SNS-ASA EC TABLET (DELAYED-RELEASE)

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ACETYLSALICYLIC ACID

Fáanlegur frá:

SANIS HEALTH INC

ATC númer:

N02BA01

INN (Alþjóðlegt nafn):

ACETYLSALICYLIC ACID

Skammtar:

80MG

Lyfjaform:

TABLET (DELAYED-RELEASE)

Samsetning:

ACETYLSALICYLIC ACID 80MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

OTC

Lækningarsvæði:

SALICYLATES

Vörulýsing:

Active ingredient group (AIG) number: 0101169013; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-12-09

Vara einkenni

PRESCRIBING INFORMATION
SNS-ASA EC
80mg Tablets
(Acetylsalicylic acid delayed-release tablets, USP)
ANALGESIC, ANTI-INFLAMMATORY, AND ANTIPYRETIC
SANIS HEALTH INC.
Date of Revision:
1 President’s Choice Circle
November 29, 2019
Brampton, Ontario
L6Y 5S5
www.sanis.com
Submission Control N
o
: 227459
_SNS-ASA EC Prescribing Information Page 2 of 10_
PRESCRIBING INFORMATION
SNS-ASA EC
80mg Tablets
(Acetylsalicylic acid delayed-release tablets, USP)
THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION
ANALGESIC, ANTI-INFLAMMATORY, AND ANTI-PYRETIC
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM / STRENGTH
CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS
Oral
Delayed-Release tablets/
E.C. 80 mg
Colloidal Silicon Dioxide, Glyceryl Stearate, Lactose Anhydrous,
Methacrylic Acid Copolymer, Methylated Silica, Methylcellulose,
Polydimethylsiloxane, Polysorbate, Pregelatinized Starch, Sodium
Lauryl Sulfate, Sodium Bicarbonate, Stearic Acid, Sorbic acid,
Sulfuric Acid, Talc, Titanium Dioxide, Triethyl Citrate.
ACTION AND CLINICAL PHARMACOLOGY
ASA interferes with the production of prostaglandins in various organs
and tissues through
acetylation of the enzyme cyclo-oxygenase. Prostaglandins are
themselves powerful irritants and
produce headaches and pain on injection in man. Prostaglandins also
appear to sensitize pain
receptors to other noxious substances such as histamine and
bradykinin. By preventing the synthesis
and release of prostaglandins in inflammation, ASA may avert the
sensitization of pain receptors.
The antipyretic activity of ASA is due to its ability to interfere
with the production of
prostaglandin E
1
in the brain. Prostaglandin E
1
is one of the most powerful pyretic agents known.
INDICATIONS AND CLINICAL USE
Acetylsalicylic acid (ASA) is indicated for fever and the relief of
mild to moderate pain of a variety
of conditions such as, ache and pains, cold and flu, headache,
arthritis or rheumatism, migraine,
menstrual cramps, following dental work or intervention, toothache,
muscle sprains and strains.
S