SEREVENT DISKHALER REFILL

Active substance: SALMETEROL

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Product Summary
1.

Trade Name of the Medicinal Product
Serevent Diskhaler / Salmeterol Diskhaler 50 micrograms/Serevent Diskhaler Refill.

2.

Qualitative and Quantitative Composition
Salmeterol (as xinafoate) 50 mcg
As per ECMA No. 762575 issued by Spain.

3.

Pharmaceutical Form
Packs comprising 14 disks delivering a mixture of salmeterol and lactose.
Inhalation powder.

Clinical Particulars
4.1.

Therapeutic Indications
As per UK PL 10949/0069

4.2.

Posology and Method of Administration
As per UK PL 10949/0069

4.3.

Contra-indications
As per UK PL 10949/0069

4.4.

Special Warnings and Precautions for Use
As per UK PL 10949/0069

4.5.

Interactions with other Medicaments and other forms of Interaction
As per UK PL 10949/0069

4.6.

Pregnancy and Lactation

As per UK PL 10949/0069

4.7.

Effects on Ability to Drive and Use Machines
As per UK PL 10949/0069

4.8.

Undesirable Effects
As per UK PL 10949/0069

4.9.

Overdose
As per UK PL 10949/0069

Pharmacological Properties
5.1.

Pharmacodynamic Properties
As per UK PL 10949/0069

5.2.

Pharmacokinetic Properties
As per UK PL 10949/0069

5.3.

Preclinical Safety Data
None stated

Pharmaceutical Particulars
6.1.

List of Excipients
As per ECMA No. 762575
Issued by Spain.

6.2.

Incompatibilities
As per UK PL 10949/0069

6.3.

Shelf Life
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 and sunlight. The foil blisters should only be
pierced immediately prior to use. Failure to observe this instruction will affect the operation
of the Severent diskhaler. Contains lactose.

6.5.

Nature and Contents of Container
Regularly spaced double-foil blister disks and a diskhaler in a printed carton.
Pack size: 14, disks of 4 powder filled blisters.

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 10383/0375

9.

Date of First Authorisation/Renewal of Authorisation
None stated

10.

Date of (Partial) Revision of the Text
None stated

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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.

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