Phenoxymethylpenicillin - AFT

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Phenoxymethylpenicillin potassium 56.568 mg/mL equivalent to 50 mg/mL phenoxymethylpenicillin;  ;  

Commercializzato da:

AFT Pharmaceuticals Ltd

INN (Nome Internazionale):

Phenoxymethylpenicillin potassium 56.568 mg/mL (equivalent to 50 mg/mL phenoxymethylpenicillin)

Dosaggio:

250 mg/5mL

Forma farmaceutica:

Granules for oral solution

Composizione:

Active: Phenoxymethylpenicillin potassium 56.568 mg/mL equivalent to 50 mg/mL phenoxymethylpenicillin     Excipient: Orange 175-78-8 Orange flavour J1978 10814413 Saccharin sodium Sodium benzoate Sucrose As Caster sugar.

Confezione:

Bottle, plastic, HDPE, for 100mL., 100 mL

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Biotika a.s.

Indicazioni terapeutiche:

Treatment of mild to moderately severe infections caused by penicillin-sensitive organisms. The following infections will usually respond to an adequate dosage of Penicillin.

Dettagli prodotto:

Package - Contents - Shelf Life: Bottle, plastic, HDPE, for 100mL. - 100 mL - 24 months from date of manufacture stored at or below 25°C 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Data dell'autorizzazione:

2000-10-19

Scheda tecnica

Page 1 of 9
NEW ZEALAND DATA SHEET
1.
PHENOXYMETHYLPENICILLIN–AFT
Phenoxymethylpenicillin-AFT (granules for oral solution, 125 mg/5 mL
and 250 mg/ 5 mL)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenoxymethylpenicillin-AFT 125 mg/5 mL:
Following reconstitution, each 5 mL of solution contains 125 mg
phenoxymethylpenicillin (as
potassium salt).
Phenoxymethylpenicillin-AFT 250 mg/5 mL:
Following reconstitution, each 5 mL of solution contains 250 mg
phenoxymethylpenicillin (as
potassium salt).
Excipient(s) with known effect:
This product also contains sugar: approximately 2.8 g per 5 mL in the
125 mg/5 mL strength, and
2.9 g per 5 mL in the 250 mg/5 mL strength.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Granules for oral solution.
Pale orange granular powder with an orange odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderately severe infections caused by
penicillin-sensitive organisms. The
following infections will usually respond to an adequate dosage of
Penicillin.
Streptococcal infections
Mild to moderate infections of the upper respiratory tract, scarlet
fever and erysipelas.
Note: Streptococci in groups A C G H L and M are very sensitive to
penicillin.
Pneumococcal infections
Mild to moderately severe infections of the respiratory tract.
Prevention of bacterial endocarditis in patients with congenital
and/or rheumatic heart lesions who are
Page 2 of 9
about to undergo dental procedures or minor upper respiratory tract
surgery or instrumentation.
Oral penicillin should not be used as adjunctive prophylaxis for
genitourinary instrumentation or
surgery, lower intestinal tract surgery, sigmoidoscopy or
complications of childbirth.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The usual dosage is 250 mg every four to six hours for adults and
children. For younger children the
dosage is 125 mg every four hours. Higher doses may be used in more
severe infections. To ensure
maximum absorption each dose should be taken one hour before meals.
250 mg two or