GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Flucloxacillin Capsules BP 500mg
b) Flucloxacillin Capsules BP 250mg
b) Flucloxacillin Capsules BP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Flucloxacillin Capsules BP 500mg
Each hard gelatin Capsule contains:
Flucloxacillin Sodium BP
Equivalent to Flucloxacillin……………500mg
Approved colours used in capsule shell.
b) Flucloxacillin Capsules BP 250mg
Each hard gelatin Capsule contains:
Flucloxacillin Sodium BP
Equivalent to Flucloxacillin………………250mg
Approved colours used in capsule shell.
Each hard gelatin Capsule contains:
Flucloxacillin Sodium BP
Equivalent to Flucloxacillin……………500mg
Approved colours used in capsule shell.
b) Flucloxacillin Capsules BP 250mg
Each hard gelatin Capsule contains:
Flucloxacillin Sodium BP
Equivalent to Flucloxacillin………………250mg
Approved colours used in capsule shell.
THERAPEUTIC INDICATIONS:
Flucloxacillin is used to treat bacterial infections of the skin and soft tissues, respiratory tract, bone, intestine, urinary tract, brain, and blood.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light & moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Flucloxacillin Capsules BP 500mg Technical Specification:
| Product Name: | Flucloxacillin Capsules BP |
| Brand Name: | Generic |
| Strength: | 500mg, 250mg |
| Dosage Form: | Capsules (Hard gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | β-lactam Antibiotic, Anti-bacterial & Penicillin |
| Indication: | Flucloxacillin is used to treat bacterial infections of the skin and soft tissues, respiratory tract, bone, intestine, urinary tract, brain, and blood. |
| Storage: | Store below 25°C. Protect from light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Flucloxacillin Capsules BP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Flucloxacillin Capsules BP 500mg
Each hard gelatin Capsule contains:
Flucloxacillin Sodium BP
Equivalent to Flucloxacillin……………500mg
Approved colours used in capsule shell.
THERAPEUTIC INDICATIONS:
Flucloxacillin is used to treat bacterial infections of the skin and soft tissues, respiratory tract, bone, intestine, urinary tract, brain, and blood.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light & moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
