MRF 1

Proxeed PLUS - France et Afrique
Valeur Nutritionnelle pour 1 sachet (5g) :
Protéines
Glucides
Lipides
L-carnitine
Fructose
Acétyl-L-carnitine HCL
Vitamine C
Acide citrique
Coenzyme Q10
Zinc
Acide folique
Sélénium
Vitamine B12
0.01 g
2.28 g (dont sucres 2.23 g)
0.0 g
1000 mg
1000 mg
500 mg
90 mg (112,5% AJR*)
50 mg
20 mg
10 mg (100% AJR*)
200 μg (100% AJR*)
50 μg (91% AJR*)
1,5 μg (60% AJR*)
*Apport Journalier Recommandé
Ingrédients:
Fumarate de L-carnitine
Sucrose
Fructose
Acétyl-L-carnitine HCL
Acide L-ascorbique (Vitamine C)
Acidifiant : acide citrique
Lactate de Zinc
Arome citron
Édulcorant : acésulfame-K
Levure de sélénium 0,2%
Coenzyme Q10
Cyanocobalamine 0,1% (vitamine B12)
Acide folique
Dosage:
1sachet par jour, dissous dans 200 ml d’eau ou de jus d’orange avant le repas, le matin ou le soir. Il est
recommandé d’utiliser Proxeed Plus pendant au moins 6 mois consécutifs. Ne pas dépasser la dose journalière
recommandée. Les compléments alimentaires doivent être utilisés dans le cadre d’un mode de vie sain et ne pas
être utilisés comme substituts d’un régime alimentaire varié et équilibré. N’utilisez pas ce produit si vous êtes
hypersensible à l’un des composants de Proxeed  Plus. Ce produit n’est pas recommandé pour les enfants de
moins de 12 ans.
Utilisation:
Proxeed Plus est un complément alimentaire constitué d’un complexe de L-carnitine, vitamines et minéraux.
Proxeed Plus contient du zinc qui contribue à une fertilité et une reproduction normales et du sélénium qui
contient une spermatogenèse normale.
Conservation:
Conserver à une température ambiante (15-25°C), à l’abri de la lumière. Tenir hors de la portée et de la vue des
jeunes enfants.
Pour plus d’informations:
Veuillez contacter votre pharmacien ou JUVISE Pharmaceuticals :
[email protected]/+33 4 26 29 40 00/www.juvisepharmaceuticals.com.
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Distribué par:
JUVISE Pharmaceuticals, 149 Boulevard Stalingrad-69100 Villeurbanne-France +33 4 26 29 40 00/
[email protected]/ www.juvisepharmaceuticals.com.
Proxeed Plus est une marque déposee de : Sigma-Tau industrie farmaceutiche riunite s.p.a – Pomezia (Rome),
Italy.
Proxeed Plus est fabriqué par: E-Pharma Trento S.p.A-Trento,Italy
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Proxeed PLUS – France and African countries
Nutritional value per 1 sachet (5g):
Proteins
Carbohydrates
Fats
L-carnitine
Fructose
Acetyl-L-carnitine HCL
Vitamine C
Citric acid
Coenzyme Q10
Zinc
Folic Acid
Selenium
Vitamine B12
0.02 g
2.28 g (including 2.23 g sugars)
0.0 g
1000 mg
1000 mg
500 mg
90 mg (112,5% RDA*)
500 mg
20 mg
10 mg (100% RDA*)
200 μg (100% RDA*)
50 μg (91% RDA*)
1,5 μg (60% RDA*)
* Recommended Daily Allowance
Ingredients:
L-carnitine fumarate
Sucrose
Fructose
Acetyl-L-carnitine HCL
L-ascorbic Acid (Vitamin C)
Acidifier : citric acid
Zinc Lactate
Flavour :Lemon flavour
Sweetener : acesulfame K
Selenium yeast 0,2%
Coenzyme Q10
Cyanocobalamine 0,1% (vitamine B12)
Folic acid
Dosage:
1 Sachet a day, dissolved in 200ml water or orange juice before meals, morning or evening. It is recommended to
take Proxeed Plus for at least 6 months. Do not exceed the recommended daily dose. A food supplement should
not be used as a substitute for a balanced diet and a healthy lifestyle. Do not use this product in case of
hypersensitivity to one of the ingredients of Proxeed  Plus. This product is not recommended for children under
12.
Use:
Proxeed Plus is a food supplement that consists of a vitamin-mineral complex with L-carnitine. Proxeed Plus
contains zinc for contribution to normal fertility and reproduction and selenium to support normal
spermatogenesis.
Storage:
Store at room temperature (15-25°C) and protect from light. Keep out of the reach and sight of young children.
