Cyanocobalamin Injection 1000mcg Taj Pharma

Cyanocobalamin Injection 1000mcg Taj Pharma

1. Name of the medicinal product

Cyanocobalamin Injection 500mcg Taj Pharma
Cyanocobalamin Injection 1000mcg Taj Pharma

2. Qualitative and quantitative composition

Cyanocobalamin 0.5mg
Excipients              q.s.

Cyanocobalamin 1.0mg
Excipients              q.s.

3. Pharmaceutical form

Solution for injection.

4. Clinical particulars

4.1 Therapeutic indications

Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency. Schilling test.

Not indicated for treatment of toxic amblyopias – use Neo-Cyanocobalamin.

4.2 Posology and method of administration

Route of administration: intramuscular.

Adults and Children

Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement:

Initially: 250 to 1000mcg intramuscularly on alternate days for one to two weeks, then 250mcg weekly until the blood count is normal.

Maintenance: 1000mcg monthly.

Addisonian pernicious anaemia and other macrocytic anaemias with neurological complications:

Initially: 1000mcg intramuscularly on alternate days as long as improvement is occurring.

Maintenance: 1000mcg monthly.

Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes and strict vegetarianism:

250mcg – 1000mcg monthly.

Schilling Test:

An intramuscular injection of 1000mcg cyanocobalamin is an essential part of this test.

4.3 Contraindications

Hypersensitivity to cyanocobalamin or any other constituents

Cyanocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated.

Not indicated for treatment of toxic amblyopias – use Neo-Cyanocobalamin.

4.4 Special warnings and precautions for use

Precautions:

The dosage schemes given above are usually satisfactory, but regular examination of the blood is advisable. If megaloblastic anaemia fails to respond to Cyanocobalamin, folate metabolism should be investigated. Doses in excess of 10mcg daily may produce an incomplete haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. The haematological and neurological state should be monitored regularly to ensure adequacy of therapy. Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period. Platelet count should be monitored during the first weeks of use in megaloblastic anaemia due to the possible occurrence of reactive thrombocytosis.

4.5 Interaction with other medicinal products and other forms of interaction

Chloramphenicol-treated patients may respond poorly to Cyanocobalamin. Serum concentrations of cyanocobalamin may be lowered by oral contraceptives but this interaction is unlikely to have clinical significance.

Antimetabolites and most antibiotics invalidate vitamin B12 assays by microbiological techniques.

4.6 Pregnancy and lactation

Cyanocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated. Cyanocobalamin is secreted into breast milk but this is unlikely to harm the infant, and may be beneficial if the mother and infant are vitamin B12 deficient.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Hypersensitivity reactions have been reported including skin reactions (e.g. rash, itching) and exceptionally anaphylaxis. Other symptoms reported include fever, chills, hot flushing, dizziness, malaise, nausea, acneiform and bullous eruptions, tremor and injection site reactions including injection site pain, injection site induration and injection site necrosis. Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.

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

Treatment is unlikely to be needed in cases of overdosage.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Cyanocobalamin is a form of vitamin B12.

5.2 Pharmacokinetic properties

Cobalamins are absorbed from the gastro-intestinal tract, but may be irregularly absorbed when given in large therapeutic doses. Absorption is impaired in patients with an absence of intrinsic factor, with a malabsorption syndrome or with a disease or abnormality of the gut, or after gastrectomy.

After injection of cyanocobalamin a large proportion is excreted in the urine within 24 hours; the body retains only 55% of a100-microgram dose and 15% of a 1000-microgram dose. Vitamin B12 is extensively bound to specific plasma proteins called transcobalamins; transcobalamin II appears to be involved in the rapid transport of the cobalamins to tissues. Vitamin B12 is stored in the liver, excreted in the bile, and undergoes extensive enterohepatic recycling; part of an administered dose is excreted in the urine, most of it in the first 8 hours; urinary excretion, however, accounts for only a small fraction in the reduction of total body stores acquired by dietary means. Vitamin B12 diffuses across the placenta and also appears in breast milk.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium chloride

Acetic acid

Water for injections

6.2 Incompatibilities

None.

6.3 Shelf life

18 months.

6.4 Special precautions for storage

Protect from light. Do not store above 25°C

6.5 Nature and contents of container

1ml clear, one-point cut (OPC) colourless glass Type 1 Ph Eur ampoules packed in cartons of 5 ampoules

6.6 Special precautions for disposal and other handling

None stated.

7. MANUFACTURED IN INDIA BY:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Cyanocobalamin Injection 500mcg, 1000mcg Taj Pharma

Patient Information Leaflet:

Cyanocobalamin Injection 1000 micrograms/ml

Cyanocobalamin

Read all of this leaflet carefully before you are given this medicine.

• Keep this leaflet.You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• In this leaflet, Cyanocobalamin 1000 micrograms/ml Solution for Injection will be called Cyanocobalamin.

