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GMP Azithromycin Tablets 500mg GMP

GMP Azithromycin Tablets 500mg GMP

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The table below lists the adverse reactions identified through clinical trial experience and postmarketing surveillance by system organ class and frequency.

The frequency grouping is defined using the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000) and Not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post-marketing surveillance:

System Organ Class

Frequency

Adverse reaction

Infections and infestations

Uncommon

Candidiasis

Vaginal infection

Pneumonia

Fungal infection

Bacterial infection

Pharyngitis

Gastroenteritis

Respiratory disorder

Rhinitis

Oral candidiasis

Not known

Pseudomembranous colitis (see section 4.4)

Blood and lymphatic system disorders

Uncommon

Leukopenia

Neutropenia

Eosinophilia

Not known

Thrombocytopenia

Haemolytic anaemia

Immune system disorders

Uncommon

Angioedema

Hypersensitivity

Not known

Anaphylactic reaction (see section 4.4)

Metabolism and nutrition disorders

Uncommon

Anorexia

Psychiatric disorders

Uncommon

Nervousness

Insomnia

Rare

Agitation

Depersonalisation

Not known

Aggression

Anxiety

Delirium

Hallucination

Nervous system disorders

Common

Headache

Uncommon

Dizziness

Somnolence

Dysgeusia

Paraesthesia

Not known

Syncope, convulsion

Hypoaesthesia

Psychomotor hyperactivity

Anosmia

Ageusia

Parosmia

Myasthenia gravis (see section 4.4).

Eye disorders

Uncommon

Visual impairment

Not known

Blurred vision

Ear and labyrinth disorders

Uncommon

Ear disorder

Vertigo

Not known

Hearing impairment including deafness and/or tinnitus

Cardiac disorders

Uncommon

Palpitations

Not known

Torsades de pointes (see section 4.4)

Arrhythmia (see section 4.4) including ventricular tachycardia electrocardiogram QT prolonged (see section 4.4)

Vascular disorders

Uncommon

Hot flush

Not known

Hypotension

Respiratory, thoracic and mediastinal disorders

Uncommon

Dyspnoea

Epistaxis

Gastrointestinal disorders

Very common

Diarrhoea

Common

Vomiting

Abdominal pain

Nausea

Uncommon

Constipation

Flatulence

Dyspepsia

Gastritis

Dysphagia

Abdominal distension

Dry mouth

Eructation

Mouth ulceration

Salivary hypersecretion

Not known

Pancreatitis

Tongue discolouration

Hepatobiliary disorders

Uncommon

Hepatitis

Rare

Hepatic function abnormal

Jaundice cholestatic

Not known

Hepatic failure (which has rarely resulted in death) (see section 4.4)*

Hepatitis fulminant

Hepatic necrosis

Skin and subcutaneous tissue disorders

Uncommon

Rash

Pruritus

Urticaria

Dermatitis

Dry skin

Hyperhidrosis

Rare

Photosensitivity reaction

Acute generalised exanthematous pustulosis (AGEP)

Not known

Steven-Johnson syndrome

Toxic epidermal necrolysis

Erythema multiforme

Musculoskeletal and connective tissue disorders

Uncommon

Osteoarthritis

Myalgia

Back pain

Neck pain

Not known

Arthralgia

Renal and urinary disorders

Uncommon

Dysuria

Renal pain

Not known

Renal failure acute

Nephritis interstitial

Reproductive System and breast disorders

Uncommon

Metrorrhagia

Testicular disorder

General disorders and administration site conditions

Uncommon

Oedema

Asthenia

Malaise

Fatigue

Face oedema

Chest pain

Pyrexia

Pain

Peripheral oedema

Investigations

Common

Lymphocyte count decreased

Eosinophil count increased

Blood bicarbonate decreased

Basophils increased

Monocytes increased

Neutrophils increased

Uncommon

Aspartate aminotransferase increased

Alanine aminotransferase increased

Blood bilirubine increased

Blood urea increased

Blood creatinine increased

Blood potassium abnormal

Blood alkaline phosphatase increased

Chloride increased

Glucose increased

Platelets increased

Hematocrit decreased

Bicarbonate increased

Abnormal sodium

Injury and poisoning

Uncommon

Post procedural complication


NINGBO VOICE BIOCHEMIC CO. LTD

 

Since 2015, NINGBO VOICE BIOCHEMIC CO. LTD. is a professional company to offer one-package service for Contract Manufacturing; international pharmaceutical registration, processing quality controlling and shipment. All the FPP (Finished Pharmaceutical Products ); APIs (Active Pharmaceutical Ingredients); Chemicals (Pharmaceutical Intermediates ); Veterinary Pharmaceuticals supplied by us meet requirements of Standard GMP and current BP,USP version.


Ningbo Voice Bioquímica Empresa. Es una empresa profesional de ofrecer un paquete de servicio para International Farmacéutica registro, procesamiento, control de calidad y envío.
Podemos suministrar productos farmacéuticos cualificados (FPPs, APIs, productos de cuidado de la salud) de acuerdo a la norma GMP y actual BP, USP version.


Ningbo Voice Biochemic Entreprise. est une compagnie professionnelle offre un service d'enregistrement international forfait pour le contrôle de la qualité pharmaceutique, traitement, et l'expédition. Nous fournir des produits pharmaceutiques (FPPs, APIs, des produits de soins de santé) selon la norme GMP et BP, USP version.



Your kindly purchase enquiry or Contract Manufacturing proposal would be highly appreciated.

Address:No. 298,West Zhongshan Rd.. Ningbo, Zhejiang, P. R. China , 315000

E-Mail: info@pharma-voice.com / medicren@hotmail,com

Attn: Dr. Medic Ren ( General Manager, Pharmacist)

Tel/Fax: 0086 574 87330957; Mobile:13806670686 ; 17702506716



Company Info

  • Company Name: NINGBO VOICE BIOCHEMIC CO. LTD
  • Representative: Quan Sheng Ren
  • Product/Service: Oncology Anticarcinogenic , Antipyretic Analgesics , Antiparasitic & Antimycotic , Digestive System Drug , Neural System Remedy , Respiratory System Remedy
  • Capital (Million US $): 200000RMB
  • Year Established: 2015
  • Export Percentage: 61% - 70%
  • Contact Person: Mr. Medic Ren
  • Tel: 86-574-87330957
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