SPC Adverse Drug Reaction Reporting Form

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1. Patient Details:* This field is required
Name/Initial e.g. x.y
Gender
Age
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Are you Pregnant ?* This field is required
YES
NO
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2. Adverse Drug Reaction* This field is requiredWhat happened?
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Seriousness of the Adverse Drug Reaction?* This field is required
Non-serious
Serious
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Type Seriousness of the Adverse Drug Reaction?* This field is required
Patient died
Life threatening
Admitted to hospitalor prolong hospitalization
Congenital anomaly
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3. Suspected Medication:* This field is required
Abiraterone SPC 250mg F.C. Tablets
Azacitidine SPC 100mg Injection
Bortezomib SPC 3.5mg Pow for Sol for Inj.
Capecitabine SPC 150mg F.C. Tablets
Capecitabine SPC 500mg F.C. Tablets
Docetaxel SPC 20mg/1ml Solution for Infusion
Docetaxel SPC 80mg/4ml Solution for Infusion
Imatinib SPC 100mg Tablets
Imatinib SPC 400mg Tablets
Lenalidomide SPC 5mg Capsules
Lenalidomide SPC 10mg Capsules
Lenalidomide SPC 25mg Capsules
Pemetrexed SPC 500mg Powder for Sol for Inf.
Zoledronic Acid SPC 5mg/100ml Solution for Infusion
SPC Medication Name
Dose, Frequency
Route of administration (e.g. Oral, IV or SC)
Indications
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Did medication stop because of side effect?
If above is "YES", please specify the date?
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Action Taken for the medication
Drug Withdrawn
Dose Increased
Dose Reduced
Dose not changed
Unknown
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The Patient outcome:
Recovered
No Improvement
Fatal
Unknown
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Event subsided after stopping (dechallenge):
NO
YES
Unknown
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Event reappear after reintroducing (rechallenge):
NO
YES
Not Applicable
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Your Above answer is YES, please specify:
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4. Concomitant Medications and Medical History:Concomitant Medications (any other Medication that the patient is taking) and Medical History (any chronic diseases that the patient has. For example: Diabetes, Hypertension, etc
Concomitant Medications
Medical History
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5. Reporter’s Information:
Name
Please enter your email
Please enter your phone
Hospitals' Name
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Dear Healthcare Professional,

Adverse Drug Reaction (ADR) is a response to a medicinal product which is noxious and unintended. This includes side effects arising from use of a medicine within the terms of the marketing authorization (e.g. the authorized indications), as well as from use outside the terms of the marketing authorization, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure.

Confidentiality: Reporter's and patient's identity are held in strict confidence by Sudair Pharma and protected to the fullest extent of the law, information provided by the reporter will be strictly protected and will not be used in any way against him / her.

Please fill out the reporting form providing the most complete information. Use a separate form for each ADR. Attachment of additional documents (e.g. doctor's records, laboratory results, etc.) are highly appreciated as they would support Sudair Pharma assessment of the event. Kindly submit the completed form to:

Pharmacovigilance and Drug Safety Department

Tell phone: 920001432 (ex. 107)

Fax: + (966) 11 466 8195

Email: Pharmacovigilance@SudairPharma.com

Website: www.sudairpharma.com
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