Meganano Gel 15gm

Nanocrystalline Silver Gel

Each gram of gel contains:

Silver as Nano particles 0.02 mg

Perfumed gel base q.s.

Colour: Carmoisine

0.02mg per g

Gel for external application

4.1 Therapeutic Indication

For the treatment of burns and wound infections.

4.2 Posology and method of administration

For cutaneous use only.

• Clean the wound using an appropriate wound cleaner.
• Apply a layer of Meganano gel to shallow wounds or completely fill deep wounds.
• Cover the gel with appropriate secondary dressing such as gauze, hydrocolloid foam or film, depending on wound drainage.
• The dressing should normally be changed daily (24 hrs) but for wounds which are less exudative, less frequent changes (every 48/72 hrs) may be acceptable, at the discretion of the treating physician. Cleansing and debriding should be performed before application.

4.3 Contraindications

• Meganano gel is contraindicated in patients with hypersensitivity to silver or any other ingredients of the preparation.
• Its utility is limited when used in heavily exudating wounds or wounds covered with thick eschar.

4.4 Special warnings and precautions for use

• Discontinue Meganano gel usage if signs of sensitivity appear
• Meganano gel should be removed and the wound should be thoroughly cleaned prior to hyperbaric oxygenation or any other therapy where the presence of metals is contraindicated.
• Meganano gel is for external use only and it should not be surgically implanted

4.5 Drugs interactions

As silver may inactivate enzymatic debriding agents, their concomitant use may be inappropriate.

4.6 Use in special populations

Pregnancy and lactation

There are no adequate and well controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. This drug should be used during pregnancy only if clearly justified. Caution should be exercised when used in nursing mothers. It is not known whether silver nano particles are excreted in human milk.

Children

Safety and effectiveness in pediatric patients have not been established.

4.7 Effects on ability to drive and use machines

Meganano gel have no influence on the ability to drive and use machines.

4.8 Undesirable effects

Meganano gel local applications are tolerated very well with some infrequently occurring side effects. These effects include skin necrosis, erythema multiforme, burning sensation, rashes, and interstitial nephritis.

Excessive use of silver preparations leads to an accumulation of silver in the human body. Silver-based products are contraindicated for people who are allergic to silver. The chronic use of silver products can result in an accumulation of silver particles in the hair, skin, kidneys, liver, heart and muscles due to high methionine- containing proteins, such as keratin, myosin, tropomyosin, troponin, and key dipeptide glutathione.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

Website: https://www.zuventus.co.in/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Overdose is unlikely. If necessary, remove the medication by washing with warm water. If accidental ingestion occurs, an appropriate method of gastric emptying may be used if considered appropriate.

Mechanism of Action

Silver as nanoparticles in Meganano gel has a powerful & broad spectrum antimicrobial action owing to its ability to disrupt the bacterial cell wall & inhibition of bacterial cell respiration. It also prevents the bacterial cell multiplication by attacking the bacterial DNA. Silver as nanoparticles in Meganano gel exhibits good anti-inflammatory properties as indicated by inhibition of matrix metalloproteinases 2 and 9.

Meganano gel is a hydrophilic gel which retains skin moisture and thereby promotes healing. It has better rheological properties, spreadability and ease of application. It allows the vital gaseous exchange across its surface but does not allow entry of microbes in the wound, thus forming an antiseptic barrier.

Antimicrobial Spectrum

Silver nanoparticles in Meganano gel have a broad spectrum antimicrobial activity against bacteria, yeast and molds. Silver is highly effective against all the pathogens that may colonize the wound, most importantly:

Staphylococcus aureus (including methicillin resistant Staphylococcus aureus [MRSA]), Beta-hemolytic Streptococcus and other streptococcal spp., Proteus, E. coli, Klebsiella, Enterococci (including Vancomycin Resistant Enterococci [VRE]), Pseudomonas, Acinetobacter etc.

6.1 Animal Toxicology or Pharmacology

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development

Meganano gel is a clear, transparent gel with silver as nanoparticles synthesized by a proprietary biostabilization process, indicated for burn and wound care. Silver as nanoparticles is a broad spectrum antimicrobial without any reported resistance. It exhibits effective antibacterial and antifungal activity at 30 fold less silver concentration. It triggers cellular antioxidant system and prevents oxidative damage. When the interaction of silver nanoparticles with commonly used antibiotics was investigated, the observed effects were synergistic for Ceftazidime, additive for Streptomycin, Kanamycin, Ampiclox, Polymixin B and antagonistic for Chloramphenicol.

Sufficient data have been obtained to demonstrate that silver will inhibit bacteria that are resistant to other antimicrobial agents.

Silver nanoparticles in Meganano gel induce apoptosis which could favour scarless wound healing. Acute dermal toxicity studies on silver nanoparticles showed complete safety for topical application. Being a transparent gel it allows direct monitoring of the wound. It is least toxic to the tissues, non-irritating and non-staining.

Above mentioned properties make Meganano gel a safer and better alternative to conventional antimicrobial agents in the form of a topical antimicrobial formulation.

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on pack

8.3 Packaging information

• A tube of 15 gm
• A tube of 50 gm.
• A container of 200 gm

8.4 Storage and handing instructions

Store in a cool, dry & dark place. Do not freeze.

Keep out of reach of children.

Keep tube tightly closed after use.

• Meganano gel is used for the treatment of burns and wound infections.
• Advice patients not to take this medicine, if they are allergic to silver. Signs of an allergic reaction include a rash, or itching
• Advice patients to clean and dry the area before applying Meganano Gel and do not exceed the dose and frequency of application.
• Tell the patients if they get any side effects, talk to the doctor. This includes any possible side effects not listed in this leaflet.
• Advice patients if they have any further questions, ask the doctor or pharmacist.

01-07-2024