Active ingredients: Polydeoxyribonucleotide
PLACENTEX "5.625 mg / 3ml solution for injection"
PLACENTEX: "2.25 mg / 3ml solution for injection"
Placiousx package inserts are available for pack sizes: - PLACENTEX "5.625 mg / 3ml solution for injection", PLACENTEX: "2.25 mg / 3ml solution for injection"
- PLACENTEX "0.08% cream", PLACENTEX "0.75 mg / 3ml cutaneous solution"
- PLACENTEX 0.75 mg / ml eye drops
WHY IS PLACIOX USED? What is it for?
Placiousx is a polydeoxyribonucleotide-based medicine indicated for the repair of tissue damage. Placiousx has a healing activity (it is able to accelerate the healing process of wounds, ulcers and burns) and anti-dystrophic (repairing activity of damage to an organ or tissue).
Contraindications When Placentex should not be used
Do not use PLACENTEX
- if you are allergic to polydeoxyribonucleotide or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before you take Placularx
Talk to your doctor or pharmacist before using PLACENTEX.
If you have an allergy, your doctor will need to stop treatment with this medicine and, if necessary, start desensitizing medical therapy (treatment to reduce allergy).
Interactions Which drugs or foods can modify the effect of Placox
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
No interactions have been reported with other medicinal products used together with PLACENTEX.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
PLACENTEX does not affect the ability to drive or use machines.
PLACENTEX: "5.625 mg / 3ml solution for injection",
PLACENTEX "2.25 mg / 3ml solution for injection"
contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, meaning it is essentially a 'sodium-free' product.
Dose, Method and Time of Administration How to use Placiousx: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
PLACENTEX: "5.625 mg / 3ml solution for injection",
PLACENTEX "2.25 mg / 3ml solution for injection"
One vial a day intramuscularly or subcutaneously, for cycles of 15-20 days, repeatable, or according to medical prescription.
Overdose What to do if you have taken too much Placiousx
If you use more PLACENTEX than you should
No cases of overdose have been reported.
In case of accidental ingestion of an excessive dose of PLACENTEX, notify your doctor immediately or go to the nearest hospital.
If you forget to use PLACENTEX
Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Placularx
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Italian Medicines Agency - Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "Expiry".
The expiry date refers to the last day of that month.
Do not throw any medicines into wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What PLACENTEX contains
PLACENTEX: "5.625 mg / 3ml solution for injection",
- The active ingredient is polydeoxyribonucleotide. Each 3 ml vial contains 5,625 mg of polydeoxyribonucleotide.
- The other ingredients are: sodium chloride, water p.p.i.
PLACENTEX "2.25 mg / 3ml solution for injection"
- The active ingredient is polydeoxyribonucleotide. Each 3 ml vial contains 2.25 mg of polydeoxyribonucleotide.
- The other ingredients are: sodium chloride, water p.p.i.
Description of the appearance of PLACENTEX and contents of the pack
PLACENTEX: "5.625 mg / 3ml solution for injection" 5 ampoules of 3ml
PLACENTEX "2.25 mg / 3ml solution for injection" 5 ampoules of 3ml
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PLACENTEX
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmaceutical Forms for parenteral use:
PLACENTEX INTEGRO: 1 ampoule of 3 ml contains:
Active Ingredient: Polydeoxyribonucleotide 5.625 mg
PLACENTEX 50%: 1 ampoule of 3 ml contains:
Active Ingredient: Polydexoxyribonucleotide 2.25 mg.
Pharmaceutical forms for external use:
PLACENTEX POMATA: 100 g of ointment contain:
Active ingredient: 80 mg polydeoxyribonucleotide
PLACENTEX 10%: 1 ampoule of 3 ml contains:
Active Ingredient: Polydexoxyribonucleotide 0.75 mg.
PLACENTEX EYE DROPS: each 10 ml bottle contains:
Active Ingredient: Polydexoxyribonucleotide 7.5 mg
03.0 PHARMACEUTICAL FORM
PLACENTEX INTEGRO, PLACENTEX 50%: 5 ampoules of 3 ml for parenteral use,
PLACENTEX POMATA: 25 g tube of ointment,
PLACENTEX 10%: 10 ampoules of 3 ml for external use,
PLACENTEX EYE DROPS: 10 ml bottle.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
For parenteral use.
PLACENTEX INTEGRO, PLACENTEX 50%: Connective pathologies on a dystrophic or dystrophic-ulcerative basis: healing, antidystrophic.
For external use.
PLACENTEX POMATA: Skin and connective tissue disorders on a dystrophic or dystrophic-ulcerative basis: healing, antidystrophic.
PLACENTEX 10%: Connective disorders on a dystrophic or dystrophic-ulcerative basis: healing, antidystrophic.
PLACENTEX COLLIRIO: Dystrophic-ulcerative pathologies of the conjunctiva and cornea: microtrauma from contact lenses, healing.
