Active ingredients: Permethrin
NIX® "1% skin emulsion" bottle 59 ml
Indications Why is Nix used? What is it for?
WHAT IS IT"
Nix contains permethrin, an anti-parasitic substance.
WHY "IT IS USEDTreatment of head lice infestations (Pediculus humanus variety capitis)
Contraindications When Nix should not be used
Known hypersensitivity to NIX®, its components or other pyrethroids or pyrethrins.
Precautions for use What you need to know before taking Nix
Pregnancy and breastfeeding: The use of NIX® should be avoided during pregnancy and breastfeeding.
Children: For children over 6 months of age see "HOW TO USE THIS MEDICINAL PRODUCT". In children under 2 years of age, NIX® should be applied after consulting your doctor.
Senior citizens: No specific data are available regarding the use of NIX® in the elderly, however it is believed that NIX® is indicated for use in the elderly.
Interactions Which drugs or foods can modify the effect of Nix
If you are using other medicines ask your doctor or pharmacist for advice.
There are no known interactions with the NIX®.
Warnings It is important to know that:
NIX® is for external use only.
There are no known negative effects of NIX® on the ability to drive and use machines. In case of concomitant skin conditions, consult your doctor. The NIX® has no irritating power to the eyes. However, one should try to avoid direct contact with the latter during the application. In case this happens accidentally, the eyes should be rinsed immediately with plenty of water.
It is good for nurses involved in multiple applications of NIX® to wear protective gloves.
Although Permethrin is heat stable and NIX® has a low flammability potential, it is not known whether the use of a hair dryer will negatively affect the effectiveness of NIX® in treating head lice infestations.
During the clinical studies, demonstrating the efficacy of NIX®, normal hair washes were used which, therefore, are not believed to significantly affect the efficacy of the drug in the therapy of the aforementioned infestations.
Dose, Method and Time of Administration How to use Nix: Posology
Like
Adults and children over 6 months of age: wash hair with a suitable shampoo, according to the instructions. After the final rinse, dry them so they stay moist. Shake the bottle of NIX® well before use.
How many
Apply NIX® to the skin and hair in sufficient quantity to ensure that both are well covered. Pay particular attention to the area behind the ears and the nape of the neck.
The amount of skin emulsion necessary for the treatment obviously varies in relation to the thickness and length of the hair. Generally, in subjects with normal hair, one bottle of NIX® is sufficient for individual treatment in most subjects.
It is advisable to carry out an accurate control also to the rest of the family members and to those who have been in close contact with the affected patient and possibly extend the treatment to these as well.
Let the NIX® act on the hair for 10 minutes, then rinse it well and dry it.
How long
In most cases, a single application is usually sufficient to eliminate head lice.
The parasite eggs remain adherent to the hair even after being destroyed and this, therefore, is not a sign of ineffectiveness of the treatment.
Combing the hair in order to remove dead eggs and parasites is not necessary for therapeutic efficacy but can be done for aesthetic reasons.
Do not exceed the recommended doses and times.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Overdose What to do if you have taken too much Nix
There are no reports of NIX® overdose. Based on studies conducted on animals and humans, it is extremely unlikely, even after incorrect use and excessive applications, that the quantity of Permethrin necessary to produce clinically relevant toxic effects can be reached.
The most probable symptoms and signs, following repeated and excessive applications, would be those similar to hypersensitivity.
There are no reports of accidental ingestion of NIX®. If this happens it is advisable to consult your doctor.
It is possible that, in the case of accidental ingestion by young children, an alcoholic intoxication may occur due to the presence, in the NIX®, of isopropyl alcohol. In such cases it may be necessary to go to the emergency room for the execution of a gastric lavage within 2 hours of ingestion and the adoption of a therapy indicated for alcoholic poisoning.
Side Effects What are the side effects of Nix
They are more commonly made up of itching, which is present in most cases even before treatment, and more rarely of redness, swelling or moderate piercing-like sensations in the scalp.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform the doctor or pharmacist of the appearance of undesirable effects not described in the package leaflet.
Expiry and Retention
Store away from light at a temperature not exceeding 25 ° C.
Warning: do not use the medicine after the expiry date indicated on the package. This date refers to the product in intact and correctly stored packaging.
Keep this medicine out of the reach of children.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
COMPOSITION
100 g of NIX® "1% skin emulsion" contain
Active ingredient: Permethrin 1g
Excipients: Isopropyl alcohol; Base cream.
HOW IT LOOKS
Skin emulsion, 59 ml bottle.
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
NIX®
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of Nix "1% skin emulsion" contain:
Permethrin 1 g
03.0 PHARMACEUTICAL FORM
Skin emulsion.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of head infestations caused by Pediculus humanus variety capitis.
04.2 Posology and method of administration
Adults and children over 6 months of age:
Wash your hair with a suitable shampoo following the instructions.
After the final rinse, dry them so they stay moist.
Shake the bottle of Nix well before use.
Apply Nix to the scalp and hair in sufficient quantity to ensure that both are well covered. Pay particular attention to the area behind the ears and the nape of the neck.
