The text starts here.

News Release

FOR IMMEDIATE RELEASE
June 30, 2004

Eisai Launches the First Treatment in Japan for Apnea of Prematurity
Low Concentration Aminophylline, APNISSION (R) Injection 15mg

Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced the July 1st launch of APNISSION (R) Injection 15mg, a low-concentration, intravenous aminophylline solution, for the treatment for apnea of prematurity, following the drug's national health insurance price listing on June 25. APNISSION (R) is the first medicine in Japan to achieve approval for the treatment of apnea of preterm or low birth weight infants (apnea of prematurity).


It is reported that approximately 25% of preterm or low birth weight infants, who tend to be born with underdeveloped respiratory functions, develop apnea of prematurity, which can cause various disorders in the brain and other organs.


Because there has been no drug approved for the treatment of apnea of prematurity in Japan, a need has developed among practitioners for an injectable form of aminophylline or theophylline in a diluted concentration suitable for preterm or low birth weight infants.


Since the launch of Neophylline (aminophylline) in 1950 as a cardiotonic and antiasthmatic agent, Eisai has been committed to meeting medical needs in this area as the supplier of aminophylline and theophylline. Through the launch of APNISSION (R) the Company hopes to contribute to improvement in the treatment of premature patients suffering from apnea.



[The product outline, explanation of terms and a photograph are attached below for reference]



Contacts:

Eisai Co., Ltd.
Corporate Communications Department
03-3817-5120 (Tokyo)



[ Product Outline of APNISSION (R) Injection 15mg ]
Product Name : APNISSION (R) Injection 15mg
Generic Name : Aminophylline
Composition :
APNISSION (R) Injection is a colorless, clear injection fluid in one-point-cut ampules containing the following ingredients :


Content per ampule
(3 mL)
Active ingredientsAminophylline15 mg
Inactive ingredientsEthilenediamine0.66 mg
tonicity agentadequate amount
DescriptionAPNISSION (R) Injection is a colorless, clear solution.
pH8.5 - 9.5
Osmotic pressureabout 1 (ratio relative to isotonic sodium chloride solution)
Note: Aminophylline contains 80% theophylline.
Indications : Primary apnea of preterm or low birth weight infants (Apnea of prematurity)
Dosage and
Administration :
The initial dosage of 4-6 mg/kg (0.8-1.2 mL/kg) and then a maintenance dosage of 2-6 mg/kg (0.4-1.2 mL/kg) daily in two or three divided doses are gradually administered intravenously. The dosage may be adjusted depending on the patient's symptoms and/or blood concentrations.
Price : 175 yen
Packaging : Box of 10 ampules
Production Approval Date : February 27, 2004
Japan National Health Insurance Listing Date : June 25, 2004
Launch Date : July 1, 2004
Manufacturer and Distributor : Eisai Co., Ltd.

[ Product photograph ]

APNISSION(R) Injection 15mg

[ Explanation of Terms ]

1. Apnea

1) The absence of breathing lasting for over twenty seconds.

2) The absence of breathing lasting for less than twenty seconds accompanied by bradycardia (less than 100 beats per minute) and/or cyanosis.

2. Preterm infant

An infant of 22 to 37 weeks gestation.
(An extremely premature infant is of 22 to 28 weeks gestation.)

3. Low birth weight infant

An infant with a birth weight of less than 2,500g.
(A very low birth weight infant has a birth weight of less than 1,500g; an extremely low birth weight has a birth weight of less than 1,000g.)