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What is the most important information I should know about Hansamed Spray?
Hansamed Spray oral rinse should not be used by persons who are known to be hypersensitive to Hansamed Spray or other formula ingredients.
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What are the possible side effects of Hansamed Spray?
The most common side effects associated with Hansamed Spray oral rinses are (1) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation; and (3) an alteration in taste perception; see WARNINGS and PRECAUTIONS.
Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of Hansamed Spray rinse.
The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%.
Among post marketing reports, the most frequently reported oral mucosal symptoms associated with Hansamed Spray oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.
Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using Hansamed Spray oral rinse.
There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Hansamed Spray oral rinse.
For local use of Hansamed Spray ICPA Health Products: trichomonas coleitis, cervical erosion, itching of the vulva, prevention of sexually transmitted diseases (including gonorrhea, syphilis, trichomoniasis, chlamydia, ureaplasmosis); gingivitis, stomatitis, aphthae, paradont, alveolitis, disinfection of removable dentures, sore throat; postoperative care for patients in ENT and dentistry.
Treatment of wounds, burn wounds and surfaces, disinfection of the patient's skin.
Treatment of surgeons', nurses' hands and operating field before diagnostic manipulation operation.
Disinfection of work surfaces of devices (including thermometers) and equipment which heat treatment is not desirable.
Hansamed Spray is used to help treat periodontal disease (a disease of your gums), which is caused by bacteria growing beneath the gum line. Hansamed Spray works by killing the bacteria. Up to eight Hansamed Spray implants are placed between your teeth and gums in places where the gum has a deep pocket. Your dentist will place the Hansamed Spray implants after your teeth have been thoroughly cleaned.
Hansamed Spray is available only with your dentist's prescription.
Hansamed Spray mouthwash contains Chlorhexidine digluconate 1% v/v, equivalent to Hansamed Spray solution 0.2% w/v. It also contains ethanol, macrogolglycerol hydroxystearate, sorbitol, flavour and water.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Do not take by mouth. Hansamed Spray topical is for use only on the skin.
Rinse the skin before applying Hansamed Spray topical. Apply only enough medicine to cover the area you are treating. Do not apply this medicine to deep cuts, scrapes, or open skin wounds.
To use Hansamed Spray topical soap, apply only enough to cover the area you are treating. Wash the area gently, then rinse thoroughly with plain water. Avoid using over large areas of skin.
This medicine is made under sterile conditions, but its contents are not sterilized. It is possible for bacteria to get inside the product and contaminate it, which could spread infection. To avoid contaminating your medicine with bacteria:
Use only the swab, pad, or applicator provided with your medicine.
If no applicator is provided, use only a clean cotton ball or cotton swab to apply this medicine.
Do not touch the tip of the medicine bottle with your fingers or touch it to your skin.
Do not dilute the medicine with water or other liquid.
Use the applicator (pad, swab, or other dressing) only once. Throw away after one use.
Call your doctor if your symptoms do not improve, or if they get worse while using Hansamed Spray topical.
Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.
If this medicine is packaged in a single-use foil wrapper or other container, use it only once. Throw away after one use, even if there is still medicine left in it. Do not save for later use.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Garlic has been used for hardening of the arteries (atherosclerosis) and high blood pressure (hypertension). Consult your doctor for more information if you have heart disease or high blood pressure. Garlic has also been used to prevent tick bites.
Some herbal/dietary supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.
The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
How to use Hansamed SprayTake this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.
If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.
15 mL twice daily after brushing.
Oral rinse should be retained for 30 seconds then expectorated after rinsing.
Usual Adult Dose for Mucositis
15 mL twice daily after brushing.
Oral rinse should be retained for 30 seconds then expectorated after rinsing.
Usual Adult Dose for Periodontitis
Initial: One 2.5 mg chip inserted into a periodontal pocket with probing pocket depth greater than or equal to 5 mm, up to 8 chips in one visit.
