GEROVITAL-H3

Original Romanian product of Md.PhD. ANA ASLAN

Translation of the manufacturer insert for tablets and ampoules

Composition:

Procaine hydrochloride 0.1000g, Benzoic acid 0.0060g, Potassium metabisulfite 0.0050g, Disodium phosphate 0.0005g.

Supplied in:

Either in 6 x 5ml ampoules or 25 x 100mg tablets (sugar coated).

Actions
The complex effects of Gerovital-H3® are due to its activity both at the level of the central and neurovegetative nervous systems, and at the level of the cells, through the stimulation of tissues regeneration and the improvement of metabolic processes, the product has also been proved to act in the oxidation reduction phenomena of the cell.
By its eutrophic action, the product maintains the equilibrium of the cortical processes and ensures the normal activity of the nervous system.
Gerovital-H3® exerts an antiacetylcholinic, sympatholic, antihistamine and antiallergic effect, the product decreases the excitability of the striated muscles; it also acts as a spasmolytic, antifibrillary, vasodilating, diuretic and lipotropic agent.

Indications
Preventative and curative treatment of old age phenomena. It is also indicated in tropic disorders, neuritis, cerebral and peripheral arteriosclerosis, Parkinson's disease, spondylosis, arthrosis, osteoporosis, neurodermitis, eczema, alopecia, psoriasis, sclederma and vitiligo.

Contraindications
Specific allergy to procaine (individual tolerance will be tested).

Adverse Reactions
No adverse reactions have been recorded. With procaine sensitive persons, the following phenomena may however appear; cephalea, shaking, bradycardia or tachycardia, motor or psychic restlessness, allergic reactions.

Incompatibility
Gerovital H3 should not be administered simultaneously with sulphonamides (inactivation), eserine or prostigmine.

Dosages and Administration
Preventative treatment of old age phenomena;

Per Os (orally)- 2 tablets daily, two or three hours after meals, over a period of 12 days. The treatment should be repeated after a one month break.

Parentally - 1 intramuscular injection three times a week, over a period of 4 weeks. The treatment should be repeated after an intermission of 1 to 2 months.

The association of both methods of administration is recommended.
· 4 series of injections (3 per week, a total of 12 ampoules); 30 days break; 4 series of tablets (2 daily for 12 days). After 24 days of intermission a new course of treatment may be begun.
· The curative treatment is generally, a long term one; 1 intramuscular injection 3 times a week (12 injections per month). After a 10 day break the treatment should be resumed. The series of injections could be alternated with the oral treatment; 6 series of injections and 5 series of tablets, with 10 day intermissions between the courses.
· In arthritis, Gerovital H3 may be administered intra-arterially or both intra and periartially.
· In arthrosis, it may be administered intra-articulary and periarticulary.
· In asthma and vasospasm, 1 ampoule can be administered daily, in slow intravenous injection there will be a 2 or 3 courses of 12 injections, with 7 day breaks between them.
· In cases of advanced old age phenomena, the parental treatment alone is recommended.

Storage
At room temperature, protected from light and humidity.

ASLAVITAL

Original Romanian product of Md.PhD. ANA ASLAN

Translation of the manufacturer insert for tablets and ampoules

Composition:

1 ampoule contains 0,100 g of procaine hydrochloride and an activating factor.

1 sugarcoated tablet contains 0,100 g of procaine hydrochloride, an activating factor and an antiatherogeneous factor.

Pharmacotherapeutic action:

Eutrophic regenerative agent with cellular biocatalityc action. It has an anti atherogenous (lipotropic) action, regulates certain, stages in the fats and cholesterol metabolism. It improves the cerebral circulation and the metabolism of the nervous cell. It is an energizing, an enzymopoetic and an anti depressive agent. Coronary andperipheral vasodilating agent. Spasmolitic agent.

Indications:

Prophylactic and curative treatment in the predominantly cerebral and cardiovascular aging forms : inopsychic and physical asthenia, intellectual overworking troubles of memory and concentration power, depressive and hyperemotivity states. In generalized atherosclerosis or that with cerebral, coronary and peripheral (arteritis) predominance, as well as in preventing and fighting thromboemolic accidents and posthemorrhagic sequelae.

Contraindications:

Procaine sensitivity. The tolerance of the drug should be tested : 1 ml subcutaneously in the first day and 2 ml intramuscularly in the 2nd day. If it is well tolerated the treatment may be resumed as per indications.

Dosage and administration

Prophylactic treatment:

- it is advisable to associate the parenteral route with the oral one according to the following treatment scheme : series of 12 intramuscular injections and 12 sugarcoated tablets, with a period of 4 weeks, in a rhythm of 1 injection every other day (3 a week) and 1 sugarcoated tablet a day, after breakfast, in the injectionless days (3 day a week) ; pause of 2-3 weeks between the series. Repeat the injections and sugarcoated tablets series 4-5 times yearly.

Curative treatment:

- in cerebral and vascular affections, 8 series a year should be administrated, of 12 i.m. injections (3 weeks) and 24 sugarcoated tablets (2 a day, one after breakfast,and one after lunch,in the injectionless days), with 1-2 weeks pauses between series. In acute cerebrovascular failure the preparation may be administrated intravenously. In arteritis cases, the intraarterial treatment is to be preferred .

- in psychic ashenia or disorders of the central nervous system with young people, the curative scheme of treatment shall be used for 3 months, followed by the prophylactic scheme. The treatment may be individualized as per the physician's advice.

Adverse reactions:

Have not been reported . In the case of procaine sensitive persons vaphalagia, tremblings,bradycardia, motor or physic agitation, allergic reactions may appear .

Therapeutic icompatibilities:

Do not administer at the same time with sulphonamides (competitive antagonistic agents), eserine or prostigmine.

Storage:

At room's temperature, protected from light and moisture.

Supplied in:

Boxes with 6 ampoules.

Bottles with 24 sugar-coated tablets.