Consumer medicine information

Leucovorin Calcium Injection

Folinic acid

BRAND INFORMATION

Brand name

Pfizer (Perth) Leucovorin Calcium Injection

Active ingredient

Folinic acid

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Leucovorin Calcium Injection.

What is in this leaflet

This leaflet answers some common questions about Leucovorin Calcium Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Leucovorin Calcium Injection against the benefits this medicine is expected to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases, this leaflet may be given to you after the medicine has been used.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Leucovorin Calcium Injection is used for

Leucovorin Calcium Injection contains calcium folinate. It belongs to a group of vitamins used as an antidote to the harmful effects of methotrexate therapy. Calcium folinate acts in the same way as folic acid which may be low in these patients.

Leucovorin Calcium Injection may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Leucovorin Calcium Injection.

Before you are given Leucovorin Calcium Injection

When you must not be given it

Do not have Leucovorin Calcium Injection if you have an allergy to:

  • any medicine containing leucovorin calcium (calcium folinate or folinic acid)
  • any of the ingredients listed at the end of this leaflet
  • any similar medicines.

You must not be given Leucovorin Calcium if you have or have had any of the following medical conditions:

  • pernicious anaemia
  • any other megaloblastic anaemias which are due to a lack of Vitamin B12.

Before you are given it

Tell your doctor if:

  1. you have any allergies to:
  • any other medicine
  • any other substances, such as foods, preservatives or dyes
  1. you are pregnant or intend to become pregnant
  2. you are breastfeeding or plan to breastfeed
  3. you have or have had any medical conditions, especially the following:
  • fits or convulsions (epilepsy)
  • Vitamin B12 deficiency
  • cancer which has spread to other parts of the body such as the brain

Taking other medicines

Tell your doctor if you are taking any other medicines, including:

  • all prescription medicines
  • all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop

Some medicines may be affected by Leucovorin Calcium Injection, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Tell your doctor or pharmacist if you are taking any of the following:

  • medicines used to treat cancer, such as fluorouracil
  • medicines to treat epilepsy (fits), such as phenobarbitone, phenytoin, primidone, succinimides.
  • medicines such as co-trimoxazole, pyrimethamine, methotrexate and antibiotic with antifolate effect.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How Leucovorin Calcium Injection is given

Leucovorin Calcium Injection is given by injection into the veins or muscle, usually 24 hours after the methotrexate was given. Leucovorin Calcium Injection must only be given by a doctor or nurse.

Your doctor will decide which strength of Leucovorin Calcium Injection you need and how much you need to be given. This will depend on any previous treatment you have had and any current treatment you are taking.

If you are given too much (overdose)

If you are given too much folinic acid, you may experience some of the effects listed under "Side Effects" below.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

While you are having Leucovorin Calcium Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Leucovorin Calcium Injection.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests on your blood and urine to make sure the medicine is working.

Things you must not do

Do not have Leucovorin Calcium Injection to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Leucovorin Calcium Injection affects you. This medicine may cause fainting or seizures in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are having Leucovorin Calcium Injection. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

It can be difficult to tell whether side effects are the result of being given Leucovorin Calcium Injection, effects of your condition or side effects of other medicines you may be taking. For this reason it is important to tell your doctor of any change in your condition.

Do not be alarmed by the list of side effects. You may not experience any of them

Ask your doctor or pharmacist to answer any questions that you may have.

Tell your doctor if...

Tell your doctor if you notice any of the following and they worry you:

  • skin rash
  • diarrhoea
  • nausea and vomiting

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor as soon as possible if...

Tell your doctor as soon as possible if you notice any of the following:

  • persistent or severe diarrhoea
  • sore mouth, throat or stomach
  • fever
  • redness, pain or peeling of skin on the hands or feet

The above list includes serious side effects that may require medical attention.

Go to hospital if...

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

  • seizures, fits or fainting
  • allergies

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Some people develop an allergy to Leucovorin Calcium Injection; this may appear as an itchy rash or high temperature after the injection. If you experience this, or a swelling of the face, lips, tongue or throat, and/or difficulty in breathing, you should inform the doctor or nurse immediately.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Product description

What it looks like

Leucovorin Calcium Injection is a clear, yellowish solution.

Steriluer ampoule:

Leucovorin Calcium Injection 50 mg (folinic acid) in 5 mL (sterile) AUST R 61885

Leucovorin Calcium Injection 100 mg (folinic acid) in 10 mL (sterile) AUST R 61887

Ingredients

Leucovorin Calcium Injection contains calcium folinate in water for injections containing sodium chloride. It does not contain any preservatives.

Supplier

Leucovorin Calcium Injection is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

Date of preparation

This leaflet was revised in December 2019

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Pfizer (Perth) Leucovorin Calcium Injection

Active ingredient

Folinic acid

Schedule

S4

 

1 Name of Medicine

Calcium folinate.

