SEREVENT DISKHALER 50MCG

Active substance: SALMETEROL XINAFOATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Application for Marketing Authorization
for Medicinal Products for Human Use
In the Member States of the European Community
Volume IIA 1993
Product Summary
1.

Trade Name of the Medicinal Product
Serevent Diskhaler

2.

Qualitative and Quantitative Composition
Salmeterol (as xinafoate)
contains lactose

3.

50.0

mcg

Pharmaceutical Form
Inhalational powder.
Packs comprising 7 or 14 disks delivering a mixture of salmeterol and lactose.

Clinical Particulars
4.1.

Therapeutic Indications
As per UK PL NO. 10949/0069

4.2.

Posology and Method of Administration
As per UK PL NO. 10949/0069

4.3.

Contra-indications
As per UK PL NO. 10949/0069

4.4.

Special Warnings and Precautions for Use
As per UK PL NO. 10949/0069

4.5.

Interactions with other Medicaments and other forms of Interaction
As per UK PL NO. 10949/0069

4.6.

Pregnancy and Lactation
As per UK PL NO. 10949/0069

4.7.

Effects on Ability to Drive and Use Machines
As per UK PL NO. 10949/0069

4.8.

Undesirable Effects
As per UK PL NO. 10949/0069

4.9.

Overdose
As per UK PL NO. 10949/0069

Pharmacological Properties
5.1.

Pharmacodynamic Properties
As per UK PL NO. 10949/0069

5.2.

Pharmacokinetic Properties
As per UK PL NO. 10949/0069

5.3.

Preclinical Safety Data
None stated

Pharmaceutical Particulars
6.1.

List of Excipients
As per ECMA No: 027890045
Issued by: Italy

6.2.

Incompatibilities
As per UK PL NO. 10949/0069

6.3.

Shelf Life
N/A The expiry date will not exceed that of the purchased product

6.4.

Special Precautions for Storage

Store below 25°C away from direct heat or sunlight. The foil blisters should only be pierced
immediately prior to use. Failure to observe this instruction will affect the operation of the
Serevent Diskhaler. Contains lactose.
6.5.

Nature and Contents of Container
Regularly spaced double foil blister disks and a diskhaler in a printed carton.

6.6.

Instruction for Use/Handling
None stated

Administrative Data
7.

Marketing Authorisation Holder
Primecrown Ltd.,
27 York Street,
London W1H 4PY.

8.

Marketing Authorization Number
PLPI 10383/0271

9.

Date of First Authorisation/Renewal of Authorisation
None stated

10.

Date of (Partial) Revision of the Text
None stated

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)