GEROVITAL GH3 injectable solution Package leaflet

 

Pharmaceutical form:

Injectable solution intramuscular

 

Composition:

One ampoule contains:

Procaine hydrochloride100 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.

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. 

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 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 ofaccidentally 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: 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: June, 2014

**************************************

GEROVITAL GH3 tablets Package leaflet

Pharmaceutical form: sugar-coated tablets

Composition:

 

One sugar-coated tablet contains: Procaine hydrochloride100 mg, Benzoic acid6 mg, Disodium phosphate dodecahydrate0.5 mg, Potassium metabisulfite.. 5 mg

 

Excipients: maize starch, mannitol, gelatin, talcum, magnesium stearate, colloidal silicon dioxide, titanium dioxide, schellack, corn starch, sodium bicarbonate

 

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, 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 packagea lthough the tablets are still ok after 6 month of the expiration date as far as you store it carefully far from heat and/or moisture.

 

Packaging:

Primary package: green carton box with 24 tablets as 2 plastic blisters with 12 tablets each.

Secondary package: 50 boxes with 1200 tablets

 

The date of the last revision of the leaflet:

June, 2014