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Biotine IM 0.5% Single Ampoule (Vitamin H Injection)

Biotine IM 0.5% Single Ampoule (Vitamin H Injection)

Biotine 0.5%

Injectable vitamin supplement
  • Supplied in the UK as an unlicensed medicine (special) under the responsibility of the prescriber and the dispensing pharmacy
  • Based on the Biotine 0.5% Vitamin H intramuscular solution manufactured under GMP standards by Bayer for licensed markets
  • Distribution through a GPhC Registered distance Selling pharmacy (AestheticsRx Pharma) in line with UK regulations on unlicensed medicines
  • Use is restricted to prescription by appropriately qualified prescribers with documentation of dosing schedules and professional IM injection training for administrators
Intramuscular biotin (Vitamin B7/H) injection for hair, skin and nails

Description

Biotine IM 0.5% Single Ampoule is an unlicensed intramuscular injection containing 0.5% biotin (Vitamin H, also known as Vitamin B7) supplied for prescription use via AestheticsRx Pharma. Each 1 ml ampoule provides 5 mg of biotin in a sterile aqueous solution intended for deep intramuscular administration by appropriately trained professionals. Biotin is a water-soluble B-complex vitamin that supports the metabolism of carbohydrates, fats and proteins into energy and is involved in keratin synthesis, contributing to the normal growth and maintenance of skin, hair and nails. These injections are used in aesthetic and dermatology settings as a vitamin supplement to help support skin health, nail strength and hair growth, particularly in patients with increased demands or suspected deficiency. As an unlicensed medicine in the UK, Biotine IM 0.5% may only be prescribed by suitably qualified prescribers (doctors, dentists, independent prescribing nurses or pharmacists), and injectors must hold certification in intramuscular administration and specific training in the administration of Biotine.

Bnefits

  • Provides a concentrated 0.5% (5 mg/ml) biotin (Vitamin H/B7) dose via intramuscular injection for high systemic exposure
  • Intended to support the normal healthy growth and development of skin and hair
  • Helps support nail strength and the structure of hair and nails through stimulation of keratin synthesis
  • Contributes to normal macronutrient metabolism, helping the body use carbohydrates, fats and proteins for energy
  • Water-soluble vitamin with minimal long-term storage, reducing risk of accumulation compared with fat-soluble vitamins
  • Single 1 ml ampoule format is convenient for dose preparation and administration in-clinic
  • Useful adjunct in aesthetic protocols for hair and nail support when clinically appropriate and prescribed by a qualified prescriber

Indications

  • Use as a vitamin H (biotin) supplement in adults where a prescriber considers intramuscular biotin appropriate, particularly for support of hair, skin and nail health
  • Adjunctive support in diffuse hair thinning or increased shedding within a wider hair-loss management plan, under medical supervision
  • Situations where the prescriber judges parenteral biotin to be preferable to, or in addition to, oral supplementation (e.g. adherence concerns or specific clinical protocols in aesthetics)
  • Aesthetic medicine protocols aimed at supporting keratin-based tissues (hair and nails) in suitable adult patients

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 aqueous solution for intramuscular injection
  • Strength: 0.5% biotin, providing 5 mg biotin per 1 ml ampoule
  • Single-use glass ampoule containing clear solution for deep intramuscular use
  • Vitamin H (biotin) parenteral supplement used in aesthetics and dermatology as an unlicensed medicine in the UK

Packaging

  • Single 1 ml glass ampoule supplied per order (Biotine IM 0.5% Single Ampoule listing)
  • Product derived from standard pack configuration of 6 x 1 ml ampoules (Biotine 0.5% Vitamin H) for clinic stock, with this SKU sold as an individual ampoule
  • Outer pharmacy packaging and labelling provided by AestheticsRx Pharma in accordance with UK unlicensed medicine supply regulations
  • Ampoules intended for single use only and must be discarded after opening

