HISTAGLOBIN

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

HISTAGLOBIN

S4	T546 (Act 101/1965)

PROPRIETARY NAME:
(and dosage form)

HISTAGLOBIN

DESCRIPTIVE NAME OF MEDICINE
Immunobiological Treatment for Allergic Conditions.

PHARMACOLOGICAL CLASSIFICATION:
Category A30 Biologicals.

SCHEDULING STATUS
S3

COMPOSITION:
Each vial contains lyophilised powder with the following active components:

	Human Gammaglobulin	12 mg
	Histamine Dihydrochloride	0,15 mcg
	This is resuspended before use, with the supplied 2 mL Water for Injection.

IDENTIFICATION:
Each Histaglobin vial contains white, lyophilised powder in a soft tablet form.

PHARMACOLOGICAL ACTION OF THE MEDICINE:
Symptoms of allergy are caused by a sudden release of various chemical factors, amongst which Histamine is predominant. A diminution in natural protection against histamine can be observed in certain subjects with a predisposition to allergy. In these cases HISTAGLOBIN builds up antihistamine protection, whilst at the same time reducing allergic symptoms. HISTAGLOBIN is a systemic treatment against allergic conditions, but not a remedy for allergic attacks. HISTAGLOBIN usually leads to the progressive subsidence of allergic conditions within three or four weeks from the end of treatment. The duration of this protection may vary from patient to patient, and may last from several months to several years. HISTAGLOBIN consists of histamine fixed on an active protein fraction extracted from human blood (gammaglobulin) in strictly defined proportions.

INDICATIONS:
HISTAGLOBIN is a basic treatment for allergic conditions and not a remedy for acute symptoms. It is therefore recommended for all allergic complaints whatever their symptoms or causes.

(a)	Respiratory: bronchial asthma, asthmatic bronchitis, chronic bronchitis, spasmodic tracheitis, hay fever, allergic rhinitis.
(b)	Cutaneous: eczema, urticaria, generalised skin allergies.
(c)	Nervous: migraine.
(d)	Gynaecological: premenstrual syndrome when of allergic aetiology.
(e)	HISTAGLOBIN may be used prophylactically with children (where there is a family history of allergy) who are about to undergo an adenoidectomy or tonsillectomy.

CONTRA-INDICATIONS:
It is advisable to avoid treatment during pregnancy or during menstruation. Do not administer during an acute allergic attack.

DOSAGE AND DIRECTIONS FOR USE:
Subcutaneous Injection.
ADULTS - IMMEDIATELY: A series of 4 injections - 1 injection every 4 days.
4 WEEKS LATER: A further series of 4 injections - 1 injection every 4 days. If a favourable response is obtained within 4 weeks of completing the above 2 series, the following dosage regime should be carried out:
IMMEDIATELY: (after 4 weeks of last injection) 1 injection every 4 weeks for a series of 4 injections.
TOTAL INJECTIONS: 12.
BOOSTER: 1 YEAR LATER: A further series of 4 injections - 1 injection every 4 days should be administered annually.

CHILDREN - GENERAL INDICATIONS: As above, but interval between injections should be 8 days instead of 4 days.

DOSAGE FOR SEASONAL ALLERGIES: (Hayfever, asthma, chronic bronchitis, etc.) Give the first 8 injections, as set out under GENERAL INDICATIONS, 3 months before seasonal manifestations are expected.

DOSAGE FOR PREMENSTRUAL SYNDROME: 1 injection on the 6th, 13th and 20th day of the menstrual cycle for 1 cycle. Then 1 injection every 20th day of all following cycles until menopause if necessary.

DOSAGE FOR ADENOIDECTOMY AND TONSILLECTOMY: A series of 4 injections, 6 weeks before the operation, followed by a new series 4 weeks after the operation. N.B.: For allergic migraines, chronic urticaria, atopical eczema, some authors suggest a series of 16 injections, without interruption, at 2-day intervals.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
HISTAGLOBIN is normally well tolerated even by children and infants, however, in very rare cases an exacerbation of the clinical symptoms is observed after the 1st and 2nd injection. This is only of a transient nature and is usually a sign that the system is responding favourably to the medication. It can be alleviated by the usual symptomatic treatment. Injections must always be given subcutaneously.

Use a cold syringe, as HISTAGLOBIN is thermolabile.

Always treat any existing superinfection before beginning HISTAGLOBIN treatment. Never start treatment during an acute allergic attack, specially an acute asthmatic attack. In such cases the usual specific remedy must be used first. Should an acute attack occur after an injection of HISTAGLOBIN treatment, this should be viewed as a positive sign. Discontinue HISTAGLOBIN treatment until symptomatic treatment has alleviated the acute attack, and then continue the HISTAGLOBIN regime.

In small doses, corticoid therapy is compatible with HISTAGLOBIN treatment. In many cases the doses of corticoids can be gradually reduced, or even stopped. HISTAGLOBIN is not contra-indicated with desensitization treatment. In a good number of cases a combined treatment appears to reinforce the effects. It is important to remember that results may only be evident 3 to 4 weeks after the end of treatment.

The duration of HISTAGLOBIN protection may vary from patient to patient and may last from several months to several years. The physician should establish the appropriate intervals for the booster injection according to patient results.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Generally HISTAGLOBIN is tolerated without ill effects even by children and infants. Should an acute attack occur after an injection of HISTAGLOBIN treatment, this should be viewed as a positive sign. Discontinue HISTAGLOBIN treatment until symptomatic treatment has alleviated the acute attack, and then continue the HISTAGLOBIN regime.

CONDITIONS OF REGISTRATION:
To be advertized to the professions only.

PRESENTATION:

Boxes of	(a) 4 vials of HISTAGLOBIN dry lyophilized powder and
	(b) 4 ampoules of solvent viz. 2 mL Water for Injection.

STORAGE DIRECTIONS:
Dry form –Protect vial from direct sunlight, below 30°C.
Resuspended form –Discard any unused solution.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MIRREN (PTY) LTD
18 Golden Drive, Morehill, Benoni

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

25.02.85

Unified