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 详细处方信息以本药内容附件PDF文件（200992220315711.pdf）的“原文Priscribing Information”为准
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Sciele公司近日表示5%的苯甲醇洗液（benzyl alcohol lotion）已正式在美国上市用于治疗头虱病，商品名为Ulesfia，Ulesfia是首个通过使头虱窒息而杀死头虱的处方药物，没有潜在的神经毒性方面的副作用。Ulesfia可用于6个月在以上人群。

    每天全球有600-1200万3-12岁的儿童感染头虱，通过堵塞头虱的呼吸孔而头虱窒息而亡。使公司表示很高兴能在头虱高发期在美国上市该药。试验表明使用5%的苯甲醇洗液每周两次，每次10分钟可使75%的患者免除头虱。
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FDA Approves Ulesfia
The U.S. Food & Drug Administration (FDA) has approved Ulesfia, the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects.

Each year, approximately 6 to 12 million children between the ages of 3 and 12 years are infested with head lice. To survive, lice breathe through sophisticated spiracles that close upon contact with most liquids, allowing the lice to go into suspended animation and survive for hours without respiration. Benzyl alcohol prevents lice from closing their spiracles, thereby asphyxiating them within ten minutes and causing death.

Ulesfia Patient Information
Read the Patient Information that comes with Ulesfia before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Note: For use on scalp hair and scalp only

What is Ulesfia?
Ulesfia is a prescription medicine used to get rid of lice in scalp hair of children and adults. It is not known if Ulesfia is safe for children under 6 months of age or in people over age 60.

Once Ulesfia is washed off, a fine-tooth comb may be used to remove treated lice and nits from the hair and scalp. All personal items exposed to the hair or lice should be washed in hot water or dry-cleaned. See "How do I stop the spread of lice?" at the end of this leaflet.

What should I tell my healthcare provider before I use Ulesfia?
Tell your healthcare provider if your baby was born early so your healthcare provider can decide if your infant is old enough for Ulesfia.

Tell your healthcare provider about all of your medical conditions, including if you:

have any skin conditions or sensitivities,
are pregnant or planning to become pregnant. It is not known if Ulesfia can harm your unborn baby,
are breastfeeding. It is not known if Ulesfia passes into your breast milk or if it can harm your baby. You should choose to breastfeed or use Ulesfia, but not both. Talk to your healthcare provider about other ways to feed your baby while using Ulesfia.
How should I use Ulesfia?
Use Ulesfia exactly as prescribed. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
Use Ulesfia in two treatments that are one week apart. Ulesfia gets rid of lice but does not get rid of lice eggs so a second treatment is needed one week (7 days) after the first treatment.
Ulesfia coats the lice on your scalp and scalp hair. It is important to use enough Ulesfia to coat completely every single louse and to leave it on your scalp for the full 10 minutes. See the detailed Patient Instructions for Use at the end of this leaflet.
Because you need to completely cover all of the lice with Ulesfia, you may need help in applying Ulesfia to your scalp and hair. Make sure that you and anyone who helps you apply Ulesfia reads and understands this leaflet and the Patient Instructions for Use.
Children need adult help in applying Ulesfia.
Do not get into eyes. If Ulesfia gets in the eye, flush with water right away.
Do not swallow Ulesfia. If swallowed, call your healthcare provider right away.
Wash your hands after you apply Ulesfia.
What are the possible side effects of Ulesfia?
People using Ulesfia may have skin or eye:

itching,
redness,
irritation. If skin or eye irritation happens, rinse with water right away, then call your healthcare provider or go to the emergency department.
These are not all the side effects of Ulesfia. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store Ulesfia?
Store Ulesfia in a dry place at room temperature, (59 °to 86° F or 15°to 30° C).
Do not freeze Ulesfia.
Keep Ulesfia and all medicines out of the reach of children.

What are the ingredients in Ulesfia?
Active ingredient: benzyl alcohol, 5%
Inactive ingredients: purified water, mineral oil, sorbitan monooleate, polysorbate 80, carbomer 934P and trolamine

General Information about Ulesfia
Medicines are sometimes prescribed for conditions other than those described in the patient information leaflets. Do not use Ulesfia for any condition for which it was not prescribed by your healthcare provider. Do not give Ulesfia to other people, even if they have the same symptoms as you. It may harm them.

