Paracetamol GIGAfarm tablets

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

paracetamol

Dostopno od:

Arpimed LLC

Koda artikla:

N02BE01

INN (mednarodno ime):

paracetamol

Odmerek:

500mg

Farmacevtska oblika:

tablets

Enote v paketu:

(200/20x10/) in blister

Tip zastaranja:

OTC

Status dovoljenje:

Registered

Datum dovoljenje:

2019-12-17

Lastnosti izdelka

SUMMARY PRODUCT CHARACTERISTIC (SPC)
PARACETAMOL GIGAfarm 500 MG TABLETS TRADE NAME – PARACETAMOL GIGAfarm 500 mg tablets INTERNATIONAL NON-PROPERTY NAME – PARACETAMOL
COMPOSITION
Each tablet_ _of _PARACETAMOL GIGAfarm 500 mg _contains:
_ACTIVE INGREDIENT: _PARACETAMOL – 500 mg;
_INACTIVE _
_INGREDIENTS:_
microcrystalline
cellulose,
lactose
monohydrate,
maize
starch,
povidone,
magnesium stearate, talc purified.
CHEMICAL NAME AND CAS NUMBER
4´-Hydroxyacetanilide; 103-90-2.
PHARMACOLOGICAL GROUP AND ATC CODE
Analgesic and antipyretic; ATC code - N02BE01.
PHARMACOLOGICAL ACTION
PARACETAMOL has analgesic, antipyretic and weak inflammatory action.
The mechanism of action
is associated with inhibition of prostaglandin synthesis and the
influence on the thermoregulation
center in the hypothalamus.
PHARMACOKINETICS
PARACETAMOL is readily absorbed from the gastrointestinal tract with
peak plasma concentrations
occurring about 10 to 60 minutes after oral doses. PARACETAMOL is
distributed into most body
tissues. It crosses the placenta and is present in breast milk.
Plasma-protein binding is negligible at
usual therapeutic concentrations but increases with increasing
concentrations. The elimination half-life
of PARACETAMOL varies from about 1 to 3 hours.
PARACETAMOL is metabolised predominantly in the liver and excreted in
the urine mainly as the
glucuronide and sulfate conjugates. Less than 5% is excreted as
unchanged PARACETAMOL. A
minor hydroxylated metabolite (_N_-acetyl-_p_-benzoquinoneimine), is
usually produced in very small
amounts by cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in
the liver and kidney. It is
usually detoxified by conjugation with glutathione but may accumulate
following PARACETAMOL
overdosage and cause tissue damage. USES

Pain
syndrome
of
mild
to
moderate
intensity
of
different
genesis
(including
headache,
toothache, neuralgia, myalgia, arthralgia);

Catarrhal fever and infectious and inflammatory diseases; ADMINISTRATION
The usual ADULT AND CHILDREN OVER 12 YEARS SINGLE DOSE