SUNNYFUNGAL
NAME OF THE MEDICINAL PRODUCT
SUNNYFUNGAL INTRAVENOUS INFUSION 2MG/ML
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluconazole 2mg/ml in a saline solution for intravenous infusion.
PHARMACEUTICAL FORM
Sunnyfungal Intravenous Infusion 2mg/ml is available in a 0.9% aqueous sodium chloride solution, presented in glass infusion vials 50 ml
CLINICAL PARTICULARS
1. Genital candidiasis. Vaginal candidiasis, acute or recurrent. Candidal balanitis. The treatment of partners who present with symptomatic genital candidiasis should be considered.
2. Mucosal candidiasis. These include oropharyngeal, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). Normal hosts and patients with compromised immune function may be treated.
3. Tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal Candida infections. Sunnyfungal is not indicated for nail infections and tinea capitis.
4. Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection. These include infections of the peritoneum, endocardium and pulmonary and urinary tracts. Candidal infections in patients with malignancy, in intensive care units or those receiving cytotoxic or immunosuppressive therapy may be treated.
5. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). Normal hosts, and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Sunnyfungal can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.
6. For the prevention of fungal infections in immunocompromised patients considered at risk as a consequence of neutropenia following cytotoxic chemotherapy or radiotherapy, including bone marrow transplant patients.
Posology and method of administration
Contraindications
Sunnyfungal should not be used in patients with known hypersensitivity to fluconazole or to related azole compounds or any other ingredient in the formulation.
Co-administration of other drugs known to prolong the QT interval and which are metabolised via the enzyme CYP3A4 such as cisapride, astemizole, pimozide and quinidine are contraindicated in patients receiving fluconazole (see sections 4.4 Special Warnings and Special Precautions for Use and 4.5 Interaction with Other Medicaments and Other Forms of Interaction).
Overdose
There have been reports of overdosage with fluconazole and in one case, a 42 year-old patient infected with human immunodeficiency virus developed hallucinations and exhibited paranoid behaviour after reportedly ingesting 8200mg of fluconazole, unverified by his physician. The patient was admitted to the hospital and his condition resolved within 48 hours.
In the event of overdosage, supportive measures and symptomatic treatment, with gastric lavage if necessary, may be adequate.
As fluconazole is largely excreted in the urine, forced volume diuresis would probably increase the elimination rate. A three hour haemodialysis session decreases plasma levels by approximately 50%.
List of excipients
Sunnyfungal Intravenous Infusion is a sterile aqueous solution which is made iso-osmotic with sodium chloride.
Incompatibilities
No specific incompatibilities have been noted
Shelf life
Current stability data support a shelf life of 2 years for the intravenous infusion , to be used immediately after opening
Special precautions for storage
Do not freeze intravenous infusion
.
Nature and contents of container
Sunnyfungal Intravenous Infusion will be supplied in clear Type I glass infusion vials 50ml) sealed with rubber bungs on crimping with aluminium over-caps.
Special precautions for disposal and other handling
Sunnyfungal Intravenous Infusion Do not freeze. The infusion does not contain any preservative. It is for single use only. Discard any remaining solution.
MARKETING AUTHORISATION HOLDER
Sunny pharmaceutical
Badr City , Cairo,
Egypt
SUMMARY OF PRODUCT CHARACTERISTICS for FERCAYL
Sunnypyramid Injection Qualitative and quantitative composition
SUNNYFUNGAL NAME OF THE MEDICINAL PRODUCT
Peptrelif Injection 50 mg/2ml NAME OF
FERMED 20 mg .Name of the
Etasylsunny 250/2ml solution for IV injection