2 Qualitative and Quantitative Composition

Calcium folinate as equivalent to folinic acid 50 mg/5 mL, 100 mg/10 mL, containing calcium folinate 54 mg in 5 mL (equivalent to 50 mg folinic acid) and 108 mg in 10 mL (equivalent to 100 mg folinic acid).
Calcium folinate potency is usually expressed in terms of equivalent units of folinic acid.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pfizer (Perth) Leucovorin Calcium Injection is a sterile, isotonic, clear, yellowish, preservative-free solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Pfizer (Perth) Leucovorin Calcium Injection is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). It is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

4.2 Dose and Method of Administration

Dosage.

Laboratory tests.

Patients treated with Pfizer (Perth) Leucovorin Calcium Injection following methotrexate therapy, including inadvertent overdose, or patients with impaired methotrexate elimination, should have serum creatinine and methotrexate concentrations determined at least once daily.
Urine pH: in cases of methotrexate overdose or delayed excretion, monitor as appropriate to ensure maintenance of pH ≥ 7.0. Foods, drinks and drugs that may increase urinary acidity should be avoided during the therapy.

Leucovorin calcium rescue after high dose methotrexate therapy.

The dose of Pfizer (Perth) Leucovorin Calcium Injection required depends on the amount of methotrexate administered and whether there is impaired methotrexate elimination. Table 1 provides dosing guidelines for a methotrexate dose of 12 to 15 g/m2 by intravenous infusion over 4 hours. Pfizer (Perth) Leucovorin Calcium Injection is commenced 24 hours after the start of the methotrexate infusion.
Delayed methotrexate excretion may be caused by a third space fluid accumulation (i.e. ascites, pleural effusion), renal insufficiency or inadequate hydration.
Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure. In addition to Pfizer (Perth) Leucovorin Calcium Injection, these patients require hydration and urinary alkalinisation (pH 7.0 or greater), and close monitoring of fluid and electrolyte status until the serum methotrexate concentration has fallen below 0.05 microM and the renal failure has resolved.

Inadvertent methotrexate overdose.

Pfizer (Perth) Leucovorin Calcium Injection should be administered as soon as possible after inadvertent overdosage of methotrexate because the effectiveness of calcium folinate decreases as the time interval between methotrexate and calcium folinate administration increases. The recommended dose is 10 mg/m2 IV or IM every 6 hours until the serum methotrexate concentration is less than 0.01 microM.
Serum creatinine and methotrexate concentrations should be determined at 24 hour intervals. If the 24 hour serum creatinine concentration has increased 50% over baseline, or the 24 hour methotrexate concentration is greater than 5 microM or the 48 hour concentration greater than 0.9 microM, the dose of Pfizer (Perth) Leucovorin Calcium Injection USP should be increased to 100 mg/m2 every 3 hours until the methotrexate concentration is less than 0.01 microM.
Hydration (3 L/day) and urinary alkalinisation with sodium bicarbonate solution should be employed concomitantly.

Method of administration.

Pfizer (Perth) Leucovorin Calcium Injection may be administered by the intramuscular or intravenous route. Calcium folinate should not be administered intrathecally.

Dilution.

For intravenous infusion, Pfizer (Perth) Leucovorin Calcium Injection may be diluted in glucose 5% or sodium chloride 0.9%, both in water for injections. Further diluted solutions of calcium folinate in glucose 5% intravenous infusion and sodium chloride 0.9% intravenous infusion are stable for 24 hours when stored between 2°C to 8°C.
Pfizer (Perth) Leucovorin Calcium Injection contains no antimicrobial preservative; use once only and discard any residue. To avoid microbial contamination hazards, infusion should be commenced as soon as practicable after preparation.

Administration.

Admixed solutions for parenteral administration should be visually inspected for particulate matter and discolouration prior to administration where solution and container permit. Do not use if solution is cloudy or precipitated.
Because of the calcium content of Pfizer (Perth) Leucovorin Calcium Injection, no more than 160 mg (16 mL) should be injected intravenously per minute.

4.3 Contraindications

Folinic acid should not be used for the treatment of pernicious anaemia or other megaloblastic anaemias secondary to vitamin B12 deficiency.
Known hypersensitivity to the active substance(s) or to any of the excipients.

4.4 Special Warnings and Precautions for Use

Calcium folinate should be administered only 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.
Calcium folinate should be used with folic acid antagonists, e.g. methotrexate, or fluoropyrimidines, e.g. fluorouracil, only under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
Because of the calcium content of leucovorin calcium injections, no more than 160 mg (16 mL) should be injected intravenously per minute.
Calcium folinate is not suitable for the treatment of pernicious anaemias and other anaemias resulting from lack of vitamin B12. Haematological remissions may occur, while the neurological manifestations remain progressive.
Many cytotoxic medicinal products direct or indirect DNA synthesis inhibitors - lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with folinic acid.
In epileptic patients treated with phenobarbital, phenytoine, 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 Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.)
Simultaneous therapy with a folic acid antagonist is not recommended because the effect of the folic acid antagonist is either reduced or inhibited.

