1. NAME OF THE MEDICINAL PRODUCT

Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active SubstanceQuantityReference Standard
Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma Acetate1.04 mgPh Eur
equivalent to
Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma1.00 mg

An overage of 7.5% has been incorporated

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Solution for Injection

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency. Tobacco amblyopia and Leber’s optic atrophy

4.2 Posology and method of administration

Posology

Adults and Paediatric population

The following dosage are suitable for adults and children.

Addisonian pernicious anaemias and other macrocytic anaemias without neurological involvement.

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

Maintenance: 1000 micrograms every two to three months

Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement

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

Maintenance:1000 micrograms every two of three months.

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

1000 micrograms every two or three months.

Tobacco amblyopia and Leber’s optic atrophy

Initially:1000 micrograms daily by intramuscular injection for two weeks then twice weekly as long as improvement is occurring.

Maintenance: 1000 micrograms every one to three months as required.

Method of Administration

Intramuscular injection

4.3 Contraindications

Hypersensitivity to Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma or to any of the ingredient in this preparation.

4.4 Special warnings and precautions for use

It is advisable to confirm the diagnosis of Vitamin B12 deficiency before giving Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma; regular monitoring of the blood is recommended..

If megaloblastic anaemia fails to respond, folate metabolism should be investigated. Doses in excess of 10 micrograms daily may produce a haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.

Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period.

4.5 Interaction with other medicinal products and other forms of interaction

Chloramphenicol

Parenteral chloramphenicol may attenuate the effect of Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma in anaemia.

Oral contraceptives

The serum concentration of Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma may be lowered.

The above interactions are unlikely to be of clinical significance but should be taken into account when performing assays for blood concentrations.

Vitamin B12 assays by microbiological techniques are invalidated by antimetabolites and most antibiotics.

Paediatric population

Interaction studies have only been performed in adults.

4.6 Fertility, pregnancy and lactation

Pregnancy

Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma injection should not be used for the treatment of megaloblastic anaemia of pregnancy.

Breast-feeding

Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma is secreted into breast milk but is unlikely to harm the infant.

Fertility

No data available

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

The following undesirable effects may occur with the use of Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma Acetate in the following frequencies:

Very common (> 1/10)

Common (> 1/100, <1/10)

Uncommon (> 1/1,000, <1/100)

Rare (> 1/10,000, <1/1,000)

Very rare (<1/10,000), (cannot be estimated from the available data) are not known.

There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. Therefore, all the undesirable effects listed are classed as “frequency unknown”.

The following effects have been reported and are listed below by body system:

System organ classFrequencyUndesirable effects
Blood and lymphatic system disordersNot KnownReactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.
Immune system disordersNot KnownHypersensitivity reactions including rash; itching; exanthema. Antibodies to Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma-transcobalamin II complex have developed during Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma therapy.

Anaphylaxis

Metabolism and nutrition disordersNot KnownInitial hypokalaemia
Nervous system disordersNot KnownHeadache, paraesthesia, tremor.
Cardiac disordersNot KnownArrhythmias secondary to hypokalaemia.
Gastrointestinal disordersNot KnownNausea, vomiting, diarrhoea.
General disorders and administration site conditionsNot KnownFever, chills, hot flushes; dizziness; malaise; pain; Injection site reactions including injection site pain, injection site erythema, injection site pruritus, injection site induration, and injection site swelling.
Skin and subcutaneous tissue disordersNot KnownAcneiform and bullous eruptions
Renal and urinary disordersNot KnownChromaturia

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 required in the case of overdose.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antianaemic preparations -Vitamin B12

Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma is used in the treatment and prevention of Vitamin B12 deficiency. For adults, the daily requirement of Vitamin B12 is probably about 1 to 2 micrograms and this amount is present in most normal diets. However, Vitamin B12 only occurs in animal products, not in vegetables, and therefore strict vegetarian or vegan diets that exclude dairy products may provide an inadequate amount, although a deficiency may not be apparent for many years.

Deficiency is more likely in patients with malabasorption syndromes or metabolic disorders, nitrous-oxide induced megalobastosis, or following gastrectomy or extensive ileal resection. Deficiency leads to megaloblastic anaemias and demyelination and other neurological damage.

On oral intake, Vitamin B12 substances bind to intrinsic factor, a glycoprotein secreted by the gastric mucosa, and are then actively absorbed from the gastrointestinal tract. A specific anaemia known as pernicious anaemia develops in patients with an absence of intrinsic factor. Absorption is also impaired in patients with disease or abnormality of the gut.

Treatment usually results in rapid haematological improvement and a striking clinical response. However, neurological symptoms respond more slowly.

5.2 Pharmacokinetic properties

Distribution: Transcobalamin II appears to be involved in the rapid transport of the cobalamins to tissues. Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma is extensively bound to specific plasma proteins (transcobalamins).

Elimination: Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma is stored in the liver, excreted in the bile, and undergoes extensive enterohepatic recycling; part of the dose is excreted in the urine, most of it in the first 8 hours.

Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma diffuses across the placenta and also appears in breast milk. Hydroxocobalamin Injection USP  30000mcg/30ml Taj Pharma is better retained than cyanocobalamin; 90% of a 100 microgram dose and 30% of a 1000 microgram dose are retained, a range believed to be sufficient for body requirements for 2 to 10 months.

5.3 Preclinical safety data

There is no additional information relevant to the prescriber.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glacial acetic acid Ph Eur

Sodium chloride Ph Eur

Water for injection Ph Eur

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months

6.4 Special precautions for storage

Store at or below 25°C. Protect from light.

6.5 Nature and contents of container

Type I glass ampoules in cardboard box.

5 ampoules per pack.

6.6 Special precautions for disposal and other handling

None.

  1. 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

PATIENT INFORMATION LEAFLET

HYDROXOCOBALAMIN INJECTION USP
30000MCG/30ML
TAJ PHARMA

Hydroxocobalamin

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 or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

  1. What Hydroxocobalamin Injection is and what it is used for
  2. What you need to know before you are given Hydroxocobalamin injection
  3. How Hydroxocobalamin injection is given to you
  4. Possible side effects
  5. How to store Hydroxocobalamin injection
  6. Contents of the pack and other information

 

  1. WHAT HYDROXOCOBALAMIN INJECTION IS AND WHAT IT IS USED FOR

This medicine contains Hydroxocobalamin which is a form of Vitamin B12.  It is given for:

  • Addisonian pernicious anaemia (caused when absorption of Vitamin B12 from the stomach is reduced).
  • Tobacco amblyopia (poor sight caused by toxins such as tobacco).
  • Leber’s atrophy (degeneration of the optic nerve resulting in loss of central vision).
  • Treatment/prevention of other macrocytic anaemias due to deficiency in vitamin B12.

Vitamin B12 is needed for physical growth and development and for the formation of red blood cells in the bone marrow. It is also required for

absorption of folic acid and carbohydrates from food and for keeping the nerve (neurological) system healthy.

The body only requires a small amount of the vitamin daily so a deficiency may take months or even years to develop. Eventually, the formation of abnormally large red blood cells (macrocytes) with reduced ability to carry oxygen from enlarged cells (megaloblasts) in the bone marrow, gives rise to

anaemia. Symptoms of Vitamin B12 deficiency anaemia include sore mouth and tongue, numbness and tingling in the arms and legs, memory loss and depression.

  1. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYDROXOCOBALAMIN INJECTION

Do not use Hydroxocobalamin Injection:

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions:

Tell your doctor or nurse:

  • If you are aware of abnormal heart beats whilst receiving Hydroxocobalamin injections.
  • If, after several weeks’ treatment you do not feel any improvement.

Other medicines and Hydroxocobalamin injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.

Hydroxocobalamin injection can interfere with the action of some other drugs and some drugs can have an effect on Hydroxocobalamin injection. The following drugs can cause some problems when taken together with Hydroxocobalamin Injection:

  • chloramphenicol (an          antibiotic)

can reduce   the          effects    of

Hydroxocobalamin injection.

  • oral contraceptives may reduce the blood levels of Hydroxocobalamin injection.
  • The following medicines do not alter the effectiveness of Hydroxocobalamin
  • Injection but make it more difficult to measure the amount of Vitamin B12 in the body:
    • antimetabolites (used to treat tumours and blood disorders).

Pregnancy, breast feeding and fertility Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Hydroxocobalamin injection should not be used for the treatment of megaloblastic anaemia of pregnancy.

Breast feeding

If you are breast feeding you should tell your doctor before you are given this medicine.

Hydroxocobalamin injection passes into the breast milk but is unlikely affect your baby.

Fertility

No data available

Driving and using machines

Your medicine is unlikely to affect your ability to drive or to operate machinery. However, some people may feel dizzy or drowsy when given Hydroxocobalamin injection. If this happens to you, do not drive or operate machinery.

Hydroxocobalamin injection contains sodium:

Hydroxocobalamin injection contains less than 1mmol (23mg) of sodium per 2ml (essentially ‘sodium-free’).

  1. HOW HYDROXOCOBALAMIN INJECTION IS GIVEN TO YOU

Hydroxocobalamin will be given to you by injection into a muscle. The dose depends on your individual needs and responses to treatment. Your

blood levels of Vitamin B12 and folic acid are likely to be monitored both before and during treatment. If you have doubts about the treatment or

want more information about your medicine or the monitoring procedure, do ask the doctor or nurse.

Adults and Children

Initial dose: This varies between 250 mcg and 1mg given daily or on alternative days. The actual dosage depends on your specific illness and your response to treatment.

Maintenance dose: Your doctor will check your condition regularly. When he/she feels that your health has improved sufficiently, your dose of Hydroxocobalamin Injection will be reduced to 1mg every 2-3 months or  as required.

If more Hydroxocobalamin injection is used than should be:

Being given more than the intended dose of hydroxocobalamin injection is unlikely to cause a problem requiring treatment.

Tell the doctor if you are experiencing any side effects or think you may be reacting badly so that he/she can give appropriate treatment.

If you have already left the medical premises, contact your nearest hospital, doctor or nurse.

If a dose of Hydroxocobalamin Injection is forgotten:

It is unlikely that you will miss a dose as your doctor or nurse will be giving it to you. However, it is important not to have a double dose if you have missed one. Ask your doctor or nurse when you should have the next dose.

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

  1. POSSIBLE SIDE EFFECTS

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

Tell your doctor immediately if you experience any of the following symptoms after you have been given the injection. Although they are very rare, these symptoms can be serious.

  • swelling of the lips and face, difficulty in breathing, skin rash and redness (these may be symptoms of a serious allergic reaction)
  • irregular heartbeat (caused by low levels of potassium in the blood) during early stages of treatment.

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

Acniform and bullous eruptions (acne-like and blistery skin eruptions)

Not known: frequency cannot be estimated from the available data

  • Headache, dizziness
  • Nausea (feeling sick), vomiting, diarrhoea
  • Malaise (feeling unwell)
  • Rash, itching
  • Injection site reactions including injection site pain, injection site erythema, injection site pruritus, injection site induration, and injection site swelling (Reactions at the site of the injection)
  • Exanthema (a widespread skin rash)
  • Chromaturia (unusual coloured urine)
  • Fever
  • Hot flushes (a feeling of intense heat with sweating and rapid heartbeat)
  • Chills (feeling of coldness accompanied by shivering)
  • Paraesthesia (feeling of pins and needles)
  • Tremor (tremble or shakes)
  • Hypokalaemia (decreased potassium levels in the blood)
  • Reactive thrombocytosis (body produces too many platelets)

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.

  1. HOW TO STORE HYDROXOCOBALAMIN INJECTION

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 refers to the last day of that month. Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light.

If only part used, discard the remaining solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hydroxocobalamine injection contains
The active substance is Hydroxocobalamin.
The other ingredients are sodium chloride, glacial acetic acid in water for injections.

What Hydroxocobalamin injection looks like and contents of pack
Hydroxocobalamin injection is a sterile solution for injection.
Each glass ampoule contains 1ml of solution, which contains the active ingredient hydroxocobalamin acetate (equivalent to hydroxocobalamin 1mg in 1ml sterile solution). Each carton contains five 1ml ampoules.

  1. 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