Mannitol 20%

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

MANNITOL

Sẵn có từ:

DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece

Mã ATC:

B05BC01

INN (Tên quốc tế):

MANNITOL 200 mg/l

Dạng dược phẩm:

SOLUTION FOR INFUSION

Thành phần:

MANNITOL 200 mg/l

Loại thuốc theo toa:

POM

Khu trị liệu:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Tình trạng ủy quyền:

Withdrawn

Ngày ủy quyền:

2007-10-25

Tờ rơi thông tin

MANNITOL 20% 
SOLUTION FOR INFUSION 

COMPOSITION: Active ingredient: Mannitol 

  Excipient: Water for injections 
PHARMACOTECHNICAL FORM: Solution for infusion 
CONTENT IN ACTIVE INGREDIENT: 100ml of the solution contain 20g
of Mannitol. 
PACKAGING:  The product is packed in polyethylene
bottles of 250, 500 and 
1000ml. 
PHARMACOTHERAPEUTIC CATEGORY: Antiedemic 
MARKETING AUTHORIZATION HOLDER – MANUFACTURER:  
DEMO SA, 21
st
 km National Road Athens - Lamia, 145 68 Kryoneri, Athens, 
Greece, Tel. [phone], Fax: [phone] 
GENERAL INFORMATION: Mannitol 20% solution for
infusion is sterile and 
pyrogen free. It belongs to the therapeutic category of diuretics
and 
diagnostic agents for determination
of renal function, acting through osmotic 
diuresis.  
INDICATIONS: Osmotic acting diuretic, rapidly excreted by the
kidneys, 
dragging along water and sodium. Main indications include
cerebral 
oedema, pharmaceutical poisoning, and severe renal failure
(prevention and 
evaluation of oliguria). It is also indicated for intraocular
pressure reduction 
before iridectomy or another required surgery for glaucoma.  
CONTRAINDICATIONS: Heart failure, non
reversible anuria, dehydration, 
intracranial hemorrhage, pulmonary oedema.  
SPECIAL PRECAUTIONS AND WARNINGS DURING USAGE: Renal failure, 
pregnancy. Before its administration, a careful
evaluation of the condition of 
the cardiovascular system and continuous monitoring of diuresis and
serum 
electrolyte balance is required. It should not be
re-administered to patients 
that remained unuric after a test administration.
Extravasation should be 
avoided (danger of local necrosis).  
The infusion rate should be checked (slow and constant).  
The product is sterile and pyrogen free and is indicated for one
use only. 
Before use, the solution is heated in a water-bath at 37
°C. The clarity a

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS 
MANNITOL 20% 
SOLUTION FOR INFUSION 
1.  NAME OF THE MEDICINAL PRODUCT 
MANNITOL 20% / DEMO Solution for infusion 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 1000 ml of the solution contains 200.0mg of Mannitol. 
For excipients, see § 6.1 
3.  PHARMACEUTICAL FORM 
Solution for IV Infusion 
4.  CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Osmotic acting diuretic, rapidly excreted by the kidneys,
dragging along water and sodium. Main 
indications include cerebral oedema, pharmaceutical poisoning, severe
renal failure (prevention and 
evaluation of oliguria). It is also indicated for intraocular
pressure reduction before iridectomy or 
another required surgery for glaucoma.  
4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
A slow infusion rate should be used.  
As diuretic: 50-200 g of Mannitol every 24 hours in a 20% solution.

Test dose by fast infusion: 20 mg of Mannitol (100 ml solution).  
In ophthalmology: Adults and children 0.5–2 g/kg of body weight of
Mannitol in 20% solution. It is 
administered by drip intravenous infusion over a period of 30-60
minutes. The usual effective dose is 
1g/kg of body weight.  
4.3 CONTRAINDICATIONS 
-  Heart failure  
-  Non reversible anuria 
-  Dehydration 
-  Intracranial hemorrhage 
-  Pulmonary oedema.  
Page 2 of 4 

4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
Renal failure, pregnancy. Before its administration, a careful
evaluation of the condition of the 
cardiovascular system and continuous monitoring of diuresis and
serum electrolyte balance is 
required. It should not be re-administered to patients that remained
unuric after a test administration. 
Extravasation should be avoided (danger of local necrosis).  
There is no specific regimen for children younger than 12 years.
The infusion rate should be checked 
(slow and constant). 
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 
The pH (