KLINITOX®

Botulinum Toxin Type A – 100 Units
For Intramuscular Injection
For Use by Qualified Healthcare Professionals Only

Precision in Aesthetic Neuromodulation

KLINITOX® is a refined botulinum toxin type A developed for healthcare professionals who demand control, consistency, and clinical confidence in every treatment.

Formulated under strict pharmaceutical standards, KLINITOX® delivers predictable muscle relaxation and natural facial balance, supporting high-quality aesthetic outcomes in glabellar line treatment.

Technical Information

1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each single-use vial contains:

  • Active Substance: Clostridium botulinum toxin type A – 100 Units
  • Stabilizer: Human Serum Albumin – 0.5 mg
  • Tonicity Adjuster: Sodium Chloride (Pharmacopoeial Grade) – 0.9 mg

The product contains no antimicrobial preservatives.

Units of biological activity are specific to KLINITOX® and are not interchangeable with other botulinum toxin preparations.

2. PHARMACEUTICAL FORM

Sterile, vacuum-dried (lyophilized) powder for solution for injection.
The product appears as a white to slightly yellow dry powder in a transparent, colorless glass vial.

After reconstitution with preservative-free sterile 0.9% sodium chloride solution, KLINITOX® forms a clear, colorless, particle-free solution suitable for intramuscular administration.

3. CLINICAL PARTICULARS

3.1 Therapeutic Indication

KLINITOX® is indicated for the temporary improvement of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults aged 19 to 65 years.

3.2 Mechanism of Action

Botulinum toxin type A acts by selectively inhibiting the presynaptic release of acetylcholine at the neuromuscular junction. The toxin binds to cholinergic nerve terminals, undergoes internalization, and cleaves SNAP-25 protein, thereby blocking synaptic vesicle fusion and neurotransmitter release.

This results in temporary chemical denervation of the targeted muscle, leading to a reduction in muscle contraction. The effect is reversible through axonal sprouting and neuromuscular junction regeneration.

3.3 Dosage and Administration

Glabellar Lines

Reconstitute KLINITOX® with preservative-free sterile 0.9% sodium chloride to obtain a final concentration of:

100 Units / 2.5 mL (4 Units / 0.1 mL)

Using a sterile 30-gauge needle:

  • Inject 0.1 mL into 2 sites per corrugator muscle
  • Inject 0.1 mL into 1 site in the procerus muscle

Total recommended dose: 20 Units across 5 injection sites

Injection Considerations

  • Avoid injection near the levator palpebrae superioris to reduce the risk of ptosis.
  • Injections into the medial corrugator and central brow should be administered at least 1 cm above the superior ciliary margin.
  • Avoid intravascular injection.
  • Apply firm digital pressure to the supraorbital rim during injection to minimize inferior diffusion.
  • Direct the needle centrally and superiorly.
  • Administer the exact calculated dose.

Muscle mass, anatomical variation, and muscle activity should be clinically evaluated before dose determination.

3.4 Duration of Effect

The clinical effect in glabellar lines typically persists for approximately 3 to 4 months.

The safety and efficacy of more frequent administration have not been clinically established. Re-treatment intervals should not be less than 3 months.

4. RECONSTITUTION AND HANDLING

Reconstitute only with preservative-free sterile 0.9% sodium chloride.

Procedure:

  1. Withdraw the appropriate volume of diluent using a sterile syringe.
  2. Inject the diluent slowly into the vial.
  3. Avoid agitation and bubble formation to prevent protein denaturation.
  4. If the vacuum does not draw the diluent into the vial, discard the vial.
  5. Record the date and time of reconstitution.

The reconstituted solution must be:

  • Clear
  • Free of visible particulate matter
  • Stored at 2–8 °C
  • Used within 24 hours

Each vial is for single-patient use only.

5. DILUTION TABLE

Diluent Added (0.9% NaCl)Resulting Dose (Units / 0.1 mL)
1.0 mL10.0 U
2.0 mL5.0 U
4.0 mL2.5 U
8.0 mL1.25 U

Dose adjustment may also be achieved by modifying injection volume:

  • 0.05 mL → 50% dose reduction
  • 0.15 mL → 50% dose increase

6. WARNINGS AND PRECAUTIONS

6.1 Distant Spread of Toxin Effect

Post-marketing reports indicate that botulinum toxin effects may spread beyond the injection site. Symptoms may include:

  • Muscle weakness
  • Dysphagia
  • Dysphonia
  • Dysarthria
  • Dyspnea
  • Diplopia
  • Ptosis
  • Urinary incontinence

Severe dysphagia or respiratory compromise may be life-threatening.

6.2 Hypersensitivity

Rare cases of anaphylaxis, urticaria, serum sickness, soft tissue edema, and respiratory distress have been reported.

Discontinue use immediately if hypersensitivity occurs.

6.3 Neuromuscular Disorders

Patients with ALS, myasthenia gravis, Lambert-Eaton syndrome, or peripheral neuropathies may exhibit increased sensitivity and are at higher risk of systemic weakness.

6.4 Dysphagia

Common in cervical dystonia treatment; rarely severe. Fatal aspiration pneumonia has been reported.

6.5 Cardiovascular Events

Rare reports include arrhythmia and myocardial infarction, particularly in patients with underlying cardiovascular disease.

6.6 Non-Interchangeability

Units of biological activity are specific to KLINITOX®. They are not equivalent to other botulinum toxin formulations.

7. CONTRAINDICATIONS

KLINITOX® is contraindicated in:

  • Patients with known hypersensitivity to botulinum toxin or formulation components
  • Patients with neuromuscular junction disorders
  • Severe pulmonary impairment
  • Pregnancy and lactation
  • Active urinary tract infection (for intravesical administration)

8. ADVERSE REACTIONS

Serious adverse reactions (rare):

  • Death
  • Pneumonia
  • Severe systemic weakness
  • Anaphylaxis
  • Arrhythmia
  • Myocardial infarction

Common local reactions:

  • Injection site pain
  • Inflammation
  • Hematoma
  • Local infection
  • Burning sensation
  • Local muscle weakness
  • Skin rash
  • Pruritus

9. DRUG INTERACTIONS

Caution with:

  • Aminoglycoside antibiotics
  • Polypeptide antibiotics
  • Muscle relaxants
  • Benzodiazepines
  • Anticholinergic agents

Concurrent use may potentiate neuromuscular blockade.

Persistent concomitant administration with aminoglycosides is contraindicated.

10. USE IN SPECIAL POPULATIONS

Pregnancy and Lactation

Not recommended. Animal studies have demonstrated reproductive toxicity.

Pediatric Use

Safety and efficacy in individuals under 18 years have not been established.

11. OVERDOSE

Symptoms may be delayed.
Severe cases may require:

  • Hospitalization
  • Respiratory support
  • Mechanical ventilation
  • Administration of botulinum antitoxin

Antitoxin does not reverse established neuromuscular weakness.

12. STORAGE AND EXPIRATION

  • Store unopened vials refrigerated at 2–8 °C
  • Do not freeze
  • Shelf life: 36 months from date of manufacture
  • Reconstituted product must be used within 24 hours

Dispose of unused product and materials as medical waste.
For accidental spillage, inactivate using diluted hypochlorite solution (0.5–1%).

13. PRESENTATION

100 Units per vial
Single-use sterile glass vial

Scroll to Top