ABOUT EXEMPTIA INJECTION

Exemptia Adalimumab injection is a potent
TNF-inhibitor and anti-inflammatory drug manufactured by Zydus Cadila. It binds
to tumor necrosis factor-alpha (TNFα). TNFα normally binds to TNFα receptors,
which leads to the inflammatory response of autoimmune diseases. By binding to
TNFα, Exemptia reduces this inflammatory response. The TNF-inhibitor affects
the body’s defense system, i.e. the immune system that protects the body from
infection.

MEDICINAL USES

Exemptia 40 mg prefilled syringe is used to treat certain types of arthritis
(inflammatory disorder that typically affects the small joints in hands and
feet) including:

Ulcerative colitis: Disease that causes ulcers on the lining of the large gut.

Crohn’s Disease: Serious inflammation of gastrointestinal tract.

heumatoid
arthritis (RA): It is a long-lasting autoimmune disease that causes pain,
swelling, stiffness and loss of function in your joints. It can affect any
joint but is common in the wrist and fingers.

Psoriatic arthritis: It happens because your immune system is overactive. It
affects mostly people who have psoriasis, a skin disease that’s also related to
the immune system.

Ankylosing
spondylitis : An inflammatory arthritis affecting the spine and large joints.

Plaque psoriasis: Plaque psoriasis is a chronic autoimmune condition. It
appears on the skin in patches of thick, red, scaly skin.

Juvenile
idiopathic arthritis : Juvenile idiopathic arthritis (JIA), also known as
juvenile rheumatoid arthritis (JRA) is currently the most widely accepted term
to describe various types of chronic arthritis in children.

EXEMPTIA INJECTION SIDE EFFECTS:

The following is a list of common side effects that may occur
from the use of Exemptia Prefilled Syringe Powder. This is not a comprehensive
list. Consult your doctor if you observe any of the following side effects,
especially if they do not go away.

Fever , Headache , Acne , Chest pain , Nausea , Abdominal
pain , Sinusitis , Confusion , Dehydration , Back pain , Allergic respiratory
symptoms , Rise in blood lipid level , Pain at injection site , Urinary  tract infection etc.

EXEMPTIA INJECTION PRECAUTIONS:

Adalimumab is given by an injection under the skin. Your
pharmacist will tell you how often to take an injection of Exemptia. Do not try
to inject it yourself until you have been shown the right way to give the
injections and have read and understood this Instructions for Use.

·        
Change
the injection site each time to lessen injury under the skin.

·        
Do not
inject into any areas of the skin that are sore, bruised, red, or hard.

·        
Do not
increase your dose or use this drug more often or for longer than prescribed.

·        
Do not
have immunizations/vaccinations without the consent of your doctor.

·        
Avoid
contact with people who have recently received live vaccines (such as flu
vaccine inhaled through the nose).

·        
Before
using Adalimumab 40mg injection, tell your doctor or pharmacist if you are
suffering from any major diseases, especially of: current/recent/repeated
infections (such as hepatitis B, TB infection, histoplasmosis), blood/bone
marrow problems , seizures, cancer, heart disease (especially heart failure)
etc.

·        
Do not
use this Arthritis drug for a condition for which it was not prescribed. It may
be harmful for you.

·        
During
pregnancy, this medication should be used only when clearly needed.

·        
Discuss
the risks and benefits with your doctor.Inform your doctor, if you are
breastfeeding. The medicine may pass into your breast milk and could be harmful
to the baby.

·        
You and
your physician should decide if you will breastfeed or use Adalimumab
Injection. You should not do both.

 

STORAGE REQUIREMENTS:

Store at 2°C to 8°C (36°F to 46°F) in original container; do
not freeze. Do not use if frozen even if it has been thawed. Do not store in
extreme heat or cold. Protect from light. Keep Exemptia injection and all other
medicines out of the reach of children.

Exemptia Adalimumab injection is a potent TNF-inhibitor and anti-inflammatory drug manufactured by Zydus Cadila. It binds to tumor necrosis factor-alpha (TNFα). TNFα normally binds to TNFα receptors, which leads to the inflammatory response of autoimmune diseases. By binding to TNFα, Exemptia reduces this inflammatory response. The TNF-inhibitor affects the body’s defense system, i.e. the immune system that protects the body from infection.
USES

Exemptia 40 mg prefilled syringe is used to treat certain types of arthritis (inflammatory disorder that typically affects the small joints in hands and feet) including –