This leaflet summarizes the most important information about Ulesfia. If you would like more information, talk to your healthcare provider. You can also ask your healthcare provider for information about Ulesfia that is written for healthcare professionals.

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Sciele Pharma Announces Availability Of Ulesfia (Benzyl Alcohol Lotion 5%), First Prescription Non-Neurotoxic Head Lice Treatment

Sciele Pharma, Inc., a Shionogi Company, announced the availability of Ulesfia (Benzyl Alcohol Lotion 5%), the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects. Approved by the U.S. Food & Drug Administration (FDA), Ulesfia is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia is available now by prescription nationwide in time for peak head lice season.

"We are pleased to introduce Ulesfia during the summer camp months and ahead of the back-to-school period, two settings and seasons when head lice infestations are prevalent and cause anxiety for parents and children," said Ed Schutter, President and Chief Operating Officer of Sciele Pharma. "This novel product delivers on our goal to provide an effective FDA approved head lice treatment that does not contain a neurotoxic chemical and addresses possible resistance issues."

Each year, approximately 6 to 12 million children between the ages of 3 and 12 years are infested with head lice, parasites that survive by injecting small amounts of saliva and removing small amounts of blood from the scalp every few hours(1). To survive, lice breathe through sophisticated spiracles that close upon contact with most liquids, allowing the lice to go into suspended animation and survive for hours without respiration. Ulesfia's unique mechanism of action is facilitated through the use of benzyl alcohol which prevents lice from closing their spiracles, thereby asphyxiating them within ten minutes and causing death.

"Outbreaks of head lice are beginning now, when kids are interacting at summer camps, and will peak when they return to school," said Anthony J. Mancini, M.D., FAAP, FAAD, Head, Dermatology, Children's Memorial Hospital and Professor of Pediatrics and Dermatology, Northwestern University's Feinberg School of Medicine. "We are excited to have a new treatment option for this challenging medical problem that is effective without using harsh chemicals, and will not encounter the increasing resistance of lice to therapies that contain neurotoxic chemicals."

Sciele is collaborating with the National Association of School Nurses to help educate health professionals and the public about head lice.

Full prescribing information for Ulesfia (Benzyl Alcohol Lotion 5%) is available here (pdf). Sciele acquired from Summers Laboratories the rights to this novel, patented product in the United States.

About Head Lice

Generally found on the scalp, around the ears and at the nape of the neck, the adult louse is about the size of a sesame seed and can be a yellowish-gray or reddish-brown color(2). Eggs, or nits, are smaller and are silver in color(3). The most common symptom of head lice is head scratching caused by sensitivity to the louse's saliva(1), although red bite marks may also be noticed(2). While lice are not considered an infectious disease, transmission from one individual to another can occur during direct contact or through the sharing of personal items such as hats, helmets, brushes or combs(1). Lice are not a sign of poor hygiene, and they do not transmit disease.

About Sciele Pharma, Inc.

Sciele Pharma, Inc., a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs more than 1,000 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork.

On October 9, 2008, Shionogi & Co., Ltd. and Sciele Pharma announced the completion of Shionogi's acquisition of Sciele. Sciele is now an indirect wholly owned subsidiary of Shionogi.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd., headquartered in Osaka, Japan, is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi's Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of people who need them. In addition, Shionogi is engaged in some new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi's primary goal.

About Summers Laboratories, Inc.

Summers Laboratories is a privately-held pharmaceutical company specializing in highly-targeted prescription and non-prescription products for pediatric and adult dermatology. Summers' leading brand is Triple Paste(R) Medicated Ointment for diaper rash. According to IRI data, Triple Paste is one of the fastest growing diaper rash treatments in the U.S. Triple Paste and other Summers Labs products are carried nationwide by the largest drugstore chains: Target, Wal-Mart and other major retailers. In addition to the lice asphyxiating product recently acquired by Sciele Pharma, Summers Laboratories is working on developing, licensing or acquiring niche prescription and non-prescription dermatological products.

于2011-03-17更新