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Biotine Bayer 0.5% Vitamin H IM Injection

Biotine Bayer 0.5% Vitamin H IM Injection

Biotine Bayer

Injectable vitamin supplement
  • Authorised medicinal product in France (BIOTINE BAYER 0,5 %, solution injectable I.M.) with marketing authorisation granted in 1997 and public documentation via the ANSM medicines database
  • Manufactured by Bayer Healthcare under Good Manufacturing Practice (GMP) standards for human medicinal products
  • Subject to national medicines regulations, pharmacy Only distribution and pharmacovigilance requirements in EU markets where it is authorised
  • Packaged with official patient information leaflet and Summary of Product Characteristics outlining indications, dosage, contraindications, adverse effects and storage
Intramuscular biotin (Vitamin B7/H) injection for diffuse alopecia and hair support

Description

Biotine Bayer IM 0.5% is a prescription intramuscular solution containing 0.5% biotin (Vitamin H, also known as Vitamin B7) manufactured by Bayer Healthcare. Each 1 ml glass ampoule provides 5 mg biotin in a sterile aqueous solution for deep intramuscular injection. Classified pharmacotherapeutically as Vitamin H for dermatology, it is authorised as an adjunctive treatment for diffuse hair loss (diffuse alopecia) in adults and is widely used in dermatology and aesthetic practice to help slow hair shedding and support hair and nail keratin synthesis. As a water-soluble B-complex vitamin, biotin also plays a key role in normal metabolism of carbohydrates, fats and proteins into energy, and helps maintain healthy skin and hair when deficiency or increased demand is present. The product is supplied in boxes of 6 single-use 1 ml ampoules and must be administered by a healthcare professional.

Bnefits

  • Provides a concentrated 0.5% (5 mg/ml) dose of biotin (Vitamin H/B7) directly via intramuscular injection for high systemic bioavailability
  • Indicated as an adjunctive treatment for diffuse hair loss (diffuse alopecia) in adults
  • Helps slow down hair loss and supports healthy hair growth by promoting keratin synthesis
  • Supports normal growth and maintenance of skin, hair and nails as a B-complex vitamin
  • Contributes to normal metabolism of carbohydrates, fats and proteins into energy
  • Water-soluble vitamin formulation, with excess generally excreted rather than stored in the body
  • Well-characterised medicinal product with long-standing marketing authorisation and defined dosage regimen
  • Produced by a major global pharmaceutical manufacturer under GMP standards
  • Convenient single-use 1 ml ampoules supplied in a 6-ampoule box for a full treatment course

Indications

  • Adjunctive treatment of diffuse hair loss (diffuse alopecia) in adults
  • Supportive treatment to help slow hair shedding and promote hair regrowth in diffuse alopecia when prescribed by a physician
  • Vitamin H (biotin) supplementation where deficiency or increased requirements may contribute to hair and nail problems, as assessed by a healthcare professional
  • Dermatological and aesthetic protocols aimed at improving hair density and quality as part of a broader hair-loss management plan

Composition

  • Biotin (Vitamin H/B7) 5 mg per 1 ml ampoule (0.5% w/v solution)
  • Sodium dihydrogen phosphate dihydrate
  • Sodium bicarbonate
  • Methyl parahydroxybenzoate (E218)
  • Propyl parahydroxybenzoate (E216)
  • Water for injections

Formulation

  • Sterile solution for intramuscular injection
  • Strength: 0.5% biotin, providing 5 mg biotin per 1 ml ampoule
  • Single-use glass ampoules containing clear aqueous solution
  • Pharmacotherapeutic class: Vitamin H (Dermatology)
  • Prescription-only medicinal product reserved for adults

Packaging

  • Cardboard box containing 6 single-use glass ampoules
  • Each ampoule: 1 ml solution for intramuscular injection with 5 mg biotin
  • Outer carton with full regulatory labelling, CIP/EAN code 3400936909045 and package leaflet
  • Supplied as a medicinal product through pharmacies and authorised wholesalers

Usage

  • For intramuscular injection only; administration must be performed by a doctor, nurse or other appropriately trained healthcare professional.
  • Indicated dose (adults only): 1 or 2 ampoules per administration, three times per week, by intramuscular route.
  • Typical regimen used in hair-loss protocols: 1–2 ampoules IM, 3 times weekly, for a treatment period of 6 weeks, unless your prescribing physician advises otherwise.
  • Ampoules are single-use; discard any unused solution immediately after opening in accordance with local regulations.
  • The injection should be given deeply intramuscularly, following standard aseptic technique and local practice for IM injections.
  • Patients should follow their doctor’s prescription and should not alter dose or frequency without medical advice.
  • Because biotin can interfere with certain laboratory assays, patients should inform their doctor and the laboratory that they are receiving biotin injections before blood tests are performed.
  • Use in children and adolescents is not indicated; the product is reserved for adults.
  • It is generally preferable to avoid use during pregnancy and breastfeeding unless a physician judges that potential benefits outweigh possible risks.
  • If a dose is missed, do not double the next dose; follow the schedule advised by the prescribing clinician.

Contraindications

  • Known hypersensitivity or allergy to biotin (vitamin H/B7) or to any of the excipients, including methyl or propyl parahydroxybenzoate (parabens), sodium dihydrogen phosphate dihydrate, sodium bicarbonate or water for injections
  • Use in children and adolescents, as the product is indicated and dosed for adults only
  • History of serious allergic reactions to parahydroxybenzoate preservatives (such as urticaria, bronchospasm or angioedema)
  • Situations where intramuscular injection is contraindicated (e.g. at or near infected, inflamed or traumatised skin or muscle at the intended injection site)
  • Use during pregnancy or breastfeeding is generally not recommended unless clearly needed, based on physician risk–benefit assessment

Adverse Effects

  • Local injection-site reactions such as pain, tenderness, redness or mild swelling
  • Allergic skin reactions (e.g. itching, rash, urticaria, local or generalised oedema) related to biotin or to parahydroxybenzoate excipients
  • Very rarely, more significant hypersensitivity reactions could occur (e.g. difficulty breathing, facial or throat swelling), which require urgent medical attention
  • As with other intramuscular injections, there is a small risk of local haematoma, infection or nerve irritation if the injection is not performed correctly
  • Biotin at this dose can interfere with certain laboratory tests, potentially causing falsely high or low results; this is not an adverse effect in itself but an important safety consideration requiring test interpretation adjustments

Storage Conditions

  • Keep out of the sight and reach of children.
  • Store at a temperature below 25°C as indicated in the package leaflet.
  • Do not freeze and protect ampoules from excessive heat and direct sunlight.
  • Do not use after the expiry date printed on the outer carton and ampoule (EXP), which refers to the last day of the indicated month.
  • Do not use the solution if the ampoule is damaged or if any visible changes in the solution are observed.
  • Discard unused medicinal product or waste material in accordance with local pharmaceutical waste regulations; do not dispose of via wastewater or household waste.

Duration

Standard recommended course for diffuse hair loss in adults is 1 or 2 ampoules administered intramuscularly three times per week for approximately 6 weeks, with duration ultimately determined by the prescribing physician.

Onset

Clinical improvement in diffuse hair loss typically develops gradually over several weeks of therapy; slowing of hair shedding may be observed during the 6-week course, while visible changes in hair density and quality can take several weeks to months and vary between individuals.

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