to 4,
Athiyawad, Dabhel,
Daman- 396210 (INDIA)

Calcium Folinate Injection IP 10mg/ml Taj Pharma
Package leaflet: Information for the patient

Calcium Folinate

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

  • Keep this leaflet. You may need to read itagain.
  • If you have any further questions, ask your doctor orpharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harmthem, even if their signs of illness are the same asyours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section4.

What is in this leaflet:

  1. What Calcium Folinate is and what it is used for
  2. What you need to know before you take Calcium Folinate
  3. How to take Calcium Folinate
  4. Possible side effects
  5. How to store Calcium Folinate
  6. Contents of the pack and other information
1 WHAT CALCIUM FOLINATE 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 anticancer medicine fluorouracil.

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM FOLINATE

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 B12

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 the same time take special care if:
? you have had radiotherapy
? you have stomach or bowel trouble

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

Special care is also needed if you are elderly and you are to receive calcium folinate and fluorouracil treatment at the same time.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with Calcium Folinate Injection, for example:
? folic acid antagonists (see section 1 ?What Calcium Folinate is and what it is used for? for examples of these medicines) – the effectiveness of these medicines will be reduced by calcium folinate
? fluorouracil (anti-cancer medicine) ? the effectiveness and side effects of this
? medicine will be increased by calcium folinate? medicines used to treat epilepsy (phenobarbitone, phenytoin, primidone or? succinimides) ? the effectiveness of these medicines may be reduced by calcium folinate. Your doctor may check blood levels of these medicines and change your dose to prevent increased convulsions (fits)

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding.

It is unlikely that your doctor will ask you to take/use a folic acid antagonist or fluorouracil whilst you are pregnant or breast-feeding. However, if you have taken/used a folic acid antagonist whilst pregnant or breast-feeding, this medicine (calcium folinate) may be used to reduce its side effects.

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about one of the ingredients of Calcium Folinate Injection
This medicinal product contains 12.5 mmol (287 mg) sodium per 850 mg dose. To be taken into consideration by patients on a controlled sodium diet.

3 HOW TO TAKE CALCIUM FOLINATE

This medicine may be given by injection (using a syringe) into muscle. Alternatively it may be given by injection or infusion (drip) into a vein. If it is given by infusion Calcium Folinate Injection will be diluted first.

Dose
Your doctor will work out the correct dose of Calcium Folinate Injection for you and how often it must be given. It will depend upon the medical condition which is being treated.

If you are given too much or too little Calcium Folinate Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4 POSSIBLE SIDE EFFECTS

Like all medicines, Calcium Folinate Injection 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 experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint. This is a serious side effect. You may need urgent 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 convulsions (fits) in patients with epilepsy
? depression
? agitation
? problems with the digestive system
?? difficulty sleeping (insomnia)

Combination therapy with 5-fluorouracil only:
If you receive calcium folinate in combination with an anticancer medicine containing fluoropyrimidines, it is more likely that you experience the following side effects of this other medicine:

Very common: may affect more than 1 in 10 people
? nausea
? vomiting
? severe diarrhoea
? drying out which may be due to diarrhoea
? inflammation of the lining of the intestine and mouth (life-threatening conditions have occurred)
? reduction in the number of blood cells (including life-threatening conditions)

Common: may affect up to 1 in 10 people
? redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome) Not known: frequency cannot be estimated from the available data
? elevated ammonia level in the blood

Your doctor may do tests to check for low levels of calcium in your blood.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5 HOW TO STORECALCIUM FOLINATE

Keep out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is stated on the vial and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage
The vials should be stored in the outer carton, in order to protect from light, in a refrigerator.

Visible signs of deterioration
Only clear, pale yellow solutions should be used. If cloudy in appearance or particles can be seen, the solution should be discarded.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcium Folinate contains
The active substance is folinic acid.
Each millilitre (ml) of solution contains:
10 milligrams (mg) of folinic acid in the form of calcium folinate IP.

The other ingredients are sodium chloride and Water for Injections. See section 2 ?Important information about one of the ingredients of Calcium Folinate Injection? for further information about the sodium content.

Contents of the pack

Calcium Folinate Injection is a clear, pale yellow solution for injection which comes in glass containers called vials.
It is supplied in packs containing:
? 1 x 50 mg/5 ml vial
? 1 x 100 mg/10 ml vial
? 1 x 300 mg/30 ml vial

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
at SURVEY NO. 188/1, 190/1TO 4, ATHIYAWAD , DABHEL,
DAMAN- 396210 (INDIA)

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    Thalidomide hard capsules Tablets IP 100mg Taj Pharma Overview INTRODUCTION Thalidomide 100 Capsule is used in the treatment of multiple myeloma and lepra reaction. This medicine belongs to a group of medicines which affect how your immune system works. Thalidomide 100 Capsule should be taken on empty stomach, but try to have it at the […]

  • Imatinib Mesylate Tablets IP 100mg (Tyronib) Taj Pharma

    Imatinib Mesylate Tablets IP 100mg (Tyronib) Taj Pharma Overview INTRODUCTION OF TYRONIB TABLET Tyronib 100 mg Tablet is used in the treatment of blood cancer (chronic myeloid leukaemia and Acute lymphocytic leukemia) and gastrointestinal stromal tumour. Tyronib 100 mg Tablet should be taken in a dose as recommended by the doctor. You should continue to […]

  • Cyclophosphamide Dry Powder for Injection IP 500mg Taj Pharma

    Cyclophosphamide Dry Powder for Injection IP 500mg Taj Pharma Overview INTRODUCTION Cyclophosphamide 500mg Injection is used in the treatment of different kinds of cancers. It is also used to treat kidney disease known as nephrotic syndrome in children after other treatments have not worked. It may be also used to treat other conditions, as determined […]

  • Cabazitaxel Concentrate and solvent for solution for infusion IP 60mg Taj Pharma

    Cabazitaxel Concentrate and solvent for solution for infusion IP 60mg Taj Pharma Overview INTRODUCTION Cabazitaxel Injection belongs to the general group of medicines called antineoplastics. It is used for the treatment of advanced prostate cancer. It works by interfering with the growth of cancer cells, which are eventually destroyed. Cabazitaxel Injection is given under the […]

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