Calcium folinate/ methotrexate.

Calcium folinate must not be administered intrathecally (see Section 4.2 Dose and Method of Administration).
An accidental overdose with a folate antagonist, such as methotrexate, should be treated quickly as a medical emergency. As the time interval between methotrexate administration and calcium folinate rescue increases, calcium folinate effectiveness in counteraction toxicity decreases.
Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure and all toxicities associated with methotrexate (please refer to the health-care professional labeling 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. Calcium folinate has no effect on non-haematological toxicities of methotrexate, such as the nephrotoxicity resulting from drug methotrexate and/or metabolite precipitation in the kidney.
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 resistance to folinic acid rescue as both medicinal products share the same transport system.

Calcium folinate/ fluorouracil.

Calcium folinate must not be mixed with fluorouracil in the same IV injection or infusion. Calcium folinate may enhance the toxicity profile of fluorouracil, particularly in elderly or debilitated patients. The most common manifestations are leucopenia, mucositis, stomatitis and/or diarrhoea, which may be dose limiting. In addition, hematological adverse reactions have been observed. Deaths from severe enterocolitis, diarrhoea and dehydration have been reported in elderly patients receiving fluorouracil and calcium folinate. Concomitant granulocytopenia and fever were present in some but not all patients. When calcium folinate and fluorouracil are used in combination, in cases of toxicity the fluorouracil dosage has to be reduced more than when fluorouracil is used alone.
Combined calcium folinate/ fluorouracil treatment should not be initiated or maintained in patients with symptoms of gastrointestinal (GI) toxicity, regardless of the severity, until all of these symptoms have completely disappeared. Because diarrhoea may be a sign of GI toxicity, patients presenting with diarrhoea must be carefully monitored until the symptoms have disappeared completely, since rapid clinical deterioration leading to death can occur. If diarrhoea and/or stomatitis occur, it is advisable to reduce the dose of fluorouracil. Seizures and/or syncope have been reported rarely in cancer patients receiving calcium folinate, usually in association with fluoropyrimidine administration, and most commonly in those with CNS metastases.
In elderly patients and patients who have undergone preliminary radiotherapy, it is recommended to begin with a reduced dosage of fluorouracil.
Calcium levels should be monitored in patients receiving combined calcium folinate/fluorouracil treatment and calcium supplementation should be provided if calcium levels are low.
Under circumstances leading to delayed methotrexate elimination, treatment with calcium folinate may need to be prolonged.

Use in the elderly.

Elderly patients are at increased risk of severe toxicity when receiving combination therapy of calcium folinate and fluorouracil. Particular care should be taken when treating these patients.

Paediatric use.

There are no data available on use in children.

Effects on laboratory tests.

Fluorouracil/calcium folinate therapy.

Complete blood count (CBC) with differential and platelets: prior to each treatment; weekly during the first two courses; at time of anticipated white blood cell (WBC) nadir in all courses thereafter.
Electrolytes and liver function tests: prior to each treatment for the first three courses and prior to every other course thereafter.

Methotrexate/calcium folinate therapy.

Serum creatinine levels and serum methotrexate levels: at least once daily.
Urine pH: in cases of methotrexate overdose or delayed excretion, monitor as appropriate, to ensure maintenance of pH ≥ 7.0.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Calcium folinate may enhance the toxicity of fluoropyrimidines e.g. fluorouracil. Calcium folinate may counteract the antiepileptic effect of phenobarbitone, phenytoin, primidone and succinimides, and 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). Clinical monitoring, including plasma concentrations, and dose adjustment of the antiepileptic drugs is recommended during calcium folinate administration and after discontinuation.
High intravenous or intramuscular doses of calcium folinate may reduce the efficacy of intrathecally administered methotrexate.
When calcium folinate is given in conjunction with a folic acid antagonist (eg cotrimoxazole, pyrimethamine, methotrexate, antibiotic with antifolate effect) the efficacy of the folic acid antagonist may either be reduced or neutralised (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Calcium folinate has been taken by a large number of pregnant women and women of childbearing potential without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed. However caution is essential in the use of calcium folinate in pregnant women as the safety of calcium folinate in pregnancy has not been established. During pregnancy, flurouracil and 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 fetus. 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.
 It is not known whether calcium folinate is excreted in human milk. Calcium folinate should be used with caution in nursing mothers.
Calcium folinate in combination with 5-fluorouracil is not recommended for use in women who are breast-feeding.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Leucovorin calcium.

