Meganano Gel 200gm
Therapy Area
Anti Infective
1.0 Generic name
Nanocrystalline Silver Gel
2.0 Qualitative and quantitative composition
Each gram of gel contains:
Silver as Nano particles 0.02 mg
Perfumed gel base q.s.
Colour: Carmoisine
3.0 Dosage form and strength
0.02mg per g
Gel for external application
4.0 Clinical particulars
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.
5.0 Pharmacological properties
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.
6.0 Non-clinical properties
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
7.0 Description
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.
8.0 Pharmaceutical particulars
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.
9.0 Patient Counselling Information
- 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.
12.0 Date of revision of text
01-07-2024
About Leaflet
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
- If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet?
- What Meganano® is and what it is used for?
- What you need to know before you take Meganano®?
- How to take Meganano®?
- Possible side effects
- How to store Meganano®?
- Contents of the pack and other information
1. What Meganano gel is and what it is used for?
Meganano gel is a medicated gel containing nanocrystalline silver.
Meganano gel utilizes silver nanoparticles to destroy bacterial cell walls, inhibit their growth, and kill them by releasing silver ions making it highly effective against a variety of bacteria. Additionally, it reduces inflammation in wounds, promoting faster healing, making it valuable in medicine and industry for combating infections.
It is used for the treatment of burns and wound infections.
2. What you need to know before you take Meganano Tablet?
Do not use Meganano Gel if you:
- Are allergic to silver or any other ingredients in the gel.
- Have heavily exudating wounds or wounds with thick eschar/dry scab.
Warnings and Precautions:
- Discontinue use if signs of sensitivity or allergic reactions occur.
- Remove the gel and clean the wound thoroughly before any other treatment where the presence of metals is contraindicated.
- Meganano Gel is for external use only and should not be surgically implanted.
Pregnancy and Breastfeeding
- There are no adequate studies on the use of this gel in pregnant women.
- Use only if clearly needed and justified.
- Caution is advised for nursing mothers as it is unknown if silver nanoparticles are excreted in breast milk.
Children
Safety and effectiveness in pediatric patients have not been established.
Other medicines and Meganano Gel:
No known drug interaction has been reported yet.
Driving and using machines
Meganano Gel does not affect your ability to drive or use machines.
3. How to use Meganano Gel?
- For external use only.
- Clean the wound thoroughly.
- Apply a layer of Meganano Gel to shallow wounds or fill deep wounds completely.
- Cover with an appropriate dressing (gauze, hydrocolloid, foam, or film).
- Change the dressing daily or as directed by your doctor.
If you use more Meganano than you should or accidentally swallow the gel
- If you should accidentally use too much gel, you may find that your skin becomes irritated. Wash off as much as you can, and when the irritation has gone down, start using it again as directed.
- In the rare event that you accidentally swallow any of this product, seek medical advice
If you forget to use Meganano gel
- Don't worry if you forget to use your gel at the right time. When you remember, start using the product again, in the same way as before.
- If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side-effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Meganano Gel is generally well-tolerated, but some people may experience:
- Skin necrosis
- Erythema multiforme
- Burning sensation
- Rashes
- Interstitial nephritis
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top end of the home page.
Website link: https://www.zuventus.co.in/drug-safety-reporting
By reporting side effects, you can help provide more information on the safety of this medicine.
You can also report the side effect with the help of your treating physician.
5. How to store Meganano gel?
- Store in a cool, dry, and dark place.
- Do not freeze.
- Keep out of reach of children.
- Keep the tube tightly closed after use.
6. Contents of the pack and other information
Pack size: Meganano Gel is available in different sizes:
- A tube of 15 grams
- A tube of 50 grams
- A container of 200 grams
Each gram of gel contains:
Silver as Nano particles 0.02 mg
Perfumed gel base q.s.
Colour: Carmoisine
Marketing Authorisation Holder
Zuventus Heathcare Ltd.
Zuventus House, Plot Y2,
CTS No: 358/A2, Near
Nahur Railway Station,
Nahur (West),
Mumbai 400 078.
This leaflet was last revised in July 2024.