Pharmaceutical form: Injectable solution - intramuscular
Composition:
One ampoule contains:
- Procaine hydrochloride (100 mg)
- Benzoic acid (6 mg)
- Disodium phosphate dodecahydrate (0.5 mg)
- Potassium metabisulfite (5 mg)
- Distilled water for injectable solutions (up to 5 ml)
Pharmacotherapeutic group: Alimentary tract and metabolism. Tonic preparations. ATC code: A13 AN01
Therapeutic indications:
DEPRESSIVE SYNDROME: light and moderate depression, in precocious stages, especially when conventional therapy is not well-tolerated or it has contraindications;
PARKINSONIAN SYNDROMES: where it can be used in monotherapy or associated with other antiparkinsonian drugs, especially with dopaminergic agents;
OSTEOARTHRITIS: chronic degenerative rheumatism;
SYSTEMIC ARTERIOSCLEROSIS: with hypercholesterolemia, ischaemic heart disease, arteritis, cerebral atherosclerosis;
PROTECTION AGAINST AGING PHENOMENA;
Posology and method of administration:
Before starting the treatment with
Gerovital® H3 it is compulsory to test individual sensitivity to procaine, as follows: 1 ml from the injectable solution of Gerovital® H3 will be administered subcutaneously and after 24 hours the test should be repeated with 1.5 ml solution intramuscularly. If any allergic reaction occurs, the treatment is not recommended.
DEPRESSIVE SYNDROME:
Injectable solution:
1-st week: 1 ampoule (5 ml) intramuscular injection/day, 3 times a week (i.e., on Monday, on Wednesday and on Friday);
2-nd week: 1.5 ampoules (7.5 ml) intramuscular injection/day, 3 times a week;
3-rd week: 1.5 ampoules (7.5 ml) intramuscular injection/day, 3 times a week;
4 - th week: 2 ampoules (10 ml) intramuscular injection/day, 3 times a week.
The treatment should be repeated 4-6 times a year.
Total treatment: aprox 110 ampolules/year
PARKINSONIAN SYNDROMES:
Injectable solution: 1 ampoule (5 ml) intramuscular injection/day for 15 days
Total treatment: aprox 180 ampolules/year
Sugar-coated tablets: 2 tablets/daily for 15 days
Total treatment: aprox 360 tablets/year
OSTEOARTHRITIS:
Injectable solution: 1 ampoule (5 ml) intramuscular injection/ day, for 15-21 days and then
1 ampoule (5 ml) intramuscular injection/3 times a week (every other day), for 4 weeks;
The treatment should be repeated 4-5 times a year.
Total treatment: aprox 160 ampolules/year
Sugar-coated tablets: during the pauses in injections series, 1-2 tablets/day for 12-18 days/month, can be administrated.
Total treatment: aprox 180 tablets/year
SYSTEMIC ARTERIOSCLEROSIS:
Depending of the intensity and the localization of the process, the treatment should be as follows:
Injectable solution: 1 ampoule (5 ml) intramuscular injection/day 3 times a week for 4 weeks.
The treatment should be repeated 5-6 times a year.
Total treatment: aprox 72 ampolules/year
Sugar-coated tablets: between the injections series, oral treatment may be added - 2 sugar-coated tablets/day, 12 days.
Total treatment: aprox 150 tablets/year
Sugar-coated tablets: in some cases the treatment can be exclusively oral; 3 sugar-coated tablets/day, 21 days in 6-8 series/year
Total treatment: aprox 500 tablets/year
PROTECTION AGAINST AGING PHENOMENA:
Injectable solution: 1 ampoule (5 ml) intramuscular injection/day, 3 times a week (one ampoule every other day), over a period of 4 weeks
Total treatment: aprox 100 ampolules/year
Sugar-coated tablets: 2 sugar-coated tablets/ day, after meals, in the morning and in the afternoon, for 12 days.
Total
treatment: aprox 150 tablets/year
Series of injections and sugar-coated tablets should be alternated yearly, continuously or with one-month pause between them. The schedule and the frequency of pauses will be decided by the geriatrist, according with the aging status of the patient.
Contraindications:
*Hypersensitivity to procaine in antecedents or tested.
*Severe arterial hypotension.
*Associated treatment with sulfonamides (except the antidiabetic ones) and with acetylcholinesterase agents: neostygmine, eserine (physostigmine) and pyridostigmine.
Precautions regarding medicinal product administration:
Before starting the treatment, a test for individual tolerance to procaine should be made (see under Posology and method of administration).
The treatment must take place under medical supervision, mainly in the first series of treatment, in order to establish the optimal dose.
The product should be administered with caution in patients with orthostatic hypotension.
Although procaine medication is not carcinogenic, it is not recommended to the patients with cancer, as its stimulating effect on mitotic potential of the neoplasic cell is not excluded.
Interactions with other medicinal products or other substances:
Gerovital® H3 should not be administered simultaneously with sulphonamides (antagonistic mechanism of action) - except the antidiabetic ones, anticholinesterases: neostygmine, eserine (physostigmine) and pyridostigmine.
Special warnings:
Pregnant and breast-feeding women: the studies on animals did not show teratogenic effects. In absence of teratogenic effects on animals, malformative effects on humans are not expected. However, the clinical experience with Gerovital® H3 is mainly on patients over the procreation period. For these reasons we do not recommend the use of the product during pregnancy and lactation.
Potential effect on the ability to drive or to use machines: the product does not interfere with these abilities.
Adverse reactions, which can occur during the use of the medicinal product:
Administration of Gerovital® H3 may produce allergic reactions in patients with hypersensitivity to procaine like skin rash or pruritus.
These effects impose an immediate stop of the treatment.
Minor effects may occur especially at the beginning of the treatment like: dizziness, weakness and palpitations. These effects can be avoided if after the injection the patient rests in bed for 10-15 minutes.
Overdose:
There are no reports of overdose related to administration of Gerovital® H3. In case of accidentally injection of high doses, severe hypotension, convulsions, coma, respiratory arrest may occur.
The treatment is symptomatic and support of vital functions.
Storage:
*Store below 25 C.
*Keep out of the reach of children.
*Do not use after the expiry date printed on the package.
Packaging:
Folding box with 5 brown ampoules of 5 ml
Manufacturer, name and country:
ZENTIVA N.V., Romania.
Buy Online:
markastore.com - official retailer
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