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herpes vaccine available in Europe by new one ..... Herpes Simplex 1 Forum

Date:   3/7/2006 1:57:03 AM ( 18 y ago)
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URL:   https://www.curezone.org/forums/fm.asp?i=373127

There eis a vaccine that has been used in Italy/Czech for a while (since 1977) apparently, called Lupidon G and H. I've done some research on the net and all seem to be in favour of it and it has no negative side effects. Here is info I received from thje manufacturer re: the product characteristics:

SUMMARY OF PRODUCT CHARACTERISTICS

1. TRADE NAME OF THE MEDICINAL PRODUCT: LUPIDON G

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
LUPIDON G - Active ingredient: 1 ml ampoule contains: inactivated Herpes simplex virus type II: 100.000 AHU (Antigenic Herpes simplex Unit = 10.000 EID50)

3. PHARMACEUTICAL FORM. 1 ampoule ready for subcutaneous administration.

4. . CLINICAL PARTICULARS
4.1 Therapeutic indications: immunoprofilaxis of recurring type II Herpes simplex infections
4.2. Posology and method of administration
The ampoules must be injected subcutis after a strong shake.
The therapy requires a sequence of opportunely spaced administrations as follows:
1st month: 1 ampoule weekly
2nd month: 1 ampoule weekly
3rd month: 1 ampoule weekly
4th month: 1 ampoule each two weeks
5th month: 1 ampoule each two weeks
6th month: 1 ampoule monthly
7th month: 1 ampoule monthly
8th month: 1 ampoule monthly
9th month: 1 ampoule monthly
1 recall every 2 or 3 months for a total amount of 10 ampoules. After that may be further recalls are necessary each 3 - 6 months.
Children from 7 to 14 years old: half of the adult dose following the same therapeutic schedule; in case of serious form adult dose can be administered.
4.3. Contra-indications. Allergy to egg albumin or to other components of the product
4.4. Special warnings and special precautions for use. Keep out of the reach of children. Shake the ampoule before use. Precautions for use are not foreseen.
4.5. Interaction with other medicaments and other forms of interaction. Unknown.
4.6. Pregnancy and lactation
Like for other antiviral vaccines, avoid the use during pregnancy, particularly in the first period. If necessary the doctor has to evaluate carefully the ratio risk/benefit.
4.7. Effects on ability to drive and use machines.
Does not interfere with driving or using equipments.
4.8. Undesirable effects.
Seldom local light reactions like swellings or cutaneous eruption can take place; in a very few cases a light rise of temperature may occur. Anyway these effects are of little importance and temporary.
In predisposed patients sometime allergic reactions may happen: that is due to the proteins of eggs, where the viruses are cultivated.
4.9. Overdose.
Overdosage with LUPIDON H or LUPIDON G has not been reported.

5. PHARMACOLOGICAL
5.1. Pharmacodynamic properties : pharmacotherapeutic goup (ATC code): J07VX
For what concerns the pharmaco-dynamic in man, clinical tests show a significative increase of the total lymphocytes, above all of T Helper and NK cells.
Particularly significative for what concerns the therapeutical result is the increase of the rate TCD4/TCD8.
These immunological data are constantly verified and connected with the best clinical results evidencing a very remarkable reduction of the relapses number per year and of their length and intensity.


5.2. Pharmacokinetic properties:
The antigenic material contained in the drug in a quite low quantity, difficult to be studied pharmacokinetically, follow the normal absorbing route of the antigens administered by subcutaneous route and makes active the cell-mediated component of the immune response both specifically and aspecifically like the immuno-stimulant drugs.
5.3. Preclinical safety data:
The toxichological tests showed that the drug is very well tolerated: no sign of acute toxicity were evidenced in the rat and in the mouse after the administration of doses up to 5 ml/kg by intra-peritoneal administration; the chronic toxicity is irrelevant and the treatment on dogs and rats with doses up to 0,5 ml/kg/die for 1 year does not cause toxic effects detectable on any organ or tissue. The drug has no teratogen effects either on the fertility in the rat or rabbit or cause undesirable effects in the peri and post-natal period at dose up to 0,5 ml/kg.
The mutagenesis and cancerogenesis tests made in vitro and in vivo according to the normal methods gave always negative results.

6. PHARMACEUTICAL PARTICULARS
6.1. Excipients – 1 ml ampoule contains: sodium chloride mg 8, potassium chloride mg 0,2, potassium phosphate monobasic mg 0,2, sodium phosphate dibasic dihydrate mg 1,15, calcium chloride hydrate mg 0,1, magnesium chloride hexahydrate mg 0,1, phenol red mg 0,01, proteinic nitrogen less than mg 0,05, water for injectable products up to 1 ml.
6.2. lncompatibilities. Unrecorded
6.3. Shelf life : 24 months provided the product is kept according to suggested precautions for storage. The product must be considered expired even before the deadline if a yellowish colour is showed.
6.4. Special precautions for storage
Keep the ampoules out of light in refrigerator at +2°/+8°C.
6.5. Nature and contents of container
Carton lithographed box containing 4 glass ampoules of 1 ml
6.6. Instructions for use and handling: none

7. MARKETING AUTHORIZATION HOLDER
BRUSCHETTINI S.r.l., Via Isonzo 6 - Genova (Italy)

8. MARKETING AUTHORIZATION NUMBER
LUPIDON G: 027387063

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
February 1991

10. DATE OF LAST REVISION OF THE TEXT
September 2003


 

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