Byvalson Sds (Nebivolol/Valsartan)

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Byvalson SDS
BYVALSON (nebivolol/valsartan) 5 mg/ 80 mg tablet is a fixed-dose combination that combines two FDA approved, once daily, blood pressure lowering agents with different mechanisms of action (“0023-5874-30 : Byvalson”).
Nebivolol (marketed in the U.S. as BYSTOLIC) is a beta-adrenergic receptor blocking agent that is preferentially beta-1 selective up to and including the 10 mg dose and in extensive metabolizers (“Allergan Announces FDA Approval of BYVALSON™ (nebivolol and Valsartan) – Allergan”). While nebivolol’s mechanism of action has not been definitively established, possible factors include vasodilation and decreased peripheral vascular resistance (PVR), reduced heart rate and myocardial contractility, suppression of renin, and reduced sympathetic activity.
Valsartan is an angiotensin II receptor blocker (ARB) that blocks the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby blocking its vasoconstrictor and aldosterone-secreting effects (“Allergan Announces FDA Approval of BYVALSON™ (nebivolol and Valsartan) – Allergan”).
BYVALSON is shown for the treatment of hypertension, to lower blood pressure.­­ BYVALSON might be utilized alone or as a part of blend with other antihypertensive specialists. Bringing down pulse decreases the danger of lethal and nonfatal cardiovascular occasions, basically strokes and myocardial areas of localized necrosis. These advantages have been seen in controlled trials of antihypertensive medications from a wide assortment of pharmacologic classes, including the beta-blocker class to which nebivolol primarily has a place and the ARB class to which valsartan mainly has a place. There are no controlled trials showing hazard lessening with BYVALSON (Byvalson).
BYVALSON has been assessed for wellbeing in patients with hypertension. A sum of 1,664 patients got no less than 1 measurements of an altered dosage mix of nebivolol/valsartan in a 8-week trial. A sum of 807 patients got no less than 1 measurement of nebivolol and valsartan in an open-name wellbeing study; of these, 621 patients finished 180 days and 476 patients finished 360 days of open-mark treatment with nebivolol and valsartan.
The wellbeing of the 5 mg/80 mg dosage of nebivolol/valsartan was assessed amid the initial 4 weeks of a 8-week fake treatment controlled trial. Amid the 4 week time span, the general frequency of unfriendly occasions on treatment with BYVALSON 5 mg/80 mg was like fake treatment and the individual parts (nebivolol 5 mg and valsartan 80 mg). Cessation of treatment because of a clinical unfriendly occasion happened in 2.0% of patients treated with BYVALSON 5 mg/80 mg versus 3.2% of patients given fake treatment and around 1% of patients given nebivolol 5 mg or valsartan 80 mg as monotherapy.

Section 1. Identification of the substance/mixture and of the company/undertaking

1.1 product code: 0023-5874-30
product name: Byvalson
synonyms:
1.2 Relevant identified uses of the substance or mixture and uses advised against:
Relevant identified uses: For research use only, not for human or veterinary use.

Section 2. Hazards identification

2.1 Classification of the Substance or Mixture:
2.1.1 Classification according to Regulation (EC) No 1272/2008 CLP: Toxic To Reproduction, Category 2
Aquatic Toxicity (Chronic), Category 3
2.1.2 Classification according to Directive 1999/45/EC: T: Toxic
Reproductive Hazard: 3
Risk Phrases: R52/53, R62, R63
For full text of R- phrases: see SECTION 15.
2.2 Label Elements:
2.2.1 Labeling according to Regulation (EC) No 1272/2008 CLP:

GHS signal word: warning
GHS Hazard Phrases:
H361: Suspected of damaging fertility or the unborn child
H412: Harmful to aquatic life with long lasting effects.
GHS Precaution Phrases:
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required.
P273: Avoid release to the environment.
GHS Response Phrases:
P308+313: IF exposed or concerned: Get medical attention/advice.
GHS Storage and Disposal Phrases:
Please refer to Section 7 for Storage and Section 13 for Disposal information.
2.2.2 Labeling according to Directive 1999/45/EC:
Reproductive Hazard: 3
2.3 Adverse Human Health Harmful to aquatic life with long lasting effects.
Effects and Symptoms: Material may be irritating to the mucous membranes and upper respiratory tract. May be harmful by inhalation, ingestion, or skin absorption. May cause eye, skin, or respiratory system irritation. Suspected of damaging fertility or the unborn child. To the best of our knowledge, the toxicological properties have not been thoroughly investigated.

Section 3. Composition/information of ingredients

CAS # / RTECS #
Hazardous Components (Chemical Name)/ REACH Registration No.
Concentration
EC No./
EC Index No.
Risk Phrases/ GHS Classification

137862-53-4
NA
Valsartan
100.0 %
604-045-2
NA
T; Rp:3, R62-63-52/53
Toxic Repro. 2: H361 Aquatic (C) 3: H412

Section 4. First aid measures.

Description of first aid measures:
In Case of Inhalation: Remove to fresh air. If not breathing, give artificial respiration or give oxygen by trained personnel. Get immediate medical attention.
In Case of Skin contact: Immediately wash skin with soap and plenty of water for at least 15 minutes. Remove contaminated clothing. Get medical attention if symptoms occur. Wash clothing before reuse.
In Case of Eye Contact: Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Have eyes examined and tested by medical personnel.
In Case of Ingestion: Wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Get medical attention. Do NOT induce vomiting unless directed to do so by medical personnel.