    Ulcerative colitis : Disease that causes ulcers on the lining of the large gut.
    Crohn’s Disease : Serious inflammation of gastrointestinal tract.
    Rheumatoid arthritis (RA) : It is a long-lasting autoimmune disease that causes pain, swelling, stiffness and loss of function in your joints. It can affect any joint but is common in the wrist and fingers.
    Psoriatic arthritis : It happens because your immune system is overactive. It affects mostly people who have psoriasis, a skin disease that’s also related to the immune system.
    Ankylosing spondylitis : An inflammatory arthritis affecting the spine and large joints.
    Plaque psoriasis : Plaque psoriasis is a chronic autoimmune condition. It appears on the skin in patches of thick, red, scaly skin.
    Juvenile idiopathic arthritis : Juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis (JRA) is currently the most widely accepted term to describe various types of chronic arthritis in children.

EXEMPTIA COMMON SIDE EFFECTS :

The following is a list of common side effects that may occur from the use of Exemptia Prefilled Syringe Powder. This is not a comprehensive list. Consult your doctor if you observe any of the following side effects, especially if they do not go away.

Fever , Headache , Acne , Chest pain , Nausea , Abdominal pain , Sinusitis , Confusion , Dehydration , Back pain , Allergic respiratory symptoms , Rise in blood lipid level , Pain at injection site , Urinary tract infection etc.

SAFETY INFORMATION (Precautions) :

    Adalimumab is given by an injection under the skin. Your pharmacist will tell you how often to take an injection of Exemptia. Do not try to inject it yourself until you have been shown the right way to give the injections and have read and understood this Instructions for Use.
    Do not share Exemptia prefilled syringe to other people, even if they have the same condition.
    Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into any areas of the skin that are sore, bruised, red, or hard.
    Do not increase your dose or use this drug more often or for longer than prescribed.
    Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
    Before using Adalimumab 40mg injection, tell your doctor or pharmacist if you are suffering from any major diseases, especially of: current/recent/repeated infections (such as hepatitis B, TB infection, histoplasmosis), blood/bone marrow problems , seizures, cancer, heart disease (especially heart failure) etc.
    Do not use this Arthritis drug for a condition for which it was not prescribed. It may be harmful for you.
    During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
    Inform your doctor, if you are breastfeeding. The medicine may pass into your breast milk and could be harmful to the baby. You and your physician should decide if you will breastfeed or use Adalimumab Injection. You should not do both.

PROPER STORAGE OF EXEMPTIA :

Store at 2°C to 8°C (36°F to 46°F) in original container; do not freeze. Do not use if frozen even if it has been thawed. Do not store in extreme heat or cold. Protect from light. Keep Exemptia injection and all other medicines out of the reach of children.

ADRIAMYCIN Doxorubicin
Injection:

Adriamycin is a cancer medication that interferes with the
growth and spread of cancer cells in the body. It is classified as an antitumor
antibiotic. Antitumor antibiotics are made from natural products produced by
species of the soil fungus Streptomyces. These drugs act during multiple phases
of the cell cycle and are considered cell-cycle specific.

MEDICINE USES :

Doxorubicin is used for the various treatments like Acute
lymphoblastic leukemia (ALL), Acute myeloblastic leukemia (AML), Bone sarcoma,
Breast cancer, Endometrial cancer, Gastric cancer, Head and neck cancer,
Hodgkin lymphoma, Non-Hodgkin lymphoma, Liver cancer, Kidney cancer, Multiple
myeloma, Neuroblastoma, Ovarian cancer, Small Cell Lung cancer, Soft tissue
sarcoma, Thyomas, Thyroid cancer, Transitional cell bladder cancer, Uterine
sarcoma, Wilms’ tumor and Waldenström macroglobulinemia

DOXORUBICIN COMMON SIDE EFFECTS:

Missed menstrual periods; darkening of your skin or nails;
temporary hair loss; feeling weak or tired; mild nausea, diarrhea; or eye
redness, puffy eyelids.

Call your doctor at once if you have:

 feeling short of breath
(even with mild exertion), swelling, rapid weight gain; fever, chills, body
aches, flu symptoms, sores in your mouth and throat; pale skin, easy bruising,
unusual bleeding, feeling like you might pass out;
chest pain, sudden cough, cough with foamy mucus, rapid
breathing, coughing up blood; lower back pain, blood in your urine, little or
no urinating;
Doxorubicin may cause your urine to turn a reddish-orange
color. This side effect by itself is usually not harmful. However, call your
doctor if you also have upper stomach pain, clay-colored stools, or jaundice
(yellowing of your skin or the whites of your eyes).

Call your doctor for medical advice about side effects.

ADRIAMYCIN DOXORUBICIN INJECTION PRECAUTIONS :

·        
Before
using Adriamycin, tell your doctor or pharmacist if you are allergic to it; or
to lincomycin; or if you have any other allergies. This product may contain
inactive ingredients, which can cause allergic reactions or other problems.
Talk to your pharmacist for more details.

·        
Before
using this medication, tell your doctor or pharmacist your medical history,
especially of: a current infection, low blood cell counts (e.g., anemia,
neutropenia, thrombocytopenia), gout, heart problems (e.g., recent heart
attack, heart failure, irregular heartbeat), a history of receiving any
anthracycline-type drug (e.g., Adriamycin, idarubicin, daunorubicin,
mitoxantrone), kidney problems, liver disease, severe mouth sores (stomatitis),
radiation treatment (especially to the chest area).

·        
This
medication may lower sperm count or may cause abnormal sperm to form, possibly
causing infertility or birth defects. Consult your doctor for more details.

·        
This medication
can affect menstruation in females and cause premature menopause. Consult your
doctor or pharmacist for details.

·        
This
medication is not recommended for use during pregnancy. It may harm an unborn
baby. It is recommended that men and women use effective forms of birth control
(e.g., condoms and birth control pills) while being treated with this
medication and for 6 months after stopping the medication. Consult your doctor
for more details and to discuss reliable forms of birth control.

STORAGE REQUIREMENTS:

Refrigerate unopened vials of Doxil at 2°– 8°C (36°– 46°F).
Do not freeze.

DRUG INTERACTIONS:

Medicines that may harm the liver (eg, acetaminophen,
mercaptopurine, methotrexate, ketoconazole, isoniazid, certain medicines for
HIV infection) because the risk of Doxorubicin’s side effects may be increased.
Ask your doctor if you are unsure if any of your medicines might harm the liver

This document does not contain all possible interactions.
Keep a list of all your medications with you, and share the list with your
doctor and pharmacist.

产品介绍:

阿法替尼于2013年7月在美国上市，之后陆续在全球70多个国家获批用于治疗EGFR突变的非小细胞肺癌患者。临床试验数据显示，阿法替尼可明显延长EGFR突变的非小细胞肺癌患者的生存期。

 阿法替尼是第二代EGFR TKI（酪氨酸激酶抑制剂），与第一代可逆的EGFR TKI不同的是，阿法替尼会不可逆地与EGFR结合，从而达到关闭癌细胞信号通路、抑制肿瘤生长的目的。

 阿法替尼是第一个也是唯一一个与最好的化疗方案相比可延长最常见EGFR突变类型肺癌患者生存的TKI7-8，对一线化疗或者第一代TKI治疗（即易瑞沙、凯美纳或特罗凯）治疗失败的病人，能显著改善无进展生存期。

 阿法替尼（中文商品名吉泰瑞）于2017年2月已获中国药管局（CFDA）批准进口。此前，该药在70多个国家被批准用于治疗EGFR突变阳性非小细胞肺癌患者，并在多个国家成为了EGFR靶向药物的首选。

 阿法替尼在2016年分别获得美国FDA和欧盟批准用于治疗铂类化疗时或化疗后病情恶化的晚期肺鳞状细胞癌患者。

 碧康制药生产的Afanix是该药在全球的首仿药，也是迄今为止唯一获得政府监管机构批准合法生产的仿制药。

碧康制药由欧洲财团参与投资，是南亚地区唯一执行欧盟技术规范，并且在孟加拉两大证券交易所主板上市的大型制药企业，产品符合欧洲药典和美国药典标准。

相比其他来源不清晰的所谓同一种仿制药，即使其主要成份含量与碧康产品相接近，但由于不具备严格规范的GMP标准生产场所和政府部门的严格监管，其产品中影响药物吸收率的溶出度和生物利用度也与碧康产品具有很大差异。

 为保证用药安全，敬请谨慎选择！

适应症:

适用于晚期EGFR基因突变非小细胞肺癌的治疗和HER2阳性的晚期乳腺癌患者。阿法替尼是一种口服药物，是表皮生长因子受体(EGFR)和人表皮受体2(HER2)酪氨酸激酶的不可逆抑制剂，是第二代EGFR靶向药物。

适用于用于治疗铂类化疗时或化疗后病情恶化的晚期肺鳞状细胞癌患者。

用法与用量:

阿法替尼的推荐剂量是40mg/天，每天1次，直至疾病进展或患者无较长耐受。 口服，空腹服用，至少餐前1小时或餐后2小时服用。