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Zoledronic acid Teva Pharma (zoledronic acid) – Conditions or restrictions regarding supply and use - M05BA08

Updated on site: 11-Oct-2017

Medication nameZoledronic acid Teva Pharma
ATC CodeM05BA08
Substancezoledronic acid
ManufacturerTeva B.V.

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Teva Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82

HU-2100 Godollo

Hungary

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherland

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency:

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Additional risk minimisation measures

The Marketing Authorisation Holder (MAH) shall provide an educational programme targeting all physicians who are expected to prescribe/use Zoledronic acid Teva Pharma for the treatment of osteoporosis prior to the launch in Member States. The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authorities in

Member States prior to distribution of the educational programme. The educational programme contains the following:

Physician educational material

Patient educational material

The physician educational material should contain the following key messages:

Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Zoledronic acid Teva Pharma

Contraindication in patients with creatinine clearance < 35 ml/min

Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity

Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diurectic therapy

Need to infuse Zoledronic acid Teva Pharma slowly over a period of no less than 15 minutes

Once-yearly dosing regime

That all patients should be provided with the educational material and be counselled about:

o Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non-smoking and healthy diet

o Key signs and symptoms of serious adverse events o When to seek attention from the health care provider

The patient educational material should contain the following key messages:

Contraindication in pregnancy and in breast-feeding women

Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non- smoking and healthy diet

Key signs and symptoms of serious adverse events

When to seek attention from the health care provider

In addition, the following documents should be included in the patient information pack:

Package leaflet

Patient reminder card on osteonecrosis of the jaw

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