ALIMEMAZINE TARTRATE 7.5 MG/5ml Syrup

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

TRIMEPRAZINE (ALIMEMAZINE) TARTRATE

可用日期:

Kinedexe UK Limited

ATC代码:

R06AD01

INN（国际名称）:

TRIMEPRAZINE (ALIMEMAZINE) TARTRATE

剂量:

7.5 MG/5ml

药物剂型:

Syrup

给药途径:

oral use

每包单位数:

100ml

处方类型:

Product subject to prescription which may be renewed (B)

治疗组:

: Phenothiazine derivatives

治疗领域:

Phenothiazine derivatives

疗效迹象:

Alimemazine has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus. Alimemazine tartrate 7.5mg / 5ml syrup should be used for this indication in children. Alimemazine may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years. Alimemazine tartrate 30 mg / 5ml syrup can be used for the specific indication of pre-anaesthesia sedation in children

授权状态:

Authorised

授权日期:

2015-09-18

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alimemazine tartrate 7.5mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml dose contains 1.5mg of alimemazine tartrate.
Also contains
Sucrose
680 mg/ml
Sodium sulphite anhydrous (E221) 1.0 mg/ml
Sodium metabisulphite (E223)
1.0 mg/ml
Ethanol
40.2 mg/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Clear, colourless to pale yellow, syrupy liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alimemazine has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and
pruritus. Alimemazine tartrate 7.5mg / 5ml syrup should be used for this indication in children.
Alimemazine may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years.
Alimemazine tartrate 30 mg / 5ml syrup can be used for the specific indication of pre-anaesthesia sedation in children
(see Section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
Not recommended for infants less than 2 years old.
Do NOT exceed the recommended dose (see also section 4.9).
Children over 2 years of age:
_Urticaria and pruritus_
Aged 2 – 5 years: 2.5mg (1.7ml) three to four times per day
Aged 5 – 12 years: 5mg (3.3ml) three to four times per day
As a sedative before anaesthesia
(Children aged 2-7 years:) the maximum dosage recommended is 2mg (approx. 1.3ml) per kg bodyweight 1-2 hours
before the operation.
For the indication of sedation prior to anaesthesia, which requires a once only, high dose of alimemazine, the higher
strength (30mg/5ml) syrup should be prescribed in order to limit ethanol exposure (see Section 4.4).
HEALTH PRODUCTS REGULATORY AUTHORITY
______________________________________________________________________________________