For more information:
Please contact your pharmacy or Sigma-Tau HealthScience: [email protected]
0031 (0)30 670 23 23
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Distributed by:
JUVISE Pharmaceuticals, 149 Boulevard Stalingrad-69100 Villeurbanne-France +33 4 26 29 40 00/
[email protected]/ www.juvisepharmaceuticals.com.
Proxeed Plus is a registered trademark of: Sigma-Tau industrie farmaceutiche riunite s.p.a – Pomezia (Rome),
Italy.
Proxeed Plus is manufactured by: E-Pharma Trento S.p.A-Trento, Italy
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Proxeed PLUS – South Africa
Applicant Name: PHARMACO DISTRIBUTION (PTY) LTD
Proprietary Name: PROXEED® PLUS
Dosage Form and Strength: Each Sachet contains L-carnitine (fumarate) 1725 mg, Fructose 1000 mg, Acetyl-L-carnitine 500 mg, Vitamin C 90 mg, Citric Acid 50 mg, Coenzyme
Q10 20 mg, Zinc 10 mg, Folic Acid 200 µg, Selenium 50 µg and Vitamin B12 1.5 µg.
PROPOSED PACKAGED INSERT:
SCHEDULING STATUS
Not Scheduled
PROPRIETARY NAME AND DOSAGE FORM
Proxeed® PLUS Sachets
COMPOSITION
Each sachet contains:
Compostition
Units
/Sachets
L-carnitine (fumarate)
mg
1725
Fructose
mg
1000
Acetyl-L-carnitine HCl
mg
500
Vitamin C
mg
90
Citric Acid
mg
50
Coenzyme Q10
mg
20
Zinc
mg
10
100
Folic Acid
µg
200
100
Selenium
µg
50
91
Vitamin B12
µg
1.5
60
%RDA*
112.5
PHARMACOLOGICAL CLASSIFICATION
A.32.2 Other Substances
PHARMACOLOGICAL ACTION
L-carnitine is a component of both seminal plasma and sperm cells and plays an important role in sperm
maturation and potential sperm motility.
Fructose is one of the major energy-yielding substrates present in seminal fluid. Sperm utilizes fructose
as an energy source.
Acetyl-L-carnitine is the acetyl ester of L-carnitine. Acetyl-L-carnitine is the most prominent form of
carnitine in sperm and is important in sperm membrane stabilization. Acetyl-L-carnitine also serves as a
circulating energy source for sperm and provides primary fuel to sperm motility.
Vitamin C is an antioxidant present in the seminal plasma.
Citric acid is a key intermediate in the major energy producing pathways used by sperm and other body
tissues.
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PROPOSED PACKAGED INSERT:
Coenzyme Q10 acts as an antioxidant as well as a metabolic substrate and is concentrated in the
mitochondria of the mid piece of the sperm. The mitochondria is the structure responsible for energy
production in cells, within the sperm.
Zinc is important for the production of semen and contributes to fertility and reproduction.
Folic acid contributes to the quality of seminal fluid.
Selenium is a powerful antioxidant and is thought to stabilize the integrity of the sperm flagella. The
flagella is the system that helps sperm move towards the egg for fertilization.
Vitamin B12 is involved in cell maturation and DNA synthesis.
INDICATIONS
Proxeed® Plus is a food supplement that supports male reproductive health with ingredients that
contribute to optimize sperm quality, a key factor in the process of conception. Sperm quality refers to
motility (the sperm’s ability to move spontaneously and actively), sperm count, volume of sperm produced
and morphology (form and dimension of sperm). Among healthy couples who are taking longer than
expected to conceive, reduced sperm quality is a contributing factor in nearly 40% of all cases.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
WARNINGS
Seek advice from a health care professional before taking Proxeed® PLUS Sachets.
INTERACTIONS
None known
DOSAGE AND DIRECTIONS FOR USE
Take 1 sachet daily. Mix the contents of the sachet with water or juice and drink the solution in the
morning and evening before meals. It is recommended that Proxeed® PLUS be taken for a period of at
least 6 consecutive months or for as long as you are attempting to conceive.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Gastro-intestinal symptoms may occur with overdosage.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
None known. Treatment is symptomatic and supportive.
IDENTIFICATION
Light orange granules.
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PROPOSED PACKAGED INSERT:
PRESENTATION
Unit carton containing 30 Sachets
STORAGE INSTRUCTIONS
Store in a cool, dry place, at or below 25 °C, away from direct sunlight.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER
To be allocated.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Pharmaco Distribution (Pty) Ltd
3 Sandown Valley Crescent,
South Tower, 1st Floor
Sandton 2196
DATE OF PUBLICATION OF THE PACKAGE INSERT
To be allocated.
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