Biotin 0.5% B7 Vitamin H, IM 1mlx5 vials/requires vial file

Description

Important Requires vial vile to open the vial

 

 

NAME  5x1ml BIOTIN,  0.5%, I.M. injectable solution

QUALITATIVE AND QUANTITATIVE COMPOSITION

Biotin (vitamin H)  5.0 mg For a 1ml vial

PHARMACEUTICAL FORM

Injectable solution.

 

Therapeutic Indications:

Supplementary treatment for hair loss.

 

Dosage and how to use: ONLY TO BE TAKEN BY ADULTS.

Intramuscular injection.

1-2 injections, 3 times a week for 6 weeks.

 

Contraindications:

Hypersensitivity to one of its components in particular paraben.

 

Special warnings and side effects

This drug contains Methyl parahydoxybenzoate and propyl, and can cause delayed allergic reactions; sometimes immediate reactions such as urticaria and bronchospasm.

 

Interactions with other drugs

Not applicable.

 

Pregnancy and breast feeding:

Pregnancy:

There is no clear evidence of malformations detected in animals.

In clinical studies, there are no particular malformative or fetotoxic effects appeared to date.

However monitoring pregnancies exposed to this drug is not enough to rule out any risk.

For precaution measures, it is advisable not to take this drug during pregnancy.

 

Breast feeding:

Due to the lack of available information, it is not advisable to take this drug during breast feeding.

 

Effects on the ability to drive and operate machinery:

No effects on the ability to drive vehicles or use machinery have been found.

 

Side effects:

Signs of allergic-like hypersensitivity, principally skin allergies (urticaria, angioedema, breakout, itchiness) have been reported.

 

Overdose:

No risk of a biotin overdose has been traced.

 

PHARMACOLOGICAL PROPERTIES

 

Pharmaco-dynamic properties:

Vitamin H

(D: Dermatology

 

Pharmacokinetics properties:

Not applicable

 

Preclinical safety data

Lack of results into the study of toxicity for the animal. However, biotin tolerance is widely documented.

 

Pharmaceutical data

 

List of dilutants:

Sodium dihydrogen phosphate dihydrate, sodium bicarbonate, methylparaben (E218), propylparaben (E216), water for injections.

 

Shelf life:

3 years.

 

Storage precautions:

Store in a place below 25°C.

 

Nature and contents of outside packaging:

Type I easy-open 1ml colourless glass vials.

 

Precautions for handling and disposal

If your symptoms persist, consult your doctor.

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Actual products may vary due to product enhancement.