Section 5. Firefighting measures

5.1 Suitable Extinguishing Media: Use alcohol-resistant foam, carbon dioxide, water, or dry chemical spray. Use water spray to cool fire-exposed containers.
Unsuitable Extinguishing Media: A solid water stream may be inefficient.
5.2 Flammable Properties and hazards: No data available.
Flash Pt: No data.
Explosive Limits: LEL: No data. UEL: No data.
Auto-ignition Pt: No data.
5.3 Fire Fighting Instructions: As in any fire, wear self-contained breathing apparatus pressure-demand (NIOSH approved or equivalent), and full protective gear to prevent contact with skin and eyes.

Section 6. Accidental release measures

6.1 Protective Precautions, Protective Equipment and Emergency Procedures: Avoid raising and breathing dust, and provide adequate ventilation. As conditions warrant, wear a NIOSH approved self-contained breathing apparatus, or respirator, and appropriate personal protection (rubber boots, safety goggles, and heavy rubber gloves).
6.2 Environmental precautions: Take steps to avoid release into the environment, if safe to do so.
6.3 Methods and Material for Containment and cleaning up: Contain spill and collect, as appropriate. Transfer to a chemical waste container for disposal in accordance with local regulations.

Section 7. Handling and storage

7.1 Precautions to Be Taken in Handling: Avoid breathing dust/fume/gas/mist/vapours/spray. Avoid prolonged or repeated exposure.
7.2 Precautions to Be Taken in Storing: Keep container tightly closed. Store in accordance with information listed on the product insert.

Section 8. Exposure controls/personal protection

8.1 Exposure Parameters:

CAS #
Partial Chemical Name
Britain EH40
France VL
Europe

137862-53-4
Valsartan
No data.
No data.
No data.

CAS #
Partial Chemical Name
OSHA TWA
ACGIH TWA
Other Limits

137862-53-4
Valsartan
No data.
No data.
No data.

8.2 Exposure Controls:
8.2.1 Engineering Controls (Ventilation etc.): Use process enclosures, local exhaust ventilation, or other engineering controls to control airborne levels below recommended exposure limits.
8.2.2 Personal protection equipment:
Eye Protection: Safety glasses
Protective Gloves: Compatible chemical-resistant gloves
Other Protective Lab coat
Clothing:
Respiratory Equipment NIOSH approved respirator, as conditions warrant.
(Specify Type):
Work/Hygienic/Maintenance Practices: Do not take internally. Facilities storing or utilizing this material should be equipped with an eyewash and a safety shower. Wash thoroughly after handling

Section 9. Physical and chemical properties

9.1 Appearance and Odor: A crystalline solid
Melting Point: No data.
Boiling Point: No data.
Flash Pt: No data.
Evaporation Rate: No data.
Explosive Limits: LEL: No data. UEL: No data.
9.2 Other Information
Percent Volatile: No data.
Molecular Formula & Weight: C24H29N5O3 435.5

Section 10. Stability and reactivity.

Reactivity: no data available
Stability: stable
Stability notes: stable if stored in accordance with information listed on the product insert
Polymerisation: will occur
Conditions to avoid: no data available
Incompatibility materials to avoid: no data available
Hazardous decomposition or by-products: no data available

Section 11. Ecological information

Toxicity: Avoid release into the environment. Runoff from fire control or dilution water may cause pollution

Section 12. Disposal considerations.

Waste disposal method: Dispose in accordance with local, state, and federal regulations.

Section 13. Transport information.

13.1 LAND TRANSPORT (US DOT):
DOT Proper Shipping Name: Not dangerous goods.
DOT Hazard class:
UN/NA Number
13.2 LAND TRANSPORT (European ADR/RID): ADR/RID
Shipping Name: Not dangerous goods.
UN Number:
Hazard Class:
13.3 AIR TRANSPORT (ICAO/IATA):
ICAO/IATA Shipping Name: Not dangerous goods.
Additional Transport: Transport in accordance with local, state, and federal regulations.
Information:

Section 14. Regulatory information

Reproductive Hazard: 3
European Community Risk and Safety Phrases:
R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R62 Risk of impaired fertility.
R63 Possible risk of harm to the unborn child.
S24/25 Avoid contact with skin and eyes.
S36/37/39 Wear suitable protective clothing, gloves and eye/face protection.

Regulatory Information This SDS was prepared in accordance with Regulation (EC) No.1272/2008 and
Statement: European Directive 67/548/EEC as amended.

Section 15. Other information.

Additional information about the product: no available data
Company policy or disclaimer: DISCLAIMER: this information is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes.
N.A= not available
N.P= not applicable
N.D= not determined
N.E= not established
N.R= not required.

Works Cited
“0023-5874-30 : Byvalson.” Medical Data Services. Services and Products for Healthcare. Desktop and Online Applications, www.hipaaspace.com/Medical_Billing/Coding/National.Drug.Codes/0023-5874-30.
“Allergan Announces FDA Approval of BYVALSON™ (nebivolol and Valsartan) – Allergan.”Allergan – Leading Growth Pharma – Allergan, www.allergan.com/news/news/thomson-reuters/allergan-announces-fda-approval-of-byvalson-nebiv.
Byvalson, www.byvalson.com/.
Jentadueto, X. R. “NEW DRUG APPROVALS.” (2016).