GEROVITAL H3 - GH3 injectable
solution Package
leaflet
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:
Protection of the
organism against aging phenomena.
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,
arthritis, cerebral
atherosclerosis.
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 should 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 - GH3 should not be administered simultaneously with sulphonamides (antagonistic
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
Potential
effect on the ability to drive or to use machines:
The
product does not interfere with these abilities.
Posology and method of administration:
Before starting the treatment with Gerovital GH3 it is compulsory to test individual sensitivity to procaine, as follows:
1 ml from the injectable solution of Gerovital GH3 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.
For protection of the organism against aging phenomena (standard schedule), alternative
courses of injections and tablets of Gerovital H3 - GH3 should be administered, as follows:
Injectable
solution:
1 intramuscular injection, 3 times a week (one ampoule every other
day),
over
a period of 4 weeks (12 ampoules).
Sugar-coated
tablets: 2 sugar-coated tablets/ day, after meals, in the morning and in the
The schedule and the frequency of pauses will be decided by
Curative
treatment:
Depressive syndrome:
1-st
week: 1 ampoule i.m. /day, 3 times a week (i.e., on Monday, on Wednesday and on
Friday);
2-nd
and 3-rd week: 1 ½ ampoules i.m., 3 times a week;
4
– th week: 2 ampoules i.m., 3 times a week.
The
treatment should be repeated 4-6 times a year.
Parkinsonian syndromes:
Daily
administration of 1 ampoule i.m. and two sugar-coated tablets, for 15 days.
Osteoarthritis:
1 ampoule i.m. / day, for 15-21 days and then 1 ampoule i.m. 3 times a week
(every other day),
for
4 weeks, repeated of 4-5 times /year.
During the pauses in injections series,
1-2 sugar-coated
Systemic arteriosclerosis:
Depending
of the intensity and the localization of the process, the treatment should be
as
follows:
1 ampoule i.m. / day, 3 times a week, 4 weeks (12 ampoules), repeated 5-6 times
/year.
Between
the injections series, oral treatment may be added - 2 sugar-coated tablets
/day, 12 days.
In
some cases the treatment can be exclusively oral: 3 sugar-coated tablets/ day,
21 days in 6-8
Adverse
reactions, which can occur during the use of the medicinal product:
Administration
of Gerovital H3 - GH3 may produce allergic reactions in patients with
hypersensitivity
These effects impose an immediate stop of the treatment.
Minor
effects may occur especially at the beginning of the treatment like: dizziness,
weakness
These effects can be avoided if after the injection the patient
rests in bed for 10-
Overdose:
There
are no reports of overdose related to administration of Gerovital GH3.
In case
of
The
treatment is symptomatic and support of vital functions.
Storage:
Store
below 25.0 C.
Keep
out of the reach of children.
Do
not use after the expiry date printed on the package.
Packaging:
Primary
package: brown ampoule of 5 ml
Secondary
package: folding box with 5 brown ampoules of 5 ml wih expiry date on each vial's label
The date of the last revision of
the leaflet:
April, 2010
**************************************
Pharmaceutical form
Sugar-coated Tablets
Composition:
One sugar-coated tablet contains:
Procaine hydrochloride……………………100 mg
Benzoic acid…………………………………6 mg
Disodium phosphate dodecahydrate……….0.5 mg
Potassium metabisulfite…………………….. 5 mg
Pharmacotherapeutic group:
Alimentary tract and metabolism. Tonic preparations.
ATC code: A13 AN01
Therapeutic indications:
Protection of the
organism against aging phenomena.
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,
arthritis, cerebral
atherosclerosis.
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 should 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 - GH3 should
not be administered simultaneously
with sulphonamides (antagonistic
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
Potential
effect
on the ability to drive or to use machines:
The
product does not interfere with these abilities.
Posology and method of administration:
For protection of the organism against aging phenomena
(standard schedule), alternative
Injectable solution:
1 intramuscular injection, 3 times a week (one ampoule every other day),
over a period of 4 weeks (12 ampoules).
Sugar-coated tablets: 2 sugar-coated tablets/ day, after meals, in the morning
and in the
afternoon, for 12 days.
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
Between the injections series, oral treatment may be added - 2 sugar-coated tablets /day, 12 days.
In some cases the treatment can be exclusively oral: 3
sugar-coated tablets/ day, 21 days in 6-8
Adverse reactions, which can occur during the use of
the medicinal product:
Administration of Gerovital H3 - GH3 may produce allergic
reactions in patients with hypersensitivity
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 - GH3.
In case of
The treatment is symptomatic and support of vital functions.
Storage:
Store below 25.0 C.
Keep out of the reach of children.
Do not use after the expiry date printed on the package otherwise you may not enjoy all its benefits although our Gh3 products are still good within one year after the expiry date because we keep it in a climate controlled area.
Packaging:
Primary package: green box with 25
tablets
Secondary package: 20 boxes with 500
tablets
The date of the last revision of the leaflet:
April, 2010
