GEROVITAL 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 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 GH3 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 GH3 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.
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 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
afternoon,
for 12 days.
one-month
pause between them.
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
tablets
/ day, 12-18 days / month, can be administrated.
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
series
/ year.
Adverse
reactions, which can occur during the use of the medicinal product:
Administration
of Gerovital GH3 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 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
folding box with 10 brown ampoules of 5 ml
The
date of the last revision of the leaflet:
**************************************
GEROVITAL
GH3 tablets Package
leaflet
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
Excipients:
maize starch, mannitol, gelatin, talcum, magnesium stearate, sugar, povidone
K30,
sodium
carboxymethylcellulose, colloidal silicon dioxide, titanium dioxide, schellack,
yellow
wax,
carnauba wax .
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 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.
Gerovital GH3 should not be administered simultaneously with
sulphonamides (antagonistic
mechanism of action) – except the antidiabetic ones,
anticholinesterases: neostygmine, eserine
(physostigmine) and pyridostigmine.
Pregnant and breast-feeding women:
The studies on animals did not show teratogenic effects. In
absence of teratogenic effects on
animals, mutant effects on humans are not expected. However, the clinical experience
with Gerovital GH3 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.
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 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
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
the geriatrist, according with the aging status of the
patient.
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
series / year.
Adverse reactions, which can occur during the use of
the medicinal product:
Administration of Gerovital GH3 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 GH3. 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 25.0 C.
Keep out of the reach of children.
Do not use after the expiry date printed on the package.
Packaging:
Primary package: green box with 25
tablets
Secondary package: 20 boxes with 500
tablets
The date of the last revision of the leaflet:
May, 2008