In this leaflet:

1. What Cyanocobalamin is for
   2. Before you are given Cyanocobalamin
   3. How you will be given Cyanocobalamin
   4. Possible side effects
   5. How to store Cyanocobalamin
   6. Further information.
2. What Cyanocobalamin is for

Cyanocobalamin is a form of Vitamin B12, an essential vitamin which is needed for the production of red blood cells.

Cyanocobalamin is used to prevent and treat certain types of anaemia, including Addisonian pernicious anaemia, and other kinds of anaemia which result from a deficiency of Vitamin B12.

It is also used for a test called the Schilling Test, which measures your ability to absorb Vitamin B12 from the bowel.

2. Before you are given Cyanocobalamin

You should not be given Cyanocobalamin if:

• You are allergic to the active ingredient, cyanocobalamin
• You are allergic to any of the other ingredients of Cyanocobalamin (see section 6.)
• You have a condition called toxic amblyopia (poor vision which may be due to Vitamin B12 deficiency).

If any of the above applies to you talk to your doctor or nurse.

Check with your doctor before being given Cyanocobalamin if:

• You are pregnant, planning to become pregnant or breast-feeding
• You have megaloblastic anaemia. This is a blood disorder where you have larger than normal blood cells

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

• Antibiotics (for treating infections) or antimetabolites (medicines which stop cells dividing, such as mercaptopurine for leukaemia), as these treatments may interfere with tests to measure the levels of Vitamin B12 in your blood or urine
• An antibiotic called chloramphenicol, as you may not respond well to Cyanocobalamin
• Oral contraceptives ‘The Pill’
• Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you talk to your doctor or nurse.

Pregnancy and breast-feeding

Cyanocobalamin should not be used in pregnancy for treating a kind of anaemia called megaloblastic anaemia, unless you also have a Vitamin B12 deficiency.

Cyanocobalamin is found in breast-milk but it is unlikely that it will harm your baby.

If you are pregnant, trying to become pregnant or are breast-feeding, ask your doctor or nurse for advice before being given Cyanocobalamin.

Driving and using machines

Cyanocobalamin may cause dizziness. If this happens to you, do not drive or use machinery.

3. How you will be given Cyanocobalamin

Important:

Your doctor will choose the dose that is right for you.

You will be given Cyanocobalamin by your doctor or nurse as an injection into a muscle. You may be given it just once or it may be repeated every other day, weekly or monthly, depending on how much your body needs.

Adults and Children

• Treatment of anaemia:
  • Without neurological (nervous system) involvement: Initially 250 – 1000 micrograms, every other day for 1 to 2 weeks, then 250 micrograms weekly until the blood tests are normal.
  • Maintenance dose: 1000 micrograms every month.
  • With neurological involvement: 1000 micrograms every other day for as long as improvement is noticed.
    Maintenance dose: 1000 micrograms every month.
• Prevention of anaemia:
  • 250 -1000 micrograms every month.
• Schilling Test:
  • 1000 micrograms.

Medical check-ups

While you are receiving this medicine, your doctor will want you to have regular blood tests to check your condition. This is to make sure that your medicine is working properly and that the dose you are receiving is right for you.

If you are given more Cyanocobalamin than you should

If you think you have been given too much Cyanocobalamin, you are unlikely to need any special treatment. However, if you suffer any discomfort or side effects you should tell your doctor.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Stop using Cyanocobalamin and seek immediate medical help if you have an allergic reaction.

This includes any of the following symptoms:

• Difficulties in breathing
• Swelling of your eyelids, face or lips
• Rash or itching especially those covering your whole body
• Collapse.

Effects on the heart and blood

• Low blood potassium levels and irregular heart beat during the early stages of treatment
• Thrombocytosis (where you have a high number of platelets in your blood)

Effects on the eyes and skin

• Acne-like rash
• Blisters
• Pain at the site of injection
• The skin may become hard at the site of injection
• The skin around the injection site may die.

Effects on the stomach and bowel

• Feeling unwell or sick

Effects on the nervous system

• Dizziness
• Tremor

Other effects

• Fever
• Chills
• Hot flushes
• Pain.

Reporting of side effects

If you get any side effects, talk to your doctor 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 store Cyanocobalamin

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

Do not use Cyanocobalamin after the expiry date on the label. The expiry date refers to the last day of that month.

Store below 25°C. Keep Cyanocobalamin in the original packaging in order to protect it from light.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6. Further information

What Cyanocobalamin contains

The active substance is cyanocobalamin BP at a strength of 1000 micrograms (1 mg) per ml of solution.

The other ingredients are sodium chloride, acetic acid and water for injection.

What Cyanocobalamin looks like

Cyanocobalamin 1000 micrograms/ml Solution for Injection is a sterile solution.

It comes in packs of 5 ampoules, each containing 1 ml of solution.

7. MANUFACTURED IN INDIA BY:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com