04.2 Posology and method of administration
PLACENTEX INTEGRO, PLACENTEX 50%: 1 ampoule per day intramuscularly or subcutaneously, for cycles of 15-20 days repeatable or according to medical prescription.
PLACENTEX POMATA: local applications once or twice a day or according to medical prescription.
PLACENTEX 10%: local applications 1 or 2 times a day, soaking sterile gauze or according to medical prescription.
PLACENTEX EYE DROPS: 2 or 3 drops in the conjunctival fornix 2-4 times a day or according to medical prescription.
04.3 Contraindications
Hypersensitivity to the active substance or to one of the excipients.
04.4 Special warnings and appropriate precautions for use
The product is neither addictive nor risk of drug addiction. In case of subjective hypersensitivity to the component, suspend the administration and, if necessary, initiate medical desensitizing therapy. No particular precautions for use emerged.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known drug interactions or incompatibilities.
04.6 Pregnancy and lactation
There were no contraindications to use in pregnancy or lactation.
04.7 Effects on ability to drive and use machines
It does not affect the ability to drive and use machines.
04.8 Undesirable effects
The natural origin of the component allows an absorption practically free of unwanted effects.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: healing,
ATC code PLACENTEX INTEGRO, PLACENTEX 50%: V03AX
PLACENTEX 10%, PLACENTEX POMATA: D03AX49
PLACENTEX EYE DROPS: S01XA49
The active principle of PLACENTEX is Polydexoxyribonucleotide (PDRN), a natural product, obtained by selective extraction with an original technology from the Mastelli Laboratory. PDRN is chemically a linear polyanion, whose monomer units consist of deoxyribonucleotides joined by a phosphodiester bond; has an Average Molecular Weight of about 350 K.D. and it is heat resistant. This feature also made it possible to use the classic hot treatment procedure in an autoclave at 121 ° C, obtaining the maximum guarantee of sterility. PDRN has a traditional and documented effect in connective tissue repair and trophism. This effect occurs both with the tropism of the active principle towards the damaged focus, through the complex that is formed by the affinity of the PDRN towards platelets and fibronectin, and with the stimulus to cell regeneration. This last effect is ascribed: in part to the synergistic action of the PDRN and its metabolites with the growth factors and in part to the activation of the metabolic pathways of the "salvage" which involve significant energy savings in the neo-synthesis of DNA, phase essential for tissue repair.
05.2 "Pharmacokinetic properties
The active component of the drug follows the normal metabolism of endogenous and exogenous polydeoxyribonucleotides.
05.3 Preclinical safety data
The drug is characterized by an undetectable toxicity at the maximum administrable doses. Acute toxicity studies on rats and mice did not allow to identify the LD50 which was higher than the maximum administrable doses (30 ml / kg Placularx Integro). Systemic chronic toxicity studies on the basis of 1 ml / kg / day of the same preparation did not determine either mortality or obvious pathologies affecting the individual organs studied macro and microscopically, or alterations to the general state of health. Topical chronic toxicity studies (0.5 mg / kg / day of Placiousx Pomata) did not determine either mortality or obvious pathologies affecting the individual organs studied macro and microscopically, or alterations to the general state of health.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
INTEGRAL PLACENTEX: sodium chloride; water p.p.i.
PLACENTEX 50%: sodium chloride; water p.p.i ..
PLACENTEX POMATA esters of oleic acid of decyl alcohol, cetylstearyl alcohol, anhydrous lanolin, alkyl p-hydroxy benzoates, imidazolidinylurea, aromatic base, purified water.
PLACENTEX 10%: sodium chloride; water p.p.i ..
PLACENTEX COLLIRIO: polyvinylpyrrolidone, methyl-p-hydroxy benzoate, propyl-p-hydroxy benzoate, sodium edetate, monobasic sodium phosphate, dibasic sodium phosphate, water p.p.i ..
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
No special storage precautions. It is a good idea to keep medicines away from heat sources and protected from light.
06.5 Nature of the immediate packaging and contents of the package
PLACENTEX INTEGRO: 5 ampoules of 3 ml
PLACENTEX 50%: 5 ampoules of 3 ml
PLACENTEX POMATA: tube of 25 g
PLACENTEX 10%: 10 ampoules of 3 ml
PLACENTEX EYE DROP: 10 ml dropper bottle
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Mastelli S.r.l. - Via Bussana Vecchia n ° 32 - 18038 Sanremo (IM)
08.0 MARKETING AUTHORIZATION NUMBER
INTEGRAL PLACENTEX: 004905129,
PLACENTEX 50%: 004905156
PLACENTEX 10%: 004905143
PLACENTEX POMATA: 004905131
PLACENTEX EYE DROPS: 004905117.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Marketed in 1999
10.0 DATE OF REVISION OF THE TEXT
March 2011