Usage

  • Biotine IM 0.5% is an unlicensed prescription-only medicine; it may only be prescribed by suitably qualified prescribers (doctors, dentists, independent prescribing nurses or pharmacists) and administered by professionals with certification in intramuscular (IM) injections and specific training in Biotine administration.
  • The prescription must state a clear dosing schedule defined by the prescriber; AestheticsRx specifically requests that a dosing schedule be provided on the prescription.
  • Typical reference regimen for the corresponding licensed Biotine 0.5% (Bayer) product is 1–2 ampoules (5–10 mg) intramuscularly, three times per week for 6 weeks in adults; however, for this unlicensed use, the exact dose and frequency must follow the prescriber’s individualised instructions.
  • Ampoules are for intramuscular injection only and are single-use; any remaining solution after opening should be discarded and not stored for later use.
  • Administer deep intramuscularly (e.g. in the gluteal region or other appropriate IM site) using aseptic technique, following local clinical guidelines for IM injections.
  • Because biotin can interfere with certain laboratory assays (especially immunoassays for hormones such as TSH, troponins and others), patients should inform healthcare providers and laboratories that they are receiving intramuscular biotin before undergoing blood tests.
  • Use is restricted to adults; it should not be used in children or adolescents unless specifically justified and supervised by an appropriate specialist prescriber.
  • Its use in pregnancy and breastfeeding should only occur if the prescriber considers that potential benefits clearly outweigh risks, given the unlicensed status.
  • If a scheduled injection is missed, the patient should follow the prescriber’s advice rather than doubling the next dose.

Contraindications

  • Known hypersensitivity or allergy to biotin (Vitamin H/B7) or to any of the excipients, including methyl and propyl parahydroxybenzoate (parabens), sodium dihydrogen phosphate dihydrate, sodium bicarbonate or other formulation components
  • History of serious allergic reactions to parahydroxybenzoate preservatives (e.g. urticaria, bronchospasm, angioedema)
  • Use in children and adolescents unless specifically justified and supervised by an appropriate specialist (typical adult-focused dosing and safety data)
  • Situations where intramuscular injection is contraindicated at the chosen site (e.g. local infection, significant trauma, severe muscle atrophy at the injection site)
  • Relative contraindication in pregnancy and breastfeeding due to unlicensed status, unless the prescriber deems use essential after an individual risk–benefit assessment

Adverse Effects

  • Local injection-site reactions such as pain, tenderness, erythema or mild swelling at the injection site
  • Possible local haematoma, bruising or, rarely, infection if injection technique or asepsis is suboptimal
  • Hypersensitivity reactions, including rash, pruritus or urticaria, potentially related to biotin or paraben preservatives
  • Very rare risk of more serious allergic reactions (e.g. angioedema, bronchospasm, anaphylaxis) requiring immediate medical attention
  • Biotin-related interference with certain laboratory test results (especially some immunoassays), potentially leading to falsely high or low values if laboratories are not informed
  • As with other intramuscular injections, transient discomfort or feeling of heaviness in the injected limb can occur post-injection

Storage Conditions

  • Store below 25°C, away from direct heat sources and direct sunlight.
  • Do not freeze the ampoules.
  • Keep ampoules in their outer carton or protective packaging until use to reduce light exposure and risk of breakage.
  • Keep out of the sight and reach of children.
  • Do not use the ampoule after the expiry date printed on the label and carton.
  • Do not use if the ampoule is damaged or if the solution shows visible signs of deterioration (e.g. particulate matter, discoloration).
  • Discard any unused solution immediately after opening, in accordance with local requirements for disposal of pharmaceutical waste.

Duration

As an unlicensed product, treatment duration must be defined by the prescriber on an individual basis. In many protocols based on the licensed Biotine 0.5% reference product, courses of approximately 6 weeks with injections several times per week are used, but for this AestheticsRx single-ampoule supply, the precise duration and total number of injections are determined by the prescribing clinician.

Onset

Supportive effects on hair, skin and nails develop gradually. Patients may begin to notice reduced shedding or changes in hair and nail quality after several weeks of regular treatment, but visible cosmetic improvements typically take weeks to months and vary according to baseline status, underlying causes and concurrent therapies.

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