Maintenance: Administration is recommended once every 3 months in pockets with remaining probing depth greater than or equal to 5 mm.
Usual Adult Dose for Skin Disinfection, Preoperative
Hansamed Spray 2% cloth:
Patient preoperative skin preparation:
Hold package in one hand and lift flap on backside of package with the other hand. Grasp flap at top and pull down to tear flap away and expose foam. Alternatively, using sterile scissors, cut off end seal of package. Transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination. Use the first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use the second cloth to prepare larger areas.
DRY SURGICAL SITES: (such as the abdomen or arm): Use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one minute. Do not rinse.
MOIST SURGICAL SITES: (such as the inguinal fold): Use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Do not rinse.
Hansamed Spray 4% solution:
SURGICAL HAND SCRUB: Do not dilute. Wet hands and forearms with water and scrub for 3 minutes with about 5 ml and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces. Wash for an additional 3 minutes with 5 ml and rinse under running water. Dry thoroughly.
HEALTHCARE PERSONNEL HANDWASH: Do not dilute. Wet hands with water. Dispense about 5 ml into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
PATIENT PREOPERATIVE SKIN PREPARATION: Do not dilute. Apply liberally to surgical site and swab for at least 2 minutes. Dry with a sterile towel. Repeat procedure for an additional 2 minutes and dry with a sterile towel.
SKIN WOUND AND GENERAL SKIN CLEANSING: Do not dilute. Thoroughly rinse the area to be cleaned with water. Apply a minimum amount necessary to cover the skin or would area and wash gently. Rinse again thoroughly.
Usual Pediatric Dose for Gingivitis
The safety and efficacy of Hansamed Spray has not been established in patients less than 18 years old. However, the use of Hansamed Spray may be appropriate in some situations.
15 mL twice daily after brushing.
Oral rinse should be retained for 30 seconds then expectorated after rinsing.
Usual Pediatric Dose for Mucositis
The safety and efficacy of Hansamed Spray has not been established in patients less than 18 years old. However, the use of Hansamed Spray may be appropriate in some situations.
15 mL twice daily after brushing.
Oral rinse should be retained for 30 seconds then expectorated after rinsing.
Usual Pediatric Dose for Periodontitis
The safety and efficacy of Hansamed Spray has not been established in patients less than 18 years old. However, the use of Hansamed Spray may be appropriate in some situations.
Initial: One 2.5 mg chip inserted into a periodontal pocket with probing pocket depth greater than or equal to 5 mm, up to 8 chips in one visit.
Maintenance: Administration is recommended once every 3 months in pockets with remaining probing depth greater than or equal to 5 mm.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Dialysis
No adjustment recommended
Other Comments
Hansamed Spray topical cloths are not sterile.
Hansamed Spray topical cloths should not be microwaved.
Hansamed Spray solution should be used with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Hansamed Spray topical cloths should not be used in premature or low birthweight infants, infants receiving phototherapy, or infants less than 2 months of age. Hansamed Spray topical cloths and Hansamed Spray 4% solution should not be used for lumbar punctures or in contact with the meninges, or on open wounds or as a general skin cleanser.
Hansamed Spray topical cloths and Hansamed Spray 4% solution should not make contact with the eyes, nose, or mouth. If contact occurs, the affected area should be washed with cold water and a doctor should be contacted.
Hansamed Spray 4% solution should not be diluted.
Repeated general cleansing of large areas of the body with Hansamed Spray 4% topical solution should be avoided except when the underlying condition makes it necessary to reduce the bacterial population of the skin.
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What other drugs will affect Hansamed Spray?
Hansamed Spray is incompatible with the soap, and detergents containing anionic group (saponins, sodium lauryl sulfate, sodium carboxymethyl cellulose).
Hansamed Spray ICPA Health Products is compatible with any medication containing cationic group (cetrimonium bromide, benzalkonium chloride).