The amount of cream needed for the treatment obviously varies in relation to the thickness and length of the hair. Generally, in subjects with normal hair, one bottle of Nix is sufficient for individual treatment in most subjects.
It is advisable to carry out an accurate control also to the rest of the family members and to those who have been in close contact with the affected patient and possibly extend the treatment to these as well.
Leave the Nix on the hair for 10 minutes, then rinse it well and dry it. In most cases, a single application is usually sufficient to eliminate head lice.
The parasite eggs remain adherent to the hair even after being destroyed and this, therefore, is not a sign of ineffectiveness of the treatment.
Combing the hair in order to remove dead eggs and parasites is not necessary for therapeutic efficacy but can be done for aesthetic reasons.
Do not exceed the recommended doses and times.
In children under 2 years of age, Nix should be applied after consulting your doctor.
Senior citizens:
No specific data are available on the use of Nix in the elderly, however it is believed that the statements about the latter are applicable to this category of patients and therefore Nix is indicated for use in the elderly.
04.3 Contraindications
Known hypersensitivity to Nix, its components or other pyrethroids or pyrethrins.
04.4 Special warnings and appropriate precautions for use
Keep out of reach of children.
For external use only.
It is good for nurses involved in multiple applications of Nix to wear protective gloves.
In case of concomitant skin diseases, contact your doctor.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions with the Nix.
04.6 Pregnancy and lactation
The use of Nix should be avoided during pregnancy and breastfeeding.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
They are more commonly made up of itching, which is also present in the majority of cases even before treatment, and more rarely of moderate redness, swelling or stabbing sensations on the scalp.
04.9 Overdose
There are no reports of Nix overdose. Based on studies conducted on animals and humans, it is extremely unlikely, even after incorrect use and excessive applications, that the quantity of Permethrin necessary to produce clinically relevant toxic effects can be reached.
The most probable symptoms and signs, following repeated and excessive applications, would be those as a kind of hypersensitivity reaction.
There are no reports of accidental ingestion of Nix. If this happens it is advisable to consult your doctor immediately.
It is possible that, in the case of accidental ingestion by young children, an alcoholic intoxication occurs due to the presence of isopropyl alcohol in the Nix. In such cases it may be necessary to perform a gastric lavage within 2 hours of ingestion and to adopt the therapy indicated for alcoholic intoxications.
Nix is devoid of eye irritating power. However, direct contact with the latter should be avoided during application. If this occurs accidentally, the eyes should be rinsed immediately with plenty of water.
Although Permethrin is heat stable and Nix has a low flammability potential, it is not known whether the use of a hair dryer will negatively affect the effectiveness of Nix in treating head lice infestations.
During the clinical studies, demonstrating the effectiveness of Nix, normal hair washes were used which, therefore, are not believed to significantly affect the efficacy of the drug in the therapy of the aforementioned infestations.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Specialty containing Permethrin, a synthetic pyrethroid with high antiparasitic activity against head lice (Pediculus humanus capitis) and related eggs. This parasite is able to infest the scalp by anchoring itself to the base of the hair where it can remain indefinitely feeding on the host's blood and reproducing rapidly through the deposition of eggs and the subsequent birth of nymphs. This infestation is highly transferable from a individual to the other through direct contact with the boss. Nix, due to its particular properties, is rapidly absorbed through the external coating of insects, causing their death in a short time. Its destructive activity against parasite eggs is increased by the simultaneous presence, in its formulation, of isopropanol.
05.2 "Pharmacokinetic properties
Permethrin is rapidly hydrolyzed to its inactive metabolites, which are mainly excreted in the urine. Application of the fluid cream to the hair of volunteers, for the recommended application time, was accompanied by extremely low or undetectable levels of permethrin metabolites in plasma and urine.
In vitro studies have shown that Permethrin levels in hair are not affected by chlorine at concentrations used in swimming pool water.
05.3 Preclinical safety data
Carcinogenesis and mutagenesis
In repeated long-term studies for carcinogenic potential in rats, no oncogenic effects were shown. Similar studies in mice have shown species-specific increases in the appearance of lung adenomas (benign neoplasms common in mice and associated with a "high spontaneous incidence). In one of these studies, an increase in the incidence of benign hepatic adenomas was observed. and alveolar lung carcinomas limited to female mice and when Permethrin was administered with food at a rate of approximately 750 mg / kg bw / day for 2 years. These data are not believed to indicate significant oncogenic potential. of Permethrin in the human species.
Permethrin mutagenicity tests were negative, as were in vivo and in vitro genetic toxicity studies.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Isopropyl alcohol; Base cream.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store away from light and at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
59ml plastic bottle: Price L.
06.6 Instructions for use and handling
See paragraph 4.2.
07.0 MARKETING AUTHORIZATION HOLDER
Chefaro Pharma Italia S.r.l. - Via del Mare, 36 - 00040 Pomezia - Rome - Italy
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 028017022
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 20.05.1991
10.0 DATE OF REVISION OF THE TEXT
01/05/2005
