Engystol
Engystol 1.1ml Injection
FULL PRESCRIBING INFORMATION: CONTENTS*
- ENGYSTOL DESCRIPTION
- ENGYSTOL INDICATIONS AND USAGE
- ENGYSTOL DOSAGE AND ADMINISTRATION
- ENGYSTOL CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ENGYSTOL ADVERSE REACTIONS
- OVERDOSAGE
- CLINICAL PHARMACOLOGY
- DOSAGE
FULL PRESCRIBING INFORMATION
ENGYSTOL DESCRIPTION
| Each 1.1 ml solution for injection ampule contains: | |||
| Active Ingredients: | |||
| Ingredient name | Potency | Quantity | Final dilution |
| Asclepias vincetoxicum | 6X | 6.6 µl | 8.22X |
| Asclepias vincetoxicum | 10X | 6.6 µl | 12.22X |
| Asclepias vincetoxicum | 30X | 6.6 µl | 32.22X |
| Sulphur | 4X | 3.3 µl | 6.52X |
| Sulphur | 10X | 3.3 µl | 12.52X |
Inactive Ingredients:
Water for injection 1,073.6 μl
Sodium Chloride 8.78 μl
INDICATIONS AND USAGE
Engystol® Injection Solution is a homeopathic drug product indicated for the support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.
ENGYSTOL DOSAGE AND ADMINISTRATION
General Considerations
• The dosage schedules listed below can be used as a general guide for the administration of Engystol® Injection Solution.
• Engystol® Injection Solution may be administered s.c., i.d., i.m., or i.v.
• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents.
• Draw up required dose into syringe.
• Discard any unused ampule contents. Do not reuse ampule.
Standard Dosage:
Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days.
Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days.
Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days.
Acute Dosage:
Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage.
Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage.
Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.
ENGYSTOL CONTRAINDICATIONS
Engystol® Injection Solution is contraindicated in patients with known hypersensitivity to Engystol® or any of its ingredients.
WARNINGS AND PRECAUTIONS
Keep out of reach of children.
ENGYSTOL ADVERSE REACTIONS
Post-marketing Experience
• The following adverse events have been identified during post-marketing use of Engystol® Injection Solution. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Allergic (hypersensitivity) skin reactions may occur in isolated cases.
To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203
info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.
CLINICAL PHARMACOLOGY
Mechanism of Action
The exact mechanism of Engystol® Injection Solution is not fully understood.
Pharmacodynamics
Not applicable for homeopathic medicinal products.
DOSAGE
1 ampule containing 1.1 ml solution for injection each containing the active ingredients in the strengths listed under Description.
EngystolCYNANCHUM VINCETOXICUM ROOT and SULFUR INJECTION
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