Phenoxymethylpenicillin 250mg/5ml oral solution

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Phenoxymethylpenicillin potassium

Dostępny od:

Crescent Pharma Ltd

Kod ATC:

J01CE02

INN (International Nazwa):

Phenoxymethylpenicillin potassium

Dawkowanie:

50mg/1ml

Forma farmaceutyczna:

Oral solution

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 05010101; GTIN: 5017123025990

Status autoryzacji:

Marketed

Data autoryzacji:

2009-01-23

Ulotka dla pacjenta

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

Charakterystyka produktu

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