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Return to PJ Online Home Page The Pharmaceutical Journal Vol 266 No 7138 p336
March 10, 2001

Products

    Prescription Products Recall Miscellany

Prescription Products

Neurobloc injection

Composition: Botulinum toxin type B 5,000iu/ml.
Presentation: Solution for injection.
Storage and stability: Store between 2-8C. Do not freeze. Keep the container in the outer carton to protect from light. Vials may be stored for up to 8 hours at room temperature.

Action:
Neuromuscular blocking agent.
Indications: Treatment of cervical dystonia (torticollis).
Contraindications: Hypersensitivity to active substance or excipients; pregnancy and lactation; individuals with other known neuromuscular diseases (eg, amyotrophic lateral sclerosis, peripheral neuropathy) or neuromuscular junctional disorders (eg, myasthenia gravis, Lambert-Eaton syndrome).
Dosage and administration: Administer only by intramuscular injection. The solution in the vials is ready to use but may be diluted with 0.9 per cent sodium chloride solution for injection (see SPC).

Adults (including 65 years of age), the dose and frequency should be adjusted depending on response. The initial dose is 10,000iu and should be divided between two to four of the most affected muscles. An initial dose of 5,000iu may be considered, but 10,000iu may increase the likelihood of benefit. Injections may be repeated as required (see SPC). For patients with reduced muscle mass, the dose should be adjusted according to individual need.

Children (<18 years of age), safety and efficacy have not been demonstrated.

Hepatic and renal impairment, not studied (see SPC).

Overdosage: No cases reported. See SPC.
Precautions: Care should be taken to ensure that the product is not injected into a blood vessel. An immune response may develop following repeated administration. The dosage units for botulinum toxin type B are not interchangeable with the same dosage units of botulinum toxin type A products (see SPC).
Drug interactions: The effect of administering other botulinum neurotoxin serotypes concurrently is unknown. Co-administration of botulinum toxin type B and aminoglycosides or agents interfering with neuromuscular transmission (eg, curare-like compounds) should be considered with caution.
Side effects: Very common (>10 per cent) adverse reactions included dry mouth, injection site pain and dysphagia. Common (>1 per cent, < 10 per cent) adverse reactions included torticollis (worsening from baseline), neck pain, dyspepsia, voice alteration, myasthenia, taste perversion. Electrophysiological jitter, not associated with weakness or other electrophysiological abnormalities, may be experienced in some distant muscles.

Net price: Single vials, 2,500iu/0.5ml £111.20, 5,000iu/1ml £148.27, 10,000iu/2ml £197.69.
Supplier: Elan Pharma, Elan House, Avenue One, Letchworth, Hertfordshire SG6 2HU. Tel 01462 707393, fax 01462 707282.
Legal class: POM.

SPC changes

The summaries of product characteristics for Astra Zeneca's Plendil (felodipine) 2.5mg tablets and Arimidex (anastrozole) have been updated. The shelf life of Plendil 2.5mg tablets has been reduced from three years to 18 months and the shelf life of Arimidex has been changed from three years to five years. The company says that the packaging for Plendil 2.5mg tablets is being updated and new packs should be available during March.

Asmabec Clickhaler

Celltech Medeva says that the supplier of Asmabec (beclometasone dipropionate) Clickhaler, CCL Pharmaceuticals, is unable to maintain regular supply of the 100µg and 250µg strengths of the product. The company expects this situation to be temporary and suggests that, in the meantime, patients may be transferred to an alternative beclometasone inhaler. Supplies of salbutamol Clickhaler are unaffected. Further information can be obtained from the company's medical information department (tel 01372 364000).

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Recall

Beclometasone dipropionate recall (March 2)

3M Health Care is recalling the following batches of beclometasone dipropionate inhalers, in the liveries of 3M Health Care and Generics (UK).

The recall is because the company has discovered that some inhalers from these batches may deliver sporadic low doses of active ingredient. Recipients are requested to quarantine stock from these batches and return it to their supplier for credit or replacement.

Further information can be obtained from 3M Health Care (tel 0585 850673).

  Pack size Batch numbers Expiry date
3M Health Care livery    
Filair 100 inhaler 200 dose GBJ005A, GBJ077A and GBJ078A October, 2003
    GBK077A November, 2003
    GBL033A December, 2003
Filair Forte inhaler 200 dose GBJ082B, GBJ080B and GBJ081A October, 2003
    GBK131B November, 2003
    GBL014A December, 2003
Generics (UK) livery    
50µg inhaler 200 dose GBL030A December, 2003
100µg inhaler 200 dose GBJ079A October, 2003
    GBK078A November, 2003
    GBL031A and GBL032B December, 2003
250µg inhaler 200 dose GBJ080A and GBJ081C October, 2003
    GBK131A November, 2003

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Bili-Labstix

Bayer is discontinuing Bili-Labstix urine analysis test strips from the end of June. The company says that Multistix SG test strips can be used as an alternative to Bili-Labstix test strips and provides the same test parameters together with two additional tests for specific gravity and urobilinogen.

Nova T 380 intrauterine device

Schering Health Care's Nova T 380 intrauterine device is now reimbursable on the NHS and is included in the Drug Tariff as from March 1 (net price, £13.50).

Nelson's homeopathic creams

The packaging of Nelson's homeopathic range of creams has been redesigned as shown above.

Sepsis website

Eli Lilly and Company has launched a website to provide health care professionals with information about sepsis. The website (www.sepsis.com) includes information on the epidemiology and pathophysiology of sepsis as well as links to other resources.

IBS guide book

A “What should I do?” health management guide to irritable bowel syndrome (IBS) has been launched by RTFB Publishing. The publisher says that the book provides patients with information on IBS and the treatment options available. Copies of the book can be obtained from
RTFB Publishing
Building 2, Shamrock Quay
Southampton SO14 5QL

tel 023 8022 9041
fax 023 8022 7274

priced £7.99 (plus postage and packaging).

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