Phenoxymethylpenicillin 250mg/5ml oral solution

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Phenoxymethylpenicillin potassium

Dostupno od:

Crescent Pharma Ltd

ATC koda:

J01CE02

INN (International ime):

Phenoxymethylpenicillin potassium

Doziranje:

50mg/1ml

Farmaceutski oblik:

Oral solution

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 05010101; GTIN: 5017123025990

Status autorizacije:

Marketed

Datum autorizacije:

2009-01-23

Uputa o lijeku

MHRA Approved & Implementation Date : 17.05.2022
MHRA Approved and Implementation date : 17.05.2022
MHRA Approved and Implementation date : 17.05.2022

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Phenoxymethylpenicillin 250mg/5ml Granules for Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Phenoxymethylpenicillin Potassium 277.18mg equivalent to 250mg
phenoxymethylpenicillin per 5ml of reconstituted product.
Excipients: Each 5 ml contains 2.55g of sucrose, 2.4mg of ponceau 4R
(E124)
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Granules for oral solution
Light pink powder with an odour of strawberry
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenoxymethylpenicillin and potassium phenoxymethylpenicillin are
indicated in the
treatment of mild to moderately severe infections associated with
micro-organisms
whose susceptibility to penicillin is within the range of serum levels
attained with these
dosage forms. The following infections will usually respond to
adequate doses:
Streptococcal infections (without bacteraemia): Mild to moderate
infections of the
upper respiratory tract, scarlet fever and mild erysipelas.
Pneumococcal infections: Mild to moderately severe infections of the
respiratory tract.
Staphylococcal infections sensitive to penicillin: Mild infections of
the skin and soft
tissues.
Fusospirochaetosis (Vincent’s gingivitis and pharyngitis): Mild to
moderately severe
infections of the oropharynx usually respond to therapy with oral
penicillin.
Prophylactic use: Prophylaxis with oral penicillin has proved
effective in preventing
recurrence of rheumatic fever and chorea.
Patients with a past history of rheumatic fever receiving continuous
prophylaxis may
harbour penicillin-resistant organisms. In these patients, the use of
another prophylactic
agent should be considered.
Note: Severe empyema, bacteraemia, pericarditis, meningitis and
arthritis should not be
treated with Phenoxymethylpenicillin during the acute phase.
2
Consideration should be given to official guidance on the appropriate
use of
antibacterial agent.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 125 – 500