Rapamune (sirolimus) tablets and oral solution - Pfizer Limited - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.5 Interaction with other medicinal products and other forms of interaction has been updated to include potential interactions with CYP3A4 inhibitors, which may decrease the metabolism of sirolimus and increase sirolimus blood levels. Such inhibitors include e.g. certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g. troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, telaprevir), nicardipine, br...
Source: NeLM - SPC Changes - March 1, 2013 Category: Drugs & Pharmacology Source Type: news
Rivotril (clonazepam) 0.5 and 2 mg tablets and 1mg/mL Concentrate for Solution for Injection or Infusion - Roche Products Limited - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.3 Contraindications has been updated to include "Rivotril must not be used in patients in a coma, or in patients known to be abusing pharmaceuticals, drugs or alcohol."
Section 4.4 Special warnings and precautions for use has been updated to include the warning that the concomitant use of Rivotril with alcohol or/and CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects of Rivotril possibly including severe sedation, clinically relevant respiratory and/...
Source: NeLM - SPC Changes - March 1, 2013 Category: Drugs & Pharmacology Source Type: news
Glivec (imatinib) - Novartis Pharmaceuticals UK Limited - revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.2 Posology and method of administration has been updated to include information with regard to paediatric use. Specifically, it states that there is no experience in children with CML below 2 years of age. There is limited experience in children with Ph+ ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST and HES/CEL aged less than 18 years of age have not been established in clinical trials. Currently availab...
Source: NeLM - SPC Changes - February 28, 2013 Category: Drugs & Pharmacology Source Type: news
Dostinex (cabergoline) tablets - Pfizer Limited - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Sections 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects have been updated to include impulse control disorders, which include pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating.
Please see link to the SPC for full prescribing information (Source: NeLM - SPC Changes)
Source: NeLM - SPC Changes - February 28, 2013 Category: Drugs & Pharmacology Source Type: news
RoActemra (tocilizumab) 20mg/ml Concentrate for Solution for Infusion - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.6 (fertility, pregnancy and lactation) of the SPC has been updated to include the statement that a vailable non-clinical data do not suggest an effect on fertility under tocilizumab treatment. (Source: NeLM - SPC Changes)
Source: NeLM - SPC Changes - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Prevenar 13? suspension for injection (pneumococcal polysaccharide conjugate vaccine) - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.1 of the SPC has been updated to give the following therapeutic indications:
Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.
Please see SPC link for full prescribing information. (Source: NeLM - SPC Changes)
Source: NeLM - SPC Changes - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Enbrel (etanercept) - all formulations - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.8 (undesirable effects) of the SPC has been updated to include Hepatitis B reactivation as an adverse reaction of unknown prevalence.
Hepatitis B is included in the list of serious infections that occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
Please see seperate SPC links for full prescribing information. (Source: NeLM - SPC Changes)
Source: NeLM - SPC Changes - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Revatio (sildenafil) tablets, powder for oral suspension and solution for injection - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.8 (undesirable effects) of the SPC has been updated to include hameaturia, penile haemorrhage and haematospermia as uncommon adverse events.
Please see seperate SPC links for full prescribing information. (Source: NeLM - SPC Changes)
Source: NeLM - SPC Changes - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Voltarol® (diclofenac) various formulations - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.2 of the SPC has been updated to include severe renal and hepatic impairment as contraindications. Caution is advised when using these medicines in mild and moderate renal or hepatic impairment.
Volteral® ampoules are not recommended for use in children.
Please see links to separate SPCs for full prescribing information (Source: NeLM - SPC Changes)
Source: NeLM - SPC Changes - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Transiderm Nitro® (glyceryl trinitrate) 5mg and 10mg patches - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.3 of the SPC has been updated to include severe hypotension and hypovolemia as contraindications.
Section 4.4 has also been updated to include these changes.
Please see link to the SPC for full prescribing information. (Source: NeLM - SPC Changes)
Source: NeLM - SPC Changes - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Orencia® (abatacept) 125mg solution for injection - New Formulation
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Bristol-Myers Squibb has been granted marketing authorisation for a new formulation given by subcutaneous injection.
Orencia® (abatacept) in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including methotrexate or a tumour necrosis factor-alpha inhibitor.
Please see link to SPC for full prescribing information. (...
Source: NeLM - SPC Changes - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
