A. Tetracosactide Injection BP 250mcg/ml
GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Tetracosactide Injection BP 250mcg/ml
Each ml contains:
Tetracosactide Acetate Eq. to
Tetracosactide BP…………………250 mcg
Excipients…………………………q.s.
Water for Injections……………….q.s. to 1 ml
250 mcg of Tetracosactide is equivalent to 25 I.U. ACTH
Each ml contains:
Tetracosactide Acetate Eq. to
Tetracosactide BP…………………250 mcg
Excipients…………………………q.s.
Water for Injections……………….q.s. to 1 ml
250 mcg of Tetracosactide is equivalent to 25 I.U. ACTH
THERAPEUTIC INDICATION:
It is used in young children to treat some types of seizure (fit), such as infantile spasms. Synacthen Depot works by causing the adrenal glands to increase the production of natural "steroid" hormones that can help to reduce the symptoms of certain diseases.
DIRECTION OF USE:
Use immediately after opening the ampoule.
Discard any unused portion.
As directed by Endocrinologist.
Discard any unused portion.
As directed by Endocrinologist.
CAUTION & WARNING:
CAUTION:
Do not use the injection if the contents are not clear, contains visible particulate or any discoloration is observed.
Do not accept if ampoule is broken.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE. Warning:
Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.
Do not use the injection if the contents are not clear, contains visible particulate or any discoloration is observed.
Do not accept if ampoule is broken.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE. Warning:
Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.
STORAGE & DOSAGE:
Storage:
Store between 2ºC to 3ºC.
Protect from light.
Do not freeze. Dosage:
As directed by an Endocrinologist.
Please refer product insert for more information.
Store between 2ºC to 3ºC.
Protect from light.
Do not freeze. Dosage:
As directed by an Endocrinologist.
Please refer product insert for more information.
Tetracosactide Injection BP 250mcg/ml Technical Specification:
| Product Name: | Tetracosactide Injection BP |
| Brand Name: | FEZOTRA |
| Strength: | 250mcg/ml |
| Dosage Form: | Liquid Dosage form Injection |
| Packing: | Single dose Vial |
| Route of Administration: | For I.V. and I.M. use only (After dilution) |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Adrenocortical Insufficiency, ACTH |
| Indication: | It is used in young children to treat some types of seizure (fit), such as infantile spasms. Synacthen Depot works by causing the adrenal glands to increase the production of natural “steroid” hormones that can help to reduce the symptoms of certain diseases. |
| Storage: | Store between 2ºC to 3ºC. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Tetracosactide Injection BP 250mcg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tetracosactide Injection BP 250mcg/ml
Each ml contains:
Tetracosactide Acetate Eq. to
Tetracosactide BP…………………250 mcg
Excipients…………………………q.s.
Water for Injections……………….q.s. to 1 ml
250 mcg of Tetracosactide is equivalent to 25 I.U. ACTH
THERAPEUTIC INDICATION:
It is used in young children to treat some types of seizure (fit), such as infantile spasms. Synacthen Depot works by causing the adrenal glands to increase the production of natural “steroid” hormones that can help to reduce the symptoms of certain diseases.
DIRECTION OF USE:
Use immediately after opening the ampoule.
Discard any unused portion.
As directed by Endocrinologist.
CAUTION & WARNING:
CAUTION:
Do not use the injection if the contents are not clear, contain visible particulate or if any discolouration is observed.
Do not accept if the ampoule is broken.
WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
STORAGE & DOSAGE:
Storage:
Do not freeze.
Protect from light.
Store between 2ºC to 3ºC.
Dosage:
As directed by an Endocrinologist.
Please refer product insert for more information.