Allergic sensitisations, including anaphylactoid reactions, pyrexia and urticaria have occurred after parenteral administration.
Nausea and vomiting have been reported with very high doses of calcium folinate.
In addition, haematological adverse reactions, such as leucocytopenia and thrombocytopenia, may occur. These adverse reactions are dose dependent and their occurrence can usually be decreased by reducing the dosage of cytotoxic drugs. To control these adverse reactions, haematological values, e.g. blood leucocyte and thrombocyte levels and serum electrolyte (e.g. Na, K, Ca) and creatinine levels should be closely monitored. See Table 2.
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some fatal, have been reported in patients receiving leucovorin in combination with other agents known to be associated with these disorders. A contributory role of leucovorin in these occurrences of SJS/TEN cannot be excluded.

Leucovorin calcium in combination with fluorouracil.

Generally the safety profile of calcium folinate depends on the applied regimen of fluorouracil due to enhancement of fluorouracil induced toxicities.
The most common dose limiting adverse reaction occurring in patients receiving combination of calcium folinate and fluorouracil are stomatitis and diarrhoea. Fatalities have occurred as a result of gastrointestinal toxicity (predominantly mucositis and diarrhoea) and myelosuppression. In patients with diarrhoea, rapid clinical deterioration leading to death can occur (see Section 4.4 Special Warnings and Precautions for Use).
Seizures and/or syncope have been reported rarely in cancer patients receiving calcium folinate, usually in association with fluoropyrimidine administration (see Section 4.4 Special Warnings and Precautions for Use).
Additional undesirable effects of calcium folinate when used in combination with fluorouracil follow. See Table 3.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Folinic acid is an intermediate in the metabolism of folic acid and can therefore be considered as a naturally occurring substance. Large doses have been administered with no apparent adverse effects. Such doses suggest that administration of this drug is relatively safe. Signs of excessive dosing, if they occur, should be treated symptomatically.
Excessive amounts of calcium folinate may nullify the chemotherapeutic effect of folic acid antagonists.
For information on the management of overdose, contact the Poisons Information Centre on 131126.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Class: Antidote for folic acid antagonists.

Mechanism of action.

Folinic acid (leucovorin) is the 5-formyl derivative of tetrahydrofolic acid (THF), the active form of folic acid. Folinic acid as a cofactor participates in many metabolic reactions including purine synthesis, pyrimidine synthesis and amino acid conversion. Calcium folinate is used in cytotoxic therapy as an antidote to folic acid antagonists (such as methotrexate) which block conversion of folic acid to tetrahydrofolate by binding the enzyme dihydrofolate reductase.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Distribution.

Following administration, calcium folinate enters the general body pool of reduced folates. It has been reported that following intravenous and intramuscular administration peak serum levels of total reduced folates are achieved within a mean time of 10 minutes and 52 minutes respectively. Peak levels of 5-formyl THF appear at 10 minutes and 28 minutes following intravenous and intramuscular administration respectively. Folate is concentrated in the cerebrospinal fluid and liver although distribution occurs to all body tissues.

Metabolism.

Reduction in the levels of parent compound coincides with the appearance of the active metabolite 5-methyl THF which becomes the major circulating form of the drug. Peak levels are observed at 1.5 and 2.8 hours following intravenous and intramuscular administration respectively. The terminal half life for total reduced folates is reported as 6.2 hours.

Excretion.

Folates are excreted in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride in water for injections.

6.2 Incompatibilities

Pfizer (Perth) Leucovorin Calcium Injection has been reported to be incompatible with injectable forms of methotrexate, fluorouracil, droperidol and foscarnet.

6.3 Shelf Life

The expiry date (month/year) is stated on the package after EXP.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Refrigerate, do not freeze. Protect from light.

6.5 Nature and Contents of Container

Pfizer (Perth) Leucovorin Calcium Injection USP 50 mg (folinic acid) in 5 mL (sterile) Plastic Vial AUST R 12724.
Pfizer (Perth) Leucovorin Calcium Injection USP 100 mg (folinic acid) in 10 mL (sterile) Plastic Vial AUST R 49312.
Pfizer (Perth) Leucovorin Calcium Injection USP 50 mg (folinic acid) in 5 mL (sterile) Steriluer ampoule. AUST R 61885.
Pfizer (Perth) Leucovorin Calcium Injection USP 100 mg (folinic acid) in 10 mL (sterile) Steriluer ampoule. AUST R 61887.
Not all pack size maybe marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Calcium folinate is a white or light yellow, amorphous or crystalline powder, sparingly soluble in water and practically insoluble in acetone and ethanol.
Chemical name: calcium 5-formyl-tetrahydropteroylglutamate.
The empirical formula is C20H21CaN7O7, xH2O and the molecular weight 511.5 (anhydrous).

Chemical structure.

The structural formula is:

CAS number.

1492-18-8.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes