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HISTAGLOBULIN

TRADE NAME OF THE PHARMACEUTICAL PRODUCT

HISTAGLOBULINA
(Immunoglobulinum humanum, Histamini dihydrochloridum)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

  1. human gammaglobulin 12 mg
  2. histamine dihydrochloride 0.15 µg

PHARMACEUTICAL FORM

Freeze dried matter and diluent for the preparation of solution for injections.

CLINICAL PARTICULARS

Indications

Chronic allergy diseases such as: bronchitis, bronchial asthma, hay fever, as well as allergic dermatitis such as: nettle rash, Quincke’s oedema, eczema.

Posology and method of administration

The product should be administered via the subcutaneous route. The dosage regimen is dependent on the physician’s instructions. The dosage should be individualized to the age and state of the patient.

Basic treatment:

  1. Infants over 1 year - 2 ml daily: 3 or more doses in intervals of 8 - 15 days,
  2. Adults - 2 ml daily: 3 or more doses in interval of 4 - 7 days.

Maintenance treatment:

  1. If indicated, after a period of 4 - 8 weeks, the basic treatment can be repeated or 1 dose of the product administered every 2 - 3 months.
  2. It is indicated to start the treatment 2 - 3 months before the expected occurrence of allergic symptoms (e.g. before the florescence of grasses).
  3. The treatment may be carried out in association with antihistaminic medicines.

Contraindications

Pregnancy, acute allergic states, pneumonia, nephritis, cholangioitis and exacerbation of chronic infections. Hypersensitivity to human immunoglobulins.

Special warnings and special precautions for use

Must not be administered intravenously.
The product is intended for subcutaneous injections. The recommendations of a physician should be strictly followed. In the case of intolerance of human immunoglobulin allergic symptoms may occur. At the onset of anaphylactic shock the appropriate medical procedure should be followed. Do not continue treatment with Histaglobulina.

Histaglobulina is manufactured from human plasma. In the case of the administration of a product obtained from human blood or plasma the transmission of infectious agents cannot be completely excluded. This refers also to unknown pathogens. However, the risk of transmitting infectious agents is minimized by:

  1. selection of donors on the basis of clinical anamnesis, and the testing of both single plasma unit as well as the plasma pool against the presence of the superficial antigen of hepatitis virus type B (HBsAg), genetic material of hepatitis type C (HCV-RNA) and antibodies against the virus HIV1 and HIV2,
  2. testing each series of gammaglobulin (immunoglobulins of the class IgG) and each series of the product Histaglobulina for the presence of antigen HBsAg and antibodies against the virus HIV1 and HIV2 and antibodies against the virus of hepatitis type C (HCV).

Interactions with other medicinal products and other forms of reactions

None

Pregnancy and lactation

Histaglobulina should not be used in pregnant and breast feeding women.

Effects on ability to drive and use machines

No effects on the ability to drive or use machines have been observed.

Undesirable effects

Histaglobulina is generally well tolerated by children and adults. Adverse reactions e.g. headaches, chill, fever, nausea or allergic reactions may occur occasionally. Rarely, local reactions at injection site may occur: minor redness and swelling.

The first injection of the product may be followed by an exacerbation of the clinical symptoms of disease. However, the treatment should not be stopped, but the anti-symptomatic treatment switched. At the onset of anaphylactic reaction treatment with Histaglobulina should be stopped.

Overdose

The consequences of an overdose in humans are not known.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic and pharmacokinetic properties

Histaglobulina contains histamine dihydrochloride and purified human gamma globulin (immunoglobulin of the class IgG) obtained from the plasma of healthy blood donors. Histaglobulina, after subcutaneous administration, activates the synthesis of antihistamine antibodies which binds the released histamine, considerably diminishing the disease symptoms.

Histamine belongs to the mediators of allergic reactions and is found in different tissues and blood cells in bonded form. Its bioactivity is revealed as a result of antigen-antibody reaction. Plasma proteins of healthy individuals have the ability to bond with and inactivate the free histamine (i.e. histaminopexia).

In patients with allergy the Histaglobulina causes an increase in the histaminopexic activity of plasma proteins, suppressing or completely eliminating the disease symptoms.

Preclinical safety data

In research on laboratory animals (guinea pigs and mice) it was observed that Histaglobulina is harmless, and does not show intensive toxicity.

PHARMACEUTICAL PARTICULARS

Composition and list of excipients

Composition of active substance:

  1. Human gammaglobulin - 12 mg
  2. Histamine dihydrochloride – 0.15 micrograms

Excipients:

  1. pentahydrous sodium thiosulfate - 32 mg
  2. saccharose - 40 mg

Diluent: water for injections - 2 ml

Incompatibilities

None

Shelf life

2 years.

Special precautions for storage

  1. Store at 2°C - 8°C.
  2. Use immediately after dilution.

Nature and contents of container

  1. 3 vials with freeze dried matter + 3 ampoules with diluent 2 ml each
  2. Vials made of neutral, colourless glass of the volume of 5 ml, closed with a rubber stopper and metal cap, and ampoules made of neutral glass of 2 ml volume in a cardboard box.

Instructions for use and handling and disposal

Before the use of the medicinal product the expiry date on the label should be checked. Remove the cap from the vial and disinfect the surface of the rubber stopper with 70% ethyl alcohol.

Open the ampoule of diluent, after disinfection with 70% ethyl alcohol, by breaking the neck off. Then, draw 2 ml of diluent from the ampoule into a sterile syringe and introduce it to the vial with freeze dried matter. Blend properly.

The product should be used immediately.